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VAERS ID: 753093 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-11-19
   Days after vaccination:4
Submitted: 2018-06-06
   Days after onset:198
Entered: 2018-06-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 177602 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute pulmonary oedema, Autopsy, Death
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine; Esomeprazole; TRIATEC HCT
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201703218

Write-up: This is a serious spontaneous case, initially received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 24-Nov-2017 and concerns a 63-year-old, adult, female patient. Patient''s historical condition was not reported. The patient had no known allergies. Concomitant medications included: esomeprazole, TRIATEC HCT and amlodipine for an unknown indication. On 15-Nov-2017, at 16:45 hours, the patient received AGRIPPAL S1 (dose: 0.5 ml, route of administration: intramuscular, batch number: 177602, anatomical location and expiry date: not reported). On 19-Nov-2017 (in the morning), after 5 days of administration of vaccine, the patient was found dead on bed. It was reported that, autopsy was performed, and cause of death was reported as acute pulmonary oedema. The reporter assessed this case as serious (fatal) and the causality as not related to the suspect vaccine. Follow up report received via health authority on 22-Dec-2017: The patient''s age was added. The indication, route of administration, and vaccination date of the suspect vaccine was added. It was reported that, autopsy was performed, and cause of death was acute pulmonary oedema. The narrative was amended accordingly. Non-significant follow-up received via health authority (IT-MINISAL02-439043) on 08-Jan-2018: The patient had no known allergies. It was reported that the patient was not hospitalized. On 19-Nov-2017 (In the morning), the patient was found dead on bed. The narrative was amended accordingly. Follow-up received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 17-Jan-2018: "As reported causality" was changed from related to not related (in the event assessment tab). The narrative was amended accordingly. Follow-up received from health authority (reported to health authority by a physician) (IT-MINISAL02-439043) on 08-Jan-2018: No new information was available. Hence, no updates were made to the narrative. Non-significant case correction received with agency 24-Nov-2017: The case comment was amended. No changes were made in the narrative. Case Comment: The patient had concomitant medications that were suggestive of pre-existing cardiac condition/and associated diuretic. Medical history is deficient, but sudden death with autopsy suggestive of pulmonary edema suggest pre-existing cardiac condition. Time to onset is 5 days. Based on the available information, the company assesses the event death is not related to vaccine as it can be attributed to underlying medical condition. Further details regarding clinical status of the subject at the time of vaccination, any symptoms before the death, any known medical allergies or medical conditions and details on concomitant medications, are needed for complete assessment.


VAERS ID: 753133 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-06-06
Entered: 2018-06-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown to Ongoing, Osteoporosis, very big deficiency of Vitamin D and calcium; Unknown to Ongoing, Vitamin D deficiency; Unknown to Ongoing, Calcium deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201800944

Write-up: This serious spontaneous case, initially received from other non-health professional on 08-Mar-2018, concerning an elderly female patient of unspecified age. The patient''s current conditions included: osteoporosis, deficiency of Vitamin D and calcium. On an unspecified date in 2016, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in Oct-2015, the patient was also administered with non-company suspect drug ACLASTA (route of administration: intravenous, once a year, dose, anatomical location, batch number, expiry date: not reported). On an unspecified date in 2017, after administration of the flu vaccine, the patient experienced pneumonia. On an unknown date, the patient passed away. As per the reporter, the cause of her death was pneumonia which was occurred due to flu vaccine. It was unknown whether autopsy was performed. The reporter considered this case as serious (fatal) and assessed the causality as related to the suspect vaccine. Case Comment: An elderly female with vitamin D and calcium (reported as big deficiency), died due to pneumonia after receiving INN flu vaccine (after an unknown period). The patient was taking ACLASTA for Vitamin D deficiency, with unspecified renal condition prevented further use of ACLASTA. Vitamin D deficiency and progressive age are known to increase predisposition to infection. Hence, considering the minimal information provided regarding onset latency, lab investigations confirming the causative organism for pneumonia and concomitant medical conditions, the company assesses the events as not related to suspect vaccine.


VAERS ID: 753134 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-24
Onset:2014-11-25
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1282
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure immeasurable, Cardiac arrest, Coma, Pupil fixed, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157258

Write-up: Case number PHHY2014IT157258, is a combined initial and follow up spontaneous report received from a consumer (son) on 28 Nov 2014 and from health authority (reference number: 282214) on 02 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340227) on 08 Dec 2014 and a follow up received from a lay press newspaper article (journalist) on 08 May 2015. This report refers to an 89 year old female patient. Her medical history was not reported. On 12 Nov 2014, 14 Nov 2014 and on 18 Nov 2014 the patient took unspecified medication (right and left heel). The patient was never vaccinated with FLUAD in the past. She was vaccinated with FLUAD (batch number: 143301) 0.5 ml intramuscular on 24 Nov 2014. The patient presented with deep comatose state, pupillary reflex was absent; blood pressure was not detectable and cardiac arrest on 25 Nov 2014, Paramedical Intervention was called. She had a sudden death at 11:10 AM on the same day before the arrival of the ambulance. The death occurred after about 22 hours from the vaccination. The article reported that the result of the autopsy performed on 02 Dec 2014 had the following result: there was no causal relationship between the death and the vaccination with FLUAD. The article also ruled out any type of allergic reaction. The elderly patient would have died of a clinical picture compromised of different pathologies. Health authority assessed the event as serious and causality as unassessable (reported as unclassified). Based on the performed review on FLUAD 2014/2015 batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340227) on 08 Dec 2014: Updated FLUAD 2014/2015 batch review report. Follow up received from a lay press newspaper article (journalist) on 08 May 2015: updated reporter comment. Follow up received from health professional via Health Authority (RNF: IT-MINISAL02-282214): Start date of suspect vaccine was changed from 25-Nov-2014 to 24-Nov-2014. Onset of the event was changed from 26-Nov-2014 to 25-Nov-2014. The suspect product indication was updated as flu vaccination. The reporter assessed the causality between the events and vaccine as unassessable (reported as unclassifiable). Cardiac arrest was added as cause of death. Case Comment: This case concerns an 89-year-old female patient, who developed, coma state, absent pupillary reflex and cardiac arrest leading to death 22 hours after receiving a dose of FLUAD vaccine. It was reported that autopsy performed ruled out any allergic reaction to vaccine and stated that there was no causal relationship between the death and suspect vaccine. Based on the available information, nature of the events and considering the age of the subject, the causal role of suspect vaccine seems unlikely, hence assessed as not related.


VAERS ID: 753136 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-21
Onset:2014-11-24
   Days after vaccination:3
Submitted: 2018-05-31
   Days after onset:1283
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiomyopathy NOS; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157155

Write-up: Case number PHHY2014IT157155 is an initial spontaneous report received from a health care professional via Health Authorities (reference number: 282033) on 30 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 340230) on 08 Dec 2014. This case refers to an 85 years old male patient. He was in good health condition despite important cardiopathy NOS. Current condition included heart disease, unspecified. Concomitant medication was not reported. He was vaccinated with first booster dose of FLUAD (batch number: 143301 and expiry date: Jul 2015), intramuscularly on 21 Nov 2014 at 16:00 PM. On 24 Nov 2014, he died in a very short time for probable acute cardiac crisis. Health authority reported the case as serious and assessed the causality as unassessable (reported as unclassifiable). Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340230) on 08 Dec 2014: Updated FLUAD batch review report. Following an internal review of the data received on 30 Nov 2014. The manufacturer receipt date 30 Nov 2014 of the previously reported information was corrected from 01 Dec 2014 to 30 Nov 2014. Follow-up information received on 01-Jun-2017, from physician via Health Authority (IT-MINISAL02-282033): Added medical history (heart disease), updated reported causality.


VAERS ID: 753153 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2014-11-12
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1295
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 142901 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Acute kidney injury, Arthralgia, Blood gases abnormal, Bronchoscopy abnormal, Cardiac arrest, Cardiogenic shock, Computerised tomogram abnormal, Death, Dyspnoea, Ejection fraction decreased, Electrocardiogram abnormal, Endotracheal intubation, Headache, Hyperglycaemia, Hyperhidrosis, Hyponatraemia, Hypoxia, Intensive care, Lactic acidosis, Mechanical ventilation, Oxygen saturation decreased, Pallor, Pleural effusion, Respiratory failure, Tachycardia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Allopurinol; insulin; PANTORC; CARDIOASPIRIN; CARDICOR; LUVION; COVERLAM; UDCA; DEURSIL; SINVACOR
Current Illness: Unknown to Ongoing, COPD; Unknown to Ongoing, Hypertension, Hypertension in heart failure; Unknown to Ongoing, Insulin dependent diabetic; Unknown to Ongoing, Chronic renal failure; Unknown date, Metabolic syndrome; Unknown date, Diabetic retinopathy;
Preexisting Conditions: Unknown date, Hemiparesis (left), Left hemiparesis due to stroke; Unknown to 31-May-2018, 20:37, Stroke, Left hemiparesis due to stroke; Unknown date, Cardiomyopathy; Unknown date, Heart failure; Unknown date, Aortic ectasis; Unknown date, Antibiotics; Unknown date, Hyperuricemia; Unknown date, Glaucoma; Unknown date, Polyarthritis
Allergies:
Diagnostic Lab Data: 26-NOV-2014: Blood pressure (PA): 98/70 mmHg; 26-NOV-2014: Heart beat: 84 beat/min.; 26-NOV-2014: Oxygen saturation: 70%; 26-NOV-2014: Body temperature (TC): 36 degrees C, GSC 15; 26-NOV-2014: Hemogas-analysis (EGA): Metabolic acidosis with marked increase in the lactates, hypoxia with P/F reduced hyponatremia and hyperglycaemia; 27-NOV-2014: Fibro-bronchoscopy and CT scan: Presence of pleural effusion bilaterally that requested the positioning of a thoracic drainage on the right side; 27-NOV-2014: ECG: Akinesia of the apical segments of the left ventricle with reduced ejection fraction (EF) (30%).
CDC Split Type: PHHY2014IT157743

Write-up: Case number PHHY2014IT157743, is an initial spontaneous report received from a health care professional via Health Authorities (HA report no: 282247) on 01 Dec 2014 with a follow up report received from the Health Authorities on 03 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340351) on 09 Dec 2014. This report refers to a 73-year-old female patient. Medical history included left hemiparesis due to stroke, chronic obstructive pulmonary disease (COPD), cardiopathy, aortic ectasia, insulin dependent diabetes, chronic renal failure, diabetic retinopathy, glaucoma, ipovisus, and polyarthritis and hypertension in heart failure. Concomitant medications included PANTORC gastroresistant tablet at a dose of 20 mg orally, CARDIOASPIRIN gastroresistent tablets at a dose of 100 mg orally, CARDICOR tablets at a dose of 1.25 mg orally, LUVION tablets at a dose of 25 mg orally, COVERLAM tablets at a dose of 20 mg orally, DEURSIL hard capsules at a dose of 300 mg, SINVACOR coated tablets at a dose of 20 mg orally, Allopurinol tablets at a dose of 300 mg orally, UDCA capsules at a dose of 300 mg, and insulin. On 11 Nov 2014, she was administered with FLUAD (batch number: 142901) at a dose: 0.5 ml intramuscularly. On 12 Nov 2014, the patient experienced cephalgia and stomach pain. On 13 Nov 2014, the patient experienced dyspnea, gastralgia and arthralgia. Medical therapy for treating events included LASIX 250 mg infusion, noradrenaline, dobutamine, antibiotics NOS and pleural drainage. The patient was hospitalized on 26 Nov 2014, at 06:40 AM in intensive care for worsening respiratory failure, severe lactic acidosis, hyponatremia, acute renal failure, and cardiogenic shock. On objective examination of the patient was conscious, pale, sweated, tachycardic, with vesicular murmur reduced, anuric. The relevant lab details were blood pressure (PA) was 98/70 mmHg, heart beat was 84 beat/min, oxygen saturation was 70 percent. Body temperature (TC) was 36 degrees C, GSC 15, hemogas-analysis (EGA) was metabolic acidosis with marked increase in the lactate, hypoxia with P/F reduced hyponatremia and hyperglycaemia. In anamnesis left hemiplegia due to previous stroke, diabetes, ischaemic-hypertensive cardiopathy, chronic renal insufficiency, and as reported by the relatives, recent anti-flu vaccination. At the emergency department (PS) medical therapy under emergency has been performed, mask for CPAP has been positioned, chest X-ray, ECG, and cardiological and resuscitation consultants have been requested. The physician resuscitator, after having evaluated the hematobiochemical examinations, and instrumental examinations performed, and considering the worsening of the clinical conditions, proceeded with the tracheal intubation of the patient with ventilator assistance, and programmed the admission of the patient at the General Resuscitation Department. At the department PICCO catheter has been positioned for the hemodynamic monitoring that evidenced a low cardiac output with reduced contractility indexes, (not legible) within the normal limits, and peripheral vascular resistances increased. Based on the hemodynamic parameters the therapy with vasoactive amines had been modulated, and diuretic had been administered with the addition to the correction of the acidosis and of the hyperglycaemia. On the day 27, due to the worsening of the respiratory exchanges firstly a fibro-bronchoscopy had been performed, afterwards a CT scan of the chest, which evidenced the presence of pleural effusion bilaterally that requested the positioning of a thoracic drainage on the right side; antibiotic therapy had been started. In the following hours (not legible) episodes of polymorphous ventricular tachycardia, treated with cardiac massage, defibrillator, and medical therapy. The echocardiography 2d for evaluation follow-up evidenced akinesia of the apical segments of the left ventricle with reduced ejection fraction (ER) (30 percent). At the hour 08:25 AM of the day 29 onset of ventricular fibrillation that, despite of the repeated defibrillations, evolved to cardiac arrest leading to the patient''s death. On 29 Nov 2014, the patient died. Outcome of stomach pain, dyspnea, arthralgia and cephalgia was reported as fatal. The reporter assessed the causality of the events as not related. Health authority assessed the events as serious (fatal). Based on the performed review on FLUAD 2014/2015 batch number: 142901, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow up report was received from the Health Authorities (HA reference number: 282247) on 03 Dec 2014: Updated formulation, concentration and dose of concomitant medications. Follow-up information received from the Quality Assurance Department (reference number: 340351) on 09 Dec 2014: Updated FLUAD 2014/2015 batch review report. Following an internal review of the data received on 01 Dec 2014, The manufacturer receipt date 01 Dec 2014 of the previously reported information was corrected from 02 Dec 2014 to 01 Dec 2014. Follow up received on 11-Apr-17: Added current conditions diabetic retinopathy, glaucoma, ipovisus, and polyarthritis lab data (Blood pressure, Heart rate, Oxygen Saturation, Body temperature, hemogas-analysis (EGA), CT scan, fibro-bronchoscopy, ECG), concomitant drugs (PANTORC and UDCA, added treatment drugs (diuretic and antibiotic). Cause of death (as cardiac arrest) and deleted other causes (stomach pain, arthralgia, cephalgia, dyspnoea), added event details and reporter''s comment. Accordingly, updated narrative. Follow-up information received on 01-Jun 2017, from health professional via Health Authority (RNF: IT-MINISAL02-282247): The suspect product indication was updated as flu vaccination. Events respiratory failure aggravated, serious lactic acidosis, renal failure acute, cardiogenic shock were added with details. Updated narrative accordingly. Case Comment: This case concerns a 73-year-old female patient who developed Dyspnea, stomach pain, arthralgia and cephalgia 3 days after receiving a dose of FLUAD vaccine and Respiratory failure aggravation, cardiogenic shock, acute renal failure and lactic acidosis 16 days after vaccination. The patient died 18 days after vaccination due to cardiac arrest. It was reported that patient is suffering from Insulin-dependent diabetes mellitus, metabolic syndrome, hyperuricemia, arterial hypertension, and hypertensive cardiopathy in decompensation phase, aortic Ectasia, sequels of hemorrhagic ictus cerebri with sequels of left hemiparesis, and sensitive syndrome, chronic cerebral vasculopathy, sequels of acute pericarditis, diabetic retinopathy, glaucoma, ipovisus and polyarthritis. It was reported that the CT scan of the chest, showed the presence of pleural effusion bilaterally and 2D Echocardiography showed Akinesia of apical segments of the left ventricle with reduced ejection fraction (30%). Even thought the temporal relations is plausible: the events and fatal outcome of the events are better explained by underlying medical condition of the patient. Hence the causal role of vaccine FLUAD is assessed as not related.


VAERS ID: 753155 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-14
Onset:2014-11-16
   Days after vaccination:2
Submitted: 2018-05-31
   Days after onset:1291
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143002 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute pulmonary oedema, Death, Electrocardiogram abnormal
SMQs:, Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Dyslipidemia; Arthrosis multiple; Polyneuritis; COPD (Chronic obstructive pulmonary disease); Hypertensive cardiomyopathy; Cardiac arrhythmia; Venous insufficiency; Anxious depression; Fatty liver
Preexisting Conditions: Diabetic gangrene, wet diabetic gangrene of the right foot the patient was amputated at the middle third of the right leg
Allergies:
Diagnostic Lab Data: 16-NOV-2014, Electrocardiogram, abnormal
CDC Split Type: PHHY2014IT161316

Write-up: Case number PHHY2014IT161316, is a combined initial and follow up spontaneous report received from a healthcare professional via health authority (HA, reference number: 283413) and from Quality Assurance department (reference number: 341716) both on 09 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341716) on 19 Dec 2014. This report refers to a 78-year-old female patient. The patient''s historical condition included web diabetic gangrene of the right foot of the patient was amputated at the middle third of the right leg in 2011. The patient''s concurrent condition included diabetes mellitus (since an unspecified date), hypertension (since an unspecified date), dyslipidemia (since an unspecified date), diffuse polyarthrosis (since an unspecified date), diabetic polyneuritis (since an unspecified date), COPD (chronic obstructive pulmonary disease, since an unspecified date), venous insufficiency lower limbs (since an unspecified date), anxious-depressive syndrome (since an unspecified date), chronic fatty liver disease (since an unspecified date), hypertensive cardiomyopathy (since an unspecified date), cardiac arrhythmia (since an unspecified date). The patient''s concomitant medications were not reported. The patient was vaccinated with FLUAD (dose: 0.5 ml, frequency: total, batch number: 143002 and expiry date: Jul 2015) intramuscularly at a dose of 0.5 ml on 14-Nov-2014 at 10 am in good clinical condition. On 16-Nov-2014, she developed acute pulmonary oedema into diabetes mellitus. When paramedical intervention arrived, ECG (electrocardiogram) was performed and resulted flat. It was reported that the patient died on 16-Nov-2014 at 16:10 hours. The outcome of acute pulmonary edema was fatal. The cause of death was reported as acute pulmonary edema due to severe cardiomyopathy. It was unknown whether autopsy was done or not. Health authority assessed the event was unassessable. This report was considered as serious (death). Based on the performed review on FLUAD batch number: 143002, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that might be potentially related to the reported events. QA department confirmed that, the involved batches were compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 341716) on 19 Dec 2014: Updated FLUAD batch review report. Follow up received on 6-Apr-2017 from a health care professional: Added historical condition (wet diabetic gangrene of the right foot the patient was amputated at the middle third of the right leg in 2011), current condition (hypertension, dyslipidemia, diffuse polyarthrosis, diabetic polyneuritis, COPD, venous insufficiency lower limbs, anxious-depressive syndrome, chronic fatty liver disease, hypertensive cardiomyopathy, cardiac arrhythmia), lab data (ECG) updated indication of the vaccine (anti flu vaccination), added event (cardiomyopathy) with details (outcome, seriousness and causality). Accordingly, update narrative. Follow-up information received on 05-Jun-2017, from other non-healthcare professional (commander) via Health Authority (IT-MINISAL02-283413): The suspect product indication was updated as influenza immunization. The reporter causality was changed from related to unassessable. Significant case correction received on 05-Sep-2017: Changed verbatim of the event from acute pulmonary edema to acute pulmonary edema into diabetes mellitus. The event cardiomyopathy was deleted due to cardiomyopathy was not reported as an event via health authority and cardiomyopathy was the pre-existing condition of the patient. Case Comment: This case concerns a 78-year-old female patient who developed acute pulmonary edema 2 days after receiving a dose of FLUAD VACCINE and died of severe acute pulmonary edema due to severe cardiomyopathy. Even though the temporal relationship is plausible, based on the patient''s medical history and current medical condition of diabetes mellitus, hypertension, dyslipidemia, diffuse polyarthrosis, diabetic polyneuritis, COPD, venous insufficiency lower limbs, anxious-depressive syndrome, chronic fatty liver disease, hypertensive cardiomyopathy and cardiac arrhythmias, the causal role of the suspect vaccine is unlikely. Hence, the causality was assessed as not related. Since the cause of death is severe pulmonary edema due to severe cardiomyopathy, fatal outcome of the pulmonary edema is better explained by underlying medical conditions of the patient such as hypertensive cardiomyopathy and cardiac arrhythmia.


VAERS ID: 753156 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-17
Onset:2014-12-17
   Days after vaccination:0
Submitted: 2018-05-31
   Days after onset:1260
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143401 / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure decreased, Death, Hypotension, Incorrect route of product administration, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-29
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOX; TRITTICO; NORVASC; CARDIOASPIRIN; TAVOR
Current Illness:
Preexisting Conditions: Steroid therapy; Mastitis bacterial, in 2006 hospitalization; Vascular encephalopathy; Cognitive impairment; Feeding disorder; COPD; Percutaneous endoscopic gastrostomy, about 1 year
Allergies:
Diagnostic Lab Data: 17-DEC-2014, Blood pressure measurement, 140/80, normal; 17-DEC-2014, Blood pressure measurement, 85/50, depressed; 17-DEC-2014, Blood pressure measurement, 110/70, depressed
CDC Split Type: PHHY2014IT167250

Write-up: Case number PHHY2014IT67250 is a combined initial spontaneous report received from a Health Authority (HA, reference number: 285972) on 22 Dec 2014, with follow up information received on the same date, with a combined follow up received from Health Authority on 09 Jan 2015 and 12 Jan 2015 respectively, with the follow-up information received from Quality Assurance Department (reference number: 344592) on 15 Jan 2015 and a follow up received from Health Authority on 21 Jan 2015. This report refers to a 95 years old female patient. The patient''s past medical history included tuberculous mastitis (hospitalized in 2006), chronic obstructive pulmonary disease (COPD), chronic vascular encephalopathy, severe cognitive impairment with refusal to feed. For about one year the patient was a carrier of percutaneous endoscopic gastrostomy. Concomitant medications included LANSOX, TRITTICO, NORVASC, CARDIOASPIRIN and TAVOR. Vaccination history included administration of influenza vaccine (manufacturer unknown, batch number: not reported). She was vaccinated with FLUAD (batch number: 143401) subcutaneously (characterised as inappropriate route of vaccination) in the left deltoid at a dose of 0.5 ml on 17 Dec 2014 approximately at 16:00. Subsequent to the vaccination, the patient blood pressure was 140/80 mmHg, was in good health and answering to the questions. On the same day three hours after the vaccination, the patient experienced vomiting, tachycardia and hypotension (blood pressure: around 85/50 and saturation 94%). The patient was administered regular fluid infusion at drip slowly (saline, vial 500 cc plus URBASON 20 mg) and administered liquids. The patient was stabilized. The blood pressure of the patient recovered to 110/70 mmHg. Therapy with concomitant medications TRITTICO, TAVOR and NORVASC was interrupted after the adverse events. In the following days, the patient had high and low pressure and the patient was put on corticosteroid therapy (URBASON 20 mg) by infusion in saline once daily. On 24 Dec 2014, emergency service was called and the physician confirmed to administer the current treatment of the patient. On 29 Dec 2014, the patient died due to drowsiness in senile cachexia. The outcome of the events was fatal. It was reported that autopsy was not performed. The Health Authority assessed the case as serious and causality as unassessable (reported as undetermined) to the administration of FLUAD. Based on the performed review on FLUAD batch number: 143401, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Combined follow up received from Health Authority on 09 Jan 2015 and 12 Jan 2015 respectively: updated medical history, vaccination history, lab data, outcome of the events and other clinically relevant information in the narrative. Follow-up Information received from the Quality Assurance Department (reference number: 3445492) on 15 Jan 2015: Updated FLUAD batch review report. Follow up received from Health Authority on 21 Jan 2015: updated concomitant medications and HA comment (autopsy was not performed). Follow-up information received on 07-Jun-2017, from physician via Health Authority (RNF: IT-MINISAL02-285972): Added patient initials, medical history (percutaneous endoscopic carrier for a year), cause of death, added event (inappropriate route of vaccination), updated events details. Case Comment: MAC: This 95 year old patient with severe cognitive impairment, cachexia and a PEG feeding tube, developed hypotension, tachycardia, vomiting, and oxygen desaturation approximately 3 hours following vaccination. Although the close temporal relationship of the events to the vaccine raise the possibility of a hypersensitivity reaction, it was reported that she was treated with IV fluids and liquids with recovery on the same day, suggests her hypotension may also have been related to dehydration, a frequent complication of chronic cachexia and tube feedings. Over the subsequently days, exact onset was not reported, her blood pressure fluctuated and she was started on corticosteroids for unspecified reasons. Twelve days after the vaccination and an unspecified number of days following fluctuation of her blood pressure, it was reported that she died due to "senile cachexia". Based on the reported date, the most likely cause of death appears to be advanced age, senile cognitive impairment and chronic cachexia: a causal relationship to FLUAD vaccination appears unlikely.


VAERS ID: 753254 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-27
Onset:2014-11-28
   Days after vaccination:1
Submitted: 2018-05-31
   Days after onset:1279
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Cardiopulmonary failure, Clonus, Death, Dehydration, Depressed level of consciousness, Diarrhoea, Hyperpyrexia, Influenza, Nuclear magnetic resonance imaging brain abnormal, Pleural effusion, Seizure, Sopor, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchopneumonia; COPD; Confusional state; Pleural effusion; Chronic obstructive bronchopneumopathy; Cor pulmonale; Kidney failure chronic; Postictal confusion
Preexisting Conditions: Stroke, hospitalized two months ago
Allergies:
Diagnostic Lab Data: 15-NOV-2014, Nuclear magnetic resonance Imaging abnormal, Area of hyperintensity in the sequences Flair involved the temporo-insular region and thalamic region on the right side anomalies slow-irritative on the hemispheric derivations on the right side in the context of a recording diffusely slowened
CDC Split Type: PHHY2014IT161309

Write-up: Case number PHHY2014IT161309, is an initial spontaneous report received from a healthcare professional via health authority (HA, reference number: 283341) on 09 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341670) on 16 Dec 2014 with a follow up received from a healthcare professional via health authority on 09 Jan 2015. With a follow, up information received on 11-Apr-2017. This report refers to an 86-year-old female patient. The patient medical history was ictus cerbri (admission at the department two months ago). Concurrent conditions included, COPD, bronchopneumonia, pleural effusion, post-stroke confusion, postictal confusion, kidney failure chronic cor pulmonale and chronic obstructive bronchopneumopathy (BPCO). No concomitant medication was reported. The patient was vaccinated with FLUAD (0.5 ml, intramuscular, batch number: 143301 and expiry date: Jul 2015) on an unknown date (about one week before hospitalisation) by her general practitioner. On an unknown date, the patient had hyperpyrexia, vomiting, diarrhea NOS and flue-status after the administration of the vaccine. Hyperpyrexia lasted until 15-Nov-2014. The patient had not travelled or has not been exposed to ticks. On an unknown date, the patient had aphasia, convulsions, reduction of the conscience status/responsivity and soporous with clonus at the left hemiside. No signs of endocranial hypertension had been observed. On 15-Nov-2014 encephalous magnetic nuclear resonance (RMN) with contrast material performed and the area of hyper intensity the sequences Flair involved the temporo-insular region and thalmic region on the right side. The report was doubtful nature (encephalitis) anomalies slow-irritative on the hemispheric derivation son the right side in the context of a recording diffusely slowed. On 28 Nov 2014, she developed cardio-respiratory failure, unspecified pleural effusion, diarrhea NOS and dehydration and was hospitalized. The patient died on 04 Dec 2014 and the cause was unknown. Outcome of the events was fatal except for hyperpyrexia which resolved. Autopsy performed was unknown. The patient''s relatives believed the clinical condition of the patient had worsened and this led to the hospitalization of the patient. The Health Authority considered the causality as unassessable (reported as unclassifiable) for the events dehydration, diarrhea NOS, unspecified pleural effusion, cardio-respiratory failure and as not related for the other events. Based on the performed review on FLUAD batch number: 143301, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with CGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 341670) on 10 Dec 2014: Updated QA reference number only. Follow-up Information received from the Quality Assurance Department (reference number: 341670) on 16 Dec 2014: Updated FLUAD batch review report. Follow-up received from healthcare professional via health authority on 09 Jan 2015: updated current conditions (chronic pulmonary heart disease, previous stroke, bronchopneumonia and pleural effusion) and reporter comments. Follow up received from the reporter on 11-APR-2017: Added current condition (BPCO, updated historical condition (recent ictus cerebri), added lab data (RMN, events (hyperpyrexia, vomiting, aphasia, convulsions, reduction of the conscience status/responsivity and flue status), updated reporter''s causality (not related) and reporter''s comment. Updated narrative accordingly. Follow-up report was received from the physician via Health Authority (IT-MINISAL02-283341) on 05-Jun-2017: Physician was added as a reporter. Concurrent conditions (from chronic pulmonary heart disease to cor pulmonale and chronic renal failure to kidney failure chronic) were updated and postictal confusion was added. The indication of the suspect vaccine (flu prevention) and route of administration (intramuscular) was updated. Description as reported and to be coded for the events was updated. The reporter causality was changed from not related to unassessable for the events dehydration, diarrhea NOS, unspecified pleural effusion and cardio-respiratory failure.


VAERS ID: 753293 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-25
Onset:2014-11-29
   Days after vaccination:4
Submitted: 2018-05-31
   Days after onset:1278
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test normal, Cachexia, Cardiac disorder, Death, Interstitial lung disease, Ischaemic cardiomyopathy, Large cell lung cancer, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tiklid; TRIATEC; LOBIVON; LAROXYL; LASIX; SINVACOR; ZYLORIC; Minias
Current Illness: Hemiparesis (left); Post procedural stroke; Bedridden; Malnutrition; Dehydration; Pressure sore; Urinary incontinence; Living in care; Postictal state
Preexisting Conditions: Stroke
Allergies:
Diagnostic Lab Data: Blood test, Normal, In the past
CDC Split Type: PHHY2014IT158328

Write-up: Case number PHHY2014IT158328 is an initial spontaneous report received from a health care professional via health authority (HA reference number: 282518) on 03 Dec 2014 with a follow-up information received from Quality Assurance Department (QA reference number: 340731) on 09 Dec 2014 and a follow up information received from the health authority on 06 Apr 2015. This case refers to an 88 years old male patient. His current conditions included left hemiparesis and post stroke state. He was under integrated home care and was bedridden with malnutrition and dehydration complicated by pressure ulcer at the third stage with left hemiparesis from previous stroke and urinary incontinence. His blood test was normal in the past. Concomitant medication included Tiklid 250 mg coated tablet 1 dosage form daily, TRIATEC 5 mg tablet 1 dosage form daily, LOBIVON 5 mg tablet 1 dosage form daily, LAROXYL 40 mg/ml oral drops at a dose of 5 drops daily, LASIX 25 mg tablet, SINVACOR 40 mg film coated tablet, ZYLORIC 300 mg tablet 1 dosage form daily and Minias 2.5 mg/ml oral drops at a dose of 20 drops daily. He was vaccinated with FLUAD (batch number: 143301, expiry date: 31 Jul 2015) at dose of 0.5 ml intramuscularly on 25 Nov 2014. On 29 Nov 2014, the patient died. Autopsy was done and the results revealed that the cause of death was "senile cachexia in patient with chronic ischemic cardiomyopathy, large cell lung cancer, interstitial pneumonia, left hemiparesis as a result of stroke and syndrome of bedridden patient with urinary incontinence and malnutrition and dehydration. Lungs showed a macroscopic picture of interstitial pneumonia with cancer of the upper lobe of right lung unknown to the doctor until the autopsy. Hence severe respiratory failure was represented as the cause of death of patient in association with compromised cardiac conditions. In conclusion, the autopsy did not show a causal like between FLUAD and death, it was just a co-incidence. The reporter stated that the relation between the vaccination and the adverse drug reaction was possible. Based on the performed review on FLUAD batch number 143301, there was no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that might be potentially related to the reported events. QA department confirmed that the involved batches were complaint with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340731) on 09 Dec 2014: Updated FLUAD batch review reported. Follow up information received from the health authority on 06 Apr 2015: Updated current conditions, indication for suspect vaccine, concomitant medications dosage details, causality and autopsy results.


VAERS ID: 753367 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-26
Onset:2018-02-06
   Days after vaccination:560
Submitted: 0000-00-00
Entered: 2018-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N3483 / 3 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Atelectasis, C-reactive protein increased, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Death, Drug ineffective, General physical health deterioration, Haemophagocytic lymphohistiocytosis, Intensive care, Lung disorder, Pleural effusion, Pleural fluid analysis, Pneumonia pneumococcal, Polymerase chain reaction, Pyrexia, Streptococcus test positive
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-08
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: Serotype 19F Pneumococcus; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180205; Test Name: Chest X-ray; Result Unstructured Data: Test Result: pneumonia; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180222; Test Name: Chest CT; Result Unstructured Data: Test Result: severe left pleural effusion, complete atelectasis; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180305; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 379, Test Result Unit: mg/l; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180221; Test Name: Fungal test; Result Unstructured Data: Test Result: negative; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180221; Test Name: Pleural fluid analysis; Result Unstructured Data: Test Result: Pleural liquid was sanguineous and inflammatory wi; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.; Test Date: 20180221; Test Name: PCR; Result Unstructured Data: Test Result: negative to pneumococcus and aspergillosis; Comments: Chest computerized tomodensitometry (22Feb2018): severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Pleural liquid (21Feb2018): pleural liquid was sanguineous and inflammatory with no malignant cell.
CDC Split Type: FRPFIZER INC2018236672

Write-up: This is a spontaneous report received from the National Health Products Safety Agency (ANSM). Regulatory authority report number PS20180544. A 24-month-old female patient received 3 doses of PREVENAR 13, intramuscular, at single dose, for immunisation: 1st dose on 26Oct2015, 2nd dose on 21Dec2015, 3rd dose on 26Jul2016 (lot# N3483). Relevant medical history and concomitant medications were not reported. The patient was a full term. The patient experienced pneumonia Serotype 19F and pneumopathy on 06Feb2018. She died on 08Mar2018 due to acute respiratory distress syndrome, pneumonia Serotype 19F and pneumopathy. It was unknown if an autopsy was performed. Clinical course: on 06Feb2018 the patient developed fever. Outpatient chest radiography showed pneumonia leading to hospitalization on 08Feb2018 for respiratory distress syndrome in a context of influenza virus A superinfection. Amoxicillin (CLAMOXYL) and salbutamol sulfate (VENTOLINE) were administered. On the background of significant oxygen therapy requirement and deterioration on 10Feb2018, the patient was transferred to the intensive care unit and received amoxicillin / potassium clavulanate (AUGMENTIN) then cefotaxime sodium (CLAFORAN) due to an absence of improvement. The patient was transferred to another''s hospital intensive care unit on 12Feb2018. Extracorporeal membrane oxygenation was started. Antibiotic therapy including vancomycin (unspecified trade name), clindamycin (DALACINE), cefotaxime sodium (unspecified trade name)and gentamicin (unspecified trade name) was instituted. Blood culture was positive to serotype 19F Pneumococcus. Immune work-up was not performed. On 21Feb2018 polymerase chain reaction of pleural liquid was negative to pneumococcus and aspergillosis. Pleural liquid was sanguineous and inflammatory with no malignant cell. The patient was administered caspofungin acetate (CANCIDAS), linezolid (unspecified trade name), meropenem (MERONEM) and cefotaxime sodium (unspecified trade name). Chest computerized tomodensitometry on 22Feb2018 revealed severe left pleural effusion, complete atelectasis of left lung, atelectasis from right upper and lower lobes. Due to macrophage-activation syndrome, steroid therapy was started. On 05Mar2018, 24 hours after steroids withdrawal, a deterioration of the status was observed. C-reactive protein increased to 379 mg/l. The patient received meropenem, vancomycin and micafungin sodium (MYCAMINE). The patient died on 08Mar2018. Based on the Official French Method of Causality Assessment, the causal relationship between pneumococcal 13-val conj vac (dipht crm197 protein) and the adverse events drug ineffective with pneumonia was assessed by the Agency as "doubtful". The information on the lot numbers has been requested.; Reported Cause(s) of Death: Pneumonia Serotype 19F; Pneumopathy; Drug ineffective; acute respiratory distress syndrome.


VAERS ID: 753529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FISA2018SA147150

Write-up: progressive lymphoma; progressive lymphoma; influenza A (H1N1); Initial unsolicited report received from literature in Finland on 30-May-2018. Abstract: Background: Influenza A(H1N1) causes serious complications in immunocompromised patients. The efficacy of seasonal vaccination in these patients has been questioned. AIM: To describe two outbreaks of influenza A(H1N1) in immunocompromised patients. METHODS: Two outbreaks of influenza A(H1N1) occurred in our institution: on the kidney transplant ward in 2014 including patients early after kidney or simultaneous pancreas-kidney transplantation, and on the oncology ward in 2016 including patients receiving chemotherapy for malignant tumours. Factors leading to these outbreaks and the clinical efficacy of seasonal influenza vaccination were analysed. FINDINGS: Altogether 86 patients were exposed to influenza A(H1N1) during the outbreaks, among whom the seasonal influenza vaccination status was unknown in 10. Only three out of 38 vaccinated patients were infected with influenza A(H1N1), compared with 20 out of 38 unvaccinated patients (P = 0.02). The death of one out of 38 vaccinated patients was associated with influenza, compared with seven out of 38 unvaccinated patients (P = 0.06). Shared factors behind the two outbreaks included outdated facilities not designed for the treatment of immunosuppressed patients. Vaccination coverage among patients was low, between 40% and 70% despite vaccination being offered to all patients free of charge. Vaccination coverage of healthcare workers on the transplant ward was low (46%), but, despite high coverage on the oncology ward (92%), the outbreak occurred. CONCLUSION: Seasonal influenza vaccination was clinically effective with both a reduced risk of influenza infection and a trend towards reduced mortality in these immunocompromised patients. Several possible causes were identified behind these two outbreaks, requiring continuous awareness in healthcare professionals to prevent further outbreaks. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Influenza vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient''s medical history revealed that, the patient was immunocompromised. It was reported that, the patient is in chemotherapy. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed influenza A (H1N1) and had progressive lymphoma. On an unspecified date, the patient died due to progressive lymphoma. Lab data and corrective treatment were not reported. The outcome of events was not reported. It was unknown if autopsy was done. List of documents held by sender: none.; Sender''s Comments: This case concerns a patient with history of immunocompromised status and chemotherapy who developed Influenza A (H1N1) infection and lymphoma an unspecified time after vaccination with INFLUENZA vaccine. The latency is not known. Patient''s immunocompromised state and chemotherapy also hinder adequate antibody response development with vaccination. In addition, further information and lab data will be needed to rule out alternate causes of lymphoma. Based upon the reported information, role of the vaccination cannot be assessed and the case cannot be judged to be a vaccination failure.; Reported Cause(s) of Death: progressive lymphoma


VAERS ID: 753820 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-03-26
Onset:2018-05-21
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2018-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 167301 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningococcal bacteraemia
SMQs:, Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEGLAXOSMITHKLINEIE2018GS

Write-up: invasive group B ?meningococcal disease; This case was reported by a other health professional via local affiliate and described the occurrence of meningococcal bacteremia in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number 167301, expiry date unknown) for prophylaxis. On 26th March 2018, the patient received the 1st dose of Bexsero. On 21st May 2018, 56 days after receiving Bexsero, the patient experienced meningococcal bacteremia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningococcal bacteremia was fatal. It was unknown if the reporter considered the meningococcal bacteremia to be related to Bexsero. Additional details were provided as follows: This case was received from health care professional (HCP) via GlaxoSmithKline (GSK) employee. Age at vaccination was not reported. The reporter stated that the patient died from invasive group B meningococcal disease. In accordance with the national immunisation programme for Meningococcal B vaccination, the patient was vaccinated with a dose of Bexsero. No other information was provided. Follow up would be sent.


VAERS ID: 753821 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Death, Drug interaction, Haemoptysis, International normalised ratio decreased, Labelled drug-drug interaction medication error, Platelet count decreased, Product administration error, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Influenza vaccine; ASA; Celecoxib; Warfarin; HYDROCHLOROTHIAZIDE; Lorazepam; Montelukast sodium; HYDROXYCHLOROQUINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: INR; Result Unstructured Data: Test Result: 8, Test Result Unit: unknown; Test Name: Platelet count; Result Unstructured Data: Test Result: Abnormal, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201810

Write-up: INR decreased; Platelet count decreased; Contusion; Drug interaction; Hemoptysis; Pyrexia; Labelled drug-drug interaction medication error; Drug administration error; This case was reported by a other health professional via regulatory authority and described the occurrence of inr decreased in a 67-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine) for prophylaxis. Co-suspect products included acetylsalicylic acid (Asa) tablet for drug use for unknown indication, celecoxib unknown for drug use for unknown indication, lorazepam unknown for drug use for unknown indication, montelukast sodium unknown for drug use for unknown indication, warfarin sodium (Warfarin) tablet for drug use for unknown indication, hydrochlorothiazide unknown for drug use for unknown indication and hydroxychloroquine unknown for drug use for unknown indication. On an unknown date, the patient received Influenza vaccine (unknown), Asa (unknown) at an unknown dose and frequency, celecoxib (unknown) at an unknown dose and frequency, lorazepam (unknown) at an unknown dose and frequency, montelukast sodium (unknown) at an unknown dose and frequency, Warfarin (unknown) at an unknown dose and frequency, hydrochlorothiazide (unknown) at an unknown dose and frequency and hydroxychloroquine (unknown) at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine, Asa, celecoxib, lorazepam and montelukast sodium and an unknown time after starting Warfarin, the patient experienced inr decreased (serious criteria death and other: serious as per reporter), platelet count decreased (serious criteria death and other: serious as per reporter), contusion (serious criteria death and other: serious as per reporter), drug interaction (serious criteria death and other: serious as per reporter), hemoptysis (serious criteria death and other: serious as per reporter), fever (serious criteria death and other: serious as per reporter), labeled drug-drug interaction medication error (serious criteria death and other: serious as per reporter) and drug administration error (serious criteria death and other: serious as per reporter). On an unknown date, the outcome of the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error were fatal. The reported cause of death was inr decreased, hemoptysis, platelet count decreased, pyrexia, drug administration error, contusion, drug interaction and labelled drug-drug interaction medication error. The reporter considered the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error to be possibly related to Influenza vaccine, Asa and Warfarin. It was unknown if the reporter considered the inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, fever, labeled drug-drug interaction medication error and drug administration error to be related to celecoxib, lorazepam and montelukast sodium. Initial information was reported by a other health professional via regulatory authority on 11th June 2018: death nos, inr decreased, platelet count decreased, contusion, drug interaction, hemoptysis, pyrexia, labelled drug-drug interaction medication error and drug administration error. Sender''s comment: Limited information about event details of death, exact cause of death, complete medical history, concomitant medications, relevant investigations and autopsy findings, if any, precludes a meaningful causality assessment for event death. Without details regarding therapy dates of the suspect drugs (hydrochlorthiazide, celecoxib,lorazepam and montelukast sodium) and their indication, clinical course of the reported events, event start date, time to onset of events, supporting investigations (with base line value) precludes the meaningful causality assessment of all reported events. Hence, causality assessed as not assessable with suspect drugs. Note: Death nos was reported as event, however it was removed as cause of death were reported. Lab Comments: On unknown date the patient underwent below lab test and result was found as: International normalised ratio: 8 Platelet count: Abnormal; Reported Cause(s) of Death: International normalised ratio decreased; Haemoptysis; Platelet count decreased; Pyrexia; Drug administration error; Contusion; Drug interaction; Labelled drug-drug interaction medication error


VAERS ID: 755525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardio-respiratory arrest, Death, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2018253699

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB (other manufacturer control number IT-GLAXOSMITHKLINE-IT2018GSK090384). A 4-month-old female patient received PREVENAR 13 at single dose, ROTARIX orally and INFANRIX HEXA, all on an unspecified date, for prophylaxis. The patient''s medical history and concomitant medications were not reported. The patient died on an unspecified date due to cardiopulmonary arrest and respiratory distress. The seriousness criteria reported for these events were: resulted in death and medically significant. An autopsy was performed but results were not provided. Information on the batch number has been requested. Reported Cause(s) of Death: Respiratory distress; Cardiopulmonary arrest.


VAERS ID: 756776 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Death, Influenza like illness
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to communicable disease (Patient was among resident cases of influenza-like-illness during respiratory outbreak in care homes)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: equal to or more than 37.8, Test Result Unit: degree C
CDC Split Type: GBGLAXOSMITHKLINEGB2018GS

Write-up: This case was reported in a literature article and described the occurrence of influenza like illness in a subject who received Influenza vaccine unspecified 2013-2014 season for prophylaxis. Concurrent medical conditions included exposure to communicable disease (Patient was among resident cases of influenza-like-illness during respiratory outbreak in care homes). On an unknown date, less than a year after receiving Influenza vaccine unspecified 2013-2014 season, the subject developed influenza like illness. Serious criteria included death. The outcome of influenza like illness was fatal. The reported cause of death was influenza like illness. It was unknown if the investigator considered the influenza like illness to be related to Influenza vaccine unspecified 2013-2014 season. Relevant Tests: Lab test performed on unspecified date: Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Body temperature result was equal to or more than 37.8 degree C. Additional information was provided. This case was reported in a literature and described the occurrence of influenza-like-illness (ILI) in a patient of unspecified age and gender who was vaccinated with unspecified influenza vaccine 2013-2014 season (manufacturer unknown) for prophylaxis. This case corresponds to table 1 and 2 reported in this literature article. The patient was part of the study that described the characteristics of respiratory outbreaks in care homes during a four-year period (2012-13, 2013-14, 2014-15, and 2015-16), and aimed to identify factors that predict which respiratory outbreaks were more likely to be positively identified as influenza. The influenza season runs from week 40 (early October) to week 20 (mid-May). Outbreaks were notified between weeks 40 and 18 (30-week duration). The patient was among the resident cases of ILI during respiratory outbreaks in care homes. No information on patient''s family history or concomitant medication was provided. On an unspecified during 2013-2014 influenza season, the patient received unspecified influenza vaccine 2013-2014 season (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between early October 2013 and mid-May 2014 of influenza season, an unknown period after vaccination, the patient had developed ILI during a respiratory outbreak. [In this study, a respiratory outbreak was defined as 2 or more cases of ILI arising with the same 48 h period, or 3 or more cases arising within the same 72 h period which meet the same clinical case definition and where an epidemiological link can be established. ILI was defined as oral temperature of equal to or more than 37.8 deg.C plus new onset or acute worsening of one or more respiratory symptoms: cough (with or without sputum), hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing, sneezing, chest pain, or in older people an acute deterioration in physical or mental ability without other known cause. Respiratory specimens were collected for virological testing. Ninety-two of the 95 outbreaks were tested for influenza, with 70/92 testing positive. Influenza A (H3) was the most frequent flu type reported (89%), with only small proportions of the other flu types identified; 4% Flu B; 3% Flu A (untyped); and 1% Flu A (H1N1)]. On an unspecified date, the patient died associated with ILI during the respiratory outbreak. [In this study, an outbreak-associated death was defined as that occurring due to confirmed influenza, or respiratory symptoms that a clinician felt might be attributed to influenza]. It was unknown if an autopsy was performed. The case has been considered as serious due to death. Treatment was unknown. The authors did not comment on the relationship between the event of ILI and unspecified influenza vaccine 2013-2014 season. The authors concluded, "this study has added to the body of evidence showing the clinical significance of respiratory outbreaks in care homes during the influenza season. This reinforces the importance of seasonal influenza vaccination for care home residents and staff and good outbreak management in order to reduce the associated morbidity and mortality. Early recognition of potential outbreaks, efficient laboratory testing and reporting of results, implementation of infection control advice, including antiviral treatment and prophylaxis if appropriate, reduce transmission of infection in a care home. Accurate data reporting and recording enable a clear picture of the severity of an outbreak to be identified and assessed". Lab Comments: Lab test performed on unspecified date; Reported Cause(s) of Death: Influenza like illness.


VAERS ID: 756924 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-04-23
Onset:2017-08-10
   Days after vaccination:109
Submitted: 0000-00-00
Entered: 2018-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dysaesthesia, Ejaculation disorder, Fatigue, Insomnia, Lyssavirus test positive, Paraesthesia, Piloerection, Priapism, Rabies, Saliva analysis abnormal, Scrotal disorder, Spermatorrhoea, Sputum culture positive, Urine analysis abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Fertility disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tacrolimus; Mycophenolate mofetil; PREDNISONE; Rabies Immunoglobulin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant (from a donor with acute disseminated encephalomyelitis with rabies)
Allergies:
Diagnostic Lab Data: Test Date: 20170815; Test Name: Saliva analysis; Result Unstructured Data: Test Result: rabies virus-specific nucleic acid, Test Result Unit: unknown; Test Date: 20170815; Test Name: Sputum culture; Result Unstructured Data: Test Result: rabies virus-specific nucleic acid, Test Result Unit: unknown; Test Date: 20170815; Test Name: Urine analysis; Result Unstructured Data: Test Result: rabies virus-specific nucleic acid, Test Result Unit: unknown
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 50-year-old male subject who received Rabies Vaccine for prophylaxis. Co-suspect products included Rabies Immunoglobulin for prophylaxis. The subject''s past medical history included kidney transplant (from a donor with acute disseminated encephalomyelitis with rabies). Concomitant products included tacrolimus, mycophenolate mofetil and prednisone. On 10th August 2017, 109 days after receiving Rabies Vaccine, 123 days after receiving Rabies Vaccine, 130 days after receiving Rabies Vaccine, 134 days after receiving Rabies Vaccine and 137 days after receiving Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies on 10th August 2017 with serious criteria of death and GSK medically significant, dysesthesia of lower extremity on 10th August 2017, scrotal disorder on 10th August 2017, priapism on 10th August 2017, ejaculation disorder on 10th August 2017, paresthesia lower limb on 10th August 2017, fatigue on 10th August 2017, spermatorrhea on 14th August 2017, insomnia on 14th August 2017, piloerection on 14th August 2017, weakness on 14th August 2017 and transmission of an infectious agent via transplant with serious criteria of GSK medically significant. The outcome of vaccination failure was fatal on 16th August 2017. The outcome(s) of the additional event(s) included rabies (fatal on 16th August 2017), transmission of an infectious agent via transplant (unknown), dysesthesia of lower extremity (unknown), scrotal disorder (unknown), priapism (unknown), ejaculation disorder (unknown), spermatorrhea (unknown), insomnia (unknown), piloerection (unknown), paresthesia lower limb (unknown), weakness (unknown) and fatigue (unknown). The subject died on 16th August 2017. The reported cause of death was rabies. It was unknown if the investigator considered the vaccination failure, rabies, dysesthesia of lower extremity, scrotal disorder, priapism, ejaculation disorder, paresthesia lower limb, fatigue, spermatorrhea, insomnia, piloerection, weakness and transmission of an infectious agent via transplant to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: On 15 August, rabies virus-specific nucleic acid was detected in patient''s saliva, urine and sputum samples. According to the diagnostic criteria, the patient was laboratory confirmed as positive for rabies. [In this study, the level of neutralizing antibody after PEP was greater than 0.1 IU/mL in four recipients, three of whom had an antibody level greater than or equal to 0.5 IU/mL, indicating a positive protective antibody response to vaccination]. Diagnostic results (unless otherwise stated, normal values were not provided): On 15th August 2017, Saliva analysis result was rabies virus-specific nucleic acid unknown, Sputum culture result was rabies virus-specific nucleic acid unknown and Urine analysis result was rabies virus-specific nucleic acid unknown. Additional information was provided. This case was reported in a literature and described the vaccination failure in 50-year-old male who was vaccinated with unspecified purified chick embryo cell rabies vaccine (manufacturer unknown) for post exposure prophylaxis (PEP). This case corresponds to the transplant recipient 4 in this article. The patient was part of a retrospectively study from 2015 to 2017 of the 4 cases of probable transmission of rabies through organ transplants, which is now a common problem. The study aimed to summarise and analyse the clinical characteristics, treatment and prophylaxis of rabies transmitted through solid organ transplantation to guide clinical work. In this study, the donor 2 was a 11-year-old girl. On 22 September 2016, the donor experienced the initial symptoms of nausea, chills and vomiting. One day later, her condition worsened, and she suffered from fever, disorder of consciousness, coma, respiratory failure and decreased blood pressure, followed by insipidus and myasthenia gravis on 5 October 2016. On 11 October 2016, she died after an initial diagnosis of acute disseminated encephalomyelitis. The results of Cerebrospinal fluid (CSF) analysis were normal. Magnetic resonance imaging (MRI) revealed diffuse signal abnormalities throughout the brain and cervical spinal cord. Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis, cytomegalovirus, Epstein Barr virus, coxsackie virus, herpes simplex virus, adenovirus and rubella virus tests were negative. The family members denied exposure to potentially rabid animals or history of rabies vaccinations. The liver and kidneys were donated for transplantation to transplant recipient 3 and 4 respectively. On 11 October 2016, the patient received kidney transplant from donor 2. The allograft recovered successfully and the immunosuppressive regimen included tacrolimus, mycophenolate mofetil and prednisone. The patient''s family members denied exposure to potentially rabid animals or history of rabies vaccinations. No information on patient''s family history was provided. On 26 March 2017, the patient received the 1st dose of unspecified purified chick embryo cell rabies vaccine immediately after confirmation of rabies in deceased recipient 3 (administration route and site unspecified, batch number not provided). The patient received 5-dose vaccination regimen (5 doses of purified chick embryo cell rabies vaccine, the first given directly after suspected exposure and subsequently on days 3, 7, 14, and 28) with 1 dose of rabies immunoglobulin (20 IU/ kg). On 10 August 2017, 109 days after vaccination, the patient experienced paraesthesia of lower limbs, fatigue, icy skin of lower limb, persistent contraction of scrotum, priapism, continuous feeling of ejaculation and ejaculation. On 14 August 2017, the patient developed weakness, spermatorrhea, insomnia and bristling. The patient was clinically diagnosed with rabies. On 15 August, rabies virus-specific nucleic acid was detected in patient''s saliva, urine and sputum samples. According to the diagnostic criteria, the patient was laboratory confirmed as positive for rabies. [In this study, the level of neutralizing antibody after PEP was greater than 0.1 IU/mL in four recipients, three of whom had an antibody level greater than or equal to 0.5 IU/mL, indicating a positive protective antibody response to vaccination]. On 16 august 2017, the patient died without invasive mechanical ventilation. It was unknown if autopsy was performed. This case has been considered as vaccination failure. This case has been considered serious due to death/ vaccination failure. The author did not comment on relationship between the event of rabies infection and unspecified purified chick embryo cell rabies vaccine. The author stated ?The two donors were initially diagnosed with viral encephalitis and acute disseminated encephalomyelitis, which were reclassified as rabies due to typical symptoms and confirmation of rabies in recipients who received the organs. Thus, the cause of rabies in the recipients was considered transmission through organ transplantation from infected donors''. The author concluded "The transmission of rabies through solid organ transplantation is a life-threatening and notable problem. The mortality rate is extremely high after the development of rabies. Serological testing and aetiological diagnosis are recommended for donors with a high risk of rabies or clinically suspected rabies. Organs should be discarded when rabies is confirmed or suspected, especially if the donor is diagnosed with encephalitis of unknown cause. It is important to establish a supervisory system to manage donor-derived infectious disease. When rabies-infected donor organs are inadvertently transplanted, recipients must receive post exposure prophylaxis in a timely manner, which may be the only possible and effective method to prevent transmission of rabies". Lab Comments: On 15 August, rabies virus-specific nucleic acid was detected in patient''s saliva, urine and sputum samples. According to the diagnostic criteria, the patient was laboratory confirmed as positive for rabies. [In this study, the level of neutralizing antibody after PEP was greater than 0.1 IU/mL in four recipients, three of whom had an antibody level greater than or equal to 0.5 IU/mL, indicating a positive protective antibody response to vaccination]. Reported Cause(s) of Death: Rabies.


VAERS ID: 757170 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-19
Onset:2017-08-24
   Days after vaccination:644
Submitted: 0000-00-00
Entered: 2018-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood culture positive, Death, Pneumonia, Sepsis, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Chronic obstructive pulmonary disease; Intravenous drug user (IVDU); Lung cancer; Pancreatitis recurrent; Pneumothorax; Smoker; Splenectomy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131807AUS001122

Write-up: Information was obtained on a request by the Company from the agency (HA # 419346) via Public Case Detail regarding a 60 year old male patient. The patient had PMH lung cancer with large tumor, chronic obstructive pulmonary disease (COPD), pneumothorax since 2010, recurrent pancreatitis and Type 2 diabetes mellitus (T2DM). He was an alcohol user, smoker and intravenous drug user (IVDU). He had a history of traumatic splenectomy. On 11-JUL-2006 and 19-NOV-2015, the patient was vaccinated with dose 1 and 2 of PNEUMOVAX 23 (1 DF) for prophylaxis. Reporter stated that the patient experienced vaccination failure and developed severe pneumonia and sepsis with underlying conditions on 24-AUG-2017. His blood culture revealed streptococcal pneumonia sterotype 3. It was reported that on the same day, the patient deceased after 24 hour admission in hospital. Reporter considered all the events to be possibly related to PNEUMOVAX 23. Reported Cause(s) of Death: pneumonia; sepsis; vaccination failure.


VAERS ID: 757849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood culture positive, Death, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: Positive for pneumococcus x2
CDC Split Type: ARPFIZER INC2018260054

Write-up: This is a spontaneous report from a contactable consumer. A 3-year-old female patient received two doses of PREVENAR 13 (lot number and expiration date not reported); both via unspecified routes of administration on unspecified dates at single doses for immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced multifocal pneumonia and was hospitalized on 22Jun2018. The patient underwent lab tests and procedures which included blood culture on unspecified date with result of positive for pneumococcus x2. It was also reported that the experienced sepsis due to pneumococcus on unspecified date. The outcome of the event multifocal pneumonia/blood culture was positive for pneumococcus x2 was unknown. The patient died on 24Jun2018 as a result of sepsis due to pneumococcus. It was unknown if an autopsy was performed. Information on lot number, batch number and expiration date has been requested.; Reported Cause(s) of Death: Sepsis due to pneumococcus.


VAERS ID: 760606 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-07-23
Entered: 2018-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Arthralgia, Asthenia, Community acquired infection, Condition aggravated, Cough, Influenza, Influenza A virus test positive, Intensive care, Myalgia, Polymerase chain reaction, Pyrexia, Renal failure, Respiratory tract infection, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-tobacco user; Kidney failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, Greater than 38, elevated; Influenza virus test, Influenza virus A, Positive; On an unspecified date: Nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for influenza virus A infection. Laboratory diagnoses were performed using multiplex ANYPLEX II RV16 and RB5 PCR assay (Seegene) or the Film array 1 respiratory panel (Blomerieux).
CDC Split Type: 201802953

Write-up: This literature report, initially received on 12-Jul-2018, was reported by other health professional and concerns an 82-year-old, elderly male patient. This study was conducted on a continuous series of 249 confirmed influenza infections, for which poorly neutralized in vitro strains, was considered as reason for vaccination failure and more severe diseases. A continuous series of patients who were hospitalized from 24-Dec-2017 (week 52) through 01-Apr-2015 (week 14) with symptoms of respiratory infection (fever, cough, dyspnoea), with or without headache, myalgia, or arthralgia were included in the study. The diagnostic procedures for viral respiratory tract infections included at least one respiratory sample (nasopharyngeal aspirate or bronchoalveolar lavago) which was positive for influenza virus. Laboratory diagnoses was performed using multiplex ANYPLEX (TM) II RV16 and RBS PCR assays (Seegene) or the Film array 1 respiratory panel (Blomerieux) for emergency cases. Young children (less than 5 years) and elderly patients (greater than 65 years) were known to be at high risk of complications and were included in this study. Nosocomial infections were defined as those which had symptom onset after 48 hours of hospitalization or admission in a nursing home. Young children were at lower risk of comorbidities (OR = 0.16, 95precent Cl - 0.08 0.35), admission in ICU (OR = 0.14, 95percent Cl = 0.04 0.51) and severe disease (OR = 0.29, 95percent Cl = 0.14 0.61) in comparison to patients aged 5-65 years. In contrast, elderly patients were at higher risk of comorbidities (OR = 2.00, 95pecent Cl = 1.05 3.79) but at lower risk of atypical infections (OR = 0.23, 95percent Cl = 0.09 0.61) and they were more frequently vaccinated (OR = 3.30, 95percent Cl = 1.18 9.24) in comparison to patients aged 5-65 years. Also, elderly patients were at higher risk of infection with A(H3N2) (OR = 2.39, 95percent Cl = 1.16 4.94) and at lower risk of infection with A(H1N1) pdm09 (OR = 0.33, 95percent Cl = 0.14 0.82) in comparison to patients aged 5-65 years. The 2014-2015 influenza season started with a high risk of vaccination failure because of the predominant circulation of variant strains. This risk was further increased by the low vaccination coverage (53percent) of patients at risk of severe influenza disease. Vaccination failure was confirmed by the low estimated vaccine effectiveness (VE), especially for elderly patients greater than 65 years (VE = 5 percent, 95 percent Cl = -8-16 percent). This study identified that elderly patients (OR = 3.30, 95 percent Cl = 1.18 9.24), comorbidities (OR = 14.75, 95 percent Cl = 1.83 118.75) and female patients (OR = 0.38, 95 percent Cl = 0.16 0.92) were associated with influenza vaccination. The patient had no history of alcohol and tobacco use. The patient''s current condition included Kidney failure (since an unspecified date). On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 04-Feb-2015 (reported as week 6), the patient was hospitalized due to the fever, cough, myalgia, arthralgia, asthenia and rhinorrhea which were considered as symptoms of respiratory infection. During hospitalization, nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for influenza virus A infection which was diagnosed as community acquired infection. Laboratory diagnoses was performed using multiplex ANYPLEX (TM) II RV16 and RB5 PCR assays (Seegene) or the Film assay 1 respiratory panel (Biomerieux). Subsequently, the patient was diagnosed with influenza A. On an unspecified date, the patient was admitted to the intensive care unit (ICU) with initial complication severe acute respiratory distress syndrome (ARDS) and subsequent complication kidney failure. The patient was hospitalized for 08 days in ward and was under observation for kidney failure. No antiviral medications were received. On an unspecified date, the patient died. It was unknown, whether autopsy performed. At the time of this report, the outcome of the events was not reported. The reporter assessed the events (influenza, vaccination failure, ARDS and kidney failure) as serious (hospitalization). As per the reporter, the events- Influenza A virus infection and vaccination failure were related to the suspect vaccine. This case was cross-linked to case 201802947 (same reporter).


VAERS ID: 760607 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-07-23
Entered: 2018-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Community acquired infection, Cough, Death, H3N2 influenza, Influenza, Influenza A virus test positive, Myalgia, Polymerase chain reaction, Pyrexia, Respiratory tract infection, Rhinorrhoea, Sepsis, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, greater than 38 Fever, elevated; On an unspecified date: Nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for Influenza virus A [H3N2] infection. Laboratory diagnoses were performed using multiplex Anyplex II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux).
CDC Split Type: 201802970

Write-up: This literature report, initially received on 12-Jul-2018, was reported by other health professional and concerns an 81-year-old, elderly, male patient. This study was conducted on a continuous series of 249 confirmed influenza infections, for which poorly neutralized in vitro strains, was considered as reason for vaccination failure and more severe diseases. A continuous series of patients'' who were hospitalized from 24-Dec-2014 (week 52) through 01-Apr-2015 (week 14) with symptoms of respiratory infection (fever, cough, dyspnoea), with or without headache, myalgia, or arthralgia were included in the study. The diagnostic procedures for viral respiratory tract infections included at least one respiratory sample (nasopharyngeal aspirate or bronchoalveolar lavage) which was positive for influenza virus. Laboratory diagnoses were performed using multiplex Anyplex (TM) II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux) for emergency cases. Young children (less than 5 years) and elderly patients (greater than 65 years) were known to be at high risk of complications and were included in this study. Nosocomial infections were defined as those which had symptom onset after 48 hours of hospitalization or admission in a nursing home. Young children were at lower risk of comorbidities (OR = 0.16, 95 percent Cl = 0.08 plus or minus 0.35), admission in ICU (OR = 0.14, 95 percent Cl = 0.04 plus or minus 0.51) and severe disease (OR = 0.29, 95 percent Cl = 0.14 plus or minus 0.61) in comparison to patients aged 5 plus or minus 65 years. In contrast, elderly patients were at higher risk of comorbidities (OR = 2.00, 95 percent Cl = 1.05 plus or minus 3.79) but at lower risk of atypical infections (OR = 0.23, 95 percent Cl = 0.09 plus or minus 0.61) and they were more frequently vaccinated (OR = 3.30, 95 percent Cl = 1.18 plus or minus 9.24) in comparison to patients aged 5 plus or minus 65 years. Also, elderly patients were at higher risk of infection with A (H3N2) (OR = 2.39, 95 percent Cl = 1.16 plus or minus 4.94) and at lower risk of infection with A (H1N1) pdm09 (OR = 0.33, 95 percent Cl = 0.14 plus or minus 0.82) in comparison to patients aged 5 plus or minus 65 years. The 2014-2015 influenza season started with a high risk of vaccination failure because of the predominant circulation of variant strains. This risk was further increased by the low vaccination coverage (53 percent) of patients at risk of severe influenza disease. Vaccination failure was confirmed by the low estimated vaccine effectiveness (VE), especially for elderly patients greater than 65 years (VE = 5 percent, 95 percent Cl = 8-16 percent). This study identified that elderly patients (OR = 3.30, 95 percent Cl = 1.18 plus or minus 9.24), comorbidities (OR = 14.75, 95 percent Cl = 1.83 plus or minus 118.75) and female patients (OR = 0.38, 95 percent Cl = 0.16 plus or minus 0.92) were associated with influenza vaccination. The patient''s current condition included diabetes. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 05-Mar-2015 (reported as week 10), the patient was hospitalized due to the fever (body temperature greater than 38 or less than 35), cough, myalgia, arthralgia, asthenia and rhinorrhea which were considered as symptoms of respiratory infection. During hospitalization, nasopharyngeal aspirate or bronchoalveolar lavage was tested and was found to be positive for Influenza virus A infection which was diagnosed as community acquired infection. Laboratory diagnoses were performed using multiplex Anyplex (TM) II RV16 and RB5 PCR assays (Seegene) or the Film array 1 respiratory panel (Biomerieux). Subsequently, the patient was diagnosed with influenza A, H3N2 infection [sequence reported as 3C.2a] [considered as vaccination failure]. The patient''s initial complication was sepsis. The event was considered as severe and no antiviral medications were taken. The patient was hospitalized for 06 days. On an unspecified date, the patient died. It was unknown if autopsy was performed. The outcome of the events was not reported. The reporter assessed the events influenza infection and sepsis as serious (hospitalization, and death). As per the reporter, the events- Influenza A virus infection and vaccination failure were related to the suspect vaccine. This case was linked to 201802947 due to same reporter. Case Comment: an 81-year-old, male patient, with diabetes mellitus was hospitalized with symptoms of respiratory infection (fever, cough, myalgia, arthralgia, asthenia, and rhinorrhea) and diagnosed with influenza infection (considered as vaccination failure), an unknown period after receipt of INN flu vaccine. The causality for the events influenza virus infection and vaccination failure was considered as unassessable, due to minimal information regarding onset latency between vaccination to events. Subsequently the patient had complication of sepsis and died, an unspecified period after receipt of suspect vaccine. The event sepsis was considered as not related to suspect vaccine, considering the infectious aetiology of the event. The event death can be explained by sepsis in a diabetic elderly person, rather than suspect vaccine. Hence, the event death was considered as not related to suspect vaccine. The case will be reassessed upon receipt of new information. The company assessed the case as serious (hospitalization, medically significant).


VAERS ID: 760371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-06-28
Onset:2018-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD233A / UNK - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T91132 / UNK - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB811AD / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-06-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201812

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 10-week-old male patient who received INFARIX HEXA (batch number A21CD233A, expiry date unknown) for prophylaxis. Co-suspect products included ROTARIX liquid formulation (batch number AROLB811AD, expiry date unknown) for prophylaxis and PREVENAR 13 (batch number T91132, expiry date unknown) for prophylaxis. On 28th June 2018, the patient received INFANRIX HEXA (intramuscular) 1 dosage form(s), ROTARIX liquid formulation (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 29th June 2018, 1 days after receiving INFANRIX HEXA and ROTARIX liquid formulation, the patient experienced sleepy (serious criteria hospitalization) and unwell (serious criteria hospitalization). On an unknown date, the patient experienced death unexplained (serious criteria death, hospitalization and GSK medically significant). On 30th June 2018, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the sleepy and unwell were not recovered/not resolved. The patient died on 30th June 2018. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained, sleepy and unwell to be related to INFANRIX HEXA and ROTARIX liquid formulation. Additional details: Age at vaccination was not reported, however the patient was child at the time of vaccination. Initial information was received from a physician via regulatory authority on 18th July 2018: death unexplained, sleepy and unwell. Reported Cause(s) of Death: Death unexplained.


VAERS ID: 760566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia pneumococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131807JPN002199J

Write-up: Initial information has been received from a physician concerning an 84-year-old male patient. The underlying/concomitant disease was cerebrovascular disorder. Pneumococcal vaccine (product name unknown) was inoculated as prophylaxis (The inoculation date, dose and lot number were not reported). No concomitant drugs were reported. Premorbid Performance Status (PS) was 3. In 2014, pneumococcal pneumonia developed. pneumonia: healthcare-associated pneumonia (HCAP). Pneumonia Severity Index [PSI]: severe. Serogroup: 6A. On an unspecified date, the patient died of pneumococcal pneumonia. This is one of several reports received from the same reporter. Reporter''s comment: Not provided. The reporting physician did not assess the causal relationship between pneumococcal pneumonia and pneumococcal vaccine. The reporting physician did not assess the seriousness of pneumococcal pneumonia. Upon internal review, pneumococcal pneumonia was assessed as serious (other medically significant event).; Sender''s Comments: JP-MSD-1807JPN002208J: JP-MSD-1807JPN002209J:; Reported Cause(s) of Death: Pneumonia pneumococcal.


VAERS ID: 760626 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia pneumococcal
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131807JPN002209J

Write-up: Initial information has been received from a physician concerning a 68-year-old female patient. The underlying/concomitant disease was cardiac disease. Pneumococcal vaccine (product name unknown) was inoculated as prophylaxis (The inoculation date,dose and lot number were not reported). No concomitant drugs were reported. Premorbid Performance Status was (PS) 1. In 2017, pneumococcal pneumonia developed. pneumonia: HAP.PSI: mild,Serotype: 19 F. On an unspecified date, the patient died of pneumococcal pneumonia. This was one of several reports received from the same reporter. Reporter''s comment: Not provided. The reporting physician did not assess the causal relationship between pneumococcal pneumonia and pneumococcal vaccine. The reporting physician did not assess the seriousness of pneumococcal pneumonia. Upon internal review, pneumococcal pneumonia was assessed as serious (other medically significant event).; Sender''s Comments: JP-MSD-1807JPN002199J:; Reported Cause(s) of Death: Pneumonia pneumococcal.


VAERS ID: 760703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-06-29
Onset:2016-07-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER P21 / UNK UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 050415 / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dyspnoea, Hyperthermia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUSAKK2018SA194932AA

Write-up: Initial information received on 16-Jul-2018 regarding an unsolicited valid serious case received from Health Authorities (under reference number: 176422). This case involves a 9 months old female patient who experienced shortness of breath, weakness and hyperthermia, while she received vaccines IMOVAX POLIO, HEPATITIS B VACCINE (RDNA) and PREVENAR 13. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Liver function disorder and Kidney function disorder were reported as Unknown. Pregnancy was reported as no. On 29-Jun-2016, the patient received 0.5 ml dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site. On 29-Jun-2016, the patient received 0.5 ml dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot 050415 via intramuscular route in unknown administration site. On 29-Jun-2016, the patient received a dose of suspect HEPATITIS B VACCINE (RDNA) not produced by Sanofi Pasteur lot P21 via intramuscular route in unknown administration site. On 04-Jul-2016, the patient developed a serious shortness of breath 6 days following the administration of IPV (VERO), 6 days following the administration of PREVENAR 13 and 6 days following the administration of HEPATITIS B VACCINE (RDNA). This event was leading to death. The patient was hospitalized for this event. On 04-Jul-2016, the patient developed a serious weakness 6 days following the administration of IPV (VERO), 6 days following the administration of PREVENAR 13 and 6 days following the administration of HEPATITIS B VACCINE (RDNA). This event was leading to death. The patient was hospitalized for this event. On 04-Jul-2016, the patient developed a serious hyperthermia 6 days following the administration of IPV (VERO), 6 days following the administration of PREVENAR 13 and 6 days following the administration of HEPATITIS B VACCINE (RDNA). This event was leading to death. The patient was hospitalized for this event. On 04-Jul-2016, the patient developed a serious death 6 days following the administration of IPV (VERO), 6 days following the administration of PREVENAR 13 and 6 days following the administration of HEPATITIS B VACCINE (RDNA). This event was leading to death. The patient was hospitalized for this event. Laboratory test was not reported. Final diagnosis was (fatal) hyperthermia, (fatal) weakness and (fatal) shortness of breath. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for shortness of breath, as Fatal on an unknown date for weakness and as Fatal on an unknown date for hyperthermia. It is unknown if an autopsy was done. The cause of death was reported as Dyspnoea, Asthenia, Hyperthermia and death (unspecified). The reporter assessed the causal relationship between the event and suspect as conditional. List of documents held by sender: none. Sender''s Comments: This case concerns an infant patient who presented with dyspnea, asthenia and hyperthermia 5 days after vaccination with IMOVAX POLIO, HEPATITIS B and PREVENAR 13 vaccines with fatal outcome. The time to onset is compatible. There is, however, no information regarding patient''s birth history, congenital anomaly, condition at the time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information and considering that multiple vaccines preceded the events, the role of an individual vaccine cannot be assessed. Reported Cause(s) of Death: shortness of breath; weakness; hyperthermia; death.


VAERS ID: 760843 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia, Pneumonia pneumococcal
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131807JPN002208J

Write-up: Initial information has been received from a physician concerning an 68-year-old male patient. The underlying/concomitant disease was cerebrovascular disorder. Pneumococcal vaccine (product name unknown) was inoculated as prophylaxis (The inoculation date, dose and lot number were not reported). No concomitant drugs were reported. Premorbid Performance Status (PS) was 4. In 2017, pneumococcal pneumonia developed. Pneumonia: healthcare-associated pneumonia (HCAP). Pneumonia Severity Index [PSI]: severe. Serogroup: 6B. On an unspecified date, the patient died of pneumococcal pneumonia. This is one of several reports received from the same reporter. Reporter''s comment: Not provided. The reporting physician did not assess the causal relationship between pneumococcal pneumonia and pneumococcal vaccine. The reporting physician did not assess the seriousness of pneumococcal pneumonia. Upon internal review, pneumococcal pneumonia was assessed as serious (other medically significant event). Sender''s Comments: 1807JPN002199J: Reported Cause(s) of Death: Pneumonia pneumococcal.


VAERS ID: 761063 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided, This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 1 February 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B1 (a consistent temporal relationship but insufficient evidence for vaccine causality). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-08-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.15-month-old male patient who was vaccinated with unspecified oral polio virus; unspecified DPT and unspecified hepatitis B virus vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 14 August 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761065 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-02-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 28 February 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761066 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month and 6 days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in India from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 10 September 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of India''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761067 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 13 days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 13 December 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of India''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761068 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-02-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 22 days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 20 February 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.5-month -old female patient who was vaccinated with unspecified oral polio virus vaccine; unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 December 2012, the patient received unspecified OPV, DPT and Hepatitis virus vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761070 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: .This case was reported in a literature article and described the occurrence of unknown cause of death in a 18-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included measles virus vaccine live attenuated (Measles) for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 18-month -old male patient who was vaccinated with unspecified oral polio virus (OPV) vaccine, unspecified diphtheria- pertussis (acellular or whole cell)- tetanus (DPT) vaccine and unspecified measles vaccine (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by India''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 4 June 2014, the patient received unspecified OPV, DPT and measles vaccines (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2014, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B2 (conflicting evidence or inconsistency about a causal association to immunization). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761071 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-08-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN A
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 15-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Concomitant products included retinol (Vitamin A). On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 15.7-months old female patient who was vaccinated with unspecified oral polio virus (OPV) vaccine and unspecified diphtheria- pertussis (acellular or whole cell)-tetanus- (DPT) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in India from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). The patient received Vitamin A concomitantly. No information on patient''s medical or family history or concurrent condition was provided. On 23 August 2012, the patient received unspecified OPV and DPT vaccines (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761072 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN A
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 18-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Concomitant products included retinol (Vitamin A). On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 18-month -old male patient who was vaccinated with unspecified oral polio virus (OPV) vaccine and unspecified diphtheria- pertussis (acellular or whole cell)-tetanus- (DPT) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). The patient received Vitamin A concomitantly. No information on patient''s medical or family history or concurrent condition was provided. On 1 March 2013, the patient received unspecified OPV and DPT vaccines (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B2 (conflicting evidence or inconsistency about a causal association to immunization). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761073 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-months and 6 days-old female patient who was vaccinated with unspecified oral polio virus (OPV) vaccine and unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency and website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 16 May 2012, the patient received unspecified OPV and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761074 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-01-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month-old male patient who was vaccinated with unspecified oral polio virus (OPV) vaccine; unspecified hepatitis B virus (HBV) vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 21 January 2012, the patient received unspecified OPV, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the National AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761075 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included bcg vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in India from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 9 March 2013, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries. to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761076 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-08-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 22 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell) - tetanus - (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 29 August 2012, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761077 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK - / -
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 22 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell) - tetanus - (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 September 2012, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761078 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-10-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included bcg vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 27 days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 31 October 2012, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761079 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-06-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 6 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria-pertussis (acellular or whole cell)-tetanus- (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 12 June 2013, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761137 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-04-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old female subject who received DTP vaccine for prophylaxis. On an unknown date, less than a year after receiving DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4.1-month-old female patient who was vaccinated with unspecified DTP vaccine (manufacturer unknown) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 18 April 2012, the patient received unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-07-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 60-month-old male subject who received DTP vaccine for prophylaxis. On an unknown date, less than a year after receiving DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine. Additional intion was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 60.7-month-old male patient who was vaccinated with unspecified DTP vaccine (manufacturer unknown) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 26 July 2012, the patient received unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761139 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received DTP vaccine for prophylaxis. On an unknown date, less than a year after receiving DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.4-month-old female patient who was vaccinated with unspecified DTP and unspecified HBV vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 1 March 2013, the patient received unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of India''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761140 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.5-month -old male patient who was vaccinated with unspecified Oral Polio Virus (OPV) vaccine and unspecified diphtheria-tetanus-pertussis (acellular or whole cell) (DTP) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 12 December 2012, the patient received unspecified OPV and unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761141 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-07-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus-(DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 July 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-07-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 23-days-old female patient who was vaccinated with unspecified OPV; unspecified DPT and unspecified HBV vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 12 July 2013, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761143 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-07-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 22-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 24 July 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761144 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-10-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 5-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 October 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761145 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 20-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 11 February 2015, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761146 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 54-day-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 54-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 15 December 2012, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761147 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-02-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 2 February 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761148 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 20 March 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761149 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3-month and 19 days-old male patient who was vaccinated with unspecified OPV; unspecified DPT and unspecified HBV vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 15 October 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761150 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 30-day-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 30 days-old male patient who was vaccinated with unspecified OPV; unspecified DPT and unspecified HBV vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 September 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761151 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-05-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 15 days-old male patient who was vaccinated with unspecified OPV; unspecified DPT and unspecified HBV vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 26 May 2014, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2014, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
UNK: VACCINE NOT SPECIFIED (FOREIGN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2 month old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.5-month-old male patient who was vaccinated with unspecified OPV vaccine; unspecified DPT vaccine (manufacturer unknown for both) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 19 December 2012, the patient received unspecified OPV, DPT and Hepatitis virus vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month-old female patient who was vaccinated with unspecified OPV; unspecified DPT, unspecified HBV and unspecified BCG vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 14 August 2012, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761189 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old male subject who received DTP vaccine for prophylaxis. On an unknown date, less than a year after receiving DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3-month-old male patient who was vaccinated with unspecified DTP and unspecified HBV vaccine (manufacturer unknown for both) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 16 June 2012, the patient received unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761190 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4.5-month -old male patient who was vaccinated with unspecified Oral Polio Virus (OPV) vaccine and unspecified diphtheria-tetanus-pertussis (acellular or whole cell) (DTP) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 1 February 2012, the patient received unspecified OPV and unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 5-month -old female patient who was vaccinated with unspecified OPV vaccine and unspecified DTP vaccine (manufacturer unknown for both) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 7 February 2012, the patient received unspecified OPV and unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761192 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month and 5-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 24 September 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761193 (history)  
Form: Version 2.0  
Age: 1.33  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.4-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 11 January 2012, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761194 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.4-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 11 October 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-08-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.8-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 10 August 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761196 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.7-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 1 August 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761197 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 12 December 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761198 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-05-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 5.9-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The AEFI Assessment reviewed all serious/severe AEFI reports which were reported to AEFI surveillance program. These reports were further verified by the complete AEFI Committee and submitted to the Agency. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 16 May 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761199 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.7-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 4 January 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761200 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-12-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.4-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 27 December 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761201 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-09-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.3-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 18 September 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional narrative was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.4-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 11 November 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761203 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-05-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 8-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in an 8-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The AEFI subcommittee reviewed all serious/severe AEFI reports which were reported to AEFI surveillance program. These reports were further verified by the complete AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 2 May 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3.4-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 16 June 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761205 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 45-day-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 45-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 8 February 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided.On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761206 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-06-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 14 June 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month-old female patient who was vaccinated with unspecified OPV; unspecified DPT and unspecified HBV vaccines (manufacturer unknown for all) for prophylaxis. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported in this country from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by this country''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 18 November 2013, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of campaign immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B2 (conflicting evidence or inconsistency about a causal association to immunization). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of this country''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 1 February 2014, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2014, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.5-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 18 January 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category A1 (the vaccine product). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761210 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-06-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 12 June 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761211 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-10-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The AEFI Assessment committee reviewed all serious/severe AEFI reports which were reported to AEFI surveillance program. These reports were further verified by the complete AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 24 October 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761212 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-01-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month and 3 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 4 January 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761213 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-06-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 5-month and 19 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The AEFI Assessment committee reviewed all serious/severe AEFI reports which were reported to AEFI surveillance program. These reports were further verified by the complete AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 14 June 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the AEFI, the case was taken up for causality assessment by trained experts of the subcommittee of the AEFI committee]. This case has been considered as serious due death. The case report was classified under category B1 (a consistent temporal relationship but insufficient evidence for vaccine causality). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761214 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2-month and 19 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency and website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 21 September 2015, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761215 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-01-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month -old female patient who was vaccinated with unspecified oral polio virus (OPV) vaccine; unspecified hepatitis B virus (HBV) vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to AEFI surveillance program. These reports were further verified by the complete AEFI Committee and submitted to the Agency for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Agency website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 5 January 2012, the patient received unspecified OPV, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Agency, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the AEFI committee]. This case has been considered as serious due death. The case report was classified under category B1 (a consistent temporal relationship but insufficient evidence for vaccine causality). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received DTP vaccine for prophylaxis. Co-suspect products included BCG vaccine for prophylaxis. On an unknown date, less than a year after receiving DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.3-month-old male patient who was vaccinated with unspecified DTP and unspecified BCG vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 4 January 2012, the patient received unspecified DTP and unspecified BCG vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761296 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-02-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN A
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 66-month-old male subject who received DTP vaccine for prophylaxis. Concomitant products included retinol (Vitamin A). On an unknown date, less than a year after receiving DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 66-month-old male patient who was vaccinated with unspecified diphtheria-tetanus-pertussis (acellular or whole cell) (DTP) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). Vitamin-A was administered as a concomitant medication. No information on patient''s medical or family history or concurrent condition was provided. On 15 February 2013, the patient received unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B2 (conflicting evidence or inconsistency about a causal association to immunization). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of India''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761297 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a month after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month 19-days-old male patient who was vaccinated with unspecified Oral Polio Virus (OPV) vaccine, unspecified diphtheria-tetanus-pertussis (acellular or whole cell) (DTP) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 6 December 2012, the patient received unspecified OPV and unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761298 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 9-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent and DTP vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent and DTP vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 9.1-month -old male patient who was vaccinated with unspecified Oral Polio Virus (OPV) vaccine and unspecified diphtheria-tetanus-pertussis (acellular or whole cell) (DTP) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by India''s National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 27 September 2012, the patient received unspecified OPV and unspecified DTP vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761299 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-04-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 7-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 7-month and 20-days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 9 April 2015, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761300 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-03-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.9-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 7 March 2012, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761301 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-01-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-day-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a week after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3-days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 27 January 2012, the patient received unspecified OPV, unspecified DTP and unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761302 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-09-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 11 September 2013, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761303 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-01-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 2.5-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 10 January 2015, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761304 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 3-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 3-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 2 June 2012, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761305 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.5-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 15 November 2012, the patient received unspecified OPV, unspecified DTP, unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B1 (a consistent temporal relationship but insufficient evidence for vaccine causality). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-09-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 5-month -old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 18 September 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category B2 (conflicting evidence or inconsistency about a causal association to immunization). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761307 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-10-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 19 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 16 October 2013, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2013, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of India''s AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 761308 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-01-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-month-old male subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 4-month and 19 days-old male patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 7 January 2016, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2016, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


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