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VAERS ID: 586911 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-19
Onset:2012-07-19
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1098
Entered: 2015-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiogenic shock, Chills, Death, Dyspnoea, Pneumonia, Pulmonary hypertension, Pyrexia, Right ventricular failure, Septic shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), 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: 2012-07-19
   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: Con Meds -None; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: hypertension; congestive heart failure; dyslipoproteinemia
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA106414

Write-up: Initial unsolicited literature report received from a pharmacist on 16-Jul-2015. A 68 years old female patient, had received a dose of Influenza Vaccine (dose details, batch number, expiry date, route of administration and site of administration were not reported) on 19-Jul-2012. The patient had a history of hypertension, congestive heart failure and dyslipoproteinemia. The family history was unknown. She did not take any concomitant medications. On 19-Jul-2012, same day post-vaccination, the patient was febrile, she developed chills and dyspnea. She died on 19-Jul-2012. The physician had diagnosed that patient had died due to severe pulmonary hypertension, right side heart failure, suspected septic/cardiogenic shock and pneumonia. It was reported that after the death cause evaluation, the result stated that it was not related to the vaccine. Laboratory investigations and corrective treatments were not reported. Relationship of the suspect vaccine and the events per the reporter: No. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: cardiogenic shock, septic shock, pulmonary hypertension, failure right heart, pneumonia.


VAERS ID: 586912 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-27
Onset:2012-07-27
   Days after vaccination:0
Submitted: 2015-07-22
   Days after onset:1090
Entered: 2015-07-23
   Days after submission:1
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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   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: Con Meds = None; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Diabetes mellitus; hypertension; COPD; polycythemia
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA106415

Write-up: Initial unsolicited literature report received from a healthcare professional on 16 July 2015. A 49-year-old female patient had received a dose of Influenza vaccine (batch number, route and site of administration were unknown) on 27 July 2012. Patient''s medical history included diabetes mellitus (DM), COPD (chronic obstructive pulmonary disease), HTN (hypertension) and polycythemia. The patient did not receive any concomitant medication. On 27 July 2012, same day unspecified time after vaccination, the patient was found dead. Physician was not able to perform diagnosis as the corpse was not taken to the hospital. Laboratory investigations and corrective treatment were unknown. Autopsy was not performed. Patient died of an unknown cause. The causality was reported as not related to vaccine. Documents held by sender: none.


VAERS ID: 588567 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-07-19
Onset:2012-07-20
   Days after vaccination:1
Submitted: 2015-07-23
   Days after onset:1098
Entered: 2015-07-24
   Days after submission:1
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, Fatigue, Hyperhidrosis, Peripheral coldness
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-20
   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: Con Meds -None; Indomethacin
Current Illness:
Preexisting Conditions: Abdominal pain; flatulence
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA106412

Write-up: A 69 years old male patient who did not take any concomitant medications had received a dose of Influenza vaccine (dose details, batch number, expiry date, route of administration and site of administration were not reported) on 19 July 2012. The patient had a history of abdominal pain with flatulence and was taking Indomethacin regularly. The family history was unknown. On 20-Jul-2012, next day post-vaccination; the patient experienced fatigue and sweating and was found cold bodied and dead at home. Laboratory investigation and corrective treatments were not reported. At the time of report, the outcome of the events fatigue, sweating and body temperature was unknown. Relationship of the suspect vaccine and the events per the reporter was reported as "No". Documents held by sender: none. Lab tests unknown. Cause(s) of Death: death NOS.


VAERS ID: 588606 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2015-06-22
Onset:2015-06-23
   Days after vaccination:1
Submitted: 2015-07-24
   Days after onset:31
Entered: 2015-07-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L7078 / 3 LL / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C39011 / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L21066 / 2 RL / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA228BC / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Decreased appetite
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-23
   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: 14-MAR-2015 to Unknown, Baby premature, Child was delivered preterm with a birth weight of 890 g; 14-MAR-2015 to Unknown, Oxygen consumption, Spent 2 and a half months on continuous oxygen; 14-MAR-2015 to 14-MAR-2015, BCG, Immunisation, No adverse effect, at Birth, AROLA228BC; 14-MAR-2015 to 14-MAR-2015, Polio vaccine, Immunisation, No adverse event, at birth, batch number K5385; 27-APR-2015 to 27-APR-2015, Polio vaccine, Immunisation, No adverse event, 6 weeks immunization, batch number K5555; 27-APR-2015 to 27-APR-2015, Rotavirus vaccine, Immunisation, No adverse event, 6 weeks immunizations, batch number AROLA976AR; 27-APR-2015 to 27-APR-2015, PENTAXIM, Immunisation, No adverse event, 6 weeks immunization, batch number K8486; 27-APR-2015 to 27-APR-2015, Hepatitis B, Immunisation, No adverse event, 6 weeks, batch number 303301/0; 27-APR-2015 to 27-APR-2015, PREVENAR 13, Immunisation, No adverse event, 6 weeks immunization, lot X080620; 25-MAY-2015 to 25-MAY-2015, PENTAXIM, Immunisation, No adverse event, 10 weeks immunization, batch number K8485; 25-MAY-2015 to 25-MAY-2015, Hepatitis B, Immunisation, No adverse event, 10 weeks immunization, batch number 303301/0
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015244278

Write-up: This is a spontaneous report from a consumer. A 3-months-old female patient of an unspecified ethnicity received the second dose of PREVENAR 13, (lot L21066, exp. date Jul2017), via an unspecified route of administration on 22Jun2015 at single dose in right thigh, third dose of PENTAXIM, (lot L7078, exp. date Aug2016), via an unspecified route of administration on 22Jun2015 in left thigh, third dose of Hepatitis B, (lot 3C3901/1, exp. date Sep2016), via an unspecified route of administration on 22Jun2015 in right thigh and second dose of rotavirus vaccine, oral on 22Jun2015. Medical history included premature baby on 14Mar2015 to an unknown date (Child was delivered preterm with a birth weight of 890 g), oxygen consumption from 14Mar2015 (Spent 2 and a half months on continuous oxygen). The patient''s concomitant medications were not reported. No history of allergies in this child was obtained. The parents denied any history of using any traditional medicine on the child at the time. There were no other AEFIs reported from this child in the last 30 days. The child lives with the parents, the baby has not a twin/triplet and with no disability present (including birth defects). The mother does not need additional support to care for this child. Baby head circumference at birth was 38 cm. The patient had previously received the following vaccines, at birth BCG (batch number 113047A) in the right arm, oral polio vaccine first dose (batch number K5385); on 27Apr2015 (6 weeks) oral polio vaccine second dose (batch number K5555), rotavirus vaccine first dose (batch number AROLA976AR) orally, DTP-Hib-IPV first dose (batch number K8486) in the left thigh, hepatitis B first dose (batch number 303301/0) in the right thigh, pneumococcal 13-val conj vac (first dose (lot X080620) in the right thigh; on 25May2015 (10 weeks) DTP-Hib-IPV second dose (batch number K8485) in the left thigh, hepatitis B second dose (batch number 303301/0) in the right thigh. The child has had no previous reaction after immunization. The health status of the child was assessed before immunization. On the day of Immunization the baby weighed 2.9 kg. The child was well and eligible for immunizations. The mother also reported that the child was well and that there are no allergies to immunizations. Then the child was immunized. The parents reported that the child was well after immunization until during the night. No fever, no vomiting or any rash was observed. At around midnight the child cried but slept well. No swelling was observed on the vaccine site. Mother stated that since the morning on the 23Jun2015 the child refused breast milk. According to the parents the child started not feeling well at about 11h00 on the 23Jun2015. There was no fever, no vomiting or any other except that the child had a weak cry and refused feeds. On the way to the clinic at around 14h00 the child passed away. On arrival there was not heartbeat and no pulse heard; skin anaemic. The patient died on 23Jun2015. An autopsy was performed and results were not provided.


VAERS ID: 588577 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-07-28
Entered: 2015-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507GBR011813

Write-up: Information has been received from Sanofi Pasteur MSD (Sender case report number GB-1577272925-E2015-08469) on 24-JUL-2015. Serious case received from a consumer via lay press on 19/Jul/2015. This case is not medically confirmed. This case is linked to E2015-08375 (same reporter). An unknown number of female patients of unreported age, with no concomitant medication reported, received injections of GARDASIL, (batch number not reported), series site and route not reported, on unreported date. The majority of the teenagers were perfectly healthy prior to vaccination. On unreported dates, some young people have died following vaccination with most post mortem results unable to show a conclusive cause of death. A petition, from the Agency of HPV Vaccine Injured Patients, stated that there was a growing pattern of illness emerging among young girls since the vaccine was introduced. The agency has been contacted by more than 130 families since 2008 and more than half of these have come forward indicating the rate was accelerating. The case was considered serious for death.


VAERS ID: 588987 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-05
Onset:2015-05-05
   Days after vaccination:0
Submitted: 2015-07-31
   Days after onset:87
Entered: 2015-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood test, C-reactive protein, Culture, Death, Differential white blood cell count, Metabolic function test, Microbiology test, Pyrexia, Respiratory arrest, Sudden infant death syndrome, Viral test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-05-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Tobacco user, maternal (10 cigarettes/day)
Allergies:
Diagnostic Lab Data: Butyryl carnitine C4 1.53, Propionylcarnitine - 5.22, Venous NH4 more than 1700, Phenobarbital less than 1.1 mg/L, Paracetamol less than 3 mg/L, Hydroxylated acyclcarnitines 1.31, Ethyl alcohol 0.13g/L. Anisocytosis and Poikilocytosis was positive, serum glycemia was 157 mg/dl. Bacteriology: Staphylococcus haemolyticus. Probable myco contamination: Negative. Microbiological examination (LCR) Direct examination and cultures: Negative. Microbiological examinations (stools): Absence of Salmonella, Shigella, Yersinia, Campylobacter. Virology: CMV, Enterovirus, HSV1, HSV2, VZV, EBV: Negative. Imaging: no objectivated fracture. Elevated rates of most amino acids with lowered arginine. The profile is not characteristic of a metabolism inborn disorder but consistent with a metabolic examination. 2015, Blood bicarbonate, 5 mmol/L; 2015, Blood creatine phosphokinase, 2952 iu; 2015, Blood immunoglobulin E, less than 2000 u/L; 2015, Blood lactate dehydrogenase, 2775 iu; 2015, Blood lactic acid, more than 13.32 mmol/L; 2015, Blood lactic acid, more than 13.3 mmol/L; 2015, Blood potassium, more than 10 mmol/L; 2015, C-reactive protein, less than 1 mg/L; 2015, Haemoglobin, 9.4 g/dL; 2015, Lymphocyte count, 96.5%; 2015, Mean cell volume, 105 fL; 2015, Mean cell volume, 26.6 g/dL; 2015, Red blood cell count, 3.37 x 10E6/mm3
CDC Split Type: BE2015GSK108355

Write-up: This case was reported by a pharmacist via regulatory authority and described the occurrence of sudden infant death in a 4-month-old male patient who received INFANRIX HEXA. Co-suspect products included ROTARIX. The patient''s past medical history included smoker (Maternal (10 cigarettes/day)). On 5th May 2015, the patient received the 2nd dose of INFANRIX HEXA (intramuscular) .5 ml and the 1st dose of ROTARIX (oral) 1.5 ml. On 5th May 2015, less than a day after receiving INFANRIX HEXA and ROTARIX, the patient experienced febrile reaction. On 10th May 2015, the patient experienced sudden infant death (serious criteria death and GSK medically significant) and respiratory arrest (serious criteria death and GSK medically significant). The patient was treated with Adrenaline. On 10th May 2015, the outcome of the sudden infant death and respiratory arrest were fatal. On an unknown date, the outcome of the febrile reaction was unknown. The patient died on 10th May 2015. The reported cause of death was sudden infant death and respiratory arrest. An autopsy was performed. It was unknown if the reporter considered the sudden infant death, respiratory arrest and febrile reaction to be related to INFANRIX HEXA and ROTARIX. Additional details were provided as follows: On 5th May 2015, less than a day after vaccination with INFANRIX HEXA and ROTARIX, the patient experienced small febrile reaction, but which did not necessitate PERDOLAN. On 10th May 2015, the patient was in overall good health and well on a general and digestive level. At 4.30 pm, the patient drank carrot soup for the first time. At 7.30 pm, the patient experienced respiratory arrest. The patient was intubated, ventilated, adrenalin (5 doses), no cardiac rhythm upon admission. At 9.10 pm, the patient was died suddenly during sleep. Post-mortem sampling, analyses not validated and to be controlled in an accredited forensic lab. Physiochemical examinations of blood showed ethyl alcohol 0.13 g/L (to be confirmed by a reference method because test not validated on post-mortem matrix. Phenobarbital was less than 1.1 mg/L, paracetamol was less than 3 mg/L, glycaemia (on serum) was 157 mg/dL, lactic acid was more than 13.3 mmol/L, potassium was more than 10 mmol/L, bicarbonates was 5 mmol/L, venous NH4 was more than 1700.0 ug/dL, lactate dehydrogenase was 2775 IU, C-reactive protein was less than 1 mg/L, creatine phosphokinase was 2952 IU and total immunoglobulin E was less than 2.0 kU/L. Erythrocyte parameters included erythrocytes was 3.37 10x6/mm3, haemoglobin was 9.4 g/dL, mean corpuscular volume 105 fl, mean corpuscular concentration was 26.6 g/dL. Anisocytosis and poikilocytosis was positive. Leukocyte parameters showed lymphocytes was 96.5 percent. Microbiological examinations (venous puncture) showed bacteriology: Staphylococcus haemolyticus. Probable myco contamination was negative. Microbiological examinations (LCR): Direct examination and cultures was negative. Microbiological examinations (stools) showed there was absence of Salmonella, Shigella, Yersinia and Campylobacter. Virology showed cytomegalovirus, Enterovirus, Human simplex virus 1 and 2, varicella zoster virus and Epstein Barr virus was negative. In Imaging, there were no objectivated fracture. Miscellaneous examinations showed lactate (LCR) was more than 13.32 mmol/L, saturated acylcarnitines, Propionyl carnitine C3 was 5.22. Butyryl carnitine C4 was 1.53, hydroxylated acylcarnitines was 1.31. There was elevated rates of most amino acids with lowered arginine. The profile was not characteristic of a metabolism inborn disorder but consistent with a metabolic examination. Implementation of a right saphenous vein catheter, volume expansion 100 mL. Adrenaline was administered in 1/10000 6 mL 2x (10 times the dose). Reporter also mentioned that no causality link could be demonstrated between event and INFANRIX HEXA and ROTARIX.


VAERS ID: 592324 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-24
Onset:2015-07-26
   Days after vaccination:2
Submitted: 2015-07-31
   Days after onset:5
Entered: 2015-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Gastrointestinal disorder, Myocardial infarction, Refusal of treatment by relative
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-27
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RO2015GSK108261

Write-up: This case was reported by a physician via other and described the occurrence of heart attack in a infant male patient who received ROTARIX. On 24th July 2015, the patient received ROTARIX. In July 2015, less than a week after receiving ROTARIX, the patient experienced heart attack (serious criteria death and GSK medically significant) and gastrointestinal disorder. On an unknown date, the outcome of the heart attack was fatal and the outcome of the gastrointestinal disorder was unknown. The reported cause of death was heart attack. An autopsy was performed. It was unknown if the reporter considered the heart attack and gastrointestinal disorder to be related to ROTARIX. Additional details were provided as follows: On 26th July 2015, the patient''s parents brought him to hospital for gastrointestinal issues. The physician who saw the patient recommended interment but the patents refused. On Monday 27th July 2015, they brought again the patient to the hospital and after that the patient was transferred to another hospital at emergency room The patient had a heart attack and died. The physician mentioned that the patient was a twin.


VAERS ID: 595419 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-07
Entered: 2015-08-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Biopsy skin, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Endoscopy abnormal, Lymphocyte count decreased, Nocardiosis, Oesophageal candidiasis, Polymerase chain reaction positive, Pulmonary mass, Respiratory disorder, Skin lesion
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-25
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: ZOSTAVAX, 09-JUN-2015; Influenza vaccine; MEDROL
Current Illness:
Preexisting Conditions: Non-Hodgkin''s lymphoma (treated with 5 cycles of chemotherapy with bendamustine); Hypertension arterial; Chronic anemia; Auricular fibrillation; Nocardiosis (admitted to hospital and prescribed with ceftriaxone and trimethropin sulfa); Aplastic anemia (possible a multifactorial aplastic anemia and TPM SX); Abdominal pain (the patient was hospitalized on several occasion as result)
Allergies:
Diagnostic Lab Data: 17-JUL-2015, Biopsy skin; 17-JUL-2015, Blood immunoglobulin G, Negative result for blood VZ; 17-JUL-2015, Blood immunoglobulin M, Negative result for blood VZ; JUL-2015, Endoscopy, esophageal candidiasis; 17-JUL-2015, Lymphocyte count, 15; 17-JUL-2015, Lymphopenia, 187; 17-JUL-2015, Polymerase chain reaction, Positive PCR in alveolar liquid
CDC Split Type: 2015261233

Write-up: This is a spontaneous report from a contactable physician received from Merck. A 65-year-old male patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose. Medical history included non-Hodgkin''s lymphoma (treated with 5 cycles of chemotherapy with bendamustine), hypertension arterial, chronic anemia, auricular fibrillation, pulmonary nocardiosis (as result the patient was admitted to the hospital and was prescribed with ceftriaxone and trimethropin sulfa; as symptoms for this diagnosed the patient experienced pulmonary nodules and a compromised periphery airways), aplastic anemia (possible a multifactorial aplastic anemia and TPM SX), abdominal pain (the patient was hospitalized on several occasion as result). Concomitant medication included ZOSTAVAX (Lot# K009354) subcutaneous, on 09Jun2015; influenza vaccine and MEDROL tablet, at 8 mg daily. The patient was hospitalized as result of abdominal pain on 13Jul2015. During hospital stay it was observed an evolution of pulmonary speculated nodules as well as a compromised periphery airways as notice when the patient was diagnosed with nocardiosis, after undergoing an endoscopy in Jul2015 the patient was diagnosed with esophageal candidiasis and on 14Jul2015 the patient started to develop some unspecified skin lesion (varicella was consider as a cause but it was not confirmed). The patient underwent lab tests and procedures on 17Jul2015 which included: biopsy skin (performed first by LCR and then by PCR), blood immunoglobulin G (negative result for blood VZ), blood immunoglobulin M on 17Jul2015 (negative result for blood VZ), lymphocyte count 15, lymphopenia 187 and polymerase chain reaction (positive PCR in alveolar liquid). The patient died on 25Jul2015 as result of a refractory shock. It was unknown if an autopsy was performed.


VAERS ID: 595422 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2015-08-03
Onset:2015-08-04
   Days after vaccination:1
Submitted: 2015-08-06
   Days after onset:2
Entered: 2015-08-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14C10A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-04
   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: APGAR score, 10/10
CDC Split Type: 2015261748

Write-up: This is a spontaneous report from a contactable physician through regulatory authority (regulatory authority report number V15100392) and from a contactable physician (who gave the injection) via a Pfizer sales representative. A 3-month-old male patient (birth weight of 2902 g) received on 03Aug2015 at 15:15 PM the second dose of PREVENAR 13 (lot number 14C10A, expiry date 30Apr2017) at 0.5 ml single, the first dose of QUATTROVAC at 1 dosage form, single and the second dose of ACTHIB at 1 dosage form, single all subcutaneously. Patient body weight at birth was appropriate for age and APGAR score was 10/10, without any medical history. Relevant medical history and concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 04Aug2015 at 07:00 AM and he died. At 07:00 AM on 04Aug2015, the patient was found lying face-down. The patient was emergently transferred to the hospital in the morning of 04Aug2015. He was found to be in cardio-respiratory arrest. Cardiopulmonary resuscitation was performed, but the patient did not react to it and the death was confirmed. Autopsy was not yet performed. Maternal and child health handbook was not brought to the hospital and details of injections given on 03Aug2015 was unknown. The reporting physician classified the event as serious for fatal outcome and assessed the causality as unassessable. The reporting physician (the physician who gave the injection) commented that since the baby was found face-down, high possibility of accident was considered.


VAERS ID: 607358 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-27
Onset:2015-08-03
   Days after vaccination:7
Submitted: 2015-08-13
   Days after onset:10
Entered: 2015-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L0111 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L59072 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K019814 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-08-03
   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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DEU005342

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number E2015-09117) on 12-AUG-2015. Case was received from the Health Authority on 07-Aug-2015 (reference no. PEI2015047123). Case is medically confirmed. A 2-month-old male patient received a first dose of HEXYON (lot-no. L0111-1) IM into the left thigh, first dose of ROTATEQ (lot-no. K019814) oral and first dose of PREVENAR 13 (Pfizer, lot-no. L59072) IM into the right thigh on 27-Jul-2015. One week later, on 03-Aug-2015, the patient suddenly died. Death cause was reported as SIDS (Sudden infant death syndrome). It was not reported whether the autopsy was performed or not.


VAERS ID: 607369 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-05-03
Onset:2015-08-06
   Days after vaccination:825
Submitted: 2015-08-13
   Days after onset:7
Entered: 2015-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Demyelinating polyneuropathy, Diarrhoea, Dizziness, Headache, Hypoaesthesia, Mobility decreased, Movement disorder, Pyrexia, Quadriplegia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-06
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/2013, Body temperature, Fever
CDC Split Type: WAES1508COL004387

Write-up: This spontaneous report was received from the local news (local radio, television, and online newspaper) concerning to a female patient of approximately 19 to 20 years (discrepancy among media news). Information regarding the patient''s medical history, concurrent conditions or concomitant therapy was not provided. On an unspecified date in May 2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml injection (strength, lot number and expiration date were not provided), 0.5 ml intramuscular. Subsequently, on an also unspecified date in May 2013, after the vaccination, the patient experienced muscle numbness, movement disorder (no specific description was provided) and dizziness. On 25-OCT-2013, the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection (strength, lot number and expiration date were not provided), 0.5 ml intramuscular. On the same month, also after vaccination, the patient experienced headache, diarrhoea, vomiting and pyrexia. Later, on an unknown date in 2014, the patient experienced mobility decreased in her limbs. Then on the same year, she got quadriplegic and, according to the news, in 2014, she was diagnosed with demyelinating polyneuropathy (there was no exact description or clear information concerning when or where the diagnosis was given). In 2015, the patient experienced the first respiratory arrest and recovered from it on an unknown date in the same year. Consequently, on 06-AUG-2015 at 19:-00, the patient experienced the second respiratory arrest and died from it. It was unknown if an autopsy was performed. At the time of this report, the patient had not recovered from quadriplegia. The outcome of demyelinating polyneuropathy, vomiting, pyrexia, headache, dizziness, diarrhoea, hypoaesthesia, movement disorder and mobility decreased was unknown. Additional information is not expected because contact information is not available.


VAERS ID: 607562 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-11
Entered: 2015-08-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Autonomic nervous system imbalance, Axonal neuropathy, Blood electrolytes normal, Blood pressure increased, Blood test normal, Cardiac arrest, Chest X-ray normal, Death, Delirium, Dysphagia, Electrocardiogram abnormal, Endotracheal intubation, Heart rate increased, Hypotonia, Liver function test normal, Mechanical ventilation, Muscle contractions involuntary, Muscular weakness, Nerve conduction studies abnormal, Neurological examination abnormal, Neurological symptom, Nuclear magnetic resonance imaging spinal abnormal, Paralysis, Paraparesis, Pyrexia, Rabies, Renal function test normal, Respiratory distress, Respiratory failure, Respiratory rate increased, Restlessness, Sensory loss, Sinus tachycardia, White matter lesion, Wound abscess, Wound treatment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular 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), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Animal bite, He had bite marks at multiple sites on his body involving lower limbs, trunk, left upper limb and right ear lobe and bite marks were of category III; Wound treatment; Wound, Left lower limb was more affected due to multiple and large wounds on left side; Endotracheal intubation; Mechanical ventilation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 160/100, High; Electrocardiogram, Abnormal, Sinus tachycardia; Heart rate, 110/min, High; Nerve conduction studies, Abnormal, Pure motor axonal neuropathy in bot the lower limbs; Nuclear magnetic resonance imaging spinal, Abnormal, Magnetic resonance imaging of the cervicodorsal spine including lower brainstem showed hyperintense signal on T2 weighted image involving predominantly central gray matter of spinal cord from D-5 to L-1 vertebral levels suggestive of long-segment myelitis; Respiratory rate, 30/min, High
CDC Split Type: PHHY2015IN095485

Write-up: Case number PHHY2015IN095485 is an initial literature report received on 15 May 2015. The author discussed about an unusual case of suspected paralytic rabies in a patient which posed a diagnostic dilemma with post vaccination myelitis, after receiving complete post exposure prophylaxis including anti-rabies immunoglobulin. This report refers to a 55 year old male patient. He was bitten by a jackal and he had bite marks at multiple sites on his body involving lower limbs, trunk, left upper limb and right ear lobe. He was vaccinated with complete post exposure prophylaxis with RABIPUR (manufacturer: Chiron Behring, batch number: not reported) on unknown dates as per vaccination schedule (2 site intra dermal injection on days 0, 3, 7, and 28). He also received anti-rabies immunoglobulin locally and intramuscularly (total dose, 6.6 mL) and was referred to surgery department for local wound management. He was presented with features suggestive of paralytic rabies after 1 and a half month of jackal bite. He had a 3 day history of acute neurologic illness starting with moderate grade fever for 1 day followed by progressive asymmetric weakness of both lower limbs (left more than right). On examination, vital parameters were stable and multiple bite marks of category III were present. Left lower limb was more affected due to multiple and large wounds on left side; however, myoedema was absent. There was abscess formation in left lower limb wound. Neurological examination revealed hypotonia in left lower limb along with asymmetric paraparesis with motor power of grade 3/5 in right lower limb and 1/5 in left lower limb. Deep tendon reflexes were brisk except for absent knee jerk on left side with bilateral silent plantar responses. On sensory examination, there was impairment of sensations for pinprick and crude touch below D-6 spinal level (left more than right), whereas joint position sense was intact. Diffuse fasciculations were present on tongue, both upper and lower limbs and on trunk. Examination of other systems was unremarkable. Investigations including routine hemogram, liver and renal function tests, serum electrolytes, electrocardiogram and chest x-ray were normal. Based on clinical presentation and history of complete post exposure prophylaxis, post vaccination myelitis was considered as the first possibility. Magnetic resonance imaging (MRI) of the cervicodorsal spine including lower brainstem showed hyperintense signal on T2 weighted image involving predominantly central gray matter of spinal cord from D-5 to L-1 vertebral levels suggestive of long-segment myelitis. MRI brain and cerebrospinal fluid examination were planned for further evaluation, but the patient became restless after 12 hours of admission. Hence the investigations were postponed. Subsequently he became delirious and developed weakness in upper limbs, dysphagia and respiratory distress. It was reported that the course was fulminant as he developed delirium, autonomic dysfunction, aggravation of weakness and respiratory failure on the very next day of admission. On repeat examination, his pulse rate was 110/minute, blood pressure was 160/100 mmHg and respiratory rate was 30 per minute. The chest X-ray was normal and electrocardiogram showed sinus tachycardia. Neurologic examination revealed fasciculations all over the body, generalized hypotonia and areflexia with bilateral silent plantar responses. Nerve conduction study was suggestive of pure motor axonal neuropathy in both the lower limbs. Because of respiratory distress, he was intubated and put on ventilatory support; but after 1 hour, he developed sudden cardiac arrest and could not be revived. It was reported that he died within 5 days of onset of illness. His family members did not give consent for postmortem examination. In view of rapid downhill course, some unusual clinical features such as fasciculations, delirium, autonomic dysfunction on very next day of hospitalization and MRI finding suggestive of central gray matter involvement of spinal cord, the diagnosis of post vaccination myelitis was revised and a possibility of paralytic rabies was kept, although the diagnosis of rabies was not confirmed by serology or autopsy. The author stated that although it appeared to be post vaccination myelitis at the time of admission, later based on the clinical features and course paralytic rabies was considered as a strong possibility because the patient underwent complete recommended intradermal post exposure prophylaxis schedule with anti-rabies, immunoglobulin. The author stated that possible causes of failure of post exposure prophylaxis in the patient might be accounted by large injection of viral load in view of multiple, large and deep bite; any wound might have escaped from immunoglobulin injection and poor wound management and hygiene as the patient was from rural area and the patient consulted in anti-rabies clinic next day after the bite. However, possibility of any unusual strain of rabies virus should also be considered. The author concluded the article stating that although the failure of post exposure prophylaxis was very rare, paralytic rabies should always be suspected in patients who present as myelitis, acute disseminated encephalomyelitis (ADEM) and Guillain-Barre syndrome with history of rabid animal bite. Prompt diagnosis of rabies was of paramount importance for institution of appropriate infection control and public health measures, although it might not affect management outcome.


VAERS ID: 607577 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-26
Onset:2015-06-12
   Days after vaccination:17
Submitted: 2015-08-14
   Days after onset:63
Entered: 2015-08-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 144801 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-12
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015DE097863

Write-up: Case number PHHY2015DE097863, is an initial spontaneous report from Health Authority (reference number: DE-PEI-PEI2015048324) received on 11 Aug 2015. This report refers to a 28-month-old male patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of first dose of BEXSERO (batch number: 144801) on 02 Mar 2015 and the patient tolerated the vaccine well. The patient was vaccinated with the second dose of BEXSERO (batch number: 144801) intramuscularly on 26 May 2015. On 12 Jun 2015, 17 days after receiving the second vaccination, the patient died from an unknown cause. Causality was not reported. It was not reported whether an autopsy was performed.


VAERS ID: 607675 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508NZL009159

Write-up: The spontaneous report was received from Regulatory Authority regarding a patient of unknown age and gender. The patient''s medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL dose, route unknown. Concomitant medications were not reported. On an unknown date the patient died due to sudden death. The pathologist was investigating the possibility of a heridatory cardiac conduction problem. The reporter considered sudden death to be not related to GARDASIL. This is one of several reports received from the same reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.


VAERS ID: 607685 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508NZL007396

Write-up: This spontaneous report was received from a regulatory authority (agency# H201502731) regarding a patient of unknown age and gender. The patient''s medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with GARDASIL dose, route not reported. Concomitant medications were not reported. On an unknown date (also reported as 6 months after third vaccination) the patient was dead suddenly (fatal). The reporter considered sudden death was not related to GARDASIL. This is one of several reports received from the same reporter. Additional information is not expected.


VAERS ID: 607688 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-07
Onset:2015-07-09
   Days after vaccination:2
Submitted: 2015-08-21
   Days after onset:43
Entered: 2015-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC381AA / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Electrocardiogram abnormal, Epistaxis, Mouth haemorrhage, Musculoskeletal stiffness, Petechiae, Pulse absent, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-09
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: Cough
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK118424

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 6-week-old male patient who received ENGERIX B Pediatric (batch number YHBVC381AA, expiry date 16th March 2016). The patient''s past medical history included cough. On 7th July 2015, the patient received the 1st dose of ENGERIX B Pediatric (intramuscular) 10 ug. On 9th July 2015, 2 days after receiving ENGERIX B Pediatric, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), nose bleed, mouth hemorrhage and petechia. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the nose bleed, mouth hemorrhage and petechia were unknown. The patient died on 9th July 2015. The reported cause of death was death. It was unknown if the reporter considered the unknown cause of death, nose bleed, mouth hemorrhage and petechia to be related to ENGERIX B Pediatric. Additional information included: The patient had no family medical history or allergic history. After vaccination, the patient was taken home within 3 to 4 minutes without any abnormal events. On the evening of 8th July 2015, the patient''s mother did not find any abnormal event when she was milk feeding the boy. On the morning of 9th July 2015 at 7 am, she found bleeding on boy''s nose and mouth and performed artificial respiration and took the boy to the hospital. When they arrived, the physician found the patient''s limbs stiff with skin petechiae. There was no response, no heartbeat and no breath nor any response of ECG. Death was diagnosed without death cause.


VAERS ID: 607719 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Wrong drug administered
SMQs:, Medication errors (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508NZL009160

Write-up: This spontaneous report was received from a Regulatory Authority regarding a baby of unknown age and gender. The patient''s medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL dose, route unknown. Concomitant medications were not reported. On an unknown date the GARDASIL was administered to a baby which was a medication error. The baby died after two years of the medication error. The reporter considered death to be not related to GARDASIL. This is one of several reports received from the same reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.


VAERS ID: 607720 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508NZL009158

Write-up: This spontaneous report was received from Regulatory Authority regarding a patient of unknown age and gender. The patient''s medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL dose, route unknown. Concomitant mediations were not reported. On an unknown date the patient committed suicide and died. The reporter considered Suicide to be not related to GARDASIL. This is one of several reports received from the same reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.


VAERS ID: 607836 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Neoplasm malignant
SMQs:, Non-haematological malignant tumours (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015PR101253

Write-up: Case number PHHY2015PR101253 is an initial spontaneous report received from a consumer (patient''s mother who was a nurse) via sales representative on 14 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: not reported) in 2013. Some months later, she went to doctor''s office as she was not feeling well and was diagnosed with cancer. In 2014, the patient died from cancer. The causality of the event was not reported.


VAERS ID: 608029 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-26
Entered: 2015-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508COL009556

Write-up: This spontaneous report was received from a journalist in an article published in a local newspaper regarding a female patient of unknown age. The patient''s concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency and route were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced adverse events (not reported) associated with vaccine administration, which lead to the death of the patient. The outcome of adverse event was reported as fatal. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as there are no contact details available for further follow-up.


VAERS ID: 608236 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-07-16
Onset:2015-07-16
   Days after vaccination:0
Submitted: 2015-08-19
   Days after onset:34
Entered: 2015-08-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER PLU014A14 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 63A801914038 / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Alanine aminotransferase, Aspartate aminotransferase increased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood gases abnormal, Blood glucose increased, Blood urea increased, Bradycardia, C-reactive protein, Cardiac arrest, Crying, Death, Diet refusal, Dyspnoea, Endotracheal intubation, Full blood count, Globulin, Haemoglobin, Lethargy, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal, Mechanical ventilation, Metabolic acidosis, Mycobacterium tuberculosis complex test, Oxygen saturation decreased, Protein total decreased, Seizure, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-07-17
   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: Con Meds -Unknown; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: Intrauterine growth retardation; Transient tachypnea of the newborn; born to a PIH mother; born at 8 month and has Transient tachypnea of the newborn; The patient did not have any past history of similar event, adverse event after precious vaccinations, history of vaccine, drug or food allergy, pre-existing illness, congenital disorder, history of hospitalization in past 30 days, family history of any disease.
Allergies:
Diagnostic Lab Data: On 16 July 2015, BE-32.3 was recorded. On 17 July 2015, BE-28.3 was recorded. On unspecified date, Total cell 32, 980, P44, L49 25.7 (4.91 lakh), Mean corpuscular heamoglobin 32, mean corpuscular hemoglobin concentration 32.7, TB blood tests 1.12, DB 0.44 an IB 0.68 were recorded; PH, 16JUL2015, 6.375; PCO2, 16JUL2015, 20.6; PO2, 16JUL2015, 77.9; bicarbonate, 16JUL2015, 2.8; PH, 17JUL2015, 6.89; PCO2, 17JUL2015, 19.2; PO2, 17JUL2015, 56.6; bicarbonate, 17JUL2015, 3.6; hemoglobin, UNK, 32; mean corpuscular volume, UNK, 98; protein total, UNK, 5.5; albumin, UNK, 4.2; globulin, UNK, 1.3; SGOT, UNK, 68; SGPT, UNK, 2.9; alkaline phosphatase, UNK, 963.0; Urea, UNK, 23.0; blood glucose, UNK, 157.2; C-reactive protein, UNK, Less than 6
CDC Split Type: 2015SA111926

Write-up: Initial unsolicited report received from a pharmacist via company representative on 28 July 2015. A child (age and gender not reported), whose medical history and concomitant medications unknown, had received a second dose of Diphtheria/Tetanus/Whole cell pertussis/Hib (PRP/T/Hepatitis B (RDNA) vaccine Shantha (SHAN 5) batch number PLU014A14, expiry date, route and site of administration were not reported) on 16 July 2015 in a mass vaccination program. On 17 July 2015, one day post vaccination the baby died due to an unknown cause. It was unknown if autopsy was performed. Laboratory investigations were unknown and corrective treatments were not reported. Documents held by sender: none. Follow-up information received from a physician on 4 August 2015. A 2-month-old female patient, Patient had received Diphtheria/Tetanus/Whole cell pertussis/Hib (PRP/T/Hepatitis B (RDNA) vaccine Shantha (SHAN 5) intramuscularly on 16 May 2015 and second dose of OPV (batch number-63A801914038, expiry date- December 2016) through oral route on unspecified date in Jun-2015 (illegible) 11:30 AM. Patient''s birth history: born to a (pregnancy induced hypertension) positive mother, born at 8 month. Birth weight: 2.15 kg (admission to NICU for 4 days and had Transient tachypnea of the newborn. On 16 July 2015, 22 hours patient was continuously crying with refusal of feeding. Patient had presented with lethargy, refused to feed and convulsion (one episode), since one day. At admission child was in severe shock with gasping. Therefore child was incubated and ventilated. Patient had severe acidosis, bicarbonate correction was given, but acidosis persisted, in born error of metabolism was suspected, child had persisting desaturation with bradycardia, had cardiac arrest and could not be relieved. On 16 July 2015, investigations such as PH 6.75, PCO2 20.6, PO2 77.9, HCO3 2.8, BE-32.3. On 17 July 2015, investigations such as PH 6.89, PCO2-19.2, PO2-56.6, HCO3 3.6, BE-28.3. Other tests such as CBC: hemoglobin 8.4, Total Cell 32, 980, P44, L49 25.7 (4.91 lakh), Mean corpuscular volume 98, Mean corpuscular hemoglobin 32, mean corpuscular hemoglobin concentration 32.7, TB blood tests 1.12, DB 0.44, IB 0.68, total protein 5.5, albumin 4.2, globulin 1.3, SGOT 68, SGPT 29, alkaline phosphatase-963.0, Urea-23.0, Creatinine-0.74, Random blood sugar-157.2 and C-reactive protein was less than 6. Causes of death are reported refractory shock (immediate cause), sepsis with severe metabolic acidosis (antecedent cause) and inborn error of metabolism. Manner of death was reported natural. Patient''s body was handed to patients relatives. Patient was brought to physician and was referred to various hospitals. It was reported that there was causal relationship as per the reporter. Follow-up information received from a physician as per the reporter. Follow-up information received from a physician on 04 August 2015. A female patient had received a second dose of Diphtheria/Tetanus/Whole cell pertussis/Hib (PRP/T/Hepatitis B (RDNA) vaccine Shantha (SHAN 5) (Expiry date: March 2016) intramuscularly in left thigh (mid-antero lateral aspect) and second dose of Poliomyelitis vaccine (inactivated) (OPV) on 16 July 2015. The patient was also vaccinated with first dose of BCG vaccine (batch number, expiry date, dose, route and site of administration were not reported) on 16 July 2015. The patient did not have any past history of similar event, adverse event after previous vaccinations, history of vaccine, drug or food allergy, pre-existing illness, congenital disorder, history of hospitalization in past 30 days, family history of any disease. The baby had intrauterine growth restriction (a birth complication). On 16, July 2015 at 13:00 hours, after 1 hour 30 minutes of vaccination, the patient presented with continuous crying and refusal of feeds. On 16 July 2015, at 17:00 hours, after 5 hour 30 minutes of vaccination, the patient had increased intensity of crying and at 18:00 hours, after 6 hour 30 minutes of vaccination, the patient was lethargic. On 16 July 2015 at 19:30 hours, 8 hours after vaccination, the patient was hospitalized with severe shock/ refractory shock, gasping. On 16 July 2015, after vaccination the patient had developed suspected sepsis, acidosis/ metabolic acidosis, persisting desaturation, bradycardia and cardiac arrest. On 17 July 2015 at 18:00 hours, the patient was died. List of Documents held by Sender: none.


VAERS ID: 608249 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-27
Entered: 2015-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood immunoglobulin M increased, CD4 lymphocytes decreased, Cytomegalovirus infection, Cytomegalovirus test positive, Death, Dyspnoea, HIV test negative, Lymphopenia, Mechanical ventilation, Packed red blood cell transfusion, Platelet transfusion, Pneumonia, T-lymphocyte count decreased, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: No other medications
Current Illness: Primary immunodeficiency syndrome
Preexisting Conditions: Thrombocytopenia, increased aspartate aminotransferase and alanine aminotransferase; Lymphopenia; Rubella; Packed red cells; Platelet concentrate; Hospitalisation, at 7 days of age; Immunoglobulin, intravenous, for 3 days
Allergies:
Diagnostic Lab Data: Blood immunoglobulin A, normal; Blood immunoglobulin E, normal; Blood immunoglobulin G, normal; Blood immunoglobulin M, increased, CD4 lymphocytes, decreased; Cytomegalovirus test, positive; HIV test, negative; T-lymphocyte count, decreased
CDC Split Type: ID2015GSK122448

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 patient who received Hepatitis B vaccine. Co-suspect products included BCG vaccine. The patient''s past medical history included hospitalization (at 7 days of age), thrombocytopenia (increased aspartate aminotransferase and alanine aminotransferase), lymphopenia and rubella. Previously administered products included immunoglobulin (intravenous, for 3 days), packed red cells and thrombocyte concentrate transfusion. Concurrent medical conditions included primary immunodeficiency syndrome. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BCG vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), pneumonia (serious criteria hospitalization and GSK medically significant), cytomegalovirus infection (serious criteria GSK medically significant), dyspnea and lymphopenia. The patient was treated with ganciclovir. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pneumonia, cytomegalovirus infection, dyspnea and lymphopenia were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, pneumonia, cytomegalovirus infection, dyspnea and lymphopenia to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of pneumonia in a 3-month-old female patient who had received an unspecified hepatitis B vaccine and an unspecified Bacillus Calmette-Guerin vaccine (manufacturers unknown). The authors believed that the subject suffered from a primary immunodeficiency that went undiagnosed during a previous admission. During that episode the patient had required referral to a neonatology unit at 7 days of age after being treated with intravenous immunoglobulin for 3 days in another hospital for thrombocytopenia and increased aspartate aminotransferase and alanine aminotransferase. Laboratory tests performed at the time showed lymphopenia (lymphocytes ranged between 35.6% - 66%; retrospective calculation revealed total lymphocyte count ranged between 2760 - 3830/uL). In addition to this she had normal neutrophil count according to the authors but increased immunoglobulin M and G rubella antibodies as well as increased immunoglobulin G toxoplasma, cytomegalovirus and herpes simplex virus 1 antibody levels. According to these results she was diagnosed with rubella infection, received packed red cells and thrombocyte concentrate transfusion and was discharged in good condition after 24 days of treatment. No further information on the patient''s family history or concomitant medication was provided. On an unspecified date after her discharge from hospital, the patient received an unspecified hepatitis B vaccine and an unspecified Bacillus Calmette-Guerin vaccine in an outpatient clinic (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 3 months of the vaccinations, the patient developed dyspnoea and was eventually admitted to a paediatric intensive care unit due to pneumonia that required ventilatory support. The authors mentioned that she had developed a severe infection but no further information was provided; however they commented that she had tested positive for cytomegalovirus immunoglobulin M and that she was treated with ganciclovir. She was also found to have lymphopenia, increased immunoglobulin M levels and decreased cluster of differentiation 3 and 4 levels at this time. She died after 30 days of hospitalisation. This was a fatal case. The cause of death was not specified. It is unknown if a post-mortem was performed. The laboratory test showed lymphopenia, increased levels of immunoglobulin M with normal levels of immunoglobulin G, A and E and decreased cluster of differentiation 3 and 4 levels. Human immunodeficiency virus polymerase chain reaction was negative. Cytomegalovirus immunoglobulin M was positive. Treatment consisted of ganciclovir (dose and route unspecified). The authors did not comment on any causal relationship between the vaccines and the event. The authors concluded that "complete blood count test result does not automatically include the value of total lymphocytes; it included only the percentage of lymphocytes. Because the lymphocytes percentage were always within normal limits, the treating physicians were not concerned with the low value of total lymphocytes, reflecting the low levels of T and/or B lymphocytes. Unfortunately, the patient then underwent severe infection and further tests found low cluster of differentiation 4 lymphocyte levels with increased levels of immunoglobulin M. There should be an opportunity to explore primary immunodeficiency, especially in this case the possibility of Severe Combined Immune Deficiency in the first hospitalization during newborn period. If we were aware of primary immunodeficiency, this patient could be treated and prevented for possible severe infections. Simple tests such as complete blood count need to be interpreted in more detailed of the presence of lymphopenia or neutropenia to be indicative of primary immunodeficiency".


VAERS ID: 592727 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-03
Entered: 2015-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Brain scan abnormal, Cerebral ischaemia, Death, General physical health deterioration, Mechanical ventilation, Respiratory failure, Seizure
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, Normal; Heart rate, Normal; Scan brain, no blood flow through the brain; Vital signs measurement, Normal
CDC Split Type: WAES1508IRL006124

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number # IE-1577272925-E2015-09389) on 19-AUG-2015. Serious case received from a company representative who originally saw the report posted by a health writer on a website on 10-AUG-2015. This case is not medically confirmed. A male patient of unreported age, no medical history and concurrent conditions reported, received an injection of MMR (manufacturer unknown, batch number not reported), series site and route not reported, on unknown date. The baby became seriously ill within 4 hours after vaccination. The parents of the baby realized that he was having a serious problem. His condition continued to deteriorate even after several visits to the doctor. He was hospitalized after seizures, and went into respiratory failure while hospitalized. He was put on a ventilator to keep him alive. When he was in the hospital doctors did a cerebral profusion scan to evaluate blood blow in the brain. The scan showed normal vital signs, normal blood pressure, normal heart rate, etc. but there was no blood flow through the brain. The baby''s family and his physicians watched him slowly die while the respirator did his breathing for him. Basically they were watching his brain as he went through the stages of sudden infant death after vaccine exposure. The outcome of the events seizures and respiratory failure and no blood flow through the brain was fatal. The causality of the events was not reported. Upon internal review events seizures and respiratory failure were determined to be medically significant. This is one of several reports from the same reporter. This is a corrected report. Country of incidence was changed.


VAERS ID: 608933 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-08
Entered: 2015-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Diarrhoea, Microangiopathy, Omenn syndrome, Parenteral nutrition, Pneumocystis jirovecii infection, Pneumocystis test positive, Rotavirus infection, Rotavirus test positive, Venoocclusive disease
SMQs:, Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (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: No other medications
Current Illness: Combined immunodeficiency, Artemis deficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient tested positive for Pneumocystis jirovecii and rotavirus (G1P8) at 4 months of age
CDC Split Type: GB2015GSK127963

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 patient who received Rotavirus vaccine. Concurrent medical conditions included combined immunodeficiency (Artemis deficiency). Concomitant products included Rotavirus vaccine. On an unknown date, the patient received the 2nd dose of Rotavirus vaccine (oral). On an unknown date, unknown after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death, hospitalization and GSK medically significant), rotavirus infection (serious criteria death and hospitalization), chronic diarrhea (serious criteria death and hospitalization), Omenn syndrome (serious criteria death and GSK medically significant), pneumocystis jirovecii infection (serious criteria GSK medically significant), microangiopathy (serious criteria death) and venoocclusive disease (serious criteria death. On an unknown date, the outcome of the unknown cause of death, rotavirus infection, chronic diarrhea, Omenn syndrome, pneumocystis jirovecii infection, microangiopathy and venoocclusive disease were fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, Omenn syndrome, pneumocystis jirovecii infection, microangiopathy and venooclusive disease to be related to Rotavirus vaccine. The reporter considered the rotavirus infection and chronic diarrhea to be possibly related to Rotavirus vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of death in a 4-month-old male patient who had received unspecified rotavirus vaccines (manufacturers unknown). The patient''s concurrent medical conditions included severe combined immunodeficiency (Artemis deficiency) which was diagnosed after the vaccination had been administered. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates the patient received two doses of an unspecified rotavirus vaccine at 2 and 3 months of age (dosages unknown; oral route; batch numbers not provided). On an unspecified date since July 2013, within 1 month of the second vaccination, the patient presented with chronic diarrhoea and Omenn''s syndrome. In addition to this Pneumocystis jirovecii and rotavirus (G1P8) were isolated from the patient too. He later developed thrombotic microangiopathy and veno-occlusive disease and passed away. This was a fatal case. Cause of death was not specified. It is unknown if a post-mortem was performed. The patient tested positive for Pneumocystis jirovecii and rotavirus (G1P8) at 4 months of age. According to the authors the patient had cleared the virus prior to his decease but they did not specify when. Treatment consisted of matched unrelated donor bone cord transplant and engrafted. He also received parenteral nutrition for 47 days post-treatment. The authors believed that the patient had been infected by the rotavirus vaccine strain. The authors concluded that "We believe these are the first patients to be reported experiencing chronic rotavirus vaccine strain infection. A high penetrance of symptomatic rotavirus infection in severe combined immunodeficiency patients was predictable, because it was described following introduction of the vaccine in the routine childhood vaccination schedule in 2006. The requirement to establish a newborn screening program for severe combined immunodeficiency was therefore reinforced and successfully introduced in many states from May 2010. As in many countries, newborn screening for severe combined immunodeficiency has not yet been approved; until this happens, it is likely that infants with severe combined immunodeficiency will continue to be immunized with live vaccines, thus complicating and increasing their hospital stay and treatment costs". This case is 1 of the 7 valid cases reported in the same literature article.


VAERS ID: 608997 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-08
Entered: 2015-09-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy skin abnormal, Body temperature increased, Death, Herpes zoster, Polymerase chain reaction positive, Rash generalised, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Preexisting Conditions: Herpes zoster
Allergies:
Diagnostic Lab Data: Biopsy skin, varicella zoster; Body temperature, 38.3 Centigrade; Polymerase chain reaction, varicella zoster pulmonary
CDC Split Type: 2015300248

Write-up: This is a spontaneous report from a non-contactable physician received through Merck Pharmacovigilance Team. A patient of unspecified age ethnicity and gender received PREVENAR 13 via an unspecified route of administration on an unspecified date single dose. Medical history included herpes zoster episode from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced rash disseminated after 37 days from the time of vaccination on an unspecified date with outcome of unknown. Results of a polymerase chain reaction test performed on an unspecified date was found a varicella zoster pulmonary, which produced died of the patient on an unspecified date. The number of injuries related to Herpes Zoster episode was reported as 50 injuries. The total duration of the Herpes Zoster episode was of 2 days/weeks (pending clarification). The patient did not experienced rash in the next 24 hours after vaccination. The patient underwent other lab tests and procedures which included: body temperature of 38.3 centigrade and a biopsy skin which results indicated presence of varicella zoster (lab test date not provided). It was not reported if an autopsy was performed. No follow-up attempts possible. No further information is expected.


VAERS ID: 609247 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-14
Entered: 2015-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509SEN006062

Write-up: This initial spontaneous report was received from a physician (head of the immunization division in Agency) via a company representative, referring to a 9 year old female patient. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot# and expiration date were not provided). There was no concomitant medication described. The physician stated that on an unknown date, the patient died. The relatedness between death to GARDASIL was not reported. Additional information has been requested.


VAERS ID: 609390 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-16
Entered: 2015-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509BGR007142

Write-up: Information has been received from SPMSD (MFR control number not provided) on 10-SEP-2015. This spontaneous report as received from a physician (according to the physician, the case was originally reported in a literature in a local Journal) refers to a patient of unknown age and gender. Information about patient''s concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with HPV vaccine (manufacturer unknown) (lot #, dose, route not reported). Concomitant medications were not provided. On an unknown date the patient died. The cause of death was unknown. It was unknown if autopsy had been done. The causality was unspecified. Additional information is expected.


VAERS ID: 609644 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-16
Entered: 2015-09-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Lower respiratory tract infection
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2014GSK054817

Write-up: This case was reported in a literature article and described the occurrence of death in a elderly patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine unspecified 2013-2014 season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine unspecified 2013-2014 season, the patient experienced death (serious criteria death and GSK medically significant) and chest infection (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death and chest infection were fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and chest infection to be related to Influenza vaccine unspecified 2013-2014 season 4. Additional information was provided: This case was reported in a literature article and describe the occurrence of death in an elderly subject who was vaccinated with unspecified influenza vaccine. No information on the patient''s past medication or family history was provided. No concomitant medications were reported. On an unspecified date, the patient received unspecified annual influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, the patient died (cause of death unspecified). The information about autopsy was not provided. This case was speculatively considered as the index case for the outbreak of H3N2 influenza in the hospital. The treatment for the adverse event was not reported. The authors did not comment on causality relationship between the vaccine and the event. The author''s conclusion stated that "A combination of factors resulting in this outbreak were identified: Low vaccine efficacy in the elderly rendering them susceptible, an unusual environment with increased bed movement and aerosolising procedures, increased nosocomial transmission potential in an open plan unit, reduced suspicion of influenza causing an outbreak in April, testing delay without nosocomial transmission potential in an open plan unit, reduced suspicion of influenza causing an outbreak in April, testing delay without onsite laboratory, and delay in results over bank holidays if not marked urgent. The points to be further considered were: Earlier typing to confirm possible outbreaks, improving awareness of out of hours testing arrangements, and reviewing prophylaxis guidance in vaccinated high risk/ elderly patients, if protection by vaccination is unreliable".


VAERS ID: 609734 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2015-02-16
Onset:2015-03-04
   Days after vaccination:16
Submitted: 2015-09-14
   Days after onset:193
Entered: 2015-09-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal operation, Activated partial thromboplastin time prolonged, Activated partial thromboplastin time ratio, Acute kidney injury, Alanine aminotransferase normal, Anaemia postoperative, Aspartate aminotransferase increased, Bilevel positive airway pressure, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood bilirubin increased, Blood calcium normal, Blood chloride normal, Blood creatinine, Blood culture negative, Blood fibrinogen normal, Blood glucose decreased, Blood lactic acid increased, Blood potassium increased, Blood sodium normal, Blood urea normal, Body temperature decreased, Bradycardia, Brain oedema, C-reactive protein increased, Capillary nail refill test abnormal, Central venous catheterisation, Coagulation factor V level decreased, Coagulation factor VII level decreased, Coagulation factor X level decreased, Cyanosis, Cytomegalovirus test negative, Death, Dermatologic examination abnormal, Endotracheal intubation, Enema administration, Enterostomy, Fundoscopy abnormal, Gamma-glutamyltransferase increased, Gastrointestinal motility disorder, Gastrointestinal necrosis, Gastrointestinal wall thickening, Haematocrit decreased, Haemodynamic test normal, Haemoglobin decreased, Histology abnormal, Hyperkalaemia, Hypoglycaemia, Hypotonia, Hypoxia, Intensive care, Irritability, Miosis, Nasal flaring, Necrotising enterocolitis neonatal, Neurological examination abnormal, Oedema peripheral, Osteopenia, Oxygen saturation decreased, PCO2 increased, PO2 decreased, Packed red blood cell transfusion, Pain, Pallor, Parenteral nutrition, Platelet count decreased, Platelet transfusion, Pneumatosis intestinalis, Presyncope, Procalcitonin increased, Protein total decreased, Prothrombin time prolonged, Prothrombin time ratio, Red blood cell count decreased, Regurgitation, Respiration abnormal, Respiratory distress, Resuscitation, Retinopathy, Skin discolouration, Staphylococcus test positive, Tachypnoea, Thrombocytopenia, Transfusion, Unresponsive to stimuli, Urine output decreased, Use of accessory respiratory muscles, Volvulus, White blood cell count increased, pH body fluid decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Osteoporosis/osteopenia (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-04-02
   Days after onset: 28
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: CUROSURF; saline solution; albumine; LIQUIGEN; oxacillin; folic acid; ferrostrane; DOLIPRANE; UVESTEROL; STEROGYL; econazole
Current Illness:
Preexisting Conditions: Unknown, Premature birth, Born at 26 weeks post-last menstrual period (LMP); Unknown, Birth weight low, birth weight was 560 g (second weight percentile); Unknown, Intrauterine growth retardation
Allergies:
Diagnostic Lab Data: 28-MAR-2015, Activated partial thromboplastin time, 45; Activated partial thromboplastin time ratio; 28-MAR-2015, Activated partial thromboplastin time ratio, 1.4; 28-MAR-2015, Alanine aminotransferase, 62 IU/L; 17-DEC-2014, Apgar score, 7/8/9/9; 28-MAR-2015, Aspartate aminotransferase, 128 IU/l; 17-DEC-2014, Auscultation, Regular heart sounds without murmur; 17-DEC-2014, Auscultation, Clear with symmetrical lung sounds; 07-MAR-2015, Auscultation, No murmur; 28-MAR-2015, Auscultation, Tachypnea, symmetric and clean vesicular murmur; 28-MAR-2015, Auscultation, respiratory whimper, intercostal retractions, and; 26-DEC-2014, Bacterial test, Positive to Staphylococcus aureus; 08-JAN-2015, Bacterial test, Positive to Enterobacter cloacae; 02-FEB-2015, Bacterial test, Positive to Staphylococcus aureus; 09-MAR-2015, Bacterial test, Negative to Staphylococcus aureus; 28-MAR-2015, Bacterial test, positive to Staphylococcus epidermidis; 28-MAR-2015, Blood alkaline phosphatase, 780; 28-MAR-2015, Blood bicarbonate, 17.6; 28-MAR-2015, Blood bicarbonate, 23; 28-MAR-2015, Blood bicarbonate, 24; 28-MAR-2015, Blood bilirubin, 29 IU/l; 28-MAR-2015, Blood calcium, 2.41 mmol/l; 28-MAR-2015, Blood chloride, 105 mmol/l; MAR-2015, Blood creatinine, 105; Blood culture, Sterile culture from central catheter sampling; DEC-2014, Blood culture, Sterile culture from cord catheter sampling; 17-DEC-2014, Blood culture, Sterile; 25-DEC-2014, Blood culture, Positive to Staphylococcus aureus; 04-MAR-2015, Blood culture, Sterile; 28-MAR-2015, Blood culture, Negative; 2015, Blood culture, Sterile culture from central catheter sampling; 28-MAR-2015, Blood fibrinogen, 2; 29-MAR-2015, Blood fibrinogen, 1.8; 17-DEC-2014, Blood gases, -3.6; Blood glucose, Increased g/l; 28-MAR-2015, Blood glucose, 0.44 g/l; 28-MAR-2015, Blood lactic acid; 8.4 mmol/l; 28-MAR-2015, Blood lactic acid, 1.7 mmol/l; 28-MAR-2015, Blood potassium, 7.8 mmol/l; 29-MAR-2015, Blood potassium, Hyperkalemia mmol/l; 28-MAR-2015, Blood pressure, 114/63 mmHg; 28-MAR-2015, Blood pressure, 114/64 mmHg; 28-MAR-2015, Blood pressure, 111/65 mmHg; 28-MAR-2015, Blood pressure, 75/34 mmHg; 21-DEC-2014, Blood sodium, 163 mmol/l; 28-MAR-2015, Blood sodium, 134 mmol/l; MAR-2015, Blood urea, 15; 17-FEB-2015, Body height, 37.5; 28-MAR-2015, Body temperature, 33.3; 28-MAR-2015, Body temperature, 35.4; 17-DEC-2014, C-reactive protein, less than 3 mg/l; 25-DEC-2014, C-reactive protein, 46 mg/l; 29-DEC-2014, C-reactive protein, 8 mg/l; 06-JAN-2015, C-reactive protein, 4 mg/l; 04-MAR-2015, C-reactive protein, less than 3 mg/l; 28-MAR-2015, C-reactive protein, 3 mg/l; 29-MAR-2015, C-reactive protein, 89 mg/l; Cardiovascular examination, No murmur; 28-MAR-2015, Cardiovascular examination, Femoral and peripheral pulse; 17-DEC-2014, Chest X-ray, Diffuse alveolar syndrome; 29-MAR-2015, Coagulation factor, Drop of coagulation factors; 29-MAR-2015, Coagulation factor V level, not detectable; 29-MAR-2015, Coagulation factor VII level, 14; 29-MAR-2015, Coagulation factor X level, 14; Cytomegalovirus test, Negative; 28-MAR-2015, Dermatologic examination, gray infant, no rash; 19-DEC-2014, Echocardiogram, Ductus arteriosus with size 1.8 mm; 24-DEC-2014, Echocardiogram, enlarged ductus arteriosus at 1.8 mm; 26-DEC-2014, Echocardiogram, enlarged ductus arteriosus at 1.8 mm; 29-DEC-2014, Echocardiogram, enlarged ductus arteriosus at 1.8 mm; 01-JAN-2015, Echocardiogram, ductus arteriosus with size 2.2 mm; 06-JAN-2015, Echocardiogram, ductus arteriosus persisted at 2.5 mm; 13-FEB-2015, Echocardiogram, ductus arteriosus was completely closed; 22-FEB-2015, Fundoscopy, stage II, area II retinopathy; 10-MAR-2015, Fundoscopy, Stage II, area II retinopathy; 17-MAR-2015, Fundoscopy, stage 1-2 in peripheral zone 2, without stage plus; 28-MAR-2015, Gamma-glutamyltransferase, 70; 17-DEC-2014, Gastric fluid analysis, Negative/sterile; 28-MAR-2015, Haematocrit, 34; Haemodynamic test, Stable; 07-MAR-2015, Haemodynamic test, Stable; 17-DEC-2014, Haemoglobin, 14.7 g/dl; 25-DEC-2014, Haemoglobin, 8.4 g/dl; 28-MAR-2015, Haemoglobin, 10.8 g/dl; 28-MAR-2015, Haemoglobin, 4.1 g/dl; 17-FEB-2015, Head circumference, 28; 07-MAR-2015, Head circumference, 29.5; 28-MAR-2015, Heart rate, 159; 28-MAR-2015, Heart rate, 60; 28-MAR-2015, Heart rate, 145; 28-MAR-2015, Heart rate, 150; 03-APR-2015, Histology, peritoneum: 45 ml hemorrhagic effusion; 28-MAR-2015, Imaging procedure, major colon distention, wall thickening; 28-MAR-2015, Neurological examination, pupils were in reactive myosis; 28-MAR-2015, Oxygen saturation, 85-86%; 28-MAR-2015, Oxygen saturation, 98%; 28-MAR-2015, Oxygen saturation, 100%; 28-MAR-2015, Oxygen saturation, 88%; 17-DEC-2014, PCO2, 55.9; 28-MAR-2015, PCO2, 56; 28-MAR-2015, PCO2, 86; 28-MAR-2015, PO2, 56; 28-MAR-2015, PO2, 28; 28-MAR-2015, Physical examination, severe abdominal distention; 17-DEC-2014, Platelet count, 119000/mm3; 28-MAR-2015, Platelet count, 450000/mm3; 29-MAR-2015, Platelet count, 21000/mm3; 28-MAR-2015, Procalcitonin, 11; 29-MAR-2015, Procalcitonin, 100-162; 28-MAR-2015, Protein total, 45 g/l; 29-MAR-2015, Prothrombin level, 15; 29-MAR-2015, Prothrombin time ratio, 20; 28-MAR-2015, Red blood cell count, 3.48x10 9/l; 28-MAR-2015, Respiratory rate, 50; 28-MAR-2015, Respiratory rate, 65; 28-MAR-2015, Respiratory rate, 39; 18-DEC-2014, Ultrasound skull, Normal; 22-DEC-2014, Ultrasound skull, Normal; 01-JAN-2015, Ultrasound skull, Normal; 07-JAN-2015, Ultrasound skull, Bilateral candelabra calcification; 22-JAN-2015, Ultrasound skull, Unchanged versus the one from D21; FEB-2015, Ultrasound skull, Normal; 17-DEC-2014, Weight, 560 g; 20-DEC-2014, Weight, 510 g; 17-FEB-2015, Weight, 1580 g; 04-MAR-2015, Weight, 1720 g; 12-MAR-2015, Weight, 2170 g; 18-MAR-2015, Weight, 2275 g; 28-MAR-2015, Weight, 2500 g; 17-DEC-2014, White blood cell count, 6730/mm3; 04-MAR-2015, White blood cell count, 9740/mm3; 28-MAR-2015, White blood cell count, 17700/mm3; 17-DEC-2014, pH body fluid, 7.57 pH units; 28-MAR-2015, pH body fluid, 7.06 pH units; 28-MAR-2015, pH body fluid, 7.18 pH units; Apgar score (17Dec2014): 7 at 1 min, 8 at 3 min, 9 at 5 min, 9 at 10 min.; Silverman-Anderson Index (17Dec2014): 3/10 (apnea); Auscultation (17Dec2014): Regular heart sounds without murmur. Femoral pulse detected. Soft and no guarding abdomen without mass; Transthoracic echocardiography (24Dec2014 - D7): persistent enlarged ductus arteriosus at 1.8 mm without pulmonary hypertension; Transthoracic echocardiography (01Jan2015 - D15): revealed ductus arteriosus with size 2.2 mm associated with left cavities dilation; Transfontanellar ultrasound (07Jan2015 - D21): bilateral candelabra calcification predominant on the left side, including left lenticular mineralisation; no other disorders were highlighted; Blood sodium (21Dec2014): Severe increased of blood sodium at 163 mmol/L; Height (17Feb2015): 37.5 cm; Head circumference (17Feb2015): 28 cm; Walsh test (unspecified date): Normal; Head circumference (07Mar2015): 29.5 cm; Capillary refill time (28Mar2015): 5 seconds; Respiratory rate (28Mar2015): 65/min; Heart rate (28Mar2015): 145/min; Auscultation (28Mar2015): respiratory whimper, intercostal retractions, and seesaw respiration; Heart rate (28Mar2015 - 7:45 am): 150/min; Respiratory rate (28Mar2015 - 07:45): 39/min; Heart rate (28Mar2015 - 09:30 am): 159/min; Blood pressure average (28Mar2015 - 09:30 am): 55; Respiratory rate (28Mar2015 - 09:30 am): 50/min; Respiratory examination (28Mar2015 - 09:30 am): tachypnea, symmetric and clean vesicular murmur, respiratory distress signs, with respiratory seesaw, inter and sub-costal retractions, nasal flaring; Cardio-vascular examination (28Mar2015): perceived femoral and peripheral pulse. Inferior limb edema; Abdominal examination (28Mar2015): severe abdominal distention. Collateral abdominal circulation; Neurological examination (28Mar2015): pupils were in reactive myosis, fontanels were normal; Abdomen without preparation (28Mar2015): major colon distention, wall thickening, pneumatosis suspicion and no pneumoperitoneum; Heart rate (28Mar2015): bradycardia at 60/min; Post-mortem sampled ascites (28Mar2015): positive to Staphylococcus epidermidis, sterile pleural and pericardic fluid; Potassium (28Mar2015): hyperkalemia at 7.8 mmol/L; Blood glucose (28Mar2015): 2 episodes of hypoglycemia at 0.44 g/L; Platelets (29Mar2015): thrombocytopenia at 21000; Hemoglobin (28Mar2015): postoperative anemia at 4.1 g/dl
CDC Split Type: 2015301023

Write-up: This is a spontaneous report received from the Agency. Regulatory Authority report number FR-AFSSAPS-CN20150597. A 02-month-old female patient received or started to receive the suspect products: ALDACTONE, unknown route, on 06Jan2015, unspecified dose, for patent ductus arteriosus; PREVENAR 13 (batch number unknown), unknown route, on 16Feb2015 and 16Mar2015, at 1 injection (0.5 ml); RIFAMYCINE CHIBRET, intraocular route, on 17Dec2014 then from 08Jan to 12Jan2015, unspecified dose; CAFEINE COOPER, unknown route, on 17Dec2014, at unspecified dose, for neonatal apnea; Vitamin K1 ROCHE, oral route, on 17Dec2014, at unspecified dose, for hemorrhage prophylaxis; LASILIX, unknown route, from 01Jan2015 to 30Jan2015, at unspecified dose, for patent ductus arteriosus; CEFOTAXIME PANPHARMA, intravenous route, from 25Dec2014 to 26Dec2014, at unspecified dose, for Staphylococcal sepsis; VANCOMYCINE SANDOZ, intravenous route, from 25Dec2014 to 26Dec2014, at unspecified dose, for Staphylococcal sepsis; BRISTOPEN, intravenous route, from 25Dec2014 to 06Jan2015, at unspecified dose, for Staphylococcal sepsis; BACTROBAN, nasal route, from 03Jan2015 to 07Jan2015, from 04Feb2015 to 09Feb2015, from 18Feb2015 to 23Feb2015, and from 03Mar2015, at unspecified dose, for infection; TOBREX, intraocular route, from 13Jan2015 to 21Jan2015, at unspecified dose, for infection; TRIFLUCAN, unknown route, from 19Dec2014 to 12Feb2015, at unspecified dose, for infection prophylaxis; NEOSYNEPHRINE, intraocular route, on 22Feb2015, 10Mar2015 and 17Mar2015, at unspecified dose, for diagnostic procedure; MYDRIATICUM, intraocular route, on 22Feb2015, 10Mar2015 and 17Mar2015, at unspecified dose, for diagnostic procedure; INFANRIX HEXA (batch number unknown), unknown route, on 16Feb2015 and 16Mar2015, at 1 injection. Patient''s relevant medical history included premature birth at 26 weeks post-LMP, low weight birth at 560 g (second weight percentile), and intrauterine Growth Retardation. Mother relevant history: 40-year-old mother without medical history, blood type O Rhesus positive, immune status positive for toxoplasmosis, rubella and cytomegalovirus, negative for hepatitis B virus, Human Immunodeficiency Virus and Hepatitis C virus. Father history: No relevant medial history. Pregnancy: Arterial hypertension occurred at 15 weeks post-last menstrual period (LMP) and ALDOMET, LOXEN and nifedipine (unspecified trade name) were introduced. Vaginal sampling returned positive with Streptococcus B. Steroid therapy was administered on 15 and 16Dec2014. Concomitant treatments included: CUROSURF, 1 dose on 17Dec2014; Evidence of hypovolemia on day 0 required fluid resuscitation with saline solution on 17Dec2014 for hypovolemia; albumin on 17Dec2014 for hypovolemia; "FORTIPRE" started on 10Feb2015; LIQUIGEN started on 14Feb2015; oxacillin from 25Dec2014 to 06Jan2015 for Staphylococcal sepsis; Folic acid 2.5 mg once daily; FERROSTRANE 0.70% syrup, 0.5 ml twice daily; DOLIPRANE drinkable suspension, one weight dose each 6 hours if needed; UVESTEROL A D E C one dose n degree 1 per day; STEROGYL two drops once daily; econazole (unspecified trade name). The patient developed necrotizing enterocolitis neonatal on 04Mar2015, which could have led to the patient''s death on 02Apr2015 at 03:10 a.m. Comment: Premature female newborn, born at 26 weeks post-LMP, weight 560 g (second weight percentile), following in utero transfer to neonatal unit at 25 weeks and 5 days post-LMP, for Intrauterine Growth Retardatation (IUGR) and pre-eclampsia. C section was performed at 26 weeks post-LMP for micro-oscillating fetal rhythm. Neither cord nor placenta abnormality was detected. At birth: Apgar score: 7 (1 minute) / 8 (3 minutes) / 9 (5 minutes) / 9 (10 minutes). Suction was performed then assisted ventilation with NEOPUFF was instituted from the first minute to admission in neonatal unit. Cord pH: 7.57, Base deficit: -3.6 Partial pressure of carbon dioxide: 55.9. On 17Dec2015 (Day 0), admission in neonatal intensive care unit for prematurity care. On admission: Normal skin coloration. Non-invasive ventilation by biphasic INFANT-FLOW. Silverman-Anderson Index: 3/10 (apnea). Pulmonary auscultation was clear with symmetrical lung sounds. Regular heart sounds without murmur. Femoral pulse detected. Soft and no guarding abdomen without mass. Initial work-up. Total blood count: leukocytes 6730/mm3, haemoglobin 14.7 g/dl, platelet count 119000/mm3. C-reactive protein below 3 mg/l. Direct examination of gastric sampling returned negative. Chest CT scan revealed diffuse alveolar syndrome. Initial therapeutic measures: Central venous catheter insertion in umbilical vein. Caffeine loading dose administration. Vitamin K administration. Eye disinfection with rifamycin sodium, eye drop. Outcome during intensive care unit stay, from 17Dec2014 to 17Feb2015: Regarding respiratory condition: Caffeine therapy. Intubation at the first hour, administration of 1 dose of poractant alfa. Extubation was performed on day 1 and relayed by biphasic INFANT-FLOW. On day 6, the child was re-intubated. Invasive ventilation from day 6 to day 11. Noninvasive ventilation by biphasic INFANT-FLOW from day 11 to day 53. From day 53 to day 57, INFANT-FLOW and continuous positive pressure ventilation were alternately used. Continuous positive pressure ventilation was administered from day 58 to day 59. Then from day 60, 34 weeks and 4 days post-LMP corrected term, sequences of OPTIFLOW were administered. Regarding cardiac condition: Evidence of hypovolemia on day 0 required fluid resuscitation with saline solution then with albumin. On day 2, transthoracic echocardiography (TTE) detected ductus arteriosus with size 1.8 mm. Enlarged ductus arteriosus persisted at 1.8 mm on TTE performed on day 7 without pulmonary hypertension. It also persisted on TTE performed on day 9 and day 12. On day 15, TTE revealed ductus arteriosus with size 2.2 mm associated with left cavities dilation. Treatment with furosemide was introduced from day 15 to day 44 then associated with spironolactone on day 20. On day 20, ductus arteriosus persisted at 2.5 mm on TTE. Control TTE revealed progressive closure of ductus arteriosus, ductus arteriosus was completely closed on day 58. Regarding gastrointestinal and diet condition: Parenteral nutrition was administered by central venous catheter inserted on umbilical vein from day 0 to day 2. Culture from central catheter sampling returned sterile. A second central venous catheter (premicath) was inserted on day 2 and withdrawn on day 40 (culture returned sterile). On 26Jan2015, day 40, another central venous catheter (Vygon) was inserted then withdrawn on day 57 (culture returned sterile). Breastfeeding via nasogastric tube was initiated on day 1. Food fortification with FORTIPRE was instituted on day 55. LIQUIGEN was administered from day 59. The lowest patient''s weight was 510 g on day 3, then regular weight gain resumed. On day 62, body weight was 1580 g, the patient was transferred. Bowel motility was irregular and was stimulated with frequent enema. On infection point: Initial C-reactive protein was lower than 3 mg/L, with sterile gastric sampling and blood culture. Day 8 C-reactive protein was 46 mg/L with positive Staphylococcus aureus blood culture. The patient received antibiotic treatment with cefotaxime sodium, vancomycin hydrochloride and oxacillin from Day 8 to Day 9, then only oxacillin from Day 10 to Day 20. C-reactive protein controls were 8 mg/L on Day 12, and 4 mg/L on Day 20. On 26Dec2014 there was a positive Staphylococcus aureus nose sampling. From Day 17 to Day 21 the infant was treated with mupirocin. To cancel Staphylococcus aureus carrying by parents, they received as well mupirocin and had BETADINE shower. On 08Jan2015 there was purulent eye discharge, and sampling revealed Enterobacter cloacae complex. The infant received rifamycin sodium eye-drops from Day 22 to Day 26, followed by tobramycin eye-drops from Day 27 to Day 35, after feedback from antimicrobial susceptibility test. On 02Feb2015 a new Staphylococcus aureus nose sampling was still positive; hence the infant received a new treatment with mupirocin from Day 49 to Day 54. During the complete central catheter - from Day 2 to Day 57 - the patient received TRIFLUCAN. On neurological point: Transfontanellar ultrasound (TFU) on Day 1, Day 5 and Day 15 were normal. On Day 21, TFU revealed bilateral candelabra calcification predominant on the left side, including left lenticular mineralization; no other disorders were highlighted. Urine cytomegalovirus test was negative. Day 36 TFU was unchanged versus the one from Day 21. On 22Feb2015 dilated fundus examination, with instillation of phenylephrine hydrochloride and tropicamide, at unspecified dosage, revealed - for both eyes - a stage II in area II. On metabolic point: Guthrie test was done on 20Dec2014. From Day 1 to Day 5, phototherapy was necessary due to jaundice. Due to high blood glucose level the infant received insulin (not specified) from Day 2 to Day 9. Severe hypernatraemia at 163 mmol/L on Day 4, within significant sodium intake context. Haematologically: Initial Hemoglobin (Hb) was 14.7 g/dl. On Day 8 Hb was 8.4 g/dl. Four transfusion of packed red cells were done on Day 8, Day 16, Day 22 and Day 35. On vaccination cover: Pneumococcal 13-valent conjugate vaccine and DTaP-Hep B-IPV-Hib vaccines were made on 16Feb2015. Batch numbers were unspecified. On 17Feb2015 the 62-days-old infant (corresponding to the corrected term of 34 weeks and 6 days amenorrhoea) was transferred to intensive care unit. She weighed 1580 g, her height was 37.5 cm and her cranial circumference was 28 cm. Outcome in term of intensive care unit from 17Feb2015 to 12Mar2015: unspecified. Cardio-respiratory point: Non-invasive ventilation, with OPTI-FLOW, followed by ambient air on 03Mar2015 (Day 76 - corresponding to the corrected term of 36 weeks and 6 days amenorrhoea). WALSH test was normal. Heart rhythm was regular without cardiac murmur. There was hemodynamic stability. Gastro-intestinally and nutritionally: He developed bloating, however the abdomen was soft, well colored, not inflamed, and tympanic. It improved with VASELINE nursing several times daily. Breastfeeding initially exclusive was completed by gastric tube feeding with supplement of 8 x 30 ml enriched of 5% of FORTIPRE and LIQUIGEN. Gradually doses were increased till 7 x 40 ml. Then, due to desaturation periods, uncomfortable infant and very bloated abdomen, the nutrition was decreased. Premature milk formula started on 04Mar2015 at Day 77 and alternated with pasteurized mother milk. The weight increased gradually and moderately until 04Mar2015 reaching 1720 g; then the increase accelerated with a weight of 2170 g (including splint weight) on 12Mar2015. On infection point: Chronic nose Staphylococcus aureus carrying led to a new treatment of 5 days of mupirocin from 18Feb2015 to 23Feb2015, then from 03Mar2015 to 08Mar2015. On 09Mar2015 Staphylococcus aureus test was negative. Due to bloated infant with pain and desaturation, on 04Mar2015 an infectious work-up was performed: C-reactive protein was lower than 3 mg/L, leucocytes were at 9740/mm3, and peripheral blood culture was sterile. On orthopedic point: The infant developed severe osteopaenia with previous healed fracture at femur proximal ends and at humerus distal ends. There was no prior family history of constitutional bone disease. Following the multidisciplinary consultation meeting, it was decided to start vitamin, calcium and phosphor supplementation; mother vitamin and calcium supplementation; and to immobilize the lower limbs using plastered splints - with caution using - in order to support consolidation. Neurologically: TFU performed at week 36 was normal. On 22Feb2015 and 10Mar2015 ocular fundus revealed stage II, area II retinopathy. Psychomotor development was normal. The infant was dynamic with very good social contact. On 12Mar2015, at the civil age of 85 days (corresponding to the corrected term of 38 weeks and 1 day amenorrhea) and the weight of 2170 g, the infant was transferred to the Pre-exit unit. Disease progress within Pre-exit unit from 12Mar2015 to 18Mar2015: Respiratory point highlighted normal breathing within ambient air. Caffeine treatment was pursued. Gastro-intestinally and nutritionally: Feeding autonomy was reached on 16Mar2015 (at D89). Nutrition with "Pre" stage II milk formula or pasteurized mother milk, enriched with 0.7 ml LIQUIGEN, 6 times daily, and with FORTIPRE 5%, and thickened with MAGICMIX 2%. The growth is normal. The transit was spontaneous but required abdominal massages to decrease abdominal meteorism as well as regular enemas. On 18Mar2015 the infant weight was 2275 g. The cranial circumference was 29.5 cm on 07Mar2015. No height measurement was done due to splints. Cardiac examination: no murmur on auscultation, stable hemodynamic parameters. Considering infections: INFANRIX HEXA and PREVENAR 13 vaccinations were performed on 16Mar2015 leading to multiple apnea episodes during the following 48 hours. Neurological examination: Eye fundus on 17Mar2015 revealed stage 1-2 in peripheral zone 2, without stage plus. The infant was discharged home on 19Mar2015 with a weight of 2 kg and 275 g at the civil age of Day 91 or adjusted term of 39 weeks of gestation (amenorrhea). Nutrition: Milk Pre-etape II, six times 701 ml, with MAGIC MIX 2%, and 0.7 ml of oil (ISIO4 type) in the bottles. Treatment on discharge: Folic acid at 2.5 mg once daily; iron 0.70% syrup: 0.5 ml twice daily; Caffeine citrate (trade name not specified) 0.46 ml daily; paracetamol drinkable suspension, one weight dose each 6 hours if needed; retinol/ergocalciferol/alpha-tocopherol/ascorbic acid one dose n degree 1 per day; ergocalciferol two drops once daily; isotonic sodium chloride 5.85%, 0.7 ml/bottle; and econazole. Monitoring to be continued at home. Were scheduled: eye fundus consultation, in the follow-up unit of neonatology on 31Mar2015. In conclusion: Prematurity established at 26 weeks of gestation for pre-eclampsia and severe intrauterine growth retardation (IUGR). Severe IUGR was detected in the second percentile. Packed red cell transfusions were administered 4 times. invasive ventilation was administered during 6 days. Non-invasive ventilation during 54 days. Walsh test. Umbilical venous catheter for two days. Central catheter for 55 days. Breastfeeding and mixt nutrition. The infant was included in the perinatology system. Discharge without caffeine and monitored supervision. New hospitalization in the pediatric intensive care unit between 28Mar2015 and 02Apr2015. On 28Mar2015, the parents arrived with the infant to the emergency room for pre-syncope with loss of contact for a few seconds, associating generalized hypotonia, then regurgitation by the mouth and the nose for several times associating peri-oral cyanosis. The infant was described as painful and fussy from 27Mar2015 at about 10 p.m. On 27Mar2015, stools were soft and liquid, and well molded. On arrival to the emergency room at 4:50 a.m.: oxygen saturation was 85-86% in ambient air, capillary refill time was 5 seconds, generalized hypotonia, respiratory rate 65/min, blood pressure: 111/65 mmHg, heart rate: 145/min, body temperature: 35.4 degree C. Auscultation showed: respiratory whimper, intercostal retractions, and seesaw respiration. At 5:20 am. Oxygen saturation was 88% under 2 L of oxygen, but persistence of seesaw respiration, distended abdomen and blood pressure: 114/64 mmHg. The infant was transferred in the pediatric intensive care unit. Blood gases at 5:30 am: pH 7.18, partial pressure of CO2 (PCO2) 56, partial pressure of O2 (PO2): 56, HCO3 17.6, lactates: 8.4 mmol/L. Noninvasive assisted ventilation started with (CPAP): Continuous Positive Airway Pressure, FiO2: 24% for a saturation of 94-95%. At 7:45 am, heart rate was 150/minute, respiratory rate: 39/minute, blood pressure: 114/63, oxygen saturation 100% under 5 L of O2. Action taken: Intubation, ventilation with propofol (unspecified trade name) 10 mg and CELOCURINE 3.5 mg. Intubation tube 3.5 with balloon, landmark 8.5. Ventilation in positive pressure ventilation in assisted / controlled mode, respiratory rate: 60/min, inspiratory pressure: 30, positive expiratory pressure (PEP) 4, fraction of inspired O2 (FiO2) 100%. Sedation with midazolam hydrochloride (unspecified trade name) 100 gamma/kg/hour and sufentanil (unspecified trade name) 0.1 gamma/kg/hour. Intravenous antibiotic therapy was instituted with gentamicin (unspecified trade name) and cefotaxime sodium. During transport: ventilation difficulties due to significant abdominal distention. On admission to the unit on 28Mar2015 at 9:30 am: Weight 2500 g, cardiac rate: 159/min, body temperature: 33.3 degree C, blood pressure: 75/34 mmHg, blood pressure average: 55, oxygen saturation 98%, respiratory rate: 50/min. There was major abdominal distention, collateral abdominal venous circulation, non-depressible abdomen, gray skin coloration, cutaneo-mucous paleness. On respiratory examination: tachypnea, symmetric and clean vesicular murmur, respiratory distress signs, with respiratory seesaw, inter and sub-costal retractions, nasal flaring. Ventilated in BIPAP bilevel positive air pressure inspiratory pressure: 30, PEP: 5, respiratory rate 60, FiO2: 100%. Intubation tube: 3.5, landmark: 9.5. Cardio-vascular examination showed: perceived femoral and peripheral pulse. Inferior limb edema. Abdominal examination showed: severe abdominal distention. Collateral abdominal circulation. Skin examination: gray infant, no rash. Neurological examination: pupils were in reactive myosis, fontanels were normal. Posterior plastered splints were present over the two lower limbs. Initial work-up showed: Blood gases: pH: 7.06, PCO2: 86, paPO2 28, bicarbonates: 24 and lactates: 1.7. Blood electrolytes: blood sodium: 134 mmol/L, potassium: 7.8 mmol/L, chloride: 105 mmol/L, HCO3-23, proteins: 45 g/L, calcium 2.41 mmol/L. C-reactive protein was 3 mg/L, procalcitonin: 11. Blood count: red cells: 3.48 x 10^9/l, hemoglobin: 10.8 g/dl, hematocrite: 34, platelet count 450 000/mm3, white blood cells: 17 700. Hemostasis profile: partial thromboplastin time was 45, rate: 1.4, fibrinogen: 2. Liver function tests: bleeding time: 29 IU/L, alkaline phosphatase 780, gamma glutamyltransferase: 70, aspartate transaminase: 128 IU/L, alanine transaminase: 62 IU/L. Abdomen without preparation: major colon distention, wall thickening, pneumatosis suspicion and no pneumoperitoneum. Recommendations followed: fasting, gastric tube without aspiration, continuation of antibiotic therapy with cefotaxime sodium, gentamicin, and addition of metronidazole by slow intravenous infusion. Sedation with midazolam and sufentanil was continued. Surgical management as matter of emergency. Course within the department. Hemodynamic conditions. Given the instability and blood pressure fluctuations the patient initially received fluid replacement, she experienced severe bradycardia (60 beats/minute) on hypoxia necessitating cardiopulmonary resuscitation for 2 minutes. A 3rd volume replacement was required then catecholamine (noradrenaline 0.5 ug/kg/min which was increased to 4.5 ug/kg/min on 29Mar2015). On 28Mar2015 decrease of cardiac contractility, dobutamine (unspecified trade name) was started at 5 ug/kg/min increased to 10 ug/kg/min. Dobutamine was then decreased to 7.5 ug/kg/min after monitoring on 28Mar2015 at 7:20 pm showing shortening fraction 35%. Due to the increasing noradrenaline demand, hydrocortisone hemisuccinate (unspecified trade name) was added on 28Mar2015. Surgical management on 28Mar2015 at 11:40 am in the pediatric intensive care unit for suspected bowel volvulus. Aspect of diffuse necrosis with no possible resection. Enterostomy, New surgical control on 30Mar2015: diffuse necrosis of the bowel with only 5 cm area of uninvolved bowel. Necrosis also involved the right colon and the ileocecal valve. Clinical surveillance for 48-72 hours was decided. Third surgical evaluation on 01Apr2015: no regression. Necrosis of ileocecal valve and right colon persisted. Viable 5-cm bowel segment. Considered the diffuse necrosis and the lack of improvement it was decided to limit the reanimation treatment. Respiratory conditions: improvement of ventilation after abdominal surgical decompression. Bilevel positive airway pressure (BIPAP) ventilation with frequency of 40, expiration positive pressure 4, maximum pressure between 23 and 25. Infection: post-mortem sampled ascites returned positive to Staphylococcus epidermidis, sterile pleural and pericardic fluid. Peripheral culture negative on 28Mar2015. The patient presented with fever during hospital stay. Peak C-reactive protein value 89 on 29Mar2015. Procalcitonin peak level 100-162 on 29Mar2015. IV antibiotic therapy with metronidazole, cefotaxime sodium, gentamicin and vancomycin was continued. Vancomycin was discontinued on 29Mar2015 while gentamicin was withdrawn on 30Mar2015. Regarding metabolism: hyperkalemia on 28Mar2015 and 29Mar2015 necessitating IV insulin therapy along with bicarbonate 42% boluses, salbutamol by inhalation, insulin glucose 30%, calcium gluconate. Two episodes of hypoglycemia (blood glucose 0.44 g/l on 28Mar2015) required IV glucose 30%. Hematology: drop of coagulation factors (nadir on 29Mar2015): prothrombin time 20, fibrinogen 1.8, factor V not detectable, factor VII and X 14, factor II 15, associated to thrombocytopenia (nadir platelets 21 000). No disseminated intravascular coagulation (DIC) detected. Postoperative anemia (Hemoglobin 4.1 g/dl) on 28Mar2015 requiring red blood cell (RBC) transfusion. She received in total 3 units of RBC, 6 fresh frozen plasma and 2 platelet concentrate. Neurologic condition: the infant remained intubated and sedated during the whole hospital stay. Cerebral edema set in on 28Mar2015 and 29Mar2015 requiring osmotherapy by hypertonic saline solution and mannitol. Renal conditions: acute renal failure with decreased urine output on 30Mar2015 and 31Mar2015, maximum urine 15, creatinine 105. Initiation of a treatment with furosemide IV push until 8 mg/kg/day allowing resumption of normal urine output. Gastrointestinal condition: parenteral nutrition started with a binary solution of glucose, amino acids, electrolytes and trace elements (PEDIAVEN NOUVEAU NE) from 28Mar2015 to 01Apr2015. Regarding the prosthesis: a right subclavian two-lumen Central Venous Catheter, 4.5 French 8 cm on 28Mar2015 and a three-lumen left femoral catheter, 4.5 French 12 cm on 29Mar2015 were inserted. After consultation between surgeon and pediatric intensive care department team and after the patient''s parents had been informed, it was decided to limit the care after the 3rd surgical evaluation which revealed necrosis of the right colon and ileocecal valve. The patient died on 02Apr2015 at 3:10 am. In conclusion: extended bowel necrosis on probable enterocolitis ulcer-necrotizing. Invasive ventilation for 10 days. Right subclavian catheter for 6 days. Left femoral catheter for 5 days. Premature newborn. Distributive shock. Vasoactive catecholamines for 6 days. Histopathology examination on 03Apr2015 regarding abdominal organs: peritoneum: 45 ml hemorrhagic effusion. All suspect drugs were withdrawn. Spironolactone, caffeine and phytomenadione were withdrawn on unspecified date, rifamycin sodium was stopped on 12Jan2015, furosemide was withdrawn on 30Jan2015, cefotaxime sodium and vancomycin were discontinued on 26Dec2014, oxacillin was stopped on 06Jan2015, mupirocin was withdrawn on 08Mar2015, tobramycin was discontinued on 21Jan2015, fluconazole was stopped on 12Feb2015, phenylephrine hydrochloride and tropicamide were stopped (punctually administered for diagnosis on 22Feb, 10Mar and 17Mar2015), pneumococcal 13-valen conjugate vaccine and DTaP-Hep B-IPV -Hib vaccine were discontinued (context of vaccination on 16Feb and 16Mar2015). Necrotizing enterocolitis neonatal could have led to the patient''s death on 02Apr2015 at 03:10 a.m. Based on the Official Method of Causality Assessment, the causal relationships between spironolactone, rifamycin sodium, caffeine, phytomenadione, furosemide, cefotaxime sodium, vancomycin, oxacillin, mupirocin, tobramycin, fluconazole, phenylephrine hydrochloride, tropicamide, pneumococcal 13-valent conjugate vaccine, DTaP-Hep B- IPV-Hib vaccines and the adverse event necrotizing enterocolitis neonatal were assessed by the Agency as "doubtful". No follow-up attempts possible. No further information expected.


VAERS ID: 609787 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-21
Entered: 2015-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509SEN009015

Write-up: This initial spontaneous report was received from a physician (head of the immunization division) via a company representative, referring to three patients of unknown age and gender. There was no information about patients'' concomitant therapies, concurrent conditions, medical histories provided. On unknown dates, the patients were vaccinated with the first dose of GARDASIL injection (strength, dose, route and site of administration, lot numbers and expiration dates were not provided). The physician stated that on an unknown dates, the patients died. The relatedness between death and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.


VAERS ID: 610203 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-22
Entered: 2015-09-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Haemophilus infection, Meningitis
SMQs:, Noninfectious meningitis (narrow), 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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA139080

Write-up: Initial unsolicited report received from consumer (mother) and non-healthcare professional (sales consultant) on 10-Sep-2015. This case involves a six-year-old female patient, who had received a dose of Haemophilus Influenzae B (batch number, manufacturer: unknown, route and site of administration were not reported) on unspecified date. It was confirmed that patient''s vaccine card was complete (unspecified regarding which kind of vaccines she had received against HiB) and the child died due meningitis by HIB by medical department of the school. The reporter does not know if it was administered at a public or private health care unit. Medical history and concomitant medications were reported as unknown. On unspecified date in 2015, after vaccination, the patient experienced meningitis by Haemophilus influenzae B due to which the patient was dead. It was due to lack of efficacy. The reporter was informed that the sanitary surveillance went to the school and ruled out any possibility of a meningitis outbreak. Laboratory investigations were reported as unknown and corrective treatments were not reported. Outcome of the event was reported as fatal. Documents held by sender: none. This case involves a vaccine containing Haemophilus influenzae B antigens, manufacturer Unk (lot number not provided). It could potentially be 095 (HIB) or 315 (DTP-HIB-IPV) vaccine AWARE codes. Lab tests unknown. Cause (s) of Death: Haemophilus influenzae meningitis.


VAERS ID: 610350 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-11
Onset:2015-09-12
   Days after vaccination:1
Submitted: 2015-09-24
   Days after onset:12
Entered: 2015-09-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER Y201404011 / 2 AR / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K00481 / 2 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal X-ray, Breath sounds abnormal, Crying, Death, Dyspnoea, Gastroenteritis, Gastrointestinal sounds abnormal, Intussusception, Respiratory symptom, Respiratory tract congestion, Sepsis, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-09-14
   Days after onset: 2
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: Con Meds -Unknown; Prev Meds -Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Physical examination (12 September 2015): Pulse: 178 per min, Respiratory rate: 42 per min, Blood pressure: 90/53 mmHg; Throat congestion; shortness of breath; Respiratory three concave symptom; Lungs breath sounds coarse; Abdomen slightly elevated; Bowel sounds weak; X-ray examination showed intussusception; Body temperature, 12SEP2015, 37.7 Degree C; WBC, 12SEP2015, 22.5, G/L; Cause of Death: intussusception, septicemia
CDC Split Type: 2015SA141961

Write-up: Initial unsolicited report received from a Hospital (medical record of the hospital provided) via company representative on 16 September 2015. This case involves a five month-old male patient who was vaccinated with a 0.5 ml second dose of IMOVAX Polio (batch number: K0048-1) and a 0.5 ml second dose of Haemophilus Influenzae B (batch number: Y201404011) both via intramuscular route in the in the arm on 11 September 2015. The patient''s medical history and concomitant medications were not reported. On 12 September 2015, one day following the vaccination, the patient vomited and cried for 4 hours, about 10 ml each time and vomited six times. The patient was taken to hospital where the X-ray examination showed intussusception and then the patient was transferred to another hospital. On the same day, the patient had throat congestion, shortness of breath respiratory three concave symptom and examination revealed lungs breath sounds coarse, abdomen slightly elevated and his bowel sounds were weak. On an unknown date, the patient was diagnosed with acute gastroenteritis and septicemia. On 12 September 2015, laboratory data included X-ray examination which showed intussusception, physical examination included temperature: 37.7 degree Celsius, pulse: 178 per min, respiratory rate: 42 per min, blood pressure: 90/53 mmHg and WBC: 22.5 gm/l. The patient''s corrective treatment was not reported. On 14 September 2015, the patient died. The outcome of the events intussusception, septicemia was fatal and for the events acute gastroenteritis, respiratory three concave symptom/shortness of breath and throat congestion was unknown. List of documents held by sender: none.


VAERS ID: 610536 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2015-08-04
Onset:2015-08-07
   Days after vaccination:3
Submitted: 2015-09-23
   Days after onset:47
Entered: 2015-09-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 922678 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blindness, Death, Haematology test abnormal, Pyrexia, Seizure, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-10
   Days after onset: 3
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: 08-AUG-2015, Haematology test, abnormal
CDC Split Type: 2015313909

Write-up: This is a spontaneous report from a contactable physician received via a sales representative. A 6-month-old male patient of an unspecified ethnicity received a single dose of PREVENAR 13 (Lot # 922678), via an unspecified route of administration on 04Aug2015 as well as INFANRIX HEXA, via an unspecified route of administration on 04Aug2015 at unknown dose. Medical history and concomitant medications were not reported. The patient started to experience intense fever on 07Aug2015 and as result he underwent an hematology test on 08Aug2015 that show that the patient was experiencing a viral infection (the patient''s mother was told to go to the hospital if the symptoms continue). The fever persisted on 09Aug2015 and on 10Aug2015 the patient''s mother call the physician to express her concern since the patient was down, still with lots of fever and with the eye sight lost, as result the patient was taken to a nearby hospital where he experienced a convulsive episode and as result was admitted to the ICU where on the same day on the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the other reported events was unknown.


VAERS ID: 597773 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-29
Entered: 2015-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervix carcinoma, Death
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509USA013451

Write-up: This spontaneous report as received from an unknown reporter via Merck Vaccines report refers to a 23-year-old female patient. The patient''s concurrent conditions and medical history were not reported. On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown). Concomitant medications were unknown. The patient was diagnosed with cervical cancer on an unspecified date. The cervical screening program sets the minimum age for pap smears at 25- three years older than the patient was when her cervical cancer was diagnosed. The article noted that nearly all cervical cancer cases were caused by quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown), the most common sexually transmitted disease. The patient''s family noted that she had even taken precautions, getting the quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown) to protect against it. The patient''s mother said she was worried about cervical cancer because both her grandmothers had died from it, though scientists have not discovered any genetic factors that contribute to the disease. The patient had died from cervix carcinoma on an unspecified date. The reporter did not provide the causality assessment between the event cervix carcinoma and quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown). The event cervix carcinoma was assessed as serious due to medically significant and death. Additional information is not expected as reporter details were not provided.


VAERS ID: 613199 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-28
Entered: 2015-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Encephalopathy, Immunology test abnormal, Neurological symptom
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Immunology test, revealed antibodies HPV16LI
CDC Split Type: WAES1509CAN013174

Write-up: This spontaneous report as received from a retired physician via article and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported) dose 1. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported) dose 2. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported) dose 3. On an unknown date (reported as "shortly after the first dose), the patient experienced neurologic symptoms. And it was reported that the patient died, on an unknown date, six months after the third dose of vaccine. The autopsy, otherwise normal, showed encephalopathy, the immuno-histology of cerebral blood vessels revealed antibodies HPV16LI, hypothesis raised, to be verified of course, of an auto-immune cerebral vasculitis caused by vaccine''s antigen. The relatedness between adverse events and GARDASIL was not reported. Upon internal review the event of encephalopathy was considered as medically significant. This is one of two reports received from the same reporter. Additional information is not expected as the physician retired and no follow up is possible.


VAERS ID: 613237 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-28
Entered: 2015-09-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Encephalopathy, Human papilloma virus test positive
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Immunology test, revealed antibodies HPV16LI
CDC Split Type: WAES1509CAN013170

Write-up: This spontaneous report as received from a retired physician via article and refers to a 14 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported) dose 2. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported) dose 2. On an unknown date, 2 weeks after the second dose of GARDASIL, the patient experienced encephalopathy and died. The autopsy, otherwise normal, showed encephalopathy, the immuno-histology of cerebral blood vessels revealed antibodies HPV16LI, hypothesis raised, to be verified of course, of an auto-immune cerebral vasculitis caused by vaccine''s antigen. The relatedness between the event and GARDASIL was unknown. Upon internal review the event of encephalopathy was considered as medically significant. This is one of two reports received from the same reporter. Additional information is not expected as the physician retired and no follow up is possible.


VAERS ID: 613257 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Male  
Location: Foreign  
Vaccinated:2011-08-05
Onset:2013-10-07
   Days after vaccination:794
Submitted: 2015-10-01
   Days after onset:724
Entered: 2015-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0211Z / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Ammonia increased, Apnoea, Areflexia, Aspartate aminotransferase increased, Bacterial test positive, Blood creatinine decreased, Blood heavy metal increased, Blood ketone body absent, Blood lactate dehydrogenase increased, Bradycardia, Candida test positive, Cardiac arrest, Cardio-respiratory arrest, Cerebral atrophy, Cerebral disorder, Continuous positive airway pressure, Cyanosis, Cytogenetic analysis normal, Cytomegalovirus test positive, Death, Developmental delay, Disability, Electroencephalogram abnormal, Encephalitis, Encephalopathy, Exaggerated startle response, Feeding disorder, Full blood count normal, Growth retardation, HIV test positive, Hepatitis C virus test positive, Hypermetropia, Hypokalaemia, Hypotonia, Hypoventilation, Immunology test abnormal, Intensive care, Laboratory test abnormal, Loss of personal independence in daily activities, Microcephaly, Motor developmental delay, Multiple chemical sensitivity, Myoclonus, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, PO2 decreased, Pallor, Plagiocephaly, Poisoning, Posture abnormal, Resuscitation, Serology negative, Speech disorder developmental, Strabismus, Treponema test positive, Unresponsive to stimuli, Visual evoked potentials abnormal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-08
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Medical observation, no known allergies; Immunisation
Preexisting Conditions: Medical observation, eutocic delivery after well controlled term gestation. Controlled pregnancy without complication. Epidural during delivery. Dilatation during 13/14 hours (dystocic), prolonged vaginal expulsive (2/3h). Oxytocic, epidural analgesia, normal delivery no requiring resuscitative measures. Apgar of 9/10, breastfed without problems and no sleep alterations; Son of non-consanguineous parents, 1st pregnancy and 1st son, born after a normal pregnancy at 41 plus 6 week through vaginal delivery (weight 3.490 gr., cranial perimeter 34/34.5 em) with prolonged expulsive but good general state, cephalohematoma, early jaundice (bilirubin 16.5) at the third day of age that was treated with natural phototherapy; On 05-JAN-2011 a routinely medical checkup with the usual healthy checkup program did not reflect any alteration in the patient. On 29-MAR-2011 the patient presented with postural plagiocephaly and torticollis with neck right lateralization, noonal neurological exploration. Mouth asymmetry when crying since birth; On 30-MAR-2011: diagnosis of congenital torticollis; Breastfeeding until he was 16 months old; Healthy alive father 38 years old, healthy alive mother 33 years old; Mother suffered from lymphoblastic leukemia when she was 20 years old. His mother history was blood group O/RH+ and appendectomy; Mother head circumference: 54.5 and father: 60 em; No neurological relative''s relevant medical history; Maternal grandparents alive with good health stay. Paternal grandfather 81 years-old with hypercholesterolemia and depression. Paternal grandmother 67 years-old with aneurysm cerebral with leg paralysis as sequelae; 10/26/2010, ENGERIX-B, first dose of hepatitis B vaccine at birth (ENGERIX, by GSK, number: XHBVSP70AK); INFANRIX; NEISVAC-C; INFANRIX HEXA; PREVENAR
Allergies:
Diagnostic Lab Data: EEG (09NOV2011): generalized interictal epileptiform activity with sleep and superficial sleep. Outgrowth discharges with generalized peaks of short length. Brain MRI (06-OCT2011): scarce volume for his age, not presenting structural anomalies, good differentiation between white and grey matter. On 27-APR-2012 and 17-MAY-2012 a report showed pathogens: Ascaris Lumbricoide and Larvae (in brain), Strongiloides (in brain), Fasciola Hepatica, Oxiurio (Entewb. Veoniculae), bacteria: Clostrydium Tetani, Treponema Pallidum, Strepotomyce Griseus, Virus HIV p24 and Rev. Tran. (in thymus), VIH (1 and 2) in thymus, cytomegalovirus, hepatitis C; fungi: Candida albicans in blood. Heavy metals positive in thymus and brain, kidneys and liver (cobalt, nickel, aluminum), colorant negative, toxics negative, solvents negative, benzene in thymus, immune system: lack of rodanase enzyme, cytochrome C and gluthatione in saliva, ferritin enzyme present in white blood cells in brain, lack of betaglycan in white blood cells, intoxication by vaccines, hereditary grade 3 intoxication, low, presence of toxic immunosuppressors (heavy metals and azoic colorants). Those analysis showed noonal complete blood count, normal biochemical analysis except for increased AST-GOT, low creatinine, toxicology (all normal), aminoacids in urine showed elevated taurine, genetic studies showed no mutation of Rett-Foxg1 syndrome gene, increased level of lactate dehydrogenase, low partial 02 blood pressure, very high anunonia ion in plasma, serum aminoacids: very high histidine (684 micwmol/1), very low glycine, they included cranial MRI, electroencephalogram-sleep deprivation with abnormal conclusions, evoked cortical visual potentials also with abnormal results. 09/19/2011, Blood ketone body, normal; 09/19/2011, Blood lactate dehydrogenase, increased, normal; 09/27/2011, Electroencephalogram, normal; 09/19/2011, Serology test, negative
CDC Split Type: WAES1509ESP014639

Write-up: This case is linked with case E2015-10587 (same reporter, similar adverse events). Case of vaccination error (1st dose ROTATEQ administered (adm) after 32 weeks (wks) of age when according to SmPC 1st dose of ROTATEQ should not be adm. later 32 wks of age) and possible overdose (a dose of DTPa-IPV-Hib-HB and a dose of Hep B vaccine probably adm. on same date) received from a legal claim through company lawyer 22SEP15. Case medically confirmed (several medical reports received). The following vaccines were adm. (routes not reported): 1st dose ENGERIX, manufactured GSK, batch number (#) XHBVSP70AK at birth. 2nd dose of ENGERIX, batch # A21LA779B on 16MAR11, 3rd dose HBVAXPRO, batch# NP28771 on 13JUL11. INFANRIX, GSK, 1st dose (batch# A20CA605A) on 16MAR11, 2nd dose (batch# A20CA562B) on 16MAY11. INFANRIX HEXA, batch# A21CA800A on 13JUL11. ROTATEQ: 1st dose (batch# 0480Z) on 30MAR11, 2nd dose (batch# 1265Z) on 08JUN11, 3rd dose (batch #0211Z) on 05AUG11. NEISVAC C, Baxter: 1st dose (batch# VN914233) on 16MAR11 and 2nd dose (batch# VN914233) on 16MAY11. PREVENAR 13, manufactured Wyeth: 1st dose (batch #E88580) on 30MAR11, 2nd dose (batch# F01211) on 08JUN11 and 3rd dose (batch# illegible) on 05AUG11. There were discrepancies between vaccines adm. between different documents provided: According to claimants there was 1st dose of ROTATEQ adm 30MAR11, this dose does not appear in Regional Health Authorities vaccination card. According to claimant on 16MAR11, patient (pt) received NEISVAC C and INFANRIX HEXA, according to regional authorities he was vaccinated that day with a INFANRIX IPV + Bib a ENGERIX B and a NEISVAC C. According to claimant, pt was vaccinated 16MAY11 with NEISVAC C and INFANRIX HEXA when according to regional authorities vaccination card he received that a meningococcal C vaccine and DTPa-Hib-IPV vaccine (GSK vaccine). According to claimant he received 3rd dose of HBVAXPRO on 13JUL11 concomitantly with dose of DTPa-Hib-IPV vaccine when according to Regional Health Authorities he received a dose of INFANRIX HEXA so it is not clear whether the pt received a dose of HBVAXPRO or not. In the documentation provided there were one report from Health Authorities, one from the claimant and several medical reports. Agency Report: Male, son of non-consanguineous parents, born after a normal pregnancy at 41 plus 3 (41 plus 6 according to medical reports) week through vaginal delivery (weight (wt) 3.490 gr., head circumference 34/34.5 em) with prolonged expulsive but good general state (Apgar 9/10), cephalohematoma (at 48 hours according to lawyers report), reanimation maneuvers not required. Early jaundice treated with natural phototherapy. 05JAN11, routinely medical checkup within usual healthy checkup program didn''t reflect any alteration in pt. 29MAR11 report, written he presented with postural plagiocephaly and torticollis with neck right lateralization, physiotherapist visit prescribed. Normal neuro exploration. 30MAR11, physiotherapist started treating him and noticed he presented a hypotonia picture so decided to derive him for evaluation (report issues 31MAY11 and stated reason for visit was to evaluate muscle tone after derivation from physiotherapist). Several physicians (phys.) did not observe the picture referred by physiotherapist and in one report it was reflected torticollis evidenced when he was 2 months old being treated by physiotherapist, was diagnosis (dx) hypotonia so he was derived to the neuropediatrician when he was 5 months (mths) old who referred normal evaluation. In the physiotherapist''s report it was reflected neuropediatrician that assessed him did not find any significant alteration, denying presence of hypotonia. In report of neuropediatrician it as stated that physiotherapist insisted on existence of hypotonic picture, with poor cephalic equilibration, evaluated by 2 pediatricians and one neuropediatrician when he was 5 mths old and none study was indicated and decided expecting attitude. 31MAY11, hospital (hosp) report informed of no anomalies in exploration and only control and follow-up by pediatrician was recommended (to stop therapy was recommended according to lawyer''s report). Next visit at same hosp. 04AUG15 due to intermittent awakenings during night reported they were considered to be related to teething and was discharged with analgesic treatment (tx) (apirteal according to lawyer''s report, dose and dates not reported). In this report, neurologic exploration normal. First report of phys. other than physiotherapist reported any grade of hypotonia was dated 31AUG11, diagnosing him of mild axial hypotonia, incomplete sitting with retarded motor skills for age. Clinical judgment was mild idiopathic motor development delay (within the normal limits for age). From that moment on, reports started to refer alterations in pt''s exploration. First one 12SEP11, stated that diagnosis (dx) was hypotonia of unknown origin, psychomotor development delay to evaluate. Reports 27SEP11 and 23NOV11 reflected that he was also assessed by other phys. Two reports from 13SEP11 and 06OCT11 reflected neither diagnostic impression nor recommended therapeutic attitude, presumably because incomplete reports had been sent to Agency. Both reports only compile anamnesis and exploration data and in one of them diagnostic tests data. After global evaluation and complementary studies (among them, evoked potentials that revealed a slightly delayed P100 wave in a bilateral and symmetric way in the visual stimulation with glasses, electroencephalogram with slowed background activity for his age and generalized intedctal epileptiform activity with sleep and superficial sleep) initial tx with DEPAKINE indicated, which damaged his general state and later KEPPRA with same result, so eventually all antiepileptic tx was withdrawn. Dx performed after that moment unmistakably evidence clinical features (hypotonia with unstable cephalic hold, no sitting position, no intentional manipulation or very scarce, globally retarded maturation, scarce interaction with environment, retarded motor maturation, deficient prelanguage for his age, usual awakenings and from 9 mth old on, sporadic myoclonias) in this reports: hosp. 23NOV11 (psychomotor development delay, hypotonia under study and sleepy, not included in HA''s report), medical center report from 30JAN12 (idiopathic congenital encephalopathy, severe global psychomotor development delay, myoclonias) (report from a phys. 14MAR12 (early postnatal progressive encephalopathy, myoclonias of cortical-subcortical origin). After 12MAR12, highlighted info was report from a foundation on 11DEC12 his parents brought him in order to check if he was intoxicated by metals. That foundation diagnosed him of multiple chemical sensitivity. Very poorly structured info, probably related to a visit to an environmental medicine center (only one of reports was dated and signed, on 29-NOV-2012), where different determinations were performed (cellular analysis, salvia testing) and different recommendations performed (walnut tree dye, liquid chlorophyll, wild oregano oil, curcuma, fennel and betaine among others). Hosp. report 7/8-OCT2013 due to cardio-respiratory arrest, from which he eventually died. Health Authorities assessed possible relationship between clinical features and vaccination. First of all, they tried to establish temporal sequence between pt''s vaccination and clinical features he presented with. In light of documents that were submitted they concluded that no neurologic alterations were present at the time of birth and that it was physiotherapist who detected first signals of alarm once the clinical picture stated to develop. So, start of clinical picture, clinical picture of progressive character, must had happened between moment he was derived from pediatry to physiotherapy (29MAR11) and moment that physiotherapist requested evaluation of the picture of hypotonia she had observed (31MAY11). It was not possible to determine exact moment of debut of symptomatology. In HAs report it was highlighted that there were discrepancies btwn vaccination card provided by Reg. PV center and vaccinations mentioned in legal claim regarding pentavalent or hexavalent vaccines, but according to HAs report they weren''t SPMSD vaccines. Conclusion of HA were he developed a picture of progressive encephalopathy; it was impossible to precise exact moment symptoms appeared and thus it was not possible to determine latency period between one or another vaccine adm. and debut of clinical picture; since available scientific information had reported cases of encephalopathy/encephalitis associated to adm. of at least 2 vaccines he was adm; and before difficulty to reconcile previous points, they considered impossible whether to absolutely accept or refute a possible causality relationship between the vaccination and appearance of clinical feature. Claimant''s Report: Pt history: Mother suffered from lymphoblastic leukemia when she was 20 years old. Eutocic delivery after well controlled term gestation. Neonatal torticollis. Controlled pregnancy without complication. Epidural during delivery. 30MAR11, visited physiotherapist for first time for rehabilitation when 3 mths old, derived from his pediatrician due to dx of congenital torticollis. Infant also presented with series of alert signals such as: pulgar stay and no control capacity of trunk nor cephalic. Besides, he did not respond properly to any neurological test showing a blocked maturing development. 31MAY11, neuropediatrician found the infant noonal and stopped the therapy. 12SEP11, he did not adopt sitting position gross psychomotor: poor cephalic hold/control and occipital flattening, 4-limb hypotonia and sterotyped movements. The dx was hypotonia without clinical cause and motor development delay to evaluate. The recommendations were: visit physiotherapist, neuropediatrician and ophthalmologist. 13SEP11, he visited a neuropediatrician due to hypotonia he suffered since he was 3 mths old. At the time of that reporting, he showed unstable cephalic hold. Globally retarded maturation. It was reported that for at least 2 mths he presented with episodes of non-grouped abrupt whole body startle response, approx. 20-30/day, only during vigil. Absent reflexes and convergent strabismus also reported in medical reports. 06OCT11, a neuropediatrician diagnosed him with global maturation retardation, cerebral-motor disorder, symptomatic microcephaly and possible myoclonias. It was reported that he had improved and with less shakes than before, he suffered from plagiocephaly and cerebral MRI showed scarce volume for his age, not presenting structural anomalies. 23NOV11, a pediatrician reported hypermetropia. He requested clinical analysis and blood analysis for valproic acid. 30JAN12 and NOV2011 medical Center reported that a generalized myoclonia with generalized P.O. discharge was registered. In the exploration severe axial hypotonia was remarked. Wt and head circumference stagnation observed. Cranial TAC was advised in order to rule out presence of calcifications. Results from gene CDKL5 and MECP2 studies were pending. Certain genes remained to be checked for mutations. In NOV-2011 treatment with DEPAKINE was started. In NOV2011 medical Center diagnosed microcephaly and axial hypotonia. JAN2012: DEPAKINE was withdrawn due to intolerance. A "cellular analysis" on 23FEB12 showed: probable antiphospholipid syndrome "thrombus", metal intoxication and red blood cells with irregular shape among other (see lab comments). 14MAR12: neuropediatrician suggested copper metabolism study, blood ammonia study, among others. It was found that blood ammonia and glutamic oxaloacetic transaminase (GOT) levels were discreetly elevated. It was highlighted that he had feeding issues, with a very low wt curve, confirming microcephaly and cerebral atrophy suggested in the neural image. It was also mentioned pyramidalism, visual sensory impairment and feeding difficulties (in MR). Report on 12SEP12, reported a cellular analysis that indicated that metal intoxication persisted apparently due to whooping cough vaccine. 21SEP12, etiologic assessment performed by to physicians reported that taking into account Karch-Lasagna algorithms relationship between vaccination and encephalitis was considered probable (related to third dose of INFANRIX HEXA), meaning that adverse effect produced after vaccination could be due to the vaccine. An alternative explanation would be less possible. 11DEC12 his parents visit a foundation to see if his child was intoxicated with the metals contained in the vaccines. He was taken to a non-conventional therapist that achieved a clear improval with tx. After 1 month the evoked potentials were repeated and they were normal. Brain activity also improved. After 2 or 3 months of tx a progressive improval was observed at that time and also the motor movility was improving. He had always stayed at home, he had not attended kindergarten. He eated 50% ecological food and drank filtered water. Test QESSI performed and diagnosed of Multiple Chemical Sensibility. 15JUN12, Pharmacovigilance service concluded to keep the case as not evaluated for the application of causality KarhLasagna algorithym of the Pharmacovigilance Service, which could be later reviewed as long as new clinical data, explorations, course and diagnostic were provided for any period from his birth until that moment. 28AUG12 Agency granted 80% disability: multiple disability, encephalopathy of unknown origin, maturing retardation. 08OCT13 he died. Death report reported of a 2 year-old male brought to ER by his parents in cardio-respiratory arrest. They reported that he was at home pale, cyanotic and not reacting, and he was like that for 5-10 minutes. In minutes before arrest he had a yogurt. No previous convulsions to the episode. No fever or other associated symptoms. Diagnosis at discharge, main: cardio-respiratory arrest, chronic encephalopathy of unknown origin. Partial report of a physician on 25MAR14 stated that the vaccine INFANRIX HEXA, administered on 13JUL11 as per calendar, as the cause of post vaccination encephalopathy. Regional HA report confirmed 80% of disability. Pediatrician Medical report (patient died): admitted 07OCT13. Pt hx was psychomotor development delay, hypotonia, no sitting position, no bipedalism, absence of spontaneous language, myoclonias of morning predominance, bad oral tolerance, wt and ht stagnation, not known medical allergies, bad tolerance to some NSAIDs. Current illness was cardio-respiratory arrest, his parents noticed at home that he was pale, cyanotic, and not reacting, for over 5-10 minutes. His physical exploration showed that his initial constant were blood pressure of 60/30, 70/40 mmHg, when he arrived to pediatric intensive care unit (PICU) it was 100/50 mmHg. He showed asystolia, 30 beats/min (extreme bradycardia for minutes), 100, 120 beats/min (previous to his transfer to PICU. When he arrived it was 140 beats/min. O2 saturation 100% post-intubation (fraction of inspired oxygen 100%), bad general state, badly perfunded, cyanosis and generalized paleness, absence of spontaneous breathing movements, asystole, generalized hypoventilation, tympanitic abd. to palpation, mydriatic pupils with little reaction (under atropine effects). Advanced cardiopulmonary resuscitation during 20 minutes. An intraosseous line was inserted. He evolved requiring 5 doses of adrenaline, bicarbonate and volumetric expansion. After 20 min. of cardiopulmonary resuscitation pulse present with spontaneous beats, being moved to PICU. Hemodynamic after arrest: Normal and stable BP during first hrs with no vasoactive support required. Oscillating Heart rate with bradycardia episodes of even 53 beats/min, lactic at adm: 15 mmol/1, creatinine kinase: 166 U/L, troponin I 0.01, 0.02, 0.04 mcg/1, bad perfusion and coloration since his adm. Resp connected to mechanical ventilation with low aggressive parameters since adm. Normal cardiopulmonary auscultation. Synchronized intermittent mandatory ventilation plus pressure support with normal respiratory pattern with spontaneous breathing since first hour of adm. and he was changed to CPAP plus PS. Limitation of therapeutic efforts was agreed with parents, keeping CPAP until maintained apnea with subsequent asystole, dying at 19:45 (08-OCT-2013). Diuresis since adm. He showed hypopotassaemia of 2.1 mEq/1 and hypocalcemia of 4.7 mg/dl starting being corrected until death. Hyperglycaemia around 300 mg/dl requiring insulin therapy and continuous perfusion. Bad neurological state since adm, with absence of reactivity, axial predominant atrophy with limb hypertonia, marked clonus, initial mydriasis due to atropine moving to fixed bilateral miosis with fixed ocular upward deviation. No corneal reflex or eye-head. Sporadic myoclonias similar to those previously presented. Initial apnea test negative, but after that he had two apneas that ended in asystolia, limitation of therapeutic efforts and started agonic breathing. Alternating Bispectral Index around 50 with suppression ration from 0 to 20. Once limitation of therapeutic efforts and agonic breathing started sedation-analgesia was initiated. Txs received: adrenaline, bircarbonate, physiological saline, atropine, midalozam, fentanyl, calcic gluconate, actrapid insulin, sodium chloride, potassium chloride, glucose serum 5%. Discharge diagnoses: cardio-respiratory arrest, chronic encephalopathy of unk origin. Relevant Test/Laboratory Data: 09NOV11. EEG: generalized interictal epileptiform activity with sleep and superficial sleep. Outgrowth discharges with generalized peaks of short length. Brain MRI: scarce volume for his age, not presenting structural anomalies, good differentiation between white and grey matter. 27SEP11. Vigil EEG was normal. As his parents reported, he suffered a shake with intermittent light stimulus which was not recorded in EEG. 19SEP11: normal lactic, normal beta-OH butyrate, negative TORCH serology. On 27APR12 and 17MAY12 a report showed pathogens: Ascaris Lumbricoide and Larvae (in brain), Strongiloides (in brain), Fasciola Hepatica, Oxiurio (Entewb. Veoniculae), bacteria: Clostrydium Tetani, Treponema Pallidum, Streptomyce Griseus, Virus HIV p24 and Rev. Tran. (in thymus), VIH (1 and 2) in thymus, cytomegalovirus, Hep C; fungi: Candida albicans in blood. Heavy metals positive in thymus and brain, kidneys and liver (cobalt, nickel, aluminum), colorant negative, toxics negative, solvents negative, benzene in thymus, immune system: lack of rodanase enzyme, cytochrome C and gluthatione in saliva, ferritin enzyme present in white blood cells in brain, lack of betaglycan in white blood cells, intoxication by vaccines, hereditary grade 3 intoxication, low, presence of toxic immunosuppressors (heavy metals and azoic colorants). Those analysis showed normal CBC, normal biochemical analysis except for increased AST-GOT, low creatinine, toxicology (all normal), aminoacids in urine showed elevated taurine, genetic studies showed no mutation of Rett-Foxg1 syndrome gene, increased level of lactate dehydrogenase, low partial 02 blood pressure, very high ammonia ion in plasma, serum aminoacids: very high histidine (684 micwmol/1), very low glycine, They included cranial MRI, electroencephalogram-sleep deprivation with abnormal conclusions, evoked cortical visual potentials also with abnormal results. All available medical records will be provided upon request. Additional information has been requested.


VAERS ID: 613411 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2015-08-25
Onset:0000-00-00
Submitted: 2015-10-01
Entered: 2015-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Pyrexia, Viral upper respiratory tract infection, Volvulus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Intestinal malrotation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2015JPN137900

Write-up: This case was reported by a pharmacist via licensee and described the occurrence of volvulus of bowel in a 3-month-old female patient who received ROTARIX. Concurrent medical conditions included intestinal malrotation. Concomitant products included ACTHIB, PREVENAR 13 and BIIMMUGEN. On 25th August 2015, the patient received the 2nd dose of ROTARIX (oral). On 26th August 2015, 1 days after receiving ROTARIX, the patient experienced pyrexia. On an unknown date, the patient experienced common cold. On 27th August 2015, the patient experienced volvulus of bowel (serious criteria death and GSK medically significant). On an unknown date, the outcome of the volvulus of bowel was fatal and the outcome of the pyrexia and common cold were unknown. The patient died on 27th August 2015. An autopsy was performed. The autopsy determined cause of death was volvulus of bowel. It was not reported if the reporter considered the volvulus of bowel, pyrexia and common cold to be related to ROTARIX. On 26 August 2015, the subject was diagnosed with common cold. On 27 August 2015, at noon, the subject suddenly deteriorated and died. The subject had pre-existing intestinal malrotation, and the cause of death was reportedly midgut volvulus associated with the intertinal malrotation.


VAERS ID: 613757 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-23
Onset:2015-09-23
   Days after vaccination:0
Submitted: 2015-10-05
   Days after onset:12
Entered: 2015-10-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L0201 / 2 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L75199 / 2 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Apparent life threatening event, Brain death, C-reactive protein normal, Death, Hyporesponsive to stimuli, Laboratory test normal, Multiple organ dysfunction syndrome, Somnolence, Ultrasound scan normal, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-09-24
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown to Ongoing, Poor sleep; Unknown, Hemiotomy, not continuing; 11-JUN-2015 to 11-JUN-2015, PREVENAR 13, Immunisation, No adverse effect, Dose 1; 11-JUN-2015 to 11-JUN-2015, HEXYON, Immunisation, No adverse effect, Dose 1
Allergies:
Diagnostic Lab Data: U5 examination (23Sep2015): no pathological findings, the examination showed that the development was age appropriate. C-reactive protein, negative; 23-SEP-2015, Laboratory test, No pathological findings
CDC Split Type: 2015321724

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sponsored program, and from the Health Authority. Regulatory Authority report number DE-PEI-PEI2015058358. A contactable physician reported that a 7-month-old male patient of unspecified ethnicity received second dose of PREVENAR 13 (Lot # L75199, Exp date Feb2017), via an unspecified route of administration in the right thigh, on 23Sep2015 between 9:00 am and 9:30 am, at 0.5 ml single, and second dose of HEXYON (Lot # L0201-46380-B), via an unspecified route of administration in the left thigh, on 23Sep2015 between 9:00 and 9:30 am, at 1 DF single. Relevant medical history included ongoing poor sleep and hemiotomy (not continuing). Concomitant medications were not reported. The patient previously received first dose of PREVENAR 13 and HEXYON on 11Jun2015, with no adverse effect. On 23Sep2015 at 06:00 pm the patient experienced apnea and on 23Sep2015 apparent life threatening event, multi organ failure and brain death. At home vomiting occurred and the patient was sleepy. The mother found the patient in bed with the blanket over the face, hardly responsive. After the apnea the child was reanimated by the baby emergency physician for 15 minutes and admitted to hospital. Events were considered serious per hospitalization and life threatening. Apnea, multi organ failure and brain Death were also considered leading to disability. The patient underwent lab tests and procedures which included U5 examination (23Sep2015): showed no pathological findings, the examination showed that the development was age appropriate; C-reactive protein (unspecified date): negative. No signs of infection were observed. On 24Sep2015 the patient died due to apnea, brain death and multi organ failure. It was unknown if an autopsy was performed.


VAERS ID: 613779 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-05-26
Onset:0000-00-00
Submitted: 2015-10-08
Entered: 2015-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER K73061 / UNK LA / IM
HEPAB: HEP A + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER AHABB323AQ / UNK RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER ATYPB107CA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Histiocytosis haematophagic
SMQs:, Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015141705

Write-up: This case was reported by an other health professional via regulatory authority and described the occurrence of haemophagocytic lymphohistiocytosis in an 11-year-old female patient who received AMBIRIX (batch number AHABB323AQ, expiry date unknown). Co-suspect products included TYPHERIX (batch number ATYPB107CA, expiry date unknown) and REVAXIS (batch number K7306-1, expiry date unknown). On 26th May 2015, the patient received AMBIRIX (intramuscular) 1 ml, TYPHERIX (intramuscular) .5 ml and REVAXIS (intramuscular) .5 ml. On an unknown date, an unknown time after receiving AMBIRIX and TYPHERIX, the patient experienced haemophagocytic lymphohistiocytosis (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the haemophagocytic lymphohistiocytosis was fatal. The reported cause of death was haemophagocytic lymphohistiocytosis. An autopsy was not performed. It was unknown if the reporter considered the haemophagocytic lymphohistiocytosis to be related to AMBIRIX and TYPHERIX. Regulatory authority verbatim: Haemophagocytic lymphohistiocytosis proven. Admitted to hospital but history of 3-4 weeks prior to that. Patient met all criteria for haemophagocytic lymphohistiocytosis (HCH). No other trigger identified. Fatal outcome.


VAERS ID: 613989 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-13
Entered: 2015-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510JPN004921

Write-up: Initial information has been received from a consumer concerning an elderly patient of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On an unknown date, the patient was vaccinated subcutaneously with a dose of PNEUMOVAX NP (lot# and dose were unspecified). On an unspecified date, the patient died due to pneumonia. The reporter considered that it was drug effect incomplete (vaccination failure). It was unknown if an autopsy was performed. The consumer stated that it is not necessarily the case that pneumonia will definitely be prevented by pneumococcal vaccine. The reporter considered that pneumonia was serious due to death and the relatedness of PNEUMOVAX NP with pneumonia and vaccination failure was not reported. Additional information has been requested.


VAERS ID: 614039 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-16
Entered: 2015-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Public       Purchased by: Other
Symptoms: Death, Faecal vomiting
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510BRA007876

Write-up: This spontaneous report was received via consumer concerns a non-identifiable female patient of unknown age. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL 0.5 ml, intramuscular at the public ambulatory clinic. On an unknown date, the patient experienced feces eliminated via mouth. On an unknown date, the patient died. the cause of death was unknown. The outcome of the adverse event was fatal. The relatedness for the adverse event to GARDASIL was not provided by reporter. The reporter added that the patient''s mother was under neurologist and psychologist care due to patient''s death. This case was related to BRA/15/3616, BRA/15/3617, BRA/15/3620, BRA/15/3621 (1510BRA007829) and BRA/15/3634 (1510BRA007881) due to same reporter (patient''s mother from patient from case BRA/15/3616-consumer- heard from non-identified people when sharing her daughter adverse experience). Additional information is not expected as reporter could not provide additional details on first contact as she does not know every person she mentioned on these reports- hearsay (heard from non-identified people when sharing her daughter adverse experienced).


VAERS ID: 614042 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-08-28
Onset:2015-08-29
   Days after vaccination:1
Submitted: 2015-10-16
   Days after onset:48
Entered: 2015-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER LO1335 / UNK UN / IM
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA565AF / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB336AC / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Epistaxis, Loss of consciousness, Sudden infant death syndrome, Thymus enlargement
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-29
   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:
Current Illness: Unknown
Preexisting Conditions: Premature baby, the child was preterm born on pregnancy week 38
Allergies:
Diagnostic Lab Data:
CDC Split Type: LV2015145600

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of sudden death in a 2-month-old female patient who received SYNFLORIX (batch number ASPNA565AF, expiry date unknown). Co-suspect products included ROTARIX (batch number AROLB336AC, expiry date unknown)and HEXACIMA (batch number LO133-5, expiry date unknown). The patient''s past medical history included premature baby (the child was preterm born on pregnancy week 38). Concomitant products included BCG injection. On 28th August 2015, the patient received 1st doses of SYNFLORIX (intramuscular) .5 ml, ROTARIX (oral) 1 ml and HEXACIMA (intramuscular) .5 ml once daily (.5 ml daily). On 29th August 2015, 21 hours after receiving SYNFLORIX and ROTARIX and HEXACIMA, the patient experienced unconsciousness (serious criteria GSK medically significant) and epistaxis. On an unknown date, the patient experienced thymus enlargement (serious criteria death and GSK medically significant). On 29th August 2015, 22 hours after receiving SYNFLORIX and ROTARIX and HEXACIMA, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the thymus enlargement and sudden death were fatal and the outcome of the unconsciousness and epistaxis were not recovered/not resolved. The patient died on 29th August 2015. The reported cause of death was sudden death. An autopsy was performed. The autopsy determined cause of death was thymus enlargement. It was unknown if the reporter considered the thymus enlargement, unconsciousness, epistaxis and sudden death to be related to SYNFLORIX and ROTARIX. RA verbatim: 13-OCT-2015: Reported by Centre. Two months old girl 28.08.2015 was vaccinated with the 1st dose of HEXACIMA IM, SYNFLORIX IM and ROTARIX orally. On the second day, 29.08.2015 at 9:00, 21 hour after vaccination, the girl was unconscious, her nose was bleeding, the child''s death certified at 9.58. According to forensic medical expertise results performed by the Forensic Medical Examination Centre. Pathological diagnosis is: main diagnosis - Sudden death syndrome; background diagnosis - thymomegaly (degree of thymomegaly not specified). Accordingly to SPCC data, vaccination place was inspected, no procedural errors detected. Additional data: the child was preterm born on pregnancy week 38, she received prophylactic BCG antituberculosis vaccination on the second day after birth. No adverse events occurred after vaccination with BCG, no other illnesses, no concomitant diseases diagnosed.


VAERS ID: 614052 (history)  
Form: Version 1.0  
Age: 1.75  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-16
Entered: 2015-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Rash, Scab, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Neonatal disorders (narrow), Hypersensitivity (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510CAN007141

Write-up: This spontaneous report was received in an article on 11-OCT-2015 by the patient''s parents and refers to their 21 month old female child. The patient''s medical history and concurrent conditions were not reported. The patient''s family was throwing a party to celebrate their deceased daughter and raise funds for research into vaccine safety. The couple strongly believe their only daughter would still be alive, perhaps helping to plan her own sweet 16 party, had she not been vaccinated. They stated "She loved Halloween. She was a wise little woman. She spoke so well. She demanded having five or six hats so that she could put on a different one each time she woke up". On an unspecified date, one afternoon, the patient was vaccinated with the latest regularly scheduled measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) of unknown strength (dose, dosage details, batch/lot number unknown). Approximately in August 2001, months after getting the vaccine, two months before her second birthday she did not wake up and died. The patient''s official cause of death was Sudden Infant Death Syndrome (SIDS). It''s what medical professionals told them off the record at the time and hindsight that makes them think that the patient''s death was related to vaccine complications. Every time she was vaccinated she broke out into hives, she would cry in discomfort for days afterwards. After getting the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown), her parents stated that she had the worst reaction, manifested in a scabbing rash that lasted months. The parents stated that they were no anti-vaxers and wished they knew more before they made their choices. The reporter considered the events to be related to Measles, Mumps and Rubella (Wistar RA 27-3) Virus Vaccine, Live (Manufacturer unknown). Additional information is not expected as no contact details was provided.


VAERS ID: 614072 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-09-21
Onset:2015-09-22
   Days after vaccination:1
Submitted: 2015-10-19
   Days after onset:27
Entered: 2015-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC301DJ / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sepsis
SMQs:, 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO2015147616

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sepsis in a 3-month-old female patient who received ENGERIX B (batch number AHBVC301DJ, expiry date unknown). Co-suspect products included ENGERIX B (batch number AHBVC301DJ, expiry date unknown). On 3rd August 2015, the patient received the 1st dose of ENGERIX B (parenteral). On 21st September 2015, the patient received the 2nd dose of ENGERIX B (parenteral). On 22nd September 2015, 1 day after receiving 2nd dose of ENGERIX B, the patient experienced sepsis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sepsis was fatal. The reported cause of death was sepsis. It was unknown if the reporter considered the sepsis to be related to ENGERIX B and ENGERIX B. RA verbatim text: Infant died of sepsis, cause unknown, 2 days after second dose hepatitis B vaccination. Baby had received first dose 03-Aug-2015 (same batch no as second dose). Initial information received in phone call from physician on 15-OCT-2015. This is a preliminary report. Agency has requested further information. Causality will be assessed after receipt of hospital records.


VAERS ID: 614273 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-21
Entered: 2015-10-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F43126 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Death, Pleural effusion, Pneumococcal bacteraemia, Pneumonia pneumococcal, Pneumothorax
SMQs:, Interstitial lung disease (broad), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015349551

Write-up: This is a spontaneous report from a contactable physician. A 3-year-old (45-month-old) female patient received PREVENAR 13 first dose (lot number: F22933) on an unknown date at 2 months of age, at 0.5 ml single, 2nd dose (lot number: F36231) on an unknown date at 4 months of age, at 0.5 ml single and 3rd dose (lot number: F43126) on an unknown date at 6 months of age at 0.5 ml single. Medical history and concomitant medications were not provided. The patient was not a premature baby and was a healthy infant. At the age of 45 months, the patient died on an unspecified date in 2015 due to pneumococcal bacteraemia with focus of pneumonia, pleural effusion on the left side, severe ARDS (acute respiratory distress syndrome) and pneumothorax both sides. Serotype was not provided. It was unknown if any autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 614310 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-26
Entered: 2015-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510RUS010616

Write-up: Information for this initial, spontaneous report was received on 19-OCT-2015 from the lawyer of a physician. As it was reported there was a case of fatal outcome (child, gender and age unknown) on the 31st day after vaccination with ROTATEQ (date and dose not reported). The cause of death (as a preliminary) was noted to be sudden infant death syndrome not related to vaccination (date of death not reported). No follow-up is expected as the reporter refused to provide contact details. No further information is anticipated.


VAERS ID: 605320 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-23
Entered: 2015-10-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Atrophy, Cerebral atrophy congenital, Death neonatal, Foetal exposure during pregnancy, Ischaemia, Mechanical ventilation
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (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: Azathioprine (NGX)
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015GB039240

Write-up: Case number PHHY2015GB039240, is an initial spontaneous report from a physician via RA (ADR 22921631) received on 01 Apr 2015 via Agency. This report refers to an 23-days-old baby patient (delivered at full term) of unknown gender. The patient''s medical historical and concomitant medications were not reported. Mother''s medical history included ulcerative colitis and pregnancy loss (3 times). All genetic investigations were normal and she was vaccinated with influenza virus vaccine. On an unknown date, the patient''s mother took azathioprine (manufacturer, formulation unknown) at a dose of 50 mg/day for colitis ulcerative. Mother was unwell for 2 weeks post-influenza injection. Unknown cause of ischemia and atrophy of cord developed antenatally. When the baby was born, atrophy of cervical spinal cord and medulla oblongata were noted. Baby was ventilator dependent and care was withdrawn. On 23rd day of the birth, the baby died. The events were considered as serious (death, congenital anomaly and medically significant) by the physician. The causality of the events was not reported. Following an internal review of the information received on 01 Apr 2015, Following correction was done: Case classification was added as Pregnancy Prospective Related. Suspect drug was coded as influenza virus vaccine - unknown inn (nvd).


VAERS ID: 615043 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-15
Onset:2015-09-17
   Days after vaccination:2
Submitted: 2015-11-02
   Days after onset:46
Entered: 2015-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Death, Decreased appetite, Herpes zoster, Mental impairment
SMQs:, Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-10-15
   Days after onset: 28
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: bisacodyl; chlorhexidine gluconate; DAKTARIN; fludrocortisone; lactulose; lansoprazole; nutritional supplements; acetaminophen, rivastigmine; sertraline hydrochloride; simvastatin; SINEMET; ZEROBASE
Current Illness: Immunisation; Parkinson''s disease; Dry skin; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511GBR000201

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # GB-1577272925-E2015-11912) on 30-OCT-2015. This serious AE case was reported by the RA, on 27/Oct/2015. GB-MHRA ADR 23194367. This case is medically confirmed as it was reported by a physician. A 72 year-old male patient (94 kg), with a previous medical history of dementia due to Parkinson''s disease, received an injection of ZOSTAVAX, lot/batch #not reported, serious route and site not reported, on 15/Sep/2015. Patient was concomitantly receiving bisacodyl 1/1 day from 14/Jan/2015, chlorhexidine gluconate 1 df 2/1 day from 29/May/2015, DAKTRIN 1 df 4/1 day from 7/Oct2015, fludrocortisone 1 df 2/1 day from 14/Jan/2015, lactulose 20ml 4/1 day from 14/Jan/2015, lansoprazole 1 df 1/1 day from 14/Jan/2015, nutritional supplement from 28/Jul/2015, paracetamol 2df 4/1 day from 12/Dec/2014 to 7/Aug/2015, rivastigmine 1 df 2/1 day from 14/Jan/2014, sertraline 1 df 1/1 day from 14/Jan/2015, simvastatin 1 df 1/1 day from 14/Jan/2015, SINEMET 1 df 4/1 day from 14/Jan/2015 and ZEROBASE for dry skin from 5/Aug/2015 to 30/Sep/2015. Two days following vaccination, on 17/Sep/2015 patient experienced sudden and severe deterioration in mental functions. 2 weeks later patient had shingles, possible ADEM. Initially treated with acyclovir then sent home to die with Label Terminal Parkinson''s disease. Patient was no longer eating. Patient certainly developed shingles on 30/Sep/2015, pattern is of acute disseminated encephalomyelitis (ADEM). Patient was admitted by the HCP who confirm the suspicion of ADEM. As part of his medical history, patient was suffering from dementia of Parkinson''s disease, but was happy and smiling and eating. Patient died on 15/Oct/2015. Reported cause of death was acute disseminated encephalomyelitis. At the time of reporting the outcome was reported as fatal. The RA considers this case as serious due to patient hospitalisation, life threatening reaction and fatal outcome.


VAERS ID: 615333 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-30
Entered: 2015-11-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015367314

Write-up: This is a spontaneous report from a contactable physician received via a sales representative. This contactable physician reported the same event for two different patients (twins). This is the first of two reports. A patient of unspecified age ethnicity and gender received PREVENAR 13 via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death 2 days after vaccination, on an unspecified date. No cause of death was specified. It was not reported if an autopsy was performed.


VAERS ID: 615337 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-10-30
Entered: 2015-11-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015367328

Write-up: This is a spontaneous report from a contactable physician received via a sales representative. This contactable physician reported the same event for two different patients (twins). This is the second of two reports. A patient of unspecified age, ethnicity and gender received PREVENAR 13 via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death 2 days after vaccination, on an unspecified date. No cause of death was specified. It was not reported if an autopsy was performed.


VAERS ID: 615431 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-10-01
Submitted: 2015-11-03
   Days after onset:33
Entered: 2015-11-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-01
   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: 2015371246

Write-up: This is a spontaneous report from a contactable physician via company representative. An infant patient of an unspecified ethnicity and gender received on the same unspecified date PREVENAR 13, at 0.5 ml, single and INFANRIX HEXA, at 1 DF, single both via an unspecified route of administration. The patient medical and concomitant medications were not reported. The patient experienced sudden infant death syndrome 4 days after immunisation with PREVENAR 13 and INFANRIX HEXA unspecified date in Oct2015. The patient died on Oct2015. An autopsy was performed but the physician had not yet received the autopsy report.


VAERS ID: 615519 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-06
Entered: 2015-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511CAN002758

Write-up: This spontaneous report was received from a consumer via Sanofi Pasteur and refers to a female patient (the reporter''s daughter) of unknown age. There was no information about patient''s concurrent conditions, concomitant medication and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On an unknown date, the patient passed after vaccine administration. The cause of death was not reported. The relatedness between the event and GARDISIL was not reported. This is one of several report received from the same reporter. Additional information has been requested.


VAERS ID: 615574 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-06
Entered: 2015-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthma, Condition aggravated, Death, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Unknown to Ongoing, Asthma, Under unspecified treatment
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015375045

Write-up: This is a spontaneous report obtained from a contactable physician (pneumonologist) through a Pfizer sale representative. A 85-year-old male patient of an unspecified ethnicity received, on an unspecified date, in 2015, PREVENAR 13 single dose. Relevant medical history included ongoing asthma in recession (under unspecified treatment). Concomitant medications were unknown. On an unspecified date, 10 days after vaccination (in 2015), the patient experienced exacerbation of asthma, pulmonary embolisms and died (unknown cause of death). It was not reported if an autopsy was performed. Clinical outcome of the other events, pulmonary embolism and exacerbation of asthma, was unknown at the time of patient''s death.


VAERS ID: 615577 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-23
Onset:2015-10-27
   Days after vaccination:4
Submitted: 2015-11-06
   Days after onset:10
Entered: 2015-11-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC484A / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L75179 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-27
   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: ZYMAFLUOR D 500
Current Illness:
Preexisting Conditions: Unknown to Ongoing, Acne infantile, Undescended testis, on the right side; Unknown, Infection, 06-Nov-2015 08:56; 13-OCT-2015 to 13-OCT-2015, ROTATEQ, Immunisation, No adverse effect, first dose, lot L011176;
Allergies:
Diagnostic Lab Data: Sonography of hips (18Sep2015): on the left: 67/35degree, 1a; on the right 58/ 48degree, 1a, examination complicated by restless child, exclusion of hip dysplasia; Examination (18Sep2015): acne, small testis on the right side, no evidence of malformation. Fontanel was soft and flat, Heart was rhythmic, lung inconspicuous, pharynx free of irritation; Examination (23Oct2015): showed the patient in good general condition, eardrums normal, pharynx without pathologic finding, nose free, no enlargement of lymph nodes, normal lung
CDC Split Type: 2015377142

Write-up: This is a spontaneous report from a contactable physician received from Health Authority. Regulatory Authority report number: DE-PEI-PEI2015066991. A 2-month-old male patient of an unspecified ethnicity received the first dose of PREVENAR 13, (lot L75179) in the right thigh at 0.5 ml single and the first dose of INFANRIX HEXA, (lot A21CC484A) in the left thigh at 1 dosage form (DF) single, both intramuscularly on 23Oct2015. Medical history included acne neonatorum, undescended testis (right), and infection. The patient was born through a spontaneous delivery (cephalic presentation). At birth, Apgar score was 10/10, weight was 4120 g, length was 56 cm. An examination performed on 18Sep2015 showed acne, small testis on the right side, no evidence of malformation. Fontanel was soft and flat, heart was rhythmic, lung inconspicuous, pharynx free of irritation. On 18Sep2015, sonography of hips resulted 67/35degreem 1a on the left, 58/ 48degree, 1a, on the right. The examination was complicated by restless child. Dysplasia was excluded. Concomitant medication included ZYMAFLUOR D 500. The patient previously took the first dose of ROTATEQ, (Sanofi Pasteur, lot L011176) orally on 13Oct2015 at 1 DF single which had been well tolerated. At the time of vaccination, the child was healthy. The examination performed on 23Oct2015 showed the patient in good general condition, normal eardrums, pharynx without pathologic finding, nose free, no enlargement of lymph nodes, normal lung. The patient was found lifeless in his bed on 27Oct2015 at 21:00. No cardiopulmonary resuscitation was performed. The caused of death was unknown. It is not known whether an autopsy was performed. No follow-up attempts needed. No further information expected.


VAERS ID: 609508 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-16
Onset:2015-10-22
   Days after vaccination:6
Submitted: 2015-11-12
   Days after onset:21
Entered: 2015-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER BJ14T / UNK AR / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K009223 / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain injury, Death, Hepatic failure, Intestinal ischaemia, Multiple organ dysfunction syndrome, Renal failure, Sepsis, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Ischaemic colitis (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-10-22
   Days after onset: 0
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: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/15/2013, Pneumococcal vaccine, no adverse event; 10/2014, Influenza virus vaccine (unspecified), no adverse event; 10/2013, Influenza virus vaccine (unspecified), no adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511DEU005522

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DE-1577272925-E2015-12322) as a part of a business agreement on 09-NOV-2015. Case of fatal outcome was received from the Health Authority on 02-Nov-2015 (reference no. PEI2015066426). Case is medically confirmed. A 71-year-old female patient received a dose of PNEUMOVAX 23, lot-no. K009223, expiration date was not reported) IM into the upper arm and a dose of XANAFLU, Abbott, lot-no. BJ14T IM into the upper arm on 16-Oct-2015. One day later, on 17-Oct-2015, the patient was diagnosed with sepsis of unknown origin, multiorgan failure, kidney and liver failure, suspected mesenterial ischemia, and septic shock. Diagnosis was confirmed by laboratory tests, clinical picture, computerized tomography of chest and abdomen. Perforation of the intestine, cholecystitis, pneumonia, ischemia, and cerebral hemorrhage were excluded. On 18-Oct-2015, hypoxic brain damage occurred which was ascribed to a delayed start of therapy. The patient died on 22-Oct-2015. It was not reported whether the autopsy was performed. Medical history: Previous immunization with unspecified seasonal influenza vaccine administered in Oct-2014, unspecified influenza vaccine administered in Oct-2013, and pneumococcal vaccine (manufacturer unknown) administered on 15-Oct-2013 had been well tolerated.


VAERS ID: 609458 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-13
Entered: 2015-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza A virus test positive, Influenza like illness, Polymerase chain reaction positive, Smear buccal abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: In 2013, virology laboratory received nasopharyngeal swabs or tracheal aspirates. All samples were tested by real time RT-PCR to detect influenza A (Flu-A) and influenza B (Flu-B) genomes. 2013, Polymerase chain reaction, Flu A, positive; 2013, Smear buccal, Flu A, positive.
CDC Split Type: AR2015GSK162391

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a adult subject who received Flu seasonal TIV Dresden. In 2013, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included unknown cause of death with serious criteria of death, hospitalization and GSK medically significant and influenza like illness with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included unknown cause of death (fatal) and influenza like illness (fatal). The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the vaccination failure may have been caused by Flu seasonal TIV Dresden. It was unknown if the investigator considered the unknown cause of death and influenza like illness to be related to Flu seasonal TIV Dresden. Relevant Tests: In 2013, virology laboratory received nasopharyngeal swabs or tracheal aspirates. All samples were tested by real time RT-PCR to detect influenza A (Flu-A) and influenza B (Flu-B) genomes. Diagnostic results (unless otherwise stated, normal values were not provided): In 2013, Polymerase chain reaction result was Flu A unknown. On an unknown date, Smear buccal result was Flu A unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a possible vaccine failure in an adult patient of unspecified gender and age who had received an unspecified influenza vaccine (manufacturer unknown). The event occurred during an H1N1 influenza outbreak in the late autumn-winter of 2013. No information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date in 2013 (between weeks 21 and 31), an unknown period after the vaccination, the patient developed influenza-like illness, tested positive for influenza A and later passed away. Please note that this case has been classified as a possible vaccination failure as no information on the time to onset was provided. This was a fatal case. The direct cause of death was unspecified. It is unknown if a post-mortem was performed. Either a nasopharyngeal swabs or tracheal aspirates from the patient tested positive for influenza A on real time reverse transcription polymerase chain reaction. Treatment was unknown. The authors did not comment on any possible causal relationship between the vaccine and the events. The authors concluded that "Most patients had comorbidities, with low vaccination rates. The CURB-65 was not good predictor. The mortality was high. Only the need of mechanical ventilation assistance and cancer were predictors of mortality".


VAERS ID: 618513 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-13
Entered: 2015-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Bedridden
Preexisting Conditions: Contraceptive
Allergies:
Diagnostic Lab Data: Body temperature, 37.2 degrees C.
CDC Split Type: WAES1511JPN007465

Write-up: Information has been received from a patient''s family concerning an elderly female patient (bedridden) who on an unspecified date was vaccinated with a dose of PNEUMOVAX NP injection (lot number, expiry date, and dosage not reported). Other concomitant medication was not reported. On an unspecified date, reporter thought that the patient will develop pneumonia if she just kept lying still in her bed, so the reporter shook her hands and moved her arms sometimes. On an unspecified date, the reporter went to the hospital every day for taking patient''s body temperature and so on, like a nurse. When the patient''s body temperature of 37.2 degrees centigrade was found, the reporter asked about the reason for the fever and was told it was that the patient developed pneumonia and one side of the lung became pure white. (Although the reporter heard that the pneumococcal vaccine was for prevention of pneumonia, but the patient developed pneumonia) so this was considered as a vaccination failure. The antibiotic also had no effect. On an unspecified date (1 month after the vaccination), the patient died. The cause of death was pneumonia. The information of autopsy was not reported. At the time of this report, the pathogenic bacteria were not confirmed. Reporter''s comment: A doctor may know about the types of the bacteria or the percentage of each type, but the patient could not be able to know such things because she was an average and elderly person. She might have thought that she would not develop pneumonia. The reporter considered that pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 610673 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-27
Onset:0000-00-00
Submitted: 2015-11-18
Entered: 2015-11-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCIRCA; Macitentan; Prednisone; CRESTOR; Amitriptyline; ATIVAN; Vitamin D; ELIQUIS; Pantoprazole
Current Illness: Pulmonary arterial hypertension; Sarcoidosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2015GSK163708

Write-up: This case was reported by a consumer via patient support programs and described the occurrence of condition aggravated in a 55-year-old female patient who received Canadian seasonal Influenza vaccine unspecified. Co-suspect products included Pneumococcal vaccine and ADCIRCA for pulmonary hypertension. Concurrent medical conditions included pulmonary arterial hypertension and sarcoidosis. Concomitant products included macitentan, prednisone, CRESTOR, amitriptyline, ATIVAN, Vitamin D, ELIQUIS and pantoprazole. On an unknown date, the patient received Canadian seasonal Influenza vaccine unspecified at an unknown dose and Pneumococcal vaccine at an unknown dose. On 27th January 2014, the patient started ADCIRCA 40 mg at an unknown frequency. On an unknown date, an unknown time after receiving seasonal Influenza vaccine unspecified and Pneumococcal vaccine, the patient experienced condition aggravated (serious criteria death and hospitalization). On 12th November 2015, the outcome of the condition aggravated was fatal. The patient died on 12th November 2015. The reported cause of death was condition aggravated. The reporter considered the condition aggravated to be related to seasonal Influenza vaccine unspecified and Pneumococcal vaccine. Additional information was provided as follows: The case received via patient support programs (for ADCIRCA). The patient had pulmonary arterial hypertension and sarcoidosis as current condition. On an unknown date, the patient received a dose of seasonal Influenza vaccine unspecified and Pneumococcal vaccine as per the physician''s advice. On an unknown date, the patient''s general condition aggravated (turned for the worst). On 10th November 2015, the patient was hospitalised. On 12th November 2015 in the morning, the patient passed away. No consent for follow-up was provided.


VAERS ID: 618924 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-19
Entered: 2015-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Hyperthermia, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511JPN010188

Write-up: Initial information has been received from an acquaintance of a 70 year old male patient who on an unspecified date was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) injection drug subcutaneously (Lot number, vaccination date, dose and indication not reported). There was no other concomitant medication reported. On an unspecified date, the patient developed hyperthermia and interstitial pneumonia. On an unspecified date, the patient died. The cause of death was unknown. Information of the autopsy was not reported. At the time of this report, the outcome of hyperthermia and interstitial pneumonia was unknown. The reporter''s comment: though it was unknown that whether Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) was the cause or not, the patient had died. The reporter did not assess the seriousness of the hyperthermia and interstitial pneumonia. The reporter did not assess the relationship of death, hyperthermia and interstitial pneumonia to Pneumococcal Vaccine, Polyvalent (23-Valent) (manufacturer unknown). Additional information is not expected as follow up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 611090 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-20
Entered: 2015-11-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511USA010001

Write-up: Information has been received from a social media site regarding a case in litigation concerning a 14 year old male patient. The patient''s concurrent conditions, medical history and concomitant medication use were not provided. On an unspecified date the patient was vaccinated with GARDASIL, unknown. On an unspecified date in 2013 the patient suffered a fatal myocardial infarction. Upon internal review myocardial infarction was considered to be a medically significant event. Additional information is not expected.


VAERS ID: 618677 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-18
Entered: 2015-11-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Altered state of consciousness, Cardio-respiratory arrest, Death, Foot amputation, Gastroenteritis, Hypoxic-ischaemic encephalopathy, Intensive care, Leg amputation, Pneumonia pneumococcal, Pyrexia, Respiratory disorder, Resuscitation, Seizure, Sepsis, Shock, Soft tissue necrosis, Streptococcus test positive, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), 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, 179 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asplenia syndrome; Univentricular heart, functional univentricular heart corrected by a surgery; Surgery; PREVENAR, first dose; PREVENAR, second dose; PREVENAR, third dose
Allergies:
Diagnostic Lab Data: Blood culture, penicillin-susceptible Streptococcus pneumoniae (serotype 10).
CDC Split Type: 2015391804

Write-up: This is a spontaneous report from a contactable physician. A 4-year-old female patient of an unspecified ethnicity received the fourth dose of PREVENAR subcutaneous on an unspecified date at a single dose. Medical history included asplenia syndrome and functional univentricular heart which was corrected by a surgery with favorable clinical course. The patient had normal psychomotor development. The patient''s concomitant medications were not reported. The patient previously received the first, second, and third doses of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) on unknown dates. On an unknown date, the patient experienced sepsis, shock, generalized convulsion, consciousness disturbed, cardio-respiratory arrest, streptococcus pneumoniae infection (serotype 10), hypoxic-ischaemic encephalopathy, and suspected gastroenteritis. The clinical course was as follows: On an unspecified date, the patient was diagnosed as having suspected gastroenteritis; however, pyrexia and vomiting persisted. Subsequently, the patient was diagnosed as having suspected gastroenteritis; however, pyrexia and vomiting persisted. Subsequently, the patient had generalized convulsion and was admitted to a hospital. After the admission, the patient had consciousness disturbed and worsening respiratory status. The patient was moved to intensive care unit (ICU). Thereafter the patient had cardio-respiratory arrest, for which resuscitation was performed. Subsequently, treatment with meropenem, cefotaxime, and teicoplanin was initiated. On an unspecified date, blood culture detected penicillin-susceptible Streptococcus pneumoniae (serotype 10). Cerebrospinal fluid was unavailable. Treatment was changed to meropenem alone; however, the patient had progression of necrosis of lower limbs. Accordingly, the patient underwent amputation of the right leg and the left foot. After the amputation, the patient''s general condition improved and antibiotic therapy was changed to ampicillin. On day 17 of the hospitalization, the patient was discharged from ICU. However, the patient had hypoxic-ischaemic encephalopathy as a late effect and had difficulty in controlling respiratory, sedative, and nutritional condition. On day 178 of the hospitalization, the patient had pyrexia of unknown origin which led to shock. On day 179 of the hospitalization, the patient died of sepsis. It was not reported if an autopsy was performed. The clinical outcome of the events, generalized convulsion, consciousness disturbed, cardio-respiratory arrest, streptococcus pneumoniae infection (serotype 10), hypoxic-ischaemic encephalopathy, shock and suspected gastroenteritis, were all assessed as unknown.


VAERS ID: 618704 (history)  
Form: Version 1.0  
Age: 1.9  
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-07
Onset:2013-12-01
   Days after vaccination:297
Submitted: 2015-11-18
   Days after onset:717
Entered: 2015-11-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92506 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Hair metal test, Sudden death, Toxicologic test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-01
   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: 2012, Hospitalization; JUL-2012, Meningitis.
Allergies:
Diagnostic Lab Data: Hair metal test, pending result; Toxicologic test, no anomaly. Autopsy (unspecified date): no anomaly.
CDC Split Type: 2015392963

Write-up: This is a spontaneous report from a contactable lawyer via legal division. A 23-month-old male patient of an unspecified ethnicity had received four doses of PREVENAR on unknown dates when the patient was an unspecified age for immunization and "two vaccinations against meningitis" on unspecified dates. The patient''s medical history included meningitis in Jul2012 for which he was hospitalized. It was unknown if the patient had concomitant treatment. On 01Dec2013, the patient "died while he was walking in a commercial area with his mother". Autopsy and toxicological investigations did not reveal any anomaly. Post mortem analysis of heavy metal in the hair was ongoing. The lawyer concluded that "this sudden death was evidently related to vaccinations he underwent". No follow-up attempts possible. No further information expected.


VAERS ID: 618691 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-15
Onset:2015-11-16
   Days after vaccination:1
Submitted: 2015-11-23
   Days after onset:7
Entered: 2015-11-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K0128 / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-16
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA184354

Write-up: Initial unsolicited report received from health Authority (CDC) via company representative on 16-Nov-2015. This case involves a two-month-old patient (gender was not reported), who was vaccinated with a 0.5 ml dose of IMOVAX POLIO (batch number was unknown, route and site of administration were not reported) on 15-Nov-2015. Medical history and concomitant medications were not reported. On 16-Nov-2015, one day after vaccination, the patient had died. Laboratory investigations and corrective treatments were not reported. The cause of death was not reported. The autopsy was not performed. Documents held by sender: none. Lab tests unknown. Cause(s) of Death: unknown cause of death.


VAERS ID: 618695 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-16
Onset:2015-11-17
   Days after vaccination:1
Submitted: 2015-11-23
   Days after onset:6
Entered: 2015-11-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K03621 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, General physical condition abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-17
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA185714

Write-up: Initial unsolicited report received from a health authority via company representative on 17 November 2015. This case involves a two-month-old female patient who was vaccinated with a 0.5 ml first dose of IMOVAX POLIO (batch number: K0362-1, expiration date and site of administration were not reported) intramuscularly on 16 November 2015 at 2:40 pm. The patient''s medical history and concomitant medication were not reported. On 16 November 2015, the patient had one time breast-feeding during 3-4 pm. On 17 November 2015 at 3:00 am, 12 hours following the vaccination, the patient was found abnormal and was taken to the hospital. Same day at 4:00 am, the patient was declared as dead. Laboratory investigation and corrective treatment were not reported. The outcome of the event was fatal. Autopsy details were not provided. List of documents held by sender: none. Lab tests unknown. Cause(s) of Death: Death NOS.


VAERS ID: 612008 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-06
Onset:2015-10-16
   Days after vaccination:10
Submitted: 2015-11-26
   Days after onset:41
Entered: 2015-11-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Death, Pertussis
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-24
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/2015, Bordetella test, positive.
CDC Split Type: ES2015GSK166025

Write-up: This case was reported by a non-health professional via other and described the occurrence of whooping cough due to bordetella pertussis (b. pertussis) in a 78-day-old male patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine. On 16th October 2015, 10 days after receiving DTP vaccine, the patient experienced whooping cough due to bordetella pertussis (b. pertussis) (serious criteria death, hospitalization and GSK medically significant). On 24th October 2015, the outcome of the whooping cough due to bordetella pertussis (b. pertussis) was fatal. The patient died on 24th October 2015. The reported cause of death was whooping cough due to bordetella pertussis (b. pertussis). It was unknown if the reporter considered the whooping cough due to bordetella pertussis (b. pertussis) to be related to DTP vaccine. Additional details were provided as follows: This case was published in a national newspaper. The patient''s mother was not immunized during pregnancy. At the age of 60 days from the birth, the patient received DTP vaccine. On 16th October 2015, the patient was hospitalized and 18 days after vaccination, the patient died due to bacteria bordetella pertussis.


VAERS ID: 619236 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-01-30
Onset:2015-02-09
   Days after vaccination:10
Submitted: 2015-11-30
   Days after onset:294
Entered: 2015-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dehydration, Haemorrhage, Loss of consciousness, Neoplasm malignant
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-09
   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: No other medications
Current Illness: Living in residential institution
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511JPN015669

Write-up: Initial information has been received from the patient''s family concerning a female patient who was living in residential institution. On approximately 2011, on an unspecified date, reported as "about 4 years ago", the patient was vaccinated with a dose of PNEUMOVAX NP injection drug, parenteral (lot number, dose and anatomical location of administration were not reported). There was no concomitant medication reported. In January 2015, (before 28-JAN-2015), the patient developed haemorrhage (the haemorrhage was continued for about 1 week to 10 days). On 28-JAN-2015, when the patient visited the hospital because of haemorrhage, the reporter was told that the patient should receive an examination in a university hospital because malignant tumour was suspected. The patient was scheduled to visit a university hospital on 02-FEB-2015. On 30-JAN-2015, the patient was vaccinated with PNEUMOVAX NP in other facility. And the patient did not know about this at that time. On 02-FEB-2015, the patient''s condition was abnormal but she was conscious and she was seen in the university hospital for an examination. On an unspecified date, (after visiting the university hospital), the patient returned to the facility. The nurse of the facility said that the patient should last less than a week. Because of that, the patient visited the hospital which she visited before. The patient could not be hospitalized as she wished because there was no vacant bed. On the promise not to visit hospitals again, the patient returned to the facility for the end-of-life care. On an unspecified date, the patient developed the dehydration-like symptom and loss of consciousness. On 09-FEB-2015, the patient died. The cause of death and information of autopsy were not reported. At the time of this report, the outcome of haemorrhage, dehydration and loss of consciousness was unknown. Reporter''s comment: not provided. The reporter considered that the death was serious. The reporter did not assess the seriousness of the haemorrhage, dehydration and loss of consciousness. The reporter did not assess the relationship of death, haemorrhage, dehydration and loss of consciousness to PNEUMOVAX NP. Additional information is not expected as the reporter did not wish to be contacted.


VAERS ID: 618727 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-02-28
Submitted: 2015-11-26
   Days after onset:271
Entered: 2015-12-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lumbar puncture, Necrosis, Streptococcus test positive, Vasculitis cerebral
SMQs:, Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-26
   Days after onset: 25
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: 2015408240

Write-up: This is a spontaneous report from a contactable physician via ACTIV, part of the observatory of bacterial meningitis. A 7-month-old male patient received three doses of PREVENAR 13. Lot numbers, dates, route and site on injections were unknown. The patient had no congenital immune deficit and no risk factor. It was unknown if the patient had concomitant treatment. On 28Feb2015, the patient was hospitalized and lumbar puncture was performed. Pneumococcus soluble antigen was found in the CSF and blood culture returned positive to Pneumococcus. The serotype identified was 7F. Therapeutic measures taken in response to the events included antibiotics treatment with ceftriaxone 100 mg/Kg/j from 28Feb2015 to 10Mar2015. The patient experienced complication with brain vasculitis and necrosis and he died on 26Mar2015.


VAERS ID: 618730 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-27
Entered: 2015-12-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Death, Meningitis bacterial, Streptococcus test positive
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-22
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: DEC-2014, Blood culture, positive to pneumococcus; DEC-2014, serology test, serotype 19F
CDC Split Type: 2015408255

Write-up: This is a spontaneous report from a contactable physician via agency, part of the observatory of bacterial meningitis. A 3-year-old male patient of an unspecified ethnicity received three doses of PREVENAR 13, via an unspecified route of administration, at unspecified dates, at 0.5 ml single. Relevant medical history and concomitant medication were not reported. On 21Dec2014 the patient was hospitalized. Blood culture was found positive to Pneumococcus. The serotype identified was 19F. The patient experienced coma and died on 22Dec0214. It was unknown if an autopsy was performed.


VAERS ID: 618757 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-01
Entered: 2015-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA195057

Write-up: Initial unsolicited report received from a physician on 24 November 2015. This case involves an infant patient (age and gender not reporter) who was vaccinated with a dose of DTAP-IPV-HIB (manufacturer: unknown, batch number, expiration date, dose, dose number, route and site of administration were not reported), a dose of PREVENAR 13 (batch number, expiration date, dose, dose number, route and site of administration were not reported) and a dose of ROTARIX (batch number, expiration date, dose, dose number, route and site of administration were not reported) between 1 January 2014 and 31 December 2014. The patient''s medical history and concomitant medication were not reported. On unspecified date, four days following the vaccination, the patient died. It was reported that , the adverse events described in this report were temporally associated and not necessarily causally linked to vaccines. A coroner''s investigations was completed which found the cause of death to be unascertained, with unsafe sleep environment as a contributing factor. Laboratory investigation and corrective treatment were not reported. The outcome of the event was fatal (reported as "not recovered"). It was reported that there was no link with vaccine. Documents held by sender: none.


VAERS ID: 618761 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-11
Onset:2015-11-12
   Days after vaccination:1
Submitted: 2015-11-30
   Days after onset:18
Entered: 2015-12-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Respiratory arrest, Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-12
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015394239

Write-up: This is a spontaneous report from a contactable consumer and from a nurse. An 8-week-old female patient of an unspecified ethnicity received first dose of PREVENAR 13, via an unspecified route of administration, on 11Nov2015 at 04:30 p.m., at single dose; first dose of INFANRIX HEXA, via an unspecified route of administration, on 11Nov2015 at 04:30 p.m., at unspecified dose and first dose of ROTATEQ, via an unspecified route of administration, on 11Nov2015 at 04:30 p.m., at unspecified dose. Relevant medical history and concomitant medications were not reported. She was breastfeed by the mother. On 12Nov2015 at 04:40 a.m., the patient was found by the father as unresponsive and not breathing in her cot. The patient experienced sudden infant death syndrome. The patient had been well on 11Nov2015. She was brought to the hospital by ambulance but was deceased. Cardiopulmonary resuscitation was attempted and ambulance brought the patient to university hospital where death was ascertained. Time elapsed between the administration of the vaccines an onset was 12 hours. The reporter''s assessment was reported as possible. It was unknown if an autopsy was performed.


VAERS ID: 618764 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-25
Entered: 2015-12-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015400188

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient''s medical history an concomitant medications were not reported. The patient was high risk with co-morbidities. On an unspecified date, days after pneumococcal 13-val conj vac (dipht crm197 protein) was given the patient passed away. It was not reported if an autopsy was performed.


VAERS ID: 619281 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-25
Onset:2015-11-25
   Days after vaccination:0
Submitted: 2015-12-01
   Days after onset:6
Entered: 2015-12-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood gases, Blood test, Cardiac massage, Cardio-respiratory arrest, Cardiogenic shock, Death, Endotracheal intubation, Loss of consciousness, Pulmonary embolism, Pulseless electrical activity, Resuscitation, Syncope, Thrombolysis, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 11/25/2015, Cardiac massage; 11/25/2015, Endotracheal intubation; 11/25/2015, Thrombolysis; 11/25/2015, Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT156466

Write-up: Case number PHHY2015IT156466, is an initial spontaneous report received from a health care professional via agency on 26 Nov 2015. This report refers to an 85-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with AGRIPPAL S1 (batch number: 152801, expiration date: 31 Aug 2016) intramuscularly into the left shoulder at a dose of 0.5 ml on 25 Nov 2015 at 11:30 AM. On the same day after vaccination, the patient collapsed with loss of consciousness. The patient was referred for a paramedical intervention for cardio respiratory arrest and pulseless electrical activity. Cardiac massage was performed and the patient was transferred to emergency room. In the emergency room blood tests were performed (results not reported) and the patient had cardiology and anesthesiology visits Intubation was performed. Thrombolysis was performed during cardiopulmonary resuscitation with the following drugs: three vials of epinephrine, heparin 5000 IU, ACTYLISE 20mg and SOLU-CORTEF. Also blood gas analysis was performed; however there was no response to resuscitation maneuvers. The outcome of the events was fatal and the patient died with the diagnosis of cardiogenic shock due to pulmonary thromboembolism. Causality was suspected to AGRIPPAL S1.


VAERS ID: 619285 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-02
Entered: 2015-12-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2015GSK171385

Write-up: This case was reported in a literature article and described the occurrence of death in a infant subject who received DTPa-IPV+HIB vaccine. Co-suspect products included PREVENAR 13. On an unknown date, 4 days after receiving DTPa-IPV+HIB vaccine and Rotavirus vaccine, the subject developed death. Serious criteria included death and GSK medically significant. The outcome of death was fatal. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the investigator considered the death to be related to DTPa-IPV+HIB vaccine and Rotavirus vaccine. Additional information: This case was reported in a literature article and it described the occurrence of death from unknown causes of an infant of unspecified gender who had received an unspecified diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type B vaccine (manufacturer unknown), PREVNAR 13 (Pfizer) and ROTARIX (GlaxoSmithKline). No information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date in 2014, the patient received a dose of either PEDIACEL (Sanofi Pasteur), INFANRIX-IPV/HIB (GlaxoSmithKline) or PENTACEL (Sanofi Pasteur), as well as a dose of PREVNAR 13 and ROTARIX (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date in 2014, 4 days after the administration of the vaccines, the patient died. This was a coroner case and was reviewed by review by the Committee of the Office of the Chief Coroner which classified the cause of death as unascertained (absence of any anatomic or toxiologic cause of death). The manner of death was classified as undetermined with unsafe sleep environment as a contributing factor; please note that this nomenclature is used when a full investigation has shown no evidence for any specific classification or there is equal evidence or a significant contest among two or more manners of death. Treatment was unknown. The authors of the report commented that no link with the vaccine had been reported. The authors concluded that "the Annual Report on Vaccine Safety is now in its third year, and has established a valuable mechanism to communicate the safety of vaccines administered in the province to support health care professionals, reassure the public and build confidence in immunization. This report finds that vaccines administered in 2014 resulted in a low rate of reported adverse events. Most reported events were mild (i.e., injection site reactions) and resolved completely. No unexpected safety issues were identified. Under-reporting of adverse events following immunisation continues to be an important limitation of adverse events following immunisation surveillance. Further research to evaluate health professionals'' awareness and practices regarding reporting of adverse events following immunisations is needed to inform strategies to increase adverse events following immunisation reporting in order to contribute to a more robust provincial vaccine safety surveillance system". This case is 1 of the 8 valid cases reported in the same literature article.


VAERS ID: 619323 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-04
Entered: 2015-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Rabies
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: No other medications
Current Illness: Animal bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK169358

Write-up: This case was reported in a literature article and described the occurrence of rabies in a patient who received Rabies NVS. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, an unknown time after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant). On an unknown date, the outcome of the rabies was fatal. The reported cause of death was rabies. It was unknown if the reporter considered the rabies to be related to Rabies Vaccine. Additional information was provided: One person who was bitten by one dog died for onset of rabies after illegal injection of rabies vaccine by a doctor from the clinic of County. Upon the exposure of this event, an emergent meeting was convened by Commission for investigation, and one investigation team comprised of the experts in epidemiology and health supervision was established and went to County urgently for investigation and management. It was found through the investigation that the doctor purchased the rabies vaccine privately from the market and performed wound management and vaccination illegally and voluntarily at home without qualification. The clinic started the vaccination without approval, the directors of the clinic, conducted the vaccination without qualification for vaccination of rabies vaccine. The Commission commended local health authorities to close the clinic and prosecute the directors who were in charge of the clinic.


VAERS ID: 619324 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-12-01
Onset:2015-12-02
   Days after vaccination:1
Submitted: 2015-12-04
   Days after onset:2
Entered: 2015-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC411AA / 2 AR / SYR
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug administered at inappropriate site, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-02
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK172047

Write-up: This case was reported by a physician via sales rep and described the occurrence of death in a 43-month-old female patient who received ENGERIX B pediatric (batch number YHBVC411AA, expiry date 31st August 2016). Co-suspect products included M-M-R vaccine. Concomitant products included ENGERIX B pediatric. On 1st December 2015, the patient received the 2nd dose of ENGERIX B pediatric (injection) 10 ug and M-M-R vaccine (injection) 1 injection at an unknown frequency. On 1st December 2015, an unknown time after receiving ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced inappropriate schedule of vaccine administered and vaccine administered and vaccine administered at inappropriate site. On 2nd December 2015, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the inappropriate schedule of vaccine administered and vaccine administered at inappropriate site were unknown. The patient died on 2nd December 2015. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site to be related to ENGERIX B pediatric. Additional information was provided: The case was reported by a physician from Center for Disease Control via sales representative. The child (3 years and 7 months old) received first dose ENGERIX-B in October 2015. She received second dose ENGERIX-B on 01 December 2015 (injection site: deltoid on upper arm) which led to an inappropriate schedule of vaccination (interval too long). In leaflet, newborn, infant and toddler should be vaccinated on anterolateral of thigh, while adult and children should be vaccinated on deltoid on upper arm, which led to an inappropriate site of vaccination. At the same time, she also received one dose of MMR vaccine (Country-made vaccine, non-GSK product). The child was sent to hospital for treatment 02 December 2015, and died on 01 December 2015. Detailed information was unknown.


VAERS ID: 619344 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-30
Onset:2015-11-30
   Days after vaccination:0
Submitted: 2015-12-07
   Days after onset:7
Entered: 2015-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC412AA / 2 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Pallor, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2015GSK171407

Write-up: This case was reported by a physician via sales rep and described the occurrence of sudden infant death in a 9-week-old male patient who received ENGERIX B pediatric (batch number YHBVC412AA, expiry date unknown). On 30th November 2015, the patient received ENGERIX B pediatric 10 ug. On 30th November 2015, several hours after receiving ENGERIX B pediatric, the patient experienced pallor facial, drug dose administration interval too long and vaccine administered at inappropriate site. On 1st December 2015 05:00, the patient experienced sudden infant death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the sudden infant death was fatal and the outcome of the pallor facial, drug dose administration interval too long and vaccine administered at inappropriate site were unknown. The patient died on 1st December 2015. The reported cause of death was sudden infant death. It was unknown if the reporter considered the sudden infant death and pallor facial to be related to ENGERIX B pediatric. Additional information was provided as follows: Medical history and concomitant medication was unknown. On 30th November 2015 11:00, the patient received 2nd dose of hepatitis B as ENGERIX B pediatric at unknown deltoid, 2 months after 1st dose of hepatitis B vaccine which led to lengthening of vaccination schedule and inappropriate vaccination site as ENGERIX should be administered at thigh as per local schedule. On 30th November 2015 in the evening, several hours after receiving ENGERIX B pediatric, the patient experienced pale face and was taken to hospital for rescue. On 1st December 2015 at 5:00 am, 1 day after receiving ENGERIX B pediatric, the hospital announced the rescue was invalid and the patient died. No new information was provided.


VAERS ID: 614717 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-01
Entered: 2015-12-14
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Death, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (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: Concomitant Drugs Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SF21800

Write-up: A report received from a pharmacist concerning two children. This is the report of the second patient, concerning a child of an unknown age and ethnicity. No information was provided about concomitant medications, concurrent diseases and relevant history. The patient received nasal FLUENZA TETRA (intranasal) with unknown dose and frequency on an unspecified date. Indication of FLUENZ TETRA was not provided. The patient experienced respiratory side effects on an unspecified date. The patient died due to respiratory side effects. Date of death was unknown. The company physician assessed the case to be serous with death criterion.


VAERS ID: 619537 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-01
Onset:0000-00-00
Submitted: 2015-12-15
Entered: 2015-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Death, Dizziness, Dysstasia, Fatigue, Hyperhidrosis, Interstitial lung disease, Intestinal obstruction, Loss of consciousness, Mobility decreased, Pyrexia, Respiration abnormal, Transfusion, Urinary incontinence, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
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: No other medications
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/2013, Body temperature Increased, a little fever; 10/28/2013, X-ray, ascites retention
CDC Split Type: WAES1512JPN007063

Write-up: Initial information has been received from a patient''s family concerning a 79 year old male patient who in December 2011 was vaccinated with PNEUMOVAX NP injection subcutaneously, (Lot number, dose and indication not reported). Other concomitant medications included unspecified antihypertensives. On an unspecified date in 2013, reported as Friday, the patient usually slept in a futon and went to bathroom in the night. But in the night of that day he couldn''t get up by himself to go to the bathroom. He asked his wife to help him to get up. Then he got up to go to the bathroom and came back to sleep. At that time, there were no cough or fever. On an unspecified date in 2013, reported as Saturday, as the patient said he was tired, his wife asked him to go to see a doctor. But at last he couldn''t go to see a doctor because the hospital opened only until 12 o''clock that day. On an unspecified date in 2013, reported as Sunday, the patient couldn''t stand up by himself in the night. He had a little fever at that time. On an unspecified date in 2013, reported as Monday morning, the patient went to the medical practitioner where he usually got his blood pressure medication and an X-ray was taken. The doctor fell to thinking and suggested the patient to observe for 2,3 days. Then medicine was prescribed. On an unspecified date in 2013, reported as Tuesday, the patient asked for help to get up to go to the bathroom at 3:30am. The patient couldn''t walk although he stood up and finally reached the bathroom with help. But the patient felt faint and clopped down and peed in his pants in front of bathroom. The patient was taken to a big hospital by an ambulance and was hospitalized. An X-ray was taken immediately and the doctor said the situation was not optimistic and asked his wife if she wanted to administer steroid to his husband although the efficacy rate was 50%. His wife told the doctor to use steroid as long as there was a little hope. Steroid was administered for 3 days. The patient sweated a lot. On an unspecified date in 2013, reported as 3 days after hospitalization, the patient only received oxygen through the nose. On an unspecified date in 2013, reported as the tenth day of hospitalization, commencing with jelly, the patient could eat gradually. On an unspecified date in 2013, reported as a month after hospitalization, oxygen was removed. The patient could go to the bathroom himself. But the doctor said his life was about a half a year left. After that the patient was told to be transferred to another hospital. On an unspecified date in 2013, reported as a month later, the patient was told that he could be discharged on 30-OCT-2013. On 28-OCT-2013, the patient lost consciousness when he got up. He was taken to the previous big hospital by an ambulance. An X-ray showed ascites retention which was caused by intestinal obstruction. But the patient did not complain of pain and he had good appetite. The doctor said that he shouldn''t eat anything today because examination of intestine was scheduled tomorrow. On 29-OCT-2013, when the patient was found sleeping soundly. After that the patient''s breathing became unusual when his wife was nearby, treatments such as oxygen inhalation and blood transfusions were performed. On 09-NOV-2013, the patient died like sleeping at 12:35. The cause of death was interstitial pneumonia and intestinal obstruction. Information about autopsy was not reported. Reporter mentioned that the doctor said it was possible that it was not only interstitial pneumonia but the circulation of blood and nutrition was also bad due to intestinal obstruction. The reporter considered that the interstitial pneumonia and intestinal obstruction were serious due to death and hospitalization. The reporter did not assess the relationship between the events and suspect vaccine. Additional information is not expected, because the reported did not wish to be contacted.


VAERS ID: 619712 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-16
Entered: 2015-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512ZAF007539

Write-up: Information has been received from a physician via a company representative referring to a female patient of unknown age. Information about patient''s concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with unspecified dose of GARDASIL (lot #, dose and route not reported). Concomitant medications were not provided. On an unknown date the patient died. The cause of death was not reported. It was unknown if an autopsy was done. The causality was not provided. Additional information has been requested.


VAERS ID: 619991 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-12
Onset:2015-12-12
   Days after vaccination:0
Submitted: 2015-12-18
   Days after onset:6
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC501AD / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray abnormal, Chills, Death, Dyspnoea, Hepatomegaly, Malaise, Product quality issue, Pulmonary haemorrhage, Septic shock, Streptococcal sepsis, Suspected transmission of an infectious agent via product, Yellow skin
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: 2015-12-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/12/2015, Chest X-ray, complete opacification
CDC Split Type: LB2015GSK176702

Write-up: This case was reported by a physician via sales rep and described the occurrence of septic shock in a 1-month-old male patient who received ENGERIX B pediatric (batch number AHBVC501AD, expiry date September 2017). Concomitant products included ENGERIX B pediatric. On 12th December 2015, the patient received the 2nd dose of ENGERIX B pediatric (intramuscular). On 12th December 2015, several hours after receiving ENGERIX B pediatric, the patient experienced septic shock (serious criteria death and GSK medically significant), streptococcal septicemia (serious criteria death and GSK medically significant), pulmonary hemorrhage (serious criteria death and GSK medically significant), hepatomegaly (serious criteria death), difficulty breathing (serious criteria death), shivering, yellow skin, feeling unwell and pharmaceutical product complaint. On an unknown date, the patient experienced septicemia due to pseudomonas (serious criteria death and GSK medically significant) and suspected transmission of an infectious agent via a medicinal product (serious criteria GSK medically significant). On 12th December 2015, the outcome of the septic shock was fatal. On an unknown date, the outcome of the streptococcal septicemia, septicemia due to pseudomonas, pulmonary hemorrhage, hepatomegaly and difficulty breathing were fatal and the outcome of the shivering, yellow skin, feeling unwell, suspected transmission of an infectious agent via a medicinal product and pharmaceutical product complaint were unknown. The patient died on 12th December 2015. The reported cause of death was septic shock, streptococcal septicemia, septicemia due to pseudomonas, pulmonary hemorrhage, hepatomegaly and difficulty breathing. An autopsy was not performed. The reporter considered the septic shock, streptococcal septicemia, septicemia due to pseudomonas, pulmonary hemorrhage, hepatomegaly, difficulty breathing, shivering, yellow skin, feeling unwell, suspected transmission of an infectious agent via a medicinal product and pharmaceutical product complaint to be probably related to ENGERIX B pediatric. Additional details were provided as follows: The patient was healthy and had received the 1st dose of ENGERIX B pediatric at birth from the hospital. On 12th December 2015, the patient came to receive the 2nd dose. His clinical examination was normal. On 12th December 2015, at 11:30 am, the patient received the 2nd dose of ENGERIX B pediatric. On the same day, at 5 pm, the patient''s father called the paediatrician and said that the patient was shivering, yellow face and was not feeling well. The paediatrician advised them to keep him warm, which helped and in 15 minutes the patient was improving. At 7 pm, the patient''s situation got worse, and the parents took the patient to the emergency room of another hospital, where the paediatrician diagnosed the case as septic shock, with complete opacification and bleeding to lungs, hepatomegaly and difficulty in breathing. An infectious disease pediatric expert was consulted who mentioned that it might be a late onset of septic shock to a group B streptococcus or pseudomonas, and it was highly unlikely that it was related to the vaccine, unless the possibility of contamination from the vaccine (no supportive laboratory confirmation was provided). On 12th December 2015, at 11:30 pm, the patient passed away. This case was also associated to a pharmaceutical product complaint.


VAERS ID: 616563 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-17
Onset:0000-00-00
Submitted: 2015-12-11
Entered: 2015-12-23
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. FJ2188 / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Bacteraemia, Cardiac arrest, Cough, Death, Haemolytic uraemic syndrome, Malaise, Pneumonia pneumococcal, Pneumonia streptococcal, Pyrexia, Streptococcus test positive, Ultrasound abdomen, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Renovascular disorders (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-27
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: CALPOL; Ibuprofen
Current Illness:
Preexisting Conditions: Previously well, no previous hospital admissions. No recurrent infections. Fully vaccinated. No known allergies. No sickle cell .
Allergies:
Diagnostic Lab Data: Blood culture, S. pnuemoniiae serotype 19A; Ultasound abdomen, spleen present
CDC Split Type: 2015SF26184

Write-up: A report has been received from physician via MHRA concerning, a 2 year old, female patient. Concomitant medications included paracetamol and ibuprofen. Patient concomitant diseases and relevant history were not reported. Patient received FLUENZ TETRA (intranasal), 1.0 dosage form started on 17-Nov-2015. Nasal flu vaccine at the General Practice surgery. 5 days later, start of systemic symptoms with fever, vomiting and cough, simultaneously for 2 siblings who has the nasal flu vaccine. Younger sibling did not receive flu vaccine and is asymptomatic. Admitted to hospital. Streptococcus pneumonia and bacteraemia with associated haemolytic uraemic syndrome on both siblings. Two days later, cardiac arrest and death. Parents very concerned about the fact that both siblings received flu vaccine a few days prior to both siblings becoming very unwell. Yellow card for older siblings will also be done. Investigation needed regarding the link between nasal flu vaccine and invasive streptococcus pneumonia infection. The patient was also unwell which started on 23-Nov-2015. The patient died from streptococcus pneumoniae pneumonia on 27-Nov-2015 and at the time of reporting, the s. pneumonia haemolytic uremic syndrome, fever, vomiting, cough, bacteraemia, cardiac arrest and unwell was ongoing. The patient died on 27-Nov-2015. The cause of death was streptococcus pneumoniae pneumonia. It was unknown whether autopsy was performed or not. Reporter assessed streptococcus pneumoniae pneumonia to be serious with the criteria of death and s. pneumonia haemolytic uremic syndrome, fever, vomiting, cough, bacteraemia, cardiac arrest and unwell to be serious with hospitalization and important medical event.


VAERS ID: 620217 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Chest pain, Death, Histology abnormal, Myocarditis, Viral test negative
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On unknown date, Histological examination confirmed the diagnosis of acute myocarditis. Unspecified virological investigations were negative.
CDC Split Type: TN2015GSK180406

Write-up: This case was reported in a literature article and described the occurrence of acute myocarditis in a 22-year-old unk patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine (unknown). On an unknown date, several hours after receiving Hepatitis B vaccine, the patient experienced acute myocarditis (serious criteria death and GSK medically significant) and chest pain (serious criteria death). On an unknown date, the outcome of the acute myocarditis and chest pain were fatal. The reported cause of death was acute myocarditis. An autopsy was performed. It was unknown if the reporter considered the acute myocarditis and chest pain to be related to Hepatitis B vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of acute myocarditis in a 22-year-old patient of unspecified gender who had received an unspecified hepatitis B vaccine (manufacturer unknown). The patient was a student according to the authors. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received a dose of an unspecified hepatitis B vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 3 hours after the vaccination, the patient presented to the emergency department complaining of chest pain, was diagnosed with acute myocarditis and passed away after a few hours. Post-mortem and histological examination were performed and myocarditis was confirmed as the cause of death. Histological examination confirmed the diagnosis of acute myocarditis. Unspecified virological investigations were negative according to the authors. No further detail was included in the abstract. Treatment was unknown. No final decision regarding a causal relationship between the vaccine and this event was included in the abstract by the authors. No conclusion was included in the abstract. This case is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 620278 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-01
Onset:2015-12-01
   Days after vaccination:0
Submitted: 2015-12-25
   Days after onset:24
Entered: 2015-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. K020985 / 3 UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Immunisation
Preexisting Conditions: ENGERIX-B, serology abnormal; Hepatitis B virus vaccine (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512NLD012374

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control number NL-1577272925-2015001419) on 23-DEC-2015. Case retrieved from a health care professional: Women working at the company health service on 22-Dec-2015. A male adult (date of birth/age not known) patient received HBVAXPRO (batch number K020985, Dose 3) in Dec-2015. Other suspect products included: Hepatitis B vaccine (manufacturer unknown, batch/lot number unknown, Dose 2) on an unknown date. ENGERIX (batch/lot number unknown, Dose 1) on an unknown date. The first doses were ENGERIX, then the company switched to HBVAXPRO (because the titers after ENGERIX were low). The patient received the 3d dose of hepatitis B vaccine. The patient experienced Death in DEC-2015, one or two days post vaccination. The patient''s outcome was reported as Fatal. Case was reported to the authorities. Cause unknown by reporter. The reporter assessed the causal relationship between Death and HBVAXPRO as Unknown. Information added on 23-Dec-2015 on request of affiliate: Agency reference number for this case from Agency: MIE4735.


VAERS ID: 620313 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-17
Onset:2015-12-17
   Days after vaccination:0
Submitted: 2015-12-24
   Days after onset:7
Entered: 2015-12-28
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1126 / UNK LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 201312088 / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-17
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA215187

Write-up: Initial unsolicited report received from CDC via company representative on 18 December 2015. This case involves a patient (age and gender unknown) who was vaccinated with a 0.5 ml of ACT-HIB (batch number and route of administration was unknown, dose in serious and site of administration were not reported) on 17 December 2015. The patient''s medical history and concomitant medications were not reported. On 17 December 2015, few hours following the vaccination (at night), the patient died. Laboratory data and corrective treatment was not reported. The autopsy report was not provided. Lists of documents held by sender: none. Lab tests unknown.


VAERS ID: 620418 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-31
Onset:2015-11-06
   Days after vaccination:6
Submitted: 2015-12-31
   Days after onset:55
Entered: 2015-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. K020302 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Sudden death
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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-06
   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: LUCENTIS
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512GBR014499

Write-up: Information has been received from Sanofi Pasteur MSD [GB-1577272925-2015001610] on 30-DEC-2015. This serious case was received on the 25-DEC-2015 from the RA. GB-MHR ADR 23285072. Case received from a physician. A 70-year-old female patient received ZOSTAVAX, lot number K020302; expiry date: unknown) via subcutaneous route on 30-OCT-2015. The patient received concomitant administration of LUCENTIS on 21-SEP-2015. 4 days after vaccination on 04-NOV-2015, the patient experienced vomiting which seemed to be improving but on 06-NOV-2015, she had a circulatory collapse. The patient died on 06-NOV-2015. Sudden death was reported. According to HA report: "external post mortem only "probably cardiovascular degeneration but seemed sensible to report in case were any similar related reports. (After discussing with public health)."


VAERS ID: 620547 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-18
Onset:2015-11-18
   Days after vaccination:0
Submitted: 2016-01-06
   Days after onset:49
Entered: 2016-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC388A / 3 RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER M50386 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA066AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Haemolytic uraemic syndrome, Pneumococcal sepsis
SMQs:, Haemolytic disorders (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-26
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2015GSK177048

Write-up: This case was reported by a physician via sales rep and described the occurrence of pneumococcal septicemia in a infant unk patient who received INFANRIX HEXA. Co-suspect products included Pneumococcal vaccine. On an unknown date, the patient received the 3rd dose of INFANRIX HEXA (unknown) .5 ml and the 2nd dose of Pneumococcal vaccine (unknown) .5 ml. On an unknown date, 4 hrs after receiving INFANRIX HEXA and Pneumococcal vaccine, the patient experienced pneumococcal septicemia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumococcal septicemia was fatal. The reported cause of death was pneumococcal septicemia. An autopsy was performed. It was unknown if the reporter considered the pneumococcal septicemia to be related to INFANRIX HEXA and Pneumococcal vaccine. Additional information included: Approximately four hours post vaccination, the patient experienced pneumococcal sepsis. After about two days, the patient died. The deceased patient was examined at a clinic. It was unknown whether or not full autopsy was performed. Follow up information was received on 4th January 2016: The case was reported for a male patient of 5 months of age. Previous vaccinations were well tolerated. There was no known concurrent medical condition or concurrent medication or any other risk factors. On 18th November 2015, the patient was vaccinated with ROTARIX liquid formulation (batch number AROLA066AA), INFANRIX HEXA (batch number A21CC388A) and pneumococcal vaccine (batch number M50386). On 18th November 2015, the patient also experienced Hemolytic-uremic syndrome. On 26th November 2015, 8 days later the patient died. On 26th November 2015, the autopsy was performed but the results were not available.


VAERS ID: 618729 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-29
Onset:2014-01-24
   Days after vaccination:301
Submitted: 2015-11-27
   Days after onset:672
Entered: 2016-01-13
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-29
   Days after onset: 5
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: 24-JAN-2014, Blood culture, positive to pneumococcus; 24-JAN-2014, Serology test, serotype 19F
CDC Split Type: 2015408254

Write-up: This is a spontaneous report from a contactable physician via agency, part of the observatory of bacterial meningitis. A 20-month-old female patient of an unspecified ethnicity received three doses of PREVENAR 13, via an unspecified route of administration, first two doses on unspecified date and third dose on 29Mar2013, AT 0.5 ml single. Relevant medical history and concomitant medications were unknown. The patient was born at full term. The patient experienced pleural pneumonia on 24Jan2014, for which was hospitalized the same day. The patient underwent lab tests and procedures which included: blood culture, positive to pneumococcus; serology test: serotype 19F. Therapeutic measures were taken as a result of the event and included antibiotic treatment. The patient died on 29Jan2014 due to the events. It was unknown if an autopsy was performed.


VAERS ID: 620705 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-13
Entered: 2016-01-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L00744 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Brain oedema, CSF culture positive, Death, Meningitis pneumococcal, Pneumococcal bacteraemia
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad), Sepsis (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:
Preexisting Conditions: Unknown, PREVENAR 13; Drug indication: Immunization, the first dose (lot number: H88976) at the age of 2 months; Unknown, PREVENAR 13; Drug indication: Immunization, the second dose (lot number H88976) at the age of 3 months; Unknown, PREVENAR 13; Drug indiciation: Immunization, the third dose (lot number: J21161) at the age of 5 months
Allergies:
Diagnostic Lab Data: 2015, Blood culture, serotype 22F; 2015, CSF culture, serotype 22F
CDC Split Type: 2016013568

Write-up: This is a spontaneous report from a contactable physician. A 19 month-old male patient of unspecified ethnicity received the 4th dose of PREVENAR 13 (lot/batch number: L00744), via an unspecified route of administration at the age of 13 month-old, on an unspecified date at a single dose. Relevant medical history and concomitant medication were not reported. The patient was not a premature baby and was a healthy infant. The patient previously received three doses of PREVENAR 13: the first dose (lot number: H88976) at the age of 2 month-old, the second dose (lot number: H88976) at the age of 3 month-old and the third dose (lot number: J21161) at the age of 5 month-old. On an unspecified date in 2015, at the age of 19 month-old, the patient experienced brain edema, pneumococcal meningitis and pneumococcal bacteremia without focus identified as due to serotype 22F by blood culture and liquor. The event was serious as the patient died. It was unknown if an autopsy was performed. This is a spontaneous report from a contactable physician. A 19 month-old male patient of unspecified ethnicity received the 4th dose of PREVENAR 13 (lot/batch number: L00744), via an unspecified route of administration at the age of 13 month-old, on an unspecified date at a single dose. Relevant medical history and concomitant medication were not reported. The patient was not a premature baby and was a healthy infant. The patient previously received three doses of PREVENAR 13: the first dose (lot number: H88976) at the age of 2 month-old, the second dose (lot number: H88976) at the age of 3 month-old and the third dose (lot number: J21161) at the age of 5 month-old. On an unspecified date in 2015, at the age of 19 month-old, the patient experienced brain edema, pneumococcal meningitis and pneumococcal bacteremia without focus identified as due to serotype 22F by blood culture and liquor. The event was serious as the patient died. It was unknown if an autopsy was performed. The causality was not reported. No follow-up attempts possible. No further information expected.


VAERS ID: 620722 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-15
Entered: 2016-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myositis
SMQs:, Rhabdomyolysis/myopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601MEX005161

Write-up: This spontaneous report as received from "what appears to be a blog or some form of online media, refers to a 14 year old female patient. The patient''s medical history or concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL. It was not specified if the patient received GARDASIL or CERVARIX. It was reported the young girl would have been diagnosed with myositis (onset date not provided), a muscle inflammation, and she would have not received an adequate treatment for this disease. On an unknown date the patient experienced death related to "HPV vaccine" (NOS). The outcome of death was reported as fatal. The outcome of myositis was unknown. No further information was provided. Additional information has been requested.


VAERS ID: 619994 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-25
Onset:2015-12-25
   Days after vaccination:30
Submitted: 2016-01-12
   Days after onset:18
Entered: 2016-01-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 152701 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Atrial fibrillation, Breath sounds abnormal, Bronchitis, Cough, Death, Dyspnoea, Dysstasia, Heart sounds abnormal, Lower respiratory tract infection, Pallor, Rales, Tachyarrhythmia, Troponin increased, Vasoconstriction, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (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), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-25
   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: COUMADIN; TRIATEC; GLICOREST; LASIX
Current Illness: Hypoglycaemia, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning); Hyperglycaemia, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning); Nutritional condition abnormal; Atrial fibrillation; Hypertension; Type 2 diabetes mellitus; Cognitive disorder; Cerebrovascular disorder; Parkinsonism; Diabetes mellitus inadequate, The glycemic compensation was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning)
Preexisting Conditions: Oxygen Therapy
Allergies:
Diagnostic Lab Data: 12/17/2015, Heart sounds, Abnormal, Significant, Poor; 12/17/2015, Troponin, Abnormal, Significant, Increase
CDC Split Type: PHHY2016IT002060

Write-up: Case number PHHY2016IT002060, is an initial and follow up spontaneous report received from a physician via Agency received via pharmaceutical company on 04 Jan 2016 and from Agency on 08 Jan 2016 (combined report). This report refers to an 82-year-old male patient. Vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) in the previous years and did not report any immediate reaction. The patient''s current conditions included glycemic compensation which was poorly satisfactory (hypoglycemia in the evening and hyperglycemia in the morning). However, according to the physician opinion, it was due to a poorly corrected nutrition. Hypokinetic syndrome (domiciliary visits every 15 days) and the patient was in good hemodynamic compensation (no signs of pulmonary stasis, no peripheral edema and good oxygen saturation in room air). Concomitant medications included GLICOREST for type 2 diabetes mellitus, COUMADIN for atrial fibrillation, TRIATEC for arterial hypertension of mild degree and LASIX 25 mg tablet. The patient was vaccinated with AGRIPPAL S1 (batch number; 152701, expiration date: 31 Jul 2016) intramuscularly into the right shoulder at a dose of 0.5 ml on 25 Nov 2015 at 12:50 PM. On 03 Dec 2015, the patient experienced cough and difficulty in maintaining the standing position. At about 12:45, when the physician arrived the patient was in bed. The patient was apyretic and had normal blood pressure. The patient presented with humid rumors and whistles at both pulmonary fields and the patient maintained good oxygen saturation in room air. It was reported that a heart rhythm due to atrial fibrillation (AF) was present; however, the heart rate was within the normal limits. The physician suspected bronchial infection and prescribed Levofloxacin 500 mg one tablet daily and the physician withdraw the therapy with LASIX tablet. After about two days, the patient''s clinical conditions worsened and the patient was hospitalized. On 15 Dec 2015 in the afternoon, the patient was discharged from the hospital. The patient was visited by the colleague of the physician late in the morning of 16 Dec 2015 and reported that the patient still had some rales at both pulmonary fields. On 17 Dec 2015 at 08:15, the patient experienced episode of vomiting and was dyspneic (rasping breath). The physician immediately went to the patient''s home and the patient was pale, tachydyspneic, almost soporous; not evaluable the oxygen peripheral saturation due to the presence of vasoconstriction; the patient''s blood pressure was normal and presented with important diffuse humid rumors, tachyarrhythmia, and poor cardiac sounds. The physician suspected acute pulmonary edema and the patient was administered LASIX two vials intramuscularly (unfortunately, the physician could not find any peripheral venous access). The physician called the first aid service. It was reported that upon the arrival of the colleagues of the emergency department, the patient was stabilized by broncho aspiration; oxygen therapy. The patient''s discharge letter read the diagnosis as infection of the low respiratory ways. The patient was directed to the local therapy. The patient''s discharge letter read the diagnosis as infection of the low respiratory ways. The patient was directed to the local town hospital. At hour 12:00, approximately, the patient had a discrete increase in the troponin value and the diagnosis of acute pulmonary edema was confirmed and the patient manifested the intention to get admitted in the hospital. On 22 Dec 2015, the patient''s daughter reported to the physician that her father''s conditions were very severe. The outcome of the events was not reported. The patient died on 25 Dec 2015 (physician supposed) and the physician was not aware of the causes that lead to the patient''s death. The physician considered it was appropriate to report the case taking into account the close temporal relation (suspected causality) between the anti-flu vaccination AGRIPPAL S1 (performed at patient''s home after a clinical visit) and the onset of the cardio-respiratory pathologies lead to the patient''s death.


VAERS ID: 620859 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2015-12-18
Onset:2016-01-02
   Days after vaccination:15
Submitted: 2016-01-20
   Days after onset:18
Entered: 2016-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER L00853 / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M50386 / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB149AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain death, Brain oedema, Death, Diarrhoea, Nuclear magnetic resonance imaging brain abnormal, Pupil fixed, Roseolovirus test positive, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-01-06
   Days after onset: 4
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 4th January 2016, CSF test showed moderate concentration of HHV6-DNS (human herpes virus 6) detected. On 4th January 2016, blood analysis showed moderate concentration of HHV6-DNS detected. On 5th January 2016, the Magnetic resonance imaging (MRI) performed which showed brain edema detected and by neurosurgical measures treated.
CDC Split Type: DE2016GSK005459

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of brain death in a 3-month-old female patient who received ROTARIX liquid formulation (batch number AROLB149AA, expiry date unknown). Co-suspect products included HEXYON (batch number L0085-3, expiry date unknown and PREVENAR (batch number M50386, expiry date unknown). On 18th December 2015, the patient received the 1st dose of ROTARIX liquid formulation (oral), the 1st dose of HEXYON (intramuscular) and the 1st dose of PREVENAR (intramuscular). On 2nd January 2016, 15 days after receiving ROTARIX liquid formulation, the patient experienced diarrhea. On 3rd January 2016, the patient experienced somnolence and vomiting. On 4th January 2016, the patient experienced brain edema (serious criteria GSK medically significant) and fixed pupils (serious criteria GSK medically significant). On 5th January 2016, the patient experienced brain death (serious criteria death, hospitalization, GSK medically significant and life threatening). On 6th January 2016, the outcome of the brain death was fatal. On an unknown date, the outcome of the brain edema, fixed pupils, somnolence, vomiting and diarrhea were unknown. The patient died on 6th January 2016. The reported cause of death was brain death. An autopsy was performed. The reporter considered the brain death, brain edema, fixed pupils, somnolence, vomiting and diarrhea to be possibly related to ROTARIX liquid formulation. Additional details were provided as follows: The information on concomitant medication was not provided. Previously the patient was healthy, there was no pre-existing medical condition. On 3rd January 2016, 16 days after vaccination with ROTARIX liquid formulation, PREVENAR and HEXYON, the patient experienced vomiting and somnolence and he was hospitalized. The magnetic resonance imaging (MRI) showed disorders in white matter. On 4th January 2016, 17 days after vaccination with ROTARIX liquid formulation, PREVENAR and HEXYON, the patient experienced fixed pupils and brain edema. The magnetic resonance imaging (MRI) showed a brain edema which was treated by a neurosurgical measurement. On 5th January 2016, 18 days after vaccination with ROTARIX liquid formulation, PREVENAR and HEXYON, the patient had brain death and was died on 6th January 2016. The only pathologic value until date of reporting was a moderate concentration of HHV6-DNS in CSF and in blood. The physician assessed the causality of the events as possible and unlikely. An autopsy was performed but results were not reported. Follow-up information was requested by regulatory authority.


VAERS ID: 620220 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2016-01-21
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Histology abnormal, Meningitis, Meningitis aseptic
SMQs:, Noninfectious meningitis (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On unknown date, Post mortem and histological examination were performed and lymphocytic encephalitis was identified as cause of death
CDC Split Type: TN2015GSK180405

Write-up: This case was reported in a literature article and described the occurrence of meningitis in a 3-month-old patient who received DTPa-IPV. On an unknown date, the patient received DTPa-IPV (unknown). On an unknown date, several hours after receiving DTPa-IPV, the patient experienced meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningitis was fatal. The reported cause of death was meningitis. An autopsy was performed. It was unknown if the reporter considered the meningitis to be related to DTPa-IPV. Additional information was provided: This case was reported in a literature article and it described the occurrence of lymphocytic encephalitis in a 3-month-old infant who had received an unspecified diphtheria, tetanus, pertussis and polio vaccine (manufacturer unknown). The patient appeared to be healthy before the event according to the authors. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received a dose of an unspecified DTPa-IPV vaccine (dosage unknown: administration route and site unspecified: batch number not provided). On an unspecified date, a few hours after the vaccination, the patient passed away. Post-mortem and histological examination were performed and lymphocytic encephalitis was identified as cause of death. No further details regarding the investigations were available from the abstract. Treatment was unknown. No final decision regarding a causal relationship between the vaccine and this event was included in the abstract by the authors. No conclusion was included in the abstract. This case is 1 of the 2 valid cases reported in the same literature article. The article corresponding to this case is not available for submission due to copyright restrictions.


VAERS ID: 620381 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-21
Entered: 2016-01-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: 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: 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: No other medicaitons
Current Illness: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016PH006148

Write-up: Case number PHHY2016PH006148, is an initial literature case report received on 16 Jan 2016. The author in the article discussed about the outcomes of influenza and/or pneumococcal vaccination among systemic lupus erythematosus (SLE) patient seen at hospital. The patients were interviewed at baseline (two weeks prior to vaccination) to determine the medications they took and their disease activity prior to vaccination and one year after the patients were followed up and were asked regarding vaccine related outcomes such as development of flu, flu like symptoms or pneumonia during the interim. This report refers to a patient of unknown demographics. The patient was vaccinated with influenza vaccine (manufacturer and bath number: not reported) and pneumococcal vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient expired due to severe sepsis from pneumonia. The author stated that the patients with adverse outcomes were pooled and compared with the group who did not suffer any unwanted events and they noted that the patients who suffered from adverse outcomes had a longer standing disease and higher steroid doses with a higher baseline disease activity. The author concluded that though various guidelines recommend vaccination among patients with systemic lupus, they observed that better outcome was seen among patients with low disease activity and those with little or no intake of immunosuppressive agents. These factors should be well accounted to ensure the best vaccination outcomes among lupus patients.


VAERS ID: 620966 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-01-05
Onset:2016-01-11
   Days after vaccination:6
Submitted: 2016-01-22
   Days after onset:11
Entered: 2016-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: CSF test, Death, Hydrocephalus, Multiple organ dysfunction syndrome, Resuscitation, Serology test
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-01-12
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/2016, CSF test, pending; 01/2016, Serology test, pending
CDC Split Type: DE2016GSK006529

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hydrocephalus in a 18-year-old female patient who received TWINRIX Adult. On 5th January 2016, the patient received the 1st dose of TWINRIX Adult 1 ml. On 11th January 2016, 6 days after receiving TWINRIX Adult, the patient experienced hydrocephalus (serious criteria death, hospitalization, GSK medically significant and life threatening). On 12th January 2016, the patient experienced multi-organ failure (serious criteria death and GSK medically significant). On 12th January 2016, the outcome of the hydrocephalus and multi-organ failure were fatal. The patient died on 12th January 2016. The reported cause of death was multiple organ failure and hydrocephalus. It was unknown if the reporter considered the hydrocephalus and multi-organ failure to be related to TWINRIX Adult. Additional details were provided as follows: Past medical history was not reported. Concomitant medication was not reported. The patient was hospitalized for the event. Serology and cerebrospinal fluid (CSF) tests were performed but the results were pending. The cause of death was reported as multiple organ failure post cardiopulmonary resuscitation (CPR). It was unknown whether an autopsy was performed.


VAERS ID: 621172 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-16
Onset:0000-00-00
Submitted: 2016-01-26
Entered: 2016-01-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / 3 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test positive, Blood culture negative, CSF culture negative, Death, Dyskinesia, Increased upper airway secretion, Irritability, Listless, Muscle twitching, Nasopharyngitis, Neisseria test positive, Pyrexia, Rhinorrhoea, Skin abrasion, Streptococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Fever, 29OCT2015
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2016SA014630

Write-up: Initial unsolicited case received from SPMSD under the reference number 2016000420. Case received from physician via other company (SSI) on 12-Jan-2016 under the reference number DKSSI0110715. A male patient of unknown age received ACTHIB (batch number unknown, dose 3) on 16-Nov-2015. Other suspect products included: DITEKIPOL (batch number unknown, dose 3) on 16-Nov-2015, PREVENAR 13 (batch number unknown, dose 3) on 16-Nov-2015. The patient experienced intermittent fever up to 40 degrees on an unknown date and mild cold on an unknown date. The patient had a medical history of intermittent fever up to 40 degrees since 29-OCT-2015. The patient''s outcome was reported as fatal. The patient died on 24-Nov-2015. During the abduction of the 13 months old boy, who was found lifeless in his cradle with the head in the pillow, the following was observed: healthy boy with no external or internal malformations. On the right lower leg a single crust tire abrasion was observed. Normal developed organs, firm, bulging, flamed lungs, large stomach contents and swellings on the brink of the heart valve between the left chambers of the heart (mitral valve). It is reported that the deceased had a long-standing illness with intermittent fever up to approximately 40 degrees, and eight days before death the boy was vaccinated with the general 12 months childhood vaccination. Furthermore, he had a slight cold before death. According to medical records from own physician, the deceased had been at a 5 months consultation, where he showed no health issues. On 24-Apr-2015, the patient had stomach problems which he received PANODIL mixture for when needed. On 20-Oct-2015, medical records from emergency doctor''s note with phone consultation where the deceased''s mother called and told that deceased had a fever that comes and goes. Temperature around 40, making little jerking his arms, that is easy twitches. No cough and no obvious focus of infection was observed. PAMOL was recommended in the evening, switch to the doctor tomorrow, where the deceased already had time due to planned 12 month child examination. Deceased seen during consultation and are snotty. The physician listened to lungs, which were normal and peered in the ears, where there were no signs of otitis media. There were cultivation of streptococci A, which was negative. On 16-Nov-2015, the deceased, is healthy at his 1 year examination, but very fussy. Has no fever and is hard to examine and want to be close to the mother. The patient receives DTP-polio vaccination and PREVENAR, which is vaccination against pneumococcal. A bacteriological examination, conducted at clinical microbiology department, there is tissue from the right lung of each detected non-hemolytic streptococci in the left lung tissue part non-hemolytic streptococci fi. kind and scattered neisseria species. The grafting of the left middle ear has not demonstrated growth. In grafting from the right middle ear individual pneumococci is detected. There is no evidence of growth in the spinal fluid or blood. A virological examination, conducted at the State Serum Institute, adenovirus in heart tissue, heart liquid in the pericardium, blood, respiratory secretions were observed. On the basis of additional histological, bacteriological and virological examination, the detected/informed and autopsy findings the cause of death is believed to be a result of infection condition with adenovirus in many organs and inflammatory changes in meninges and brain tissue. Cause(s) of death: Viral infection.


VAERS ID: 628699 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-06
Entered: 2016-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Mumps
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602TWN003627

Write-up: Information has been received from the author of a literature report. Mumps is an enveloped, single stranded RNA virus belonging to the paramyxoviridae family that causes an acute infectious disease primarily in children and young adults. Transmission of mumps occurs by droplet contact and humans are the host for mumps which highly infectious and spreads rapidly in susceptible individuals living in close proximity. The infectious period begins 7 days before the onset of parotitis and continues for 9 days afterwards. In the pre-vaccination era, the highest attack rate was among primary school children and most adolescents showed evidence of previous infection. MMR vaccine was introduced for children at primary school entry (approximately 6-7 years old). During the same year, a supplementary dose of MMR vaccine was given to 8-11 years old children. Since then all children routinely received two doses of the MMR vaccine (first dose at 12-15 months and second dose at primary school entry). Complication of mumps include orchitis, oophoritis, aseptic meningitis, encephalitis, deafness and pancreatitis. A probable cause of mumps was defined as a patient who was ill with an acute onset of unilateral or bilateral tenderness and self-limited swelling of the parotid or the salivary glands that lasted for at least two days without other apparent causes. A confirmed case was defined as a patient who had a positive laboratory test (presence of IgM antibodies and/or a four fold increased in IgG antibodies). The annual incidence of mumps was calculated by dividing the number of physician reported mumps cases by the population of the individuals of same age as reported between 2006 and 2011 in the census data and was expressed as number of mumps case per 100,000 population. Between 2006 and 2011, a total of 6612 mumps case were reported to the Center for Disease Control (CDC). The number of male patients were 4077 and the number of female patients were 2535. The vaccination status was known for 6406 of the 6612 patients; 1716 were not vaccinated, 2319 received one dose of vaccine and 2371 received two doses of the vaccine. The vaccination status for 206 patients was unknown. This case refers to a 4 year old patient of unknown gender who on an unknown date was vaccinated with one dose of M-M-R II, dose, route and frequency unknown. No concomitant medications were reported. On an unknown date the patient died as a result of complications of encephalitis. The reporter considered encephalitis to be related to M-M-R II. Upon internal review, the event encephalitis was determined to be medically significant. This is one of 3 reports linked to 1602TWN003358 and 1602TWN003628. Additional information has been requested.


VAERS ID: 628700 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-06
Entered: 2016-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Mumps
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602TWN003358

Write-up: Information has been received from the author of a literature report. Mumps is an enveloped, single stranded RNA virus belonging to the paramyxoviridae family that causes an acute infectious disease primarily in children and young adults. Transmission of mumps occurs by droplet contact and humans are the host for mumps which is highly infectious and spreads rapidly in susceptible individuals living in close proximity. The infectious period begins 7 days before the onset of parotitis and continues for 9 days afterwards. In the pre-vaccination era, the highest attack rate was among primary school children and most adolescents showed evidence of previous infection. MMR vaccine was introduced for children at primary school entry (approximately 6-7 years old). During the same year, a supplementary dose of MMR vaccine was given to 8-11 years old children. Since then all children routinely received two doses of the MMR vaccine (first dose at 12-15 months and second dose at primary school entry). Complication of mumps include orchitis, oophoritis, aseptic meningitis, encephalitis, deafness and pancreatitis. A probable cause of mumps was defined as a patient who was ill with an acute onset of unilateral or bilateral tenderness and self-limited swelling of the parotid or the salivary glands that lasted for at least two days without other apparent causes. A confirmed case was defined as a patient who had a positive laboratory test (presence of IgM antibodies and/or a four fold increased in IgG antibodies). The annual incidence of mumps was calculated by dividing the number of physician reported mumps cases by the population of the individuals of same age as reported between 2006 and 2011 in the census data and was expressed as number of mumps case per 100,000 population. Between 2006 and 2011, a total of 6612 mumps case were reported to the Center for Disease Control (CDC). The number of male patients were 4077 and the number of female patients were 2535. The vaccination status was known for 6406 of the 6612 patients; 1716 were not vaccinated, 2139 received one dose of vaccine and 2371 received two doses of the vaccine. The vaccination status for 206 patients was unknown. This case refers to a 2 year old patient of unknown gender who on an unknown date was vaccinated with one dose of M-M-R II, dose, route and frequency unknown. No concomitant medications were reported. On an unknown date the patient died as a result of complications of encephalitis. The reporter considered encephalitis to be related to M-M-R II. Upon internal review, the event encephalitis was determined to be medically significant. This is one of three reports linked to 1602TWN003627 and 1602TWN003628 as same literature link. Additional information has been requested.


VAERS ID: 628769 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-08
Entered: 2016-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602JPN003625

Write-up: This spontaneous report was received from a physician refers to an adult male patient in his 80''s. Information about the patient''s medical history and concurrent conditions was not reported. On an unspecified date in 2015, the patient was vaccinated with PNEUMOVAX NP, subcutaneously, 0.5 ml, once a day, (lot # and expiration date were not provided). Concomitant medication was not reported. In January 2016, the patient''s wife caught a common cold. In the middle of January 2016, the wife recovered from the common cold, but the patient was infected by his wife, and this caused that the patient developed pneumonia. In no time he was introduced to pulmonology in a hospital. It was proved that the pneumonia was caused by pneumococcus. The patient died about one week later, on an unspecified date in January 2016. The cause of death was the pneumonia caused by pneumococcus. No information on autopsy was provided. At the time of this report, the outcome of the common cold was unknown. The reporter''s comment: Although the patient was vaccinated with PNEUMOVAX NP, not all type could be covered. Therefore, it was possible that the pneumonia was caused by pneumococcus. It was considered that the death of the patient was largely because the patient was ages and there was nothing could be done. The reporting physician considered that the pneumonia caused by pneumococcus was serious due to death. The reporting physician did not assess the seriousness of the common cold. The reporting physician did not assess the relationship of the pneumonia caused by pneumococcus and the common cold to PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 622236 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-01-23
Submitted: 2016-02-10
   Days after onset:18
Entered: 2016-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD - / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alcohol use, Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-23
   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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPVX201601000065

Write-up: This spontaneous case report was received from a pharmacist via Janssen (report#: 00486654) on 27-Jan-2016, which was forwarded to PaxVax on the same day with follow-up information received on 05-Feb-2016 (Med-PVX-201601-043). The report describes a 21-year-old female patient who took oral Vivotif capsule for typhoid prophylaxis and was found dead after she went to a party and had alcohol. It was reported that the patient was receiving other unspecified injectable vaccines concomitantly, the details of which were not available. It was also reported that the patient had no underlying medical conditions. As per the reporter, the patient was supposed to travel on 24-Jan-2016 and therefore, she was under Vivotif therapy in order to obtain protection against typhoid fever during her travel. The reporter confirmed that the patient took only 2 doses of Vivotif and was still left with 2 doses. The reporter was not aware of the exact start date of Vivotif. The patient went to a party where she had unspecified amount of alcoholic drinks and was found dead the next day on 23-Jan-2016. The reporter stated that she doesn''t know the real cause of death. She reported this case to be a sudden death event and was not aware of any underlying medical condition of the patient. Autopsy was performed and results for the same were pending at the time of report. The details of the lot number, expiration date and NDC number of the vaccine was not available. The action taken with Vivotif with respect to the event "patient found dead" was not applicable. The reporter''s statement of the causality for the event "patient found dead" with Vivotif was not provided. Reporter''s Comments: Company comment: In this case, the patient died after taking two doses of Vivotif (the exact dates of administration is not mentioned). Also, it is mentioned that the patient consumed alcohol in a party the day before her death. There is a possibility that the patient might have had experienced sudden death. The role of alcohol ingestion in her death also cannot be ruled out. Further, the medical details for the patient are quite limited. Keeping in view the aforementioned factors, the causal association between the patient''s death and Vivotif is unlikely. Sender''s Comments: In this case, the patient died after taking two doses of Vivotif (the exact dates of administration is not mentioned). Also, it is mentioned that the patient consumed alcohol in a party the day before her death. There is a possibility that the patient might have had experienced sudden death. The role of alcohol ingestion in her death also cannot be ruled out. Further, the medical details for the patient are quite limited. Keeping in view the aforementioned factors, the causal association between the patient''s death and Vivotif is unlikely.


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