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VAERS ID: 713155 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Dyspnoea, Gastrointestinal disorder, Pneumonia measles, Regressive behaviour
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131709GBR008453

Write-up: This report describes the occurrence of a measles pneumonia and a subsequent death in a 26 month old boy receiving MMR vaccine. After receiving a dose of MMR vaccine at the age of 18 months, the child developed bowel disorder, lost all the physical skills he had, lost the words he could say, and stopped laughing and crying. Though he started to recover , at 26 months, after suffered from breathing difficulties, he was taken to causality where he later died. The post-mortem gave the cause of death as measles pneumonia. The author of the article made the following comment : "There is no proven link between MMr and autism, bowel disease or other conditions, does not prove there is no link. Surely it is the medical establishment which is operating a well-organised campaign of scaremongering rather than commissioning proper research." Following an internal review, the product coding for MMR vaccine was changed to MMR old strain.; Reported Cause(s) of Death: measles pneumonia.


VAERS ID: 714131 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-27
Onset:2017-07-02
   Days after vaccination:5
Submitted: 2017-09-19
   Days after onset:79
Entered: 2017-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-02
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 06/05/2017 06/12/2017, Bronchiolitis, hospitalized on 5th June 2017 and discharged clinically healthy on 12th June 2017
Allergies:
Diagnostic Lab Data:
CDC Split Type: BG2017GSK142552

Write-up: This case was reported by a physician via sales rep and described the occurrence of died in sleep in a 3-month-old female patient who received ROTARIX. The patient''s past medical history included bronchiolitis (hospitalized on 5th June 2017 and discharged clinically healthy on 12th June 2017. On 27 June 2017, the patient received the 1st dose of ROTARIX (oral). On 2nd July 2017, 5 days after receiving ROTARIX, the patient experienced died in sleep (serious criteria death and GSK medically significant). On an unknown date, the outcome of the died in sleep was fatal. The patient died on 2nd July 2017. The reported cause of death was died in sleep. An autopsy was performed. The reporter considered the died sleep to be unrelated to ROTARIX. Additional details were reported as follows: At the time of vaccine administration, the patient was clinically healthy. The patient died in her sleep in the afternoon. Autopsy results were not provided.


VAERS ID: 713989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-09-13
Onset:2017-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Cyanosis, Death, Epistaxis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-13
   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: INSA2017SA170706

Write-up: Initial unsolicited report received from a healthcare professional via company representative on 14-Sep-2017. This case involves a one-month-old (one and a half months old) female patient who was vaccinated with first dose of IMOVAX POLIO (batch number, expiry date, dose, route and site of administration was not reported) and first dose of OPV (manufacturer: BIOPHARMA) (batch number, expiry date, dose, route and site of administration was not reported) and PENTAVALENT VACCINE (manufacturer: BIOLOGICALE) (batch number, expiry date, dose, route and site of administration was not reported) on 13-Sep-2017 at 11:15 AM. Patient''s medical history and concomitant medications were not reported. On 13-Sep-2017, few minutes after the vaccination (also reported as two hours), patient''s parents had not even reached their house when they noticed blood oozing out of the infant''s nose and rushed back to the hospital and also patient''s feet had turned blue. When the patient''s parents reached the hospital at 12:45 pm the doctors examined the patient and declared her dead. The infant died within two hours of being vaccinated under routine immunization at the hospital (it was also reported that roughly two hours after the vaccination patient died). It was also reported that death occurred perhaps due to aspiration to patient (onset was 13-Sep-2017, few minutes after the vaccination), a medical condition in which food or liquid goes down the trachea to the lungs instead of being ingested through the food pipe. The parents must have fed the patient improperly. Reportedly, Seventeen other kids were given the OPV vaccines, 29 others were given the IPV and nine others were given the pentavalent on Wednesday but all were healthy. The patient''s parents reported that the infant died because of the vaccine and it was administered by an untrained professional while health Department officials accused the family of negligence. The Adverse Effects after Immunization committee added that the death had nothing to do with the vaccine. Laboratory investigations and corrective treatment were not reported. It was unknown if the autopsy was performed or not. (Reported as the body of the one-and-a-half-month-old child was sent for a post-mortem examination.). Documents held by sender: none. Sender''s Comments: A 1-month old female patient died few hours after receiving IMOVAX Polio along with POLIOMYELITIS VACCINE (ORAL) from other manufacturer and DIPHTHERIA, TETANUS, PERTUSSIS, HAEMOPHILUS INFLUENZAE, AND HEPATITIS B VACCINE from other manufacturer. Parents noticed some blood oozing out of her nose and her feet had turned blue. The hospital reported that death likely occurred due to "aspiration" (due to improper feeding) which would be an alternative cause of death. A detailed autopsy report would be needed to confirm this cause. Based on the information provided; the role of the given vaccines appears unlikely. Reported Cause(s) of Death: aspiration; Blood oozing out of the nose; Feet had turned blue.


VAERS ID: 714089 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R41800 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZERINC2017408001

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVENAR 13 via an unspecified route of administration, on an unspecified date of 2017, at single dose, for immunization. The patient medical history and concomitant medications were not reported. The patient died due to unknown cause 3 days after vaccination, on an unspecified date in 2017, few weeks before the report. It was unknown if an autopsy was performed. The physician reported this case to the Autonomous Community Authorities. Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such as the patient''s demographics, medical history, concomitant medications and event term details especially death cause and autopsy results is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Patient died 3 days after vaccination.


VAERS ID: 714766 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2017-09-20
Onset:2017-09-20
   Days after vaccination:0
Submitted: 2017-09-26
   Days after onset:6
Entered: 2017-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS XROTA345 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-20
   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: No other medications
Current Illness: Pyrexia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IN2017GSK147843

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown of death in a 6-week-old male patient who received ROTARIX (lyophilized formulation) (batch number XROTA345, expiry date unknown). Concurrent medical conditions included fever. On 20th September 2017, the patient received the 1st dose of ROTARIX lyophilized formulation (oral). On 20th September 2017, less than a day after receiving ROTARIX lyophilized formulation, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 20th September 2017, the outcome of the unknown cause of death was fatal. The patient died on 20th September 2017. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The physician informed that on 20th September 2017 night it was telephonically communicated to the field colleague by another physician of the immunization unit of the hospital where the patient was vaccinated. The field colleague communicated the information to his Senior Manager, who then informed to the Vaccines Medical Affairs Team. On 20th September 2017 the patient was brought for vaccination and the junior doctor assisting noticed that the patient had fever. However, the parents insisted on getting the patient vaccinated, hence; ROTARIX was administered orally. After they reached home, the patient became visibly ill and the parents took the patient to another hospital where the patient died. The caused of death was unknown. A police case had been registered against the physician and he had been arrested. The reporter refused to share any more information with the Vaccines Medical Affairs Team. The Vaccines Medical Affairs Team assured the physician about the safety of ROTARIX of which millions of doses had been administered globally. This case has been linked IN2017GSK147467 which was reported by the same reporter.


VAERS ID: 715173 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-24
Submitted: 2017-09-26
   Days after onset:1036
Entered: 2017-09-27
   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: Cardiac failure, Cystitis escherichia, Death, Dyspnoea, Polymyalgia rheumatica
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vasculitis (narrow), Opportunistic infections (broad), 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700826

Write-up: This serious spontaneous case reported by other non-health professional via health authority (IT-MINISAL02-282601) on 05-Jun-2017 and concerns 83-year-old, elderly, male patient. On an unspecified date, the patient received influenza vaccine (dose, route of administration, expiry date, anatomical location, trade name, manufacturer, batch no: not reported). On 24-Nov-2014, the patient experienced Escherichia coli cystitis, cardiac failure and dyspnoea. On unspecified date, the patient also experienced polymyalgia rheumatica. Outcome of the event polymyalgia rheumatica was not reported. The patient died on an unspecified date. It was unknown whether the autopsy performed at the time of this report. The Health Authority assessed this case as serious (death) and considered the events cardiac failure, Escherichia coli cystitis and dyspnea as related to the influenza vaccine. Follow-up information was received via health authority (IT-MINISAL02-384968) on 19-Sep-2017: Gender of the patient was updated to male from female and age was updated to 83 years. Polymyalgia rheumatica was added as an event and narrative was amended accordingly. Case Comment: This case concerns an 83 year old male patient who had died due to Cardiac failure, Escherichia coli cystitis and dyspnoea, after receiving a dose of Influenza vaccine seasonal. The information regarding the vaccination details, previous vaccination history, medical history, concomitant medications and diagnosis work-up were not reported. The causality of the events was assessed as not related with respect to the suspect vaccine due to biological implausibility. However, the case will be reassessed when more information becomes available. Due to missing information regarding the time to onset for the event polymyalgia rheumatica and complementary investigations, the causal role of suspect vaccine cannot be assessed. The event polymyalgia rheumatica was considered medically significant.


VAERS ID: 715737 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-09-29
Entered: 2017-10-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Pyrexia, Restlessness, Resuscitation, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carum Carvi; LEFAX Pump-Liquid
Current Illness: Flatulence; Passive smoking; Atopy, allergic diathesis (patient''s sister diagnosed with atopy); Plagiocephaly
Preexisting Conditions: Restlessness, since birth
Allergies:
Diagnostic Lab Data: 2017, Body temperature elevated, up to 40 degree C
CDC Split Type: DE2017GSK149203

Write-up: This case was reported by physician via regulatory authority and described the occurrence of sudden infant death syndrome in a 3-month-old female patient who received ROTARIX liquid formulation. Co-suspect products included INFANRIX HEXA and PREVENAR 13. The patient''s past medical history included restlessness (since birth). Concurrent medical conditions included meteorism, passive smoking, atopy (allergic diathesis (patient''s sister diagnosed with atopy)) and plagiocephaly. Concomitant products included carum carvi and LEFAX Pump-liquid. On an unknown date, the patient received ROTARIX liquid formulation (oral) 1.5 ml, INFANRIX HEXA (intramuscular) .5 ml and PREVENAR 13 (intramuscular) .5 ml. On 23 August 2017, less than a year after receiving ROTARIX liquid formulation and INFANRIX HEXA, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant) and marked restlessness. On an unknown date, the patient experienced fever. On 23rd August 2017, the outcome of the sudden infant death syndrome was fatal. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the marked restlessness was not reported. The patient died on 23rd August 2017. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, fever and marked restlessness to be related to ROTARIX liquid formulation and INFANRIX HEXA. Additional details were provided as follows: The age at vaccination was not reported. Approximately two days after receiving ROTARIX liquid formulation and INFANRIX HEXA, the patient had a high fever up to 40 degree C, persisting for about 24 to 48 hours. Afterwards fever was resolved. On the date of death, on 23rd August 2017, the patient showed normal behavior. The patient became restless after food intake. Due to plagiocephaly the patient was laid down to sleep in lateral position. Approximately 45 minutes later the patient was found lifeless in prone position. The cardiopulmonary resuscitation (CPR) was performed without success. It was unknown whether an autopsy was performed. It was unknown if the reporter considered the sudden infant death syndrome, fever and restlessness to be related to PREVENAR 13 as well. The regulatory authority requested further information.


VAERS ID: 715741 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-01
Onset:2017-06-20
   Days after vaccination:19
Submitted: 2017-10-02
   Days after onset:104
Entered: 2017-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB364AC / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute kidney injury, Adenovirus test, Aspiration bone marrow normal, Autopsy, Cardiac arrest, Circulatory collapse, Coagulopathy, Death, Diarrhoea, Enterovirus test negative, Epistaxis, Haemoptysis, Haemorrhagic pneumonia, Headache, Hepatic haemorrhage, Hepatic necrosis, Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Meningitis, Multiple organ dysfunction syndrome, Myocarditis, Platelet count decreased, Respiratory syncytial virus test negative, Resuscitation, Right ventricular failure, Staphylococcus test positive, Viral myocarditis, Viral sepsis, Viral test, White blood cell count decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-21
   Days after onset: 1
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: Wound, (6 cm) at right upper abdomen; Joint injury, abrasion, (3.5 x 2 cm); Skin abrasion, fresh abrasions at left thigh (max. 0.5 cm); Haematoma, at right thigh (6x6 cm); Wound, site left gluteal
Preexisting Conditions: 02/19/1997, INFANRIX+HIB, Prophylaxis, 1st dose; 04/16/1997, INFANRIX+HIB, Prophylaxis, 2nd dose; 06/14/1997, INFANRIX+HIB, Prophylaxis, 3rd dose; 05/14/1997, POLIO SABIN, Prophylaxis, 1st dose, batch number S2228E; 06/19/1997, POLIO SABIN, Prophylaxis, 2nd dose, batch number S2305E; 06/05/1998, POLIO SABIN, Prophylaxis, 3rd dose, batch number S2496F; 08/21/2012, REPEVAX, Prophylaxis, batch number H0212-3; 02/01/1999, PRIORIX, Prophylaxis, batch number 690016PD; 08/21/2012, POLIO Vaccine, Prophylaxis; Infection, unspecified, shot time before death;
Allergies:
Diagnostic Lab Data: On 17th July, Viral testing out of cardiac probe material was send. The patient''s Picornavirus DNA (including Rhino- and Enteroviruses) was done however it was found to be not detectable. 07/2017, Adenovirus test, Adenovirus DNA: not detectable; 06/21/2017, Blood glucose, 19; 07/2017, Human metapneumovirus test, Metapneumovirus RNA: Not detectable; 07/2017, Influenza virus test, Influenza virus A/B RNA: not detectable; 06/21/2017, Platelet count, 14000; 07/2017, Respiratory syncytial virus test, RSV RNA-No detectable; 07/10/2017, Staphylococcus test, positive; 06/21/2017, White blood cell count, 2300
CDC Split Type: DE2017GSK148641

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hemorrhagic pneumonia in a 20-year-old female patient who received TWINRIX adult (batch number AHABB364AC, expiry date unknown). The patient''s past medical history included infection (unspecified, short time before death). Previously administered products included INFANRIX+Hib (1st dose, received on 19th February 1997), INFANRIX+Hib (2nd dose, received on 16th April 1997), INFANRIX+HIB (3rd dose, received on 14th June 1997), POLIO SABIN (1st dose, received on 14th May 1997, batch number S2228E), POLIO SABIN (2nddose, received on 19th June 1007, batch number S2305E), POLIO SABIN (3rd dose, received on 5th June 1998, batch number S2496F), REPEVAX (received on 21st August 2012, batch number H0212-3), PRIORIX (received on 1st February 1999, batch number 690016PD) and POLIO Vaccine (received on 21st August 2012). Concurrent medical conditions included wound ((6 cm) at right upper abdomen), knee injury (abrasional (3.5 x 2 cm)), skin abrasion (fresh abrasions at left thigh (max. 0.5 cm)), hematoma (at right thigh (6x6 cm)) and puncture wound (site left gluteal). On 1st June 2017, the patient received the 1st dose of TWINRIX adult. On 20th June 2017, 19 days after receiving TWINRIX adult, the patient experienced headache. On 21st June 2017, the patient experienced viral sepsis (serious criteria death and GSK medically significant), multi-organ failure (serious criteria GSK medically significant), asystole (serious criteria GSK medically significant), circulatory collapse (serious criteria GSK medically significant), blood streaked sputum, epistaxis and diarrhea. On an unknown date, the patient experienced hemorrhagic pneumonia (serious criteria death and GSK medically significant), myocarditis (serious criteria GSK medically significant), right heart failure (serious criteria GSK medically significant), hepatic hemorrhage (serious criteria GSK medically significant), hepatic necrosis (serious criteria GSK medically significant), acute renal failure (serious criteria GSK medically significant), meningitis (serious criteria GSK medically significant) and coagulopathy. On 21st June 2017, the outcome of the hemorrhagic pneumonia and viral sepsis were fatal. On an unknown date, the outcome of the multi-organ failure, blood streaked sputum, epistaxis, headache and diarrhea were not reported and the outcome of the myocarditis, right heart failure, hepatic hemorrhage, hepatic necrosis, acute renal failure, meningitis, asystole, circulatory collapse and coagulopathy were unknown. The patient died on 21st June 2017. The reported cause of death was hemorrhagic pneumonia and viral sepsis. An autopsy was performed. It was unknown if the reporter considered the hemorrhagic pneumonia, viral sepsis. An autopsy was performed. It was unknown if the reporter considered the hemorrhagic pneumonia, viral sepsis, multi-organ failure, myocarditis, right heart failure, hepatic hemorrhage, hepatic necrosis, acute renal failure, meningitis, asystole, circulatory collapse, coagulopathy, blood streaked sputum, epistaxis, headache and diarrhea to be related to TWINRIX adult. Additional information was provided as follows: The patient had no medical history and took no concomitant medication. On admission the patient was in good general condition and nutritional condition. On 20th June 2017, the patient was well until the evening. In the evening the patient experienced headache. On 21th June 2017, the patient had experienced severe diarrhea and collapsed once. On arrival of the emergency the patient was responsive to verbal stimuli. The patient experienced asystoly, bloody foamy tracheal secretion and severe and severe nose blood. The patient''s cardiopulmonary resuscitation was without success. On 21th June 2017 at 02:01 pm, the patient died. The patient was first diagnosed of suspected hemolytic uremic syndrome (HUS), leukaemia and fulminant sepsis. The Leukaemia was ruled out by examination of bone marrow in the frame of autopsy. Also Hemolytic uremic syndrome was not confirmed. The patient''s parents stated that short time before death the patient had an infection. Symptoms on the day before admission were indicative, that it was most likely a fouyant course of a viral infection with a most likely viral myocarditis. The distinct haemorrhagic pneumonia was considered congruent to the viral infection, right heart failure, consecutive multiorgan failure acute renal failure, liver necrosis, hepatic necrosis, coagulopathy. There was also meningitis.


VAERS ID: 715876 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-09-29
Entered: 2017-10-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Death, Influenza, Malaise
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201701689

Write-up: This initial serious spontaneous case, was received on 26-Sep-2017, from other non-health professional, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported. On an unspecified date, the patient was sick for a week, it was reported that the patient had contracted with influenza. On an unspecified date (reported as at the weekend), the patient died from acute respiratory distress syndrome. It was unknown, whether autopsy was performed.


VAERS ID: 716255 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131710GBR001481

Write-up: Information was received from an online article via a company representative and refers to an unspecified number of young female patients of unknown exact age. No information about the patients'' medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection (dose, route of administration, vaccination site, lot # and expiry date were not reported) for prophylaxis. On unknown dates, the patients became paralyzed which came down to death. The reporter confirmed that death cases subsequent to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) were seen. The reporter did not provide the causality assessment between the event and the suspect vaccines. Upon internal review, the event of paralysis was determined to be medically significant. Reported Cause(s) of Death: paralyzed.


VAERS ID: 716557 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-09-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Lung cancer; Pneumonia pneumococcal; Smoker (60 packs/year)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZERINC2017424672

Write-up: This is a spontaneous report from a contactable physician (respiratory medicine) received through a Pfizer sales representative. The physician reported 9 similar cases. This is the 9th of 9 cases. A 78-year-old male patient of an unspecified ethnicity received PREVENAR 13 (Lot # and Expiration Date unknown) intramuscular on an unspecified date at single dose for immunisation. Medical history included smoker with 60 packs per year, chronic obstructive pulmonary disease (COPD), lung cancer surgery, PPSV23 was reported. The patient''s concomitant medications were not reported. The patient experienced nursing and healthcare associated pneumonia (NHCAP) on an unspecified date 3 months after receiving pneumococcal 13-val conj vac (dipht crm197 protein). The pathogen was unknown. The patient died due to NHCAP on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination schedule are lack for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): JP-PFIZER INC-2017424635 Same reporter and drug, different patient. Reported Cause(s) of Death: Nursing and healthcare associated pneumonia.


VAERS ID: 716849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test resistant, Death, Pathogen resistance, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Respiratory failure; Smoker (60 packs/ year)
Allergies:
Diagnostic Lab Data: Test Name: Antimicrobial susceptibility test; Result Unstructured Data: Test Result: beta-lactamase-negative ampicillin-resistant
CDC Split Type: JPPFIZER INC2017424667

Write-up: This is a spontaneous report from a contactable physician (respiratory medicine) received through a Pfizer sales representative. The physician reported 9 similar cases. This is the 8th of 9 cases. A 66-year-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot # and Expiration Date unknown) intramuscular on an unspecified date at single dose for immunisation. Medical history included smoker with 60 packs per year, chronic obstructive pulmonary disease (COPD), respiratory failure. No past history of pneumonia was reported. No past administration of pneumococcal polysaccharide vaccine 23 (PPSV23) was reported. The patient''s concomitant medications were not reported. The patient experienced community-acquired pneumonia on an unspecified date 6 months after receiving pneumococcal 13-val conj vac (dipht crm197 protein). The pathogen was beta-lactamase-negative ampicillin-resistant (BLNAR). The patient died due to community-acquired pneumonia on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: A possible contributory role of the suspect product cannot be excluded for the reported event community-acquired pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : JP-PFIZER INC-2017424635 Same reporter and drug, different patient.; Reported Cause(s) of Death: community-acquired pneumonia.


VAERS ID: 719567 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-01-12
Onset:2017-09-01
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2017-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUSA2017SA191699

Write-up: Initial unsolicited report received from a physician on 02-Oct-2017. This case involves a 33-month old patient (age reported as 2.8 years) (gender unknown), who was vaccinated with MENACTRA (batch number, expiry date, dose, route and site of administration was not reported) on 12-Jan-2017. The patient''s ongoing illness / medical history / risk factors were unknown and concomitant medications were not reported. On an unknown date of Sep-2017, few months after the vaccination, patient experienced meningococcaemia serotype C under provisional exclusion according to blood test result, and death happened during 24 hours (date of date also reported as Sep-2017). It was also a case of vaccination failure. Other lab test and corrective treatment was unknown. It was unknown whether autopsy was performed or not. The physician associated death with vaccination failure. Documents held by sender: none.; Sender''s Comments: This case concerns a 2-year-old child who reportedly experienced serogroup C meningococcal infection with a fatal outcome approximately 8 months after receiving MENACTRA vaccine. Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. Relevant information including but not limited to vaccination details (lot number, route, site and actual date of vaccination), vaccination history, patient''s demographics (gender and date of birth), clinical details, the diagnostic tests performed, and the patient''s medical history and immune status (B cell immunity, mannose binding lectin [MBL] and complement status, ...) is lacking to allow adequate medical assessment.; Reported Cause(s) of Death: Meningococcaemia.


VAERS ID: 719785 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131710BRA001740

Write-up: This solicited social media report was received from an unspecified reporter, concerning to an article identified on an independent site, which refers to a 2 month old female patient, who was enrolled in an unspecified study. The patient''s pertinent medical history, concurrent conditions or concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), orally (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. Subsequently on an unknown date, the patient died due to complications of unspecified adverse effects caused by the rotavirus vaccine, live, oral, pentavalent (manufacturer unknown); it was unknown if an autopsy was performed. The reporter considered the unspecified adverse effects to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). Upon internal clarification, it was confirm that this case was not a solicited social media report; it was a spontaneous report received from the journalist who wrote the article (previously mentioned), in a local magazine. This is one of three reports received from the same reporter. Sender''s Comments: BR-009507513-1710BRA001810: BR-009507513-1710BRA001681: Reported Cause(s) of Death: Complications of the adverse effects caused by the Rotavirus Vaccine.


VAERS ID: 719866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-06-01
Submitted: 0000-00-00
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131710NZL003013

Write-up: This spontaneous report as received from a regulatory authority (121228) refers to a 5 month old male patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ROTATEQ (concentration, dose, lot# expiration date were not reported). Other suspect therapies included pneumococcal 13v conj vaccine (crm197) (concentration, dose, route of administration, lot# and expiration date were not reported) and INFANRIX HEXA (concentration, dose, route of administration, lot# and expiration date were not reported). On an unknown date in June 2016 the patient experienced sudden death. The outcome of sudden death was reported as fatal. The patient died on an unknown date in June 2016. The causality assessment was not provided.


VAERS ID: 719902 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-12
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA235BA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Product quality issue
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: DE2017GSK155947

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 77-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA235BA, expiry date unknown). This case was associated with a product complaint. On an unknown date, the patient received INFLUSPLIT TETRA. On an unknown date, less than a year after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and pharmaceutical product complaint. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pharmaceutical product complaint was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to INFLUSPLIT TETRA. Additional details were provided as follows: The age at vaccination was not reported. The patient died after administration of INFLUSPLIT TETRA. The cause of death was not reported. The vaccinating physician complained the affected batch and refused to administer this batch again. This case was already sent to a regulatory authority. No more information was provided.


VAERS ID: 719951 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-09-05
Onset:2017-09-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T06010 / 2 UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CB391A / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Death
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-18
   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: Allergy to animal dander; Asthma bronchial; House dust mite allergy; Infection; Milk protein allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2017435317

Write-up: This is a spontaneous report received from a contactable physician through the Health Authority. Regulatory Authority report number DE-PEI-PEI2017085200. A 3-year-old male patient received on 05Sep2017 PREVENAR 13 (batch/lot no.: T06010) at single dose and INFANRIX-IPV+HIB (batch/lot no.:A20CB391A) at 1 DF, single, both for immunization. Information on concomitant medication was not provided. Medical history included bronchial asthma, milk protein allergy, house dust mite allergy, allergy to animal dander, and a mild infection. On 18Sep2017, the patient died probably of an asthmatic attack (possibly the child experienced further symptoms). Death cause was reported as asthmatic attack. An autopsy was not performed. Follow-up information has been requested. No follow-up attempts needed, follow-up automatically provided by PEI.; Reported Cause(s) of Death: died probably of an asthmatic attack (possibly the child experienced further symptoms).


VAERS ID: 720054 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-06-01
Submitted: 0000-00-00
Entered: 2017-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
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: 2016-06-01
   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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131710NZL003576

Write-up: Information was obtained on a request by the Company from the agency (HA# CARM121297) via a Case Line Listing concerning a 2 months old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with ROTATEQ; diphtheria toxoid (+) hepatitis B virus vaccine recombinant hepatitis B virus surface antigen (rHBsAg) (yeast) (+) Haemophilus influenzae type B (Hib) conjugate vaccine (tet toxoid) (+) pertussis acellular 2-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (DTAP-HEXA), and pneumococcal vaccine (unspecified) (PENUMOCCOCAL VACC-13) (lot #, expiration date, strength, dose, frequency, route of administration or anatomical location were not provided); all of them administered for prophylaxis. In June 2016, the patient suffered a sudden death; the cause of death was not reported. It was also unknown if an autopsy was performed. The causal relationship between the patient''s sudden death with the suspect vaccines was not provided. The original reporting source was not provided.


VAERS ID: 720537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CHOLECALCIFEROL; DIPYRIDAMOLE; THYROXINE; ALLOPURINOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZSA2017SA198734

Write-up: Initial unsolicited report received from a healthcare professional via the health authority (reference number: 111827) on 05-Oct-2017. This case was reported under annual report. This case involves a 81-year-old male patient, who was vaccinated with INFLUENZA TRIVALENT (batch number, expiry date, route, dose, dose in series and site of administration not reported) on an unknown date. Patient''s medical history was not reported. Patient''s concomitant medications included CHOLECALCIFEROL, DIPYRIDAMOLE, THYROXINE and ALLOPURINOL. On an unknown date, following the vaccination, the patient had cardiac arrest and expired on an unknown date. Lab test was not reported and corrective treatment was unknown. It was not reported whether autopsy was done or not. This case was under reports, which resulted in a fatal outcome regardless of causality. Documents held by sender: none. Sender''s Comments: This case concerns a 81 years old male patient who commenced therapy with influenza split triton thiomersal free vaccine on an unknown date. Patient died with cardiac arrest. Time to onset is unknown. Further information on the risks factors including any underlying disease, circumstances and patient''s medical condition at the time of death and detailed autopsy report would be needed for a complete assessment. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 720938 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-16
Entered: 2017-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Contraindication to vaccination, Death, Diarrhoea, Immunodeficiency, Labelled drug-disease interaction medication error, Laboratory test abnormal, Rotavirus test positive, Sepsis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Several tests performed and a severe immunodeficiency disease has been diagnosed. On an unknown date the lab test was performed. Stool analysis, Rotavirus positive
CDC Split Type: LB2017GSK157395

Write-up: This case was reported by a physician via sales rep and described the occurrence of sepsis in a 3-month-old male patient who received ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced sepsis (serious criteria death, hospitalization and GSK medically significant), diarrhea (serious criteria hospitalization), immunodeficiency (serious criteria GSK medically significant) and labeled drug-disease interaction medication error. On an unknown date, the outcome of the sepsis was fatal and the outcome of the diarrhea, immunodeficiency and labeled drug-disease interaction medication error were unknown. The reported cause of death was sepsis. An autopsy was not performed. It was unknown if the reporter considered the sepsis and immunodeficiency to be related to ROTARIX. The reporter considered the diarrhea to be probably related to ROTARIX. Additional details were reported as follows: This case was reported via a medical representative. The patient received ROTARIX at another doctor. The patient came to the reporting healthcare professional (HCP) with diarrhea that required hospitalization. The patient''s stool analysis was positive for Rotavirus. After several tests, the patient was diagnosed with severe immunodeficiency disorder, which was contraindicated to give ROTARIX, which led to labeled drug-disease interaction medication error. The patient had sepsis leading to death with no more details about the case. The reporting HCP stated that, the physician who initially vaccinated the patient with ROTARIX had no idea about the immunodeficiency disorder, as it was diagnosed later on during the hospitalization of the patient. The doctor did not accept to report, or to be asked more questions. He mentioned the information shared in this adverse event form only. No follow up could be conducted on this case at all, as the doctor refused to report and to be contacted for further questions on the case.


VAERS ID: 721219 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-03-03
Submitted: 2017-10-17
   Days after onset:227
Entered: 2017-10-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy skin abnormal, CSF test abnormal, Death, Dysphagia, Headache, Lyssavirus test positive, Paralysis, Polymerase chain reaction positive, Pyrexia, Rabies, Saliva analysis abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Skin tumours of unspecified malignancy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-13
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ERIG
Current Illness: 02/08/2017, Animal bite, class III bite on face by a stray dog confirmed later to have rabies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/07/2017, Biopsy skin, positive for Rabies; 03/07/2017, CSF test, positive for Rabies; 03/07/2017, Polymerase chain reaction, positive for Rabies; 03/07/2017, Saliva analysis, positive for Rabies
CDC Split Type: IN2017GSK159271

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 25-year-old male patient who received RABIPUR. Co-suspect products included RABIPUR, RABIPUR, RABIPUR and immunoglobulin human anti-rabies (ERIG). Concurrent medical conditions included dog bite (class III bite on face by a stray dog confirmed later to have rabies). On an unknown date, the patient received the 4th dose of RABIPUR, the 3rd dose of RABIPUR and the 2nd dose of RABIPUR. On 8th February 2017, the patient received the 1st dose of RABIPUR and ERIG at an unknown dose and frequency. On 3rd March 2017, less than a month after receiving RABIPUR, RABIPUR and RABIPUR and 23 days after receiving RABIPUR, the patient experienced vaccination failure (serious criteria death and GSK medically significant), rabies (serious criteria death and GSK medically significant), fever and headache. On 5th March 2017, the patient experienced swallowing difficult. In March 2017, the patient experienced flaccid paralysis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure, rabies and flaccid paralysis were fatal and the outcome of the fever, headache and swallowing difficult were unknown. The patient died on 13th March 2017. The reported cause of death was rabies and flaccid paralysis. The reporter considered the vaccination failure, rabies, flaccid paralysis, fever, headache and swallowing difficult to be probably related to RABIPUR, RABIPUR, RABIPUR and RABIPUR. Additional information was provided. This case was reported in a literature article and described the vaccination failure in a 25-year-old male who was vaccinated with RABIPUR (GlaxoSmithKline). The patient had sustained a class III bite on face by a stray dog on 08 Feb 2017 while working. The dog had bitten 9 individuals on the same day. It was later killed and confirmed to have rabies. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. 08 Feb 2017, the same day of dog bite, the patient received 1st dose of RABIPUR. The patient had received local wound treatment and ERIG within 12 hours. On unspecified dates, the patient received 3 doses of RABIPUR (administration site and route unspecified; batch number not provided). The patient received a total of 4 doses. The age of vaccinations was not provided. On 03 Mar 2017, after the last dose of vaccination, the patient became symptomatic with fever and headache. On 05 Mar 2017, the patient developed difficulty in swallowing. On 07 Mar 2017, the patient was found to be positive for Rabies by reverse transcriptase polymerase chain reaction (RT PCR) of saliva, cerebrospinal fluid (CSF) and skin biopsy. The patient developed flaccid paralysis. On 13 Mar 2017, the patient died due to his illness. It was unknown if an autopsy was performed. This case has been considered as vaccination failure. This case has been considered serious due to death/vaccination failure. Treatment was unknown. The authors considered the event to be probably due to (a) High viral load (ii) Site and class of bite (iii) Vaccine failure. The authors concluded "In a rabies endemic country like this, all steps as per World Health Organization (WHO) recommended post exposure prophylaxis (PEP) must be followed diligently. Unfortunately this was one of those extremely rare cases where Rabies occurred despite following all guidelines, probably due to: (a) High viral load (ii) Site and class of bite (iii) Vaccine failure".


VAERS ID: 721220 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-17
Entered: 2017-10-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Bronchoalveolar lavage abnormal, Chest X-ray abnormal, Cough, Death, Intensive care, Lymphocyte percentage, Neutrophil percentage, Packed red blood cell transfusion, Pertussis, Pneumonia, Polymerase chain reaction positive, Poor feeding infant, Pulmonary arterial pressure increased, Tachypnoea, Transfusion, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Myelodysplastic syndrome (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on an unspecified dates. At admission white blood cells (WBC)x10E3/mL(percentage lymphocytes/neutrophils): 71.5 (34/59); at peak WBCx10E3/mL(percentage lymphocytes/neutrophils) :71.5 (34/59). B. pertussis was identified in nasopharyngeal aspirate; Bronchoalveolar lavage by real-time polymerase chain reaction (RT-PCR); The patient was diagnosed with pertussis infection. Infective source was unknown. Chest X-ray, Bilateral pneumonia; Pulmonary arterial pressure, 35 mmHg;
CDC Split Type: IT2017GSK158619

Write-up: This case was reported in a literature article and described the occurrence of pertussis in a 95-day-old subject who received DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the subject developed pertussis. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included dry cough with serious criteria of hospitalization, tachypnea with serious criteria hospitalization, poor feeding infant with serious criteria of hospitalization and bilateral pneumonia with serious criteria of hospitalization and GSK medically significant. The subject was treated with clarithromycin, red blood cells and plasma. The outcome of pertussis was fatal. The outcome(s) of the additional event(s) included dry cough (unknown), tachypnea (unknown), poor feeding infant (unknown) and bilateral pneumonia (unknown). The reported cause of death was pertussis. The investigator considered that there was a reasonable possibility that the pertussis, dry cough, tachypnea, poor feeding infant and bilateral pneumonia may have been caused by DTPa vaccine. Relevant Tests: Lab tests performed on an unspecified dates. At admission white blood cells (WBC)x10E3/mL(percentage lymphocytes/neutrophils): 71.5 (34/59); at peak WBCx10E3/mL(percentage lymphocytes/neutrophils): 71.5 (34-59). B. pertussis was identified in nasopharyngeal aspirate; bronchoalveolar lavage by real-time polymerase chain reaction (RT-PCR); The patient was diagnosed with pertussis infection. Infective source was unknown. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Chest X-ray result was Bilateral pneumonia unknown. On an unknown date, Lymphocyte percentage result was see text %. On an unknown date, Neutrophil percentage result was see text %. On an unknown date, Polymerase chain reaction result was see text unknown. On an unknown date, Pulmonary arterial pressure result was 35 mmHg. On an unknown date, White blood cell count result was see text /ml. Additional information was provided. This case was reported in a literature article and described the occurrence of pertussis infection in a 95 day old patient of unspecified gender who was vaccinated with unspecified DTPa vaccine (manufacturer unknown). The patient was part of the retrospective chart review of 6 fatal cases of pertussis in infants recently admitted to tertiary care paediatric centres. In this study, 2 of the patients had a history of prematurity. 2 patients had close household contacts, thus confirming that the primary source of pertussis infection in young infants was family members, especially parents. The patient''s mother not had received either Tdap vaccine within 2 years before or vaccination recommendations during the current pregnancy. The patient was born at 40+2 gestational age. The patient had no underlying condition. No information on patient''s concomitant medication or concurrent condition was provided. On an unspecified date, the patient received 1st dose of unspecified DTPa vaccine (administration site and route unspecified; batch number not provided) and delaying vaccination was recommended for the child with severe prematurity. The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient had dry cough, tachypnea, poor feeding. (The patient had a recent history of aspecific respiratory symptoms, and bronchiolitis was invariably the initial diagnosis.) Paediatrician was the referring modality. The patient presented to the hospital with 5 day history of symptoms and was subsequently admitted. The laboratory revealed: at admission white blood cells (WBC)x10E3/mL(percentage lymphocytes/neutrophils): 71.5 (34/59); at peak WBCx10E3/mL(percentage lymphocytes/neutrophils) : 71.5 (34/59); B. pertussis was identified in nasopharyngeal aspirate; bronchoalveolar lavage by real-time polymerase chain reaction (RT-PCR); Bilateral chest x-ray revealed pneumonia; Pulmonary artery pressure: 35mmHg. The patient was diagnosed with pertussis infection. Infective source was unknown. The patient was administered clarithromycin. Red blood cells and plasma were administered additionally as an intervention in intensive care unit (ICU). On an unspecified date, 6 days after hospital admission and 1 day after ICU admission, the patient died. In this study, death attributed to pertussis was confirmed if: B. pertussis was isolated by culture or B. pertussis deoxyribonucleic acid (DNA) was identified by RT-PCR analysis from a clinical or autopsy specimen; and the clinical presentation was compatible with pertussis manifestation in infancy. The cause of death was pertussis infection. It was not reported if an autopsy was performed. This case has been considered serious due to death/hospitalisation. In this study, all but 1 infants developed severe pulmonary hypertension (PH). The authors did not comment on the relationship between the event of pertussis infection and unspecified DTPa vaccine. The authors stated "Despite strenuous therapeutic measures in ICU, including conventional mechanical ventilation, high frequency oscillatory ventilation, inotropic support and inhaled nitric oxide, our patients died. Notably, all these interventions have been significantly associated with mortality in infants with pertussis admitted to ICU". The authors stated "Pertussis deaths among infants still represent a major health concern. Physicians should reserve great attention to the diagnosis of pertussis when they deal with young children with unexplained respiratory symptoms. Effective strategies will have to include new immunization interventions, improved education about pertussis manifestations in adolescents and adults, greater awareness of the disease in the community, earlier diagnosis through modern laboratory techniques, prompt of antibiotics, and novel therapeutic approaches in the most severe cases".


VAERS ID: 721392 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-09-07
Onset:2017-09-07
   Days after vaccination:0
Submitted: 2017-10-19
   Days after onset:42
Entered: 2017-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 161501 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Pain in extremity
SMQs:, Tendinopathies and ligament 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: GB2017159547

Write-up: This case was reported by a pharmacist via regulatory authority and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 161501, expiry date unknown). On 7th September 2017, the patient received BEXSERO (batch number 161501, expiry date unknown). On 7th September 2017, the patient received BEXSERO (intramuscular). On 7th September 2017, less than a day after receiving BEXSERO, the patient experienced pain in arm (serious criteria death). On an unknown date, the outcome of the pain in arm was fatal. The reported cause of death was pain in arm. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Initial information received from pharmacist via Regulatory authority on 17th October 2017. Having spoken to the patient they informed the pharmacist that initially they had a pain in the arm for approximately 3 weeks after the vaccination.


VAERS ID: 722211 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-11
Onset:2017-10-11
   Days after vaccination:0
Submitted: 2017-10-20
   Days after onset:9
Entered: 2017-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Death, Dyspnoea, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Influenza vaccine, received vaccine past years
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR2017GSK159697

Write-up: This case was reported by a pharmacist via other and described the occurrence of allergic reaction in a 92-year-old female patient who received FLUARIX TETRA. Previously administered products included Flu vaccine (received vaccine past years). On 11th October 2017, the patient received FLUARIX TETRA. On 11th October 2017, less than an hour after receiving FLUARIX TETRA, the patient experienced allergic reaction (serious criteria death), allergic shock (serious criteria death and GSK medically significant) and dyspnea (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction and allergic shock were fatal and the outcome of the dyspnea was unknown. The patient died on 14th October 2017. The reported cause of death was allergic reaction and allergic shock. It was unknown if the reporter considered the allergic reaction, allergic shock and dyspnea to be related to FLUARIX TETRA. Additional details were reported as follows: The patient received FLUARIX TETRA and in an hour, the patient presented dyspnea, transferred to the hospital, where the symptom attributed to an allergic reaction from the vaccine. The patient was hospitalized, presented improvement but on the 3rd day the patient was died. All the above information came from the relatives of the patient via the pharmacist. No more information was available.


VAERS ID: 721865 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Completed suicide, Death, Depression, Headache, Lethargy, Mobility decreased, Photophobia, Tinnitus
SMQs:, Suicide/self-injury (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: PH0095075131710PHL008472

Write-up: This spontaneous report was received from a consumer, via an Internet journal, and refers to a 15 year old female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that prior to the vaccine, she was healthy and active, and rarely missed a day of school. On an unknown date, the patient was vaccinated with the second dose of GARDASIL prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported) by doctor''s recommendation. On an unknown date, after received the second dose of GARDASIL, she became very lethargic and could hardly get out of bed, suffering from horrible headaches. They had to black out the light in her room because of the pain it caused, and she did not leave her bed for days; the family had to hire a teacher to teach her sophomore year of high school since she could not leave her home (unspecified dates). After starting a very strict diet that an alternative health practitioner recommended, the family had some hope that she could recover, but she battled depression, and it was learned from her journals, after her death, that she had a constant buzzing sound in her head. She had tried every anti-depressant drug on the market without success. On an unknown date, the patient committed suicide (completed suicide), cause of death was commits suicide, it was unknown if an autopsy was performed. The outcome of disability, headache, tinnitus, depression, photophobia and lethargy was not reported. The causality between committed suicide, disability, headache, tinnitus, depression, photophobia and lethargy with GARDASIL was not reported. Upon internal review, committed suicide and disability was determined to be medically significant events.; Reported Cause(s) of Death: Commits suicide.


VAERS ID: 721966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Intensive care, Lung abscess, Oropharyngeal pain, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? 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: BRPFIZER INC2017449678

Write-up: This is a spontaneous report received from a contactable physician. An 81-year-old female patient of an unspecified race/ethnicity received PREVENAR 13, via an unspecified route of administration, on 27Jul of an unspecified year, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. In one week the patient presented with sore throat, fever and progressed to a pulmonary abscess and respiratory insufficiency. The patient was admitted to the intensive care unit (ICU) and in 1 week she died. It was unknown if an autopsy was performed. Outcome of events pulmonary abscess and respiratory insufficiency was fatal. Outcome of sore throat was unknown. Sender''s Comments: Based on the information currently available, considering this patient is 81 years old, fatal events "pulmonary abscess and respiratory insufficiency" and event of sore throat are not related to the use of PREVENAR 13 but more likely due to underlying disease. The case will be reevaluated if additional information including concomitant diseases, concomitant medication, lab data etc become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: pulmonary abscess; respiratory insufficiency.


VAERS ID: 722250 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-23
Entered: 2017-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood sodium decreased, Bordetella infection, Bordetella test positive, Death, Intensive care, Neutrophil count increased, Pertussis, Polymerase chain reaction positive, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on an unspecified dates. Severity of disease at admission was evaluated using the Paediatric Risk of Mortality Score III (PRISM III). Laboratory criteria for clinical case included the isolation of Bordetella pertussis from a clinical specimen and/or positive polymerase chain reaction (PCR) assay for B. pertussis deoxyribonucleic acid. The patient had significantly higher white blood cell counts (WBC): 77,800-31,600 and neutrophils: 29,016-12,795 than those who survived and lower minimum values of serum sodium: 125-133. In this study, chest radiographs were abnormal in 23 cases, 2 patients'' radiographs with consolidation also revealed pneumo-thorax, which was managed with chest tube placement. Laboratory confirmation of B. pertussis infection was achieved for 20 patients using PCR, while 3 of them also had a positive culture.
CDC Split Type: GR2017GSK162212

Write-up: This case was reported in a literature article and described the occurrence of death NOS in a infant subject who received DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the subject developed death NOS. Serious criteria included death and GSK medically significant. Additional event(s) included severe - grade 3 pertussis with serious criteria of hospitalization and GSK medically significant and bordetella infection with serious criteria of hospitalization and GSK medically significant. The outcome of death NOS was fatal. The outcome(s) of the additional event(s) included pertussis (unknown) and bordetella infection (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the death NOS to be related to DTPa vaccine. The investigator considered that there was a reasonable possibility that the pertussis and bordetella infection may have been caused by DTPa vaccine. Relevant Tests: Lab tests performed on an unspecified dates. Severity of disease at admission was evaluated using the Paediatric Risk of Mortality Score III (PRISM III). Laboratory criteria for clinical case included the isolation of Bordetella pertussis from a clinical specimen and/or positive polymerase chain reaction (PCR) assay for B. pertussis deoxyribonucleic acid. The patient had significantly higher white blood cell counts (WBC): 77,800-31,600 and neutrophils: 29,016-12,795 than those who survived and lower minimum values of serum sodium: 125-133. In this study, chest radiographs were abnormal in 23 cases. 2 patients'' radiographs with consolidation also revealed pneumo-thorax, which was managed with chest tube placement. Laboratory confirmation of B. pertussis infection was achieved for 20 patients using PCR, while 3 of them also had a positive culture. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Blood sodium result was see text. On an unknown date, Bordetella test result was see text. On an unknown date, Neutrophil count was see text. On an unknown date, White blood cell count result was see text. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a patient aged between 48 and 195 days of unspecified gender who was vaccinated with unspecified DTaP vaccine (manufacturer unknown). The patient was part of the study that retrospectively reviewed all cases admitted to paediatric intensive care units (PICUs) over an 11-year period in an attempt to describe the clinical features of severe pertussis infection and to identify factors associated with January 2003 and December 2013 was performed. The hospital laboratories also provided lists of all patients with the laboratory diagnosis of pertussis, and these were cross-checked with each PICU''s database. [In this study, out of 6 deceased cases, 4 were female]. The patient''s mothers had not been immunized during pregnancy or post-partum. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received at least 1 dose of unspecified DTaP vaccine (administration site and route unspecified; dosages unknown; batch number not provided). [In this study, primary infant vaccination against pertussis starts at 2 months of age and consists of three primary doses of diphtheria, tetanus and acellular pertussis combination vaccines given at 2-month intervals during the first year of life, followed by a booster vaccination during the first semester of the second year and another at 4-6 years of age. Thus, infants immunized with 1, 2, 3 or 4 doses of vaccine until the age of 2, 4, 6 and 18 months, respectively, were considered appropriately immunized] The age of vaccination was not provided. On an unspecified date between 1 January 2003 and 31 December 2013, an unknown period after the vaccination, the patient developed symptoms of pertussis infection. Subsequently, the patient was hospitalised. In this study, cough was the most prominent symptom, being present in 27 of 31 patients. Severity of disease at admission was evaluated using the PRISM III A median of 4 (1, 7) days was reported from symptoms onset to hospital admission. A clinical case was defined as a cough illness lasting at least 2 weeks with one of the following: paroxysms of coughing, inspiratory ''whoop'' or post-tussive vomiting and without other apparent cause. Laboratory criteria included the isolation of B. pertussis from a clinical specimen and/or positive PCR assay for B. pertussis DNA. Cases were classified as confirmed with acute cough illness of any duration and positive culture for B. pertussis, clinical findings that meet the clinical case definition and PCR confirmation or findings that meet the clinical case definition is met, but there is no laboratory confirmation or connection to a confirmed case. Cases meeting the clinical case definition that were serologically or by direct fluorescent antibody testing positive but by culture or PCR were negative or not performed were reported as probable cases. Household members were regarded as having a confirmed infection with B. pertussis if they met the criteria above for a case or if they had an illness compatible with pertussis and were epidemiologically linked to another confirmed case in the family. As PCR was only available in 2 of the participating PICUs from March 2009, for the other PICUs and for the years before 2009, diagnosis was based only on culture, serology and clinical findings. On admission, only 7 children satisfied the case definition, primarily because of short cough duration. The patient was diagnosed with pertussis infection]. On an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, 6 patients died because of respiratory failure or multi-organ system failure. The patients who died had significantly higher WBC: 77,800-31,600 and neutrophils: 29,016-12,795 than those who survived and lower minimum values of serum sodium: 125-133. They also had a longer duration of hospitalisation prior to their paediatric intensive care unit admission (6-1days). None of the presenting symptoms was associated with worse outcome]. In this study, chest radiographs were abnormal in 23 cases. 2 patients'' radiographs with consolidation also revealed pneumo-thorax, which was managed with chest tube replacement. Laboratory confirmation of B. pertussis infection was achieved for 20 patients using PCR, while 3 of them also had a positive culture. A total of 11 cases were classified as probable; 7 of them had positive serological tests, and the remaining 4 only met the clinical case definition. This case has been considered serious due to death/hospitalisation. Treatment was unknown. In this study, mechanical ventilation was initiated in 13 patients. Patients with radiographs suggestive of consolidation were more often treated with antimicrobials than patients with normal radiographs or with interstitial infiltrates. The authors did not comment on the relationship between the event pertussis infection and unspecified DTaP vaccine. The authors concluded "Young infants are at risk of severe pertussis. Despite advances in life support and treatment of organ failure in childhood critical illness, pertussis still has substantial mortality. Active disease surveillance and elaborate assessment of risk factors could help identify the infants at the highest risk of an adverse outcome. Prospective evaluation will disclose the benefit of novel treatment strategies". This is 1 of the 3 valid cases reported in this article.


VAERS ID: 722743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131710GBR011325

Write-up: Information has been received from a person via an online article referring to a female patient of unknown age (reported as "a young girl"). Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with unidentified Human Papillomavirus (HPV) vaccine (manufacture unknown) for prophylaxis. On an unknown date in 2012, after her second dose of the vaccine, the patient died. It was unknown if autopsy was done. Earlier 2017 (reported as this year), a high court established a causal link between the HPV vaccine (manufacture unknown) and the patient''s death. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Sender''s Comments: GB-009507513-1710USA011357.


VAERS ID: 723277 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-03-27
Onset:2017-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-10-27
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 / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Central nervous system infection, Clonic convulsion, Death, Electroencephalogram abnormal, General physical health deterioration, Hypotension, Oxygen saturation decreased, Partial seizures
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-31
   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: Prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic arch stenosis (for which, the patient taken to theater for arch repair on 13-FEB-2017); Aortic stenosis; Blalock-Taussig shunt; Cardiac insufficiency (The patient was failed to wean from cardiopulmonary bypass); Cardiac operation NOS; Chylothorax; Endocardial fibroelastosis; Mitral regurgitation; Norwood procedure; Sepsis; Thoracic duct ligation
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131710AUS009400

Write-up: Information was obtained on a request by the Company from the agency (HA # 406125) via a Public Case Detail regarding a 9 weeks old male patient. (On 04-MAR-2017, when the patient was two months old). The patient historical conditions include critical aortic stenosis with severe endocardial fibroelastosis of left ventricle and small mitral valve. The patient had Norwood operation on 27-JAN-2017. It was reported that this was complicated with blocked Blalock?Taussig (BT) shunt on the first post operation (reported as postop) night and he was put on extracorporeal membrane oxygenation (ECMO) from 27-JAN-2017 to 30-JAN-2017. Later on, he was found to have narrowing of aortic arch, so he was taken to theater for arch repair on 13-FEB-2017. The patient failed to wean from cardiopulmonary bypass due to poor cardiac function. The patient was put on extracorporeal membrane oxygenation (ECMO) and returned to pediatric intensive care unit (PICU). On 17-FEB-2017, sano operation was done and patient was came off bypass successfully. However, the patient developed chylothorax which had been refractory to treatment. Thoracic duct ligation was done on 02-MAR-2017. Chyle output was decreased but was still draining significant amount. The patient developed multiple episodes of sepsis and was very slow to wean from ventilator support. The patient''s concurrent conditions and concomitant medications were not reported. On 27-MAR-2017, the patient was vaccinated with first dose of ROTATEQ, 1 unspecified dose, 1 time (route defaulted to oral; batch/lot # was not reported) for prophylaxis. Other suspect therapies included INFANRIX HEXA (dose 1; batch/lot # was not reported) and PREVNAR 13 (dose1; batch/lot # was not reported) administered on the same day for prophylaxis (1 unspecified dose, 1 time; route and anatomical location unknown). On 28-MAR-2017, one day after vaccinations, the patient developed focal clonic seizure of left upper limb. On an unknown date in March 2017, heat ultrasound showed thickened meninges and abnormality in left caudate nucleus and electroencephalogram (EEG) showed multifocal epileptiform appearance. The patient was treated with antiepileptic, antibiotics and antiviral for central nervous system (CNS) infection. On 31-MAR-2017, the patient became rapidly hypotensive and desaturated. He required large doses of inotropes and vasopressors to maintain blood pressure. He was put on high frequency oscillatory ventilator. The patient continued to deteriorate. After discussion with the patient''s family, the decision was made to stop treatment. The patient was extubated at 19:15 hours and passed away shortly afterwards. The agency considered the event, seizure to be possibly related to the suspect therapies. The event seizure was considered to be serious due to death. Upon internal review, the event seizure was determined to be medically significant. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 723772 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza, Influenza virus test positive, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164981

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medially significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723962 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164985

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723969 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-03
Onset:2016-05-08
   Days after vaccination:5
Submitted: 2017-10-30
   Days after onset:540
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B209BA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Febrile infection-related epilepsy syndrome
SMQs:, Convulsions (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: DE2017GSK164113

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of febrile infection-related epilepsy syndrome in a 8-year-old male patient who received BOOSTRIX (batch number AC37B209BA, expiry date unknown). On 3rd May 2016, the patient received BOOSTRIX (intramuscular). On 8th May 2016, 5 days after receiving BOOSTRIX, the patient experienced febrile infection-related epilepsy syndrome (serious criteria death). On 22nd May 2016, the outcome of the febrile infection-related epilepsy syndrome was fatal. The reported cause of death was febrile infection-related epilepsy syndrome. It was unknown if the reporter considered the febrile infection-related epilepsy syndrome to be related to BOOSTRIX. Additional details were reported as follows: This case was received via a regulatory authority including barely legible source documentation. Duration of febrile infection-related epilepsy syndrome was reported as from 8th May 2016 until 22nd May 2017. The patient was died on an unspecified date. It was not reported whether stop date of the event was also the death date. Follow up has been requested by the regulatory authority.


VAERS ID: 723970 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza, Influenza virus test positive, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164983

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to ALPHARIX TETRA. Additional details were provided as follows: Five physician reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723979 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164995

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to ALPHARIX TETRA. Additional details were provided as follows: Five physicians reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723996 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-10-30
Entered: 2017-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, 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: On an unknown date, the smear test showed positive results for flu, but it was unspecified for which patient from the linked cases.
CDC Split Type: LU2017GSK164989

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received ALPHARIX TETRA. On an unknown date, the patient received ALPHARIX TETRA. On an unknown date, unknown after receiving ALPHARIX TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to ALPHARIX TETRA. Additional details were provided as follows: Five physicians reported 22 cases flu. One of the physicians reported in a rest home for (very) old patients. The age at vaccination was not reported. In 2016, the patient received ALPHARIX TETRA. On an unknown date, at the beginning of the epidemic, the physician took 3 to 4 smears which were all positive for flu, but it was unspecified for which patient from the linked cases. The physician did not remember the strain and did not continue to take smears in other patients. This case was considered to be suspected vaccination failure, as the details regarding time to onset and exact laboratory test confirmation for influenza were unknown. The physician refused to be contacted for further follow-up. As no further information could be obtained, the case was closed. This is one out of 22 cases reported by the same reporter.


VAERS ID: 723939 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Gram stain positive, Malaise, Pneumococcal infection, Post procedural infection, Streptococcus test positive, Vaccination complication
SMQs:, 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: BICILLIN G GRANULES
Current Illness: Chromosomal deletion; Fallot tetralogy; Idiopathic thrombocytopenic purpura; Infection prophylaxis
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac operation; Splenectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131710JPN003161J

Write-up: It was reported in an abstract. Initial information has been received from a physician concerning a 13-year-old male patient with 22q11.2 deletion syndrome, Fallot''s tetralogy (cardiac complication), idiopathic thrombocytopenic purpura (at the age of 10 years and 2 months) and history of surgeries for Fallot''s tetralogy (at the age of 2 years and of 12 years and 6 months) and laparoscopic splenectomy (at the age of 10 years and 8 months) who on an unspecified date was vaccinated with PNEUMOVAX NP injection for prophylaxis (dose not reported). Concomitant medication included benzylpenicillin benzathine hydrate (BICILLIN G). On an unspecified date, the patient was diagnosed with 22q11.2 deletion syndrome, which had been followed up. On an unspecified date (at the age of 11 years and 1 month), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent). On an unspecified date (at the age of 13 years and 2 months), the patient noticed malaise from the morning and died at night. Pathological autopsy revealed aggregates of gram-positive cocci in the pulmonary veins and systemic vessels but no inflammatory foci in the lungs and other organs. Pneumococci were detected by culture of the heart blood and the patient was considered to have developed overwhelming postsplenectomy infection (OPSI). The result of serotyping of the pneumococci at the external laboratory was non-typable and thus serotyping analysis was performed at the reporting institution. Multilocus sequence typing using 7 housekeeping genes showed a genetic serotype of 10A or 10C. Furthermore, analysis of wzg gene in the capslar polysaccharide region confirmed a genetic serotype of 10A (sequence type 1263). Electron microscopic analysis of isolates revealed thinner capsules as compared to those of typical isolates. Reporter''s comment: Not provided The reporting physician considered that overwhelming postsplenectomy infection due to vaccine-type pneumococci was serious due to death. Upon internal review, overwhelming postsplenectomy infection due to vaccine-type pneumococci (pneumococcal infection) was considered to be serious due to other important medical event. The reporting physician felt that overwhelming postsplenectomy infection due to vaccine-type pneumococci was related to pneumococcal vaccine. Autopsy-determined Cause(s) of Death: Post procedural infection; Pneumococcal infection.


VAERS ID: 723982 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-09-21
Onset:2017-09-29
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2017-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M7412 / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R56673 / 1 RL / UN

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Coma, Death, Hypotonia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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: 2017-10-08
   Days after onset: 9
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: NOPFIZERINC2017464195

Write-up: This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number NO-NOMAADVRE-FHI-2017-24772. A 3-month-old male patient received the first dose of PREVENAR 13 (Lot# R56673), parenteral in the right thigh, on 21Sep2017, at 0.5 ml single, for immunisation and the first dose of HEXYON (Lot# M7412), parenteral in left thigh, on 21Sep2017, at 0.5 ml single, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 29Sep2017. The patient was found lifeless in bed during the night. Cardiopulmonary resuscitation (CPR) was carried out for 40 minutes. Patient was comatose upon hospital admission, and never regained consciousness. Extensive brain damage. The patient died on 08Oct2017. It was unknown if an autopsy was performed. Although reporting physician was of the opinion that a causal relationship between the event and immunisation was unlikely, the incident was reported as an adverse event following immunisation. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 724012 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-08-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Yellow fever
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: Medical History/Concurrent Conditions: Malnutrition; Tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CDSA2017SA207827

Write-up: Initial unsolicited report received from the literature on 24-Oct-2017. This case is linked: 2017SA207838 (same literature). Abstract: Background: In 2016, there were a yellow fever (YF) outbreak with several YF confirmed and death cases reported. Due to shortage in vaccine supply, fractional dosing was proposed in preventive vaccination campaign in August 2016 where 0.1 ml were of Yellow Fever Vaccine was administered in a population of 12 million inhabitants. Pregnant women and children under 2-year-old received 0.5 ml. A pharmacovigilance system was organized to track adverse events following immunization (AEFI). This case involves a child patient (age not reported), who was vaccinated with 0.1 ml dose of YELLOW FEVER VACCINE (Batch number, expiry date, dose, route were not reported) on an unknown date of Aug-2016. Patient''s medical history included malnutrition and tuberculosis. Concomitant medications were not reported. On an unknown date, following the administration, patient had suspected yellow fever and died on an unknown date. Patient''s other laboratory test and corrective treatment was not reported. It was not reported whether autopsy was performed or not. Documents held by sender: none. Sender''s Comments: This death case concerns an unknown age and gender child who reportedly experienced yellow fever (diagnosis not confirmed) after receiving YELLOW FEVER VACCINE (from unknown manufacturer) in the context of mass vaccination during a YF outbreak. Time to onset following vaccination is not reported. To be noted that both malnutrition and tuberculosis reported as medical history may imply immunosuppression and may have been considered as contraindications to the yellow fever vaccine administration, however this is to be reviewed in a context of an ongoing outbreak. Overall, few details were provided, and the role of the vaccine cannot be assessed in this case. Reported Cause(s) of Death: yellow fever.


VAERS ID: 725564 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-08
Entered: 2017-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Discomfort, Rabies, Respiratory disorder, Salivary hypersecretion
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies immunoglobulin
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BD2017GSK171117

Write-up: This case was reported in a literature article and described the occurrence of rabies in a 85-year-old male patient who received Rabies Vaccine. Co-suspect products included Rabies Immunoglobulin. Concurrent medical conditions included animal bite (multiple deep seated bites on both thigh and leg). On an unknown date, 4 days after receiving Rabies Vaccine and Tetanus vaccine (2), the subject developed rabies. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included discomfort with serious criteria of hospitalization, salivation with serious criteria of hospitalization and respiratory disorder with serious criteria of hospitalization. The outcome of rabies was fatal. The outcome(s) of the additional event(s) included discomfort (unknown), salivation (unknown) and respiratory disorder (unknown). The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the rabies, discomfort, salivation and respiratory disorder may have been caused by Rabies Vaccine and Tetanus vaccine (2). Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a 85-year-old male who was vaccinated with unspecified anti rabies (ARV) and unspecified tetanus vaccine (manufacturer unknown for both). The patient was part of a study that aimed to observe the present situation and management of animal bite cases specially rabies patient. The study described 6 cases of rabies patient rushed to one infectious diseases hospital during the period Jun 2012 to December 2013. The patient was admitted to the Hospital with history of multiple deep seated bites on both thigh and leg. No information on patient''s medical or family history or concomitant medication was provided. On an unspecified date, the patient received unspecified ARV (intradermal) (administration site unspecified; dosages unknown; batch number not provided) and unspecified tetanus vaccine (administration site and route unspecified; dosages unknown; batch number not provided) on admission. The age of vaccination was not provided. Patient was also given unspecified antibiotic prophylaxis. Rabies Immunoglobulin (RIG) was given on next day due to unavailability of the drug. On an unspecified date between June 2012 and December 2013, 4 days after vaccination (on 5th day of admission), the patient felt discomfort, salivation followed by respiratory difficulties and died. The patient was diagnosed with rabies infection. It was unknown if an autopsy was performed. [In this study, of the total bitten patients; 30% were WHO-Category III bite. 5 patients developed rabies during the course of active immunization; two even after inoculation of RIG]. Treatment was unknown. The author did not comment on the event of rabies infection and unspecified ARV and tetanus vaccine. The authors concluded "Here all patients died in their house. We have no facilities to keep them into hospital. So, complete evaluations and reporting of the patients were not possible. It is essential to develop a setup and standard operative procedure for human rabies management". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 725573 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-08
Entered: 2017-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rabies immunoglobulin
Current Illness: Animal bite, lacerated wound around the face
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BD2017GSK171204

Write-up: This case was reported in a literature article and described the occurrence of rabies in a 18-month-old subject who received Rabies Vaccine. Co-suspect products included Rabies Immunoglobulin. Concurrent medical conditions included dog bite (lacerated wound around the face). On an unknown known date, 2 days after receiving Rabies Vaccine, the subject developed rabies. Serious criteria included death, hospitalization and GSK medically significant. The outcome of the rabies was fatal. The reported cause of death was rabies. The investigator considered that there was a reasonable possibility that the rabies may have been caused by Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a 18 month-old baby of unspecified gender who was vaccinated with unspecified anti rabies vaccine (ARV) (manufacturer unknown). The patient was part of a study that aimed to observe the present situation and management of animal bite cases specially rabies patient. The study described 6 cases of rabies patient rushed to one infectious diseases hospital during the period Jun 2012 to December 2013. The patient was admitted to the Hospital with lacerated would around the face due to dog bite. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified ARV (intradermal) on admission (administration site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. Patient was also administered rabies Immunoglobulin (RIG). On an unspecified date between June 2012 and December 2013, 2 days after vaccination (on 3rd day of admission), the patient developed rabies infection and died. It was unknown if an autopsy was performed. [In this study, of the total bitten patients: 30% were WHO-Category III bite. 5 patients developed rabies during the course of active immunization; two even after inoculation of RIG]. Treatment was unknown. The author did not comment on the event of rabies infection and unspecified ARV vaccine. The authors concluded "Here all patients died in their house. We have no facilities to keep them into hospital. So, complete evaluations and reporting of the patients were not possible. It is essential to develop a setup and standard operative procedure for human rabies management". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 725832 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-09
Entered: 2017-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Measles
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? 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: GW2017GSK171944

Write-up: This case was reported in a literature article and described the occurrence of measles in a child female subject who received DTP vaccine. On an unknown date, less than year after receiving DTP vaccine, the subject developed measles. Serious criteria included death, hospitalization and GSK medically significant. The outcome of measles was fatal. The reported cause of death was measles. The investigator considered that there was a reasonable possibility that the measles may have been caused by DTP vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of measles in a female child aged between 6 weeks to 8 months who was vaccinated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (manufacturer unknown). The patient was part of observational study who used data from Health Project''s continuous registration of all admissions to the paediatric ward at the Hospital, and investigated whether DTP was associated with higher female than male in-hospital mortality (female/male case fatality ratio (F/M CFR)) and whether the CFR comparing DTP-vaccinated and DTP-unvaccinated children differed by sex. No information on patient''s family history, medical history, concomitant medication or concurrent condition was provided. On an unspecified date, the patient received the 1 dose of unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (administration site and route unspecified; batch number not provided). The age of vaccination was not provided. On an unspecified date from May 2001 to January 2008, an unknown period after the vaccination, the patient developed measles. The patient was hospitalised and subsequently died of measles. (During admission, 16% (200/1250) of the girls and 13% (220/1694) of the boys who had received DTP died). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors considered the event of measles associated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine. The authors concluded "DTP was associated with higher female than male in-hospital motility in children aged 6 weeks to 8 months. The difference in female/male CFR was particularly pronounced after DTP3. Vaccination programmes should develop strategies, which might reduce the negative effect of DTP for girls and it should be considered to use performance indicators, which are positively associated with survival." This is 1 of 4 valid cases reported in the same literature article.


VAERS ID: 725833 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-09
Entered: 2017-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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? 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: GW2017GSK171920

Write-up: This case was reported in a literature article and described the occurrence of septicemia in a child female subject who received DTP vaccine. Concomitant products included DTP (A or W not known). On an unknown date, less than a year after receiving DTP vaccine, the subject developed septicemia. Serious criteria included death, hospitalization and GSK medically significant. The outcome of septicemia was fatal. The reported cause of death was septicaemia. The investigator considered that there was a reasonable possibility that the septicemia may have been caused by DTP vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of septicaemia in a female child aged between 6 weeks to 8 months who was vaccinated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (manufacturer unknown). The patient was part of observational study who used data from Health Project''s continuous registration of all admissions to the paediatric ward at the Hospital, and investigated whether DTP was associated with higher female than male in-hospital mortality (female/male case fatality ratio (F/M CFR)) and whether the CFR comparing DTP-vaccinated and DTP-unvaccinated children differed by sex. No information on patient''s family history, medical history, concomitant medication or concurrent condition was provided. On unspecified dates, the patient received 2 doses of unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (administration site and route unspecified: batch number not provided). The age at vaccination was not provided. On an unspecified date from May 2001 to January 2008, an unknown period after the vaccination, the patient developed septicaemia. The patient was hospitalised and subsequently died of septicaemia. (During admission, 16% (200/1250) of the girls and 13% (220/1694) of the boys who had received DTP died). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors considered the event of septicemia associated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine. The authors concluded "DTP was associated with higher female than male in-hospital mortality in children aged 6 weeks to 8 months. The difference in female/male CFR was particularly pronounced after DTP3. Vaccination programmes should develop strategies, which might reduce the negative effect of DTP for girls and it should be considered to use performance indicators, which are positively associated with survival". This is 1 of 4 valid cases reported in the same literature article.


VAERS ID: 725849 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-09
Entered: 2017-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Measles
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? 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: GW2017GSK171946

Write-up: This case was reported in a literature article and described the occurrence of measles in a child male subject who received DTP vaccine. Concomitant products included DTP (A or W not known). On an unknown date, less than a year after receiving DTP vaccine, the subject developed measles. Serious criteria included death, hospitalization and GSK medically significant. The outcome of measles was fatal. The reported cause of death was measles. The investigator considered that there was a reasonable possibility that the measles may have been caused by DTP vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of measles in a male child aged between 6 weeks to 8 months who was vaccinated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (manufacturer unknown). The patient was part of observational study who used data from Health Project''s continuous registration of all admissions to the ward at the Hospital, and investigated whether DTP was associated with higher female than male in-hospital mortality (female/male case fatality ratio (F/M CFR)) and whether the CFR comparing DTP-vaccinated and DTP-unvaccinated children differed by sex. No information on patient''s family history, medical history, concomitant medication or concurrent condition was provided. On unspecified dates, the patient received the 2 doses of unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (administration site and route unspecified; batch number not provided). The age of vaccination was not provided. On an unspecified date from May 2001 to January 2008, an unknown period after the vaccination, the patient developed measles. The patient was hospitalised and subsequently died of measles. (During admission, 16% (200/1250) of the girls and 13% (220/1694) of the boys who had received DTP died). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors considered the event of measles associated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine. The authors concluded "DTP was associated with higher female than male in-hospital mortality in children aged 6 weeks to 8 months. The difference in female/male CFR was particularly pronounced after DTP3. Vaccination programmes should develop strategies, which might reduce the negative effect of DTP for girls and it should be considered to use performance indicators, which are positively associated with survival." This is 1 of 4 valid cases reported in the same literature article.


VAERS ID: 725850 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-09
Entered: 2017-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Measles
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? 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: GW2017GSK171945

Write-up: This case was reported in a literature article and described the occurrence of measles in a child female subject who received DTP vaccine. Concomitant products included DTP (A or W not known). On an unknown date, less than a year after receiving DTP vaccine, the subject developed measles. Serious criteria included death, hospitalization and GSK medically significant. The outcome of measles was fatal. The reported cause of death was measles. The investigator considered that there was a reasonable possibility that the measles may have been caused by DTP vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of measles in a female child aged between 6 weeks to 8 months who was vaccinated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (manufacturer unknown). The patient was part of observational study who used data from Health Project''s continuous registration of all admissions to the ward at the Hospital, and investigated whether DTP was associated with higher female than male in-hospital mortality (female/male case fatality ratio (F/M CFR)) and whether the CFR comparing DTP-vaccinated and DTP-unvaccinated children differed by sex. No information on patient''s family history, medical history, concomitant medication or concurrent condition was provided. On unspecified dates, the patient received the 2 doses of unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine (administration site and route unspecified; batch number not provided). The age of vaccination was not provided. On an unspecified date from May 2001 to January 2008, an unknown period after the vaccination, the patient developed measles. The patient was hospitalised and subsequently died of measles. (During admission, 16% (200/1250) of the girls and 13% (220/1694) of the boys who had received DTP died). It was unknown if an autopsy was performed. This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors considered the event of measles associated with unspecified diphtheria, tetanus and pertussis (acellular or whole cell) vaccine. The authors concluded "DTP was associated with higher female than male in-hospital mortality in children aged 6 weeks to 8 months. The difference in female/male CFR was particularly pronounced after DTP3. Vaccination programmes should develop strategies, which might reduce the negative effect of DTP for girls and it should be considered to use performance indicators, which are positively associated with survival." This is 1 of 4 valid cases reported in the same literature article.


VAERS ID: 726306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-06
Onset:2017-11-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M047755 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-06
   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:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131711CHN002992

Write-up: This spontaneous report was received from a physician regarding a 49 year old female patient. The patient''s medical history, concurrent condition and concomitant therapy were not reported. On 06-NOV-2017, the patient was vaccinated with PNEUMOVAX (strength, frequency, route of administration were not reported) lot# M047755, expiry date: 26-MAY-2018. In the morning on 06-NOV-2017, the patient was also inoculated with influenza virus vaccine (strength, frequency, route of administration, lot#, expiry date were not reported) for prophylaxis. On 06-NOV-2017, the patient died. It was unknown whether autopsy was performed.


VAERS ID: 726667 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-14
Entered: 2017-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Road traffic accident
SMQs:, Accidents and injuries (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: AU2017GSK174434

Write-up: This case was reported in a literature article and described the occurrence of motor vehicle accident in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed motor vehicle accident. Serious criteria included death and GSK medically significant. The outcome of motor vehicle accident was fatal. The reported cause of death was motor vehicle accident. The investigator considered the motor vehicle accident to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of vehicle accident in an elder of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was reported to immunisation surveillance systems. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. It was reported that the vaccination was uneventful. On an unspecified date between July 2007 and June 2016, an unknown period after the vaccination, the patient had vehicle accident. Subsequently, the patient died. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors commented "Two deaths were reported, unlikely to have been vaccine-related. As a result of high annual influenza vaccination coverage in this population, coupled with age-related baseline mortality rates, deaths coincident with vaccination are likely to be more frequent in older people; robust investigation and causality assessment are therefore critical". This is 1 of the 2 valid case reported in the same literature article.


VAERS ID: 726770 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-14
Entered: 2017-11-15
   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: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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: AU2017GSK174379

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in an elder of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was reported to Immunization surveillance systems. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, patient received unspecified influenza vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between July 2007 and June 2016, an unknown period after the vaccination, the patient had post-vaccination diagnosis of acute disseminated encephalomyelitis. Subsequently, the patient died. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors commented "Two deaths were reported, unlikely to have been vaccine-related. As a result of high annual influenza vaccination coverage in this population, coupled with age-related baseline mortality rates, deaths coincident with vaccination are likely to be more frequent in older people; robust investigation and causality assessment are therefore critical". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 726887 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-15
Entered: 2017-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 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: GB2017GSK173725

Write-up: This case was reported by a non-health professional via local affiliate and described the occurrence of death in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 274 days after receiving BEXSERO, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to BEXSERO. Additional details were reported as follows: On 10th November 2017, a GlaxoSmithKline (GSK) reported that the patient who was vaccinated with BEXSERO died 9 months after their booster dose. No further information was available at the time of reporting.


VAERS ID: 727066 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-15
Entered: 2017-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bronchopulmonary aspergillosis, Continuous haemodiafiltration, Cord blood transplant therapy, Cytomegalovirus infection, Death, Engraft failure, Haematochezia, Histiocytosis haematophagic, Hyperferritinaemia, Immunodeficiency, Immunoglobulins decreased, Intussusception, Mechanical ventilation, Pancytopenia, Plasmapheresis, Vomiting
SMQs:, Acute renal failure (narrow), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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: Combined immunodeficiency; Gene mutation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2017JPN173823

Write-up: This case was reported in a literature article and described the occurrence of haemophagocytic lymphohistiocytosis in a 2-month-old male subject who received Rotavirus vaccine. Concurrent medical conditions included severe combined immunodeficiency syndrome and gene mutation. On an unknown date, the subject received Rotavirus vaccine (oral). On an unknown date, unknown after receiving Rotavirus vaccine, the subject experienced haemophagocytic lymphohistiocytosis (serious criteria death and GSK medically significant), engraft failure (serious criteria death and GSK medically significant), invagination of intestine (serious criteria GSK medically significant), bloody stool (serious criteria GSK medically significant), pancytopenia (serious criteria GSK medically significant), cytomegalovirus infection (serious criteria GSK medically significant), pulmonary aspergillosis (serious criteria GSK medically significant), vomiting, immunoglobulins decreased and hyperferritinaemia. The subject was treated with immunoglobulin human normal (Gamma-Globulin), ganciclovir, Foscarnet Sodium Hydrate), dexamethasone, ciclosporin and voriconazole. On an unknown date, the outcome of the haemophagocytic lymphohistiocytosis and engraft failure were fatal and the outcome of the invagination of intestine, bloody stool, pancytopenia, pulmonary aspergillosis, vomiting, immunoglobulins decreased and hyperferritinaemia were unknown and the outcome of the cytomegalovirus infection was recovering/resolving. The reported cause of death was haemophagocytic lymphohistiocytosis and engraft failure. It was unknown if the reporter considered the haemophagocytic lymphohistiocytosis, engraft failure, invagination of intestine, bloody stool, pancytopenia, cytomegalovirus infection, pulmonary aspergillosis, vomiting, immunoglobulins decreased and hyperferritinaemia to be related to Rotavirus vaccine. After the two-month-old male subject received ROTARIX, bloody stool and vomiting developed. He consulted the previous physician and was received treatment for intussusception; however, pancytopenia, low level of immunoglobulin and hyperferritinaemia were noted and immunodeficiency and haemophagocytic lymphohistiocytosis (HLH) were suspected, he was referred to the reporting hospital. From the examination findings, cytomegalovirus (CMV) infection and Artemis deficiency complicated with HLH were diagnosed and plasma exchange (PE) and continuous hemodiafiltration (CHFD) were performed under mechanical ventilation. Gamma-globulin (gamma-glb), ganciclovir (GCV), forcarnet (FCN), dexmedetomidine (DEX), ciclosporin (CSA) were administered. The condition of CMV infection and HLH improved but pulmonary aspergillosis was complicated. While the infectious disease was controlled with voriconazole (VRCZ), Unrelated cord blood transplantation (uCBT) was performed following reduced-intensity conditioning. After the transplantation, relapse of HLH and engraft failure occurred, and the subject died 33 days after the transplantation. Because of severe combined immunodeficiency (SCID) complicated with infectious disease and HLH, it was difficult to save his life. In this case, the subject had received live vaccine in the early postnatal period and early diagnosis of SCID by mass screening was desired.


VAERS ID: 727153 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-15
Entered: 2017-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Diarrhoea, Drug administered to patient of inappropriate age, Failure to thrive, Off label use
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (broad), Noninfectious diarrhoea (narrow), 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: Combined immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2017GSK173637

Write-up: This case was reported in a literature article and described the occurrence of death NOS in a 21-month-old patient who received Rotavirus vaccine. Concurrent medical conditions included severe combined immunodeficiency syndrome. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, unknown after receiving Rotavirus vaccine, the patient experienced death NOS (serious criteria death and GSK medically significant), failure to thrive (serious criteria GSK medically significant), diarrhea, contraindicated drug administered and off label use. On an unknown date, the outcome of the death NOS was fatal and the outcome of the failure to thrive, diarrhea, contraindicated drug administered and off label use were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death NOS, failure to thrive and diarrhea to be related to Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of severe diarrhoea and failure to thrive in a 21 month old child of unspecified gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown). The patient had current condition of severe combined immunodeficiency (SCID). No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified rotavirus vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient experienced failure to thrive and severe diarrhoea. Subsequently, on an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors did not comment on the events of severe diarrhoea, failure to thrive and unspecified rotavirus vaccine. This is 1 of the 4 valid cases reported in the same literature article.


VAERS ID: 727133 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA224959

Write-up: Initial unsolicited social media report received from a consumer on 31-Oct-2017. This case involves a four elderly adults patients (gender not reported), who were vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose, dose in series and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, following the vaccination patients died. It was reported that 4 seniors die with the flu at our local retirement home shortly after getting their free flu shot last year. Laboratory investigation and corrective treatment was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: This is a poorly documented death case with Information 4 elderly adults die with the flu at local retirement home after getting their free flu shot. Time to onset is not reported. The cause of death is unknown. No information is provided on conditions at the time of death, patient''s medical history, previous vaccination history, time to onset, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: flu like syndrome.


VAERS ID: 727134 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA224962

Write-up: Initial unsolicited social media report received from a consumer on 02 Nov 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unknown date, after having a flu shot, patient became severely ill and patient died at the age of 87 following severe reactions. Laboratory investigation and corrective treatment were not reported. The outcome of the event severely ill, severe reactions was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: In this case, patient was severely ill and died following severe reactions after vaccination with Influenza vaccine (MFR UNK). This is a poorly documented case. Further information on time to onset, vaccine manufacturer, medical history, immune status at the time of vaccination, previous vaccination and tolerance and confirmed diagnosis for the patient''s events and cause of his death are needed to fully assess this case. Based upon available information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: who had a flu shot died at age 87 following severe reactions.


VAERS ID: 727760 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-16
Onset:2017-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR N1B22 / 4 - / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16J01A / 4 - / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastroenteritis norovirus (visit at hospital on 04Nov2017)
Allergies:
Diagnostic Lab Data: Test Date: 20171116; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.4, Test Result Unit: Centigrade
CDC Split Type: JPPFIZERINC2017499469

Write-up: This is a spontaneous report from a contactable physician received from the Agency. The regulatory authority report number is v17100674. A 13-month-old male patient of unspecified race/ethnicity received the fourth single dose of PREVENAR 13 (solution for injection in pre-filled syringe, lot number 16J01A, expiration date 31Aug2019) and the fourth single dose of ACT-HIB (lot number N1B22) as injection, both at 11:10 am on 16Nov2017 for immunisation. The patient''s birth weight was 2908 g. The body temperature before the vaccination on 16Nov2017 was 36.4 degrees Centigrade. Medical history included gastroenteritis norovirus from 03Nov2017, when the patient vomited during night, requiring a visit to another hospital on 04Nov2017, leading to a diagnosis of gastroenteritis norovirus, and the patient had diarrhea until 10Nov2017 without vomiting, presenting no subsequent symptoms until vaccination. The patient was healthy at the time of interview prior to vaccination on 16Nov2017. No family history was reported. No concomitant medications, including oral drugs, were reported. The patient had previously received the first, second, and third doses of both the vaccines for immunisation on unspecified dates without adverse events. In the morning of 17Nov2017, the patient did not breathe, and then his death was confirmed. The reporting physician was informed of this from police around noon on the same day. The date of the death was 16Nov2017, and the cause of the death was unknown. It was unknown whether any autopsy was performed or not. The reporter assessed the causality of the event with vaccinations as unassessable, and commented that there was a possibility that the event was caused by other than vaccination, but details were unknown, so it was unassessable. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 728062 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-01
Onset:2017-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Malaise
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Diabetes; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HK0095075131711HKG005901

Write-up: This spontaneous report was received from a physician via a company representative and refers to an around 80 year old patient of unknown gender. The patient''s concurrent conditions included diabetes and high blood pressure. There was no information about the patient''s medical history and concomitant medications provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiry date were not provided) and with unspecified flu vaccine (dose, route of administration, lot # and expiry date were not provided) at the same time. On an unknown date, the patient felt very tired and unwell and get into hospital after suspect vaccines injection. The physician asked if the adverse effect increased after both vaccine being given at the same time. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported.


VAERS ID: 728067 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-08
Onset:2017-11-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHSA2017SA226662

Write-up: Initial unsolicited case received from a consumer on 15 Nov 2017. This case is linked to the case 2017SA226708 (PH-SAE-2017-11-003) same reporter. This case involves three-months-old male patient who was vaccinated with second dose of PENTAVALENT VACCINE (Batch number, expiry date, dose, route and site of administration were not reported) on 08 Nov 2017 Wednesday. Patient mother reported that a certain midwife was the one who injected the vaccine to the patient. Patient was healthy and had no sickness. Concomitant medications were not reported. On 09 Nov 2017, one day following the vaccination, patient experienced seizures, due to which the patient mother took the patient to a hospital and there she was advised to go to another hospital, the patient was transferred at the Medical Center on the same day. On an unknown date, following the vaccination, the patient brain was affected by bacteria (It was reported as the patient doctor said that the bacteria affected patient brain, no other reason why the patient died, only the immunization," he added). On 11 Nov 2017 around 2:00 P.M., three days after the vaccination, the patient died. Relevant lab tests and corrective treatment were not reported. It was not known whether autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: This 3-month-old baby received a second dose of a pentavalent vaccine (unspecified). The day after, as per Mother''s patient, the baby had seizures and was brought to the hospital where he died for unknown cause. "The reporter doctor said that the "bacteria" affected his brain". In the country, and according to the reporter, two pentavalent vaccines are available one from Sanofi Pasteur and the other one is from another manufacturer. Time to onset was compatible. No information regarding patient''s medical condition at the time of vaccination, medical history or product name or lot number was provided. Seizure might have multiple etiologies alternate to vaccination. Underlying preexisting infectious etiologies should be investigated and ruled out before assessing the role of the vaccine. Additional information regarding product name or lot number including autopsy details should be requested. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: bacteria affected his brain; seizure.


VAERS ID: 728068 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-08
Onset:2017-11-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-11
   Days after onset: 2
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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHSA2017SA226708

Write-up: Initial unsolicited case received from a consumer on 15 Nov 2017. This case is linked to the case 2017SA226662 _same reporter. This case involves four-months-old female patient who was vaccinated with second dose of DIPHTHERIA, TETANUS, PERTUSSIS (AC), POLIOMYELITIS (INACTIV) AND HAEMOPHILUS TYPE B CONJUG VACCINE (PENTA VACCINE) (Batch number, expiry date, doe, route and site of administration were not reported) on 08 Nov 2017 Wednesday. Patient was healthy and had no sickness. Concomitant medications were not reported. On 09 Nov 2017, one day following the vaccination, patient experienced seizures, and was assisted by a nurse and a physician. On 11 Nov 2017 around 2:00 P.M., three days after the vaccination, the patient died. It was reported as per Dr, the patient died of another cause but yet DOH is now investigating the situation. Relevant lab tests and corrective treatment were not reported. It was not known whether autopsy was performed or not. List of documents held by sender: none.; Sender''s Comments: This 4-month-old female baby who experienced seizure after a second dose of a pentavalent vaccine (unspecified). The baby was brought to the hospital where she died for unknown cause. In the country, and according to the reporter, two pentavalent vaccines are available one from Sanofi Pasteur and the other one is from another manufacturer. Time to onset was compatible. No information regarding patients medical condition at the time of vaccination, medical history or product name or lot number was provided. Seizure might have multiple etiologies alternate to vaccination. Underlying pre existing infectious etiologies should be investigated and ruled out before assessing the role of the vaccine. Additional information regarding product name or lot number including autopsy details should be requested. Based upon reported information the role of the vaccine can not be assessed.; Reported Cause(s) of Death: seizure.


VAERS ID: 728160 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-24
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Febrile convulsion, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (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: BE2017GSK179132

Write-up: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 1-year-old female patient who received DTP (A or W not known). On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant), febrile convulsion (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the sudden infant death syndrome was fatal and the outcome of the febrile convulsion and fever were unknown. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, febrile convulsion and fever to be related to DTP (A or W not known). Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever with convulsions and died the night after from a sudden infant death syndrome.


VAERS ID: 728208 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. JJ2612 / UNK NS / IN

Administered by: School       Purchased by: ?
Symptoms: Death, Lymphadenopathy, Oropharyngeal pain, Peripheral coldness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (at the age of 18 months); Tonsillitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2017SF19265

Write-up: A spontaneous report has been received from a Pharmacist concerning 5 years 1 month old, male patient. The patient''s medical history included tonsillitis and was under ENT secondary medical care and febrile convulsion at the age of 18 months. Patient concurrent diseases and concomitant drugs are not provided. The patient received nasal FLUENZ TETRA (intranasal) (Batch number: JJ2612, expiry date: 15-Jan-2018) on 15-Nov-2017 and administered at a school. On Thursday and Friday (16th-17th) the patient complained of a sore throat but was still in school, the mother also said in relation to this that the child''s ''glands were up''. On Friday the mother gave the child ibuprofen and was ''ok'' and was then placed on bed. The mother checked in on the child at midnight and did not notice anything untoward. On Saturday (18-Nov-2017) morning at 9 AM, the mother went to the child and found he was cold and non-responsive and that he had passed away. The HCP stated that he believed the child might have been pronounced or assumed dead at the scene as no attempt of CPR was made. The date for a post mortem had not been set yet. The HCP said that given this new information he no longer thought it could have been anaphylaxis due to the length of time that had passed after administration and before the death. He also stated that he thought it more likely to be a patient specific event rather that a batch issue and he would not be quarantined any further vaccines to come in. The patient died on 18-Nov-2017 and the outcome of the event of sore throat was unknown. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter assessed death as serious with fatal outcome. The company Physician assessed the event sore throat to be non-serious.; Sender''s Comments: This case concerns a male patient of 5 years, with reported fatal outcome with Q/LAIV (FLUENZ TETRA). Cause of death was further not specified. Due to limited information on concurrent conditions, cause of death, circumstances leading to death and autopsy details, it is not possible to make a conclusive assessment of the causal relationship of the fatal outcome with the suspect drug. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.


VAERS ID: 728379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-11
Onset:2016-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cough, Death, Dyspnoea, Intensive care, Respiratory tract infection viral
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-20
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20160711; Test Name: Body temperature; Result Unstructured Data: Test Result: increased; Test Date: 20170712; Test Name: Body temperature; Result Unstructured Data: Test Result: normalized
CDC Split Type: RUPFIZER INC2017500978

Write-up: This is a spontaneous report from a non-contactable physician received via a company regional medical advisor. A 3-month-old female patient of an unspecified ethnicity received 1st dose of PREVENAR 13 intramuscularly on 11Jul2016 at 0.5 ml single for immunisation. The patient medical history and concomitant medications were unknown. On 11Jul2016 at night, after vaccine administration the patient experienced temperature increased. A call for ambulance was made and the child was hospitalized on 11Jul2016. Next day, 12Jul2016, the temperature normalized after an unspecified treatment and the child was discharged on the same day. On 14Jul2016, the patient experienced cough. The physician prescribed antibiotics and inhalation. On 18Jul2016, the patient began to grasp for breath during inhalation. A call for ambulance was made and on 18Jul2016 the child was hospitalized to a regional hospital where she received a treatment in the intensive care unit. On 20Jul2016, the patient''s condition worsened and then death occurred on the same day. Cause of death was unknown. It was also unknown if autopsy had been performed. Other relevant information was reported as "regarding cough a diagnosis acute respiratory viral infection was set." The physician considered that only the event "temperature increased" was related to pneumococcal 13-val conj vac (dipht crm197 protein). All other events were not related. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "temperature increased" cannot be fully excluded considering the known adverse event profile of PREVENAR 13; however, temperature increased may also be associated with an intercurrent acute respiratory viral infection which presented in the patient as cough and grasp for breath during inhalation. In concurrence with the reporting physician, the patient''s death is considered not related to the use of PREVENAR 13 but due to the progression of the coincidental viral infection. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 728503 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-11-13
Submitted: 0000-00-00
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Depressed level of consciousness, General physical health deterioration, Meningitis, Pyrexia, Rhinorrhoea, Streptococcus test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 2017-11-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZERINC2017502133

Write-up: This is a spontaneous report from a non-contactable other HCP via medical affairs colleague. The health authority was investigating a paediatric death of invasive pneumococcal disease (IPD) and published a press release online. A 2-year-old male patient of an unspecified race/ethnicity, with good past health, received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) for immunization at single dose on unknown date. On 13Nov2017 the patient developed fever, cough, running nose and vomiting and consulted a private doctor on 14Nov2017 and 15Nov2017. He was found with decreased consciousness on 15Nov2017 evening and was brought to a local hospital. His condition deteriorated and died on 16Nov2017. The clinical diagnosis was meningitis. His cerebrospinal fluid specimen tested positive for Streptococcus pneumoniae upon laboratory testing. He had no recent travel history. Apart from his domestic helper who had upper respiratory symptoms in stable condition, other home contacts have remained asymptomatic. The outcome of the events was unknown. Pfizer is Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities. Sender''s Comments: A possible contributory role of the suspect product cannot be excluded for the reported event drug ineffective and meningitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Reported Cause(s) of Death: drug ineffective; invasive pneumococcal disease.


VAERS ID: 728550 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-11-28
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Myocardial infarction (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (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: 2013, Influenza vaccine, prophylaxis, Pneumona, received in 2013 and ended up in hospital due to pneumonia, had heart attack, heart disorder and weakened every organ (case number: AU2017GSK180223)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK180226

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a adult female patient who received Influenza vaccine. Previously administered products included Influenza vaccine with an associated reaction of pneumonia (received in 2013 and ended up in hospital due to pneumonia, had heart attack, heart disorder and weakened every organ (case number: AU2017GSK180223)). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced pneumonia, (serious criteria death and GSK medically significant), renal failure (serious criteria GSK medically significant) and heart attack (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal and the outcome of the renal failure and heart attack were not reported. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia, renal failure and heart attack to be related to Influenza vaccine. Additional details were provided as follows: The report was received from a consumer via GlaxoSmithKline social media. The patient had her shots every year. In 2014, the patient had flu shot and she experienced pneumonia, kidney failure and heart attack. Ten weeks later the patient died. The patient was not going to have 2014 flu shot after the reaction of 2013. Follow up would be conducted. The case was linked with the case AU2017GSK180223, reported by the same reporter for the same patient.


VAERS ID: 728586 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-28
Onset:0000-00-00
Submitted: 2017-11-28
Entered: 2017-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-12
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: Linagliptin; VENOFER; Folic acid; EXTRANEAL; Alfacalocidol; Furosemide; Insulin APIDRA; Dianeal Pd4; Insulin LEVEMIR, Dianeal PD4; ADALAT LA; EPREX; Ramipril; CLEXANE; Sodium bicarbonate
Current Illness: Bladder cancer; Diabetes
Preexisting Conditions: Aortic valve sclerosis; Chronic obstructive pulmonary disease; Renal vessel disorder, type unknown
Allergies:
Diagnostic Lab Data: On an unknown date the patient had the following tests and the results were found as follows: Body height: 152 centimeter; Weight: 79 kg;
CDC Split Type: GB2017180265

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of stroke in a 79-year-old female patient who received ENGERIX B. Co-suspect products included folic acid unknown for drug use for unknown indication, alfacalcidol unknown for drug use for unknown, Furosemide unknown for drug use for unknown indication, Ramipril unknown for drug use for indication, CLEXANE unknown for drug use for unknown indication, sodium bicarbonate unknown for drug use for unknown indication, linagliptin unknown for drug use for unknown indication, EXTRANEAL for automated peritoneal dialysis, Insulin APIDRA unknown for drug use for unknown indication, Dianeal Pd 4 for automated peritoneal dialysis, Dianeal Pd 4 for automated peritoneal dialysis, insulin and EPREX unknown for drug unknown indication. The patient''s past medical history included aortic valve sclerosis, chronic obstructive pulmonary disease and renal vessel disorder (type unknown). Concurrent medical conditions included bladder cancer and diabetes. Concomitant products included VENOFER. On an unknown date, the patient received ENGERIX B (intramuscular), folic acid (oral) 5 mg at an unknown frequency, alfacalcidol (oral) .25 ug at an unknown frequency, Furosemide (oral) 80 mg at an unknown frequency, rampril (oral) 2.5 mg at an unknown frequency and CLEXANE (intravenous) 20 mg at an unknown frequency. On 3rd April 2017, the patient started sodium bicarbonate (oral) 1 g once daily (1 g daily). On an unknown date, the patient started linagliptin (oral) 5 mg at an unknown frequency. On 30th March 2017, the patient stated EXTRENEAL (intraperitoneal) 2 1 once daily. On an unknown date, the patient started Insulin APIDRA (subcutaneous) at an unknown dose and frequency. On 30th March 2017, the patient started Dianeal Pd 4 (intraperitoneal) 13.6 mg/ml 5 1 once daily and Dianeal Pd 4 (intraperitoneal) 22.7 mg/ml 10 1 once daily. On an unknown date, the patient stated Insulin LEVEMIR (subcutaneous) 10 iu at an unknown frequency and ADALAT LA (oral) 60 mg at an unknown frequency, the patient started EPREX (subcutaneous) 3000 iu weekly. On an unknown date, unknown after receiving ENGERIX B, folic acid, alfacalcidol, Furosemide, Ramipril, and CLEXANE and less than a year after starting sodium bicarbonate, the patient experienced stroke (serious criteria death, hospitalization and GSK medically significant). On 12th July 2017, the outcome of the stoke was fatal. The patient died on 12th July 2017. The reported cause of death was stoke. It was unknown if the reporter considered the stroke to be related to ENGERIX B, folic acid, alfacalcidol, Furosemide, rampril, CLEXANE and sodium bicarbonate. Additional information: The age at vaccination was not reported. It was unknown if the reporter considered the stroke to be related to EPREX, ADALAT LA, LEVEMIR insulin, Insulin APIDRA, and Linagliptine. The reporter considered the stroke to be unlikely related to Dianeal PD4 and EXTRANEAL (7.5%) solution for peritoneal dialysis. The patient receive Dianeal PD4 (Glucose 1.36% w/v / 13.6 mg/ml and 2.27% w/v / 22.7 mg/ml). Initial information was received by a other health professional and consumer via regulatory authority on 24th November 2017: Sender''s comment: The fatal event of stroke appears to be related to the patient''s past medical history (renal vascular disease and diabetic) compounded by elderly age and is unlikely to be associated to the dialysate therapy. Event: fatal stroke - serious and unlikely associated. 17Nov2017.


VAERS ID: 728815 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-23
Onset:2017-11-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-11-30
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 / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Premature baby 33 to 36 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2017510432

Write-up: This is a spontaneous report from a contactable nurse. A 6-week-old male patient of unspecified race/ethnicity received 1st dose of PREVENAR 13, via an unspecified route of administration, on 23Nov2017, at single dose, for immunisation; 1st dose of INFANRIX HEXA, via an unspecified route of administration, on 23Nov2017, at unspecified dose, for immunisation; 1st dose of ROTARIX, via an unspecified route of administration, on 23Nov2017, at unspecified dose, for immunisation. Relevant medical history included premature baby 33 to 36 weeks. Concomitant medications were not reported. The patient experienced sudden unexpected death in infancy (SUDI) on 24Nov2017 at 06:45 AM. Cardiopulmonary resuscitation (CPR) was performed when the patient was found unresponsive. Paramedics came. The patient was declared deceased in emergency department (ED). It was unknown if an autopsy was performed. Causality assessment of the event was considered possibly related by the reporter.; Sender''s Comments: There is no plausible mechanism to implicate the suspect vaccines to the occurrence of the fatal event "sudden unexpected death in infancy". More information such as complete medical/family history, diagnostic workup, autopsy results and death cause are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden unexpected death in infancy (SUDI).


VAERS ID: 728835 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-21
Onset:2016-04-21
   Days after vaccination:0
Submitted: 2017-11-30
   Days after onset:588
Entered: 2017-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC463AA / 3 LA / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 201503242 / 1 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose decreased, Central nervous system infection, Death, Hypoglycaemia, Pyrexia, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: 04/23/2016, Blood glucose, Decreased; 04/23/2016, Body temperature, 38.1 degree C
CDC Split Type: CN2017GSK182315

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of sudden infant death syndrome in a 6-month-old female patient who received ENGERIX B (batch number YHBVC463AA, expiry date unknown). Co-suspect products included Meningococcal A vaccine (batch number 20150324-2, expiry date unknown). On 21st April 2016 07:59, the patient received the 3rd dose of ENGERIX B (intramuscular) .5 ml and the 1st dose of meningococcal A vaccine (subcutaneous) .5 ml. On 21st April 2016 18:00, 10 hrs 1 min after receiving ENGERIX B, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant), hypoglycemia (serious criteria death), central nervous system infection (serious criteria death and GSK medically significant) and fever (serious criteria other). On an unknown date, the outcome of the sudden infant death syndrome, hypoglycemia, central nervous system infection and fever were fatal. The reported cause of death was sudden infant death syndrome, hypoglycemia, central nervous system infection and fever. It was unknown if the reporter considered the sudden infant death syndrome, hypoglycemia, central nervous system infection and fever to be related to ENGERIX B. Additional details were provided as follows: The patient received ENGERIX B on left upper arm and Meningococcal serogroup A vaccine to right upper arm. On 23rd April 2016, the patient visited physician. The patient had fever with axillary temperate at 38.1 degree C. The patient had no local red swelling of skin and no local induration. The tentative and final clinical diagnosis was other (unspecified). The patient did not hospitalize and the reaction classification was coupling reaction. The other primary clinical diagnosis included suspect sudden infant death syndrome (SIDS), hypoglycemia and suspect intracranial infection. On an unspecified date, the patient died. It was unknown if the autopsy was performed. It was unknown if the reporter considered he sudden infant death syndrome, hypoglycemia, central nervous system infection and fever to be related to Meningococcal A vaccine as well. The additional information was unknown.


VAERS ID: 728854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA238347

Write-up: Initial unsolicited social media report received from a consumer (family member of patient) on 25-Nov-2017. This case is linked with: 2017SA238350_2017-CAN-008697 (Same reporter). This case involves a male patient (age not reported), who was vaccinated with INFLUENZA VACCINE (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, few hours following the vaccination patient did not felt well and as per the physician it was a common thing. On an unknown date, few days following the vaccination, patient started to experience breathing issues and ambulance was called and patient died in hospital two days later (hospitalization date not reported). Other details regarding hospitalization were not provided. Laboratory investigation and corrective treatment was not reported. Outcome of the events "feeling unwell" and "difficulty breathing" was not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: No information regarding patients age, medical history or condition at the time of vaccination was provided. Patient''s death could be a result of underlying etiology unrelated to vaccination. Feeling unwell and breathing issues could be due to an undiagnosed underlying medical condition that would be revealed while performing autopsy. Additional details regarding patient''s medical history, product name or lot number and autopsy results will be required to further assess the case. Based upon reported information the causality of the events could not be assessed with respect to the vaccine. Reported Cause(s) of Death: died in hospital.


VAERS ID: 729024 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2016-02-16
Onset:2016-02-17
   Days after vaccination:1
Submitted: 2017-12-01
   Days after onset:653
Entered: 2017-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC454AA / 1 RA / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 2015080323 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-01
   Days after onset: 653
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: CN2017GSK182254

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of unknown cause of death in a 5-month-old female patient who received ENGERIX B (batch number YHBVC454AA, expiry date unknown). Co-suspect products included Attenuated Poliomyelitis Diploid Vaccine (batch number 201508032-3, expiry date unknown). On 16th February 2016, the patient received the 1st dose of ENGERIX B (intramuscular) .5 ml and the 1st dose of Attenuated Poliomyelitis Diploid Vaccine (oral) 1 ml. In February 2016, 17 hrs after receiving ENGERIX B, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 17th February 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to ENGERIX B. Additional details were reported as follows: At 14:00, the patient received ENGERIX B (on right upper arm) and attenuated poliomyelitis diploid vaccine. After 17 hours of vaccination, at 07:00, the patient was dead and the specified information of death was unknown. On 17th February 2016, the physician visited. The patient did not experience fever, local red swelling of skin or local induration. The patient was not hospitalized. It was unknown if the reporter considered the unknown cause of death to be related to Attenuated poliomyelitis diploid vaccine as well. Additional information was unknown. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 729268 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-11-16
Submitted: 2017-11-29
   Days after onset:13
Entered: 2017-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angioedema, Death, Erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (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: Pantoprazole; Losartan; Cardioaspirin; AZARGA; EUTIROX; EZETROL; DEURALL
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201703169

Write-up: This initial serious spontaneous case, was received on 23-Nov-2017, from a physician, via health authority (IT-MINISAL02-438383) concerning a female patient of unspecified age. The concomitant medications included pantoprazole, losartan, cardioaspirin, AZARGA, EUTIROX, EZETROL and DEURSIL. On an unspecified date, the patient was administered with AGRIPPAL S1 (dose: 1 dose (as reported), route of administration, anatomical location, batch number, expiry date: not reported). On 16-Nov-2017, the patient developed giant hives, erythema diffuse and angioedema. On an unspecified date, the patient deceased.


VAERS ID: 729466 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-07
Onset:0000-00-00
Submitted: 2017-12-05
Entered: 2017-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC978A / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 166301 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M50948 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB850AE / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dopamine; Infant GAVISCON; Metronidazole; Spironolactone; Dexamethasone; Potassium chloride; unspecified steroids; paracetamol; Vancomycine; Clarithromycin; CUROSURF; Gentamicin; Flucloxacillin sodium; caffeine citrate; Omeprazole; Atracuri
Current Illness:
Preexisting Conditions: Caesarean section, Emergency delivery, with APGARS of 3, 3 and 8 at delivery. Airway management and chest compressions; Diastolic dysfunction, Antenatal history of absent and then reversed end diastolic flow just prior to delivery; Premature baby, Born at 27 weeks and 5 days gestation and weighed 582 grams.
Allergies:
Diagnostic Lab Data: 11/08/2017, Heart rate, No audible heart rate
CDC Split Type: GB2017183115

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of cot death in a 2-month-old female patient who received INFANRIX HEXA (batch number A21CC978A, expiry date unknown). Co-suspect products included ROTARIX liquid formulation (batch number AROLB850AE, expiry date unknown), BEXSERO (batch number 166301, expiry date May 2018) and PREVENAR 13 (batch number M50948, expiry date May 2018). The patient''s past medical history included Caesarean section, Emergency delivery, with APGARS of 3, 3 and 8 at delivery. Airway management and chest compressions; diastolic dysfunction (Antenatal history of absent and then reversed end diastolic flow just prior to delivery) and premature baby 26 to 32 weeks (Born at 27 weeks and 5 days gestation and weighed 582 grams). Additional patient notes included before being intubated and transferred to neonatal unit. Concomitant products included Sodium Hydrogen Carbonate, fluconazole, metronidazole, spironolactone, dexamethasone, potassium chloride, paracetamol, Vancomycine, Gentamicin, flucloxacillin sodium, omeprazole, Atracurium, Morphine Sulfate, Furosemide, dopamine, Infant GAVISCON, sodium chloride solution, Unspecified Steroids, 0.9% sodium chloride, CUROSURF, clarithromycin, caffeine citrate, cefotaxime, sodium feredetate, Chlorothiazide, phosphoric acid, Sodium Phosphate and Vitamin K. On 7th November 2017, the patient received INFANRIX HEXA (intramuscular), ROTARIX liquid formulation (oral), BEXSERO (intramuscular) and PREVENAR 13 (intramuscular). In November 2017, less than a day after receiving INFANRIX HEXA, ROTARIX liquid formulation and BEXSERO, the patient experienced cot death (serious criteria death and GSK medically significant). On 8th November 2017, the outcome of the cot death was fatal. The patient died on 8th November 2017. The reported cause of death was cot death. It was unknown if the reporter considered the cot death to be related to INFANRIX HEXA, ROTARIX liquid formulation and BEXSERO. Additional information: Concomitant products included milk, vitamins NOS, ABIDEC. Initial information received from other health professional via regulatory authority on 24th November 2017: Reaction/Event: Baby found lifeless in cot on neonatal unit just under 22 hours post immunizations.


VAERS ID: 729780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA242730

Write-up: Initial unsolicited social media report received from a consumer (patient''s family) on 30-Nov-2017. This case involves a female patient (age not reported), who was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and site of administration were not reported) on an unknown date. Medical history and concomitant medication was not reported. On an unspecified date, same day following the vaccination, patient got sick. On an unknown date, two weeks after the vaccination patient was hospitalized. On an unknown date, after the vaccination patient died (reported as never came home). Laboratory investigation and corrective treatment was not reported. Outcome of the event sick was not reported. It was not reported whether autopsy was done or not. List of the documents held by sender: none.; Sender''s Comments: Patient reported to be sick the same day of her flu shot. Hospitalized 2 weeks later for an unknown reason. The time to onset was compatible. Very poorly documented case retrieved on Internet (No information regarding product name, vaccination dates, patients age, medical history and medical condition at the time of vaccination, event details, diagnosis, autopsy results confirming the cause of death. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: never came home.


VAERS ID: 730371 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-11-22
Onset:2017-11-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Nasopharyngitis, Seizure
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-01
   Days after onset: 9
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: PHPFIZER INC2017524433

Write-up: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 2-month-old patient of an unspecified ethnicity, race and gender received, on 22Nov2017, PREVENAR 13 at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 22Nov2017, the patient caught colds and cough and after a few days, had convulsion and was admitted to the hospital. The patient died on 01Dec2017. The cause of death was unknown at the time of the report. It was not reported if an autopsy was performed. Clinical outcome of the other events was unknown at time of the patient''s death. The information on the lot number has been requested.; Sender''s Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: Death.


VAERS ID: 730528 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-13
Entered: 2017-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 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: FR2007GSK000033

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a adolescent female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 1 day after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided as follows: This information was collected during a market research. The age at vaccination was not reported. The mother reported that she knew an adolescent girl who died the day after vaccination. No more information would be provided.


VAERS ID: 730779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-15
Onset:2017-08-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC912A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15844 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia, Restlessness, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
   Days after onset: 6
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: LEFAX; caraway
Current Illness: Atopy (allergic diathesis (patient''s sister diagnosed with atopy)); Meteorism; Passive smoking; Plagiocephaly; Prophylaxis; Restlessness (since birth)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170817; Test Name: Body temperature; Result Unstructured Data: Lab result: 40 ?C
CDC Split Type: DE0095075131712DEU008163

Write-up: Information has been downloaded from Vigilance (DD-20171212-ddevhumanwt-093307). This spontaneous report as received from a physician via agency and refers to a 3 months old female child patient. Patient''s concurrent conditions included passive smoking, atopy (allergic diathesis (patient''s sister diagnosed with atopy), plagiocephaly, restlessness (since birth), meteorism. On 15-AUG-2017 the patient was vaccinated with (Manufacturer unknown), (ROTARIX-Rotavirus-Lebendimpfstoff), (lot # AROLB840AD, 1.5 ml, oral drops) for prophylaxis. On the same day, patient was also given other suspect therapies which included PREVENAR 13, solution for injection intramuscularly (lot#S15844, 0.5 ml, unknown) for prophylaxis and INFANRIX HEXA, solution for injection, intramuscularly (lot#A21CC912A, 0.5 ml) for prophylaxis. On the same day, patient received last administration therapies of rotavirus vaccine, live, oral, pentavalent (Manufacturer unknown) and INFANRIX HEXA prior to adverse event. Concomitant therapies included simethicone(LEFAX PUMP LIQUID) and caraway (CARUM CARVI). On 17-AUG-2017, 3 days after onset of therapy the patient experienced pyrexia (life threatening) with high fever upto 40 degree centigrade. On 19-AUG-2017, fever was resolved. On 23-AUG-2017 the patient experienced restlessness (life threatening) and sudden infant death syndrome (life threatening). On an unknown date, the patient was hospitalized due to all the events. It was reported that on the same day, the patient died due to restlessness, pyrexia, sudden infant death syndrome. It was unknown whether autopsy was performed or not. The reporter assessed the events, restlessness, pyrexia, sudden infant death syndrome as medically significant.; Reported Cause(s) of Death: high fever upto 40; Restlessness after food intake; Sudden infant death syndrome.


VAERS ID: 730790 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-27
Onset:2017-10-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N23N / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. N008420 / UNK UN / SC

Administered by: Unknown       Purchased by: ?
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: 2017-10-28
   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: Alzheimer''s disease; Immunisation; Vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO0095075131712NOR003779

Write-up: Information has been downloaded from Agency (NO-NOMAADVRE-FHI-2017-00083). This spontaneous report as received from a physician refers to a 86-year-old female patient with Alzheimer''s disease. On 27-OCT-2017, the patient was vaccinated with PNEUMOVAX, 0.5 ml, subcutaneously, lot # N008420, (expiration date was unknown). On 27-OCT-2017, the patient was also vaccinated with INFLUVAC injection, intramuscularly, 0.5 ml, batch/lot # N23N. On 28-OCT-2017, the patient suddenly died. It was unknown if an autopsy was performed. Sender''s Comments: Reporter Comments: 02-NOV-2017, NIPH: Additional information will be requested. This is a preliminary report. Sender Comments: V?r ref.: 17/713.


VAERS ID: 731154 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Liver function test increased
SMQs:, Liver related investigations, signs and symptoms (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatitis B surface antigen (HBsAg) carrier; Hospitalisation
Preexisting Conditions: Comments: Complications: other diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131712JPN000216J

Write-up: Information has been received from a pharmacist concerning a 75-year-old female patient who was a hepatitis B carrier with other diseases. The patient was being hospitalized. On an unspecified date, the patient was vaccinated with PNEUMOVAX NP for prophylaxis (Lot. Number and dose not reported). There were no concomitant medications reported. On an unspecified date, when the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent), the numerical value of liver function rose sharply. On an unspecified date, the patient died. The cause of death was "the numerical value of liver function rose sharply" and information regarding autopsy was not provided. Reporter''s comment: As the patient has other diseases and was hospitalized, I do not believe there is a direct causal relationship with pneumococcal vaccine, polyvalent (23-valent). The reporting pharmacist did not assess the relationship between "the numerical value of liver function rose sharply" and pneumococcal vaccine, polyvalent (23-valent). The reporting pharmacist considered that "the numerical value of liver function rose sharply" was serious due to death. This case has been upgraded. The reported AE has been changed to be serious due to death. Reported Cause(s) of Death: The numerical value of liver function rose sharply.


VAERS ID: 731222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2017SA238350

Write-up: Based on information received on 12-Dec-2017, the report previously considered as non-valid became valid: [Adverse event was reported]. Initial unsolicited social media report received from non-healthcare professional on 25-Nov-2017. This case is non-valid as reason for death was not specified. This case is linked with 2017SA238347 same reporter. This case involves male patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (SHOT) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, 48 hours following the vaccination patient was found dead in his apartment. Laboratory investigation and corrective treatment were not reported. It was not reported whether autopsy was performed. Follow up report received from non-healthcare professional on 12-Dec-2017. This case involves patient (Age reported as late 70s). Patient received Flu Shot in the morning. On an unspecified date, (Reported as same year) post vaccination patient had complained of not feeling well. He told another neighbor next day not feeling well and going to bed. Don''t know how long he was dead before they found him almost dead a week later. Outcome of not feeling well was not reported. List of documents held by sender: none. Sender''s Comments: No information regarding patients'' medical history or condition at the time of vaccination was provided. Elderly Patient whose death could be a result of underlying etiology unrelated to vaccination. Additional details regarding patient''s medical history, product name or lot number and autopsy results are required to further assess the case. Based upon reported information, a role of the vaccine cannot be established. Reported Cause(s) of Death: found death.


VAERS ID: 731346 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-21
Entered: 2017-12-21
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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis, Necrosis, Pneumocystis jirovecii pneumonia, Post transfusion purpura, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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: FR2017GSK195603

Write-up: This case was reported by a consumer via other manufacturer and described the occurrence of pneumocystosis in a 14-month-old patient who received INFANRIX HEXA. Co-suspect products included Rotavirus vaccine and PREVENAR 13. On an unknown date, the patient received INFANRIX HEXA at an unknown dose, Rotavirus vaccine (oral) and PREVENAR 13 at an unknown dose. On an unknown date, 4 days after receiving INFANRIX HEXA and Rotavirus vaccine, the patient experienced pneumocystosis (serious criteria death and GSK medically significant), post transfusion purpura (serious criteria death and GSK medically significant), thrombocytopenia (serious criteria death and GSK medically significant), encephalitis (serious criteria death and GSK medically significant) and necrosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumocystosis, post transfusion purpura, thrombocytopenia, encephalitis and necrosis were fatal. The reported cause of death was pneumocystosis, post transfusion purpura, thrombocytopenia, encephalitis and necrosis. It was unknown if the reporter considered the pneumocystosis, post transfusion purpura, thrombocytopenia, encephalitis and necrosis to be related to INFANRIX HEXA and Rotavirus vaccine. Additional details were provided as follows: This case was identified in a letter written by two collectives. The patient was two and a half month old at time of vaccination. The vaccination was recommended by the pediatrician. The first symptoms occurred four days after injection. The condition or life of the patient after vaccination included pneumocystosis, post transfusion thrombocytopenic purpura, resuscitation with ventriculocisternostomy and necrotizing encephalitis. The patient died at the age of 14 months. It was unknown if the reporter considered the pneumocystosis, post transfusion purpura, thrombocytopenia, encephalitis and necrosis to be related to PREVENAR 13, as well. This case is one of the cases reported in an open letter.


VAERS ID: 731431 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-11-17
Submitted: 2017-11-13
   Days after onset:361
Entered: 2017-12-21
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Malaise
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: 201702960

Write-up: This initial spontaneous case, was received from other health professional via health authority (HA ID: IT-MINISAL02-436106) on 08-Nov-2017, concerning a 94-year-old elderly female patient. On an unspecified date, the patient was administered with FLUAD (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 17-Nov-2016, the patient experienced malaise and her condition was worsened. On an unspecified date, the patient died. It was unknown, whether autopsy was done. The health authority assessed the events as serious (death) and considered the causality of the events as related. Case Comment: A 94-year-old female subject had died following vaccination. Details regarding date of vaccination, onset latency and clinical status of the subject at the time of vaccination are needed for further medical assessment. Thus, company assesses the causality as unassessable.


VAERS ID: 731471 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-21
Onset:2008-07-16
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardio-respiratory arrest, Endotracheal intubation, Headache, Loss of consciousness, Malaise, Mechanical ventilation, Mydriasis, Pain, Respiration abnormal, Resuscitation, Ruptured cerebral aneurysm, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (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), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), 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: 2008-07-16
   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: SERETIDE; NASACORT; KESTINE; VENTOLINE; HORMONAL CONTRACEPTIVES (UNSPECIFIED)
Current Illness: Allergic asthma (Stop Date: Continuing); Overweight (Stop Date: Continuing); Pollen allergy (Stop Date: Continuing); Smoker (Stop Date: Continuing)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075130812USA02421

Write-up: Information has been received from a general practitioner concerning an 18 year old female with pollen allergy, allergic asthma and who was overweight, with a family history of the mother having multiple sclerosis, who on 12-MAR-2008 was vaccinated with the first dose of HPV vaccine, lot # not reported, which was well tolerated. The patient had no toxic, no familial medical cardiac history and no risk factor of thromboembolic disease. It was reported that the second dose of HPV vaccine, lot # not reported, was given intramuscularly (IM) to the right deltoid on 21-APR-2008. Concomitant therapy included SERETIDE, VENTOLINE, NASACORT and KESTINE. There was no contraceptive use. On 16-JUL-2008 the patient experienced sudden brutal cephalgia and then she suffered from a pain evocating an aneurysm during rupture. The patient suddenly died in spite of resuscitation technique performed by the mobile emergency medical service which evoked a ruptured aneurysm. An autopsy was on-going and the results would be provided. As to the reporter there may not be any link between adverse effect and vaccination. The reported cause of death by the mobile emergency medical service was ruptured cerebral aneurysm, but it had not been confirmed yet by the results of the autopsy which were still pending. Follow-up information was received from a health authority which reported that as to the forensic physician there was a "white" autopsy from a macroscopic point of view. Toxic samples and microscopic analysis of tissue samples were awaited. An autopsy was performed on demand of the emergency physician because the death occurred at home and circumstances were difficult to be clarified. As to the general practitioner who reported the case, after violent cephalgias the patient had lost consciousness. Report of the emergency medical service noted a secondary death after cardio respiratory arrest. On this report and contrary to the declaration of the general practitioner, the patient had concomitant oestroprogestative contraceptive and was a smoker: level of her smoking was not countable but reported as weak. Follow up information was received by a fax from the health authorities on 19-DEC-2008: Medical form from the mobile emergency medical service was provided: the patient was talking with her boyfriend and suddenly she complaint with violent headaches and had lost consciousness, her breathing was stertor-like and then she had the cardio respiratory arrest. Her boyfriend made her closed cardiac massage and mouth to mouth resuscitation until arrival of fire-men (13 minutes later), she had closed cardiac massage again and ventilation. Automatic defibrillator: no shock. Mobile emergency medical service arrived 7 minutes later: orotracheal intubation was performed and adrenaline 2 mg + 1mg/3 minutes (total = 10mg) was administered. Sodium chloride 9?/?? was administered via peripheral vein. When the mobile emergency medical service arrived the patient had a reactive mydriasis. Medical resuscitation technic was made during 45 minutes. The patient died at 17 hours 17. She never had shock. No suspect lesion of violence. She had no toxic, no familial medical cardiac history and no risk factor of thromboembolic disease. Death certificate signed in medicolegal obstacle was provided. Additional information received by phone from the health authorities on 19-DEC-2008 revealed that the coroner could be reached and an autopsy confirmed that there was no visceral impairment, no sign of pulmonary embolism, no sign in favor of a myocardial infarction. At the cerebral level, there was no macroscopic sign which could have led to a meningeal or cerebral hemorrhage. Results of histological and toxicologic analysis were still awaited. Follow up information was received by mail from the health authorities on 19-DEC-2008: Toxologic work up was negative. Results of anatomopathology were awaited. Other business partner numbers include E2008-11575. No further information is available. Follow up information received from the agency. The patient presented with malaise which preceded violent cephalgia. When patient arrived at the emergency unit, her death was noted. At the time of reporting the performed autopsies had not determined the cause of death. The vaccine Gardasil was prescribed on 17-Dec-2008 and JASMINELLE from 2-JUL-2007. The events malaise and violent cephalgia were considered to be serious due to fatal outcome. Sender''s Comments: MERCK 0812USA02421: Mfr number; Reported Cause(s) of Death: sudden death, cause unknown.


VAERS ID: 731555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Death, Epilepsy, Hypotonia, Musculoskeletal stiffness
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017544354

Write-up: This is a spontaneous report from a non-contactable consumer received via a Pfizer colleague from legal division in form of a letter from a community of victims, or relatives of victims, of vaccination accidents, sent to the parliament and constitutional council. This document reported 17 vaccine "accidents", among them 7 included vaccination with PREVENAR 13. This is the first of 7 reports. A 2-month-old female patient of an unspecified race/ethnicity received vaccination, as recommended by a paediatrician, with PREVENAR 13 at single dose and INFANRIX HEXA, both on an unknown date, for immunisation. Lot numbers, dose number, route and sites of administration were unknown. The patient''s medical history and concomitant medications, if any, were not reported. On an unspecified date, 15 days after vaccination, the patient presented with the first symptoms. The patient''s life after vaccination was described as: vision loss, loss of muscular tonus and stiffness, trunk hypotonia, severe epilepsy. It was unknown if therapeutic measures have been taken in response to the events. The events had not resolved and the patient died at the age of 3 and a half years, following plentiful epileptic fits. It was unknown if an autopsy was performed or not. This case is a possible duplicate of a previously received legal case but it could be not confirmed due to lack of details. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: severe epilepsy/plentiful epileptic fits.


VAERS ID: 731556 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Encephalitis, Pneumocystis jirovecii pneumonia, Resuscitation, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017544360

Write-up: This is a spontaneous report from non-contactable consumer received via a Pfizer colleague of legal division in form of a letter from a community of victims, or relatives of victims, of vaccination accidents, sent to the parliament and constitutional council. This document reported 17 vaccine "accidents" among them 7 included vaccination with PREVENAR 13. This is the 2nd of 7 reports. A 2-month and a half-old patient of unspecified gender received on an unknown date, as recommended by a paediatrician, PREVNAR 13 at single dose for immunization, INFANRIX HEXA at unknown dose for immunization, and Rotavirus vaccine (unspecified trade name) at unknown dose for immunization. Lot numbers, dose number, route and site of administration were unknown. The patient''s medical history and concomitant medications, if any, were not reported. On an unspecified date, 4 days after the injection, the patient presented with the first (unspecified) symptoms. The patient''s condition after vaccination was described as: pneumocystosis, post transfusion thrombocytopenic purpura and necrotizing encephalitis. The patient underwent intra cranial derivation and resuscitation. The patient died on an unknown date and due to unspecified reason at the age of 14 months. It was unkown if autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 731623 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalitis, Pneumocystis jirovecii pneumonia, Post transfusion purpura, Resuscitation, Thrombocytopenic purpura, Ventriculo-peritoneal shunt
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131712FRA010198

Write-up: This spontaneous report was received from patient''s association to State referring to a 2 month old patient of unknown gender. The patient''s medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), orally, at the age of 2 months and a half, following the recommendation from the pediatrician for prophylaxis (dose, lot# and expiry date were unknown). Other suspect therapies included INFANRIX HEXA and PREVENAR 13 for prophylaxis (dose, route of administration, lot # and expiry date were unknown). On an unknown date (reported as 4 days after the injection), the patient experienced pneumocystosis, post transfusional thrombocytopenic purpura, necrotic encephalitis and resuscitation with intracranial shunt. On an unknown date, at the age of 14 months old, the patient died. It was unknown if an autopsy was performed. The causality assessment between the suspect vaccines and the aforementioned events was not reported. Upon internal review, pneumocystis jirovecii pneumonia, post transfusion purpura, encephalitis and resuscitation were determined to be medically significant events. Reported Cause(s) of Death: necrotic encephalitis; Pneumocystosis; resuscitation with intracranial shunt; post transfusional thrombocytopenic purpura.


VAERS ID: 731835 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-12-05
Onset:2017-12-06
   Days after vaccination:1
Submitted: 2017-12-22
   Days after onset:16
Entered: 2017-12-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 15E601 / UNK UN / IM
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (MENITORIX) / GLAXOSMITHKLINE BIOLOGICALS A76CA358A / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. M049774 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 580654 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-06
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: Hand-foot-and-mouth disease, Diagnosis by GP on the previous week. Infant fully recovered.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2017195347

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 16-month-old female patient who received MMR vaccine (batch number M049774 ?, expiry date unknown). Co-suspect products included BEXSERO (batch number (15E601, expiry date unknown), MENITORIX (batch number A76CA358A, expiry date unknown) and PREVENAR 13 (batch number 580654, expiry date unknown). The patient''s past medical history included hand, foot and mouth disease (Diagnosis by GP on the previous week. Infant fully recovered). Additional patient notes included previously in good health, no previous history of reactions to vaccines. On 5th December 2017, the patient received MMR vaccine (intramuscular) .5 ml, BEXSERO (intramuscular) .5 ml, MENITORIX (intramuscular) .5 ml and PREVENAR 13 (intramuscular) .5 ml. On 6th December 2017, 1 days after receiving MMR vaccine, BEXSERO and MENITORIX, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On 6th December 2017, the outcome of the sudden infant death was fatal. The patient died on 6th December 2017. The reported cause of death was sudden infant death. It was unknown if the reporter considered the sudden infant death to be related to MMR vaccine, BEXSERO and MENITORIX. Additional information: The reported lot number MMR vaccine batch number M049774 does not match with any GSK lot number. Age at vaccination was not reported. Initial information was reported by a physician via regulatory authority on 18th December 2017: Sudden infant death.


VAERS ID: 731941 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-17
Onset:2017-11-20
   Days after vaccination:3
Submitted: 2017-12-24
   Days after onset:34
Entered: 2017-12-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 178102 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Monoparesis, Polyneuropathy, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-10
   Days after onset: 20
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: 201703592

Write-up: This serious initial spontaneous case, was received from a physician via health authority (RNF: IT-IT-MINISAL02-442255) on 14-Dec-2017, concerning a 77-year-old, elderly male patient. On 17-Nov-2017, the patient was administered with AGRIPPAL (dose: 0.5 ml, batch number: 178102, route of administration, anatomical location, expiry date: 31-Jul-2018). On 20-NOV-2017, after 4 days of vaccination, the patient had respiratory arrest, hyposthenia, polyneuropathy, Guillain Barre syndrome and limb paresis. On 10-Dec-2017, the patient died and it was unknown whether the autopsy was performed or not. The reporter assessed the events as serious due to death.


VAERS ID: 731999 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pyrexia (A peak of temperature at 40 C the day before vaccination.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017544363

Write-up: This is a spontaneous report from non-contactable consumer received via a Pfizer colleague of legal division in form of a letter from a community of victims, or relatives of victims, of vaccination accidents, sent to the agency. This document reported 17 vaccine "accidents" among them 7 included vaccination with PREVENAR 13. This is the 5th of 7 reports. A 6-month-old female patient of unspecified race/ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation and the 2nd dose of INFANRIX QUINTA, via an unspecified route of administration, on an unspecified date at 4:30 PM, at unspecified dose, for immunisation. The patient previously received the 1st dose of INFANRIX QUINTA 3 months earlier for immunisation. Relevant medical history included a peak of temperature at 40 C the day before vaccination. Concomitant medications, if any, were not reported. On an unspecified date at 03:00 am (presumably the day after vaccination) the patient died (death time estimated based on body temperature and rigor mortis). Emergency services first thought of child abuse but autopsy concluded to unexplained sudden infant death. No follow-up attempts are possible, information about lot number cannot be obtained. Reported Cause(s) of Death: unexplained sudden infant death; Autopsy-determined Cause(s) of Death: unexplained sudden infant death.


VAERS ID: 732111 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-14
Onset:2017-11-19
   Days after vaccination:5
Submitted: 2017-12-27
   Days after onset:38
Entered: 2017-12-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC606BD / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Arthralgia, Asthenia, Atrial fibrillation, Blood creatinine increased, Blood pressure normal, Blood urea increased, Cardiac arrest, Cerebral ischaemia, Coma scale abnormal, Computerised tomogram head abnormal, Death, Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Fibrin D dimer increased, Focal dyscognitive seizures, Glomerular filtration rate decreased, Heart rate increased, International normalised ratio increased, Oxygen saturation decreased, Platelet count decreased, Procalcitonin increased, Prothrombin time prolonged, Pyrexia, Respiratory failure, Sepsis, Troponin I increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARANESP; FERRLECIT; FRAXIPARINE
Current Illness: Obesity; Arteriosclerosis; Epilepsy; Anaemia; 1989, Insulin-requiring type 2 diabetes mellitus; Hypertension
Preexisting Conditions: 2007, Skin ulcer; 2011, Leg amputation; 2006, Deep vein thrombosis; 2006, Nasopharyngitis; 08/2017, Cataract operation; Chronic kidney disease; 2013, Diabetic retinopathy; Diabetic nephropathy; 1998, Deep vein thrombosis; 2015, Transfusion
Allergies:
Diagnostic Lab Data: 11/18/2017, Blood creatinine, 584 umol/L; 11/19/2017, Blood creatinine, 651 umol/L; 11/18/2017, Blood pressure measurement, 120/70 mmHg; 11/18/2017, Blood urea, 22.61 mmol/L; 11/19/2017, Blood urea, 25.38 mmol/L; 11/18/2017, Coma scale, 1-1-1; 11/18/2017, Computerised tomogram head, signs of chronic ischaemia, but no acute alteration; 11/18/2017, Electrocardiogram, fibrillation auricularis, repolarization disorder, no signs of ischaemia; 11/18/2017, Fibrin D dimer, 9656.16 ng/mL; 11/18/2017 Glomerular filtration rate, 8 mL/min; 11/19/2017 Glomerular filtration rate, 7 mL/min; 11/18/2017, Heart rate, 130/min; 11/18/2017, International normalised ratio, 1.68; 11/18/2017, Oxygen saturation, 72%; 11/18/2017, Platelet count, 47 g/L; 11/18/2017, Procalcitonin, 29.92 ng/mL; 11/18/2017, Prothrombin time, 19.5 s; 11/18/2017, Troponin I, 68.2 ng/mL
CDC Split Type: HU2017197812

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 61-year-old male patient who received ENGERIX B (batch number AHBVC606BD, expiry date unknown). The patient''s past medical history included ulcus cruris (in 2007), above knee amputation (in 2011), deep vein thrombosis (in 2006), cold symptoms (in 2006), cataract operation (In August 2017), chronic renal failure, diabetic retinopathy (in 2013), diabetic nephropathy, deep vein thrombosis (In 1998) and transfusion (In 2015). Concurrent medical conditions included obesity, atherosclerosis, epilepsy, anemia, insulin-requiring type 2 diabetes mellitus (in 1989) and hypertension. Concomitant products included FRAXIPARINE, ARANESP and FERRLECIT. On 14th November 2017, the patient received ENGERIX B (intramuscular) 1 ml. On 188th November 2017, 4 days after receiving ENGERIX B, the patient experienced consciousness disturbed (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), respiratory failure (serious criteria hospitalization, GSK medically significant and other: serious as per reporter), weakness (serious criteria hospitalization and other: serious as per reporter), fever (serious criteria hospitalization), partial epilepsy (serious criteria hospitalization, GSK medically significant and other: serious as per reporter) and joint pain. On 19th November 2017, the patient experienced cardiac arrest (serious criteria death, hospitalization, GSK medically significant and other: serious as per reporter). On an unknown date, the patient experienced senticemia (serious criteria hospitalization, GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the cardiac arrest was fatal and the outcome of the septicemia was unknown and the outcome of the consciousness disturbed, respiratory failure, weakness and joint pain were not recovered/not resolved and the outcome of the fever and partial epilepsy were recovered/resolved. The patient died on 19th November 2017. The reported cause of death was cardiac arrest. An autopsy was not performed. It was unknown if the reporter considered the cardiac arrest, septicemia, consciousness disturbed, respiratory failure, weakness, fever, partial epilepsy and joint pain to be related to ENGERIX B. Additional information: Co-suspect products included 3FLUART solution for injection (batch number N1917, expiry date unknown). Age at vaccination was not provided. Initial information was reported by a physician via regulatory authority on 21st December 2017: Cardiac arrest, Septicaemia, Consciousness disturbed, Respiratory failure, Weakness, Fever, Joint pain, Partial epilepsy. Sender''s Comment: Generic symptoms including fever, joint pain, weakness are expected for both vaccines. Convulsion is a known risk of ENGERIX-B. Although the events occurred within 1 month of vaccination, they could be more likely explained by an ongoing septicaemia. The patients underlying diseases and poor health could provide a probable explanation for the sudden worsening in his condition eventually leading to his death. In accordance with the investigators opinion, all events are considered unlik...


VAERS ID: 732124 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-28
Entered: 2017-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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: DE2017GSK200698

Write-up: This case was reported by a physician via call center representative and described the occurrence of stroke in an unspecified number of adult patients who received INFLUSPLIT TETRA. On an unknown date, the patient received INFLUSPLIT TETRA at an unknown dose. On an unknown date, 28 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The reported cause of death was stroke. It was unknown if the reporter considered the stroke to be related to INFLUSPLIT TETRA. Additional information was provided as follows: The age at vaccination was not reported. At the beginning of October 2017, the physician started vaccinating patients with INFLUSPLIT TETRA. At review of documentations, the physician noticed that approximately 10 to 15 patients (older than sixty years) experienced stroke approximately four weeks after vaccination and died. The autopsy details were not provided. Batch number was requested.


VAERS ID: 732232 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-02
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
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131712FRA012749

Write-up: Information has been downloaded from database (FR-GLAXOSMITHKLINE-FR2017GSK195603). This spontaneous report was received from a consumer refers to a 14 month old patient of unknown gender. On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally for prophylaxis. Other suspect therapies included INFANRIX HEXA and PREVENAR 13. On an unknown date the patient experienced pneumocystis, encephalitis, post transfusion purpura, thrombocytopenia and necrosis. The outcome of pneumocystis, encephalitis, post transfusion purpura, thrombocytopenia and necrosis was reported as fatal. Causality assessment was not reported. The case was serious as all the events were considered as medically significant and these events led to death.


VAERS ID: 732287 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-26
Entered: 2018-01-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 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: TR2017GSK197653

Write-up: This case was reported in a literature article and described the occurrence of death nos in a subject who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, immediately after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed death nos. Serious criteria included death and GSK medically significant. The outcome of death nos was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the death nos may have been caused by Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided. This case was reported in a literature article and described death NOS in a patient aged between 11 and 42 years of unspecified gender who was vaccinated with unspecified human papilloma virus (HPV) vaccine (manufacturer unknown). The patient was a part of the study to analyse the death case after HPV vaccination. Vaccine Adverse Events Reporting System (VAERS) Database was assessed from 2006 to 2016 for all death cases following any kind of HPV vaccination. The possible causes of deaths were discussed. Out of 175 deaths after HPV vaccinations, 122 were of female, 7 were of male. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On unspecified dates, the patient received unspecified HPV vaccines (administration site and route unspecified; dosages unknown; batch number not provided). The age of vaccinations was not provided. On an unspecified date between 2006 to 2016, just after the 2nd dose of vaccination, the patient died. [In this study, possible causes of death such as sudden collapse, seizure and anaphylaxis were reported in 15 patients. Out of 175, 110 were reported by non-physicians, 65 were reported by physicians]. Most of the records were submitted (The cause of death was unknown. It was not reported if an autopsy was performed). This case has been conditioned serious due to death. The authors commented "Only one of 175 death cases seems to be associated with vaccination". The authors concluded "Safety of VAERS data about HPV vaccination is a controversial issue. Only one of 175 death cases seems to be associated with vaccination. Encouragement of girls and boys and their families about HPV vaccination should be recommended".


VAERS ID: 732290 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-02
Entered: 2018-01-02
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
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis, Pneumocystis jirovecii pneumonia, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), 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: FR2017201032

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of unknown cause of death in a 2-month-old female patient who received INFANRIX HEXA. Co-suspect products included Rotavirus vaccine and PREVENAR 13. On an unknown date, the patient received INFANRIX HEXA (unknown). On an unknown date, less than a year after receiving INFANRIX HEXA and Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death, GSK medically significant and other), encephalitis (serious criteria GSK medically significant and other), pneumocystis (serious criteria GSK medically significant and other) and purpura thrombocytopenic (serious criteria other). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the encephalitis, pneumocystis and purpura thrombocytopenic were not recovered/not resolved. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, encephalitis, pneumocystis and purpura thrombocytopenic to be related to INFARNIX HEXA and Rotavirus vaccine. Additional information: The age at vaccination was not reported. According to Imputability Method, for PREVENAR 13 causality was reported as C1S1. Initial information was received from a consumer via regulatory authority on 28th December 2017: Unknown cause of death, encephalitis, pneumocystis and purpura thrombocytopenic.


VAERS ID: 732304 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-12-29
Entered: 2018-01-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA279AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, 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: Peripheral vascular disorder; Hypertension; Chronic obstructive pulmonary disease; Myocardial ischaemia; Diabetes mellitus; Hepatitis C
Preexisting Conditions: Influenza vaccine, Prophylaxis; Cardiac arrest, several cardiac arrests and resuscitation was required
Allergies:
Diagnostic Lab Data: 2017, Computerised tomogram, not available unknown
CDC Split Type: IL2017GSK201505

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 60-year-old male patient who received FLUARIX TETRA (batch number AFLBA279AA, expiry date 31st August 2018). The patient''s past medical history included cardiac arrest (several cardiac arrests and resuscitation was required). Previously administered products included Flu vaccine. Concurrent medical conditions included peripheral vascular disease, hypertension, chronic obstructive pulmonary disease, ischemic heart disease, diabetes and hepatitis C. On an unknown date, the patient received FLUARIX TETRA (intramuscular). On an unknown date, 3 days after receiving FLUARIX TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died in 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death to be related to FLUARIX TETRA. Additional details were reported as follows: The age at vaccination was not reported, but could be 59 or 60 year old. This report was received from epidemiological department in the Ministry of Health. In 2017, the patient received FLUARIX TETRA. The patient''s last visit at his family physician was on 7th November 2017, for receiving referrals for tests and prescriptions for medications for hepatitis C treatment. After clarification with the police, they were called to the deceased''s house by the neighbors after he had not been seen for two days. The deceased was transferred to the forensic medicine, no autopsy was performed and no tests were performed. Tomography scan was performed (the ministry of health did not had the results). Date and cause of death were not known. The Ministry of Health would update if additional information was received. No Regulatory authority reference number was provided.


VAERS ID: 732321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-08-23
Submitted: 0000-00-00
Entered: 2018-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: No adverse event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
   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: LEFAX /00282601/; CARUM CARVI
Current Illness: Meteorism
Preexisting Conditions: Medical History/Concurrent Conditions: Atopy (allergic diathesis due to sister''s atopy syndrome); Hypersensitivity; Passive smoking; Plagiocephaly; Restlessness (since birth)
Allergies:
Diagnostic Lab Data: Test Date: 2017; Test Name: Body temperature; Result Unstructured Data: Test Result: up to 40 degree C; Test Date: 20170818; Test Name: Body temperature; Result Unstructured Data: Test Result: normal
CDC Split Type: DEPFIZER INC2017554037

Write-up: This is a spontaneous report from a non-contactable physician, downloaded from the Medicines Agency (MA) WEB [other manufacturer number DE-DCGMA-17174923]. A 3-month-old female patient of an unspecified ethnicity received on an unspecified date in 2017 for prophylactic vaccination, intramuscular PREVENAR 13 at single dose, oral ROTARIX at 1 DF and intramuscular INFANRIX HEXA at 1 DF. Patient was the 4th child in the family. Medical history included hypersensitivity, plagiocephaly, passive smoking, restlessness since birth, atopy (allergic diathesis due to sister''s atopy syndrome) and ongoing meteorism. Concomitant medication included dimeticone, silicon dioxide, colloidal (LEFAX) for meteorism and carum carvi for restlessness. Body temperature on 18Aug2017 was normal.On 23Aug2017 the patient experienced restlessness after food intake, exitus letalis and fever, all considered fatal. It was reported that events restlessness after food intake, exitus letalis and fever resulted in death and concurrently that cause of death was unknown. The patient died on 23Aug2017 and it was not reported if an autopsy was performed. Reporter''s comments: "2 days after vaccination (in 2017) fever up to 40 ? C for 24-48 hrs, then spontaneous decline in body temperature ;on the day of the exitus behavior as usual, restlessness after food intake, after lying down for afternoon nap in side position due to plagiocephaly, child was found 45 minutes later in a prone position avital. Measures: resuscitation." Assessment between suspect vaccines (pneumococcal 13-val conj vaccine and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid) and the events (Exitus letalis, Restlessness and fever) was unclassifiable for PEI. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Restlessness after food intake/restlessness since birth; Exitus letalis; fever; Restlessness after food intake.


VAERS ID: 732645 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-07
Onset:2017-12-19
   Days after vaccination:12
Submitted: 2018-01-04
   Days after onset:16
Entered: 2018-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA279AA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-19
   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: No other medications
Current Illness: Hypertension; Autoimmune thyroiditis; Psoriasis, treated with methotrexate
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL2017GSK201506

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death in a adult male patient who received FLUARIX TETRA (batch number AFLBA279AA, expiry date 31st August 2018). Concurrent medical conditions included hypertension, Hashimoto''s disease and psoriasis (treated with Methotrexate). On 7th December 2017, the patient received FLUARIX TETRA (intramuscular). On 19th December 2017, 12 days after receiving FLUARIX TETRA, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 19th December 2017. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to FLUARIX TETA. Additional details were provided as follows: This report was received via the Epidemiological Department in the Agency. The age at vaccination was not reported. The patient was treated with Methotrexate for psoriasis (unknown if concomitant or historical drug). Cause of death was not reported. Since this was the second death report on FLUARIX TETRA vaccination with the same batch number, and in both cases the patients were vaccinated in the same clinic, the Agency requested information from the manufacturer on death cases and severe events reported globally on FLUARIX TETRA vaccine in general, and on this batch in particular; also, whether this batch was marketed in other countries. The Agency would update if additional information was received. No regulatory authority reference number was provided. This case was linked with the case IL2017GSK201505, reported by the same reporter. Upon internal review following correction was performed on 27th December 2017: This case is not linked with case IL2017GSK201505, case linking has been removed.


VAERS ID: 732749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017555546

Write-up: This is a spontaneous report from a non-contactable consumer via GLAXOSMITHKLINE (manufacturer control number FR-GLAXOSMITHKLINE-FR2017GSK195599). This reported was downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number not provided. A 6-month-old female patient of an unspecified ethnicity received PREVENAR (Lot number unknown) and INFANRIXQUINTA (Lot number unknown), via unspecified routes of administration on unspecified dates as single doses for immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received diphtheria vaccine toxoid, hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid for prophylaxis and experienced fever. The patient experienced drug dose administration interval too long which was medically significant and unexplained sudden infant death on an unspecified date. The action taken in response to the event(s) for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable and for diphtheria vaccine toxoid, hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid was not applicable. The patient died on an unspecified date. An autopsy was performed and results were not provided. Causality assessment between suspect product and events was reported as C1S1 based on French imputability method. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-GLAXOSMITHKLINE-FR2017GSK196633; Reported Cause(s) of Death: Sudden infant death syndrome.


VAERS ID: 733227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Complement deficiency disease, Complement factor C3, Complement factor C4, Complement factor abnormal, Death, Meningococcal infection, Purpura fulminans, Total complement activity decreased, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis of face; Measles; Meningitis; Otitis media acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2018SA003471

Write-up: Initial unsolicited report received from a literature on 03 Jan 2018. The following is the abstract from the article: We report on the case of fatal "purpura fulminans" caused by Neisseria meningitidis W135 that occurred in a young soldier vaccinated a few months earlier with the tetravalent conjugate vaccine ACYW135. Biological investigations revealed adequate titers of postvaccination antibodies against serogroups A, C, and W135 and led to the post-mortem diagnosis of a complete C7 complement deficiency. Late complement component deficiency is a well-known risk factor of meningococcal diseases, but usually exposes to recurrent mild infections, whereas severe invasive meningococcal diseases are more likely to occur among properdin-deficient patients. Awareness of the potentially life-threatening nature of late complement component deficiency should lead to improved diagnosis among young people, especially when past medical history reveals recurrent mild infections. This case involves 20 years old male patient who was injected with dose of MENINGOCOCCAL VACCINE (TETRAVALENT ACYW135 CONJUGATE MENINGITIS VACCINE) (batch number, expiry date, route and site of administration were not reported) on an unspecified date according to the immunization schedule. His past medical history was significant for several infectious diseases (nondocumented meningitis during childhood, measles and acute otitis media) and a recent case of cellulitis on the face. He had never been sent on any mission outside his country since his integration. Concomitant medication was not reported. On an unspecified date, post vaccination patient had, purpura fulminans caused by Neisseria meningitidis W135. In October 2012, the health authorities notified the Center for Epidemiology and Public Health that a young person had died from purpura fulminans a few hours earlier in a hospital. It was also a case of vaccination failure. Human serum bactericidal activity tests were performed by the Institute laboratory. The patient had an undetectable CH50 level: C3, C4, C5, C6, and C8 levels were normal, but C7 was undetectable. Further biological investigations confirmed the diagnosis of a complete homozygous deficiency in C7 complement, which led to screening among his family (results not available). No sample before the vaccination was available, but post-mortem immunological analysis suggested that the vaccine injection had been followed by an immune response and an increase of antibody titers, except against serogroup Y (human serum bactericidal activity titer at 2). Corrective treatment was not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: Neisseria meningitidis infection NOS. List of documents held by sender: none.; Sender''s Comments: Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. This report of fatal purpura fulminans caused by meningococcemia represents a confirmed vaccine failure to serogroup W135. The patient was an employee (congregate housing such as dorms, etc. is known to increase the risk of contracting Neisseria meningitidis) who had a significant history for several infectious diseases including but not limited to nondocumented meningitis during childhood. Importantly, additional testing revealed complement deficiency (complete homozygous deficiency in C7 complement). Persons who have persistent (i.e., genetic) deficiencies in the common complement pathway have an increased risk for meningococcal disease and can experience recurrent disease. A point of further consideration is that the name of the manufacturer of the specific Meningococcal ACYW135 vaccine was unknown.; Reported Cause(s) of Death: purpura fulminans caused by Neisseria meningitidis W135; Autopsy-determined Cause(s) of Death: purpura fulminans caused by Neisseria meningitidis W135.


VAERS ID: 733418 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-10
Entered: 2018-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:, 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: No other medications
Current Illness: Asplenia, congenital asplenia; Atrioventricular septal defect; Double outlet right ventricle; Anomalous pulmonary venous connection, Total anomalous pulmonary venous return
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test performed on an unspecified date in 2006, the laboratory investigation revealed Streptococcus pneumoniae.
CDC Split Type: KR2018GSK002396

Write-up: This case was reported in a literature article and described the occurrence of pneumococcal bacteremia in a 68-month-old male subject who received Hib vaccine. Concurrent medical conditions included asplenia, atrioventricular septal defect, double outlet right ventricle and total anomalous pulmonary venous connection. On an unknown date, unknown after receiving Hib vaccine, the subject developed pneumococcal bacteremia. Serious criteria included death and GSK medically significant. The outcome of pneumococcal bacteremia was fatal. The reported cause of death was pneumococcal bacteremia. The investigator considered that there was a reasonable possibility that the pneumococcal bacteremia may have been caused by Hib vaccine. Relevant Tests: Lab test performed on an unspecified date in 2006, the laboratory investigation revealed Streptococcus pneumoniae. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumococcal bacteremia in a 68-month-old male who was vaccinated with unspecified Hib vaccine (manufacturer unknown). The patient was a part of a retrospective study that included children with asplenia who were treated at institute January 1997 and December 2016. [In this study, 61 were male patients among those with congenital asplenia. None of the six patients with invasive bacterial infection had chemoprophylaxis or proper vaccinations]. The patient had congenital asplenia. The patient''s co-morbidity included: atrio-ventricular septal defect (AVSD), double outlet of right ventricle (DORV), total anomalous of pulmonary venous return (TAPVR). The patient had not received any chemoprophylaxis. No information on patient''s family history was provided. On an unspecified date, the patient received unspecified Hib vaccine (administration site and route unspecified; dosages unknown; batch number not provided). It was reported that the patient had completed Hib vaccinations. The age of vaccination was not provided. On an unspecified date in 2006, an unknown period after vaccination, the patient had bacteraemia. The laboratory investigation revealed Streptococcus pneumoniae. [In this study, a total of 6 episodes were observed in 5 patients with congenital asplenia]. On an unspecified date, the patient died due to pneumococcal bacteraemia. It was unknown if an autopsy was performed. Treatment was unknown. The authors did not comment on the event of bacteraemia and Streptococcus pneumoniae infection and unspecified Haemophilus influenzae type B vaccine. The authors concluded "Although there is an increased risk of a severe infection proper vaccinations and chemoprophylaxis are still lacking. Physicians should be encouraged to implement appropriate chemoprophylaxis and immunisations for patients with asplenia".


VAERS ID: 734034 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79394 / 4 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Serology positive
SMQs:, 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:
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: serotype 3
CDC Split Type: DEPFIZERINC2018015279

Write-up: A 4 year-old female subject of an unspecified race and ethnicity received for immunization PREVENAR 13) at single doses, the first dose (lot F72853) at the age of 4 months, the second dose (lot F93511) at the age of 5 months, the third dose (lot F32598) at the age of 6 months, and the fourth dose (lot G79394) at the age of 15 months. The subject was not preterm born, had no immune deficiency and no chronic diseases. Concomitant medications were not reported. On an unspecified date in 2017 the subject experienced pneumococcal meningitis due to which died on an unspecified date. Serotype 3 was detected by CSF serology test. It was not reported if an autopsy was performed. The reporter''s assessment of the causal relationship of the event pneumococcal meningitis (serotype 3) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: pneumococcal meningitis (serotype 3); pneumococcal meningitis (serotype 3).


VAERS ID: 734242 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-16
Onset:2017-12-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Malaise, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-25
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA012100

Write-up: Initial unsolicited report received from a consumer or non-healthcare professional (via email) (unspecified relationship with the patient), which forwarded a report from a Social Media on 12-Jan-2018. This case is linked with: 2018SA012101, 2018SA012103, 2018SA012104, 2018SA012105, 2018SA012108, 2018SA012107, 2018SA009914. (Same reporter). This case involves a 40-year-old patient (gender reported as male), who was vaccinated with YELLOW FEVER VACCINE (batch number, dose, route and site of administration nor reported) on 16-Dec-2017. Patient''s medical history and concomitant medication were not reported. It was also informed that the patient''s brother died with identical symptoms 10 years ago. On 19-Dec-2017 (estimated), three days after the vaccination, patient experienced malaise with strong headaches. The patient went to the emergency room at least 2 times and after receiving unspecified corrective treatment, the pains stopped. It was informed that the patient was hospitalized and on 25-Dec-2017, nine days after the vaccination, patient died. The patient was transferred to the hospital where he died without finding out the causes. Relevant lab test and other corrective treatment were not reported. Outcome of malaise with strong headaches were not reported. Patient recovered from pain. It was not informed whether autopsy was performed or not. The cause of death was not revealed, but the main suspect was that it was a reaction to the vaccine. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed case, reported from social media and that occurred in December 2017. Reportedly, a 40 year old male patient experienced 3-days post-vaccination malaise with strong headache and died 9 days after receipt of Yellow fever vaccine (manufacturer unknown). The cause of death was not reported. Patient''s past medical history, health status at the time of vaccination, as well as results of investigations (etiological, infectious work-up, autopsy) are needed for further assessment of the case. Based upon available information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: a reaction to the vaccine.


VAERS ID: 734243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Contraindication to vaccination, Death, Product use issue
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hemodialysis; Lupus syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA012101

Write-up: Initial unsolicited report received from consumer (unspecified relationship with the patient) on 12-Jan-2018. This case is linked with 2018SA012100 (S-408 A), 2018SA012103 (S-408 C), 2018SA012104 (S-408 D), 2018SA012105 (S-408 E), 2018SA012107 (S-408 F), 2018SA012108 (S-408 G) and 2018SA009914 (Same reporter). This case involves female patient who was (currently 39 years old) who was vaccinated with dose of YELLOW FEVER VACCINE (batch number, expiry date, route and site of administration were not reported) on an unspecified date in half of Jan-2017 as she would go camping on a risky area. The patient''s premedication, and concomitant medication were not reported. Patient looked for a physician as she had lupus and was performing hemodialysis. On an unspecified date, post vaccination patient died on 21-Jan-2017 after developing an unspecified serious adverse event. It was a case of product use issue situation. As it was assessed based on local leaflet of the vaccine, which informs the vaccination is contraindicated for patient with congenital immunodeficiency or acquired that harm the cellular immunity. The State Health Secretary mentioned that it was believed that the patient was experiencing low immunity and, for this reason, had problems with the vaccine. It was informed that the government took all the necessary measures to the adequate investigation of the case and ordered unspecified specific laboratory tests (results were not provided). Corrective treatment was not reported. The physician said the risk of the patient dying from the vaccine was smaller than dying due the disease. It was not reported whether autopsy was performed. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed case, reported from social media and that occurred in January 2017. Reportedly, a 39 year old female patient with ongoing medical history of lupus and hemodialysis, died approximately 1 week after vaccination with YF vaccine (manufacturer unknown) indicated for travel. Symptoms and their evolution and results of investigations (etiological, autopsy) were not reported. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Unspecified serious adverse event.


VAERS ID: 734244 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse reaction, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-14
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: BRSA2018SA012103

Write-up: Initial unsolicited report received from a consumer (unspecified relationship with the patient) via social media on 12-Jan-2018. This case is linked with: 2018SA012101, 2018SA012100, 2018SA012104, 2018SA012105, 2018SA012108, 2018SA012107, 2018SA009914. (same reporter). This case involves an 81-year-old male patient, who was vaccinated with YELLOW FEVER VACCINE (batch number, dose, route and site of administration not reported) on 08-Jul-2008. No information regarding premedication, concomitant medication or previous therapy was provided. On an unknown date (reported as last 14), six days after the vaccination, patient died due to an unspecified reaction. The diagnosis was confirmed by a hospital. It was also informed that the patient had no contraindication to the vaccine. Relevant lab test and corrective treatment was not reported. It was not reported whether autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed retrospective case (occurring in 2008), reported from social medial. Reportedly, a 81 year old male patient died 6 days after vaccination with YF vaccine (manufacturer unknown) indicated for travel. Patient''s medical history, immune status at the time of vaccination, symptoms and their evolution, cause of death, results of investigations (etiological, autopsy) are needed for further assessment of the case. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: died due to an unspecified reaction.


VAERS ID: 734245 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Yellow fever vaccine-associated viscerotropic disease
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA012107

Write-up: Initial unsolicited report received from a consumer (unspecified relationship with the patient) via social media on 12-Jan-2018. This case is linked with 2018SA012101, 2018SA012100, 2018SA012103, 2018SA012104, 2018SA012105, 2018SA012108, 2018SA009914 (Same reporter). This case involves a 20-year-old female patient who was vaccinated with a dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient''s medical history, premedication, and concomitant medication were not reported. It was reported that the patient was not ill until receiving the vaccine. On an unknown date, following the vaccination, the patient had experienced acute viscerotropic disease. The patient was admitted to hospital on an unknown date. On an unknown date, the patient was died due to the reaction, acute viscerotropic disease, which was considered as rare. It was informed that the virus penetrated the liver tissue and that the science did not explain why instead of protecting the patient, the vaccine with the weakened virus, infected the patient. Laboratory investigations and corrective treatments were not reported. It was not reported if autopsy was performed or not. It was not reported if the patient''s physician was aware of this case. The case was also considered as serious as the patient died due to the event. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed case, reported from social media and that occurred on unspecified date. Reportedly, a 20 year old female patient died from YEL-AVD on unspecified time after vaccination with Yellow fever vaccine (manufacturer unknown). It was reported that vaccine virus penetrated liver tissue. Patient''s medical history, immune status at the time of vaccination, time to onset, symptoms and their evolution, time to death, detailed results of investigations (etiological, confirmatory for the diagnosis, autopsy) are needed to further assess this case. Reported Cause(s) of Death: Acute viscerotropic disease.


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