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VAERS ID: 643932 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-30
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: WAES1606MYS014042

Write-up: Information has been received from the author of a literature. The aims of this retrospective study were to characterize the adverse drug reactions (ADRs) reported in respect to the local paediatric population and to relate the data to specific paediatric age groups. Methods: Data on all ADRs reported to the Agency between 2000 and 2013 for individuals aged from birth to 17 years old were analyzed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR. Results: In total, 11,523 ADR reports corresponding to 22,237 ADRs were analyzed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in female (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities. Discussion: ADR reports concerning vaccines and anti-infectives were the most commonly reported in children and were mainly seen in adolescents with the most of the ADRs manifesting in skin reactions. The majority of the ADR reports were received from nurses in the public sector reporting ADRs associated with vaccine administration. The low fatality rate of ADR cases reported could potentially be caused by reporting bias due to the very low reporting percentage from the private health care institutions. This study indicated that ADR rates among the local children were higher than in developed countries. Constant ADR reporting and monitoring especially in respect to paediatric patients should be undertaken to ensure their safety. This report refers to a 1 month old female patient who enrolled in this retrospective study. The patient''s concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (lot#, dose and route were unspecified). In 2009 the patient experienced vomiting and then died on an unknown date of the same year. The cause of death was unknown. It was unknown if autopsy was performed or not. The outcome of vomiting was unspecified. The reporter considered that the hepatitis B vaccine (recombinant) (manufacturer unknown) might be contributory to the vomiting and death (unknown cause). Upon internal review, death was determined to be medically significant. This is one of three reports from the same literature (Linked report MARRS # 1606MYS014041 and 1606MYS013504). Additional information has been requested.


VAERS ID: 643933 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-30
Entered: 2016-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Streptococcal infection
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606MYS013504

Write-up: Information has been received from the author of a literature. The aims of this retrospective study were to characterize the adverse drug reactions (ADRs) reported in respect to the local paediatric population and to relate the data to specific paediatric age groups. Methods: Data on all ADRs reported to the Agency between 2000 and 2013 for individuals aged from birth to 17 years old were analyzed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR. Results: In total, 11,523 ADR reports corresponding to 22,237 ADRs were analyzed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in female (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities. Discussion: ADR reports concerning vaccines and anti-infectives were the most commonly reported in children and were mainly seen in adolescents with the most of the ADRs manifesting in skin reactions. The majority of the ADR reports were received from nurses in the public sector reporting ADRs associated with vaccine administration. The low fatality rate of ADR cases reported could potentially be caused by reporting bias due to the very low reporting percentage from the private health care institutions. This study indicated that ADR rates among the local children were higher than in developed countries. Constant ADR reporting and monitoring especially in respect to paediatric patients should be undertaken to ensure their safety. This report refers to a 7 month old male patient who enrolled in this retrospective study. The patient''s concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, dose and route were unspecified). In 2011 the patient experienced fatal adverse reaction (infection streptococcal). It was unknown if autopsy was performed or not. The reporter considered the infection streptococcal to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of three reports from the same literature (Linked report MARRS # 1606MYS014041 and 1606MYS014042). Additional information has been requested.


VAERS ID: 641455 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-01
Entered: 2016-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Gaze palsy, Hypotonic-hyporesponsive episode, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: MYSA2016SA119790

Write-up: Initial unsolicited report received from the literature on 22 June 2016. This case is linked to 2016SA119778, 2016SA119785, 2016SA119796. (same literature). The following is verbatim from the article: Background: Spontaneous reporting on adverse drug reactions (ADR) has been established since 1987, and although these reports are monitored by the drug monitoring authority, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the paediatric population and to relate the data to specific paediatric age groups. Methods: Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR. Results: In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7 percent of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9 percent of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7 percent). The most common ADRs reported were from the following system organ classes: application site disorders (32.2 percent), skin and appendages disorders (20.6 percent), body as a whole general disorders (12.8 percent) and central and peripheral nervous system disorders (11.2 percent). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0 percent) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4 percent). Only 0.28 percent of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities. This case involves a two months old male patient who was vaccinated with a dose of Dtp-Hib, a dose of POLIOMYELITIS VACCINE (ORAL) and a dose of POLIOMYELITIS VACCINE (INACTIVATED) (manufacturer: unknown, batch number, expiry date, route, dose and site of administration: not reported for all vaccines) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2010, following the vaccination, the patient had abnormal crying, hypotonic-hyporesponsive episode, fits, eyes gaze upward and fever leading to death. Lab data and corrective treatments were not reported. On an unspecified date, patient died. It was unknown whether autopsy was performed. Documents held by sender: none. Sender''s Comments: This is a poorly documented death case of a 2-months-old male child who died on an unknown date after receiving a DTP-Hib vaccine and a polio vaccine. It is not specified whether this infant received an oral or an inactivated polio vaccine. The child was abnormally crying and had hypotonic-hyporesponsive episode, fits, eyes gaze upward and fever. However, the cause of death is unknown. No information is provided on conditions at the time of death, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, time to onset, autopsy and results of investigations, etc. This case of unexplained death is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: fever; hypotonic-hyporesponsive episode; fits.


VAERS ID: 644197 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-04
Entered: 2016-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607GBR000606

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # GB-1577272925-2016006819) on 01-JUL-2016. Case received from a consumer/other non health professional on 28-JUN-2016. A 14-year-old male adolescent patient received live Measles, Mumps and Rubella Virus Vaccine, (batch number unknown) in 2008. It was reported that the reporter''s son had dies (death unexplained) 10 days after receiving MMR vaccine in 2008. The patient''s outcome was reported as Fatal.


VAERS ID: 644301 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2016-06-14
Onset:2016-06-17
   Days after vaccination:3
Submitted: 2016-07-04
   Days after onset:17
Entered: 2016-07-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC662A / 2 LG / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB291AA / 2 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: 2016-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK092960

Write-up: This case was reported by a physician via Agency and described the occurrence of sudden infant death syndrome in a 4-month-old female patient who received ROTARIX (batch number AROLB291AA, expiry date unknown). Co-suspect products included INFANRIX HEXA (batch number A21CC662A, expiry date unknown). Concomitant products included ROTARIX, INFANRIX HEXA and PREVENAR 13. On 14th June 2016, the patient received the 2nd dose of ROTARIX (oral) and 2nd dose of INFANRIX HEXA. On 17th June 2016, 3 days after receiving ROTARIX and INFANRIX HEXA, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death syndrome was fatal. The patient died on 17th June 2016. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to ROTARIX and INFANRIX HEXA. Additional details were provided as follows: Previous vaccinations with ROTARIX, INFANRIX HEXA and PREVENAR 13 were well tolerated. Concomitant medication was not reported. On 17th June 2016, the patient died. The cause of death were reported as a suspected sudden infant death syndrome (SIDS). It was not reported whether an autopsy was performed or not. Follow up had been requested by the regulatory authority.


VAERS ID: 644038 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-02-19
Onset:2016-03-04
   Days after vaccination:744
Submitted: 2016-06-30
   Days after onset:117
Entered: 2016-07-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J0453 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain herniation, Death, Drug ineffective, Headache, Intracranial pressure increased, Meningitis pneumococcal, Pyrexia, Streptococcus test positive
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: SS type, sickle cell anemia
Allergies:
Diagnostic Lab Data: 05-MAR-2016, Body temperature, fever; Lumbar puncture, pneumococcus serotype 19F
CDC Split Type: 2016317092

Write-up: This is a spontaneous report from a contactable healthcare professional received form the National Health Products Safety Agency (ANSM). Regulatory authority report number PS20160634. A 6-year-old female patient received a single dose by intramuscular route of the suspect products as immunization: PREVENAR (first dose on 17Nov2009 form unknown lot number; second dose on 29Dec2009 from unknown lot number; third dose on 27Mar2010 from lot number E06460, and PNEUMO 23 (first dose 21Nov2010 from unknown lot number; second dose on 19Feb2014 from lot number J0453-2). Relevant medical history included sickle cell disease, SS type. No concomitant medication was reported. On 04Mar2016, the patient experienced drug ineffective with pneumococcal meningitis that could have led to her death. Clinical details were as follows: On 06Mar2016, the patient was brought to the emergency unit for cephalgia for 72 hours and fever for 24 hours (05Mar2016). She presented with a clinical picture of febrile intracranial hypertension with signs of brain herniation. The patient died one hour after her arrival at the emergency unit. Lumbar puncture was performed after death and a sample was forwarded to pneumococcus national center. Pneumococcus strain was identified as serotype 19F. The final diagnosis was serotype 19F pneumococcal meningitis developed by a child previously vaccinated with pneumococcal 7-valen conjugate vaccine and pneumococcal 23-valent vaccine. Based on the Official Method of assessment, the causal relationships between the suspect products pneumococcal 7-valent conjugate vaccine and pneumococcal 23-valent vaccine and the adverse events drug ineffective and pneumococcal meningitis were assessed by the Agency as "possible". No follow-up attempts are possible. No further information is expected.


VAERS ID: 642088 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-11
Onset:2016-03-11
   Days after vaccination:0
Submitted: 2016-07-07
   Days after onset:117
Entered: 2016-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K12B / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1311 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14L02A / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Child abuse, Computerised tomogram head abnormal, Death, Fall, Haemorrhage intracranial, Resuscitation, Rib fracture, Subdural haematoma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Accidents and injuries (narrow), Hostility/aggression (narrow), Osteoporosis/osteopenia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA121528

Write-up: Initial unsolicited report received from a physician via regulatory authority (Ref: V16100248) on 29 June 2016. This case involves a 03-month-old male patient who was vaccinated with 0.5 ml first primary dose of ACTHIB (batch number: L1311) via subcutaneous route; with fist primary dose of DPT-IPV (batch number: 4K12B) and with first primary dose of PREVENAR13 (batch number: 14L02A) (expiry date, dose, route and site of administration were not reported) all on 11 March 2016 at around 10:20. The patient''s ongoing illness/medical history/risk factor was reported as eczema and dry skin. The patient''s family medical history was reported as none in particular. The body temperature before the vaccination was 36.6 Degree Celsius. The patient''s medication included Locoid Ointment, white petrolatum topical (ongoing, as corrective treatment for eczema and dry skin). On 11 March 2016, few hours following the vaccination (in the afternoon), the patient reportedly fell down while his sister was carrying him, subsequently; the patient went into cardio-respiratory arrest. He was transported to another medical center by an ambulance and resuscitated. On an unknown date, following the vaccination, the patient had intracranial haemorrhage, chronic subdural haematoma, rib fracture, and infant abuse was suspected. The patient''s laboratory data included CT scan of the whole body which was performed on admission showed chronic subdural haematoma, rib fracture, intracranial, haemorrhage, and infant abuse was suspected (confirmed as diagnosis). Corrective treatment was not reported. The outcome of cardio-respiratory arrest, intracranial haemorrhage, chronic subdural haematoma, rib fracture, reportedly fell down, infant abuse was not reported. On an unknown date the patient died. The cause of death was not reported (unspecified). It was unknown if the autopsy was performed. Upon internal review, the company decided to code the event cardio-respiratory arrest, intracranial haemorrhage, chronic subdural haematoma, rib fracture, and reportedly fell down, infant abuse was suspected which was mentioned in the narrative but was not coded by HA. Diagnosis: Death. Reporting physician''s seriousness assessment: Serious (Death). Reporting physician''s causality assessment: Unknown. Reporting physician''s comment: The alternative explanation for the event was possible infant abuse. The details were unknown because the patient did not revisit the reporting clinic after the vaccination, and his death was informed by his mother. The reporter saw the CT images his mother brought and confirmed the findings described above. List of documents held by sender: none. Sender''s Comments: This case concerns death of a 3-month-old male infant on an unspecified date following vaccination with HIB (PRP/T) VACCINE, DPT-IPV and Prevenar 13. Reportedly, the patient fell down while his sister carried him following which the patient went into cardio-respiratory arrest. CT scan revealed chronic subdural haematoma, rib fracture, intracranial haemorrhage. Infant abuse was suspected. However, the exact cause of death was not established. It was reported that several days later (on an unknown date), the infant died from an unspecified cause; Although the reported events could be likely the result of a trauma; further information on detailed autopsy reports and other medical history, etc. will be required to further assess the case. Based on the information available, a role of the vaccine seems unlikely. Reported Cause(s) of Death: he went into cardio-respiratory arrest; infant abuse was suspected; chronic subdural haematoma; died from an unspecified cause; he reportedly fell down; intracranial haemorrhage; rib fracture.


VAERS ID: 644293 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-11
Entered: 2016-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: MY2016GSK098314

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. Additional event(s) included vomiting with serious criteria of death. The outcome of unknown cause of death was fatal. The outcome(s) of the additional event(s) included vomiting (fatal). The investigator considered the unknown cause of death and vomiting to be possibly related to Hepatitis B vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of vomiting in a 1-month-old female patient who was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown). The patient was a part of a retrospective analysis of spontaneous adverse drug reactions (ADR) reports relating to paediatric patients reported to the drug monitoring authority between 2000 and 2013 maintained in the ADR reports database. ADRs on vaccines were most frequently reported by nurses (65.6%) followed by pharmacists (15.7%). For vaccines, ADRs were most commonly reported for adolescents aged between 12 and 17 years (88.3%), and more than 90% of these ADRs were experienced by female children. The highest number of ADRs reports was received from a specific state. There were 32 fatal ADRs (0.28%) during the study period with both drugs (n equal to 28) and vaccines (n equal to 4). No information on patient''s family history or medical history or concurrent condition or concomitant medication was provided. On an unspecified date between December 2008 and 2009, the patient received unspecified hepatitis B vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in 2009 at the age of 1 month, an unknown period after vaccination with unspecified hepatitis B vaccine, the patient experienced vomiting and subsequently died. The cause of death was not reported. It was unknown if an autopsy was performed. This case was considered serious due to death. The treatment for the event was not reported. The authors considered the events were possibly related to vaccination with hepatitis B vaccine. The authors concluded that "A sharp increase in ADR reporting in respect to children over the last 14 years was observed. The majority of ADRs reported for children were related to the use of vaccines and anti-infective in adolescents. In lieu of that, the prevalence of fatality caused by reported ADRs is lower than the benchmark of developed countries. Most suspected ADRs were related to vaccines, which is linked to the emerging role played by nurses in the spontaneous reporting of ADRs". This is 1 of the 4 valid cases reported in the same literature article.


VAERS ID: 644509 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-12
Entered: 2016-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dizziness, Encephalitis autoimmune, Generalised tonic-clonic seizure, Headache, Intensive care, Laboratory test normal, Lethargy, Malaise, Multiple organ dysfunction syndrome, Myalgia, Nausea, Status epilepticus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-23
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: Investigation into autoimmune encephalitis; Investigation, negative
CDC Split Type: GB2016097833

Write-up: This case was reported by a physician and described the occurrence of convulsive status encephalitis in a 16-year-old female patient who received Human papilloma type 16 + 18 vaccine. Additional patient notes included No prior history of seizures and no other cause found. In February 2016, the patient received Human papilloma type 16 + 18 vaccine (intramuscular). In March 2016, 10 days after receiving Human papilloma type 16 + 18 vaccine, the patient experienced convulsive status epilepticus (serious criteria death, hospitalization and GSK medically significant) and tonic-clonic seizures (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced multiple organ dysfunction syndrome (serious criteria death, hospitalization and GSK medically significant), myalgia (serious criteria hospitalization), lethargy (serious criteria hospitalization), headache (serious criteria hospitalization), nausea (serious criteria hospitalization), dizziness (serious criteria hospitalization), feeling unwell (serious criteria hospitalization) and encephalitis autoimmune (serious criteria hospitalization and GSK medically significant). On 23rd March 2016, the outcome of the convulsive status epilepticus was fatal. On an unknown date, the outcome of the multiple organ dysfunction syndrome was fatal and the outcome of the myalgia, lethargy, headache, nausea, dizziness, feeling unwell and encephalitis autoimmune were unknown and the outcome of the tonic-clonic seizures was not recovered/not resolved. The patient died on 23rd March 2016. The reported cause of death was multi-organ failure and convulsive status epilepticus. It was unknown if the reporter considered the convulsive status epilepticus, multiple organ dysfunction syndrome, myalgia, lethargy, headache, nausea, dizziness, feeling unwell, tonic-clonic seizures and encephalitis autoimmune to be related to Human papilloma type 16 + 18 vaccine. RA verbatim: From administration of the vaccine she complained of myalgia, lethargy, headaches, nausea, dizziness, feeling unwell. Approximately 10 days after the vaccine she had a tonic-clonic seizure, which within hours evolved into status epilepticus. This was resistant to drug treatment including anaesthetic drugs. She died from multi-organ failure secondary to status epilepticus after a period of time of intensive treatment on our Intensive Care Unit. She was treated for presumed autoimmune encephalitis, which remains the working diagnosis. However, this has not been confirmed as yet and all investigations to look for the cause of this have been negative (which can still be the case with this clinical scenario if autoimmune encephalitis). Her mother contacted me following her death to let me know in hindsight that she had the vaccine 10 days before onset of symptoms and had complained of feeling unwell since this injection.


VAERS ID: 644489 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-02-01
Onset:2016-03-01
   Days after vaccination:29
Submitted: 2016-07-13
   Days after onset:133
Entered: 2016-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dizziness, Encephalitis autoimmune, Generalised tonic-clonic seizure, Headache, Intensive care, Investigation, Lethargy, Malaise, Multiple organ dysfunction syndrome, Myalgia, Nausea, Status epilepticus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-13
   Days after onset: 133
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Investigation into autoimmune encephalitis
CDC Split Type: WAES1607GBR004196

Write-up: From administration of the vaccine she complained of myalgia, lethargy, headaches, nausea, dizziness, feeling unwell. Approximately 10 days after the vaccine she had a tonic-clinic seizure, which within hours evolved into status epilepticus. This was resistant to drug treatment including anaesthetic drugs. She died from multi-organ failure secondary to status epilepticus after a period of time of intensive treatment on our Intensive Care Unit. She was treated for presumed autoimmune encephalitis, which remains the working diagnosis. However, this has not been confirmed as yet and all investigations to look for the cause of this have been negative (which can still be the case with this clinical scenario if autoimmune encephalitis). Her mother contacted me following her death to let me know in hindsight that she had the vaccine 10 days before onset of symptoms and had complained of feeling unwell since the injection.


VAERS ID: 644180 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Male  
Location: Foreign  
Vaccinated:2016-07-01
Onset:2016-07-05
   Days after vaccination:4
Submitted: 2016-07-14
   Days after onset:9
Entered: 2016-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1Q05C / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER L010059 / 1 RL / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood test, Death, Imaging procedure, Laboratory test, Motor developmental delay, 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: 2016-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Psychomotor skills impaired
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607NLD005691

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # NL-1577272925-2016007321) on 13-JUL-2016. SUMMARY: SPECIFIC HISTORY: This moderately documented serious (Death) spontaneous case report from a community health service was received via the Health Authorities on 12-Jul-2016 under the reference number NL-LRB-222167. Case of special interest: fatal case. A 14-month-old male child patient received the first dose of M-M-RVAXPRO (therapy type: recombinant human albumin (rHA), lot number/batch number L010059, via subcutaneous route in the right thigh and the first dose of NEISVAC-C (lot number/batch number VNS1Q05C, administered via intramuscular route in the left thigh) on 01-Jul-2016. Concomitant medication was not reported. On 05-Jul-2016, the patient experienced sudden death of an unknown cause with a latency of 4 days (also reported as 5 days in the summary and the narrative of the case) after vaccination. There were no complaints before the event. PAST MEDICAL HISTORY / COMEDICATION / FAMILY HISTORY: The child had a slight delay in motor development (moved by hopping forward on the buttocks) wherefore he followed physiotherapy. The child had no adverse reactions on previous vaccinations (he had not received a similar vaccine yet). There was no history of heart disease in the family. PHYSICAL FINDINGS AND INVESTIGATIONS: Autopsy, blood, DNA and imaging tests were employed, but the results were not yet known. TREATMENT AND CLINICAL COURSE: The child was found lifeless in his bed after his afternoon nap. The ambulance was called and resuscitation was performed. The patient died on 05-Jul-2016. OUTCOME: The patient''s outcome was reported as fatal. CONCLUDING SUMMARY / KEY WORDS: male, 14 months, death, MMRVAXPRO, NEISVAC-C. CAUSALITY ASSESSMENT: Causality for the event and vaccinations were considered possible. The reporter was asked for additional information concerning the investigations that have been performed to determine the cause of death.


VAERS ID: 644451 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-02-23
Onset:2016-02-23
   Days after vaccination:0
Submitted: 2016-07-14
   Days after onset:141
Entered: 2016-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Body temperature fluctuation, Circulatory collapse, Death, Dizziness, Ear pain, Fatigue, Flushing, Glassy eyes, Intensive care, Lymph node pain, Lymphadenopathy, Malaise, Nausea, Otitis media, Pain in extremity, Pyrexia, Rash, Seizure, Somnolence, Status epilepticus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-23
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On unknown date, some tests were performed. Body temperature, 38 degree C
CDC Split Type: GB2016100292

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 16-year-old female patient who received Meningococcal ACWY Vaccine (potential MENVEO). On 23rd February 2016, the patient received Meningococcal ACWY Vaccine (potential MENVEO). On 23rd February 2016, immediately after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced dizziness (serious criteria hospitalization), tiredness (serious criteria hospitalization), leg pain (serious criteria hospitalization), unwell (serious criteria hospitalization) and rash (serious criteria hospitalization). On 7th March 2016, the patient experienced otitis media (serious criteria hospitalization). On 11th March 2016, the patient experienced status epilepticus (serious criteria death, hospitalization and GSK medically significant), seizure (serious criteria hospitalization and GSK medically significant), groggy (serious criteria hospitalization) and circulatory collapse (serious criteria hospitalization and GSK medically significant). On 23rd March 2016, the patient experienced unknown cause of death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the patient experienced fever (serous criteria hospitalization), body temperature increased (serious criteria hospitalization), nausea (serious criteria hospitalization), flushing (serious criteria hospitalization), glassy eyes (serious criteria hospitalization), ear pain (serious criteria hospitalization), swollen glands (serious criteria hospitalization), and body temperature fluctuation (serious criteria hospitalization). The patient was treated with paracetamol and Penicillin. On 23rd March 2016, the outcome of the status epilepticus was fatal. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the seizure, dizziness, tiredness, leg pain, unwell, rash, fever, body temperature increased, nausea, flushing, glassy eyes, ear pain, groggy, otitis media, circulatory collapse and body temperature fluctuation were not recovered/not resolved and the outcome of the swollen glands was unknown. The patient died on 23rd March 2016. 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, status epilepticus, seizure, dizziness, tiredness, leg pain, unwell, rash, fever, body temperature increased, nausea, flushing, glassy eyes, ear pain, swollen glands, groggy, otitis media, circulatory collapse and body temperature fluctuation to be related to Meningococcal ACWY Vaccine (potential MENVEO). Verbatim: 13-JUL-2016 I am making a yellow card report to RA concerning the tragic death of a patient who died this year. The story at the time was that she saw myself with otitis media for which she was prescribed penicillin and paracetamol, describing that she had not been terribly well for a week or 2 before but with painful ear and 3 large tender glands behind the left ear. Her temperature was 38 degrees C. She made a small recovery over the next couple of days but later whilst doing an exam at school she collapsed and went into a seizure. Unfortunately she went into status epilepticus and was admitted to hospital where she was transferred over to Paediatric Intensive Care where sadly, after many attempts to save her life, her support was turned off. I enclose all of the letters that we have from the hospital. The family declined a post mortem and no cause of her death was ever found. Her mother asked to speak to me several months later to inform me that patient had her meningitis ACW&Y vaccination at school. Her mother reports that almost immediately after this vaccination patient was reported feeling dizzy, tired and that she had pains in both her legs, she felt generally unwell, she also described a rash which she texted to a friend, although her mum is not sure where the rash was. She had what sounded like a swinging pyrexia which her temperature up and down over the next week. There was no apparent inflammation of the injection site reported. She declined to go to the gym that week, which is unusual for patient. Over the weekend she then developed earache and pyrexial symptoms, after which I saw her and prescribed the penicillin. There was no report or any great improvement over the next few days in terms of the general symptoms that she described, she increasingly became nauseous, feeling flushed and her mother describes her as being "glassy eye". On a morning she was feeling fairly groggy and unwell but as she had an exam that day her mother was keen that she went to school, unfortunately she collapsed during the exam and was transferred to hospital. As you can see from the enclosed literature they did do multiple investigations but did not establish a cause and no post mortem was done. Her mother is very keen to known whether the vaccination that she received has contributed to her death. When I saw her myself I was unaware of the vaccination that was done, this was added to our notes afterwards as it was actually done at school and this information wasn''t volunteered to me on the day that I saw her. There is no mention of this at the hospital at all and there was no mention after patient passed away. Her mother is concerned about this and I must say that the story does actually seem to fit quite well. I have explained to her mother that it could of course be a total coincidence as it often is, but she is extremely concerned that this suspected reaction be reported, particularly to see if there have been any further cases reported since the meningitis ACW&Y vaccination has been introduced. Her mother is extremely keen to be involved in any follow up. I too would be extremely grateful if you could keep me informed about any further developments on this report. We would also be very keen to know if there have been any other reports of serious side effects with this vaccine that RA have received. We will of course be perfectly happy to help you with any further information that you may require.


VAERS ID: 644091 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-15
Entered: 2016-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Death, Vaccination error
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607VNM004174

Write-up: This solicited information has been received from an unknown source via Company regarding 200 patients of unknown age and gender enrolled in a study. The patients'' concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL. There was overimmunization with GARDASIL and anaphylaxis which resulted in death of 200 patients. It was reported that anaphylaxis rate of girls who received the vaccine was much higher. It was also reported that it was 20 times higher when compared to other vaccination programs. The causality assessment of the events were not provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. This is an amended report. The events anaphylaxis and overimmunization are captured with fatal outcome. The whole narrative has been updated accordingly.


VAERS ID: 644333 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2016-06-28
Onset:2016-06-30
   Days after vaccination:2
Submitted: 2016-07-18
   Days after onset:18
Entered: 2016-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M98546 / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB468AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Brain death, Brain injury, Cardiac arrest, Death, Retinal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-07-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK100233

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 4-month-old male patient who received ROTARIX (batch number AROLB468AA, expiry date unknown). Co-suspect products included PREVENAR 13 (batch number M98546, expiry date unknown). On 28th June 2016, the patient received the 1st dose of ROTARIX (oral) and the 1st dose of PREVENAR 13 (intramuscular). On 30th June 2016, 2 days after receiving ROTARIX, the patient experienced cardiac arrest (serious criteria death, GSK medically significant and life threatening). On an unknown date, the patient experienced hypoxic brain damage (serious criteria death and medically significant). The patient was treated with Adrenalin. On 6th July 2016, the outcome of the cardiac arrest and hypoxic brain damage were fatal. The patient died on 6th July 2016. The reported cause of death was cardiac arrest and hypoxic brain damage. It was unknown if the reporter considered the cardiac arrest and hypoxic brain damage to be related to ROTARIX. Additional details were provided as follows: Concomitant medication was not reported. According to the patient mother, the patient was increasingly querulous. On 28th June 2016, at 5:30, the patient received ROTARIX and PREVENAR 13 on the right thigh. On 30th June 2016, ay 5:30, the patient experienced unclear cardiac arrest. The first reamination was performed by a non-health care professional and then reamination with adrenalin ROSC (return of spontaneous circulation) was performed until 30th June 2016, 7:20 am. In the unclear death situation the patient had no fever and no exanthema. On 6th July 2016, the patient experienced a severest hypoxic brain damage with brain death. The laboratory examination for an external trauma. Slight retinal bleeding (right more pronounced than left) was found). They were reported as possibly caused by reamination. There was no foreign body aspiration or aspiration of nourishment found in the lung. The patient''s condition was life threatening and the patient died. It was unknown if the reporter considered the cardiac arrest and hypoxic brain damage to be related to PREVENAR 13 as well.


VAERS ID: 644384 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-21
Entered: 2016-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607CAN007778

Write-up: This spontaneous report as received from a patient''s family member refers to a patient of unknown age and gender. Patient''s concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX II (strength, dose, route, lot # and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced an unspecified adverse reaction to the ZOSTAVAX II and as a result, in July 2016 (referred as "this weekend"), the patient died. It was unknown whether an autopsy was performed or not. The reporter considered the unspecified adverse reaction to be related to ZOSTAVAX II. Additional information has been requested.


VAERS ID: 644462 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-27
Onset:2016-04-07
   Days after vaccination:255
Submitted: 2016-07-12
   Days after onset:96
Entered: 2016-07-21
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L59072 / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Antemortem blood drug level, Aspartate aminotransferase normal, Autopsy, Base excess increased, Blood albumin decreased, Blood creatinine normal, Blood culture negative, Blood electrolytes normal, Blood glucose increased, Blood lactic acid, Blood pH decreased, Blood potassium decreased, Blood sodium decreased, Blood urea normal, Brain oedema, C-reactive protein increased, CSF glucose, CSF protein, CSF red blood cell count positive, CSF white blood cell count increased, Central venous catheterisation, Chest X-ray abnormal, Coma, Computerised tomogram head abnormal, Culture urine negative, Death, Diabetes insipidus, Encephalitis meningococcal, Epilepsy, Febrile convulsion, Gaze palsy, Generalised tonic-clonic seizure, Haemoglobin decreased, Hypokalaemia, Hyponatraemia, Hypotension, Lung infiltration, Mechanical ventilation, Muscle rigidity, Otitis media, PCO2 decreased, Platelet count normal, Prothrombin time shortened, Pupillary light reflex tests abnormal, Pyrexia, Respiratory failure, Sepsis, Somnolence, Staphylococcus test negative, Ultrasound Doppler abnormal, Unresponsive to stimuli, Vaccination failure, Vomiting, White blood cell count normal, White blood cells urine negative
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-04-17
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Recurrent infection; Hyperbilirubinemia postnatal phototherapy because of hyperbilirubinemia at the fourth day of life; Phototherapy; postnatal phototherapy because of hyperbilirubinemia at the fourth day of life; Respiratory syncytial virus bronchiolitis
Allergies:
Diagnostic Lab Data: 14-APR-2016, Activated partial thromboplastin time, 34.7; 14-APR-2016, Alanine aminotransferase, normal blood levels; 14-APR-2016, Aspartate aminotransferase, normal blood levels; 14-APR-2016, Blood albumin, 35 g/l; 14-APR-2016, Blood creatinine, normal blood levels; 14-APR-2016, Blood electrolytes, in a normal range; 14-APR-2016, Blood glucose, 7.9; 14-APR-2016, Blood lactic acid, 3.91; 14-APR-2016, Blood potassium, 2.8; 14-APR-2016, Blood pressure measurement, 114/81 mmHg; 14-APR-2016, Blood sodium, 127; 14-APR-2016, Blood urea, normal blood levels; 14-APR-2016, Body temperature, 36.8 Centigrade; 14-APR-2016, C-reactive protein, 339.1; 14-APR-2016, Chest X-ray, At status post intubation the foremost part of the; 14-APR-2016, Haemoglobin, 6.0; 14-APR-2016, Heart rate, 170; 14-APR-2016, Oxygen saturation, 95%; 14-APR-2016, PCO2, 4.1; 14-APR-2016, Platelet count, 359; 14-APR-2016, Prothrombin time, 46%; 14-APR-2016, Pupillary light reflex tests, abnormal; 14-APR-2016, Respiratory rate, 15; 14-APR-2016, Ultrasound Doppler; 16-APR-2016, Ultrasound Doppler, Cerebral circulation had discontinued; 17-APR-2016, Ultrasound Doppler, Cerebral circulation had discontinued; 14-APR-2016, Urine analysis, number of cells in the patient urine inconspicuous; 14-APR-2016, White blood cell count, 12.4; 14-APR-2016, pH body fluid, 7.32; BE (14Apr2016): 9.5; cerebrospinal fluid (14Apr2016): leukocytes 92 Mpt/l, erythrocytes 1248 Mpt/l, protein 13 g/l, lactate 8.5 mmol/l, glucose 0.7 mmol/l; Laboratory in progress: Blood level of phenobarbital 12.1 ul/ml, blood level of clonazepam 10.6 ng/ml, blood level of diazepam 86.4 ng/ml, blood level of nordazepam <32 ng/ml, minimal potassium 2.8, minimal sodium 118, maximal sodium 150; Microbiology (14Apr2016): Negative blood culture, negative MRSA (methicillin-resistant Staphylococcus aureus)-, MRGN (multiresistant gram-negative)- and VRE (Vancomycin-resistant enterococci)-Screening. Evidence of normal human microbiome in tracheal secretion, negative urine culture. Evidence of pneumococcal DNA in the course of a screening of cerebrospinal fluid; Cranial computed tomography (14Apr2016): Diminished density of both cerebral hemispheres, the contrast between medulla and cortex was mostly reversed. Even the basal ganglia are only zoned partially. Thalamus, cerebellum and the basal blood vessels of the brain got a relative high density. The outer subarachnoid spaces have no supratentorial distinction. The findings are indicative that a distinct cerebral edema exists, how it occurs at Status epilepticus, meningitis or hypoxia other origin; Thoracic radiography (14Apr2016): No defined pneumothorax. Shadow of the heart not enlarged. No stasis. Paramediastinal spotted, compacted tissue in the right upper lung field. Suspected infiltrate. No effusion.
CDC Split Type: 2016333552

Write-up: This is a spontaneous report from a physician received from the Health Authority (contactable). Regulatory Authority report number DE-PEI-PEI2016051426. A 13 months old male patient of an unspecified age and ethnicity received PREVENAR 13 at 0.5 ml, single, first dose on 30Apr2015 (lot L00744), second dose on 04Jun2015 (lot L48815), third dose on 27Jul2015 (lot L59072), ROTATEQ at 1 DF single, first dose on 04Jun2015, second dose on 27Jul2015 and INFANRIX HEXA at 1 DF single, first dose on 30Apr2015, second dose on 04Jun2015, third dose on 27Jul2015. The 4th vaccination was not possible on time due to recurrent infections. The patient got postnatal phototherapy because of hyperbilirubinemia at the fourth day of life. In Feb2016 the patient stayed in the in-patient therapy because of bronchiolitis caused by respiratory syncytial virus. The patient''s concomitant medications were not reported. The patient experienced meningococcal encephalitis on an unspecified date, vaccination failure on 13Apr2016, otitis media both sides on 13Apr2016, respiratory failure, global, which required ventilation on 13Apr2016, arterial hypotension on 13Apr2016 (administration of catecholamines necessary), central diabetes insipidus on 13Apr2016, hypokalaemia on 13Apr2016, hyponatraemia on 13Apr2016, fever on 07Apr2016, vomiting on 13Apr2016, tonic-clonic seizures on 14Apr2016, eyes gaze upward on 14Apr2016, brain oedema on 14Apr2016. The patient underwent lab tests and procedures which included blood potassium: 2.8 on 14Apr2016, blood pressure measurement: 114/81 mmHg on 14Apr2016, blood sodium: 118 on 14Apr2016, body temperature: 36.8 degrees C on 14Apr2016, chest x-ray: present on 14Apr2016, C-reactive protein: 339.1 on 14Apr2016, pupillary light reflex tests abnormal on 14Apr2016, ultrasound Doppler on 14Apr2016 (unknown result). The patient was treated with Dauer infusion, acyclovir, cefotaxime, cefpodoxime, vancomycin, desmopressin, electrolyte substitution, NUROFEN, activated carbon, dexamethasone, diazepam, clonazepam and phenobarbital. All the reported events had a fatal outcome. The patient died on 17Apr2016 (confirmation of cerebral death on 17Apr2016 at about 01.26 P.M.). All the reported events were considered serious as caused death, hospitalization from 14Apr2016 to 17Apr2016 and were life threatening. Result of autopsy showed meningococcal encephalitis. Clinical course of events was reported as follows. Anamnesis: The patient was febrile intermittently for six days. On 13Apr2016 the outpatient presentation of the patient to a pediatrician took place and cefpodoxime was prescribed because of otitis media. After one intake of the antibiotic the patient vomited in the evening. He was not affected in his general condition. The next morning it was difficult to wake up the patient, but he did not vomit again. A medication with NUROFEN took place because of constant high temperature. Around 11.00 A.M. the patient mother noticed eyes gaze upward. Afterwards he began to have a tonic-clonic convulsive seizure. The emergency medical service was called and the patient was taken to hospital around 01.50 P.M. Because of suspected sepsis and consecutive epileptic fit or febrile convulsion an intravenous antibiotic and antiviral medication was started after blood collection. Additionally, activated carbon and dexamethasone were administered. Diazepam, clonazepam and phenobarbital were administered when tonic-clonic convulsive seizures reappeared. Afterwards the patient was taken to infantile care unit towards 04.30 P.M. Condition at admission: Comatose patient with agonal respiration; artificial respiration was necessary. Decorticate rigidity during pain stimulus, pupils with lateral difference: average range on the right and constricted on the left. At the outside subdued pupillary light reflex. Distinct pulse rate, short capillary refill time, lung ventilated both-sided, inconspicuous auscultation of the heart. Blood pressure 114/81 mmHg, oxygen saturation 95%, heart rate 170 beats/min, breathing rate 15/min, body temperature 36.8 degree Celsius, body weight approximately 10 kg. Clinical diagnostics, appropriate findings: laboratory (SI units) at the time of admission: pH 7.32, BE 9.5, partial pressure of carbon dioxide 4.1, sodium 127, other electrolytes blood levels in a normal range, lactate 3.91, glucose 7.9, leukocytes 12.4, hemoglobin 6.0, thrombocytes 359, C-reactive protein 339.1, albumin 35 g/l, normal blood levels of creatinine, urea, alanine aminotransferase Quick and aspartate aminotransferase, Quick value 46%, partial thromboplastin time 34.7, number of cells in the patient urine inconspicuous. Status of cerebrospinal fluid: leukocytes 92 Mpt/l, erythrocytes 1248 Mpt/l, protein 13 g/l, lactate 8.5 mmol/l, glucose 0.7 mmol/l. Laboratory in progress: Blood level of phenobarbital 12.1 ul/ml, blood level of clonazepam 10.6 ng/ml, blood level of diazepam 86.4 ng/ml, blood level of nordazepam <32 ng/ml, minimal potassium 2.8, minimal sodium 118, maximal sodium 150. Microbiology: Negative blood culture, negative MRSA (methicillin-resistant Staphylococcus aureus)-, MRGN (multiresistant gram-negative)- and VRE (vancomycin-resistant enterococci)-Screening. Evidence of normal human microbiome in tracheal secretion, negative urine culture. Evidence of pneumococcal DNA in the course of a screening of cerebrospinal fluid. Cranial computed tomography on 14Apr2016: Diminished density of both cerebral hemispheres, the contrast between medulla and cortex was mostly reversed. Even the basal ganglia are only zoned partially. Thalamus, cerebellum and the basal blood vessels of the brain got a relative high density. The outer subarachnoid spaces have no supratentorial distinction. The findings are indicative that a distinct cerebral edema exists. Thoracic radiography on 14Apr2016: No defined pneumothorax. Shadow of the heart not enlarged. No stasis. Paramediastinal spotted, compacted tissue in the right upper lung field. Suspected infiltrate. No effusion. Cerebral Doppler/Duplex sonography on 16Apr2016 and 17Apr2016: Cerebral circulation had discontinued. Therapy and clinical course: A short time after admission the patient medical condition declined right up to apnea, dilated pupils which didn''t react to light and decerebrate rigidity. Intubation and artificial respiration were started immediately and a central venous catheter was placed via right hand subclavian vein. To stabilize the circulatory system a contemporary prolonged infusion of catecholamines dopamine and noradrenaline was started. Additionally the patient got a volume therapy with activated carbon. An emergency cranial computed tomography revealed suspected severe cerebral edema. A diabetes insipidus developed immediately. A medication with desmopressin and an intravenous compensation of electrolyte imbalance took place. Antibiotic therapy was switched to vancomycin, cefotaxime and acyclovir I.V. when a fulminant meningoencephalitis was suspected. The patient was always comatose and showed no reaction to irritation. Diagnostics to confirm cerebral death were performed on 16Apr2016 and 17Apr2016 according to clinical guidelines of the Medical Association. The cerebral death could be confirmed. The patient organs were donated. The following autopsy approved a fulminant meningoencephalitis as cause of death. Anamnestically known otitis media both-sided could be also detected. Follow-up attempts completed. No further information expected.


VAERS ID: 644497 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-07-01
Submitted: 2016-07-15
   Days after onset:14
Entered: 2016-07-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Death, Dyspnoea, Intensive care, Pneumococcal infection, Pyrexia, Rhinorrhoea, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pleural fluid specimen (unknown date) positive for pneumococcus
CDC Split Type: 2016340514

Write-up: This is a spontaneous report from a contactable other healthcare professional via regulatory authority (no regulatory number reported). A 4-year-old female patient of an unspecified ethnicity received a single dose of PREVENAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On 09Jul2016 the patient died due to invasive pneumococcal infection, caused by Streptococcus pneumoniae. It was not reported if an autopsy was performed. The patient, with good past health, had presented with fever, cough, runny nose and shortness of breath since 01Jul2016 and consulted two private doctors on 02Jul2016 and 04Jul2016. She attended an outpatient department at a private hospital in the early morning on 08Jul2016. She was subsequently referred to the Accident and Emergency Department at other private hospital and then sent to another public hospital. She was transferred to a Paediatric Intensive Care Unit shortly after admission for further management but died on 09Jul2016. Her pleural fluid specimen tested positive for pneumococcus. Preliminary investigations revealed that the patient had no recent travel history and her home contacts remained asymptomatic. No other similar case or outbreak has been reported so far at the kindergarten she attended.


VAERS ID: 644526 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-04
Onset:2016-07-19
   Days after vaccination:15
Submitted: 2016-07-22
   Days after onset:3
Entered: 2016-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER 4K14A / 1 RA / SC
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 9KS0IR / 2 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1428 / 2 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15F01A / 2 LL / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB256AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607JPN009164

Write-up: Initial information has been received from a physician concerning a 4 month old female infant with no primary disease/ concurrent conditions or medical history. On an unknown date in 2016, the patient was vaccinated with the first doses of HEPTAVAX-II subcutaneously (lot # and dose were not provided), ACTHIB and PREVENAR. On 04-JUL-2016, the patient was vaccinated with HEPTAVAX-II second dose, 0.25 ml, subcutaneously (lot number was not reported), ACTHIB injection drug, parenteral administration (dose and indication were not reported), adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine injection drug, parenteral administration (dose and indication were not reported) and PREVENAR injection drug, parenteral administration (dose and indication were not reported). No information on concomitant medication was provided. In the evening of 19-JUL-2016, after confirmation of the patient''s respiratory arrest (sudden death) by her parents, the infant was carried to the hospital. At the time of this report, the cause of death and information on autopsy were not reported. The reporter''s comment: It was thought that the death was caused by abuse. On 21-JUL-2016, autopsy was going to be performed. It was thought that there was no relationship between HEPTAVAX-II and death because it was two weeks since vaccination. The reporting physician considered that the event of death was serious. The reporting physician felt that the event of death was definitely not related to HEPATAVAX-II. ACTHIB, adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine and PREVENAR were considered as other suspect drugs. Upon internal review, the event of sudden death was considered to be medically significant. Additional information has been requested.


VAERS ID: 644536 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-19
Entered: 2016-07-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 220103915A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016349376

Write-up: This is a spontaneous report from a contactable physician. The physician reported 2 cases for different patients. This is the 2nd of 2 reports. An infant patient of unspecified ethnicity and gender received PREVENAR 13 (Lot# 220103915A), via an unspecified route of administration, on an unspecified date, at single dose and PENTAVALENT vaccine, via an unspecified route of administration, on an unspecified date, at an unspecified dose. The patient''s medical history and concomitant medications were not reported. The patient died on an unspecified date for an unspecified reason. It was not reported if an autopsy was performed.


VAERS ID: 644537 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-19
Entered: 2016-07-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 220103915A / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016349361

Write-up: This is a spontaneous report from a contactable physician. The physician reported 2 reports for different patients. This is the 1st of 2 reports. An infant patient of unspecified ethnicity and gender received PREVENAR 13 (Lot# 220103915A), via an unspecified route of administration, on an unspecified date, at single dose and PENTAVALENT vaccine, via an unspecified route of administration, on an unspecified date, at an unspecified dose. The patient''s medical history and concomitant medications were not reported. The patient died on an unspecified date due to an unspecified reason. It was not reported if an autopsy was performed.


VAERS ID: 644542 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-05
Onset:2016-07-06
   Days after vaccination:1
Submitted: 2016-07-20
   Days after onset:14
Entered: 2016-07-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L8184 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M52265 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Autopsy, Death, Epistaxis, Floppy infant, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-06
   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:
Preexisting Conditions: Premature baby was born Preterm at 29 weeks via Caesarean Section; Jaundice neonatal; Apnoea; Hypoglycaemia; BCG vac, Immunization, NO adverse event; Oral polio vaccine, Immunization, No adverse event
Allergies:
Diagnostic Lab Data: 05-JUL-2016, Body temperature, 36.4 degrees Centigrade; 05-JUL-2016, Head circumference, 35 cm; 05-JUL-2016, Respiratory rate, 22
CDC Split Type: 2016347440

Write-up: This is a spontaneous report from the Department of Health. A 5-week-old female patient of an unspecified ethnicity received first dose of PREVENAR 13 (lot M52265, exp. date 2017), via an unspecified route of administration at single dose, first dose of bivalent oral poliomyelitis vaccine from lot M5103 via an unspecified route of administration, first dose of HEXAXIM (lot L8184-1), intramuscular on left thigh, and rotavirus diarrhea vaccines, via an unspecified route of administration all on 05Jul2016. The patient was born Preterm at 29 weeks via Caesarean Section, her birth weight at delivery was recorded as 2.1 kilograms. She had to be admitted and nursed for a period of one week and four days in the Hospital for birth complications that included neonatal jaundice, apnoea and hypoglycaemia. The patient''s concomitant medications were not reported. Before discharge, she received this at birth BCG VAC and oral polio vaccine and experienced no adverse event. On 05Jul2016, before vaccination, the body temperature was 36.4 degrees Celsius, respiration was 22, head circumference was 35 cm, length: 43 cm. Baby looked well and reflexes were present, exclusively breast fed. According to the records from the hospital the baby was put on Nevirapine 1 mls daily, INH Prophylaxis 2 mls daily, Multivitamin syrup drops and Vitamin D daily. According to story from the mother, the baby was fine after immunisation even fed well. At 23h00 she breastfed her and put the baby to sleep, she again breastfed her at 03h00 and 04h00 am and left her sleeping on the bed. At about 06h45 (06Jul2016) she went to the bedroom to check on her baby again, only to realize that the baby was weak and floppy with whole body, she noticed slightly bleeding mixed with whitish stuff through both nostrils. The patient died on 06Jul2016. An autopsy was performed and results were not provided.


VAERS ID: 644647 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2016-03-17
Onset:2016-05-16
   Days after vaccination:60
Submitted: 2016-07-22
   Days after onset:67
Entered: 2016-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cough, Death, Diarrhoea, Dry mouth, Frequent bowel movements, Gastroenteritis, Lid sulcus deepened, Malnutrition, Rectal tenesmus, Thirst, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-28
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MUAC (18-MAY-2016): 12.5 cm; 05/18/2016, Body temperature, 36.4 degrees C; 05/18/2016, Respiratory rate, 31 cycles/min
CDC Split Type: WAES1607MLI008491

Write-up: This spontaneous report was received from a physician as part of a post marketing active surveillance, regarding a 12 month old female patient. The patient''s medical history and concurrent conditions were not reported. On 09-JUL-2015, the patient was vaccinated with first dose of ROTATEQ, oral. On 03-SEP-2015, the patient received second dose of ROTATEQ. No concomitant medications were reported. On 16-MAY-2016, the patient experienced gastroenteritis and was hospitalized on an unknown date in 2016. The illness onset dates back to 16-MAY-2016, when the infant began to have liquid non-bloody stools without vomiting and a frequency of 4 to 5 times a day. She also had tenesmus, intense thirst and abdominal pain and cough for which the mother brought the child to the health center on 18-MAY-2016. On clinical examination, patient''s weight was 6.7kg, height 73.1 cm, MUAC 12.5cm, temperature: 36.4 degree Celsius, respiratory rate FR 31 cycles/min, dry mouth, intense thirst, sunken eyes and normal skin turgor. She was therefore included in the study with the diagnosis of diarrhea in the setting of malnutrition. She received the following treatment: ORS, COTRIMOXAZOLE 120mg 2 times daily, and metronidazole 125 mg 2 times a day. This episode lasted 14 days per the memory aid. On 17-MAR-2016, the patient was vaccinated with third dose of ROTATEQ. According to the mother the episode of diarrhea for which the child was enrolled in the study had stopped. Another episode began on 25-JUN-2016. She had diarrhea associated with vomiting for which the child was brought for consultation to the medical center on 26-JUN-2016. She received treatment (no prescription available for review) which in end of the vomiting but the diarrhea worsened. The parents brought her back to the center on 27-JUN-2016 and were sent to the referral center where she received further treatment with IV fluids. The parents then took her back home with a plan to return for more IV fluids the next day but the child died on 28-JUN-2016 from 4 hours of morning at about 4am at home. On the follow up visit on 19-JUL-2016, the team was informed of the child''s death. The cause of death was not reported. The causality of the event gastroenteritis was reported as not related. Additional information is not expected as no follow-up is available.


VAERS ID: 645433 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-21
Entered: 2016-07-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain stem infarction, Coma, Death, Endotracheal intubation, Intensive care, Mechanical ventilation, Musculoskeletal stiffness, Pharyngitis, Pyrexia, Somnolence, Streptococcus test positive
SMQs:, Agranulocytosis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Respiratory failure (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: 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: 2016, Blood culture, positive for streptococcus pneumonia; 2016, Serology test, 6C
CDC Split Type: 2016349372

Write-up: This is a spontaneous report from a contactable physician via a Company representative. An approximately 2 years old (2-3 years) male patient received the fourth dose of PREVENAR 13 on an unknown date, at single dose. Relevant medical history and concomitant medications were not provided. In mid Apr2016, the patient experienced fever and was given antibiotic as infection in the throat was seen. On the second day, the patient fever persisted and he was noticed in drowsy state and having stiff neck. On the same day, he was admitted into ICU and antibiotic was given for meningitis. Patient fitted during 6 P.M., then fell into coma state and was intubated/ventilated and continued on for 10 days. The patient underwent blood culture on an unknown date in 2016 which resulted positive for streptococcus pneumonia and serotyping resulted in 6C. The reporting physician provided additional information as patient was having brain stem infarct since unknown date and was normal and active prior to the fever. These reported events involved hospitalization. The outcome of these reported events was unknown at the time of report. On an unknown date in 2016 the patient passed away. Cause of death was not reported. It was unknown if the patient had been discharged and if an autopsy was done.


VAERS ID: 645849 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-29
Onset:2016-04-30
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:82
Entered: 2016-07-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L7413 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L21066 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-30
   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: Premature birth around the gestational age of 28 weeks; 26-MAR-2016, Oral polio vaccine, Immunization, No adverse event Oral; 26-MAR-2016, BCG vac, Immunization, No adverse event intramuscular injection
Allergies:
Diagnostic Lab Data: Apgar score, Ratings were recorded as 7/10 and 9/10; His birth body length and head circumference were documented to be 34 centimeters and 28 centimeters respectively
CDC Split Type: 2016347259

Write-up: This is a spontaneous report from the Department of Health. A 6-week-old male patient of an unspecified ethnicity received, on 29Apr2016, the first dose of PREVENAR 13 (Lot. L 21066, Expiration date: Apr2018) single dose; first dose of bivalent oral poliomyelitis vaccine (Lot. M 5103, Expiration date: Jan2017); first dose of intramuscular HEXAXIM (Lot. L 7413, Expiration date: May2017); and rotavirus diarrhea vaccines (Lot. M 5103, Expiration date: Nov2017). The patient was born preterm. Concomitant medications were not reported. The patient previously received on 26Mar2016, oral polio vaccine and BCG vaccine. The patient did not experience any adverse event after the vaccinations. The patient died on 30Apr2016. An autopsy was performed (autopsy results not available). Patient''s clinical course was the following: the deceased child was a male who was delivered prematurely through caesarean section around the gestational age of 28 weeks. The indication for the operation was breech delivery as well as fetal distress. His birth weight was recorded to be 1.09 kilograms. Apgar ratings were recorded as 7/10 and 9/10. His birth body length and head circumference were documented to be 34 centimeters and 28 centimeters respectively. The child had to be on admission in the neonatal ICU of that hospital for several weeks afterwards. He did not have any history of allergy and had no history of recurrent illnesses. He was discharged from the hospital on 25Apr2016 on excellent clinical grounds with an improved body weight of 1.8 kilograms. He also had no past or current medical history of note. He was not HIV positive and was not on any chronic medications of note. Expected Date of Delivery (EDD) was 15Jun2016 but mother had to give birth some 12 weeks earlier. Details regarding the mother was the following: she had her first child in 2005. This was a male child who was also born preterm. He is alive and well and never had any reactions with any of the administered Expanded Programme of immunization (EPI) vaccinations. The mother had another pregnancy in 2010, which unfortunately, spontaneously aborted at 4 weeks. She could not attribute this miscarriage to any cogent cause. The child received "At Birth" vaccinations of oral polio vaccine and BCG VAC intramuscular injection at the Hospital just before his discharge, on 26Mar2016. There were no allergic reactions squeal after administrations of these two vaccines. The child was brought to the clinic around 09:30 on 29Apr2016 for his six weeks schedule of vaccinations. The vaccines normally administered for this age, according to the National EPI vaccination schedule include the first dose of the PREVENAR 13, first dose of bivalent oral poliomyelitis vaccine, as well as the first dose of the HEXAXIM that was administered intramuscularly on the left thigh. As at the time of presentation at the clinic for his six weeks vaccinations, he was not on any medications and had no illness of note, according to the mother. According to the records that were made available for the investigating team, the child was well and fit when he was brought in by his mother to the clinic. There were no history of fever and there was no recording of any pyrexia. Other vitals were described as normal. The vaccinations on that day were administered by the attending EPI nurse herself. He was eventually taken home by mother on satisfactory clinical grounds. No other child who received vaccines of same batch numbers as those administered to the child has ever come back with any complaint. According to the mother, the child, whilst at home was well and fine within the first few hours post vaccination. There was no vomiting and there were no abnormal respirations such as grunting nor chest wheezes. He remained so until when he was checked to be fed around the early hours of Saturday, 30Apr2016. It was at this time that the mother noticed the child had ceased breathing. She observed that he was lifeless with no chest movements. The mother and the accompanying grandmother rushed the child straight to the clinic. The child was unfortunately declared as a "Death on Arrival" (DOA) case by the two attending health care practitioners. Cause of death was unknown. Findings of the post mortem report were not provided at time of this report.


VAERS ID: 645898 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-26
Entered: 2016-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607ISR010449

Write-up: This spontaneous report as received from a physician (gynecologist) refers to a patient of unknown age and gender. The physician obtained the information from an article, which was published on the internet approximately "six month ago". Information regarding relevant medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot # not reported). Information regarding concomitant medications was not reported. The patient died as a result from GARDASIL. The date and cause of death was not specified. It was unknown whether an autopsy was performed. The physician did not remember details about what was exactly written in the article. Upon internal review, death was considered to be medically significant. Additional information has been requested.


VAERS ID: 646112 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-01-01
Submitted: 2016-07-23
   Days after onset:203
Entered: 2016-07-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Holoprosencephaly
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016351611

Write-up: This is a spontaneous report from a non-contactable pediatrician participating in the meeting of Agency through a Pfizer employee. A 5-year-old male patient of an unspecified ethnicity received PREVENAR (Lot Number: unknown), subcutaneously on an unspecified date at 0.5 ml single dose. The number of vaccinations was unknown. Medical history included holoprosencephaly on an unknown date. The patient''s concomitant medications were not reported. On an unknown date in Jan2016, the patient experienced meningitis (serotype: unknown). The patient died on an unspecified date. It was not reported if an autopsy was performed.


VAERS ID: 646165 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-05
Onset:2016-07-06
   Days after vaccination:1
Submitted: 2016-07-28
   Days after onset:22
Entered: 2016-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L8184 / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER M52265 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS B348HC / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, Death, Epistaxis, Hypotonia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-06
   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: Nevirapine; Isoniazid; Multivitamin; vitamin D
Current Illness: Unknown
Preexisting Conditions: Jaundice neonatal; Apnoea; Hypoglycaemia, birth complications; Premature baby
Allergies:
Diagnostic Lab Data: In 2016, length was 43 cm, MUAC (middle upper arm circumference) was 11 cm and reflexes were present; 2016, Body temperature, 36.4 degree C; 2016, Head circumference, 35 cm; 2016, Respiratory rate, 22; 2016, Weight, 3 kg
CDC Split Type: ZA2016GSK103453

Write-up: This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 1-month-old female patient who received ROTARIX (batch number B348HC?, expiry date January 2017). Co-suspect products included 10PN-PD-Dit (batch number M52265?, expiry date January 2017), Polio Bivalent T1 T3 oral (batch number M5103?, expiry date January 2017) and HEXAXIM (batch number L8184-1, expiry date January 2017). The patient''s past medical history included premature birth, neonatal jaundice, apnea and hypoglycemia (birth complications). Concomitant products included BCG vaccine, OPV vaccine, vitamin D, nevirapine, isoniazid and multivitamins. On 5th July 2016, the patient received ROTARIX (oral), Pneumococcal vaccine, Bivalent Poliomyelitis vaccine Types 1+3 and HEXAXIM (intramuscular). On 6th July 2016, 1 days after receiving ROTARIX, Pneumococcal vaccine and Bivalent Poliomyelitis vaccine Types 1+3, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), epistaxis, weakness and floppy. On 6th July 2016, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the epistaxis, weakness and floppy were unknown. The patient died on 6th July 2016. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death, epistaxis, weakness and floppy to be related to ROTARIX, Pneumococcal vaccine and Bivalent Poliomyelitis vaccine Types 1+3. Additional details were provided as follows: The patient was born preterm at 29 weeks via Caesarean section at one of the academic hospitals on 28 May 2016. Her birth weight at delivery was recorded as 2.1 kilograms. She had to be admitted and nursed for a period of one week and four days in this academic hospital for birth complications that would include neonatal jaundice, apnoea and hypoglycaemia. She was subsequently discharged on sound clinical grounds. Before discharge, she received her at birth vaccinations of BCG and Oral Polio. There were no associated reactions with these two antigens. On Thursday 5th July 2016, the patient was brought in by her mother to the clinic for 6 weeks immunization. She was seen and assessed by a nurse. The patient was weighed and the body temperature was checked before giving the vaccination. the patient''s vital data was recorded as follows, body temperature was 36.4 degrees Celsius, respiration was 22, head circumference was 35 cm, length was 43 cm, MUAC (middle upper arm circumference) was 11 cm and weight 3 kg. The patient looked well and reflexes were present and the patient was exclusively breast fed. According to the records from the hospital the patient was put on nevarapine 1 ml daily, isoniazid prophylaxis 2 ml daily, multivitamin syrup drops and vitamin D daily. On 5th July 2016, the patient received ROTARIX, HEXAXIM, Bivalent OPV and Pneumococcal conjugate vaccine. There were no immediate untoward developments immediately after these vaccinations. According to the patient''s mother, the patient was fine after vaccination and even fed well. At 23:00, she breastfed her and put the patient to sleep. She again breastfed her at 03:00 and 04:00 am and left her sleeping on the bed. At about 06:45, she went to the bedroom to check on the patient again and realized that the patient was weak and floppiness in the whole body. She also noticed slightly bleeding mixed with whitish stuff through the nostrils. The parents rushed the child to the academic hospital casualty and the patient was seen by a doctor in the ward and certified her dead. The patient''s parents were requested to sign for post mortem and they agreed. The post mortem was carried out and the results were pending. There was a detailed audit around the cold chain systems of the facility. This was given an excellent pass mark by the visiting investigation team. The clinic had an operational EPI dedicated minus 40 fridge in good working condition. It was well packed and temperature up to date and recorded twice a day.


VAERS ID: 646167 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-29
Onset:2016-04-30
   Days after vaccination:1
Submitted: 2016-07-28
   Days after onset:89
Entered: 2016-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L7413 / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER L21066 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS M5103 / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-30
   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:
Preexisting Conditions: Premature baby; Low birth weight baby, birth weight was 1.09 kilograms, Apgar ratings were 7/10 and 9/10, body length and head circumference were 34 centimeters and 28 centimeters
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2016GSK103452

Write-up: This case was reported by a physician via licensee and described the occurrence of unknown cause of death in a 6-week-old male patient who received ROTARIX (batch number M5103?, expiry date November 2017). Co-suspect products included 10PN-PD-Dit (batch number L21066?, expiry date April 2018), Polio Bivalent T1 T3 oral (batch number M5103?, expiry date January 2017) and HEXAXIM (batch number L7413, expiry date May 2017). The patient''s past medical history included premature birth and birth weight low (birth weight was 1.09 kilograms, Apgar ratings were 7/10 and 9/10, body length and head circumference were 34 centimeters and 28 centimeters). Concomitant products included BCG vaccine and OPV vaccine. On 29th April 2016, the patient received ROTARIX (oral), Pneumococcal vaccine, Bivalent Poliomyelitis vaccine Types 1+3 and HEXAXIM. On 30th April 2016, 1 days after receiving ROTARIX, Pneumococcal vaccine and Bivalent Poliomyelitis vaccine Type 1+3, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 30th April 2016, the outcome of the unknown cause of death was fatal. The patient died on 30th April 2016. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX, Pneumococcal vaccine and Bivalent Poliomyelitis vaccine Types 1+3. Additional details were provided as follows: The patient''s mother was aged 31 years. She also had no past or current medical history of note. She was not HIV positive and was not on any chronic medications of note. The mother is a gravida 2, para 3 lady who had her first child in 2005. The patient''s mother had another pregnancy in 2010, which unfortunately, spontaneously aborted at 4 weeks. She could not attribute this miscarriage to any cogent cause. The patient was delivered prematurely through Caesarean section on Tuesday, the 15 March 2016 around the gestational age of 28 weeks at the academic hospital. The indication for the operation was breech delivery as well as foetal distress. His birth weight was recorded to be 1.09 kilograms. Apgar ratings were recorded as 7/10 and 9/10. His birth body length and head circumference were documented to be 34 centimeters and 28 centimeters respectively. He had to be on admission in the neonatal ICU of that hospital for several weeks afterwards. Apart from being born preterm at the age of 28 weeks with a birth weight of 1.09 kilograms, there was no much of note around the medical history of the child. He did not have any history of allergy and had no history of recurrent illnesses. He was eventually discharged from the academic hospital on 25 April 2016 on excellent clinical grounds with an improved body weight of 1.8 kilograms. After the first antenatal booking during the pregnancy on 29 October 2015, the mother of the patient regularly attended care throughout the first and mid-trimesters at the clinic and according to the records there were no untoward developments during the pregnancy. Her weights, temperature, pulse and blood pressure readings during antenatal care visits were within normal parameters. Her expected date of delivery (EDD) was 15 June 2016 but she had to give birth some 12 weeks earlier. The patient received due at birth vaccinations of oral polio and BCG intramuscular injection at the hospital just before his discharge on Wednesday, the 26 of March 2016. There were no allergic reactions sequelae after administrations of these vaccines. The child was brought by his mother to the clinic around 9 hours 30 on 29 April 2016 for his six weeks schedule of vaccinations. The vaccines normally administered for this age, according to the national EPI vaccination schedule include the first dose of the PCV, the first dose of the Bivalent Oral Polio vaccine administered orally as well as the first dose of the HEXAXIM vaccine that is administered intramuscularly on the left thigh. As at the time of vaccinations, he was not on any medications and had no illness of note, according to the mother. He had a presenting weight of 1.9 kilograms. Though this weight was not appropriate for his chronological age, it was never a contraindication for vaccination. Unless there are serious cogent reasons for deferring vaccinations, such as previous allergic reaction to a vaccine or very high fever at time of presentation, there was absolutely no contraindication to the administration of any vaccine to a patient. Being born premature and being underweight were not contraindications to vaccination. Children born premature are given their due vaccines according to their chronological ages. There were no history of fever and there was no recording of any pyrexia. Other vitals were described as normal. The vaccinations on that day were administered by a qualified nurse. Like any experienced nurse would have rightly done, she requested the child to be observed for some minutes before he was finally discharged home. Mother was also duly informed to bring back child if she noticed any untoward sign or symptom that might portend to an adverse event. He was eventually taken home by mother on satisfactory clinical grounds. No other child who received vaccine of same batch numbers as those administered to the infant has ever come back with any complaint. According to the mother, whilst at home the patient was well and fine within the first few hours post vaccination. There was no vomiting and there were no abnormal respirations such as grunting or chest wheeze. He remained so until when he was checked to be fed around the early hours of Saturday, 30 April, 2016. It was at this time that the mother noticed he had ceased breathing. She observed that he was lifeless with no chest movements. The mother and the accompanying grandmother rushed him straight to the hospital. There, at this hospital, the child was declared as a death on arrival (DOA) case by the two attending health care practitioners. The patient was eventually interred on a week later after due forensic examinations had been carried out. Findings of the post mortem report were not yet out as at the time of this report.


VAERS ID: 646281 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-07-29
Entered: 2016-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1607JPN012977

Write-up: Information has been received from Sanofi Pasteur MSD via a press article. On unspecified dates the patients were vaccinated HPV vaccine (manufacturer not reported). The article stated that of 23 million women vaccinated until 2006, 12,424 (0.05%) had had probably sustained serious side effects due to the injection of the vaccine (see case # 1607JPN012974), in a total of 32 cases, resulted in death. No other information was provided. The article also mentioned that the vaccine caused nerve damage leading to pain throughout the body (see case # 1607JPN010617). No further information is expected.


VAERS ID: 646202 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-28
Onset:2015-11-25
   Days after vaccination:576
Submitted: 2016-08-01
   Days after onset:249
Entered: 2016-08-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H13610 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Haemolytic uraemic syndrome, Pneumococcal infection
SMQs:, Haemolytic disorders (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-27
   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: Premature birth (Premature baby), gestational age 35
Allergies:
Diagnostic Lab Data: 25-NOV-2015, Blood culture, pneumococcal infection serotype 19A
CDC Split Type: 2016365939

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Public Health. A 31-month-old female patient received the first dose of PREVENAR 13, (batch G15592) single dose on 31May2013 when she was 2 months old. The patient''s second dose was received on 31Jul2013 from batch G79293 when she was 4 months old. The third dose was received on 28Apr2014 from batch H13610 when the patient was 12 months old. Relevant medical history included premature birth (gestational age 35). The patient''s concomitant medications were not reported. On 25Nov2015, pneumococcal infection serotype 19A was found in blood culture. The patient was reported to be 31 months old at the time of infection. On an unspecified date the patient experienced haemolytic uraemic syndrome. The patient was not part of any clinical risk group. The patient did not have homozygous sickle cell disease or other haemoglobinopathy, history of previous invasive bacterial disease, splenic dysfunction, immunosuppressive condition or drug, malignancy, congenital abnormality, conditions associated with CSF leakage, chronic respiratory disease (including asthma), chronic disease (including cardiac, renal, liver, diabetes mellitus, cochlear implants and coeliac disease), empyema, cerebral abscess or other complications. The patient died on 27Nov2015. The cause of death was unknown. It was unknown whether an autopsy was performed. The outcomes of the events were unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 647631 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-21
Onset:2016-07-22
   Days after vaccination:1
Submitted: 2016-08-10
   Days after onset:19
Entered: 2016-08-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC700A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M55711 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, C-reactive protein increased, CSF glucose decreased, CSF neutrophil count increased, CSF protein, CSF test abnormal, Capillary nail refill test, Catheterisation venous, Chest X-ray normal, Coma scale normal, Diet refusal, Ear, nose and throat examination normal, Gastrointestinal sounds abnormal, General physical health deterioration, Hyperthermia, Hypertonia, Intensive care, Macule, Meningism, Meningitis pneumococcal, Moaning, Neurological examination abnormal, Procalcitonin increased, Pyrexia, Somnolence, Visual analogue scale
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? Yes
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: 24-JUL-2016, Blood pressure measurement, 113/90 mmHg; 22-JUL-2016, Body temperature, 38.4 Centigrade; 23-JUL-2016, Body temperature, 39.8 Centigrade; 24-JUL-2016, C-reactive protein, 340 mg/l; 24-JUL-2016, CSF glucose, <0.06 hypoglycorrhachia mmol/l; 24-JUL-2016, CSF protein, 2.93; 24-JUL-2016, CSF test, gram positive diplococci 850 cells per mm3 include; 24-JUL-2016, Chest x-ray, normal; 24-JUL-2016, Coma scale, 8; 24-JUL-2016, Ear, nose and throat examination, normal; 24-JUL-2016, Investigation, regular heart sounds without murmur and femoral pu; 24-JUL-2016, Investigation; 24-JUL-2016, Investigation, less than 3 seconds; 24-JUL-2016, Neurological examination, anterior strained and not-bulging fontanel. Deep; 24-JUL-2016, Oxygen saturation, 100% under 1L of oxygen %; 24-JUL-2016, Physical examination, non purpuric macules on the right foot; 24-JUL-2016, Physical examination, soft abdomen without tenderness, borborygmi and no; 24-JUL-2016, Procalcitonin, 52.3; 24-JUL-2016, Visual analogue scale, 1; CSF examination (24Jul2016): CSF protein 2.93 (no unit provided), hypoglycorrhachia with CSF glucose < 0.06 mmol/L, and 850 cells per mm3 including 93% of neutrophils. Direct examination found gram-positive diplococci. Neurological examination (unknown date): anterior strained but not-bulging fontanel, deep tendon reflex in 4 limbs, intermediate but reactive pupil, axial and peripheral hypertonia and meningism. Abdominal examination (unknown date): soft abdomen without tenderness, borborygmi and no hepatosplenomegaly.
CDC Split Type: 2016373426

Write-up: This is a spontaneous report received from the Safety Agency, regulatory authority report number LM20160788. A 4-month-old female patient received the second doses of the suspect vaccines PREVENAR 13, lot number M55711) at 0.5 ml single and INFANRIX HEXA lot number A21CC700A at 1 DF single, both by intramuscular route on 21Jul2016. No relevant medical history and no concomitant treatment were reported. The patient developed hyperthermia on 22Jul2016, asthenia on 23Jul2016 and pneumococcal meningitis on 24Jul2016 which were reported to be life-threatening. On 22Jul2016 fever appeared at 38.4 degree C and the patient DOLIPRANE. On 23Jul2016 fever reached 39.8 degree C, associated with severe asthenia. Paracetamol was administered systemically. On 24Jul2016 the patient presented with general health deterioration, food refusal, somnolence, moaning and grumble. Cerebrospinal fluid (CSF) direct examination allowed diagnosis of pneumococcal meningitis. CSF examination found CSF protein 2.93 (no unit provided), hypoglycorrhachia with CSF glucose < 0.06 mmol/L, and 850 cells per mm3 including 93% of neutrophils. C-reactive protein was 340 mg/L. Procalcitonin was 52.3 (no unit provided). Direct examination of CSF showed gram-positive diplococci. Neurological examination found anterior strained but not-bulging fontanel, deep tendon reflexes in 4 limbs, intermediate but reactive pupil, axial and peripheral hypertonia and meningism. Glasgow coma score was 8. Visual analogue scale was 1. Skin examination found non purpuric macules on the right foot. Ear-nose-throat examination was normal. Bilateral and symmetric vesicular murmur was detected with no adventitious lung sounds. Chest x-ray was normal. Oxygen saturation was 100% under 1L of oxygen. Regular heart sounds without murmur was observed and femoral pulse was easily detected. Capillary refill time was less than 3 seconds. Blood pressure was 113/90 mmHg. Extremities were warm. Abdominal examination found soft abdomen without tenderness, borborygmi and no hepatosplenomegaly. Corrective measures included bone catheter insertion and loading with 2mL/kg then 20 mL/kg of sodium chloride (0.9%). Empirical antibiotic coverage included CLAFORAN 200 mg/kg/day in 3 intakes and amoxicillin (unspecified trade name) 200 mg/kg/day in 3 intakes. Solution of DEXTRION was administered at 60 mL/kg. The patient was transferred to pediatric intensive care unit where 2 peripheral venous access and oxygen by nasal prongs were inserted. Blood pressure and urine output were monitored. Antibiotic therapy with cefotaxime sodium was adjusted at 300 mg/kg/day. The patient was treated also with gentamicin (unspecified trade name), dexamethasone (unspecified trade name), paracetamol and NUBAIN. The outcome of pneumococcal meningitis, hyperthermia and asthenia was unknown at the time of the Agency report. Based on the Method of Causality Assessment, the causal relationships between the suspect vaccines and the adverse events pneumococcal meningitis, hyperthermia and asthenia were assessed by the Agency as "doubtful". No follow-up attempts possible. No further information expected.


VAERS ID: 647776 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-06-29
Onset:2016-06-29
   Days after vaccination:0
Submitted: 2016-08-12
   Days after onset:44
Entered: 2016-08-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 050415 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acid base balance abnormal, Anaemia, Bacterial infection, Blood glucose decreased, Brain injury, Brain oedema, Catheter placement, Condition aggravated, Congenital anomaly, Death, Endocrine disorder, Endotracheal intubation, Enterocolitis, Generalised tonic-clonic seizure, Haemoglobin decreased, Haemothorax, Hyperthermia, Hypoproteinaemia, Hypoxia, Immune system disorder, Malaise, Mechanical ventilation, Multiple organ dysfunction syndrome, Myelocyte count, Pericardial haemorrhage, Pneumonia, Protein total decreased, Pulmonary alveolar haemorrhage, Pulmonary oedema, Rash papular, Streptococcus test positive, Toxic shock syndrome, Viral infection, White blood cell count increased
SMQs:, Cardiac failure (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: SEP-2015, Past drug event, Hepatitis B vaccine, no adverse event; SEP-2015, Past drug event, BCG vaccine, no adverse event; Respiratory disorder; Brain injury, hypoxic-ischemic damage of central nervous system; Congenital anomaly suspected; Deficiency anaemia of mild severity; Immunodeficiency; Congenital adrenal gland hypoplasia; Immune system disorder; Complication of pregnancy, toxicosis at the first trimester and premature break of amniotic water; 24-DEC-2015, DTP HB, no adverse reaction, first vaccine; 24-DEC-2015, IMOVAX POLIO, no adverse event;
Allergies:
Diagnostic Lab Data: JUL-2016, Acid base balance, acidosis; SEP-2015, Apgar score, 8/9; 2016, Bacterial test, Str. pneumoniae from right and left lungs; JUL-2016, Blood glucose, 26.74; 2016, Blood test, within normal range for the age group; JUL-2016, Blood test, hypoproteinemia up to 56.5; 29-JUN-2016, Body temperature, 39.7 Centigrade; 02-JUL-2016, Body temperature, up to 39 Centigrade; JUL-2016, Haemoglobin, 103; JUL-2016, Myelocyte count, present; 2016, Physical examination, no results; 02-JUL-2016, Physical examination, breathing and pharynx were normal, JUL-2016, White blood cell count, 20.3. Physical examination (02Jul2016): Complaints to appearance of single popular rash on the legs, considered by the physician pediatrician as allergy reaction to amoxicillin trihydrate. During the examination breathing and pharynx were normal.
CDC Split Type: 2016379152

Write-up: This is a spontaneous report from a non-contactable pharmacist received from the Agency. The Regulatory authority report numbers are 134046 and 03-33108/16. The report was supplied by local PQC group and contained an official letter of 28Jul2016 to inform that a quality check of PREVENAR 13 (lot 050415) samples would be performed due to fatal adverse reaction occurred. A 9 month-old female patient of an unspecified ethnicity received the first dose of PREVENAR 13, lot/batch 050415 at 0.5 ml single and the second dose of DTP HB, batch P21 at 0.5 ml, both intramuscular on 29Jun2016. Medical history included acute respiratory disease, hypoxic-ischemic damage of central nervous system, suspected congenital malformation, deficiency anemia of mild severity, immunodeficiency, congenital immuno endocrine dysfunction (thymomegalia and adrenal hypoplasia). Concomitant medication included the second dose of IMOVAX POLIO administered intramuscular on 29Jun2016. Anamnesis: the child was born from a mother at her third pregnancy and third delivery at gestational age 39-40 weeks, pregnancy was accompanied by toxicosis at the first trimester and premature break of amniotic water. Apgar score was 8/9. Hepatitis B vaccination and BCG vaccination were performed at the maternity hospital in Sep2015. She was discharged from the maternity hospital with the diagnosis: infant of high risk group because of perinatal pathology. Raised and grew up according to her age. Previous diseases: acute respiratory disease, and she had neurologic record due to diagnosis hypoxic-ischemic damage of central nervous system. The mother denied allergic reactions at hospital admission. Vaccination history: Hepatitis B vaccination and BCG vaccination at the maternity hospital, first diphtheria and tetanus toxoids and pertussis vaccination with Hepatitis B vaccination, polio vaccine on 24Dec2015, no reaction occurred to vaccinations. On 29Jun2016 the patient was vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein), diphtheria vaccine, hepatitis B vaccine, pertussis vaccine, tetanus vaccine and polio vaccine, after physician - pediatrician examination and after receipt of blood test results (within normal range for the age group). Clinical course of the disease: per mother, the child fell ill on 29Jun2016 with hyperthermia up to 39.7 C. From 29Jun2016 till 02Jul2016 mother did not appeal for medical aid, no treatment was provided. On 02Jul2016 she went to the hospital with the complaints to body temperature increased up to 39 C and appetite decreased. The body was examined by the physician of pediatric department, where an antipyrexial injection was done. The mother refused hospitalization in written form. The physician prescribed the ambulant therapy: FLEMOXIN 125 mg, half tablet thrice a day, warm drinking, PROTARGOL nasal drops into nasal passages. Active call was provided to territory outpatient department. On 02Jul2016 the child was examined by the physician pediatrician at home. Complaints to appearance of single popular rash on the legs, considered by the physician pediatrician as allergy reaction to amoxicillin trihydrate. During the examination breathing and pharynx were normal. On 03Jul2016 at 17:00 the condition of the baby worsened, the ambulance was called, the mother refused hospitalization. In the night from 03Jul2016 to 04Jul2016 the condition worsened: sharply tonic clonic seizures appeared, again the ambulance was called, lytic cocktail was made and dexamethasone 0.8 mg IM was administered. The baby was taken to a hospital with signs of infectious-toxic shock, pulmonary edema. The baby was immediately taken to the resuscitation room, insertion of catheter into the subclavian vein and intubation of trachea were performed, the baby was switched to artificial pulmonary ventilation. An intensive therapy was started, cardiotonic therapy with DOFAMIN as well as hormonal and antibacterial therapy. In blood tests leukocytes at 20.3, hemoglobin 103, glucose 26.74 in leucoformula, myelocytes, acid base balance with acidosis, in blood chemistry hypoproteinemia up to 56.5. During the therapy the condition was progressively getting worse, at 7.10 a biological death was diagnosed. Final combined diagnosis: generalized viral bacterial infection, bilateral pneumonia, enterocolitis. Suspected congenital malformation. Complicated multiple oral failure. Infectious toxic shock. Accompanying by hypoxic ischemic damage of central nervous system and deficiency anemia of mild severity. Immune deficiency on background. Autopsy results: combined main disease: Bilateral macrofocal polysegmental bronchopneumonia (bacterial culture Streptococcus pneumoniae from right and left lungs). Congenital immuno endocrine dysfunction (thymomegalia and adrenal hypoplasia). Complicated cerebral and pulmonary edema. Hemorrhagic syndrome: focal intraalveolar and sub pleural, subcardial haemorrhages. Anemia. Dystrophy of parenchymatous organs.


VAERS ID: 647824 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-13
Onset:2015-10-13
   Days after vaccination:0
Submitted: 2016-08-12
   Days after onset:304
Entered: 2016-08-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-12-24
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 42 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Glioblastoma
Preexisting Conditions: Ear infection; Folliculitis; Gastroenteritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL2016GSK112373

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of malaise in a 3-year-old male patient who received INFANRIX-IPV. The patient''s past medical history included otitis, folliculitis and gastroenteritis. Concurrent medical conditions included glioblastoma. On 13th October 2015, the patient received the 1st dose of INFANRIX-IPV. On 13th October 2015, several minutes after receiving INFANRIX-IPV, the patient experienced malaise (serious criteria hospitalization, life threatening and other: serious as per reporter) and vomiting. On an unknown date, the outcome of the malaise and vomiting were not recovered/not resolved. The reporter considered the malaise and vomiting to be possibly related to INFANRIX-IPV. Additional details were provided as follows: The patient had no known past drug therapy. Concomitant medication was not reported. The patient receive vaccine in unknown thigh. Because of these complaints, the patient was hospitalized for 6 weeks. On 24th December 2015, 72 days after onset of the malaise and vomiting, the patient died due to the glioblstoma. The mother of the patient said that after vaccination, the health condition of the patient deteriorated. No any physical findings and investigations were reported. No further information was available.


VAERS ID: 648255 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2016-07-27
Onset:2016-07-30
   Days after vaccination:3
Submitted: 2016-08-16
   Days after onset:17
Entered: 2016-08-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER LO3244V / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34927 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L046516 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016382436

Write-up: This is a spontaneous report received from a contactable physician via the Health Authority. Regulatory Authority report number DE-PEI-PEI2016060142. A 2 months old male patient received on 27Jul2016 the first doses of PREVENAR 13 (lot N34927) at 0.5 ml single, intramuscular, ROTATEQ (lot L046516) at 1 DF single, oral and HEXYON (lot LO3244V) at 1 DF single, intramuscular. Medical history and concomitant medication were not provided. On 30Jul2016, the patient was found dead in his bed. It was unknown if an autopsy was performed. No follow-up attempts needed. No further information expected.


VAERS ID: 649432 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-01
Onset:0000-00-00
Submitted: 2016-08-26
Entered: 2016-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVAX) / CSL LIMITED - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test abnormal, Foetal death, Foetal exposure during pregnancy, Foetal hypokinesia, Foetal movement disorder, Hypoxia, Laboratory test normal, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-06
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 Date: 20121028; Test Name: Heart rate; Result Unstructured Data: Test result: fine.; Test Date: 20121028; Test Name: Blood pressure; Result Unstructured Data: Test result: good all the way through; Test Date: 20121028; Test Name: Blood pressure; Result Unstructured Data: Test result: perfect.; Test Name: Blood tests, cord, placenta and tissues test; Result Unstructured Data: Test results: Down''s syndrome; positive.; Test Date: 20121111; Test Name: Weight; Result Unstructured Data: test result: on delivery foetus was normal weight and size.; Test Date: 20121028; Test Name: Growth measure; Result Unstructured Data: Additional test on 28-Oct-2012, growth measure was fine.
CDC Split Type: GBBEH2016072953

Write-up: This spontaneous case, initially received on 23-Aug-2016, was reported by a non health professional and concerns a 1-hours-old male patient. Weight: 3.1 kg (also reported as 3.25 kg); Height: 47 cm. Linked case: GB-BEH-2016072951 (mother''s case). The patient''s mother is fit, healthy and has had four previous pregnancies resulting in live births. There is no family history of miscarriages or still births in the family. Throughout the mother''s fifth pregnancy, bloods and blood pressure were good/perfect. The mother had no known allergies. At every appointment throughout the mother''s pregnancy, the patient''s growth, heart and movement were perfect. The patient''s heart was strong throughout pregnancy. At a midwife''s appointment three days prior to vaccination, the patient''s growth and heart beat were checked and the mother''s blood pressure and pulse were also checked. The results were fine, the patient (foetus) was very active (he never liked to be prodded) and his heart was beating strong, everything was fine. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for vaccination from 01-NOV-2012 to 01-NOV-2012. Dose regimen: Not reported, Route of administration: Transplacental. Batch number: Not reported. Non-company suspect drugs: On the same day, the patient received REPEVAX for vaccination. Dose regimen: Not reported, Route of administration: Transplacental. Batch number: Not reported. Adverse reactions/events and outcomes: After the injections, things started to slow down. On 06-Nov-2012 (reported as four and five days post vaccination), the patient''s mother noticed a decrease in the patient''s (foetal) movements / movements stopped (stop date: 09-Nov-2012, medically significant, outcome: not recovered / not resolved). The patient''s mother lost slight blood / started to lose pink (vaginal) fluid / blood and lose a little bit of (vaginal) mucus. The hospital told the patient''s mother this was normal and not to go to the hospital. The patient''s father called the delivery suite to see if the patient''s mother should attend. They informed the patient''s father that everything was fine and it could be a mucus plug. From this point, the patient''s mother noticed a decrease in the patient''s movements (medically significant, outcome: not recovered / not resolved), this was not normal as the patient had always been so strong and moved all the time. The patient''s father telephoned a further three times over the next days as the movements had stopped completely. In the end, the patient''s mother had to wait to be seen at a routine midwife appointment three days later. At this appointment, the midwife could not find a heart beat (medically significant, outcome: not reported) and discovered that the patient had died. On 11-Nov-2012, the male patient was delivered asleep (medically significant, outcome: fatal) at 36 weeks gestation. The patient was of normal weight and size for the (gestational) age of 36.5 weeks. He measured 47cm and weighed 3.1 kg (also reported as 3.25 kg), these measurements are bang on with what he should have been for 36 weeks (gestation). The patient died of hypoxia with an unknown cause (start date reported as 09-Nov-2012) medically significant, outcome: fatal). A post mortem was not carried out on the patient but all blood tests, his cord, placenta and also tissue were tested. The results showed that the patient had Down''s syndrome (medically significant, outcome: not reported). The placenta was in perfect condition and working order. The patient''s parents believe the patient to be only slightly (Down''s syndrome) as there were no visible signs of this. The outcome for foetal exposure during pregnancy is unknown (start date: 01-Nov-2012). Special circumstances for all events: drug exposure during pregnancy. The patient died on 06-Nov-2012. Cause of death: hypoxia, stillbirth. Relevant test results: 28-Oct-2012 test name: heart rate, result: fine. 28-Oct-2012 test name: blood pressure, result: good all the way through. 28-Oct-2012 test name: blood pressure, result: perfect. Unspecified date: Blood tests, cord, placenta and tissues test; results: Down''s syndrome; positive. 11-Nov-2012 test name: weight, test result: on delivery foetus was normal weight and size. Additional test on 28-Oct-2012, growth measure was fine. Parent (maternal) relevant test results: 28-Oct-2012 test name: blood pressure. test result: normal (everything was fine). 28-Oct-2012 test name: pulse, test result: normal (everything was fine). 06-Nov-2012 test name: vaginal discharge, test result: abnormality (patient started to lose pink fluid, started to lose little bits of mucus and blood). Test name: normal birth, comments: fifth pregnancy, all 4 prior resulted in live births. Reporter''s Comments: Reporter''s assessment: The health authority considered all event(s) as serious (patient died, other medically significant) and reported the preferred term foetal exposure during pregnancy. The patient''s father has a strong belief that the whooping cough vaccination caused the patient''s death on and around four days after vaccination. The patient''s parents stated that everything went downhill once the vaccines were given. They have a strong belief that all the vaccines together killed the patient. Sender''s Comments: Company comments and assessments: Listedness: Unlisted. Brand of Influenza vaccine not specified. Assessment according to the CCDS for CSL''s Influenza Virus Vaccine, all events are unlisted except foetal drug exposure which is listed as vaccination is not contraindicated in pregnant women. Causality: Unrelated. The foetus was exposed (via the mother) to Influenza vaccine in 3rd trimester at approximately 35 week gestation. Baby was diagnosed with Down''s syndrome post birth and cause of death was reported as hypoxia. The mother did not report any systemic vaccine side effects and there was a delay of 6 days before decreased foetal movement was noted. It is also not known if antenatal corticosteroids were administered to reduce complications of prematurity such as respiratory distress syndrome which is associated with foetal death. Although the etiology of foetal death is not known in 25-60% of all cases, it can be broadly attributable to foetal, maternal, or placental pathology. In this case, advanced maternal age over 35 years, presence of Down''s syndrome and absence of any immediate vaccination related systemic adverse events, causality is considered unrelated to vaccination. Reported Cause(s) of Death: Hypoxia; Stillbirth.


VAERS ID: 650632 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-08-02
Onset:2016-08-03
   Days after vaccination:1
Submitted: 2016-08-24
   Days after onset:21
Entered: 2016-08-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC738A / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M98569 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cold sweat, Death, Histology, Laboratory test normal, Microscopy, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 23-MAY-2016, INFANRIX HEXA, no adverse effect, first dose; 23-MAY-2016, PREVENAR 13, no adverse effect, first dose; 23-MAY-2016, ROTARIX, no adverse effect, first dose
Allergies:
Diagnostic Lab Data: Autopsy, macroscopic examination without irregularities. Autopsy results (unknown date): Macroscopic examination without irregularities, histological examination pending, laboratory parameters without definite signs of infection. Sepsis was excluded, no definite signs of metabolic defect. Causes of death were reported as unexplained. Autopsy-determined causes of death: Pending.
CDC Split Type: 2016397381

Write-up: This is a spontaneous report received from the Agency. RA report number DE-PEI-PEI2016063473. A 4-month-old male patient of unspecified ethnicity was vaccinated with the second doses of PREVENAR 13 (batch no.: M98569), single dose, intramuscular on the left thigh and INFANRIX HEXA (batch no.: A21CC738A), intramuscular, on the right thigh on 02Aug2016. The patient had previously received first dose of diphtheria vaccine, haemophilus influenza type B vaccine, hepatitis B vaccine, pertussis vaccine, polio vaccine, tetanus vaccine, pneumococcal 13-val conj vac (dipht crm 197 protein) and ROTARIX on 23May2016 and had been well tolerated. On 03Aug2016, the patient presented with tachycardia and cold sweat. The patient was hospitalized to undergo further examinations. A few hours after hospital admission, the infant died. According to the reporting physician, an autopsy was performed. Autopsy results: Macroscopic examination without irregularities, histological examination pending, laboratory parameters without definite signs of infection. Sepsis was excluded, no definite signs of metabolic defect. Causes of death were reported as unexplained.


VAERS ID: 650092 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-07-25
Onset:2016-07-29
   Days after vaccination:4
Submitted: 2016-08-31
   Days after onset:33
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1615 / 3 AR / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15F01A / 3 AR / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L026062 / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardio-respiratory arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA154991

Write-up: Initial unsolicited report received from a Pediatrician via health authority under reference number V16100408 and from the pediatrician via Partner Company on 22 August 2016. This case involves a four months old male patient who was vaccinated with a third 0.5 ml dose of ActHIB (batch number L1615, expiry date, dose, site of administration was not reported )subcutaneously, a third dose of Prevenar13 (batch number 15F01A, expiry date, dose, site of administration was not reported) subcutaneously and a third dose of RotaTeq (batch number L026062, expiry date, dose was not reported) orally on 25 July 2016 at 03:05 PM (reported as 15:05). It was reported that patient''s birth weight was 2572g. Patient''s condition before vaccination, underlying disease, concurrent condition, historical condition, adverse drug reaction history and allergy history reported as none. It was also reported that patient''s older brother died at the age of four years due to microcephaly and cardiac disease. Patient''s body temperature before the vaccination reported as 37.1 degree Celsius. Concomitant medications were no reported. On 29 July 2016 at 03:00 AM, four days following the vaccination, the patient experienced cardio respiratory arrest and died on same date. Laboratory investigations and corrective treatment were not reported. It was reported that on unspecified date, autopsy was performed and resulted as no abnormalities (sudden infant death syndrome). Upon internal review, the company decided to code the event: cardio-respiratory arrest which was mentioned in the narrative but was not coded by HA. Diagnosis: Sudden infant death syndrome. Reporting pediatrician''s seriousness assessment: Serious (Death). Reporting pediatrician''s causality assessment: Unknown. Reporting pediatrician''s comment: Other possible factors for the event were unknown. List of documents held by sender: none. Sender''s Comments: This is a Sudden infant death syndrome case of a 4 months old child who died 4 days after receiving HIB [PRP/T] VACCINE, simultaneously with PNEUMOCOCCAL POLYSACCHARIDE VACCINE and ROTAVIRUS VACCINE from other manufacturers. Time to onset is compatible with the role of vaccine, however more details regarding the baby (relevant medical history) and the environmental factors (smoking in the family, position during sleep, etc) would be helpful to further assess this case. In this case, autopsy was performed and did not reveal any significant findings. However, detailed autopsy report was not provided. As three vaccines were administered simultaneously, the role of each component cannot be assessed. Sudden infant death syndrome is the sudden unexplained death of a child less than one year of age and the diagnosis of the death remains unexplained even after a thorough autopsy. Reported Cause(s) of Death: cardio-respiratory arrest and died; sudden infant death syndrome; Autopsy-determined Cause(s) of Death: cardio-respiratory arrest and died; sudden infant death syndrome.


VAERS ID: 668236 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-06-25
Onset:0000-00-00
Submitted: 2016-08-31
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER K007694 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Premature baby death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1608DEU015212

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DE-1577272925-2016008586) on 30-AUG-2016. Case received from a physician on 27-Jul-2016. This case is linked to mother case E2015-07904. A male patient was exposed in utero to M-M-RVAXPRO, rHA, batch/lot number K007694 (expiration date unknown) via transplacental route (Parent route of administration: intramuscular) on 25-Jun-2015. Prenatal examinations: First trimester screening (SSW 12) unsuspicious. Sonography on 29-AUG-2015 (first trimester), and on 16-OCT-2015 (SSW 20+2 second trimester) unsuspicious. Premature baby death occurred in SSW 22+1 because of premature travail with opening of cervix and therefore amniotic sac prolapse - emergency cerclage - premature rupture of membranes because of amnion infection - syndrome - spontaneous labour: male, 540 g, child died 5 minutes after delivery. It was unknown whether an autopsy was performed. The patient''s outcome was reported as Fatal. Note: Initially the physician had reported Intrauterine foetal death.


VAERS ID: 668244 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-06-01
Submitted: 2016-08-31
   Days after onset:91
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

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: WAES1608BRA014618

Write-up: This spontaneous report was received from a consumer and refers to a child of unknown age and gender. There was no information regarding the patient''s medical history, concurrent conditions or concomitant therapies provided. The reporter found out about the event reported below from the internet (type of webpage was not specified). On an unknown date, the patient was vaccinated with a dose of ROTATEQ (lot #, expiration date and exact dose were not reported; orally). On an unspecified date in June 2016, the child died after taking ROTATEQ. The cause of death was not reported. The relatedness between the event and ROTATEQ was not assessed. Upon internal review, the event of death was determined to be medically significant. This is one of two reports received from the same reporter. Additional information is not expected as the reporter had no further information.


VAERS ID: 668330 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-31
Entered: 2016-09-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER 033021A / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Necrotising fasciitis
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: CO2016GSK118720

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of necrotizing fasciitis in a female patient who received TETANOL PUR (batch number 033021A, expiry date unknown). Concomitant products included HAB. On an unknown date, the patient received TETANOL PUR. On an unknown date, an unknown time after receiving TETANOL PUR, the patient experienced necrotizing fasciitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the necrotizing fasciitis was fatal. The reported cause of death was necrotizing fasciitis. It was unknown if the reporter considered the necrotizing fasciitis to be related to TETANOL PUR. Additional details were provided as follows: The age at vaccination was not reported. No information was reported about the medical relevant information or concomitant treatments of the patient. The patient was received TETANOL PUR and vaccine for Hepatitis (not specified) and additionally other vaccine which was not specified. The patient developed a necrotizing fasciitis at the vaccination site which caused her death. Follow-up information was received on 26th August 2016 from physician: The patient''s demographic details were updated. Communications head identified 2 journal articles about a fatal case after vaccination. to confirm this was the same case, the person of the regulatory authority was contacted by the agency who confirmed was the same case. The article mentioned that the patient received Hepatitis B vaccine (previously reported was a Hepatitis vaccine) and MMR vaccine (unknown trade name). Although causality was not reported, it is presume by the article that the event may have been caused by a wrong medical procedure. The agency was closed by the government as it was identified a non-compliance in the local requirements. It was unknown if the reporter considered the necrotizing fasciitis to be related to Hepatitis B vaccine and MMR vaccine.


VAERS ID: 673318 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-11
Onset:2016-07-24
   Days after vaccination:529
Submitted: 2016-09-05
   Days after onset:43
Entered: 2016-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Thermal burn
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609MLI001295

Write-up: Information has been received from a physician referring to a 22 month old male patient, who was enrolled in a Post Marketing Active Surveillance as a healthy control in an ongoing diarrhea surveillance. On 17-NOV-2014, 22-DEC-2014, and 11-FEB-2015, the patient was vaccinated with 3 doses of ROTATEQ, orally (frequency: once; dose and lot# were not reported), respectively. On 24-JUL-2016, a pot of hot stew spilled on the child. This resulted in burns to various parts of the body (unknown percentage). The patient was subsequently taken to the local health center. The burns were dressed and the child was discharged to home. The next day, the burned areas were worse and the child was taken to the local referral center where the physician immediately sent the child to a hospital for better care. The patient died on the same day (25-JUL-2016) at 6 pm while receiving an unknown treatment. It was unknown if an autopsy was performed. It was during the follow up visit that the mother of the patient informed the reporter of the death of the patient. The reporter considered the event to be not related to ROTATEQ. Additional information is not expected as there is no follow up required/available.


VAERS ID: 650944 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-26
Onset:2016-08-29
   Days after vaccination:3
Submitted: 2016-09-06
   Days after onset:8
Entered: 2016-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15301A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Death, Epistaxis, Pallor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA160303

Write-up: Initial unsolicited report received from a physician (pediatrician) via authority, Pharmaceuticals and Medical Devices Agency (under Reference number: V16100429) on 29 August 2016. This case involves a 04-month-old female patient who was vaccinated with 0.5 ml second primary dose of dose of ACTHIB and with second primary dose of PREVENAR 13 (batch number: 15301A) all via subcutaneous route (expiry date, and site of administration was not reported) on 26 August 2016 at 13:44. The patient did not have medical history and family history was reported as none. Birth weight: 2530 g. Concomitant medications were not reported. On 29 August 2016, at 1:35, 03 days (2 days, 11 hours) following the vaccination, the patient had epistaxis, suspected asphyxia and pallor facial and on the same date, the patient died (in a prone position). The patient''s laboratory data was not reported. The body temperature before vaccination was 37.3 degrees centigrade. Corrective treatment was not reported. It was unknown, whether the autopsy was performed or not. Upon internal review, the company decided to code the event: epistaxis, pallor facial, suspected asphyxia which was mentioned in the narrative but was not coded by HA. Diagnosis: Death (Death) Reporting pediatrician''s seriousness assessment: Serious (Death) Reporting pediatrician''s causality assessment: Unknown Reporting pediatrician''s comment: It was assumed that epistaxis was strongly suspected as the cause of the event. Suspected asphyxia due to epistaxis was another possible factor for the event. List of documents held by sender: none.; Sender''s Comments: In this case four month old infant died in a prone position on the same day of vaccination with HIB (PRP/T) VACCINE and PNEUMOCOCCAL POLYSACCHARIDE VACCINE (other company). The patient was found pallor facial, epistaxis due to that it was suspected that the patient had asphyxia. This reported sudden unexpected death might be compatible with sudden infant death syndrome ( SIDS) possibly due to asphyxia. Unexpected death of an infant <1 year of age, with onset of the fatal episode apparently occurring during sleep. In this case patient was found in prepone position which may cause asphyxia and leads to death of the infant. However detail autopsy report are needed to further assess this case. Based on the provided information the role of the vaccine cannot be drawn. More over the infant received two vaccines simultaneously hence the role of a particular vaccine cannot be assessed.; Reported Cause(s) of Death: death.


VAERS ID: 651104 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-05
Entered: 2016-09-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiotensin converting enzyme, Antinuclear antibody negative, Blood bicarbonate decreased, Blood lactate dehydrogenase, Blood pH increased, Brucella test negative, CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF test normal, Chest X-ray normal, Coma, Computerised tomogram normal, Constipation, Cytomegalovirus test negative, Death, Dysarthria, Dysphagia, Electrocardiogram normal, Endotracheal intubation, Epstein-Barr virus test negative, Facial paresis, Gait disturbance, General physical health deterioration, Herpes simplex test negative, Hydrocephalus, Hyperreflexia, Hyperventilation, Immunoglobulin therapy, Intention tremor, Muscular weakness, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, PCO2 decreased, PO2 increased, Parvovirus B19 test negative, Plasmapheresis, Polymerase chain reaction, Respiratory alkalosis, Sedation, Tachypnoea, Tongue movement disturbance, Toxoplasma serology negative, Treponema test negative, Tumour marker test, Typhus rickettsia test, Urinary retention, Varicella virus test negative, Viral test negative, Weaning failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on unknown date. The PCR in CSF for herpes simplex, varicella zoster, cytomegalovirus, Epstein-Barr virus, JC and tuberculosis were negative as well as serology for measles, parvovirus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and VSRL. Levels of angiotensin converting enzyme in serum and CSF were normal, and tumour markers and antinuclear antibodies were negative. Cranial MRI showed bilateral focal lesions in the white matter which were hyperintense in T2, with minimal enhancement after contrast. In a second MRI, performed one month after the first, involvement of deep grey substance was observed with extensive oedema of the white matter of both cerebral hemispheres and cere-bellum, with brainstem compression and secondary triventricular hydrocephalus. Blood bicarbonate, 14.6 mmol/L; Blood lactate dehydrogenase, 4.7 mmol/L; Blood pH, 7486; CSF glucose, 69 mg/dL; CSF protein, 61 mg/dL; CSF red blood cell count positive, 28 /mm3; CSF test, 11 /mm3; Chest x-ray, normal; Computerised tomogram, normal; Electrocardiogram, normal; Nuclear magnetic resonance imaging, brain; Nuclear magnetic resonance imaging, bilateral focal lesions, brain; PCO2, 12 mmHg; PO2, 126 mmHg
CDC Split Type: ES2016GSK122678

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 63-year-old male patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 14 days after receiving Influenza vaccine, the patient experienced acute disseminated encephalomyelitis (serious criteria death and GSK medically significant), hyperpnea (serious criteria death), coma (serious criteria GK medically significant), hydrocephalus (serious criteria death and GSK medically significant), dysarthria (serious criteria hospitalization), dysphagia (serious criteria hospitalization), facial weakness (serious criteria hospitalization), gait disturbance (serious criteria hospitalization), urinary retention (serious criteria GSK medically significant). tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea. The patient was treated with methylprednisolone, remifentanil, midazolam and immunoglobulins nos. On an unknown date, the outcome of the acute disseminated encephalomyelitis, hypernea and hydrocephalus were fatal and the outcome of the coma, dysarthria, dysphagia, facial weakness, gait disturbance, urinary retention, tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea were unknown. The reported cause of death was central neurogenic hyperventilation. The reporter considered the acute disseminated encephalomyelitis and hyperpnea to be possibly related to Influenza vaccine. It was unknown if the reporter considered the coma, hydrocephalus, dysphagia, facial weakness, gait disturbance, urinary retention, tongue movement impaired, intention tremor, weakness of arms, constipation and tachypnea to be related to Influenza vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of post-vaccination acute disseminated encephalomyelitis and central neurogenic hyperventilation (CNH) in a 63-year-old male patient who was vaccinated with unspecified trivalent adjuvant flu vaccine (manufacturer unknown). The patient had no personal medical history. No information on patient''s family history or concurrent condition or concomitant medication was provided. On an unspecified date, at the age of 63 years, the patient received unspecified trivalent adjuvant flu vaccine (administration route and site unspecified: dosage unknown; batch number not provided). On an unspecified date, approximately 2 weeks after vaccination with unspecified trivalent flu vaccine, the patient experienced dysarthria. dysphagia, peripheral facial weakness and gait disturbance without fever, headache or prodromal signs of infection. These symptoms had gradually appeared after vaccination. 2 weeks later, the patient was admitted to the hospital. On admission, the examination showed neither impairment of consciousness nor visual field or ocular motility disorder. The patient had sever dysarthria with palatial and tongue movement restrictions, intention tremor, abnormal heel-knee test and proximal weakness of the left arm. The tendon reflexes were hyperactive, without clonus, while both proprioception and vibratory sensation were preserved. Laboratory tests: chest x-ray, electrocardiogram (ECG) and Chest-abdomen computed tomography (CT) scan were normal. Cerebrospinal fluid (CSF) analysis showed: 11 cells/mm3, 28 red blood cells/mm3, proteins 61 mg/dL and glucose 69 mg/dL. There were no neoplastic cells or oligoclonal bands or intrathecal IgG synthesis. The polymerase chain reaction (PCR) of CSF for herpes simplex, varicella zoster, cytomegalovirus, Epstein-Barr virus, John Cunningham (JC) virus and tuberculosis were negative as well as serology for measles, parvovirus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and venereal disease research laboratory (VDRL). Levels of angiorensin converting enzyme in serum and CSF were normal, and tumour markers and antinuclear antibodies were negative. Cranial magnetic resonance (MRI) showed bilateral focal lesions in the white matter which were hyperintense on T2, with minimal enhancement after contrast. During the hospital stay, the patient developed constipation and urinary retention. On accounts of medical history, lab tests and MRI results, the patient was diagnosed with post-vaccination acute disseminated encephalomyelitis and treated with high dose methylprednisolone. Due to the emergence of a significant tachypnea, the patient was admitted to intensive care. The arterial blood gas analysis showed the following results: 7.486 pH, PaO2: 126 mmHG, PaCo2: 12 mmHG, HCO33: 14.6 mmol/L. The blood lactate was 4.7 mmol/L (VN less than 2 mmol/L). Since the patient had hyperpnoea and difficulty to protect the airway due to involvement of the lower cranial nerves, the patient was intubated and sedated with remifentanil and midazolam, which decreased the respiratory alkalosis. Repeated attempts to disconnect the respirator failed due to severe hyperventilation, ruling out concomitant infection, lunch disease or heart disease, therefore intravenous treatment was started with immunoglobulins for 5 days and 5 plasmapheresis sessions were performed. Despite treatment, the patient progressively deteriorated and went into a coma. in a second MRI, performed one month after the first, involvement of deep grey substance was observed with extensive oedema of the white matter of both cerebral hemispheres and cerebellum, with brainstem compression and secondary triventricular hydrocephalus. The patient developed CNH, refractory to treatment of the primary disease of acute disseminated encephalomyelitis. With the patient''s family consent, the life-sustaining treatments were limited. Subsequently, the patient died in the unit. The patient died from central neurogenic hyperventilation. It was not reported if autopsy was performed. This case was considered serious due to death. The authors considered the events post-vaccination acute disseminated encephalomyelitis and CNH possibly related to the unspecified adjuvant flu vaccine. The authors concluded that "The CNH forecast is ominous, with a survival of only a few months in most of the reported cases. In our patient, the CNH was refractory to treatment of the primary disease, consistent with increased severity and extent of brain and brain stem lesions. Although this adverse reaction to the flu vaccine was not communicated to the pharmacovigilance service, its causation was considered at least possible using the Karch and Lasagna algorithm".


VAERS ID: 651105 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-06
Entered: 2016-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiotensin converting enzyme, Blood bicarbonate decreased, Blood gases abnormal, Blood lactic acid increased, Blood pH increased, Blood test normal, Borrelia test negative, Brucella test negative, CSF cell count increased, CSF glucose normal, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF test abnormal, Chest X-ray normal, Coma, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Constipation, Cytomegalovirus test negative, Death, Dysarthria, Dysphagia, Electrocardiogram normal, Endotracheal intubation, Epstein-Barr virus test negative, Facial paresis, Gait disturbance, General physical health deterioration, Herpes simplex test negative, Hydrocephalus, Hyperventilation, Immunoglobulin therapy, Intensive care, Measles antibody negative, Mechanical ventilation, Muscular weakness, Mycobacterium tuberculosis complex test negative, Nuclear magnetic resonance imaging brain abnormal, PCO2 decreased, PO2 increased, Parvovirus B19 test negative, Plasmapheresis, Polymerase chain reaction, Respiratory alkalosis, Scan with contrast abnormal, Tachypnoea, Toxoplasma serology negative, Tremor, Treponema test negative, Tumour marker test, Typhus rickettsia test, Urinary retention, Varicella virus test negative, Viral test negative, White matter lesion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Procedure, Intensive care; Procedure, Endotracheal intubation; Procedure, Mechanical ventilation, Repeated attempts to disconnect the respirator failed because of severe hyperventilation; Treatment, Immunoglobulin IV, for 5 days; Procedure, Plasmapheresis, 5 sessions
Allergies:
Diagnostic Lab Data: Blood gases, Abnormal, Significant, pH: 7,486, PaO2: 126 mm Hg, PaCO2: 12 mm Hg, HCO3: 14.6 mmol/l; Blood lactic acid, 4.7 mmol/l, Significant, Normal value less than 2 mmol/l; CSF test, Abnormal, Significant, CSF analysis results were: 11 cell/mm^3, 28 RBC/mm^3, protein 61 mg/l and glucose 69 mg/dl. There were no neoplastic cells, oligoclonal bands or intrathecal IgG synthesis; Nuclear magnetic resonance imaging, Abnormal, brain, Significant, Bilateral, focal white matter lesions that were hyperintense on T2, with minimal enhancement following contrast; Nuclear magnetic resonance imaging, Abnormal, brain, A second MRI, performed a month after the first, showed deep grey matter involvement with extensive white matter edema in both brain hemispheres and the cerebellum brain stem compression, and secondary triventricular hydrocephalus
CDC Split Type: PHHY2016ES120524

Write-up: Case number PHHY2016ES120524 is an initial literature report received on 01 Sep 2016. The author described the first case of central neurogenic hyperventilation (CNH) secondary to acute disseminated encephalomyelitis following trivalent flu vaccination. This report refers to a 63 year old male patient with no personal history of interest. He was vaccinated with trivalent adjuvanted influenza vaccine (manufacturer and batch number: not reported) on an unknown date. He was admitted to the hospital for dysarthria, dysphagia, peripheral facial weakness and gait disorder, but with no fever, headache or prodromal signs of infection. The symptomatology had gradually appeared, starting approximately 2 weeks after receiving flu vaccine, which was one month before hospitalization. An examination at the time of admission showed no level of consciousness disorder and normal campimetry and eye mobility. He had severe dysarthria with restricted palate lift and tongue movement, intention tremor, abnormal left heel-knee test and proximal weakness in the left arm. Tendon reflexes were hyperactive, without clonus, while both proprioception and vibration sensitivity were conserved. The blood tests, chest-x-ray, electrocardiogram (ECG) and chest and abdomen computed tomography (CT) scans were normal. The cerebrospinal fluid (CSF) analysis results were: 11 cell/mm^3, 28 RBC/mm^3, protein 61 mg/l and glucose 69 mg/dl. There were no neoplastic cells, oligoclonal bands or intrathecal IgG synthesis, polymerase chain reaction (PCR) on CSF for Herpes simplex, Varicella zoster, Cytomegalovirus, Epstein-Barre, John Cunningham (JC) virus and tuberculosis were negative. Serum tests for measles, Parvo virus B19, Brucella, Toxoplasma, Borrelia, Rickettsia and Venereal Disease Research Laboratory (VDRL) were negative. The serum and CSF had normal levels of angiotensin converting enzyme and were negative for tumor markers and antinuclear antibodies. A cranial magnetic resonance imaging (MRI) showed bilateral, focal white matter lesions that were hyperintense on T2, with minimal enhancement following contrast. During hospitalization, the patient developed constipation and urinary retention. Based on the medical history, lab tests and MRI results, he was diagnosed with post-vaccination acute disseminated encephalomyelitis and began receiving high dose methylprednisolone treatment. The patient was admitted to intensive case because of serious tachypnea. Arterial gasometry results were: pH 7.486, partial pressure of oxygen in the arterial blood (PaO2): 126 mm Hg, partial pressure of carbon dioxide in the arterial blood (PaCO2): 12 mm Hg and bicarbonate (HCO3): 14.6 mmol/l. His arterial lactate was 4.7 mmol/l (normal value less than 2 mmol/l). Given the hyperpnea and difficulty protecting the airway because of lower cranial nerve involvement, the patient was intubated and sedated with remifentanil and midazolam, after which the respiratory alkalosis decreased. Repeated attempts to disconnect the respirator failed because of severe hyperventilation. Having ruled out concomitant infection, pulmonary involvement, or heart disease, the patient then received 5 days of intravenous immunoglobulin treatment and 5 plasmapheresis sessions. Despite the treatment, the patient progressively declined and entered a coma. A second MRI, performed a month after the first, showed deep grey matter involvement with extensive white matter edema in both brain hemisphere and the cerebellum, brain stem compression, and secondary triventricular hydrocephalus. In agreement with the patient''s family, vital support treatment was limited. He died shortly afterward in the unit. The author stated that in this patient, the CNH was refractory to primary disease treatment, as evidenced by the patient''s condition worsening and the brain and brainstem lesions spreading. The author concluded the article stating that although this adverse reaction to the flu vaccine was not reported to the pharmacovigilance department, its causal relationship was considered at least possible, according to the Karch and Lasagna algorithm.


VAERS ID: 651137 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-06
Entered: 2016-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza like illness, Influenza virus test positive, Polymerase chain reaction, Respiratory failure, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Respiratory failure
Allergies:
Diagnostic Lab Data: Lab test performed on unknown date; Polymerase chain reaction, influenza
CDC Split Type: ES2016GSK128867

Write-up: This case reported in a literature article and described the occurrence of unknown cause of death in a elderly subject who received Flu seasonal TIV Dresden. The subject''s past medical history included respiratory failure. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. Additional events included vaccination failure with serious criteria of death, hospitalization and GSK medically significant and influenza with serious criteria death and hospitalization. The outcome of unknown cause of death was fatal. The outcome of the additional events included vaccination failure (fatal) and influenza (fatal). The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death, vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unknown date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was influenza unknown. Additional information was provided: This case was reported in a literature article and described the occurrence of suspected vaccination failure in an adult patient aged older than 65 of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of a retrospective, comparative study about the prognostic factors of mortality in a group of patients infected with influenza virus. In the study, a case was defined as a patient who was hospitalized for greater than 24 hours with influenza-like symptoms and had laboratory detection by the reverse transcriptase-polymerase chain reaction test of influenza virus. The patients were divided into two groups: Dead and survival patients. The study population comprised all adult patients, who were admitted to Hospital between March and September 2014 and tested for the presence of influenza infection based on clinical suspicion. No information on patient''s medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza virus vaccine (administration route and site unknown, dosages unknown; batch number not provided). On an unspecified date, an unknown period after unspecified influenza virus vaccine, the patient developed influenza-like symptoms. Between March and September 2014, the patient was hospitalised. Subsequently, the patient had developed severe respiratory failure (In this study, 16 patients had a sepsis of respiratory origin). On an unspecified date, the patient died. The cause of the death was unknown. (In this study, 17 of the patient died as a direct result of infection. Mortality was significantly higher in women. The age was higher in mortality group of patients (72[13] versus 67 [19]). It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset is unspecified. Laboratory detection by the reverse transcriptase-polymerase chain reaction test revealed positive for influenza virus. (In this study, the viral load of influenza was higher (values not provided). Regarding the presence of mono or coinfection by influenza A and B and between the different genotypes not significantly differences were found. Neither the simultaneous isolation of other viruses significantly influenced mortality). This case has been considered serious due to death. Treatment was unknown. (In this study, only 5 patients were treated with oseltamivir with no influence on evolution). The authors did not comment on the event of influenza virus infection with unspecified influenza virus vaccine. The authors concluded "Mortality by influenza virus is low but is more frequent in female, elderly patients without vaccination. Viral load of influenza virus would be a predictor factor of mortality".


VAERS ID: 673280 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-26
Onset:2016-08-29
   Days after vaccination:3
Submitted: 2016-09-01
   Days after onset:3
Entered: 2016-09-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L15L / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15J01A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Death, Epistaxis, Pallor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 26-AUG-2016, Body temperature, 37.3 Centigrade
CDC Split Type: 2016408237

Write-up: This is a spontaneous report received from a contactable pediatrician through Pharmaceuticals and Medical Devices Agency (PMDA) Ministry of Health, Labour and Welfare (MHLW). Regulatory authority report number V16100429. A 4-month-old female patient received at 13:44 on 26Aug2016 the second dose of PREVENAR 13, lot number 15J01A, expiration date 31Aug2018) at 0.5 ml single and the second dose of ACT-HIB; (lot number L15L) at 1 DF single, both subcutaneously. The patient''s birth weight was 2530 g. The body temperature before the vaccination was 37.3 degrees centigrade. No medical history or family history was reported. The patient had no underlying diseases, allergy, drugs used concomitantly or other points of attention at the time of vaccination. On 27Aug2016 and 28Aug2016, there were no particular problems with the patient''s condition after vaccination on 26Aug2016. On 29Aug2016, the patient was fine until the point when her mother put her to bed at 01:25 AM. Ten minutes later, the patient experienced epistaxis with a pale face. The patient died lying prone at 01:48 AM on 29Aug2016. The outcome of epistaxis was fatal. It was unknown whether any autopsy was performed. The reporter classified the event of epistaxis as serious (death) and assessed its causality as unassessable. The reporter commented that the patient''s death was highly attributable to the event of epistaxis, which caused suspected asphyxia.


VAERS ID: 673410 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-07-13
Submitted: 2016-09-07
   Days after onset:56
Entered: 2016-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609VNM002838

Write-up: This solicited report was received from a social media researcher as a part of Market Research regarding an online article describing a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On an unspecified date, patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). The article listed dangerous side effects such as increase in risk of getting cervical cancer of HPV vaccine, mentioning GARDASIL. The onset date of event was reported as 13-JUL-2016 (it was also the date of the online article publication). Doctor cited in the article ensured about the vaccine''s safety and recommended people not to believe in inauthentic sources. On an unknown date in July 2016, the patient died due to the event. The relatedness between adverse event and GARDASIL was not reported. Upon internal review, the adverse event was considered to be medically significant. Additional information is not expected because there was no consent to contact the reporter.


VAERS ID: 673415 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-07-13
Submitted: 2016-09-08
   Days after onset:57
Entered: 2016-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-13
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609VNM002772

Write-up: This solicited study report was received from an online article, as part of a marketing research program, refers to a female patient of unknown age. The patient''s medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot number, dose and route were not provided). After getting the HPV vaccine, the patient died on 13-JUL-2016. The cause of death was unknown. It was unknown if autopsy was performed. However, this case had not been verified yet and it was also concluded that the HPV vaccine was safe and recommended for using for prevention of HPV diseases and cervical cancer. The death was determined to be a medically significant event by the reporter. This is one of several reports received from the same reporter. Additional information is not expected as the further information can not be obtained.


VAERS ID: 673432 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-09
Entered: 2016-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Arthritis, Death, Epilepsy, Headache, Myalgia, Myocardial infarction
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609VNM003100

Write-up: This solicited report was received from a social media researcher regarding an article about female patients who received HPV vaccine. The patient numbers were unknown. The patients'' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date/dates the patient/patients received GARDASIL (dosing details not specified). The article indicated that patients had dangerous side effects (myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache and death) after receiving GARDASIL vaccine (the onset date was also reported as 07-JUL-2016). The article also indicated the that the vaccine''s effect was not verified and could increase the risk of getting cervical cancer. The action taken with GARDASIL due to the events was reported as unknown. The outcome of the events myocardial infarction, headache, epilepsy, memory loss, arthritis, increased risk of cervical cancer and muscle ache was unknown. The causal relationship between the events myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache, increased risk of cervical cancer and death with GARDASIL was unknown. Events myocardial infarction, headache, epilepsy, memory loss, arthritis, muscle ache, increased risk of cervical cancer and death with were considered medically significant. The event myocardial infarction was considered life threatening. The events headache, epilepsy, myocardial infarction, memory loss, arthritis, muscle ache were considered to causing disability. Additional information is not expected as there was not consent for contact.


VAERS ID: 673484 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-09-04
Submitted: 2016-09-12
   Days after onset:8
Entered: 2016-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Intellectual disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609CAN004611

Write-up: This solicited report has been received from the sister of a 61 years old female patient enrolled in patient support program via a case worker. The patient''s concurrent conditions included mental retardation. The patient''s medical history and concomitant medications were not reported. On an unknown date the patient received vaccination with ZOSTAVAX II once (1 dose), intramuscularly. Patient''s sister reported that the patient passed away of a sudden event on 04-SEP-2016 and they were in shock for her sister''s death. No further information was provided. The action taken with the vaccine was not applicable. The outcome of the event was fatal. It was unknown if autopsy was performed. The causality between ZOSTAVAX II and the events ''death'' and ''sudden event'' was unknown. Upon internal review, the event ''death'' was considered as medically significant. Additional information is not expected because there was no consent to contact.


VAERS ID: 673636 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-12
Entered: 2016-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609CHL004939

Write-up: Information has been received from a gynecologist via a company representative referring to multiple female patients of unknown age. Information regarding concomitant therapy, concurrent condition and medical history was not reported. On unknown dates, the patients were vaccinated with GARDASIL 0.5 ml injection (lot # and expiration date were not reported; 0.5ml) intramuscularly. It was reported that the patients experienced encephalitis and died (date not reported). It was unknown if autopsy was performed. The causality between encephalitis and the vaccine was unknown. Upon internal review, the event encephalitis was considered to be medically significant. Additional information has been requested.


VAERS ID: 673626 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-08
Onset:2016-09-08
   Days after vaccination:0
Submitted: 2016-09-13
   Days after onset:5
Entered: 2016-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0000467322 / 1 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Living in residential institution
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609JPN005840

Write-up: Information has been received from a physician referring to a 94 years old female patient living in a group home. The patient''s medical history and concomitant medication were not provided. On 08-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX NP (dose, lot number and expiration date were not reported, route: parenteral). At the same date, the patient was died after vaccinated with PNEUMOVAX NP. At the time of the report, the cause od death and information on autopsy were not reported. The reporter''s comments: the reporter did not think it was a side effect of PNEUMOVAX NP and was afraid that death happened within 35 minutes to one hour after the vaccination. This was a patient with a poor condition originally and was scheduled for care in the facility. The reporting physician did not assess the relationship of death to PNEUMOVAX NP. Upon internal review, the event death was considered to be medically significant. Additional information has been requested.


VAERS ID: 673771 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-07
Onset:0000-00-00
Submitted: 2016-09-14
Entered: 2016-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Lung disorder
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609ZAF006351

Write-up: This spontaneous report was received from a nursing sister and refers to a 16 week old female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not provided. Approximately on 29-JUN-2016 (reported as initial vaccinations at 6 weeks), the patient was vaccinated with the first dose of ROTATEQ orally, expiration date, dose and frequency were not reported) and with the first dose of HEXAXIM (lot #, expiration date, dose, frequency and route were not provided). Approximately on 07-SEP-2016 (reported as last week Wednesday), the patient arrived at the reporter clinic and was vaccinated with another dose of ROTATEQ orally (lot #, expiration date, dose #, dose and frequency were not provided) and with a dose of HEXAXIM (lot #, expiration date, dose #, dose, frequency and route were not provided). The patient''s father went to the clinic and informed that the child was admitted to the hospital and passed away over the weekend (approximately on 10-SEP-2016 or 11-SEP-2016) due to same lung condition. According to the father, the post-mortem indicated that vaccination was the cause of death. Additional information has been requested.


VAERS ID: 653531 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-15
Entered: 2016-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Haemophilus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: ZASA2016SA167720

Write-up: Initial unsolicited report received from the literature on 07-SEP-2016. This case involves a patient (age ''reported as less than 15 years'' and gender not reported) who was vaccinated with a dose (also reported as two or more doses) of HAEMOPHILUS TYPE B (HIB) VACCINE (HIB) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient''s medical history and concomitant medications were reported as unknown. On an unspecified date, following the vaccination, the patient developed haemophilus influenza. It was a case of vaccine failure. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: haemophilus influenza. The reporter assessed the causal relationship with suspect vaccine as possible. List of documents held by sender: none. Sender''s Comments: This is poorly documented literature report case, with patient had haemophilus influenza following DIPHTHERIA, TETANUS, PERTUSSIS (AC), HEP B (RDNA), POLIO (INACTIV) AND HAEMOPHILUS B CONJUG VACCINE, DIPHTHERIA, TETANUS, PERTUSSIS (AC), POLIOMYELITIS (INACTIV) AND HAEMOPHILUS TYPE B CONJUG VACCINE. Time of vaccination and date of event is not mentioned, detail history regarding the complete course of vaccine, immune status at the time of vaccination, any infection during vaccination, technique used for vaccination, also protective efficacy are needed to further assess the case. Based on available information vaccination failure cannot be assessed.


VAERS ID: 653975 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-23
Onset:2016-08-23
   Days after vaccination:0
Submitted: 2016-09-19
   Days after onset:27
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-27
   Days after onset: 4
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: GBSA2016SA171723

Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009213. Case received from a physician by regulatory authority (Ref no. GB-MHRA-ADR 23635947) on 12-Sep-2016. A 2-month-old female infant patient received DTaP-IPV/Hib (manufacturer unknown, batch number Not known), recombinant Bexsero, (batch number unknown), Prevenar 13, (batch number unknown) administered via intramuscular route on 23-Aug-2016 and rotavirus vaccine, live (manufacturer unknown, batch number unknown) administered via oral route on 23-Aug-2016. The patient experienced Cot death on 27-Aug-2016 4 days Post Administration and Pyrexia on 23-Aug-2016 1 Days Post Administration. The patient developed a high temperature on day of administration. Sought medical attention from general practitioner who advised to give paracetamol. Temperature resolved. Baby found dead in cot with no apparent cause for death (has gone to post mortem). The patient''s outcome was reported as Fatal. The patient died on 27-Aug-2016. Sender''s Comments: Fever may occur folllowing diphtheria, tetanus, acellular pertussis, haemophilus influenza b, and polio vaccine and the time to onset is compatible. The baby death suddenly 4 days post vaccination. Coat death is not expected after the vaccine. The autopsy results, not reported, are necessary to assess the case. The case is poorly documented and not assessable. Reported Cause(s) of Death: Cot death.


VAERS ID: 654660 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-25
Onset:2016-08-01
   Days after vaccination:7
Submitted: 2016-09-22
   Days after onset:52
Entered: 2016-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1298 / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15D01A / 2 UN / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L026062 / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-01
   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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA172535

Write-up: Initial unsolicited report received from a Pediatrician via our partner company, on 15 September 2016. This case involves a four-month-old patient (gender was not reported) who was vaccinated with 0.5 ml dose of Acthib (Batch number, expiration date was not reported) by subcutaneous route on an unspecified date. Patients underlying disease, concurrent condition, historical condition, history of adverse drug reaction and allergy were reported as none. The patient did not receive any other vaccinations concomitantly. On 01 August 2016, one week post vaccination, the patient died from infection. It was reported that the patient had died when the patient''s mother phoned to the reporter for cancellation of vaccinations including ActHIB and PCV13. Lab tests and corrective treatments were not reported. It was not reported whether autopsy was performed or not. Diagnosis: Death. Reporting pediatrician''s seriousness assessment: Serious (Death). Reporting pediatrician''s causality assessment: Unknown. List of documents held by sender: none. Sender''s Comments: This is a poorly documented death case of 4 month old child who died after 1 week receiving ActHIB vaccine. Time to onset is compatible, as reported the patient died of unspecified infection. No information is provided on conditions at the time of death, patient''s medical history, previous vaccination history, detail regarding the infection, autopsy and results of investigations, etc. are needed to further assess the case. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Reported Cause(s) of Death: Death/patient died from infection.


VAERS ID: 654748 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Male  
Location: Foreign  
Vaccinated:2016-08-01
Onset:2016-08-30
   Days after vaccination:29
Submitted: 2016-09-22
   Days after onset:23
Entered: 2016-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Immunology test abnormal, Jaundice, Mouth haemorrhage, Ocular icterus, Pyrexia, Respiratory distress, Somnolence, Unresponsive to stimuli
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conjunctival disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-10
   Days after onset: 11
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:
Current Illness: HIV exposed, not recently tested
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: *Note: I do not have all the information about the patient and am telling this retrospectively. So some of the details of this case are falsified and estimated, however, the gist of the case is concerning and since WHO is actively investigating the safety of yellow fever vaccination in kids with HIV I think this is necessary to spread. Around 1 month after receiving the yellow fever vaccination, a 10 mo male became febrile. The fever lasted for 4 days. A week after the fever, the child became very jaundice. This jaundice progressed and the child started to become somnolent. He was rushed to our hospital where he became unresponsive and later died. He was known to be HIV exposed, and our ELISA confirmed that the child did have HIV. When he came in to our hospital, he was bleeding from the mouth, unresponsive, in respiratory distress, with bright yellow eyes. We attempted to get blood work to test for yellow fever, but alas, we were not able to get it. However, clinically, it seems likely that he developed yellow fever encephalitis after his yellow fever vaccination. I wish we had been unable to obtain blood, but we were not. I cannot say for sure this is an adverse event. I can say that our hospital has never had a case of yellow fever, and that symptomatically, the child seemed to have yellow fever. Again, much of the data I put in here including dates and even the patient''s full name are fabricated, but the story is true. Please email me if you have any questions.


VAERS ID: 654848 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-13
Onset:2016-09-15
   Days after vaccination:2
Submitted: 2016-09-23
   Days after onset:8
Entered: 2016-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L02201 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-15
   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: CNSA2016SA172589

Write-up: Initial unsolicited report received from a health authority (CDC) via company representative on 15 September 2016. This case involves a two month old female patient who was vaccinated with an injection of 0.5ml primary dose (P1) of IMOVAX POLIO batch number L0220-1, expiry date: unknown via intramuscular route in left thigh on 13 September 2016 at (8.49 am). Patient''s ongoing illness, medical history and risk factors were unknown. Concomitant medication was unknown. It was reported that nothing was abnormal on 13 September 2016 and 14 September 2016. On 15 September 2016, two days (one day 17 hours 11 minutes) following the vaccination, the patient had breastfeeding at 1.00 am and developed nasal bleeding at 2.00 am and was taken to hospital and patient died at 3.00 am. Lab data and corrective treatments were not reported. Autopsy performed was unknown. The outcome of event was fatal. List of documents held by sender: none. Sender''s Comments: This is a sudden death case of a 2 months old child who died approx 2 days after receiving IPV (VERO) vaccine. The child presented with Nasal bleeding after receiving the vaccine. However, the cause of death is unknown. No information is provided on conditions at the time of death. Details regarding relevant medical history, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, autopsy and results of investigations are needed for complete assessment of the case. This case of sudden unexplained death is insufficiently documented to draw a conclusion on a relationship with vaccines administration. Reported Cause(s) of Death: Nasal bleeding.


VAERS ID: 655177 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-01-01
Onset:0000-00-00
Submitted: 2016-09-26
Entered: 2016-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningococcal infection
SMQs:, Lack of efficacy/effect (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: ECULIZUMAB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA170677

Write-up: Initial unsolicited report received from a head of medical safety management office on 14 September 2016. This case involves a patient (age and gender was not reported) who was vaccinated with 0.5 ml dose of MENACTRA (Batch number, expiration date was not reported) via Intramuscular route in Jan 2016. Patient''s ongoing illness, medical history and risk factors were not reported. Patient''s concomitant medication included eculizumab. On unspecified date in Aug 2016, post vaccination, the patient died from meningococcal infection. It was not considered that MENACTRA intramuscular injection worked effectively (drug ineffective). It was not reported whether autopsy was performed or not. Diagnosis: Death (Death) due to Meningococcal infection. Reporting pediatrician''s seriousness assessment: Serious (Death). Reporting pediatrician''s causality assessment: Not related. List of documents held by sender: none. Addendum: 20-SEP-2016 Significant correction done on 20-SEP-2016 for MA Comment and to add attachment. Sender''s Comments: This case concerns a patient (age and gender not reported) who reportedly experienced meningococcal infection with a fatal outcome 7 months after receiving MENACTRA vaccine. As with any other vaccine, MENACTRA vaccine may not protect 100% of individuals. This case does not represent a confirmed vaccine failure; the specific serogroup involved was not reported. Importantly, in this report, concomitant medication reportedly included Eculizumab, which is a complement inhibitor; however, it was unknown whether this patient had received Meningococcal vaccine prior to receiving the first dose of eculizumab. Clinical details such as patient''s demographics, medical history, previous vaccination history, the start date of treatment with eculizumab, diagnostic work-up, and the specific serogroup involved- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: Meningococcal infection; vaccination failure.


VAERS ID: 655809 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:1992-12-11
Onset:1997-02-01
   Days after vaccination:1513
Submitted: 2016-09-28
   Days after onset:7178
Entered: 2016-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: CSF oligoclonal band present, CSF protein normal, Death, Demyelination, Diplopia, Extensor plantar response, Fatigue, Gait disturbance, Immunology test normal, Loss of proprioception, Lumbar puncture, Motor dysfunction, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Pyramidal tract syndrome, Sensorimotor disorder, Sensory loss, Visual evoked potentials abnormal
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Ocular motility disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-24
   Days after onset: 7143
Permanent Disability? Yes
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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lumbar Puncture: Clear liquid, 11 elements N/A in Mar-1998; Encephalic MRI: Many signals of the periventricular white matter N/A in Mar-1998; CSF Oligoclonal Bands: Discrete gamma globulin increase, 75 mg/l in Mar-1998; CSR Protein: Normal N/A in Mar-1998; Immunological assessment: negative.
CDC Split Type: WAES1609FRA013163

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number FR-1577272925-2016009572) on 27-SEP-2016. Case received from a other health professional reported by HA under the ref number PC20160541 on 22-SEP-2016. A 51-year-old female adult patient received GENHEVAC B, batch number unknown on 10-Oct-1991. Other suspect products included: Hepatitis B vaccine (recombinant) (manufacturer unknown, batch number unknown) on 07-Nov-1991, ENGERIX B (batch number unknown) on 05-Dec-1991, ENGERIX B (batch number unknown, Booster) on 11-Dec-1992, ENGERIX B (batch number unknown, Booster) on 04-Dec-1997. The patient experienced multiple sclerosis and Diplopia in Feb 1997, Paresthesia, Walking instability and Fatigability in Jan 1998, Pyramidal tract syndrome and Sensorimotor disorders in Mar 1998. The patient was admitted to hospital on 16-MAR-1998. Additional investigations included: Cervical MRI: Demyelinating spinal cord injuries: Next to C1 on the posterior cords about 12 mm of diameter and next to C2-C3 of approximately 25 mm N/A in Mar-1998, Lumbar Puncture: Clear liquid, 11 elements N/A in Mar-1998, Encephalic MRI: Many signals of the periventricular white matter N/A in Mar-1998, CSF Oligoclonal Bands: Discrete gamma globulin increase, 75 mg/l in Mar-1998, CSF Protein: Normal N/A in Mar-1998. In February 1997, onset of diplopia by damage of the left VI, regressive within few weeks. The patient was 51 years-old. In January 1998, occurrence of right sided paresthesia with derobement of the right lower limb, an instability and a walking fatigability. On 16 March 1998, hospitalization for diagnostic assessment of neurological condition. On examination: A proprioceptive instability, a bilateral Pyramidal tract syndrome more obvious at the left side (bilateral Babinski sign), a discreet sensitive deficit of the right upper limb and the right lower limb, a moderate motor deficit of the right lower limb. Results of biological tests performed during hospitalization were the following: Immunological assessment: Negative. Evoked potentials in favor or a unilateral damage of the right pre-chiasmatic visual pathways and of a damage of the medullar somesthetic pathways. Confirmation of multiple sclerosis diagnosis which was atypical by the late onset (but not exceptional). Many encephalic plates encouraged a serious of SOLUMEDROL bolus. On 24-Aug-2016, at 12:00 am, the patient died. The patient''s outcome was reported as Fatal.


VAERS ID: 656047 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2016-02-16
Onset:2016-02-18
   Days after vaccination:2
Submitted: 2016-09-28
   Days after onset:222
Entered: 2016-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L018923 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood culture, Crying, Death, Hypertonia, Loss of consciousness, Pallor, Pulse absent, Pupillary light reflex tests abnormal, Pyrexia, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions: Premature baby, at week 32; 09/13/2015, Patent ductus arteriosus, closed by ACAMOL; 09/13/2015, respiratory distress syndrome; 09/13/2015, Hyponatraemia; 11/09/2015, RSV vaccine (unspecified) 11/2015, hepatitis B virus vaccine (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609ISR013356

Write-up: Initial information was received from an agency concerning a five months old female, one of quadruplets, born prematurely at week 32, 1300 grams at birth. After birth, the baby was hospitalized in the neonatal intensive care unit (NICU) for two months and was discharged at a weight of 2550 grams. Hereditary illnesses were ruled out. The patient (pt) was vaccinated as appropriate to her age. On 16-FEB-2016, she was vaccinated with ROTATEQ orally, second dose, batch # L018923, PREVNAR and PEDIACEL. The following day, the pt experienced fever and the parents did not refer to the doctor. On 18-FEB-2016 at 19:00, the pt''s mother went to check the quadruplets and found the baby under the blanket. The mother reported that the baby was warm and unconscious. The baby was brought to the Emergency Room (ER) in a private car with no pulse, no respiration, pallor, increased tonus and pupils not responsive to light. Resuscitation attempts were unsuccessful and at 02:20 death was determined. Medical records revealed the following: PT was in the NICU from birth until 09-NOV-2015. Active diagnosis included: preterm infant between 1250-1499 grams, week 32; quadruplet first, respiratory distress syndrome (RDS), patent ductus arteriousus (PDA), closed by ACAMOL. Mother was 32 at pregnancy. Type of delivery: cesarean section. Course of delivery: quadruplet first, cried immediately, was put on CPAP and brought to NICU, placed on surfactant, after several hours extubation. Because of RDS at week 32 despite receiving celestone in week 26, the pt was placed on therapy with antibiotics under the advice of the on call doctor. Apgar: in minute one: 8, in minute five: 8. Weight 1300 grams, head circumference 29.0 cm, length 39.0 cm. Course of hospitalization: Overall normal course except for mild RDS on admission and medicinal closure of the ductus, no events of NEC, no infections, no IVH, no ROP. On first day of life, received TPN/fluids. On third day of life feeding began. Gradually increased until a complete feeding. She had mild hyponatremia in the first days, treated with sodium chloride orally, later no electrolyte disorder. Sepsis workup showed no growth. Received vaccination for respiratory syncytial virus the day she was discharged. Received vaccination for hepatitis B during hospitalization. Weight 2540 grams at discharge. Recommendations at discharge included: follow-up in the infant clinic with two to three days, vaccinations as customary; oral vitamin D drops, oral ferripil. On 18-FEB-2016, baby was brought to the ER at 02:13. Approximately 15 minutes prior to admission, the mother entered the room because another baby cried and saw the baby blue with no respiration and lifeless. The baby was immediately brought to the ER. It was noted that the day prior to admission, she had a fever and on day of admission a high fever. It was noted that two days prior to admission she was vaccinated and "it was not clear which vaccine". The pt was usually healthy since discharge from the NICU, no hospitalizations or medications. Was vaccinated as customary. It was noted there were no birth diseases in the extended family. The pt had two older siblings. Diagnosis included: dead on arrival. Illness summary included: referred due to respiratory arrest. Upon admission to ER, there was no pulse or respiration, pal with increased tonus, pupils non responsive to light. Resuscitation attempts included mask ventilation, massage, intubation and adrenaline but with no success. At 02:20, death was determined. Impression: death from unknown cause. Blood cultures were sent, there was no urine. A test tube for EXOME and a Guthrie card were taken. A CT PM was done. An autopsy was recommended to the parents but they had not decided yet. Death noticed listed cause of death as unknown. Noted there were no signs of trauma or fractures. Upon internal review, death, unconscious and respiratory arrest were considered medically significant. All available medical records will be provided upon request. No further information was available.


VAERS ID: 656120 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-29
Entered: 2016-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L00744 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF culture positive, Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (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: Test Name: CSF culture; Result Unstructured Data: Test Result: meningitis
CDC Split Type: DEPFIZERINC2016450587

Write-up: This is a spontaneous report from a contactable physician. A 14-month-old male patient of an unspecified ethnicity received PREVENAR 13 1st dose at the age of 2 months (lot no.: L59072) for immunization, 2nd dose at the age of 4 months (lot no.: L48815) and 3rd dose at the age of 5 months (lot no.: L00744) on unknown dates for immunisation. Patient was not a former preterm and had no immunodeficiency and no chronic diseases. The patient''s concomitant medications were not reported. The patient experienced pneumococcal meningitis on an unspecified date in 2016 with fatal outcome. Pathogen material was cerebrospinal fluid. Serotype was not detected. The patient died on an unspecified date. No follow-up attempts possible. No further information expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like confirmative serotype results is needed for a full medical assessment. Reported Cause(s) of Death: Pneumococcal Meningitis.


VAERS ID: 656121 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-29
Entered: 2016-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M50386 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF test abnormal, Death, Meningitis pneumococcal, Pneumococcal bacteraemia, Serology positive
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: meningitis S. pneumoniae; Comments: liquor analysis (date unknown): meningitis S. pneumoniae; Test Name: Laboratory test; Result Unstructured Data: Test Result: meningitis S. pneumoniae; Comments: liquor analysis (date unknown): meningitis S. pneumoniae; Test Name: Serology test; Result Unstructured Data: Test Result: serotype 12F; Comments: liquor analysis (date unknown): meningitis S. pneumoniae
CDC Split Type: DEPFIZERINC2016450599

Write-up: This is a spontaneous report obtained from a contactable physician. A 9-month-old male patient received PREVENAR 13 at single dose administered at the age of 2 and 3 months for immunisation. Lot numbers M10978 and M50386 respectively. Relevant medical history confirmed no premature birth or chronic diseases or immune damage. The patient''s concomitant medications were not reported. On an unspecified date in 2016 the patient experienced penumococcal meningitis. Meningitis S. pneumoniae was detected by blood culture, liquor analysis, without focus. The serotype was 12F. Seriousness criteria included death. No follow-up attempts possible. No further information expected. Sender''s Comments: Serotype 12F is not contained in PREVENAR 13, therefore a lack of efficacy in this patient can be 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 bacteremia; pneumococcal meningitis.


VAERS ID: 656124 (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: 2016-09-29
   Days after onset:224
Entered: 2016-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27705 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hypertonia, Loss of consciousness, Pallor, Pulse absent, Pupil fixed, Pyrexia, Respiratory arrest, Resuscitation, Skin warm
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization; Multiple pregnancy; Premature baby 26 to 32 weeks (Week of pregnancy 32 weeks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZERINC2016449829

Write-up: This is a spontaneous report from a contactable other HCP received from the Ministry of health. Regulatory authority report number not provided. A 5-month-old female patient of an unspecified race received the second dose of PREVENAR 13, (lot M27705) single dose, PEDIACEL and ROTATEQ, all via an unspecified route of administration on 16Feb2016 for immunization. Medical history included multiple pregnancy (1 of quadruplets), premature baby, week of pregnancy 32 and weight at birth 1300 gram. Since her discharge she was usually healthy, without hospitalizations or medications. In addition to the quadruplets they had 2 more bigger children, without congenital disease in the extended family. The patient''s concomitant medications were not reported. After birth she was hospitalized in the neonatal intensive care unit for 2 months and was released at a weight of 2550 gram. Hereditary diseases were ruled out. She was vaccinated according to her age. On 16Feb2016 she received a second dose of pneumococcal 13-val conj vac, diphtheria vaccine, haemophilus influenza type b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine and rotavirus vaccine and on the following day there was an increase of fever, they did not turn to a physician. On 18Feb2016 at 19:00 the mother woke up to check the quadruplets and found the baby under the blanket, according to the mother she was warm and unconscious. She was brought to the emergency room in a private car without pulse or breathing, pale with increased tonus, pupils without reaction to light. Resuscitation attempts did not help and at 02:20 her death was determined. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 656443 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-29
Entered: 2016-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: WAES1609JPN014113

Write-up: This spontaneous report was received from a pharmacist and company representative (physician) who noted a post on a social media website regarding an online news article. A total of 63 girls aged between 15 and 22 filed a lawsuit. They accused that in spite of serious fatal case triggered by vaccination in a foreign country, regulatory authority, still implemented the national vaccination, ignoring the safety, in the indictment. Upon internal review, death was considered medically significant. Additional information is not expected. This is one of several reports from the same source.


VAERS ID: 656279 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-30
Entered: 2016-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609HKG014423

Write-up: This spontaneous report as received from an unspecified reporter as an online article posted on a website refers to unspecified patients of unknown age and gender. No information about the patients'' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with unspecified cervical cancer vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown dates, the patients experienced side effects including suspected of death and disability. It was stated that the controversy on these side effects lingers in international medical community for a long time. The outcome of the adverse events was not reported. The reporter considered the events to be related to the vaccine. Upon internal review, the event of death was considered to be medically significant. This is one of several cases from the same reporter source. Additional information is not expected as no contact details were provided.


VAERS ID: 656286 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-09-23
Onset:2016-09-23
   Days after vaccination:0
Submitted: 2016-09-30
   Days after onset:7
Entered: 2016-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER 4L168 / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1649 / 3 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15J01A / 3 UN / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L031017 / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Cardio-respiratory arrest, Resuscitation
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), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/23/2016, Body temperature, 37 degrees C
CDC Split Type: WAES1609JPN014509

Write-up: Initial information has been received from a physician via the Agency concerning a 4 month year old male patient who on 23-SEP-2016 was orally vaccinated with ROTATEQ mixture for internal use 2 ml once a day for the third time (Lot no. L031017, indication was not reported). Information on underlying/concomitant disease and medical history was not obtained. Special notes on the pre-vaccination interview form (underlying disease, allergy, vaccination and disease within the recent 1 month, medications currently taken, adverse reaction history and growth status) included vaccinations with the recent 1 month (with PREVENAR 13, ACTHIB, TETRABIK and ROTATEQ ON 26-AUG-2016. The patient had no family history and the birth weight was 3455 g. Other suspect drugs were PREVENAR 13 injection drug (date of the third vaccination: 23-SEP-2016, dose: 0.5 ml once a day, indication: unknown, Lot no.: 15J01A), ACTHIB injection drug (date of the third vaccination: 23-SEP-2016, dose: 0.5 ml once a day, indication: unknown, Lot no.: L1649) and TETRABIK injection drug (date of the second vaccination: 23-SEP-2016, dose: 0.5 ml once a day, indication: unknown, Lot no.: 4K168). No other concomitant medications were reported. On an unspecified date, the patient was vaccinated with ROTATEQ, PREVENAR 13 and ACTHIB for the first time. On 26-AUG-2016, the patient was vaccinated with ROTATEQ , PREVENAR 13 and ACTHIB for the second time, and with TETRABIK for the first time. On 23-SEP-2016, the body temperature before the vaccination was 37.0 degree Celsius. At 3:40 p.m., the patient was vaccinated with ROTATEQ, PREVENAR 13 and ACTHIB for the third time (as described above). He was also vaccinated with ACTHIB for the second time (as described above). The patient had good milk sucking and his condition appeared to be the same as usual. At 19:49, on the same day, the patient was sleeping with his face down and was found in respiratory arrest. An ambulance was called and the patient was transferred to Medical center while cardiopulmonary resuscitation was continued. The patient was hospitalized. As of the time of the report, the outcome of cardio-respiratory arrest was unknown. Pre-vaccination interview form for TETRABIK (infants)/Pre-vaccination interview form for pneumococcal vaccine for children/re-vaccination interview form for Hib vaccine: Had the patient/patient''s parents read the explanation of the prophylactic vaccination and understand about the vaccination?: Yes; Growth history of the patient: The birth weight was 3455 g; Abnormality noted at delivery: None: Abnormality noted at birth: None; Any abnormality pointed at infant health check-ups: None; Any problem in health condition on the vaccination day: None; Diseases within the recent 1 month: None; Any family member or playmate with diseases such as measles, rubella, blisters and mumps within the recent 1 month: None; Prophylactic vaccination within the recent one month: Yes (vaccinated with ROTATEQ, PREVENAR 13 and ACTHIB, TETRABIK on 26-AUG-2016; Had the patient been suffered from congenital abnormality, cardiac/kidney/liver/cranial nerve disorder, immunodeficiency and other diseases and seen by a physician?: No; Any experience of convulsions: None; Had the patient ever experienced skin rash or urticaria due to any drug and food and felt sick: No; Any close relatives diagnosed as congenital immunodeficiency: None; Any experience of feeling sick after receiving prophylactic vaccination: None; Any close relatives feeling sick after receiving vaccination: None; Transfusion or vaccination of gamma globulin within 6 months: none; Any questions about the vaccination: None. Pre-vaccination interview form for ROTATEQ: Had the patient/patient''s parents read the explanation on the leaflet and understood about the vaccination?: Yes; Growth history of the patient: The birth weight was 3455 g; Abnormality noted at delivery: None; Abnormality noted at birth: None; Any abnormality pointed at infant health check-ups: None; Any problem in health condition on the vaccination date: None; Diseases within the recent 1 month: None; Any family member or playmate with diseases such as measles, rubella, blisters and mumps within the recent 1 month: None; Prophylactic vaccination within the recent one month: Yes (vaccinated with ROTATEQ, PREVENAR 13 and ACTHIB, TETRABIK; Had the patient been vaccinated with other live attenuated pentavalent rotavirus vaccines: No; Had the patient been suffered from special diseases (such as congenital abnormality, cardiac/kidney/liver/blood/cranial nerve disorder, immunodeficiency and other diseases) and seen by a physician: No; Any experience of repetitive symptoms such as pyrexia, diarrhea and whitish spots on cheeks and tongue or common cold which did not resolve for a long time: No; Had the patient ever experienced skin rash or urticaria due to any drug and food and felt sick: No; Any close relatives diagnosed as congenital immunodeficiency: None; Any experience of feeling sick after receiving prophylactic vaccination: None; Any close relatives feeling sick after receiving vaccination: None; Transfusion or vaccination of gamma globulin within 6 months: None; Any questions about the vaccination: None. Reporter''s comment: A possibility of sudden infant death syndrome (SIDS) was considered. The reporting physician considered that cardio-respiratory arrest was serious due to life-threatening, hospitalization, medically significant and possible disability. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ was unknown and considered PREVENAR 13 and ACTHIB, TETRABIK as other suspect drugs. The reporting physician considered "asphyxia due to sleeping with face down" as other possible causative factor (including other diseases) for cardio-respiratory arrest. No further information is available. Information has been received for a direct report from the Agency regarding a case provided by the physician.


VAERS ID: 656568 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-30
Entered: 2016-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1609ESP014508

Write-up: Information has been received from Sanofi Pasteur MSD [ES-1577272925-2016009753] on 29-SEP-2016. Case received on 26-SEP-2016. This is a non valid case as required minimum information is missing about the patient, reporter (reporter fields have been completed to allow submission). A adolescent patient of unknown sex received GARDASIL (batch number unknown) on an unknown date. According to the information gained from internet/digital media: The information found on media was misdealing and confusing. One hand, the heading said "352 adolescents died after vaccination either with GARDASIL or CERVARIX" but, there was no information on when, where and which vaccine in each case. On the other hand, sex is not clearly defined and only adolescent group was mentioned clearly. It was reported that 352 deaths but not specified dates nor countries. There is no date of the events as well. Upon internal review, the Agency had considered an invalid case, compiling all cases as GARDASIL (although it is not stated), considering country as the case was acknowledged in country (but it is not stated if there is a single country case), reporter was not known, individual patients cannot be identified neither which HPV vaccine was used in each case. Invalid case classified following GVP Module VI. The patient''s outcome was reported as Fatal.


VAERS ID: 656562 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-03
Entered: 2016-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bronchitis, C-reactive protein increased, CSF test, Carditis, Chest pain, Death, Enterovirus test negative, Epstein-Barr virus test negative, Generalised tonic-clonic seizure, Haemoglobin increased, Heart rate increased, Oropharyngeal pain, Pericardial haemorrhage, Pericarditis, Pericarditis rheumatic, Platelet count normal, Polymerase chain reaction, Pulmonary congestion, Pyrexia, Streptococcal infection, Syncope, Toxicologic test normal, Varicella virus test negative, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchitis; Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: 120/78; Test Name: body temperature; Result Unstructured Data: 39 Celsius temperature; Comments: REPORTED AS FEVER; Test Name: C-reactive protein; Result Unstructured Data: 36; Test Name: Heart rate; Result Unstructured Data: NOT REPORTED; Test Name: Hemoglobin; Result Unstructured Data: 1.65; Test Name: Leukocyte count NOS; Result Unstructured Data: 14,310; Test Name: PCR; Result Unstructured Data: NOT REPORTED; Test Name: Platelet count; Result Unstructured Data: 257,000
CDC Split Type: ITSA2016SA179845

Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009635. Case retrieved from unsolicited literature on 22-Sep-2016. A 15-year-old male adolescent patient received Diphtheria And Tetanus Adsorbed Toxoids, (batch number unknown) on an unknown date. Leading to death in 1 patient and Generalized tonic-clonic seizure 15 days post-vaccination. A previously healthy 15-year-old boy presented to his family physician with a high fever (up to 39 Degree Celsius) and chest pain. An objective examination showed normal blood pressure (120/78 mm Hg) and a mild elevation of heart rate (96 beats/min). Chest auscultation was negative for any pathologic findings. Laboratory investigations showed: C-reactive protein, 36mg/dL; leukocytes, 14,310/mm3; hemoglobin, 16.5 g/dL; and platelets, 257,000/mm3. The physician diagnosed acute bronchitis and prescribed antibiotic therapy (amoxicillin/clavulanate 40mg/kg/ day, 3 times a day). The boy was allowed to return home. After maintaining a persistent fever (about 38 Degree Celsius) at home for 3 days, the boy experienced a generalized tonic-clonic seizure that lasted about 30 to 4 0seconds. A few minutes later, the boy collapsed and was lifeless. A forensic autopsy was performed 7 hours later. The anamnesis that was collected from the boy''s parents revealed acute pharyngitis had affected the boy several weeks before, and this condition was not treated nor was it investigated further. In addition, 15 days before his death, the boy had received a vaccination for diphtheria and tetanus toxoids. The family history was negative. An external examination of the corpse (length 187cm, weight 98kg) revealed no obvious abnormalities. An autopsy revealed approximately 350mL of turbid pericardial effusion and multiple hemorrhagic foci at the internal surface of the pericardium with fibrinous pericarditis. The heart (650g) exhibited visible alterations that included the presence of many petechiae and several whitish streaks at the epicardium. A generally pale and locally reddish, mottled myocardium was also observed, along with an increase in wall thickness that extended over most of the heart. In particular, the thickness of the anterior wall of the left ventricle was 1.4 cm. The right and left lungs weighed 1075g and 988g, respectively. Both lungs exhibited marked congestion and clear ascites were observed (450 cc). Microscopically, the myocardium contained a florid lymphocytic infiltrate, along with a few scattered multinucleated giant cells and focal areas of necrosis involving the epicardium, myocardium, and endocardium. In the myocardium, epithelioid cells were occasionally observed. The infiltration of inflammatory cells was associated with diffuse cardiomyocyte edema, necrosis, and hemorrhagic foci in all of the specimens examined (e.g., left ventricular wall, right ventricular wall, and septum). Furthermore, the inflammatory infiltrate that was aggregated in foci was so abundant that it completely subverted the myocardial structure. Focal thickening of the left and right ventricular endocardium was also associated with the presence of inflammatory cells. The pericardium and epicardium showed similar changes, including edema, necrosis, and hemorrhagic foci. To characterize the molecular features of the inflammation observed, immunostaining assays were performed to detect monocyte-macrophages, T-lymphocytes, B-lymphocytes, and granulocytes with the following antibodies: monoclonal mouse antihuman CD68 (clone PG-M1), Dako M0876, 1:100 dilution), polyclonal rabbit antihuman CD3 (Dako A0452, 1:70 dilution), monoclonal mouse antihuman CD20 (clone L26, Dako M0755, 1:700 dilution), and polyclonal rabbit antihuman myeloperoxidase (Dako A0398, 1:7000 dilution), respectively. All of the specimens stained were strongly positive for CD68, the main hematopoietic differentiation marker of the monocytemacrophage lineage. These results suggest a massive macrophage infiltration had occurred. CD68 immunostaining also showed that the positive cells aggregated in foci which resembled very early granulomas. Microbiological examinations of cardiac blood, myocardium, pericardial fluid, and cerebrospinal fluid samples that were collected in a sterile fashion during the autopsy were performed. Oral cavity saprophytes were present in all of the cultures. The blood specimens were further examined by PCR (polymerasechain reaction) and all were negative for enteroviruses, varicella zostervirus, and Epstein Barr virus. A chemical-toxicological examination of the blood samples also excluded the presence of any toxic substances. Thus, based on the anamnesis, the clinical presentation, and the histological findings, postvaccination myopericarditis and rheumatic carditis were considered. After considering both the clinical and histological data, authors decided that the most likely etiology for the present case was rheumatic. In particular, the anamnestic data were crucial: a few weeks prior to death the subject suffered from a sore throat that was not pharmacologically treated. Considering all the available data, author hypothesize that the young boy had an untreated streptococcal infection that presented as a sore throat, and then a few weeks later, he developed acute pancarditis The patient''s outcome was reported as Fatal. The patient died on unspecified date. Sender''s Comments: Pancarditis is unexpected after DT vaccination. Latency is compatible. Autopsy revealed fibrinous pericardium and inflammatory cells infiltration. Pancarditis is caused by a Streptococcus A infection. Streptoccus group A could not be found in body fluids; indeed, those tests are usually negative by the time symptoms of rheumatic heart disease appear. Pancarditis is a complication of pharyngitis, as it is the case here. Based on the available information, a role of the vaccination is unlikely. Reported Cause(s) of Death: Pancarditis; Autopsy-determined Cause(s) of Death: Pancarditis.


VAERS ID: 674451 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-04
Entered: 2016-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervix carcinoma, Death
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? Yes
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: WAES1609AUS011418

Write-up: Information has been received from an unspecified reporter, via Sanofi Pasteur MSD (IRD22-SEP-2016), concerning a female patient of unknown age. The patient''s pertinent medical history and concurrent conditions were not informed. On an unknown date the patient was vaccinated with QUADRIVALENT HPV (manufacturer unknown) (lot #, expiration date, dosage and therapy route were not provided). Other suspect therapy included HPV vaccine (manufacturer unknown) (lot #, expiration date, dosage and therapy route were not provided). Concomitant therapies were not informed. It was reported that on 22-SEP-2016, part of daily press review an article about a woman dying of cervical cancer after HPV vaccination was identified. The outcome of cervical cancer was unknown at the time of the report. The causal relationship between cervical cancer and QUADRIVALENT HPV (manufacturer unknown) and HPV vaccine (manufacturer unknown) was not reported. Additional information is not expected as no reporter contact information was given. It has been determined that case # AU-009507513-1609AUS011418 is a duplicate of case # AU-009507513-1603AUS003337. Therefore, case # AU-009507513-1609AUG011418 is being deleted from our files and the cases are consolidated into case # AU-009507513-1603AUS003337.


VAERS ID: 674551 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-15
Onset:2016-09-18
   Days after vaccination:3
Submitted: 2016-10-05
   Days after onset:17
Entered: 2016-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC744A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB471AB / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-18
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT2016GSK141879

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiopulmonary arrest in a 4-month-old female patient who received INFANRIX HEXA (batch number A21CC744A, expiry date 1st October 2018). Concomitant products included ROTARIX and PREVENAR 13. On 15th September 2016, the patient received INFANRIX HEXA (intramuscular). On 18th September 2016, 3 days after receiving INFANRIX HEXA, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant) and respiratory arrest (serious criteria death and GSK medically significant). On 18th September 2016, the outcome of the cardiopulmonary arrest and respiratory distress were fatal. The reported cause of death was cardiopulmonary arrest and respiratory distress. The reporter considered the cardiopulmonary arrest and respiratory distress to be possibly related to INFANRIX HEXA. Additional details were provided as follows: On 15th September 2016, the patient received ROTARIX (AROLB471AB and PREVENAR 13. The reporter did not specify if ROTARIX was considered as suspect or concomitant. The only information was added as the patient received ROTARIX too in the same day. The clarification has been requested to regulatory authority. The cardiopulmonary resuscitation was performed. Upon internal communication on 27th September 2016: The ROTARIX and PREVENAR 13 vaccines were changed to suspect instead of concomitant. The reporter considered the cardiopulmonary arrest and respiratory distress to be possibly related to PREVENAR 13 as well.


VAERS ID: 674578 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-06
Entered: 2016-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Death, Foetal exposure during pregnancy, Pertussis, Polymerase chain reaction positive, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date, lab test was performed; Bordetella test, positive for pertussis
CDC Split Type: ES2016GSK142978

Write-up: This retrospective pregnancy case was reported by a physician via sales rep and described the occurrence of whooping cough in a male infant exposed to BOOSTRIX in utero. The mother received the product. On an unknown date, the mother received the 1st dose of BOOSTRIX. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was exposed to BOOSTRIX at week 28 of gestation and during the third trimester of pregnancy. On 10th August 2016, at [weeks gestation], the infant was born via unknown delivery. The infant was diagnosed with birth premature. On an unknown date, the infant experienced whooping cough (serious criteria death and GSK medically significant) and maternal vaccine exposure. On 28th September 2016, the outcome of the whooping cough was fatal. On an unknown date, the outcome of the maternal vaccine exposure and birth premature were unknown. The infant died on 28th September 2016. The reported cause of death was whooping cough. The reporter considered the whooping cough to be unrelated to BOOSTRIX. Additional details were provided as follows: The patient''s mother was vaccinated at 28 weeks of gestation. The patient was born at 33 weeks (approximately 5 weeks) of gestation. The patient was died due to whooping cough on 28th or 29th September 2016 (date of death pending to be confirmed). On an unknown date, the patient underwent laboratory examination which showed positive result for polymerase chain reaction for Bordetella Pertussis.


VAERS ID: 658591 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-06-01
Onset:2016-08-01
   Days after vaccination:61
Submitted: 2016-10-12
   Days after onset:72
Entered: 2016-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Wound; Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2016SA185232

Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009888. Case of death reported by a pharmacist of a hospital on 30-Sep-2016. A 76-year-old female elderly patient received Vaccin Tetanique Pasteur, (batch number unknown) around Jun-2016. On an unspecified date in Jun-2016, the patient went to emergency room with a wound that justified a tetanus vaccination (as presumably she was not vaccinated since very long time). The patient died in August 2016, 1.5 month after vaccination (the reporter did not know the cause of death). The patient had a medical history of wound in JUN-2016. The patient''s outcome was reported as Fatal. Sender''s Comments: Death is unexpected after tetanus vaccine. Death occurred 1.5 months after vaccination. The case is poorly documented. The cause of death is not reported, and no anamnesis or analysis is provided. The patient may have been infected before the vaccination. If it were the case, even with treatment, mortality rate is 10% and is higher in people over 60 years of age. Autopsy report, medical history of the patient before her death are needed to assess the case. Based on the available information, no conclusion can be drawn. Reported Cause(s) of Death: death (cause unknown).


VAERS ID: 659365 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-15
Onset:2016-09-18
   Days after vaccination:3
Submitted: 2016-10-14
   Days after onset:26
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC744A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N55090 / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AR0LB471AB / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-09-18
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2016475045

Write-up: This is a spontaneous report received from a contactable hospital physician via the Regulatory Authority. Regulatory Authority report number 378262. A 4-months-old female patient received on 15Sep2016 PREVENAR 13 (lot number N5509D; exp date 01Sep2018) 0,5 ml single intramuscular, INFANRIX HEXA (lot number A21CC744A; exp date 01Oct2018) 5 DF cyclic intramuscular and ROTARIX (lot number AR0LB471AB) oral at 1 ml monthly, all for immunization. The patient medical history and concomitant medications were not reported. The patient experienced respiratory distress and cardio-respiratory arrest on 18Sep2016. Due the events the patient underwent to cardiopulmonary resuscitation. The events were reported as serious fatal. The patient died on 18Sep2016. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory distress; Cardio-respiratory arrest.


VAERS ID: 659366 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-14
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Pneumococcal sepsis, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Primary immunodeficiency syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: pneumococcus serotype not included in PREVENAR 13
CDC Split Type: PTPFIZERINC2016475285

Write-up: This is a spontaneous report from a contactable physician. This physician reported similar events for two different patients. This is the first of two reports. A 9 month-old patient of an unspecified race, ethnicity and gender received PREVENAR 13 at single dose via an unspecified route of administration on an unspecified date for immunisation. Medical history included ongoing primary immunodeficiency, concomitant medications were not reported. The patient experienced meningitis pneumococcal and sepsis pneumococcal in 2013 due to which he died in 2013. It was reported that the pneumococcus serotype identified (not provided) was not included in the vaccine. It was not reported if an autopsy was performed. Sender''s Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient can be excluded since reported that the pneumococcus serotype identified was not included in the vaccine. 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) : PT-PFIZER INC-2016475288 Same reporter, similar event with same suspect product, different patient; Reported Cause(s) of Death: Meningitis pneumococcal; Sepsis pneumococcal.


VAERS ID: 659367 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-14
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (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: PTPFIZERINC2016475288

Write-up: This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 2nd of 2 reports. A 13-month-old patient of unspecified ethnicity and gender received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced meningitis pneumococcal in 2014. Serotype was not determined. The patient died due to meningitis pneumococcal in 2014. It was not reported if an autopsy was performed. Sender''s Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotype results and vaccination schedule is needed for a 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) : PT-PFIZER INC-2016475285 Same reporter/product, similar event, different patient; Reported Cause(s) of Death: Meningitis pneumococcal.


VAERS ID: 674539 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-14
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (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: FR2008GSK000044

Write-up: This case was reported by a consumer via market research programs and described the occurrence of multiple sclerosis in a female patient (in her 80s) who received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced multiple sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was fatal. The reported cause of death was multiple sclerosis. It was unknown if the reporter considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information was provided as follows: The case was reported during a market research (questionnaires complete through internet). The reporter reported the case for her aunty(family member). The patient died of the complications of multiple sclerosis. The autopsy details were unknown. The reporter also informed that the cousin (family member) had hepatitis B virus following maternal contamination and who realized it when he was an adult. He tried some treatment but nothing had worked. Due to the two family incidents the reporter wanted to get vaccinated (Hepatitis B vaccine) and believed that the vaccine improvements had been done and adverse evens are better mastered. No further information was available.


VAERS ID: 674542 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-14
Entered: 2016-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (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: FR2008GSK000042

Write-up: This case was reported by a consumer via market research programs and described the occurrence of progression of multiple sclerosis in a male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 11 years after receiving Hepatitis B vaccine, the patient experienced progression of multiple sclerosis (serious criteria death and GSK medically significant). In 2007, the outcome of the progression of multiple sclerosis was fatal. The reported cause of death was progression of multiple sclerosis. It was unknown if the reporter considered the progression of multiple sclerosis to be related to Hepatitis B vaccine. Additional details were provided as follows: The case reported during market research questionnaires through internet. In 1996, the patient (reporter''s father) received Hepatitis B vaccine. The patient experienced multiple sclerosis and due to his age, progression of multiple sclerosis was more rapid. In 2007, the patient died due to progression of multiple sclerosis. This case was linked with case FR2008FRA000006 as reported by same reporter and same family. No further information was available.


VAERS ID: 675008 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-13
Entered: 2016-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAPIPV: TDAP + IPV (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Foetal exposure during pregnancy
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ferrous fumarate
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient prenatal screening test, performed on an unspecified date, was found normal
CDC Split Type: GB2016GSK150420

Write-up: This prospective pregnancy case was reported by a other health professional via registry and described the occurrence of death neonatal exposed to MMR vaccine (batch number A69CD859A, expiry date unknown) in utero. The mother received the product. Co-suspect product exposures included Flu seasonal TIV Dresden and BOOSTRIX-polio (batch number AC39B076AH, expiry date December 2017). The parent''s medical history included anemia, chorioamnionitis, forceps delivery (at 40 gestational weeks), hemoglobin decreased, labor complication (at 40 gestational weeks), meconium in amniotic fluid, normal labor (at 40 gestational weeks), rubella antibody negative (seronegative test result on 16 Sep 2015) and vaginal bleeding (at 40 gestational weeks). Concomitant product exposures included ferrous fumarate. On 29th September 2015, the 30-year-old mother received MMR vaccine. On 18th October 2015, the mother received influenza vaccine unspecified On 31st March 2016, the mother received BOOSTER-polio. The mother''s last menstrual period was on 8th September 2015 and estimated date of delivery was 17th June 2016. The neonate was exposed to MMR vaccine at week 3 of gestation and during the first trimester of pregnancy. On an unknown date, at 40 weeks gestation, the neonate was born via forceps delivery and weighed 3660 grams (8lbs 1oz) at birth. The neonate was diagnosed with death neonatal (serious criteria death and GSK medically significant), maternal vaccine exposure and contraindicated drug administered. On an unknown date, the outcome of the death neonatal was fatal and the outcome of the maternal vaccine exposure and contraindicated drug administered were unknown. The neonate died in 2016. The reported cause of death was a possible chorioamnionitis. An autopsy was not performed. It was unknown if the reporter considered the death neonatal to be related to MMR vaccine, Influenza vaccine unspecified and BOOSTRIX-polio. See case GB2015GSK161790 for details regarding the mother case. Additional details provided as follows: This prospective pregnancy case was reported by the Public Health as part of a vaccine pregnancy registry. The neonate died at 20 minutes after the birth. It was not known if the neonate presented abnormalities and no autopsy was performed as pe parental choice. The lot number was reported as AC39B076AH. However, this lot number corresponded to BOOSTRIX-polio lot which was considered as suspect instead BOOSTRIX as reported. Clarification could not be obtained.


VAERS ID: 661060 (history)  
Form: Version 1.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-01
Onset:2016-10-01
   Days after vaccination:0
Submitted: 2016-10-21
   Days after onset:20
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N2A301M / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Loss of consciousness, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: Influenza, Immunisation, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2016152926

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of blackout in a 51-year-old male patient who received Influenza vaccine unspecified (batch number N2A301M, expiry date unknown). Previously administered products included Influenza Virus with an associated reaction of no adverse event. On 1st October 2016, the patient received Influenza vaccine unspecified (unknown). On 1st October 2016, less than a day after receiving Influenza vaccine unspecified, the patient experienced blackout (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the blackout was fatal. The reported cause of death was loss of consciousness. An autopsy was not performed. It was unknown if the reporter considered the blackout to be related to Influenza vaccine unspecified. Additional information: The batch number reported for Influenza vaccine N2A301M does not matching with any GSK lot number. RA verbatim: Case received from a other health professional on 03-Oct-2016. A 51-year-old male adult patient with underlying health conditions received influenza vaccine (batch number N2A301M) on 01-Oct-2016. The patient experienced Collapsed on 01-Oct-2016. It was reported that he was Ok in surgery but was found collapsed in the car in the car park of the surgery. Practice nurse gave CPR and the ambulance was called. Paramedics took over CPR and the patient was taken to hospital where he died. Post mortem to take place later this week. The patient was admitted to hospital on 01-OCT-2016. Corrective actions/drugs used to treat: CPR (cardiopulmonary resuscitation). The patient had received Flu vaccines (Received for a number of years and no incidents occurred). The patient''s outcome was reported a Fatal. The patient died on unspecified date.


VAERS ID: 675186 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610JPN011090

Write-up: Initial information has been received from a patient''s family concerning a female patient (age unknown). The patient''s medical history and concurrent condition were not provided. There was no concomitant medication reported. On an unspecified date, the patient was subcutaneously vaccinated with PNEUMOVAX NP injection (lot number, expiration date, dose, frequency and indication were not reported). On an unspecified date, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was pneumonia. Information on whether or not autopsy was performed was not obtained. Reporter''s comment: not provided. The reporter considered that the pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP. Upon internal review, pneumonia was determined to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 675214 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610JPN011008

Write-up: Information has been received from an unspecified reporter via social media concerning ten patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients died. It was unknown if autopsy was done. The events were preliminary excluded relationship to the vaccine as reported. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter.


VAERS ID: 675363 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610JPN011009

Write-up: Information has been received from Centers for Disease Control and Prevention via social media concerning eight patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On unknown dates, the patients died. It was unknown if autopsy was done. The relationship between the events and vaccine was not confirmed. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter. This safety report ID was created with the incorrect primary source country code. This safety report will be nullified and the correct primary source country code will be reflected in the new maser case file TW-009507513-161USA011603.


VAERS ID: 685078 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610TWN010466

Write-up: Information has been received from social media concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unspecified date, the patient received HPV vaccine (manufacturer unknown) (lot#, expire date, dose and route unknown). On an unknown date, the patient died. It was unknown if autopsy was done. The causality between the HPV vaccine and the event was unknown. Upon internal review, death was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected because of lack of privately contactable information for the reporter.


VAERS ID: 685117 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-21
Entered: 2016-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 4 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1610JPN011246

Write-up: Initial information has been received from a patient''s family concerning an elderly female patient who was vaccinated with PNEUMOVAX NP injection, subcutaneously, 0.5 ml once a day (lot number, expiration date and date of vaccination were not reported). There was no concomitant medication reported. On an unspecified (previously), the patient was vaccinated with PNEUMOVAX NP (dose and lot # not reported) for about three times (on an unknown date, she was vaccinated parenterally). On an unspecified date (afterwards), the patient came to developed pneumonia. On an unspecified date, the patient died. The cause of death was fall. Information related to autopsy was not provided. At the time of this report, the outcome of pneumonia was unknown. Reporter''s comment were not provided. The reporter considered that the fall was serious due to death. The reporter did not assess the seriousness of the pneumonia. Upon internal review, the pneumonia was determined to be serious as an other important medical event. The reporter did not assess the relationship of fall and pneumonia to PNEUMOVAX NP. Additional information is not expected as the reporter did not wish to be contacted.


VAERS ID: 661127 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2016-09-30
Onset:2016-10-01
   Days after vaccination:1
Submitted: 2016-10-24
   Days after onset:23
Entered: 2016-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC757A / 3 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N47895 / 3 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M004873 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia (State after Hernia); Patent ductus arteriosus; Peritonitis (state after Peritonitis); Periventricular leukomalacia; Premature baby 33 to 36 weeks (Twin premature baby 33 + 4 weeks); Retinopathy (Premature baby Retinopathy); Twin-twin transfusion syndrome (fetofetal transfusion)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2016486362

Write-up: This is a spontaneous report from a contactable physician received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2016079638. A 5-months-old male patient of an unspecified ethnicity, on 30Sep2016 received third dose of PREVENAR 13 (Lot N47895) intramuscular at single dose, third dose of INFANRIX HEXA (ACELLULAR) (Lot A21CC757A) intramuscular at single dose and third dose of ROTATEQ (Lot M004873) oral at single dose, all for immunization. Previous vaccination included pneumococcal 13-val conj vac (dipht crm197 protein), acellular pertussis, diphtheria vaccine, haemophilus influenzae b, hepatitis b vaccine, polio vaccine, tetanus vaccine and rotavirus vaccine, first dose on 12Jul2016 and second dose on 03Sep2016. All vaccinations had been tolerated. Medical history included premature baby 33 to 36 weeks, twin-twin transfusion syndrome, periventricular leukomalacia, hernia, peritonitis, retinopathy, patent ductus arteriosus. The patient''s concomitant medications were not reported. The patient was found dead in bed on 01Oct2016, on the following day in the morning after performed third vaccination. Death cause was unknown. An autopsy was performed. This case is being treated according to the Agency (Protection against Infection Act). Fatal case. No follow-up attempts needed. Follow-up automatically provided by Regulatory Authority. Reported Cause(s) of Death: Sudden death, cause unknown.


VAERS ID: 675369 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-01
Onset:2016-10-07
   Days after vaccination:67
Submitted: 2016-10-24
   Days after onset:17
Entered: 2016-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Cardio-respiratory arrest, Crying, Death, Diarrhoea haemorrhagic, Gastrointestinal obstruction, Haematochezia, Intussusception, Pneumonia, Pyrexia, Respiratory distress, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-19
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal ultrasound scan (12-OCT-2016): target sign suggesting intussusception; Body temperature (07-OCT-2016): Fever; Physical examination (October 2016): the abdomen was distended and bloody stools were observed; Body temperature (18-OCT-2016): Fever
CDC Split Type: WAES1610MLI012371

Write-up: This spontaneous report has been received from a physician concerning a 6-month-old female patient with pneumonia, enrolled in a Post Marketing Active Surveillance Program. The patient''s medical history and concomitant therapies were not provided at the time of reporting. On 31-MAY-2016, the patient was vaccinated with the first dose of ROTATEQ orally (dose and Lot/Batch# were not reported), once. On 30-JUN-2016 and 01-AUG-2016, the patient was vaccinated orally with the second and third dose of ROTATEQ (dose and Lot/Batch# were not reported), once, respectively. On 07-OCT-2016 at 08:00 hours, the patient experienced fever, inconsolable crying and vomiting. The symptoms improved during the day after treatment with metopimazine, trimebutine and paracetamol (manufacturer unknown) (doses, routes and frequencies were not reported) given by the patient''s mother. On the same date at night, the patient developed intermittent episodes of inconsolable crying and drew up her legs to her abdomen. The episodes become more frequent and severe over the time and were followed by vomiting that became bilious. The same previous treatment was given and the events remitted. On 09-OCT-2016, the patient''s parents took the baby to a health facility, where a complete consultation could not be done. The same previous treatment was continued. On 10-OCT-2016, the patient developed abdominal distention with bloody diarrhea, the patient was admitted to the pediatric unit at a hospital. On examination, the patient''s abdomen was distended and bloody stools were observed. On the same date, an ultrasound scan was performed, suggesting intussusception. The patient was transferred to pediatric surgery and had a surgery on 12-OCT-2016 at 17:00 hours. The surgery revealed an ileo-ileal intussusception and a manual reduction was done. The patient received treatment with unspecified antibiotics "saline" and nutrition, until 18-OCT-2016, when she developed fever and respiratory distress. The patient was transferred to a pediatric emergency department and a diagnosis of pneumonia and abdominal obstruction was made. The patient received treatment with oxygen, unspecified diuretics, unspecified antibiotics and paracetamol (manufacturer unknown). On 19-OCT-2016, the patient developed a cardiorespiratory arrest and passed away at 04:00 hours. It was unknown if an autopsy was performed. The reporter considered intussusception to be not related to ROTATEQ. However, the reporter did not assessed a causality between the events gastrointestinal obstruction, pneumonia and cardiorespiratory arrest and the vaccination with ROTATEQ. Upon internal review, the events intussusception, pneumonia, gastrointestinal obstruction and cardiorespiratory arrest were considered to be medically significant events. Additional information is not expected, because no follow up is required or available.


VAERS ID: 675437 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-10-17
Onset:2016-10-19
   Days after vaccination:2
Submitted: 2016-10-25
   Days after onset:6
Entered: 2016-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: 2016-10-19
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK154900

Write-up: This case was reported by a physician via call center representative and described the occurrence of sudden infant death syndrome in a infant patient who received INFANRIX HEXA. Co-suspect products included ROTARIX. On 17th October 2016, the patient received INFANRIX HEXA .5 ml and ROTARIX (oral) 1.5 ml. On 19th October 2016, 2 days after receiving INFANRIX HEXA and ROTARIX, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On 19th October 2016, the outcome of the sudden infant death syndrome was fatal. The patient died on 19th October 2016. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to INFANRIX HEXA and ROTARIX. Additional details were provided as follows. Initially, no further information was available.


VAERS ID: 661803 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-13
Onset:0000-00-00
Submitted: 2016-10-27
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER N3E661V / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B234AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple organ dysfunction syndrome, Sepsis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
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: Vaccines, Prophylaxis, were well tolerated
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK156700

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sepsis in a 83-year-old female patient who received BOOSTRIX (batch number AC37B234AA, expiry date unknown). Co-suspect products included VAXIGRIP vaccine (batch number N3E661V, expiry date unknown). Previously administered products included Unspecified vaccines (were well tolerated). On 13th October 2016, the patient received BOOSTRIX (intramuscular) and VAXIGRIP vaccine (intramuscular). In October 2016, 1 day after receiving BOOSTRIX, the patient experienced sepsis (serious criteria death, hospitalization, GSK medically significant and life threatening) and multi-organ failure (serious criteria death, hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the sepsis and multi-organ failure were fatal. The patient died in October 2016. The reported cause of death was sepsis and multi-organ failure. It was unknown if the reporter considered the sepsis and multi-organ failure to be related to BOOSTRIX. Additional details were provided as follows: The patient received BOOSTRIX in the right deltoid and VAXIGRIP in the left deltoid. Approximately 24 hours after receiving BOOSTRIX and VAXIGRIP, the patient had sepsis with multi-organ failure and approximately 24 hours later, the events resulted in death. It was not reported whether an autopsy was performed. It was unknown if the reporter considered the sepsis and multi-organ failure to be related to VAXIGRIP. The regulatory authority has requested follow-up information.


VAERS ID: 675450 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-08-19
Onset:0000-00-00
Submitted: 2016-10-27
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time normal, Asthenia, Blood creatinine increased, Blood creatinine normal, Blood gases normal, Blood lactic acid normal, C-reactive protein increased, Chest X-ray normal, Computerised tomogram abdomen normal, Cough, Cyanosis, Death, Diarrhoea, Dyspnoea, Electrocardiogram abnormal, Endotracheal intubation, Fibrin D dimer increased, Hypersensitivity, Intensive care, International normalised ratio increased, Mechanical ventilation, Myocardial necrosis marker normal, Nausea, Oxygen saturation decreased, Pneumococcal sepsis, Post procedural infection, Prothrombin level normal, Pyrexia, Sinus tachycardia, Somnolence, Streptococcus test positive, Tachycardia, Tachypnoea, Troponin increased, Urine analysis normal, Vaccination failure, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Hypertension; Obesity, body mass index: 41 kg/m2
Preexisting Conditions: Pulmonary embolism, two years prior to admission, pulmonary embolism resulted in cardiopulmonary resuscitation; Splenectomy, two years before admission, the patient underwent a splenectomy for a two-stage splenic rupture; Upper gastrointestinal haemorrhage; Urogenital haemorrhage; Splenic rupture; Angioedema; Bacterial infection, blood stream infection with Serratia marcescens; Rivaroxaban; Torsemide; Ramipril; Esomeprazole; Ceftriaxone; Piperacillin sodium (+) tazobactam sodium
Allergies:
Diagnostic Lab Data: Two years prior to admission, pulmonary embolism resulted in cardiopulmonary resuscitation. After successful resuscitation, a splenectomy due to a traumatic two-stage splenic rupture was performed. The postoperative course in the intensive care unit was complicated by an angioneurotic edema and blood stream infection with Serratia marcescens, which was cured by ceftriaxone and piperacillin/tazobactam but resulted in prolonged weaning. On admission, she displaced tachypnea (25/min), tachycardia (116/min), a slightly impaired oxygen saturation (91%), normal blood pressure (112/76 mmHg) and fever (39.0 degree Celsius). Auscultation of the lungs was normal. Palpation of the abdomen enhanced the pain in the left part of the abdomen, suggestive for diverticulitis. No skin pathologies were observed. Apart from a sinus tachycardia, the electrocardiogram was normal. Blood gas analysis revealed normal findings except for reduced oxygen saturation (81%), which lead to oxygen administration (4 l/min). Urine examination excluded a urinary tract infection. A chest x-ray and computed tomography of the abdomen was performed, which did not reveal any sign of a causative pathology. Laboratory analyses revealed no leukocytosis, normal lactate, elevated C-reactive protein (63 mg/l; normal; less than 5 mg/l), an elevated creatinine-level (1.5 mg/dl; normal less than 0.95 mg/dl) and marginalized positive troponin (123 micro-g/dl; normal less than 100 micro-g/dl). International normalised ratio (INR) (1.27) was slightly impaired and partial thromboplastin time (PTT) was normal. Oxygen saturation dropped, the patient became drowsy and short of breath while circulation still remained stable. Re-evaluation for cardiac enzymes revealed no increase in troponin levels and assessment for pulmonary embolism showed only slightly elevated D-dimers (1.1 mg/dl; normal: less than 0.5 mg/l). Laboratory analyses revealed no leukocytosis. The patient was severely obese (body mass index: 41 kg/m2), fully conscious (GCS: 15). Blood culture: Positive. Lactate: Normal. Prothrombin level: Normal.
CDC Split Type: WAES1610DEU011793

Write-up: Information has been received from Sanofi Pasteur MSD (SPMSD) (manufacturer control# DE-1577272925-2016010522) on 21-OCT-2016. Case of vaccination failure retrieved from unsolicited literature on 18-Oct-2016. A 65-year-old female elderly patient received PNEUMOVAX (batch number unknown) on an unknown date, 2 weeks after splenectomy. The patient experienced post splenectomy pneumococcal sepsis on an unknown date. Paramedics brought a 65 year old female patient to department of emergency medicine as she was in a reduced general condition. The patient was severely obese (body mass index: 41 kg/m2), fully conscious (GCS: 15) and complained about nausea, vomiting, left-sided abdominal pain, severe weakness and a slight cough. The patient denied having dyspnoea and thoracic pain. Two years prior to admission, pulmonary embolism resulted in cardiopulmonary resuscitation. After successful resuscitation, a splenectomy due to a traumatic two-stage splenic rupture was performed. The postoperative course in the intensive care unit was complicated by an angioneurotic edema and blood stream infection with serratia marcescens, which was cured by ceftriaxone and piperacillin/tazobactam but resulted in prolonged weaning. The patient had fully recovered during the past 2 years after discharge from hospital. Her further history included mild hypertension, recurrent upper gastrointestinal and urogenital bleeding following various anticoagulation treatments, which was based on esophagitis (Stage IV, Savary and Miller), and diverticulosis of the descending and sigmoid colon. Consequently, she was receiving rivaroxaban 20 mg 1x1, torsemide 5 mg 1x1, ramipril 5 mg 1x1 and esomeprazole 40 mg 1x1. All vaccinations had been administered as recommended for splenectomised patients including vaccination for Streptococcus pneumoniae (PNEUMOVAX). On admission, she displayed tachypnea (25/min), tachycardia (116/min), a slightly impaired oxygen saturation (91%), normal blood pressure (112/76 mmHg) and fever (39.0 degree Celsius). Auscultation of the lungs was normal. Palpation of the abdomen enhanced the pain in the left part of the abdomen, suggestive for diverticulitis. No skin pathologies were observed. Apart from a sinus tachycardia, the electrocardiogram was normal. In particular, there was no link to myocardial infection of pulmonary embolism. The patient received intravenous paracetamol (1 g) and 1000 ml electrolyte-solution, which normalized the fever, tachypnea and tachycardia. She was additionally administered 40 mg of pantoprazole. Blood gas analysis revealed normal findings except for reduced oxygen saturation (81%), which lead to oxygen administration (4 l/min). Urine examination excluded a urinary tract infection. A chest x-ray and computed tomography of the abdomen was performed, which did not reveal any sign of a causative pathology. Laboratory analyses revealed no leukocytosis, normal lactate, elevated C-reactive protein (63 mg/l; normal: less than 5 mg/l), an elevated creatinine-level (1.5 mg/dl; normal less than 0.95 mg/dl) and marginalized positive troponin (123 micro-g/dl; normal less than 100 micro-g/dl). International normalised ratio (INR) (1.27) was slightly improved and partial thromboplastin time (PTT) was normal. The patient was referred to intensive care unit. Two hours after admission to hospital, intravenous administration of 4 g ceftriaxone was started on suspicion of a highly feverish infection of unknown origin, accompanied by another 1,000 ml electrolyte-solution. Twenty minutes after administration of ceftriaxone, the patient''s condition deteriorated. Vomiting and diarrhoea preceded a generalized cyanosis. Oxygen saturation dropped, the patient became drowsy and short of breath while circulation still remained stable. A potential allergic reaction was suspected and subcutaneous adrenaline (0.5 mg), prednisolone (250 mg) and increased oxygen therapy were administered which primarily stabilized the patient. Re-evaluation for cardiac enzymes revealed no increase in troponin levels and assessment for pulmonary embolism showed only slightly elevated D-dimers (1.1 mg/dl; normal: less than 0.5 mg/l). Within 30 minutes, livid spots appeared on her skin which increased in size and number. The patient''s condition required intubation, mechanical ventilation and additionally, continuous increase of intravenous noradrenalin application. Despite excellent oxygenation in blood gas analysis, cyanosis persisted. Four hours after admission to hospital, the patient died. Eight hours after collection, blood cultures became positive for Streptococcus pneumoniae (serogroup: 12F), and confirmed the differential diagnosis of overwhelming Postsplenectomy Infection (OPSI) retrospectively. The patient''s outcome of "pneumococcal sepsis, cyanosis and disseminated intravascular coagulation" was reported as Fatal. The outcome of other events was reported as unknown. The patient died on unspecified date. It was unknown if the autopsy was performed.


VAERS ID: 675456 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-27
Entered: 2016-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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: BR2016GSK157581

Write-up: This case was reported by a nurse via sales rep and described the occurrence of unknown cause of death in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, an unknown time after receiving ROTARIX, 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 ROTARIX. Additional details were provided as follows: The nurse reported that the patient received Rotavirus vaccine at a public service and died some time later. During the medical information department, analysis was verified that the Rotavirus vaccine that was administered belonged to GSK (ROTARIX). It was not informed the cause of death or the date and neither was provided other details about the death. No further information was provided.


VAERS ID: 662370 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-17
Onset:2016-10-18
   Days after vaccination:1
Submitted: 2016-10-28
   Days after onset:10
Entered: 2016-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC758A / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH Q01931 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB504AC / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blood pH decreased, Death
SMQs:, Lactic acidosis (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (bellyache); Discolouration stool (Stool color: yellow, before green); Otitis media (grade: mild not ongoing); Rhinitis (sniff); Sticky eyes; Term birth
Allergies:
Diagnostic Lab Data: Test Name: Apgar score; Result Unstructured Data: Test Result: 9/10/10; Comments: Sonography pylorus (01Sep2016): result: no pyloric stenosis, pyloric passage well representable, no pathological findings. Sonography hip (01Sep2016): right hip alpha 60 beta 67, left hip alpha 70 beta 59.; Test Name: pH; Result Unstructured Data: Test Result: 7.20; Comments: Sonography pylorus (01Sep2016): result: no pyloric stenosis, pyloric passage well representable, no pathological findings. Sonography hip (01Sep2016): right hip alpha 60 beta 67, left hip alpha 70 beta 59.; Test Date: 20160901; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result: no pathological findings; Comments: Sonography pylorus (01Sep2016): result: no pyloric stenosis, pyloric passage well representable, no pathological findings. Sonography hip (01Sep2016): right hip alpha 60 beta 67, left hip alpha 70 beta 59.; Test Date: 20160901; Test Name: Echography; Result Unstructured Data: Test Result: right hip alpha 60 beta; Comments: Sonography pylorus (01Sep2016): result: no pyloric stenosis, pyloric passage well representable, no pathological findings. Sonography hip (01Sep2016): right hip alpha 60 beta 67, left hip alpha 70 beta 59.
CDC Split Type: DEPFIZERINC2016496297

Write-up: This is a spontaneous report from a contactable physician received via a sales representative and from the Health Authority. Regulatory authority report number DE-PEI-PEI2016081625. A 3-month-old male patient received 1st dose of PREVENAR 13 (batch no.:Q01931), intramuscular on thigh left on 17Oct2016 for prophylactic vaccination. Co-suspect vaccines included 1st dose of ROTARIX (batch no.: AROLB504AC, GlaxoSmithKline) 1 dose form oral, and 1st dose of INFANRIX HEXA (batch no.: A21CC758A, GlaxoSmithKline) 1 dose form intramuscular on thigh right, both administered on 17Oct2016 for prophylactic vaccination. Medical history included: abdominal pain, sticky eyes, otitis media, rhinitis, and stool discolouration. No family history of allergies, diseases. The patient''s family immigrated from another country, but since almost two years, the family has lived in this country. Four well-baby examinations (U1 to U4) were performed: U1: on an unknown date, noted: spontaneous delivery in the 40th week of gestation, pH 7.20, APGAR: 9/10/10, administration of vitamin K; U2: on an unknown date, noted: navel bloody and moist, control by pediatrician, slight upper swelling (right), administration of vitamin K, sticky eyes, abdominal pain. U3: on 01Sep2016 noted: patient spits a lot, stool color green. Sonography revealed no pyloric stenosis, pyloric passage well representable, no pathological findings. Sonography of the patient''s hip showed right hip alpha 60 beta 67, left hip alpha 70 beta 59. U4: on 17Oct2016 noted: from anamnesis resulted 2 weeks before otitis media and sniff, stool color now yellow. The patient was prescribed paracetamol 75 mg suppository, ZYMAFLUOR, VIGANTOLETTEN 500, it was not specified if the patient started the treatment. The patient died 24 hours after vaccination on 18Oct2016. Death was of unclear genesis; death cause was not reported. According to the reporting physician, the criminal investigation department got involved and an autopsy was performed. The autopsy revealed, except for an antibiotic-treated inflammation of the middle ear no medical history. The physician assessed the causality to pneumococcal 13-val conj vac (dipht crm197 protein) as not assessable. This case is being treated according to the IfSG (Protection against Infection Act). Case closed. No follow-up attempts needed, follow-up automatically provided by health authority. Reported Cause(s) of Death: unknown cause of death; Autopsy-determined Cause(s) of Death: middle ear inflammation.


VAERS ID: 675854 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-02
Entered: 2016-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Burning sensation, Cardiac arrest, Death, Diet refusal, Meningitis, Moaning, Multiple organ dysfunction syndrome, Pain, Pyrexia, Rash generalised, Screaming, Seizure, Sepsis, Skin warm, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Vaccine, Prophylaxis, the patient has all vaccines on time and even had her first year vaccines two weeks earlier
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2016GSK156168

Write-up: This case was reported by a non-health professional via local affiliate and described the occurrence of vaccination failure in a 1-year-old female patient who received meningococcal ACWY vaccine (potential MENVEO). Previously administered product included vaccine (the patient had all vaccines on time and even had her first year vaccines two weeks earlier). On an unknown date, the patient received meningococcal ACWY vaccine (potential MENVEO). On an unknown date, less than a year after receiving meningococcal ACWY vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria death and GSK medically significant), septicemia (serious criteria death and GSK medically significant), seizure (serious criteria GSK medically significant), multi-organ failure (serious criteria GSK medically significant), heart arrest (serious criteria GSK medically significant), fever, skin warm, generalized rash, pain, screaming and diet refusal. On an unknown date, the outcome of the vaccination failure, seizure, multi-organ failure, heart arrest, fever, skin warm, generalized rash, pain, screaming and diet refusal were unknown and the outcome of the meningitis and septicemia were fatal. The reported cause of death was meningitis and septicemia. It was unknown if the reporter considered the vaccination failure, meningitis, septicemia, seizure, multi-organ failure, heart arrest, fever, skin warm, generalized rash, pain, screaming and diet refusal to be related to meningococcal ACWY vaccine (potential MENVEO). Additional information was provided as follows: The patient''s parent was 29 year-old and partner was 34 year-old. At the time of reporting, the patient had her 1st birthday (few weeks back). The patient age at vaccination was not reported. The patient was in good health (rarely ill). The patient had received meningococcal A, C, W and Y strains (unspecified). In April (year not specified), the patient had experienced fever and her skin felt as though it was burning. The patient sat quietly not eating. The patient''s mother rang for my out of hour physician as it was around 6pm but she was informed not to worry and as the patient might had a head cold but the patient''s condition got worse. The patient was whimpering throughout the night and had experienced seizures. Approximately after 12 hours and numerous calls to the physician, the patient''s mother called for an ambulance. As soon as the patient reached hospital the patient''s condition worsened and had experienced rash all over her body. The patient was screaming in pain. The patient''s heart stopped 16 times and physicians were struggled to stabilize her. On an unknown date after receiving meningococcal ACWY vaccine, the patient experienced meningitis C, which led to the suspected vaccine failure. The patient died of meningitis and septicemia 24 hours after having contracted the disease. It was unknown if an autopsy was performed. The case was considered as suspected vaccination failure because the exact time to onset and vaccination schedule was unknown. No further information was provided. No consent to follow up has been provided.


VAERS ID: 663776 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-26
Onset:2016-05-07
   Days after vaccination:11
Submitted: 2016-11-03
   Days after onset:180
Entered: 2016-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC685A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M37097 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test positive, Computerised tomogram normal, Death, Enterovirus test positive, Sudden infant death syndrome, White blood cell count normal
SMQs:, Neonatal disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-07
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result: unremarkable; Test Name: Investigation; Result Unstructured Data: Test Result: enterovirus and adenovirus; Test Name: Stool analysis; Result Unstructured Data: Test Result: enterovirus and adenovirus; Test Name: WBC; Result Unstructured Data: Test Result: normal
CDC Split Type: FRPFIZER INC2016500290

Write-up: This is a spontaneous report received from the regulatory authority. Regulatory authority report number DJ20161233. A 2-month-old (12 weeks) female patient received PREVENAR 13 (lot# M37097, exp date May2018), intramuscular, on 26Apr2016, at single dose, for immunisation and INFANRIX HEXA (lot# A21CC685A), intramuscular, on 26Apr2016, at 1DF single, for immunisation. The patient had no relevant medical history and no concomitant treatment. The patient died from sudden infant death on 07May2016. Course of the event: the infant was found dead, on 07May2016, at 05:00 pm, while she was in bed taking a nap. Autopsy was not performed for cultural reason. Investigation of sudden infant death included computerized tomography scan of the entire body which was unremarkable. Stools and respiratory tract samples found enterovirus and adenovirus. White blood cell count was normal. Based on the Official Method of Causality Assessment, the causal relationships between the suspect vaccines and the adverse event were assessed by the Agency as "doubtful". No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Sudden infant death.


VAERS ID: 663996 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-04
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Toxic shock syndrome streptococcal
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2016SA200342

Write-up: Initial unsolicited report received from the literature on 29 October 2016. This case is linked with 2016SA200325, 2016SA200331, 2016SA200332, 2016SA200333, 2016SA200334, 2016SA200335, 2016SA200336, 2016SA200337, 2016SA200338, 2016SA200339, 2016SA200340, 2016SA200341 (same literature article).The following is verbatim from the article: Abstract: Disinfection should be required for all skin penetrative procedures including parenteral administration of vaccines. This review analyses medically attended infectious events following parenteral vaccination in terms of their microbiological aetiology and pathogenesis. Like ''clean'' surgical site infections, the major pathogens responsible for these events were Staphylococcal species, implicating endogenous contamination as a significant source of infection. As 70% isopropyl alcohol swabbing has been shown to effectively disinfect the skin, it would be medico-legally difficult to defend a case of sepsis with the omission of skin disinfection unless the very low risk of this event was adequately explained to the patient and documented prior to vaccination. There was a significant cost-benefit for skin disinfection and cellulitis. Skin disinfection in the context of parenteral vaccination represents a new paradigm of medical practice; the use of a low cost intervention to prevent an event of very low prevalence but of significant cost. This case involves a four months olds male patient who was vaccinated with a dose of PENTACEL and with a dose PREVNAR (batch number, expiration date, dose and site of administration was not reported for both vaccines) by parenteral route on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient experienced toxic shock syndrome and group A streptococcus infection. Patient''s Lab data and corrective treatment was not reported. On unspecified date, patient died due to toxic shock syndrome. It was unknown if autopsy was done. Documents held by sender: none. Sender''s Comments: This case corresponds to a poorly documented literature report with a mention of a 4 month old male Patient died due to toxic shock syndrome who had received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE and PNEUMOCOCCAL CONJUGATE VACCINE. Time to onset was unknown. It was reported that patient was positive for group A streptococcus. Clinical details- such as latency from vaccination, medical history, previous vaccination history, autopsy result and diagnostic work-up- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: Toxic shock syndrome.


VAERS ID: 675719 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-02
Onset:0000-00-00
Submitted: 2016-11-04
Entered: 2016-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB118AA / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER A73CA221A / UNK UN / UN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME) / UNKNOWN MANUFACTURER VNR1GO7C / UNK UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER ATYPB063CD / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Drowning, Fall, Narcolepsy
SMQs:, Convulsions (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 05/14/2007, GARDASIL, on 14th May 2007 (batch number NF14740)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK159639

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death in a 18-year-old female patient who received TWINRIX Adult (batch number AHABB118AA, expiry date unknown). Co-suspect products included FSME-IMMUN Adult (batch number VNR1G13G, expiry date unknown), STAMARIL (batch number A52852, expiry date unknown), TWINRIX Adult (batch number AHABB118AA, expiry date unknown), TYPHERIX (batch number ATYPB063CD, expiry date unknown), MENCEVAX ACWY (batch number A73CA221A, expiry date unknown), FSME-IMMUN ERWACHSENE (batch number VNR1GO7C, expiry date unknown) and GARDASIL (batch number NF14740, expiry date unknown). Previously administered products included GARDASIL (on 14th May 2007 (batch number NF14740)). Concomitant products included GARDASIL. On an unknown date, the patient received TWINRIX Adult, FSME-IMMUN Adult and STAMARIL. On 2nd July 2008, the patient received TWINRIX Adult, TYPHERIX, MENCEVAX ACWY and FSME-IMMUN ERWACHSENE. On 6th December 2007, the patient received GARDASIL. On 14th July 2008, an unknown time after receiving TWINRIX Adult and 12 days after receiving TWINRIX Adult and TYPHERIX, the patient experienced narcolepsy (serious criteria GSK medically significant). On an unknown date, the patient experienced death (serious criteria death and GSK medically significant). On 3rd September 2008, the outcome of the narcolepsy was recovered/resolved. On an unknown date, the outcome of the death was fatal. The reported cause of death was death. It was unknown if the reporter considered the death and narcolepsy to be related to TWINRIX Adult, TWINRIX ADULT and TYPHERIX. Additional details were provided as follows: On 9th July 2007, the patient received GARDASIL (batch number NF14740). The narcolepsy was observed since 1st July 2008. The cause of death of the patient was unexplained. The patient was fall from board, most likely drowning, but no water in the lungs. It was unknown if the reporter considered the unknown cause of death and narcolepsy to be related to FSME-IMMUNE, STAMARIL, MENCEVAX ACWY, FSME-IMMUNE Adult and GARDASIL as well. The follow-up information had been requested. The clarification was requested for the correct vaccination date of TWINRIX Adult, FSME-IMMUNE and STAMARIL and also the correct event onset date of narcolepsy, however, no further details regarding the vaccination and event onset date was provided hence the TWINRIX Adult, FSME-IMMUNE and STAMARIL was coded as suspect without vaccination dates.


VAERS ID: 664526 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-08
Entered: 2016-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Necrotising fasciitis, Toxic shock syndrome streptococcal
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2016SA200341

Write-up: Initial unsolicited report received from the literature on 29 October 2016. This case is linked with 2016SA200325, 2016SA200331, 2016SA200332, 2016SA200333, 2016SA200334, 2016SA200335, 2016SA200336, 2016SA200337, 2016SA200338, 2016SA200339, 2016SA200340, 2016SA200342 (same literature article). The following is verbatim from the article: Abstract: Disinfection should be required for all skin penetrative procedures including parenteral administration of vaccines. This review analyses medically attended infectious events following parenteral vaccination in terms of their microbiological aetiology and pathogenesis. Like ''clean'' surgical site infections, the major pathogens responsible for these events were Staphylococcal species, implicating endogenous contamination as a significant source of infection. As 70% isopropyl alcohol swabbing has been shown to effectively disinfect the skin, it would be medico-legally difficult to defend a case of sepsis with the omission of skin disinfection unless the very low risk of this event was adequately explained to the patient and documented prior to vaccination. There was a significant cost-benefit for skin disinfection and cellulitis. Skin disinfection in the context of parenteral vaccination represents a new paradigm of medical practice; the use of a low cost intervention to prevent an event of very low prevalence but of significant cost. This case involves a female 11-year-old patient who was vaccinated with a dose of MENACTRA, a dose of HAVRIX, a dose of GARDASIL and a dose of BOOSTRIX (batch number, expiration date, dose, site and route of administration were not reported for all vaccines) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient developed Necrotising fasciitis complicated by fatal GAS toxic shock syndrome. Patient''s Lab data and Corrective treatment was not reported. On an unspecified date patient died as Necrotising fasciitis complicated by fatal GAS toxic shock syndrome was reported. It was unknown if autopsy was done. Documents held by sender: none. Sender''s Comments: Necrotising fasciitis complicated by fatal GAS toxic shock syndrome is a potentially fatal illness caused by a bacterial toxin. Different bacterial toxins may cause toxic shock syndrome. The causative bacteria include Streptococcus pyogenes in this case. Toxic shock syndrome and necrotizing fasciitis are unlisted with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These are the infection may be due to improper sterilization issue. More over the patient received four vaccine simultaneously hence role of the particular vaccine cannot be provided. Reported Cause(s) of Death: Necrotising fasciitis; Necrotising fasciitis complicated by fatal GAS toxic shock syndrome.


VAERS ID: 664681 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-22
Onset:2016-06-15
   Days after vaccination:1485
Submitted: 2016-11-08
   Days after onset:146
Entered: 2016-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebrospinal fluid leakage, Chronic respiratory disease, Death, Gastrooesophageal reflux disease, Lower respiratory tract infection, Pneumococcal infection, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Gastrointestinal nonspecific dysfunction (narrow), Respiratory failure (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital hydrocephalus; Ventriculo-peritoneal shunt
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2016513420

Write-up: This is a spontaneous report obtained from a contactable healthcare professional through the Health Protection Agency. A 5 year-old male patient received the first dose of PREVENAR 13 single dose, on 19Jun2011 for immunization when he was 4 months old. The patient''s second dose was received on 22Mar2012 when she was 13 months old. The patient''s third dose was received on 22May2012 when she was 15 months old. Relevant medical history included a congenital hydrocephalus with VP shunt. The patient''s birth weight and gestational age were 3.63 kg and 40 plus 4 weeks respectively. Following conditions were deemed to be unrelated to this case: homozygous sickle cell disease or other haemoglobinopathy, history of previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppressive condition or drug, malignancy, cardiac chronic disease, renal chronic disease, liver chronic disease, diabetes mellitus, cochlear implants and coeliac disease. The reporter said the relatedness of the following conditions were unknown: empyema, haemolytic uraemic syndrome and cerebral abscess. The following conditions were also mentioned in the case: CSF Leakage, chronic respiratory disease, reflux, Lower respiratory tract infection and sepsis. Concomitant medications were unknown. On 15Jun2016, the patient experienced a pneumococcal infection, serotype 3 which was reported as a vaccination failure. On 18Jun2016, the patient died. No further information was available at the time of this report. No follow-up attempts possible. No further information expected.; Sender''s Comments: Serotype 3 is contained in PREVENAR 13, therefore a lack of efficacy in this patient cannot be 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 infection, serotype 3 which was reported as a vaccination failure; Pneumococcal infection, serotype 3 which was reported as a vaccination failure.


VAERS ID: 664683 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-27
Onset:2016-10-31
   Days after vaccination:4
Submitted: 2016-11-08
   Days after onset:8
Entered: 2016-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZERINC2016511787

Write-up: This is a spontaneous report from a contactable physician through a Pfizer sales representative. An adult (about 40-42 year-old) male patient of an unspecified race and ethnicity received PREVENAR 13 at 0.5 ml single and influenza vaccine at 1 dosage form single, both intramuscular on 27Oct2016 for immunization. Medical history included ongoing diabetes and ongoing hypertension and the patient was a smoker; concomitant medications were not reported. The patient experienced myocardial infarction on 31Oct2016 due to which he died. Sender''s Comments: The Company considers the reported event of myocardial infarction most likely related to patient''s underlying clinical conditions. 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: Myocardial infarction.


VAERS ID: 675891 (history)  
Form: Version 1.0  
Age: 4.4  
Sex: Female  
Location: Foreign  
Vaccinated:2015-09-30
Onset:2015-09-30
   Days after vaccination:0
Submitted: 2016-11-07
   Days after onset:404
Entered: 2016-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Death, Product quality issue
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-10-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2015GB007642

Write-up: Follow up: This was deemed nothing to do with her immunisation but her cardiac history. Case number PHFR2015GB007642, is an initial spontaneous report received from a healthcare professional via health authority (HA number: GB-MHRA-EYC 00128907) 13 Oct 2015. This is also a quality complaint (QA reference: 397043). This report refers to a 19 weeks old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of BEXSERO (batch number and expiry date: not reported) intramuscularly on 30 Sep 2015. On the same day after vaccination, patient experienced anaphylaxis. On 01 Oct 2015, patient died. It was uncertain until post mortem if this drug caused the death but it was being reported as such until otherwise known. It was unknown whether autopsy was performed or not. The causality of the event was not reported. The quality assurance department reported that, on the basis of the review performed it was possible to confirm that BEXSERO manufacturing process was under control. From a technical and quality point of view, neither any objection nor discrepancy had been identified nor was any cause identified for the reported adverse event. Non-significant follow-up information from a quality assurance department received on 15 Oct 2015: Updated QA reference number only. Significant follow up received from quality assurance department on 30 Oct 2015: Updated batch review. Follow up information received via Regulatory Authority on 20-SEP-2016: This case was associated with a product complaint. Concurrent medical conditions included cardiac disorder NOS. On 30th September 2015, less than a day after receiving BEXSERO, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the patient experienced death unexplained (serious criteria death and GSK medically significant) and product complaint. On 1st October 2015, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the anaphylaxis and product complaint were unknown. Possible anaphylaxis. It is uncertain until post mortem if this drug caused the death but it is being reported as such until otherwise known.


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