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Case Details

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VAERS ID: 761403 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Memory impairment, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), 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: GB0095075131807GBR010617

Write-up: Information was received from a producer at a news channel referring to unspecified number of 8 year old female patients. The patients'' medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, an unknown parent informed the reporter that their daughter had fits and memory issues since an unknown date, which they attributed to the vaccination with GARDASIL (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). The reporter stated that an unspecified doctor recommended the vaccination with GARDASIL as the most effective form of protection against cancer (therapeutic response unexpected); on the other hand, an unspecified scientist suggested doing further tests to prove that. Additionally, the reporter stated that the number of parents, who said that there are needs to have further investigation between vaccination with GARDASIL and the aforementioned events as well as death, was increasing. The outcome of seizure, therapeutic response unexpected and memory impairment was unknown. The reporter considered memory impairment and seizure to be related to GARDASIL; however, the relatedness between the patients'' death and GARDASIL was not reported. Upon internal review, seizure was determined to be medically significant.


VAERS ID: 761404 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-08-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

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

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1-month and 17 days-old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT) and unspecified hepatitis B virus (HBV) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 9 August 2012, the patient received unspecified OPV, DPT and HBV vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 762690 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-08-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

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

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-month-old female subject who received Poliomyelitis vaccine oral Trivalent for prophylaxis. Co-suspect products included bcg vaccine for prophylaxis. On an unknown date, less than a year after receiving Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Poliomyelitis vaccine oral Trivalent, DTP vaccine and Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a 1.6-month -old female patient who was vaccinated with unspecified oral polio virus (OPV); unspecified diphtheria- pertussis (acellular or whole cell)- tetanus- (DPT), unspecified hepatitis B virus (HBV) and unspecified Bacillus Calmette-Guerin (BCG) vaccines (manufacturer unknown for all) for prophylaxis. This case corresponds to the supplementary information (provided by the author) reported in this literature article. The patient was part of the study that described the number and types of adverse events following immunization (AEFIs) reported from 2012 to 2016, and characterised the adverse events, including mortality, by causality as determined by National AEFIs Committee using the World Health Organization''s (WHO)''s causality assessment protocol (CAP) guidelines. The National AEFI Causality Assessment Subcommittee reviewed all serious/severe AEFI reports which were reported to National AEFI surveillance program. These reports were further verified by the complete National AEFI Committee and submitted to the Ministry of Health for review. On 20 February 2017, all causality assessed serious/severe AEFI reports from the Ministry of Health and Family Welfare website were retrieved and these included AEFI reports from January 2012 to January 2016 (4 years). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On 22 August 2012, the patient received unspecified OPV, DPT, HBV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). The patient was administered vaccine as part of routine immunisation activity. The age of vaccination was not provided. On an unspecified date in 2012, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. [In this study, the final case investigation form was expected to be completed within 70 days of the event notification being sent to the medical officer to allow time for results of other reports to be reviewed, in case sent. Once the case report, preliminary case investigation, and final case investigation forms detailing the serious/severe AEFI along with supporting medical records have been received at the national AEFI Secretariat, the case was taken up for causality assessment by trained experts of the causality assessment subcommittee of the National AEFI committee]. This case has been considered as serious due death. The case report was classified under category D (unclassifiable). [The WHO''s CAP classifies AEFI reports broadly into the following four categories: (A) consistent causal association to immunization, (B) indeterminate, (C) coincidental or inconsistent causal association to immunisation, and (D) unclassifiable. Category A is further divided into reports related to (A1) the vaccine product, or (A2) a vaccine quality defect, or (A3) an immunization error, or (A4) immunization anxiety. Two subcategories under category B are also available: (B1) a consistent temporal relationship but insufficient evidence for vaccine causality and (B2) conflicting evidence or inconsistency about a causal association to immunization]. The authors concluded, "In this study of AEFI reported into a national surveillance system and subjected to causality assessment, we found majority of the reports were classified and half of them had consistent causal association with vaccine/vaccination. A few cases, especially those related to death, were unclassifiable or were classified as having an inconsistent relationship with vaccination. Most cluster AEFIs were reported following immunisation campaigns and were classified as immunization anxiety-related reactions. Though this study talks about causal classification of the reported AEFIs, it is limited by the absence of valid diagnosis of the event. Availability of information on valid diagnosis will enable to understand causality classification by the type of adverse event. Overall, continued AEFI surveillance and review of serious and severe cases is an important component of the vaccination program in all countries to ensure vaccine safety and detect signals". This is 1 of the 110 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 762880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Lung disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2018301543

Write-up: This is a spontaneous report from a contactable pharmacist from National pharmacy at a long care home received via a sales representative. A male patient of an unspecified age received in 2018 (about 3 months before this report) PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included ongoing advanced chronic obstructive pulmonary disease and ongoing lung problems. The patient''s concomitant medications were not reported. The patient had his shot and died 3 days later of pneumonia on an unspecified date in 2018. It was not reported if an autopsy was performed. Information on the batch number has been requested. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: died 3 days later of pneumonia; He got his shot and died 3 days later of pneumonia.


VAERS ID: 763484 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Measles, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131807GRC012950

Write-up: This spontaneous report was received from a physician via agency from the Monthly epidemiological surveillance report of measles virus infection which was posted at the web site of Center for Disease Control and Prevention and refers to an 18-year-old male patient with immunodeficiency. The patient''s pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On unknown dates, the patient was fully vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration dates were not reported). On unknown dates, the patient experienced measles, respiratory failure and pneumonia. On an unknown date, the patient died due to respiratory failure and pneumonia. It was not reported if an autopsy was performed. The outcome of measles was unknown. The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not reported. Upon internal review, the events of pneumonia, respiratory failure and measles were determined to be medically significant. This is one of several reports received from the same reporter. Sender''s Comments: GR-009507513-1801GRC003529: GR-009507513-1802GRC009987: Reported Cause(s) of Death: pneumonia; respiratory failure.


VAERS ID: 763958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Infection
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: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131808AUS001414

Write-up: Information was received from a doctor, and refers to a 26 year old male patient with immunocompromised. The patient medical history and concomitant therapy were not reported. In 2017 (reported as last year), the patient was seronegative when tested. On an unknown date in 2017, the patient received his primary vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot# and expiration date unknown) against chickenpox. After vaccination, the patient developed an infection and died. The cause of death was not provided. The outcome of unspecified infection was unknown. The causality assessment was not provided by the reporter.


VAERS ID: 763974 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

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

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a subject who received Human papilloma type 16 + 18 vaccine + AS04D for prophylaxis. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided. This case was reported in a literature and described the death not otherwise specified (NOS) in a patient of unspecified age and gender who was vaccinated with unspecified human papilloma virus (HPV) vaccine (manufacturer unknown) for prophylaxis. The patient was part of the retrospective observational study carried out at Pharmacovigilance Programme that collected data from the centre. In this study, out of 637 reports, majority were observed in 0-12 months of age group followed by 1-5 years. However, in 18 reports no information on age was available. Majority of AEFI (343) were reported in male while 270 in female with male to female ratio of 1.27: 1. However, in 24 reports, gender information was unavailable. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosage unknown, batch number not provided). The age of vaccination was not provided. On an unspecified date in year 2015-2016, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. In this study, majority of AEFI were reported by physicians (563), followed by the other healthcare professionals (46), pharmacists (17) and consumers or other non-healthcare professionals (5). The case has been considered as serious due to death. [In this study, an adverse event following immunization (AEFI), resulting into death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/ incapacity, or is a congenital anomaly/birth defect was considered serious]. The treatment was unknown. The author considered the event of death NOS temporally associated with unspecified HPV vaccine. The author concluded "The system of adverse event following immunization (AEFI) reporting was slowly gaining momentum. Majority of AEFI was mild. However, serious AEFI needs detail reporting, follow up, investigation for causality assessment and identify risk factors. Organized training of health care professionals in AEFI reporting and targeted spontaneous reporting of vaccine AEFI will be helpful in this regard." Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 764219 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2017-03-30
Onset:2017-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 201608058-2 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74541M / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2018SA209809

Write-up: This unsolicited case belongs to the batch that has been forwarded to the company by the Health Authorities on 30-Jul-2018 in the format of line listing. A six-month-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) [POLIOMYELITIS VACCINE (INACTIVATED)] (lot number "M74541M", manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 30-Mar-2017 at 08:20 AM. The patient also received a dose of DTaP [DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID] (lot number "201608058-2", manufacturer reported as "WUHAN BIO.", dose number, route and administration site not reported) on 30-Mar-2017 at 08:25 AM. On 31-Mar-2017 at 03:00 PM., 1 day 6 hours 40 minutes post-vaccination with IPV (VERO) and 1 day 6 hours 35 minutes post-vaccination with DTaP, other primary diagnosis reported by the HA was "asphyxia". On an unknown date, patient died. On 31-Mar-2017, patient received an unspecified corrective treatment. Final diagnosis reported by the HA was "other". It was unknown whether autopsy was performed. AEFI classification was reported as coincidence by the HA. Sender''s Comments: Poorly documented case received through a line listing of several thousand of cases from the health authority. Based on the data provided, the role of vaccine(s) cannot be assessed. Reported Cause(s) of Death: asphyxia


VAERS ID: 764220 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3A163M / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20171116; Test Name: Axillary thermometry; Test Result: 37.5 {DF}; Result Unstructured Data: 37.5 degree Celsius
CDC Split Type: CNSA2018SA209826

Write-up: This unsolicited case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities on 30-Jul-2018 in the format of line listing. A three-month-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) (lot number "N3A163M", manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 15-Nov-2017 at 10:00. On 16-Nov-2017 at 12:10, 26 hours and 10 minutes post-vaccination, the patient developed fever [37.5 degree Celsius-axillary]. It is reported as patient died. Injury degree was not reported. Final diagnosis reported by the HA was other. No other primary diagnosis was reported. At the time of this report, the outcome of the event fever was unknown and death NOS was reported as Fatal. Cause of death is not reported. It was unknown if autopsy was performed at the time of report. AEFI classification was reported as to be decided by the HA. List of documents held by the sender: None. Sender''s Comments: This is a poorly documented case received through a line listing of several thousand of cases from the Health Authorities. It involved a 3-month-old patient who presented with fever of 37.5 degree few hours post-vaccination with IPV (VERO). On an unknown date the patient died. Fever is an expected event in the few hours following vaccination; however it is unlikely that a fever of 37.5 degree C has caused the death of the patient. Details regarding relevant medical history - notably history of congenital anomaly, concurrent condition, history of infection, patient''s sleeping position; details regarding date of death, circumstances and patient''s medical condition at the time of death and detailed autopsy report would be needed for a complete assessment. To be noted that the final diagnosis was reported as "other" by the Health Authorities. Based on the limited data provided, the role of vaccine cannot be assessed.


VAERS ID: 764221 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-13
Onset:2017-11-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3C722M / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-14
   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: CNSA2018SA209840

Write-up: This unsolicited case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities on 30-Jul-2018 in the format of line listing. A nine-week-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) (lot number "N3C722M", manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 13-Nov-2017 at 10:00. On 14-Nov-2017 at 04:00, 18-hour post-vaccination, the patient died due to sudden infant death syndrome. Final diagnosis reported by the HA was "sudden infant death syndrome". It was not reported if the patient received a corrective treatment. On 14-NOV-2017, the patient outcome is reported as Fatal for sudden infant death syndrome. It is unknown if an autopsy was done. The cause of death was reported as Sudden infant death syndrome. The reporter assessed the causal relationship with suspect vaccine as coincidence. List of documents held by sender: none. Sender''s Comments: This is a poorly documented case received through a line listing of several thousands of cases from the Health Authority. It involved a nine-week old patient who died reportedly of sudden infant death syndrome the same day post vaccination with IPV (VERO). It is unknown in an autopsy was conducted. This case being insufficiently documented, further information on the condition/circumstances of the patient at the time of death, medical history (especially if any congenital anomaly), results of investigations etc. will be needed for complete assessment. Without a complete clinical history, no assessment could be made. Noteworthy, SIDS is a common cause of infant mortality without demonstrated relationship with immunization. To be noted that the Health Authorities assessed this case as not related with the vaccine administration. Reported Cause(s) of Death: Sudden infant death syndrome.


VAERS ID: 764227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-15
Onset:2017-02-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER M7279-1 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Interstitial lung disease, Respiratory disorder
SMQs:, Interstitial lung disease (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSAKK2018SA209816AA

Write-up: This unsolicited case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities on 30-Jul-2018 in the format of line listing. Case ID: 1168 A two-month-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) (lot number M7279-1, manufacturer reported as Pasteur, dose number, route and administration site not reported) on 15-Feb-2017 at 09:30 am. On 18-Feb-2017 at 07:00 AM, 2 days 21 hrs 30 min post-vaccination, the patient developed interstitial pneumonia and acute respiratory dysfunction. No other primary diagnosis was reported. Final diagnosis reported by the HA was other. According to the HA, the patient experienced acute respiratory dysfunction caused by interstitial pneumonia which was reported as secondary diagnosis. The patient received unspecified treatment on 18-February-2017. At the time of the report, the outcome was reported as death. The patient died on an unknown date. Autopsy results confirmed death from acute respiratory dysfunction caused by interstitial pneumonia. AEFI classification was reported as coincidence by the HA.; Sender''s Comments: Poorly documented case received through a line listing of several thousand of cases from the Chinese health authority. Based on the data provided, the role of vaccine(s) cannot be assessed.; Reported Cause(s) of Death: acute respiratory dysfunction; interstitial pneumonia.


VAERS ID: 764228 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-01
Onset:2017-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 2016070532 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER M74892M / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSAKK2018SA209832AA

Write-up: This unsolicited case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities on 30-Jul-2018 in the format of line listing. A three-month-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) (lot number "M74892M", manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 01-Jun-2017 at 09:00 am. The patient also received a dose of DTAP (lot number "201607053-2", manufacturer reported as "Wuhan Bio.", dose number, route and administration site not reported) on 01-Jun-2017 at 09:03 am. On 02-Jun-2017 at 16:20, 31 hours and 20 minutes post-vaccination with IPV (VERO) and 31 hours and 17 minutes post-vaccination with DTAP, patient died. Injury degree was not reported. Other primary diagnosis reported by the HA was "Sudden death". Final diagnosis reported by the HA was "other". The patient received unspecified treatment on 02-Jun-2017. The Patient was suddenly died. It was unknown if autopsy was performed at the time of report. AEFI classification was reported as coincidence by the HA. List of documents held by the sender. Sender''s Comments: Poorly documented case received through a line listing of several thousand of cases from the health authority. Based on the data provided, the role of vaccine cannot be assessed. Reported Cause(s) of Death: sudden death.


VAERS ID: 764583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131808JPN000572J

Write-up: This spontaneous report was received from an other health professional. Information has been received from an other health professional concerning 20-40 years old female patient. The patient was vaccinated with GARDASIL (AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION SYRINGE), intramuscular (start date and dose not reported). No concomitant medications were reported. Adverse experience (term as stated by respondent): Died. Concomitant therapy (include dose, indication, etc.), concurrent conditions, medical history, diagnostic tests carried out to diagnose AE: N/A. On an unknown date, the patient was dead. The cause of death and an autopsy were not reported. Reporter''s comment: The AE case was acknowledged via News within the recent two years, in which the news reported that two women died in a few months after receiving HPV vaccine. Reporter did not capture any screenshots from the news website. Reporter was unable to provide any details on the brand of the vaccine. Upon internal review, death was considered to be serious (other medically significant). Reported Cause(s) of Death: Death.


VAERS ID: 765029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Nervous system 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131808BRA003980

Write-up: This spontaneous report was received from a National Immunization Program (Health Authority) physician by a company representative and via vendor Ketchum, which obtained the information from a website and replicated by social media in a group, referring to two female patients of unknown age. The patient''s concomitant medications, medical history and concurrent condition were not reported. On unknown date, the patients were vaccinated with the Human Papillomavirus Recomb. Vaccine (it was not specified if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown)) (lot #, expiration date, dose, vaccination site and route of administration were not provided) for prophylaxis. On unknown date, reported as after the vaccination, the patients experienced unspecified neurologic issues and died on an unknown date. The cause of death was unknown. It was unknown if an autopsy was performed. The causality assessment between the events and the suspect vaccines was not provided by the reporter. This is one from several reports received from the same reporter. Sender''s Comments: BR-009507513-1808BRA003961: BR-009507513-1808BRA003987: BR-009507513-1808BRA003995: BR-009507513-1808BRA004002: Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 765030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131808BRA003995

Write-up: This spontaneous report was received from a National Immunization Program (Health Authority) physician by a company representative and via vendor, which obtained the information from a website, referring to a 9 years old female patient. The patient''s concomitant medications, medical history and concurrent condition were not reported. On unknown date, the patient was vaccinated with Human Papillomavirus Recomb. Vaccine (it was not specified if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown)) (lot #, expiration date, dose, vaccination site and route of administration were not provided) for prophylaxis. On unknown date reported as 11 days after vaccination, the patients died. The cause of death was unknown. It was unknown if an autopsy was performed. The causality assessment between the event and the suspect vaccines was not reported. This is one from several reports received from the same reporter.; Sender''s Comments: BR-009507513-1808BRA003961: BR-009507513-1808BRA003980: BR-009507513-1808BRA003987: BR-009507513-1808BRA004002:; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 765075 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131808JPN004452

Write-up: This spontaneous report was received from a unspecified reporter via social media: and refers to a patient of unknown age and gender. The patient''s pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL (AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION) for prophylaxis or with GARDASIL9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient died from the unspecified side effects. It was not reported if an autopsy was performed. The outcome of the event was not reported. The relatedness between the event and vaccines were not reported. This is one of several reports received from the same patient.; Sender''s Comments: JP-009507513-1808JPN004437: JP-009507513-1808JPN004436: JP-009507513-1808JPN004435: JP-009507513-1808JPN004434: JP-009507513-1808JPN004438: JP-009507513-1808JPN003267: JP-009507513-1808JPN004433:; Reported Cause(s) of Death: died form the side effects.


VAERS ID: 765352 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Paralysis, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a non-health professional via local affiliate and described the occurrence of unknown cause of death in about 15 child patients who received Human papilloma type 16 + 18 vaccine for prophylaxis. On an unknown date, the patients received Human papilloma type 16 + 18 vaccine at an unknown dose. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patients experienced unknown cause of death (serious criteria death and GSK medically significant), seizure (serious criteria GSK medically significant), paralysis (serious criteria disability and GSK medically significant) and headache. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the seizure, paralysis and headache were unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death, seizure, paralysis and headache to be related to Human papilloma type 16 + 18 vaccine. Additional details were provided as follows: The reporter was a deputy of the state. The case was received as news regarding adverse events with vaccines. There was a part of the news that reported case that occurred with CERVARIX. The batch number of CERVARIX was not provided. The age at vaccination was not reported. The age of patients was not provided. The reporter informed that there were about 15 cases of suspected adverse events that were caused by Human papilloma type 16 + 18 vaccine. The reporter informed that there were mothers reporting that their children died because of Human papilloma type 16 + 18 vaccine. The reporter informed the symptoms were very alike with each patient: headache, seizure, paralysis of limbs among others (not specified). It was not clear how many patients there were, reporter informed that she knew of about 15 cases, exact number was not provided. No further detail was provided. This case was linked with BR2018GSK143335 and BR2018GSK143337, reported by the same reporter. Reported Cause(s) of Death: Death NOS.


VAERS ID: 765363 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-07-11
Onset:2018-07-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 - / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / ID

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-07-13
   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: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201814

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden death unexplained in a 4-month-old female patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis and PREVENAR 13 for prophylaxis. Previously administered products included INFANRIX HEXA with an associated reaction of no adverse event, BEXSERO with an associated reaction of no adverse event and PREVENAR 13 with an associated reaction of no adverse event. Additional patient notes included No previous reaction to immunisation. Concomitant products included paracetamol. On 11th July 2018, the patient received the 3rd dose of INFANRIX HEXA (intramuscular), the 2nd dose of BEXSERO (intramuscular) and the 2nd dose of PREVENAR 13 (intramuscular). On an unknown date, less than a month after receiving INFANRIX HEXA and BEXSERO, the patient experienced sudden death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). On 13th July 2018, the outcome of the sudden death unexplained was fatal. The patient died on 13th July 2018. The reported cause of death was sudden death unexplained. It was unknown if the reporter considered the sudden death unexplained to be related to INFANRIX HEXA and BEXSERO. Additional information: The age at vaccination was not reported. However, the patient could be 3 or 4-months-old at the time of vaccination. Initial information was received from a physician via regulatory authority on 8th August 2018: Sudden death unexplained. Reported Cause(s) of Death: Sudden death.


VAERS ID: 766702 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of patients who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Yellow Fever Vaccine for prophylaxis and Tetanus Vaccine for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose, Yellow Fever Vaccine at an unknown dose and Tetanus Vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, 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 Flu Seasonal QIV Dresden. Additional details were provided as follows: The age at vaccination was not reported. The consumer informed that a few people (not specified) died after taking vaccine. The batch numbers were nor provided. No information regarding patients was provided. No further detail was provided. Reported Cause(s) of Death: Death NOS.


VAERS ID: 766704 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, 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. The reporter considered the unknown cause of death to be related to Flu Seasonal QIV Dresden. Additional details were reported as follows: The patient''s demographic details were not reported. The age at vaccination was not reported. The batch number and expired date were not reported. The reporter informed that, some people died after taking Flu vaccine. No further information was provided.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 766814 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BYSA2018SA224481

Write-up: Initial information received on 13-Aug-2018 regarding an unsolicited valid serious case received from other health care professional via Health Authorities. This case involves Child patient (age and gender unknown) who experienced anaphylactic reaction, while received vaccine IMOVAX POLIO. The patient''s past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect IPV (VERO) lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious anaphylactic reaction with unknown latency following the administration of IPV (VERO). This event was leading to death. Lab data was not provided. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for anaphylactic reaction. It is unknown if an autopsy was done. The cause of death was reported as Anaphylactic reaction. List of documents held by sender- none. Sender''s Comments: This is a poorly documented case reported by the Health Authority where a child of unknown age was reported to have anaphylactic reaction leading to death after vaccination with IMOVAX POLIO. The time to the event onset was not reported. Details regarding vaccination, child medical history, health status at the time of vaccination and autopsy report suggesting the cause of death were also not reported. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: anaphylactic reaction.


VAERS ID: 766834 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a male patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Yellow Fever Vaccine for prophylaxis. On an unknown date, the patient received Flu Seasonal QIV Dresden at an unknown dose and Yellow Fever Vaccine at an unknown dose. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure and influenza were fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu Seasonal QIV Dresden. Additional information was reported as follows: The age at vaccination was not reported. The reporter stated that he lost his brother due to the disease, even after the vaccination and stated that the vaccine was ineffective. The real reason for death was not clear. No further details were provided. This case was considered for suspected vaccination failure as the time to onset for the reaction was unknown. Reported Cause(s) of Death: Influenza.


VAERS ID: 767516 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-08-16
Onset:2018-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-27
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
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Autopsy, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SVGLAXOSMITHKLINESV2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of asphyxia in a 2-month-old male patient who received SYNFLORIX for prophylaxis. Co-suspect products included ROTARIX for prophylaxis, Pentavalent (DTP-HBV/Hib) for prophylaxis and IPV for prophylaxis. On 16th August 2018, the patient received SYNFLORIX, ROTARIX (oral), Pentavalent vaccine (DTP-HBV/Hib) and IPV. On 16th August 2018, less than a day after receiving SYNFLORIX, ROTARIX, Pentavalent vaccine (DTP-HBV/Hib) and IPV, the patient experienced asphyxia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the asphyxia was fatal. The patient died on 16th August 2018. The reported cause of death was asphyxia. An autopsy was performed. It was unknown if the reporter considered the asphyxia to be related to SYNFLORIX, ROTARIX, Pentavalent vaccine (DTP-HBV/Hib) and IPV. Additional details were provided as follows: In the morning, the patient received SYNFLORIX, ROTARIX, Pentavalent vaccine (DTP-HBV/Hib) and IPV and died on the same day. The patient''s body was sent to Legal Medicine and the complete pathological report was going to be ready within a month, but the diagnostic mentioned as cause of the death was Asphyxia Syndrome. There was no additional information about this case at the moment of this report. Reported Cause(s) of Death: Asphyxia Syndrome.


VAERS ID: 767875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2018340034

Write-up: This is a spontaneous report from a contactable other hcp. This report was received via a sales representative. An elderly female patient 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 pneumonia on an unspecified date. The patient died due to pneumonia on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the compatible temporal association, a causal relationship between the fatal event pneumonia and PREVENAR 13 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: pneumonia.


VAERS ID: 767887 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID0095075131808IDN010115

Write-up: Information has been received from a business partner representative referring to a 10 year old female patient. The patient''s concurrent condition, medical history and concomitant medication were unknown. On an unknown date (reported as 08-AUG-????) the patient was vaccinated with GARDASIL (dose, route, batch/ lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as 08-AUG-????), the patient experienced vomiting, decrease of consciousness and got hospitalized. On an unknown date (reported as 14-AUG-????), the patient passed away. The cause of death was not provided. It was unknown if autopsy was performed. The causality assessment was not provided by reporter. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 767892 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-04-01
Onset:2018-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A039C / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 17C01A / 3 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS RT003 / 2 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Autopsy, Cardio-respiratory arrest, Feeling cold, Laryngeal obstruction, Musculoskeletal stiffness, Pallor, Respiratory disorder, Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Extremely low birth weight baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPGLAXOSMITHKLINEJP2018JP

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden death unexplained in a 4-month-old male subject who received Rotarix liquid formulation (batch number RT003, expiry date unknown) for prophylaxis. Co-suspect products included QUATTROVAC (batch number A039C, expiry date unknown) for prophylaxis, ACTHIB for prophylaxis and PREVENAR 13 (batch number 17C01A, expiry date unknown) for prophylaxis. Concurrent medical conditions included extremely low birth weight baby. Concomitant products included Rotarix liquid formulation. In April 2018, the subject received the 2nd dose of Rotarix liquid formulation (oral), the 2nd dose of QUATTROVAC (subcutaneous), the 3rd dose of ACTHIB (subcutaneous) and the 3rd dose of PREVENAR 13 (subcutaneous). In April 2018, less than a day after receiving Rotarix liquid formulation, the subject experienced pallor facial, feeling cold and muscle stiffness, cardio-respiratory arrest (serious criteria death and GSK medically significant). The subject was treated with epinephrine (Adrenaline).In April 2018, less than a day after receiving Rotarix liquid formulation, the subject experienced sudden death unexplained (serious criteria death and GSK medically significant), sudden infant death syndrome (serious criteria death and GSK medically significant), respiratory system disorder (serious criteria death), laryngeal obstruction (serious criteria death and GSK medically significant), asphyxia (serious criteria death and GSK medically significant).In April 2018, the outcome of the sudden death unexplained, sudden infant death syndrome, respiratory system disorder, laryngeal obstruction, asphyxia and cardio-respiratory arrest were fatal. On an unknown date, the outcome of the pallor facial, feeling cold and muscle stiffness were unknown. The subject died in April 2018. The reported cause of death was sudden infant death syndrome, respiratory system disorder, laryngeal obstruction, asphyxia and cardio-respiratory arrest. An autopsy was performed. The autopsy determined cause of death was sudden death unexplained. It was unknown if the reporter considered the sudden death unexplained, sudden infant death syndrome, respiratory system disorder, laryngeal obstruction, asphyxia, cardio-respiratory arrest, pallor facial, feeling cold and muscle stiffness to be related to Rotarix liquid formulation. Additional Details: The subject''s birth weight was 778 g. In April 2018, the subject received the second dose of Quattrovac, third doses of ActHIB and Prevenar 13 and the second dose of Rotarix concurrently. No significant change was noted after the vaccines. On the following day of the vaccines, around the midnight, he slept on the mother''s arm. Around 3:00 a.m., the father slept in the same bed. The subject slept in between the parents. Respiratory status was unknown. Around 7:30 a.m., the father woke and found the subject lying in a 90-degree-inclined position, with facial pallor, cold feeling and stiffness. At the time of arrival of ambulance crew, cardio-respiratory arrest was noted. He was transported to the reporting hospital and cardiac massage, intratracheal intubation and administration of adrenaline were performed, but cardiopulmonary function did not recover. One hour after the emergency call, his death was confirmed. Legal autopsy was performed three days after the death, and no findings suggestive to sudden death, evident lesion or damage which could have been lethal was found. On blood testing, no increase in nonspecific immunoglobulin E (IgE) or tryptase was noted, and no findings suggestive to allergy to vaccines was noted. From the above results, the death was considered as sudden death with unknown cause; however, considering that the subject had been sleeping in between the parents, the reporting physician considered sudden infant death syndrome as possible intrinsic cause of death and nasal and oral obstruction and restricted thoracic movement as possible exogenous cause of death. In addition, considering that he had been sleeping on the mother''s arm, the reporting physician also considered possibilities of death by asphyxia which was caused by pharyngolaryngeal obstruction due to over-flexion of neck. The death was considered as sudden death with unknown cause; however, from the circumstances when he had been found in the lethal condition, sudden infant death syndrome, nasal and oral obstruction, restricted thoracic movement and asphyxia which could have been caused by conditions such as pharyngolaryngeal obstruction due to over-flexion of neck were considered as the possible cause of death. No finding suggestive to allergy to vaccines was found on the blood testing, but the causality between vaccines and the death remained unknown. Other causative factor of death: Factors such as sudden infant death syndrome and asphyxia; Reported Cause(s) of Death: Sudden infant death syndrome; Respiratory disorder; Laryngeal obstruction; Asphyxia; Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: Sudden death.


VAERS ID: 767894 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-01
Onset:2018-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A039C / 2 UN / SC
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 17C01A / 3 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS RT003 / 2 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood immunoglobulin E normal, Cardio-respiratory arrest, Choking, Endotracheal intubation, Feeling cold, Obstruction, Pallor, Sudden death, Sudden infant death syndrome, Tryptase
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result: no elevation of non-specific IgE or triptease
CDC Split Type: JPPFIZER INC2018339063

Write-up: This is a spontaneous report from a contactable physician (who was in charge of legal autopsy) via regulatory authority. Regulatory authority number v18100354. A 4-month-old male patient received the 3rd dose of PREVENAR 13 (lot# 17C01A, exp date 29Feb2020), subcutaneous, in Apr2018, at single dose, for immunisation; 2nd dose of QUATTROVAC (lot# A039C), subcutaneous, in Apr2018, at 1 DF single, for immunisation; 3rd dose of INFLUENZA VACCINE, via an unspecified route of administration, in Apr2018, at 1 DF single, for immunisation; 2nd dose of ROTARIX (lot# RT003), oral, in Apr2018, at 1 DF single, for immunisation. The patient received aforementioned vaccines at the same time. Medical history and concomitant medications were not reported. Birth weight was 778 g. Previously the patient received 1st and 2nd dose of Prevenar 13, a dose of Quattrovac, 1st and 2nd dose of influenza vaccine, 1st dose of Rotarix all for immunisation. After vaccination in Apr2018, no change was noted. On the following day at 0:00 am, the patient went to sleep on the same bed with his mother, using mother''s arm as a pillow. Around 3:00 am, father went to sleep on the same bed. The patient slept in the middle. Respiratory condition was unknown. Around 7:30 am, father woke up and found out that the patient made a 90-degree turn and was sleeping in dorsal position. The patient became facial pallor, cold and still. Upon arrival of rescue crew, cardio-respiratory arrest was noted. The patient was rushed to a hospital. Cardiac massage, endotracheal intubation and adrenalin administration were performed, however, heart and lung did not recover. Death was confirmed about 1 hour after ambulance was called. Legal autopsy was performed 3 days after death. Only findings which suggested sudden death was found. No significant lesion or injury which might be significantly fatal was found. In blood test, elevation of non-specific IgE or triptease was not noted. No findings which suggested vaccination-induced allergy were found. Thus, the cause of death was nothing but sudden death unexplained. However, considering that the patient was sleeping in the middle of his parents, sudden infant death syndrome was considered as internal cause and naso-oral obstruction, or restricted chest movement as external cause. The possibility of choking death caused by naso-oral obstruction or pharynx obstruction due to hyperflexion of neck was considered since the patient was using mother''s arm as a pillow. The reporting physician classified the event as serious (death), considered that the causality was unassessable and commented as follows: In assessing the cause of death, there was no choice but to assess it as sudden death unexplained. Based on circumstances of finding and autopsy report, the possibilities of sudden infant death syndrome or choking death caused by naso-oral obstruction, restricted chest movement, or pharynx obstruction due to hyperflexion of neck were considered. Although no findings which suggested vaccination induced allergy were obtained by blood test, causal relation between vaccination and death was unknown. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Sudden death unexplained; suspected sudden infant death syndrome; suspected asphyxia.


VAERS ID: 768353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-01
Onset:2018-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 17C01A / 3 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS RT003 / 2 UN / UN
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER A039C / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Bed sharing, Blood immunoglobulin E normal, Cardio-respiratory arrest, Endotracheal intubation, Feeling cold, Muscle rigidity, Pallor, Sudden death, Tryptase
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant 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 (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2018SA233832

Write-up: Initial information received on 22-Aug-2018 regarding an unsolicited valid serious case received from Health Authorities under reference. This case involves a 4 months old male patient who experienced sudden death unexplained, while he received vaccine ACTHIB and while treated with PREVENAR, ROTARIX and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID [DIPHTHERIA AND TETANUS TOXOIDS]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. In April 2018, the patient received the third dose of ACTHIB (dose unknown), the third dose of PREVENAR (dose unknown), the second dose of ROTARIX (dose unknown), and the second dose of DIPHTHERIA AND TETANUS TOXOIDS (dose unknown) simultaneously for prophylactic vaccination. Thereafter, no significant change was seen. The next day (at about 00:00 on an unknown date in 2018), the patient slept with his mother in the same bed using her arm as a pillow. At about 03:00, his father also slept in the same bed. The parents were sleeping with their child between them. Respiratory status was unknown. At about 07:30, the patient was found to have pallor facial, coldness, and rigidity in the supine position (moved 90 degrees) by his father. When the ambulance arrived, cardio-respiratory arrest developed. The patient was transported to the hospital. Cardiac massage and endotracheal intubation were performed and ADRENALINE was administered, but the cardiorespiratory function did not improve. Approximately 1 hour later, the patient was confirmed dead. Three days after death (on an unknown date in 2018), an autopsy was performed. The autopsy showed no findings suggestive of sudden death and no apparent potentially fatal lesion or damage. Blood tests showed no elevation of nonspecific IgE and tryptase. The outcome of sudden death unexplained was fatal. The patient developed a serious sudden death unexplained. This event was assessed as medically significant and was leading to death. Final diagnosis was sudden death unexplained. The patient was treated with ADRENALINE [EPINEPHRINE] (ADRENALINE [EPINEPHRINE]). The patient outcome is reported as Fatal on an unknown date for sudden death unexplained. An autopsy was done. Reporter comment: Causality with ACTHIB, PREVENAR, ROTARIX, and DIPHTHERIA AND TETANUS TOXOIDS: Unassessable. Other causative factors: The patient died of sudden death of unknown cause. Considering that the parents were sleeping with the patient between them and based on status when the patient was found and autopsy findings, possible causes of death included sudden infant death syndrome as an internal cause and obstruction of the nose and mouth and limited thoracic motion or asphyxia caused by obstruction of the throat due to undue neck flexion (considering that the patient slept with his mother using her arm as a pillow) as external causes of death. Blood tests showed no elevation of nonspecific IgE and tryptase. There were no findings suggestive of possible allergy to vaccine, but the causal relationship between vaccination and the death was unknown.; Sender''s Comments: This case describes Sudden death in a 4 month old infant after vaccination. The time to onset is unknown. Moreover, the age and clinical details correspond closely with the general Sudden Infant Death Syndrome (SIDS) cases. Also, multiple vaccinations preceded the event. Based upon the reported information, the role of the vaccines cannot be assessed individually.; Autopsy-determined Cause(s) of Death: Sudden death.


VAERS ID: 768377 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2018GS

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in an unspecified number of patients who received Flu vaccine unspecified for prophylaxis. Co-suspect products included YELLOW FEVER VACCINE for prophylaxis. On an unknown date, the patient received Flu vaccine unspecified at an unknown dose and YELLOW FEVER VACCINE at an unknown dose. On an unknown date, unknown after receiving Flu vaccine unspecified, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was death. It was unknown if the reporter considered the death to be related to Flu vaccine unspecified. Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the unspecified number of patients died after receiving Flu vaccine and YELLOW FEVER VACCINE. It was not clear which vaccine the reporter refers. The batch and expiry date of Flu vaccine and YELLOW FEVER VACCINE were not reported. It was unknown if the reporter considered the death to be related to YELLOW FEVER VACCINE as well. No further information was provided. Reported Cause(s) of Death: Death.


VAERS ID: 768580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-24
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: GT0095075131808USA011991

Write-up: This spontaneous report was received from a physician via a company representative refers to a 15-year-old non-pregnant, female patient. The patient''s concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patient was vaccinated an unidentified Merck HPV vaccine (name and lot number not provided; neither dose and route of administration) (the reporter could not tell which vaccine) for prophylaxis as part of the requirement to take a sports scholarship. It was unknown if the vaccine was placed in what location. The patient started a scheme of 8 doses that should be administered, of which she had received 5 doses, as informed by her parents. On an unknown date, the patient experienced serious complications (not further specified) and unfortunately died on 24-AUG-2018. The patient was not hospitalized. The causality between the event and the suspect vaccine was not provided. The reporter considered the complications to be medically significant. Reported Cause(s) of Death: experienced serious complications and unfortunately died.


VAERS ID: 768804 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131809BRA000187

Write-up: Information has been received from a vendor via a company representative from a website referring to an unspecified numbers of teenage female patient. The patient''s medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine (manufacture unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacture unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis (product origin unknown). On an unknown date, the patients died. The cause of death was not reported. It was unknown if the autopsy was done. The relationship between the event and the therapy was not reported. This is one of several reports received from the same reporter.; Sender''s Comments: BR-009507513-1809BRA000189:; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 768805 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131809BRA000189

Write-up: Information was received from an unspecified reporter via a company representative and vendor, which obtained the information from a website concerning three female patients. The patients'' concurrent conditions, medical histories and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) (dose, route, lot# and expiration date not reported) and on unknown dates, the patients died. The cause of death was unspecified. It was unknown if autopsy was done. Causality was not reported. This is one of several cases received from the same source.; Sender''s Comments: BR-009507513-1809BRA000187:; Reported Cause(s) of Death: unknown reason.


VAERS ID: 768964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-03-26
Submitted: 0000-00-00
Entered: 2018-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Aphasia, Death, Decreased appetite, Seizure
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-26
   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: AU0095075131809AUS000152

Write-up: Information has been received from an unspecified reporter via IQVIA and shared media referring to a 1 year old female patient. The patient''s medical history, current condition and concomitant therapy were unknown. On an unknown date the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live( manufacturer unknown) (dose, strength, route, frequency, batch/lot# and expiration date unknown) for prophylaxis. The vaccine caused loss of speech and appetite, horrendous seizures. It was reported the patient started to seize again by noon and that was the end of her little life. On 26-MAR-2018, the patient died. The cause of death was unknown. It was unknown if autopsy was performed. The causality assessment between the vaccine and death was not provided by reporter. Upon internal review, seizure was determined to be medically significant. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 769249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-08-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kohlmeier-Degos syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GTGLAXOSMITHKLINEUS2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of adverse event in a female patient who received HPV 16-18 (Human papilloma type 16 + 18 vaccine) for prophylaxis. The patient''s past medical history included Kohlmeier-Degos syndrome. In August 2018, the patient received Human papilloma type 16 + 18 vaccine. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. The reporter considered the adverse event to be unrelated to Human papilloma type 16 + 18 vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was received as a medical information request yesterday by a Sales representative. The physician contacted her to ask information about security and scientific support related to Human papillomavirus vaccine (VPH). The patient died last Friday three days after receiving Human papillomavirus vaccine (VPH vaccine). The physician did not specify which vaccine was applied but there is a suspect that it was GARDASIL. The physician commented that patient''s family had called him because he applied CERVARIX to the patient''s cousins. The physician was aware that VPH vaccine did not cause patient death. The patient had an illness named as Degos.


VAERS ID: 769348 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-09-18
Onset:2015-09-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Intensive care, Multiple organ dysfunction syndrome, Pneumonia, Streptococcus test positive, Vaccination failure
SMQs:, 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), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-09-24
   Days after onset: 6
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:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Excessive drinking; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131808AUS013300

Write-up: Information was obtained on a request by the Company from the agency (HA # 424320) via a Public Case Detail concerning a 57 years old female patient. The patient''s medical history included asthma, smoker, excessive alcohol (ETOH) intake. Concomitant therapy and concurrent condition were not reported. On 11-JUN-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date unknown) for prophylaxis. On 18-SEP-2015, the patient was vaccinated with another dose of PNEUMOVAX 23 (1 unspecified dose, route: subcutaneous, lot # and expiration date unknown) for prophylaxis. On 23-SEP-2015, the patient developed pneumonia with blood culture positive for streptococcus pneumoniae serotype 3 which was presented 5 days after onset of symptoms. The patient died of multi-organ failure after 1 day in Intensive care unit (ICU) on 24-SEP-2015. It was unknown if the autopsy was done. The agency considered the event to be possibly related to PNEUMOVAX 23. The original reporting source was from a healthcare professional. Reported Cause(s) of Death: multi-organ failure.


VAERS ID: 769432 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Deafness
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 97-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included aortic stenosis and deafness. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 3 days after receiving SHINGRIX, 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. The reporter considered the unknown cause of death to be unrelated to SHINGRIX. Additional information was provided as follows: The patient''s age at vaccination was not reported. However, the patient might be 96 or 97 years old at vaccination. The patient''s concurrent condition included several comorbidities. The physician informed that the death had nothing to do with SHINGRIX. No further information provided. No consent to follow up.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 769568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cognitive disorder, Death
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: JP0095075131809COL001613

Write-up: This spontaneous report was received from an unspecified reporter from social media refers to a female patient of unknown age. The patient''s pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL (AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION) for prophylaxis (dose, route of administration, lot and expiration date were not reported).. On unknown dates, the patient experienced cognitive disorder and died from unspecified reason. It was not reported if an autopsy was performed. The relatedness between the events and GARDASIL (AQUEOUS SUSPENSION FOR INTRAMUSCULAR INJECTION) was not reported. This is one of several reports received from the same reporter. Follow up information has been received on 04-SEP-2018. This is a new safety report and has been created due to safety report "JP-009507513-1808JPN003267" having been submitted with an incorrect WWUID reference "JP-009507513-1808JPN003267" that does not refer to an existing case. "JP-009507513-1808JPN003267" will be nullified. The correct WWUID "CO-009507513-1809COL001613" is referenced within this safety report and will be kept as the master case file.; Sender''s Comments: CO-009507513-1806COL013012: CO-009507513-1502COL009207: CO-009507513-1507COL001112: CO-009507513-1701COL001379: CO-009507513-1506COL004105: CO-009507513-1508COL004387: JP-009507513-1808JPN004452:; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 769570 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:1998-12-26
Onset:1999-08-01
   Days after vaccination:218
Submitted: 0000-00-00
Entered: 2018-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anosognosia, Anxiety, Apathy, Asthenia, Ataxia, Balance disorder, CSF test, Cerebellar syndrome, Choking, Clonus, Clumsiness, Cognitive disorder, Condition aggravated, Death, Demyelination, Depression, Diplopia, Disability, Dysarthria, Dyskinesia, Dysmetria, Dysphagia, Dyspraxia, Extensor plantar response, Facial paralysis, Fall, Fatigue, Gait disturbance, General physical health deterioration, Hemiplegia, Hepatitis B surface antibody negative, Hyperaesthesia, Hypersomnia, Hypertonia, Incontinence, Infection, Lhermitte's sign, Loss of personal independence in daily activities, Lymphocyte count decreased, Lymphocyte percentage decreased, Lymphocyte percentage increased, Memory impairment, Micturition disorder, Micturition urgency, Multiple sclerosis, Muscle spasticity, Neck pain, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Nystagmus, Paraesthesia, Paresis, Periarthritis, Psychiatric evaluation abnormal, Scar, Speech disorder, Suicidal ideation, Upper limb fracture, Vision blurred, Visual evoked potentials abnormal, Weight decreased, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (narrow), Hearing impairment (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-30
   Days after onset: 4473
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: Diabetes (Start Date: Month Unknown Stop Date: Continuing); Hypercholesterolaemia (Start Date: Month Unknown Stop Date: Continuing)
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalisation; Hyalitis (Start Date: Month Unknown)
Allergies:
Diagnostic Lab Data: Test Date: 20030414; Test Name: Hepatitis B surface antibody; Result Unstructured Data: Lab result: <5 IU/l; Test Date: 200311; Test Name: Lymphocyte count; Result Unstructured Data: Lab result: 2621 /mm3; Test Date: 200311; Test Name: Lymphocyte count; Result Unstructured Data: Lab result: 207 /mm3; Test Date: 200311; Test Name: Lymphocyte count; Result Unstructured Data: Lab result: 114 /mm3; Test Date: 200311; Test Name: Lymphocyte count; Test Result: 7.9 %; Test Date: 200311; Test Name: Lymphocyte percentage; Test Result: 46.8 %; Test Date: 200311; Test Name: Lymphocyte percentage; Test Result: 4.3 %; Test Date: 200311; Test Name: White blood cell count; Result Unstructured Data: Lab result: 5600 /mm3
CDC Split Type: FR0095075130202USA01615

Write-up: Case initially reported on 13-FEB-2002 under reference R020071 and find here below the initial and follow-up reports WAES numbers: WAES 0202USA01615 + duplicate number WAES 0202USA00092. Case reported through a lawyer and not medically confirmed. According to the lawyer the 48-year-old man was immunized with three doses of hepatitis B vaccine recombinant (yeast) thimerosal-containing on 26-DEC-1998, 29-JAN-1999 and 08-JUL-1999. Since August 1999 the patient had suffered from unusual asthenia and had experienced involuntary movement of the left foot. His condition aggravated with onset of transient paresthesiae and balance difficulties. He was examined by a neurologist during summer 2000. After investigations (not reported) multiple sclerosis was diagnosed. The patient had several relapses involving hospitalizations. At the time of the report, he suffered from severe asthenia, walking, balance and memory disorders, depression and a paresis of the right half of the body. He was very disabled (70%). File to be completed and medically confirmed. Follow up on 07-MAR-2002, The case was identified as a duplicate of file R020102 transmitted by Health Authorities on 27-FEB-2002: MULTIPLE SCLEROSIS - FROZEN SHOULDER - DEPRESSION Health Authorities ref PB0200084 It was reported through an association of patients (REVAHB n? 1274) to Health Authorities that a 48-year-old man was immunized with hepatitis B vaccine recombinant (yeast) thimerosal-containing on 26-DEC-1998 (P1), 29-JAN-1999 and 08-JUL-1999. In August 1999 the patient experienced asthenia, clonia of the left foot and paraesthesiae of the right upper limb and in November 1999 balance troubles (ebrious sensations) and paraesthesiae of extremities. One month later, in December 1999, he developed paresthesiae on the face, the hand and the foot on the left side with dysarthria, troubles of deglutition and micturition urgency. It resolved in two weeks. Another episode occurred in May-June 2000: paraesthesiae of both hands, balance troubles and micturition urgency. He was examined by a neurologist in August 2000 who diagnosed a cerebellar syndrome. In October 2000 a cerebral MRI showed numerous demyelinating lesions of T2-weighted hypersignals in protuberance and periventricular white matter. In January 2001 he was hospitalized for a paresis of the right half of the body with dysarthria and deglutition troubles. In February-March 2001 right hemiplegia relapsed and he was hospitalized again to be treated with infusions of methylprednisolone (MEDROL) for 5 days. Troubles persisted in the right upper limb. Another cerebral MRI confirmed supra and subtentorial lesions compatible with a demyelinating disease. In April 2001 he was hospitalized for a speech therapy and infiltration of the right shoulder linked to a frozen shoulder. At the time of the report in February 2002 the patient suffered from asthenia and hypersomnia, paraesthesiae of both hands, sequelae from the right hemiplegia and facial palsy, persistent dysarthria and deglutition troubles, dyspraxia, difficulty in focusing with the left eye, disability with the right upper and lower limbs leading to an ataxic walking, a spastic hypertonia. Tendon reflexes were acute in the four limbs and a Babinski''s sign was present on the left side. The patient suffered also from anxious and depressive syndrome with suicidal thoughts and apragmatism despite a treatment with citolopram (20mg/day) and interferon (3 injections / week since 12 April 2001). He was considered as 80% disabled. Case considered as complete by Health Authorities. Follow-up on 13-MAR-2002 Further information was received through the lawyer about this nearly 48-year-old patient. Investigations were performed in 2000: - visual and auditive evoked potentials normal - somesthesic evoked potential: bilateral disorder of conduction in the cervical medullar fibers - MRI: several T2 weighted hypersignals in the protuberance and in the periventricular areas evoking demyelinating disorder - CSF: inflammatory and lymphocytic fluid He was hospitalized several times: - from 3 to 4 November 2000 for a check-up; from 20 to 21 January 2001 for dysarthria, deglutition troubles and paresis of the right half of the body. He received infusions of methylprednisolone (MEDROL) ; - from 11 February to 16-MAR- 2001 for the same episod. A second MRI on 26-FEB-2001 confirmed the diagnosis of multiple sclerosis; - from 19 to 27 March 2001 for an infection (not reported). The patient suffered from a permanent disability of the right upper limb, from a dysarthria, a severe asthenia and was very depressive. To be mentioned that the patient was HLA B27. FILE NOW REPORTED UNDER REFERENCE E2003 -03660 Follow-up on 03-DEC-2003 upon receipt of new data from our legal department: The patient was hospitalized from 24 to 29 April 2003 for a new relapse of multiple sclerosis and treatment with infusions of corticoids. He presented with 2 episodes with diplopia, balance troubles, hyperaesthesia of the right side of the face, disability of the right hand and dysarthria. He had also a Lhermitte''s sign. See lab data. When he was discharged he was treated with interferon beta, amantadine and oxybutinine . He suffered from an other relapse (cerebellar syndrome) in September 2003. He was very disabled. Case was closed. Follow-up on 12-MAY-2004: An assessment by experts of the patient''s condition was performed on 07-MAY-2004, some new / complementary data could be obtained: On 13-MAR-2003, the patient fell down as he was having a walk with his wife, and had an elbow fracture and multiple scars on the face. Following this fall he had a new flare-up in April 2003 (see above), and kept several sequellaes: speech and balance disorders aggravated, clumsiness (he had to stop his sculpture lessons). - in June 2003: visions disorders, corticoids IV bolus performed then 4 infusions; subsequent investigations showed lesions of optic nerve; he also had severe micturition disorders and pain in neck Summer 2003 unremarkable except great fatigue due to scorching heat. At the time of the expertise, the patient was on citalopram, amantadine, oxybutynine, alfuzosine, tramadol, zolpidem. He was now dependant on his wife, he was no longer self sufficient for the day to day activities, he was very passive, had decreased intellectual capacities, had important fatigue and depression, weight decrease of 20 kg. To be noted a history of hyalitis in 1984 with hospitalisation. The patient was HLA B27 but not DR2. Finally, the neurological examination by the medical experts confirmed the physical and psychological aggravation. See Lab data. Case closed. Follow-up information received from the lawyer on 04-APR-2008: The following new information were received from legal documents. "The patient was hospitalized several times: on 03-MAR-2005 to 11-MAR-2005, 17 to 20-APR-2005, 19-OCT-2005, 21-MAR to 23-MAR-2006, 12-JUN-2006, 01 to 04-AUG-2006, 11-SEP to 27-OCT-2006, 02-JAN to 30-JAN-2007, 22-FEB to 01-MAR-2007. According to the hospital report dated 27-0CT-2006 the patient was found to have: dysmetria, major ataxia corresponding to kinetic and static cerebellar syndrome of the upper and lower limbs, discrete nystagmus rightwards, diffuse hyperesthesia including the face, other cranial nerves normal, tendon reflexes brisk, diffuse, polykinetic and symmetric. A thorough psychological assessment dated 30-MAY-2006 showed abnormal global decrease in cognitive efficiency with dysexecutive disorders and fatigability. Neurological examination showed anosognosia, frontal impairment, tetrapyramidal syndrome and marked spasticity, dysarthria, food choking and incontinence. His rate of permanent partial disability could be assessed at 90%." The case was closed. Follow-up information received from the lawyer on 08-NOV- 2011: The patient died on 30-0CT-2011. This information was not medically confirmed. Follow-up information received from the Health Authorities on 21-DEC-2011 under the reference number PB0200084: The patient died on 30-OCT-2011 from multiple sclerosis. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as ''doubtful'' (C1 S1 I1) according to the method of assessment. All the events were considered to be disabling by the reporter. Other business partner numbers include E2003-03660. In August 1999, the patient began to present with various troubles. In November 2000, 15 months after receiving his first Hepatitis B vaccination, he was diagnosed with multiple sclerosis. His health worsened to the point that he required constant care, and he died on 30-OCT-2011. Prior to his death, the patient and three family members instigated legal proceedings against company arguing the Hepatitis B vaccine was defective and there was a causal relationship between the vaccine and the onset of multiple sclerosis.


VAERS ID: 770121 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 4 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Autopsy, Biopsy brain abnormal, Blood electrolytes normal, C-reactive protein normal, CSF lymphocyte count normal, CSF white blood cell count increased, Computerised tomogram head normal, Condition aggravated, Death, Dysarthria, Dysphagia, Encephalitis, Endotracheal intubation, Hyporeflexia, Lyssavirus test positive, Mechanical ventilation, Neutrophil count increased, Neutrophilia, Oropharyngeal spasm, Pleocytosis, Pyrexia, Rabies, Salivary hypersecretion, Speech disorder, Strabismus, Suture insertion, Thirst, Tremor, Vaccination failure, Vomiting, Wound
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (Two weeks prior. The patient was bitten in his face (lips and the inner cheek))
Allergies:
Diagnostic Lab Data: Test Name: Biopsy; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Blood count; Result Unstructured Data: Test Result: neutrophilic leucocytosis, Test Result Unit: unknown; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: degree C; Test Name: Computerized tomogram; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: C-reactive protein; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 400, Test Result Unit: unknown; Test Name: Lymphocyte percentage; Test Result: 80 %
CDC Split Type: TNGLAXOSMITHKLINETN2018GS

Write-up: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 11-year-old male patient who received RABIPUR for prophylaxis. Co-suspect products included RABIPUR for prophylaxis, RABIPUR for prophylaxis, RABIPUR for prophylaxis and immunoglobulin human anti-rabies (ERIG) for prophylaxis. Concurrent medical conditions included dog bite (Two weeks prior. The patient was bitten in his face (lips and the inner cheek)). On an unknown date, the patient received the 1st dose of RABIPUR (intramuscular), the 2nd dose of RABIPUR (intramuscular), the 3rd dose of RABIPUR (intramuscular), the 4th dose of RABIPUR (intramuscular) and ERIG 40 IU/kg at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, less than a month after receiving RABIPUR, RABIPUR and RABIPUR and less than a week after receiving RABIPUR, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), rabies (serious criteria death, hospitalization and GSK medically significant), encephalitis (serious criteria death, hospitalization and GSK medically significant), fever (serious criteria hospitalization), vomiting (serious criteria hospitalization), speech disorder (serious criteria hospitalization), strabismus (serious criteria hospitalization), dysarthria (serious criteria hospitalization), tremor (serious criteria hospitalization), tendon reflex decreased (serious criteria hospitalization), excessive thirst (serious criteria hospitalization), unable to swallow (serious criteria hospitalization), oropharyngeal spasm (serious criteria hospitalization), violent behavior (serious criteria hospitalization), neutrophilia (serious criteria hospitalization), pleocytosis (serious criteria hospitalization) and hypersalivation (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, rabies and encephalitis were fatal and the outcome of the fever, vomiting, speech disorder, strabismus, dysarthria, tremor, tendon reflex decreased, excessive thirst, unable to swallow, oropharyngeal spasm, violent behavior, neutrophilia, pleocytosis and hypersalivation were unknown. The reported cause of death was rabies and encephalitis. An autopsy was performed. The reporter considered the vaccination failure, rabies, encephalitis, fever, vomiting, speech disorder, strabismus, dysarthria, tremor, tendon reflex decreased, excessive thirst, unable to swallow, oropharyngeal spasm, violent behavior, neutrophilia, pleocytosis and hypersalivation to be related to RABIPUR, RABIPUR, RABIPUR and RABIPUR. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in an 11-year old male who was vaccinated with RABIPUR (GlaxoSmithKline) for post exposure prophylaxis (PEP). The patient had no remarkable medical history. The patient''s developmental milestones were normal. The patient was bitten in his face (lips and the inner cheek) by a stray dog and wounds were sutured. No information on patient''s family history or concurrent condition or concomitant medication was provided. On an unspecified date (day 0), 12 hours after the dog bite, the patient received the 1st dose of RABIPUR intramuscularly into the deltoid region (batch number not provided) after wound cleaning. The patient also received maximum dose of equine rabies immunoglobulin (ERIG) 40UI/kg (Pasteur) into the wound. On unspecified dates, on day 3, 7 and 14 after dog bite, the patient received 3-doses of RABIPUR, intramuscularly into the deltoid region (batch number not provided) following WHO guidelines (ESSEN regimen+ERIG). On an unspecified date, at the age of 11 years, an unknown period after 4th dose of vaccination, the patient was presented to the emergency department for fever, vomiting and acute speech troubles. On physical examination, the patient was febrile at 38.5-degree C. The patient had no signs of meningeal irritation and had strabismus, dysarthria and had tremor. The patient deep tendon reflexes were very weak. Noteworthy, the patient had an intense thirst and desire to drink, however the patient was unable to swallow because of pharyngeal spasms. Subsequently the patient was hospitalised. The patient''s cerebral computed tomography (CT) scan was performed and did not show any abnormalities. The patient''s blood count revealed neutrophilic leucocytosis; normal C-reactive protein and electrolytes levels were found normal. On further questioning, his mother revealed a history of a stray dog bite two weeks prior 4 hours after admission, the patient became furious, and developed hyper-salivation. The patient condition deteriorated and succumbed to death although the patient was intubated and ventilated. The patient''s post-mortem report of cerebrospinal fluid showed a pleocytosis with 400 leucocytes (80% lymphocytes). The patient''s autopsy biopsies of cerebral cortex, cerebellum, hippocampus and medulla were positive for rabies antigen on fluorescent antibody technique. This case has been considered as suspected vaccination failure being time to onset was unknown (it was unclear that the events occurred on the same day after the last administration of RABIPUR or later). This case has been considered serious due to death/hospitalisation/suspected vaccination failure. The author did not comment on the relationship between the event of rabies encephalitis and RABIPUR. The author stated "In our case, although post exposure prophylaxis was established in an optimal way, the wound was sutured which represents a second inoculation of rabies virus and increased the chances to develop lethal encephalitis. Post-exposure prophylaxis (PEP) is not always effective. Treatment failure reported in the literature involved wounds in highly innerved regions in the body such as face wounds which is the case in this child (wound in lip and cheek), or errors in the management like: inappropriate wound cleaning, or the fact that the wound has been sutured before immunoglobulin injection, or may be some of the wounds have been missed and not injected with immunoglobulin or immunoglobulin injection was administered too late (12 hours after the bite in this case). This case alerts the physician about the importance of the first aid of the wound and of not stitching the wound before immunoglobulin injection. The extensive wound washing which is not well known by physicians (immediate and thorough flushing and washing of the wound for a minimum of 15 minutes with soap and water, detergent, Povidone iodine or other substances that kill the rabies virus) could have avoided the failure of immunoglobulin and vaccine and prevented rabies in this child. Our case has many learning points (clinical characteristic of rabies and rabies post exposure prophylaxis). It shows variability and non-specific signs of rabies encephalitis which are frequently not recognized by physicians (fever, nonspecific neurological signs, normal CT scan, cerebrospinal fluid (CSF) pleocytosis), it also alerts the physicians in endemic areas to evoke human rabies when the patient presents with encephalitis signs even when he/she has received "adequate" PEP after a dog bite." The article corresponding to this case is not available for submission due to copyright restriction. Lab Comments: Lab tests were performed on an unspecified dates. On physical examination, he had no signs of meningeal irritation; he had strabismus, dysarthria, tremor, deep tendon reflexes were very weak. Cerebral CT scan was performed and did not show any abnormalities. Normal electrolytes levels were found. Post-mortem cerebrospinal fluid showed a pleocytosis with 400 leucocytes (80% lymphocytes). On autopsy, biopsies of cerebral cortex, cerebellum, hippocampus and medulla were positive for rabies antigen fluorescent antibody technique. Reported Cause(s) of Death: Rabies encephalitis; Rabies encephalitis.


VAERS ID: 770590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-28
Onset:2018-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Autopsy, Brain death, Death, Influenza like illness, Interstitial lung disease, Loss of consciousness, Malaise, Nasopharyngitis, Respiratory arrest, Resuscitation, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Was perfectly fine and healthy before he received the vaccines
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA248885

Write-up: Initial information received on 04-Sep-2018 regarding an unsolicited valid serious social media case received from Consumer or non-Healthcare Professional. This case involves a 39 years old male patient who experienced acute respiratory distress syndrome, acute interstitial pneumonia a lung disease, seizure, cold, flu like symptoms and stop breathing, while he received INFLUENZA VACCINE and WHOOPING COUGH VACCINE. The Was perfectly fine and healthy before he received the vaccines. The patients concomitant medication and family history were not provided. On 28-April 2018, the patient received a dose of suspect INFLUENZA VACCINE from unknown manufacturer (lot number, route, site of administration, dose was not reported). On 28-April 2018, the patient received a dose of suspect whooping cough vaccine not produced by Sanofi (lot number, route, site of administration, dose was not reported). On an unknown date the patient developed cold and flu-like symptoms after getting injection on 28 Apr 2018 and decided to treat them with cold and flu tablets. In next 24 to 48 hours patients condition started deteriorated rapidly. On 1 May 2018, patient woke up and got ready for work, he was too sick and minutes later he had seizure and stopped breathing. The patients wife who is registered nurse performed CPR and ambulance was called, the paramedics rushed patient to hospital but never regained consciousness and was declared brain dead the next day. Lab data was not provided. An autopsy was done. The cause of death was reported as Interstitial lung disease and Acute respiratory distress syndrome. List of documents held by sender- none.; Sender''s Comments: A 39-year-old patient died 4 days after vaccination with FLU VACCINE (from unknown manufacturer) and WHOOPING COUGH VACCINE. The time to onset is compatible with the role of vaccines. The patient past medical history, concomitant medications were not reported. Autopsy report confirmed the cause of death as interstitial lung disease and acute respiratory distress syndrome. Additional information from past medical history, concomitant medication and laboratory infectious work-up to elicit other potential causes of acute interstitial pneumonia are needed to further evaluate role of influenza vaccine in reported events. Based upon the reported information, the role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: acute interstitial pneumonia; Autopsy-determined Cause(s) of Death: acute respiratory distress syndrome.


VAERS ID: 770647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-02-16
Onset:2018-03-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2018-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Caesarean section, Foetal distress syndrome, Foetal exposure during pregnancy, Foetal hypokinesia, Foetal monitoring abnormal, Hypertonia, Low birth weight baby, Muscle contractions involuntary, Premature baby, Pupil fixed, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Elevit; Magnesium
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201803; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: decreasing or missing baby movements., Test Result Unit: unknown
CDC Split Type: CHGLAXOSMITHKLINECH2018GS

Write-up: This retrospective pregnancy case was reported by a physician and described the occurrence of death neonatal in a female patient exposed to BOOSTRIX in utero. The mother received the product for prophylaxis. Concomitant product exposures included multivitamins, mineral supplements (Elevit) and magnesium hydrogen aspartate dihydrate (Magnesium). On 16th February 2018, the 31-year-old mother received BOOSTRIX .5 ml. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to BOOSTRIX during the third trimester of pregnancy. On 8th March 2018, at [weeks gestation], the patient was born via cesarean delivery and weighed 2140 grams (4lbs 12oz) at birth. The patient was diagnosed with tone increased, movements reduced, premature birth and birth weight low. On 11th March 2018, the patient experienced death neonatal (serious criteria death and GSK medically significant). In March 2018, the patient experienced fetal movements decreased (serious criteria GSK medically significant), brain edema (serious criteria GSK medically significant), intra-uterine hypoxia (serious criteria GSK medically significant), fixed pupils (serious criteria GSK medically significant), fasciculation and abnormal breathing. On an unknown date, the patient experienced fetal exposure during pregnancy. On an unknown date, the outcome of the death neonatal was fatal and the outcome of the fetal movements decreased, brain edema, intra-uterine hypoxia, fixed pupils, fasciculation, abnormal breathing, tone increased, movements reduced, premature birth, birth weight low and fetal exposure during pregnancy were unknown. The patient died on 11th March 2018. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the death neonatal, fetal movements decreased, brain edema, intra-uterine hypoxia, fixed pupils, fasciculation, abnormal breathing, tone increased, movements reduced, premature birth and birth weight low to be related to BOOSTRIX. Additional details were provided as follows: This case was initially received from the physician and then follow-up information was received from the physician on 5th September 2018. The patient received BOOSTRIX at 31 weeks of her pregnancy, which led to fetal exposure during pregnancy. The BOOSTRIX lot number was not known to the reporter, but it would be requested. It was the patient''s first pregnancy, which had proceeded without any complications. Two and a half weeks after the BOOSTRIX vaccination, at 33 plus 3 weeks of pregnancy a caesarian section was performed because of decreasing or missing baby movements and a pathologic electrocardiography (ECG). The newborn was 45 cm long and the head circumference was 31.5 cm. The neonate appeared to be normally developed with no apparent birth defect. However, she did not show movements, had an increased tonus and had to be ventilated via mask and then intubated. Intra-tracheal surfactant was administered to enhance pulmonary function. A brain oedema was seen, indicating intrauterine hypoxia. The baby showed fasciculations, gasping breaths and fixed pupils. Three days later, on 11th March 2018, the neonate was extubated upon request by the parents and she died. The cause of death was undetermined, an autopsy was not performed. The physician asked whether there were similar reports in relation to BOOSTRIX vaccination during pregnancy. According to Swiss PI, a vaccination with BOOSTRIX could be considered during the third trimester of pregnancy. The BOOSTRIX lot number has been requested. Lab Comments: The patient''s mother electrocardiography was performed and decreasing or missing baby movements and a pathologic electrocardiography was recorded.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 770913 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-08-01
Onset:2010-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of thrombocytopenic purpura in a 1-day-old subject who received Hepatitis B vaccine for prophylaxis. In August 2010, less than a day after receiving Hepatitis B vaccine, the subject developed thrombocytopenic purpura. Serious criteria included death. The outcome of thrombocytopenic purpura was fatal. The subject died in 2010. The reported cause of death was thrombocytopenic purpura. The investigator considered the thrombocytopenic purpura to be possibly related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the occurrence of thrombocytopenic purpura (TP) in a 1-day-old neonate of unspecified gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. The patient was part of the study to analyse the occurrence and features of TP as an adverse event following immunization (AEFI) and to detect suspicious vaccine safety signals. TP surveillance data reported during 2010-2015 were collected through the National AEFI Information Management System that were clinically diagnosed in AEFI individual cases, were analysed in this article for descriptive methodological analysis. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date in August 2010 at the age of 1 day, the patient received unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, the patients were immunized with National immunization program (NIP) vaccines/non-NIP vaccines]. On an unspecified date at the age of 1 day, on the day of vaccination, the patient developed thrombocytopenic purpura. On an unspecified date, 1-day post vaccination, the patient had died. It was unknown if an autopsy was performed. The author classified adverse event following immunisation (AEFI) as abnormal reaction. This case has been considered as serious due to death. Treatment was unknown. The authors considered the event of thrombocytopenic purpura possibly related to unspecified HBV vaccine. The authors stated, "As all the AEFI cases were the events suspected to be related with immunization, the seasonal regularity of its onset was possibly related with the vaccination behavior, and consistent with the seasonal trend of overall AEFI surveillance". The authors concluded, "The estimated incidence of TP after immunization was very low, and no confirmed safety signals were detected. We should strengthen monitoring of TP after immunization and improve assessment of causality between TP and immunization. In summary, the following recommendations were proposed: (1) in terms of surveillance, once TP is diagnosed, data on platelet count need to be collected, for example, the variable of the lowest platelet count collected could be added in AEFI individual case investigation form; it is required to upload the final conclusion on abnormal reactions (investigation and diagnosis certificate or expert conclusion); targeted information on the disease should be collected, for example, previous history, which could improve the capability of verifying cases and investigation; (2) in terms of causality assessment, relevant standard or guideline should be established as to improve the accuracy and creditability of the investigation and diagnosis; (3) in order to protect children, whether it is necessary to conduct serological surveillance of TP following MMR immunization will be investigated, providing advice on subsequent immunization for the children who have TP following MCV immunization". The article corresponding to this case is not available for submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Reported Cause(s) of Death: Thrombocytopenic purpura.


VAERS ID: 770914 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-09-01
Onset:2011-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2018GS

Write-up: This case was reported in a literature article and described the occurrence of thrombocytopenic purpura in a 1-month-old subject who received Hepatitis B vaccine for prophylaxis. In September 2011, less than a day after receiving Hepatitis B vaccine, the subject developed thrombocytopenic purpura. Serious criteria included death. The outcome of thrombocytopenic purpura was fatal. The subject died in 2011. The reported cause of death was thrombocytopenic purpura. The investigator considered the thrombocytopenic purpura to be possibly related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the occurrence of thrombocytopenic purpura (TP) in a 1-month-old infant of unspecified gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to the section 1.4 reported in this literature article. The patient was part of the study to analyse the occurrence and features of TP as an adverse event following immunization (AEFI) and to detect suspicious vaccine safety signals. TP surveillance data reported during 2010-2015 were collected through the National AEFI Information Management System that were clinically diagnosed in AEFI individual cases, were analysed in this article for descriptive methodological analysis. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date in September 2011 at the age of 1-month, the patient received unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, the patients were immunized with National immunization program (NIP) vaccines and non-NIP vaccines]. On an unspecified date at the age of 1-month, on the day of vaccination, the patient developed thrombocytopenic purpura. On an unspecified date, 4-day post vaccination, the patient had died. It was unknown if an autopsy was performed. The author classified Adverse event following immunisation (AEFI) was classified as abnormal reaction. This case has been considered as serious due to death. Treatment was unknown. The authors considered the event of thrombocytopenic purpura possibly related to unspecified HBV vaccine. The authors stated, "As all the AEFI cases were the events suspected to be related with immunization, the seasonal regularity of its onset was possibly related with the vaccination behavior, and consistent with the seasonal trend of overall AEFI surveillance". The authors concluded, "The estimated incidence of TP after immunization was very low, and no confirmed safety signals were detected. We should strengthen monitoring of TP after immunization and improve assessment of causality between TP and immunization. In summary, the following recommendations were proposed: (1) in terms of surveillance, once TP is diagnosed, data on platelet count need to be collected, for example, the variable of the lowest platelet count collected could be added in AEFI individual case investigation form; it is required to upload the final conclusion on abnormal reactions (investigation and diagnosis certificate or expert conclusion); targeted information on the disease should be collected, for example, previous history, which could improve the capability of verifying cases and investigation; (2) in terms of causality assessment, relevant standard or guideline should be established as to improve the accuracy and creditability of the investigation and diagnosis; (3) in order to protect children, whether it is necessary to conduct serological surveillance of TP following MMR immunization will be investigated, providing advice on subsequent immunization for the children who have TP following MCV immunization". This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: Thrombocytopenic purpura.


VAERS ID: 771367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131809GBR006436

Write-up: This spontaneous report was received from a consumer via local news article refers to unspecified female patients of unknown demographics. Information on patients medical history, concurrent condition and concomitant medication were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dosing details, lot# and expiry date not provided) for prophylaxis. The reporter stated that unfortunately, sometimes drugs have side-effects which could be lethal. On an unknown date, the patients had died from the vaccine and there were patients (girls) who had taken their own lives due to chronic pain because it depressed them and made them feel there was no way forward(depression). The cause of death was not reported. The outcome of pain and depression were unknown. The reporter considered pain to be related to GARDASIL. This is one of the two reports received from the same reporter.; Sender''s Comments: GB-009507513-1809GBR006436: Original Case : 1809GBR006307; Reported Cause(s) of Death: unknown.


VAERS ID: 771460 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: BEGLAXOSMITHKLINEBE2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of death in a child patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced death (serious criteria death and GSK medically significant) and coma (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the coma was unknown. The reported cause of death was unknown cause of death. The reporter considered the death and coma to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was at childhood consultation office and the consulting physician told the reporting physician that last week she had seen parents who had a prescription for BEXSERO vaccine to give to their child. The parents still doubted and asked an advice to the physician. The parents had doubts because the child of one of their friends was vaccinated with BEXSERO and afterwards child went into a coma and died. The parents said that this was due to BEXSERO. Unfortunately, the physician did not know the patient neither where it happened. The sales representative contacted the nearby hospital to find out more about this death but no information was available. Medical Information contacted the sales representative, who provided the name of the physician. Sales representative would try again to contact the reporting physician to obtain the name of the treating physician of the patient who died. The reporter would try to obtain more information. Reported Cause(s) of Death: Death NOS.


VAERS ID: 771461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Death, Intensive care, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2018GS

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 80-year-old male patient who received Influenza vaccine for prophylaxis. Concurrent medical conditions included cardiomyopathy. On an unknown date, the patient received Influenza vaccine .5 ml. On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced myocardial infarction (serious criteria death and GSK medically significant) and acute cardiac insufficiency (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the myocardial infarction was fatal and the outcome of the acute cardiac insufficiency was unknown. The reported cause of death was myocardial infarction. It was unknown if the reporter considered the myocardial infarction and acute cardiac insufficiency to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date, the patient received a dose of an unknown Influenza vaccine (manufacturer and season unspecified). Approximately two days post vaccination the patient experienced acute heart insufficiency which required intensive care treatment. The patient was hospitalised for intensive care treatment. Approximately 3 to 4 days post vaccination, the patient died from myocardial infarction. It was unknown whether or not an autopsy was performed. Reported Cause(s) of Death: Myocardial infarction.


VAERS ID: 772072 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Death, Haematochezia, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: ARGLAXOSMITHKLINEAR2018GS

Write-up: This case was reported by a physician and described the occurrence of intussusception in a infant male patient who received ROTARIX for prophylaxis. On an unknown date, the patient received the 1st dose of ROTARIX (oral). On an unknown date, 2 days after receiving ROTARIX, the patient experienced intussusception (serious criteria death, GSK medically significant and clinically significant/intervention required) and blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was fatal and the outcome of the blood in stool was unknown. The reported cause of death was intussusception. It was unknown if the reporter considered the intussusception and blood in stool to be related to ROTARIX. Additional details were provided as follows: As medical history, the patient was a healthy child with adequate weight for the gestational age. Forty eight hours after receiving ROTARIX, he was presented with blood in stools, he was diagnosed with intestinal intussusception. The patient was admitted for surgery and during that he died. This event occurred one year ago in a private medical center. The reporter was not the treating physician. The physicians that attended the patient did not want to report the case. No additional information would be obtained and the targeted follow up questionnaire (TFUQ) would not be completed since there was too much missing information. Reported Cause(s) of Death: Intussusception.


VAERS ID: 774271 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-09-21
Onset:2018-09-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3H711V / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH W52663 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC083AA / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-22
   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: ZAGLAXOSMITHKLINEZA2018GS

Write-up: This case was reported by a nurse via licensee and described the occurrence of unknown cause of death in a 3-month-old male patient who received ROTARIX liquid formulation (batch number AROLC083AA, expiry date September 2020) for prophylaxis. Co-suspect products included HEXAXIM (batch number N3H711V, expiry date February 2019) for prophylaxis and PREVENAR (batch number W52663, expiry date October 2020) for prophylaxis. On 21st September 2018, the patient received ROTARIX liquid formulation (oral), HEXAXIM and PREVENAR. On 22nd September 2018, 1 days after receiving ROTARIX liquid formulation, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 22nd September 2018. 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 liquid formulation. Additional details were provided as follows: The nurse reported the following to the vaccine helpline that they reported the case to drug safety at agency. The patient passed away on Saturday morning which was 1day after receiving vaccination. The reporter gave consent to be contacted.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 774818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Death, Dyspnoea, Influenza, Myocarditis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA268054

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case issued from a literature article. This case is linked to cases 2018SA268028, 2018SA268046, 2018SA268054, 2018SA268066, 2018SA268077, 2018SA268091, 2018SA268096, 2018SA268116, 2018SA268136, 2018SA268144, 2018SA268154, 2018SA268180, 2018SA268794, 2018SA268803, 2018SA268809, 2018SA268813, 2018SA268832, 2018SA268839, 2018SA268849, 2018SA268859, 2018SA268864, 2018SA268872, 2018SA268876, 2018SA268889, 2018SA268901, 2018SA268907, 2018SA268912, 2018SA268929, 2018SA268936, 2018SA268946, 2018SA268957, 2018SA268965, 2018SA268974, 2018SA268988, 2018SA268995, 2018SA269004, 2018SA269014 same literature article. The following is the abstract from the article- Aim- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods- Cases were extracted from VAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95 percent CI. MEDLINE was also searched. Results- In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were 15 cases in YOUNGER GROUP (YG, b18 years old) and 35 in OLDER GROUP (OG, N18 years old). Main reported vaccines were against Human Papilloma Virus (n- 6) in YG and influenza (n-16) in OG. Causality always resulted undeterminate for YG, whereas either undetermined (30 cases) and correlated (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR- 3.55, 95 percent CI- 1.23-10.24) and in OG for thyphoid vaccine (11.13, 7.73-16.03), Japanese encephalitis vaccine (8.54, 2.7-27.01), anthrax (25.5, 18.8-34.5), and, as expected, smallpox (71.88, 49.25-104.89). In database, 91 articles were found- positive/possible causality was frequently reported. Conclusions- MC and PC after immunization appear extremely rare, only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcus warrant monitoring. This case involves a 10 years old female patient who experienced myocarditis, while she received vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious myocarditis 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious chest pain 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious dyspnoea 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious influenza 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious abdominal pain 3 months following the administration of INFLUENZA VACCINE. This event was leading to death. Lab data was not reported. Final diagnosis was (fatal) myocarditis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for myocarditis, as Fatal on an unknown date for chest pain, as Fatal on an unknown date for dyspnoea, as Fatal on an unknown date for influenza and as Fatal on an unknown date for abdominal pain. It is unknown if an autopsy was done. The cause of death was reported as Myocarditis, Chest pain, Dyspnoea, Influenza, Abdominal pain. The Causality assessment (AEFI) was Undetermined. List of documents held by sender- none.; Sender''s Comments: This literature article describes a 10 years old child who was reported to have developed Myocarditis, Chest pain, Dyspnoea, Influenza, Abdominal pain 3 months after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. No information regarding medical history and tolerance to previous vaccinations was reported. Also there is no information regarding virus strain, lab tests confirming the diagnosis and patient''s immunological response to assess a potential vaccination failure. Autopsy confirmation is also not provided. Based upon reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Chest pain; Myocarditis; dyspnoea; influenza; abdominal pain.


VAERS ID: 774885 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-08
Onset:2018-05-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER P07XA / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. R002405 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cilazapril; amlodipine; simvastatin
Current Illness: Angina pectoris; Essential hypertension; Hyperlipidaemia; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131809NZL008995

Write-up: Information was obtained on a request by the Company from the Agency (CARM# 128778) via a case Line Listing concerning a 79 year old male patient. The patient''s concurrent conditions included an unspecified angina pectoris, essential (primary) hypertension, unspecified hyperlipidaemia and other medical conditions. The patient''s concomitant therapies included cilazapril, amlodipine and simvastatin. No information was provided regarding the patient''s medical history. On 08-MAY-2018, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneously, lot number R002405 for prophylaxis (anatomical location expiration date were not reported) and INFLUENZA QUADRIVALENT route of administration reported as SY (Systemic) 0.5 ml lot number P07XA for prophylaxis (expiration date was not reported). On 10-MAY-2018, the patient experienced cardiac arrest and died on an unspecified date due to the event. It was unknown whether an autopsy was performed. Additionally, the agency considered cardiac arrest to be unrelated to vaccination with ZOSTAVAX. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the zostavax vaccine and the reported event cardiac arrest cannot be established. More information regarding clinical course, and autopsy results are important for furhter assessment. Additionally the subject has as concurrent conditions angina pectoris, essential (primary) hypertension, unspecified hyperlipidaemia which are risk factors for the event. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of the product.


VAERS ID: 775027 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-23
Onset:2018-04-08
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Contraindicated product administered, Death, Yellow fever vaccine-associated viscerotropic disease
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-08
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thymectomy; Thymoma (benign)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSA2018SA270101

Write-up: Initial information regarding this unsolicited case downloaded from database without narrative (level 2A), was received on 26-Sep-2018 from other health care professional via health authority (under the reference number: GB-MHRA-ADR 24342502). The following narrative is based on the information retrieved from all other accessible data. This case involves Adult male patient who experienced yellow fever vaccine-associated viscerotropic disease and contraindicated drug administered, while he received vaccine YELLOW FEVER VACCINE. The patient''s past medical history included Thymoma with benign, Thymectomy in 2014. On 23-Mar-2018, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported. On 08 April 2018, 16 days post vaccination patient developed a serious yellow fever vaccine-associated viscerotropic disease and contraindicated drug administered (contraindicated product administered). This events was leading to death. Final diagnosis was (fatal) yellow fever vaccine-associated viscerotropic disease and (fatal) contraindicated drug administered. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on 08-Apr-2018 for yellow fever vaccine-associated viscerotropic disease and as Unknown for contraindicated drug administered. It is unknown if an autopsy was done. The cause of death was reported as Yellow fever vaccine-associated viscerotropic disease. List of documents held by sender- none.; Sender''s Comments: This case is retrieved from database which concerns an adult patient who presented with Yellow fever vaccine-associated viscerotropic disease (YEL-AVD)16 days post vaccination with YELLOW FEVER vaccine (unknown manufacturer) resulting in death. Patient has history of benign thymoma with thymectomy. Time to onset is compatible. However, history of thymoma and thymectomy has been recognized as a risk factor influencing the development of YEL-AVD and is a contraindication for yellow fever vaccination. Proper risk assessment should have been done before vaccinating the patient. Based on reported information patient''s immune status is suspected in causing reported event; Reported Cause(s) of Death: Yellow fever vaccine-associated viscerotropic disease.


VAERS ID: 775104 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Asthenia, Chills, Death, Dyspnoea, Ejection fraction decreased, Epstein-Barr virus test positive, Headache, Jaundice, Myalgia, Myocarditis, Weight increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MESALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis (in treatment with mesalazine.)
Allergies:
Diagnostic Lab Data: Test Name: ejection fraction test; Result Unstructured Data: decreased; Test Name: epstein-barr virus; Result Unstructured Data: positive; Test Name: wbc increased; Result Unstructured Data: increased
CDC Split Type: ITSA2018SA268929

Write-up: Initial information received on 22-Sep-2018 regarding an unsolicited valid serious case issued from a literature article. Abstract- To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods: Cases were extracted fromVAERS (2011-2015) and assessed for causality using standardized WHO algorithm. Disproportionality analysis was performed through reporting odds ratio (ROR) with 95%CI. Database was also searched. Results: In VAERS, 199 cases of MC or PC were collected, among which 149 reported smallpox vaccine. The remaining were: 15 cases in ''YOUNGER GROUP'' (YG; b18 years old) and 35 in ''OLDER GROUP'' (OG; N18 years old). Main reported vaccines were against Human Papilloma Virus (n = 6) in YG and influenza (n = 16) in OG. Causality always resulted "undeterminate" for YG, whereas either "undetermined" (30 cases) and "correlated" (3 cases) for OG. Statistically significant ROR was found in YG for meningococcal vaccine (ROR = 3.55; 95%CI = 1.23-10.24) and in OG for thyphoid vaccine (11.13; 7.73-16.03), Japanese encephalitis vaccine (8.54; 2.7-27.01), anthrax (25.5; 18.8-34.5), and, as expected, smallpox (71.88; 49.25-104.89). In database, 91 articles were found: positive/possible causality was frequently reported. Conclusions: MC and PC after immunization appear extremely rare; only in very few cases can a role of vaccine be actually identified. Signals for vaccines against typhus, Japanese encephalitis, anthrax and meningococcal warrant monitoring. This case involves a 61 years old male patient who experienced giant-cell myocarditis/ biopsy-proven myocarditis along with symptoms of Abdominal distension, asthenia, chills, dyspnoea, headache, jaundice, myalgia, weight increased, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history included Colitis ulcerative with in treatment with mesalazine on an unknown date. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MESALAZINE (MESALAZINE) for Colitis ulcerative. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious giant-cell myocarditis/ biopsy-proven myocarditis (myocarditis) 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious abdominal distension 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious chills 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious dyspnoea 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious asthenia 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious headache 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious jaundice 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious weight increased 7 days following the administration of INFLUENZA VACCINE. This event was leading to death. On an unknown date, the patient developed a serious myalgia following 7 days the administration of INFLUENZA VACCINE. This event was leading to death. On an unspecified date, patient was performed ECE test (result: not reported). Relevant laboratory test results included: Ejection fraction decreased - On an unknown date: (result: decreased) Epstein-Barr virus antibody positive - On an unknown date: (result: positive) White blood cell counts increased - On an unknown date: (result: increased) Final diagnosis was giant-cell myocarditis/ biopsy-proven myocarditis with symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for giant-cell myocarditis/ biopsy-proven myocarditis, for abdominal distension, for chills, for dyspnoea, for asthenia, for headache, for jaundice, for weight increased, for myalgia. It is unknown if an autopsy was done. The cause of death was not reported. The Causality assessment (AEFI) was Undetermined. Documents held by the sender: none.; Sender''s Comments: This literature article describes a 61 years old adult male patient who was reported to have developed Giant-cell Myocarditis, abdominal distension, chills, dyspnea, asthenia, headache, jaundice, weight increased and myalgia 7 days after vaccination with INFLUENZA VACCINE produced by unknown manufacturer resulting in death. The date of vaccinations, the date of events, the date of death was not reported. Patient had a medical history of ulcerative colitis. Lab tests confirming the diagnosis & Autopsy confirmation is also not provided. Based upon reported information, the role of vaccine cannot be assessed.


VAERS ID: 775675 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration
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: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a nurse via sales rep and described the occurrence of unknown cause of death in a 100-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and general physical health deterioration. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the general physical health deterioration was not reported. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and general physical health deterioration to be related to SHINGRIX. Additional information received as follows: The nurse reported that the patient in Long Term Care home received SHINGRIX. One month after injection, nursing staff reported a change in the patient''s overall health. The patient died one month later (reason not specified). The batch number was not provided. This case has been linked to the case CA2018GSK179013 (patient of same age as present case), reported by the same reporter.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 775676 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration
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: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a nurse via sales rep and described the occurrence of unknown cause of death in a 100-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and general physical health deterioration. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the general physical health deterioration was not reported. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and general physical health deterioration to be related to SHINGRIX. Additional information received as follows: The nurse reported that the patient in Long Term Care home received SHINGRIX. One month after injection, nursing staff reported a change in the patient''s overall health. The patient died one month later (reason not specified). The batch number was not provided. This case has been linked to the case CA2018GSK179013 (patient of same age as present case), reported by the same reporter. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 776016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-08-08
Onset:2018-08-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER R003928 / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Regurgitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-10
   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: COLECALCIFEROL
Current Illness: Gastrooesophageal reflux (Prescribed a specific milk); Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2018396442

Write-up: This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB (FR-009507513-1809FRA006542). A male patient of an unspecified age and ethnicity received PREVENAR 13 via an unspecified route of administration on 08Aug2018 at single dose for prophylaxis and VAXELIS (formulation: injection, lot# R003928; PkgID=U5685AA) on 08Aug2018 and another dose in 2018, for prophylaxis. Medical history included ongoing gastrooesophageal reflux disease (prescribed a specific mil) and ongoing prophylaxis. Concomitant medication included colecalciferol. On 10Aug2018, the patient experienced regurgitation and sudden death. The patient died on 10Aug2018. An autopsy was performed and results were not provided. Results of assessment for all events were reported as Not Assessed by Health Care professional. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Regurgitated; Sudden death.


VAERS ID: 776216 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131810COL002319

Write-up: Information has been received in the form of a letter from a consumer regarding a case for GARDASIL (MARRS #CO-009507513-1310COL005965). The consumer reported that the GARDASIL was promoted, even though several countries, have prohibited its use because it has caused the death of 72 people (demographics unknown). The dates and causes of death were not provided. It is unknown if autopsies were performed. Upon internal review, death of 72 people was determined to be medically significant. Additional information is not expected.; Sender''s Comments: CO-009507513-1310COL005965:; Reported Cause(s) of Death: Death.


VAERS ID: 776774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injury, Pain
SMQs:, Accidents and injuries (narrow), Hostility/aggression (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: JP0095075131810JPN000947J

Write-up: This spontaneous report as received from a other non-medical expert refers to female patients. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (inoculation volume, lot number and the date of inoculation had not been reported). On an unknown date, severe chronic generalized pain, deaths and injuries developed. On an unknown date, patients died. The cause of death and presence/absence of an autopsy were unknown. At the time of report, the outcome of severe chronic generalized pain, deaths and injuries was unknown. Reporter''s comment: not reported. The other non-medical expert thought that severe chronic generalized pain was serious due to medically significant and not asessed the seriousness of the adverse event. The other non-medical expert did not assess the relationship betweent severe chronic generalized pain, deaths, adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine. Reported Cause(s) of Death: Death.


VAERS ID: 776835 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute respiratory failure; Chronic obstructive pulmonary disease; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Unwell (been unwell for a week prior to influenza vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2018GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 76-year-old male subject who received influenza vaccine for prophylaxis. The subject''s past medical history included unwell (been unwell for a week prior to influenza vaccination). Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes and acute respiratory failure. On an unknown date, less than a year after receiving influenza vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The subject died in 2015. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to influenza vaccine. Additional information was provided. This case was reported in a literature article and described the death not otherwise specified (NOS) in a 76-year-old male who was vaccinated with unspecified influenzae vaccine (manufacturer unknown) for prophylaxis. The patient was part of report that summarised passive surveillance data for adverse events following immunisation (AEFI) for 2015 reported by 28 February 2016 to the Therapeutic Goods Administration (TGA) by state and territory health departments, health professionals, vaccine companies and the public, and compared them to long-term trends. [In this study, records contained in the Adverse Drug Reactions System (ADRS) database were eligible for inclusion in the analysis if a vaccine was recorded as ?suspected'' of involvement in the reported adverse event and either (a) the vaccination occurred between 1 January 2000 and 31 December 2015, or (b) for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 1 January 2000 and 31 December 2015]. The patient had history of chronic obstructive pulmonary disease (COPD), diabetes and acute respiratory failure. The patient had been unwell for a week prior to influenza vaccination. No information on patient''s family history or concomitant medications was provided. On an unspecified date in 2015, the patient had received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in 2015, an unknown period after vaccination, the patient had died. The cause of death was unknown. It was unknown if an autopsy was performed. The case was reported to TGA. The case was assessed using internationally consistent criteria and was entered into the ADRS database. The case has been considered serious due to death. [In this study, an AEFI was defined as ?serious'' if it met one or more of the following criteria: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalisation or prolongation of existing hospitalisation (4) results in persistent or significant disability/incapacity; (5) is a congenital anomaly/ birth defect or; (6) is a medically important event or reaction]. The authors commented, "Two deaths were reported as temporally associated with receipt of vaccines in 2015. A clear causal relationship with vaccination was unable to be determined due to confounding factors". The authors concluded "The reported AEFIs decreased in 2015 compared with 2014. The majority of AEFIs reported to the TGA were mild, transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule." This is 1 of the 2 valid cases reported in the same literature article.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 776938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood cholesterol increased; Chronic obstructive pulmonary disease; Diabetes; Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2018GS

Write-up: This case was reported in a literature article and described the occurrence of pneumonia in a 73-year-old male subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease, diabetes, blood cholesterol increased and lung cancer. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal. The reported cause of death was pneumonia, chronic obstructive pulmonary disease and squamous cell carcinoma of lung. The investigator considered the pneumonia to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia in a 73-year-old male who was vaccinated with unspecified influenzae vaccine (manufacturer unknown) for prophylaxis. The patient was part of report that summarised passive surveillance data for adverse events following immunisation (AEFI) for 2015 reported by 28 February 2016 to the regulatory authority by state and territory health departments, health professionals, vaccine companies and the public, and compared them to long-term trends. [In this study, records contained in the Adverse Drug Reactions System (ADRS) database were eligible for inclusion in the analysis if a vaccine was recorded as ?suspected'' of involvement in the reported adverse event and either (a) the vaccination occurred between 1 January 2000 and 31 December 2015, or (b) for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 1 January 2000 and 31 December 2015]. The patient had history of severe chronic obstructive pulmonary disease (COPD), diabetes, high cholesterol and lung cancer. No information on patient''s family history or concomitant medications was provided. On an unspecified date in 2015, the patient had received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date in 2015, more than 2 weeks after vaccination, the patient was hospitalised with pneumonia. Subsequently on an unspecified date, the patient had died. The causes of death were pneumonia, severe COPD and squamous cell carcinoma of the lung. It was unknown if an autopsy was performed. The case was reported to regulatory authority. The case was assessed using internationally consistent criteria and was entered into the ADRS database. The case has been considered serious due to death/hospitalisation. [In this study, an AEFI was defined as ?serious'' if it met one or more of the following criteria: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalisation or prolongation of existing hospitalisation (4) results in persistent or significant disability/incapacity; (5) is a congenital anomaly/ birth defect or; (6) is a medically important event or reaction]. The authors commented, "Two deaths were reported as temporally associated with receipt of vaccines in 2015. A clear causal relationship with vaccination was unable to be determined due to confounding factors". Reported Cause(s) of Death: pneumonia; severe chronic obstructive pulmonary disease; squamous cell carcinoma of the lung.


VAERS ID: 777020 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-08-04
Onset:2010-12-25
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E29195 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-12-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autosomal chromosome anomaly (congenital glycosylation defect); Cardiomyopathy (Chronic heart disease); Developmental delay; Infantile spasms; Therapy regimen changed (Patient previously received two doses of Prevenar.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2011035053

Write-up: This is a spontaneous report from a non contactable healthcare professional via the Agency. A 17-month-old male patient received the first dose of PREVENAR 13 (Lot number E29195, exp.date Jul2011) at 12 months on 04Aug2010 for vaccination. The patient previously received two doses of PREVENAR, 1st dose of PREVENAR on 02Sep2009 (Lot Number 37658, expiry date Aug2011) at the age of 1-month-old and the 2nd dose of PREVENAR on 28Oct2009 (Lot Number D75997, expiry date Oct2012) at the age of 3-months-old. The patient was not born premature (born at 40 weeks gestation). The patient was born with cardiomyopathy (chronic heart disease) and congenital glycosylation defect, infantile spasms and a development delay. Concomitant medications were not provided. On 25Dec2010 the patient developed a pneumococcal infection, identified as serotype 3 in blood culture. The event was considered by the reporter to be a vaccine failure. On 25Dec2010 the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. Follow-up (18Feb2011): New information reported includes: Lot numbers, product administration dates, confirmation that patient previously received PREVENAR (two doses), patient age at event, and event details. Follow-up (31Mar2011): New information reported from the manufacturing sites includes: QA Results (results within specifications). Follow-up attempts completed. No further information expected. Follow-up (22Feb2012): New information reported from the HPA includes: patient demographics, medical history and date of death. No further information expected. Follow-up (04Oct2018): New information received from the HPA included: The onset date of the events. Follow-up attempts are completed. No further information is expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): 2011035053 legacy paper report number; Reported Cause(s) of Death: unknown.


VAERS ID: 777023 (history)  
Form: Version 2.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:2013-12-09
Onset:2014-01-30
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G33996 / 3 - / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Malaise, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asplenia (congenital absence of spleen); Heart disease congenital; Sickle cell disease (homozygous)
Allergies:
Diagnostic Lab Data: Test Date: 20140130; Test Name: Serology test; Result Unstructured Data: Test Result: serotype 14
CDC Split Type: GBPFIZER INC2014130296

Write-up: This is a spontaneous report from a contactable healthcare professional via the Agency. A 16-month-old female patient received 3 doses of PREVENAR 13, via an unspecified route of administration, at single dose, for immunization: 1st dose (lot/batch# F87972, exp date 31Aug2014), on 28Nov2012 at 2 months; 2nd dose (lot/batch# F61157) on 06Feb2013 at 4 months and 3rd dose (lot/batch# G33996) on 09Dec2013 at 14 months. Medical history included heart disease congenital, asplenia (congenital absence of spleen) and sickle cell disease (homozygous) diagnosed at the time of organ donation. The patient was not born prematurely. The patient had no history of previous invasive bacterial disease, no immunosuppressive condition or drug, no malignancy, no conditions associated with CSF leakage, no chronic respiratory disease, no chronic renal or liver diseases, no diabetes mellitus, no cochlear implants, no coeliac disease or any other disorders. The patient had no complications with empyema, haemolytic uraemic syndrome or cerebral abscess. On 30Jan2014, the patient experienced a pneumococcal infection, serotype 14 which was reported as a vaccination failure. The specimen was taken from EDTA blood on 30Jan2014. It was noted that the patient got ill very quickly. On 04Feb2014, she passed away. At post mortem, it was found out that she did not have a spleen. The reporter stated that the patient belonged to more than one DH (Department of Health) Risk groups: she was in a final risk group for congenital heart defect and for asplenia. A search was performed and the result indicated that no Event Reports or Investigations have been raised against packed lot: F87972. This batch met all the criteria for market release. The batch records were reviewed and there were no relevant observations or errors associated with the packaging of the lot in question. The Certificate of Analysis showed that all QC testing complied with specifications and was QP released. The cold chain temperature control data for the bulk stock received at agency, the packed stock stored at agency and during its journey to the markets distribution Centre were all satisfactory thus confirming suitable storage condition was maintained at all times and no impact to product quality, safety or efficacy. The complaint was unconfirmed as no root cause has been identified and no trend has been identified by the Team. Reports of this nature will continue to be evaluated and monitored for trends. No further action was warranted at this time. For batch F61157 all investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation. No follow-up attempts possible. No further information is expected. Agency investigation reports for batch G33996 (Complaint Number: 2014-06-0028542-WA): Investigation Report Conclusion/Summary: The Complaint states: PPU/CUST/1405042. Per medical judgment and based upon event terms or additional information presented in the case, e.g., injection site cellulitis for an injectable product, suspected transmission of an infectious agent, complaints related to medical device failures, and notification of potential product tampering (provide reported verbatim event and any other pertinent details if needed): AE Description LOE. Vaccine Only: FDA 15-day Report: Yes. A search was performed and the result indicates that two Event Reports have been raised against packed lot: G33996. One is regarding high temperature excursions on OMCL samples. It must be noted that the samples concerned are for testing purposes only; there is no risk to packed stock. This batch met all the criteria for market release. Both Event Reports have been reviewed from an operational and technical perspective, actions addressed and approved/closed prior to Q.P. release. This batch met all the criteria for market release. The Event Reports would not have caused this type of complaint. Note: Any PPU Customer Complaint Investigations are not listed below as they are recorded and trended within agency. The batch records were reviewed and there were no relevant observations or errors associated with the packaging of the lot in question. The Certificate of Analysis shows that all QC testing complied with specifications and was QP released. The cold chain temperature control data for the bulk stock received agency, the packed stock stored at agency and during its journey to the markets distribution Centre were all satisfactory thus confirming suitable storage condition was maintained at all times and no impact to product quality, safety or efficacy. A search was performed in PCOM that identified one complaint for a Lack of Effect raised against packed Lot: G33996. There are no additional complaints for a Lack of Effect regarding interim lot no: The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Team. Reports of this nature will continue to be evaluated and monitored for trends. No further action is warranted at this time. Investigation Report Conclusion/Summary: Conclusion: This summarises the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation. An evaluation of the reserve sample and complaint sample was not applicable under this Adverse Event as the Adverse Event was reported for the interim drug product lot. An evaluation of the complaint history confirms that this is the first Adverse Event received for this interim drug product lot. On the basis of this evaluation, there is no requirement to investigate this Adverse Event further or escalate to the Product Quality Complaint Trending Meeting. Conclusion: An evaluation of the complaint history confirms that this is the first complaint for this Filled batch G33996 from packaged lot F78146 and is the first complaint for this product complaint c1assification/ subclass for Filled batch F78146 that has been received for evaluation. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer. Agency will continue to monitor complaints for this Fill lot. No further action is required at this time. Investigation Report Conclusion/Summary: Conclusion: This summarizes the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, safety, purity or quality of the product were identified during the technical evaluation. An evaluation of the reserve sample and complaint sample was not applicable under this Adverse Event as the Adverse Event was reported for the bulk drug product lot. No follow up attempts possible. No further information expected. Follow-up (03Jul2014): New information received from PCOM included final investigation reports and expiry date of batch F87972 updated (31Aug2014). No follow-up attempts possible. No further information expected. Follow up (18Jul2014): New information received from PCOM includes: investigation results for batch G33996.No follow up attempts possible. No further information expected. Follow up (05Jan2015): Additional information received from the contactable healthcare professional via the Agency includes: information that the patient belonged to more than one DH (Department of Health) Risk groups. No follow-up possible. No further information expected. Follow up (30Apr2015): New information received from a contactable healthcare professional via the Agency includes: patient details. No follow-up attempts possible. No further information expected. Follow-up (04Oct2018): New information reported from the Agency includes: medical history updated. 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. 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. The follow-up information received does not alter the previous company clinical evaluation. Linked Report(s) : 2014130296 Legacy paper report number; Reported Cause(s) of Death: Pneumococcal disease, serotype 14; Pneumococcal disease, serotype 14.


VAERS ID: 777024 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H06883 / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Meningitis, Pneumococcal infection, Pneumococcal sepsis, Streptococcus test positive, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-26
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: Asplenia; Intestinal obstruction (due to a congenital band); Laparotomy (congenital band which was resected by laparotomy and a primary anastomosis)
Allergies:
Diagnostic Lab Data: Test Date: 20141126; Test Name: Blood culture; Result Unstructured Data: Test Result: Pneumococcal infection, serotype 6C
CDC Split Type: GBPFIZER INC2015150724

Write-up: This is a spontaneous report from a contactable healthcare professional via the Health Protection Agency. An 11-month-old female patient received PREVENAR 13, first dose (batch/lot G34370, expiry date Jun2015) on 29Jan2014 at the age of 8-weeks and second dose on 22Apr2014 (batch/lot H06883, expiry date: Jul2015) at the age of 4-months, both at single dose for immunization. Concomitant medications were not reported. The patient was not born prematurely. The patient was in a clinical risk group for asplenia. The patient had no homozygous sickle cell disease or other haemoglobinopathy, no history of previous invasive bacterial disease, no immunosuppressive condition or drug, no malignancy, no congenital abnormality, no conditions associated with CSF leakage, no chronic respiratory disease, no chronic diseases (including cardiac, renal or liver), no diabetes mellitus, no cochlear implants, no coeliac disease or any other disorders. The patient had no complications with empyema, haemolytic uraemic syndrome or cerebral abscess. It was reported that the patient also had intestinal obstruction due to a congenital band which was resected by laparotomy and a primary anastomosis. On an unknown date, the patient experienced a pneumococcal infection, serotype 6C. Even if serotype was provided as 6C, the reporter considered the event as a vaccination failure. The specimen was taken from the blood culture at post mortem on 26Nov2014. The patient also experienced meningitis on an unknown date. On an unspecified date, the patient experienced cardiac arrest with fatal outcome. On 26Nov2014 the patient experienced sudden unexpected death. A sample taken at post mortem showed acute septicaemia due to streptococcus pneumonia which developed rapidly and the patient died in her sleep. An autopsy was performed. Autopsy results were not available. The patients final risk group was reported to be asplenia (shown at post mortem). The outcome of the events prior to death were unknown at the time of the report. No follow-up attempts possible. No further information expected. Follow-up (04Oct2018): New information received from the Health Protection Agency (HPA) includes: reactions data (cardiac arrest added as event with fatal outcome). No follow-up attempts possible. No further information expected.; Sender''s Comments: Serotype 6C is not contained in PREVENAR 13, therefore a lack of efficacy in this patient can be excluded. Sudden death with cardia arrest is due to severe pneumococcal infection which represents an intercurrent infectious condition unrelated to PREVENAR 13. 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) : 2015150724 Legacy paper report number; Reported Cause(s) of Death: Sudden death; cardiac arrest


VAERS ID: 777025 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: CSF test abnormal, Death, Drug ineffective, Encephalitis, Meningitis pneumococcal, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-06
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: Medical History/Concurrent Conditions: Cochlea implant (developmental health risk); Premature birth; Vasculitis
Allergies:
Diagnostic Lab Data: Test Name: CSF test; Result Unstructured Data: Test Result: Serotype 1
CDC Split Type: GBPFIZER INC2015150727

Write-up: This is a spontaneous report from a contactable healthcare professional via the Health Protection Agency. An infant male patient received the first dose of PREVENAR 13)on 22Aug2013 for immunization when he was 8 weeks old. The patient''s second dose was received on 31Oct2013 when he was 4 month old and the third dose was received on 22Apr2014 when he was 9 month old. Lot. numbers for all 3 doses were unknown. Relevant medical history included cochlear implant (developmental health risk) and vasculitic infarct. The patient was born prematurely. The mother was GBS + ve therefore baby had iv antibiotics prophylaxis. Asplenia or Splenic Dysfunction, immunosuppression status, malignancy information, congenital anomaly, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease, diabetes statuse, empyema status, haemolytic uraemic syndrome, cerebral abscess and was coeliac disease were noted as no. Concomitant medications were unknown. At the age of 5 months the patient experienced Pn Meningitis and Encephalitis. On an unknown date, the patient experienced a pneumococcal infection, serotype 1 which was reported as a vaccination failure. The specimen was taken from cerebrospinal fluid. The outcome of the events was unknown. On 06Jul2016, the patient died. It was unknown whether an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected. Follow-up (05Feb2016): This follow-up report is being submitted to amend previously reported information: event "Therapeutic product ineffective" changed to "Drug ineffective". Company Clinical Evaluation comment Serotype 1 is contained in PREVENAR 13, therefore a lack of efficacy in this patient cannot be excluded. Follow up (04Oct2018): New information reported from the Health Protection Agency included: medical history, risk factors, new events of Pn Meningitis and Encephalitis, death outcome. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Serotype 1 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.,Linked Report(s) : 2015150727 legacy paper report number; Reported Cause(s) of Death: Pneumococcal infection, serotype 1; Pneumococcal infection, serotype 1; Pn Meningitis; Encephalitis.


VAERS ID: 777026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-20
Onset:2014-11-28
   Days after vaccination:373
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G33995 / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Empyema, Pleural fluid analysis, Pneumococcal infection, Pneumothorax, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-12
   Days after onset: 410
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: 20141128; Test Name: Pleural fluid analysis; Result Unstructured Data: Test Result: pneumococcal infection, serotype 3
CDC Split Type: GBPFIZER INC2015151604

Write-up: This is a spontaneous report from a contactable healthcare professional via the Health Protection Agency. A 26-month-old male patient received the first single dose of PREVENAR 13 (batch number F87972, expiry date Aug2014) on 06Nov2012 for immunization when he was 8 weeks old. The second and third vaccine single doses were received respectively from batch F60157, expiry date 31Dec2014, on 16Jan2013 when he was 4 month old and from batch G33995, expiry date Jan2015, on 20Nov2013 when he was 14 months old. Relevant medical history and concomitant medications were not reported. It was noted that the patient did not have the following conditions: Previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppression status, malignancy, congenital anomaly, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease, diabetes status, haemolytic uraemic syndrome, cerebral abscess, developmental health risk, cochlear implant. On 28Nov2014, the patient experienced a pneumococcal infection, serotype 3 which was reported as a vaccination failure. The specimen was taken from pleural fluid on 28Nov2014. The patient died on 12Jan2016 due to these events. On an unknown date the patient experienced also right empyema, thoracic and other complications (pneumothorax). The outcome of the events was unknown. Investigational results for vaccine batch F61157 included the following information. Baxter results of evaluations summary comments: neither an actual nor a companion sample was available for evaluation. Engineering/quality review summary: A review of the executed batch records confirmed that the batch was manufactured according to cGMP procedures. All batch release criteria were met. Havant root cause and conclusion: The batch records were reviewed and there were no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received at Havant, the packed stock stored at Havant and during its journey to the markets distribution centre were all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. There are 5 other complaints for the reported packed lot regarding lack of effect. The root cause has not been determined and the complaint is unconfirmed. A trend has not been identified by the Global Safety Team. Investigational results for vaccine batch F87972 included the following information. Havant root cause and conclusion: the batch records were reviewed and there were no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received at Havant, the packed stock stored at Havant and during its journey to the markets distribution centre were all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. There are 3 other complaints for the reported packed lot regarding lack of effect. The root cause has not been determined and the complaint is unconfirmed. A trend has not been identified by the Global Safety Team. Baxter results of investigation summary: neither an actual nor a companion sample is available for evaluation. Engineering/quality review summary: A review of the executed batch records confirmed that the batch was manufactured according to cGMP procedures. All batch release criteria were met. The Havant Investigation results for vaccine batch G33995 included: No complaint was confirmed. The batch records were reviewed and there were no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received at Havant, the packed stock stored at Havant and during its journey to the markets distribution centre were all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. There is 1 other complaint for the reported packed lot regarding lack of effect. The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Global Safety Team. Reports of this nature will continue to be evaluated and monitored for trends. No further action is warranted at this time. No follow-up attempts possible. No further information expected. Follow-up (18Jun2015): New information from Product Quality Complaints Group includes: investigational results for vaccine batches F61157 and F87972. Follow-up (25Jun2015): New information from Product Quality Complaints Group includes: The Havant Investigation results for batch G33995. Follow-up (04Oct2018): New information received from the Health Protection Agency includes: PREVENAR 13 batch updated to F60157 from F61157, Birthweight, fatal outcome for pneumococcal infection/vaccination failure, Death date, other complications (pneumothorax), patient''s details. 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; Therapeutic product ineffective.


VAERS ID: 777027 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 19794 / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cough, Death, Empyema, Hypophagia, Jaundice, Pneumococcal infection, Pyrexia, Streptococcus test positive, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-04
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: Sickle cell disease (Homozygous)
Allergies:
Diagnostic Lab Data: Test Date: 20161203; Test Name: Serology test; Result Unstructured Data: Test Result: pneumococcal infection, serotype 3
CDC Split Type: GBPFIZER INC2018404856

Write-up: This is a spontaneous report from a contactable healthcare professional via Public Heath (formally known as the Health Protection Agency). An 11-month-old male patient received 2 doses of PREVENAR 13, via an unspecified route of administration, at single dose, for immunisation: 1st dose (batch# M02005) on 01Mar2016 at 2 months, 2nd dose (batch# 19794) on 26Apr2016 at 4 months. Medical history included sickle cell disease (homozygous) from 15Jan2016. The patient was born at a gestational age of 39 plus 6 (not prematurely), birth weight was 3590 g. It was noted that the patient did not have the following conditions: congenital anomaly associated with CSF leakage, chronic respiratory disease; cardiac, renal and liver disease; diabetes, developmental health risk, cochlear implant and coeliac disease. History of previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppression, malignancy, haemolytic uraemic syndrome was unknown. Concomitant medications were unknown. The patient experienced pneumococcal infection, serotype 3; empyema, reduced feeding, vomiting, fever, jaundice, cough all on unspecified date. The patient underwent lab tests and procedures which included serology test (03Dec2016): showed pneumococcal infection, serotype 3. On 04Dec2016 the patient died due to pneumococcal infection, serotype 3. Outcome of the other events (reported as complications) was unknown. An autopsy was performed, no further information was available at the time of this report. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. 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; pneumococcal infection, serotype 3.


VAERS ID: 777028 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F41331 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Palliative care, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-07
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: Cerebral palsy
Preexisting Conditions: Medical History/Concurrent Conditions: Premature baby 26 to 32 weeks (gestational age of 27)
Allergies:
Diagnostic Lab Data: Test Date: 20170429; Test Name: Investigation; Result Unstructured Data: Test Result: pneumococcal infection, serotype 3; Test Date: 20050420; Test Name: Weight; Test Result: 1 kg
CDC Split Type: GBPFIZER INC2018404865

Write-up: This is a spontaneous report from a contactable healthcare professional via Public Health (formally known as the Health Protection Agency). A 12 year old male patient received PREVENAR 13 (Batch/lot: F41331) on 05Dec2011 at single dose for immunisation when 6 years old. With regards to the relevant medical history, the following was noted: It was noted that the patient was born prematurely at a gestational age of 27 and had congenital cerebral palsy. The birthweight was 1 kg. It was noted that the patient did not have the following conditions: homozygous sickle cell disease, asplenia or splenic dysfunction, immunosuppression, malignancy, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease information, diabetes, developmental health risk, cochlear implant and coeliac disease. The reporter said the status of the following conditions were unknown: previous invasive bacterial disease, empyema status, haemolytic uraemic syndrome and cerebral abscess. The relevant concomitant medications were unknown at the time of this report. On 29Apr2017, a specimen was taken. Based on this specimen, it was reported that the patient experienced a pneumococcal infection, serotype 3. The patient was transferred to a Palliative care facility due to the fact that death was expected. The patient was noted to be 144 months old at the infection. On 07Jun2017, the patient died due to pneumococcal infection, serotype 3. The reporter said they considered this case as a vaccination failure. It was noted that no post mortem was done. Date of admission to the hospital was unclear and there was no discharge summary received. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumococcal infection, serotype 3.


VAERS ID: 777029 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R87459 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Haemolytic uraemic syndrome, Jaundice, Pleural effusion, Pneumococcal infection, Pulmonary haemorrhage, Pulseless electrical activity, Streptococcus test positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Respiratory failure (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: 2018-04-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: Streptococcus pn; Test Date: 20180331; Test Name: Investigation; Result Unstructured Data: Test Result: pneumococcal infection, serotype 3; Test Date: 20170411; Test Name: Birthweight subnormal; Test Result: 3.02 kg
CDC Split Type: GBPFIZER INC2018404870

Write-up: This is a spontaneous report from a contactable healthcare professional via regulatory authority. An 11 month old male patient received PREVENAR 13 on 20Jun2017 (From Batch: R87459) when 2 months old at single dose for immunization. With regards to the relevant medical history, the following was noted: the patient was not born prematurely. It was noted that the patient did not have the following conditions: congenital anomaly, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease, diabetes, empyema, cerebral abscess, developmental health risk, cochlear implant, coeliac disease. The reporter said the status of the following conditions were unknown: homozygous sickle cell disease, history of previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppression, malignancy. The relevant concomitant medications were unknown at the time of this report. On 31Mar2018, a specimen was taken. Based on this specimen, it was reported that the patient experienced a pneumococcal infection, serotype 3. The patient was 11 months old at the infection. It was noted that a blood culture was taken which was positive for Streptococcus pn (assumed to be pneumonia). On an unknown date, the patient experienced Haemolytic Uraemic Syndrome. Additional comments included the following: Pulmonary haemorrhage, Cardiac arrest with electromechanical dissociation, Pleural effusion, Haemolytic Uraemic Syndrome. Increasing jaundice. The patient was transferred to a hospital for further management on 01Apr2018. On 02Apr2018, the patient died due to pneumococcal infection, serotype 3. The outcome of the other events was not provided at the time of this report. The reporter said they considered this case as a vaccination failure. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: pneumococcal infection, serotype 3 (Streptococcus pn).


VAERS ID: 777163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a male patient who received seasonal Influenza vaccine unspecified for prophylaxis. On an unknown date, the patient received seasonal Influenza vaccine unspecified at an unknown dose. On an unknown date, unknown after receiving seasonal Influenza vaccine unspecified, the patient experienced pneumonia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia to be related to seasonal Influenza vaccine unspecified. Additional information received as follows: This case was reported by the patient''s granddaughter. The age at vaccination was not reported. The consumer said that vaccines made people sick. The patient (the reporter''s grandfather) died of pneumonia few years before the reporting day, not too long after receiving the flu shot. No consent for follow up was given. This was 1 of the 4 cases reported by the same reporter. Reported Cause(s) of Death: pneumonia.


VAERS ID: 778013 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-16
Onset:2018-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Agitation, Aphasia, Blindness, CSF test abnormal, Cerebrovascular accident, Cognitive disorder, Concomitant disease progression, Creutzfeldt-Jakob disease, Death, Dizziness, Electroencephalogram abnormal, Encephalopathy, Gait disturbance, Memory impairment, Nuclear magnetic resonance imaging brain abnormal, Reading disorder, Sedation, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA278801

Write-up: Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case via TGA reconciliation under reference: (AU-TGA-0000437249). This case involves a 77 years old male patient who died due to concomitant disease progression, while he received vaccine FLUZONE HIGH DOSE. The patient''s past medical history and concomitant medication were not provided. On 16-May-2018, the patient received one dose unspecified injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route. On 17-May-2018, The patient developed a serious concomitant disease progression 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event led to death of the patient. Case description: Patient was doing some reno work on a boat for 3 weeks and was feeling good and went back up on boat the next day but found he lost his ability to read as the words looked like they are jiggling/moving and mild dizzy. Also when he looked at his van, the car appears out of shape. No nausea or headaches, No weakness of face or limbs, patient never had eyes checked by optometrist before but he usually used a magnifying glass to read. On 28-May-2018, patient again represented to GP for assessment, and experienced visual loss, memory impairement / cerebrovasxular accident, thereafter, Referred to emergency department. Patient was hospitalised for stroke because he presented problems with 4 weeks of progressive functional that declined characterised. visual distortion progressed to almost complete visual loss, Cognitive impairment progressing to severe agitation, Receptive and expressive aphasia and Gait disturbance Principal Diagnosis Sporadic Creutzfeldt-Jakob Jacob Disease (CJD): Hedenhain variant. Patient was admitted under the neurology team, MRI of brain showed left occipital cortical ribboning, initial EEG showed with PLEDs in a similar location to MRI abnormality. Indicating a likely diagnosis of CJD. No family history, Negative antibodies on blood and CSF for autoimmune encephalitis, Progressive functional declined during inpatient stay, second Lipoprotein and MRI brain test was performed under general anaesthetic. MRI showed progressive bilateral widespread cortical ribboning, EEG was performed again and showed progressive generalised encephalopathy, there was a significant behavioural disturbance and aggression required security special and sedation, On 21-May-2018, Patient required visit to general physician 5 days post vaccination. (Other relevant tests included Physical examinations: Physical examinations: Temperature: 37 degree Celsius, Tymphanic BP (sitting): 140/79 Pulse: 50, Visual acuity - Right Eye 6/9, Left Eye - 6/24, MRI brain showing left occipital cortical ribboning. Initial EEG- with PLEDs in a similar location to MRI abnormality. LP and CSF- unremarkable biochemistry. 14-3-3 protein strongly positive. Tau protein positive. Indicating a likely diagnosis of CJD. CSF again positive for 14-3-3. MRI showing progressive bilateral widespread cortical ribboning. repeat EEG- progressive generalised encephalopathy. No focal neurological deficit. Referral to optometrist for urgent assessment Final diagnosis was (fatal) concomitant disease progression. As corrective measure, consulted with palliative care team for advice on sedation and decision was made for comfort cares. The outcome of the event was fatal and event end date was reported as 27-Jun-2018. No autopsy was performed (based on sentence reported as family decided against autopsy), the cause of death was not reported.; Sender''s Comments: This case involves a 77-year-old male patient who experienced concomitant disease progression leading to death the other day after receiving FLUZONE HIGH DOSE. Cause of death was not reported. Autopsy results are unavailable as family decided against autopsy. Post vaccination, Patient was also hospitalized for stroke, complete visual loss, cognitive impairment progressing to severe agitation, receptive and expressive aphasia, gait disturbance, sporadic Creutzfeldt-Jakob Jacob disease- Heidenhain variant (principal diagnosis). During inpatient stay, he experienced progressive functional decline. Lab tests results showed 14-3-3 protein strongly positive, tau protein positive, cerebrospinal fluid- came positive for 14-3-3. MRI showed progressive bilateral widespread cortical ribboning, and repetitive EEG showed progressive generalized encephalopathy. The loss of progressive body functionality due to multiple impairments played a role in this fatal outcome. In order to complete assessment of influenza vaccination in reported outcome, full past medical history and concomitant medications information is needed as well as results of autopsy report and laboratory evaluations.Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Concomitant disease progression.


VAERS ID: 778699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Death, Pneumonia, Squamous cell carcinoma of lung
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes; High cholesterol; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA283347

Write-up: Initial unsolicited report received from the literature on 08-Oct-2018. Verbatim of the article: Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2015 reported to the Therapeutic Goods Administration and compares them to long-term trends. There were 2,924 AEFI records for vaccines administered in 2015; an annual AEFI reporting rate of 12.3 per 100,000 populations. There was a decline of 7% in the overall AEFI reporting rate in 2015 compared with 2014. This decline in reported adverse events in 2015 compared to the previous year was mainly attributable to fewer reports following the HPV vaccine and replacement of monovalent vaccines (Hib, MenCCV and varicella) with combination vaccines such as Hib-MenC, and MMRV. AEFI reporting rates for most individual vaccines were lower in 2015 compared with 2014. The most commonly reported reactions were injection site reaction (26%), pyrexia (17%), rash (16%), vomiting (8%) and headache (7%). The majority of AEFI reports (85%) were described as non-serious events. There were two deaths reported, but no clear causal relationship with vaccination was found. This case involves a 73-year-old male patient who was vaccinated with influenza vaccine (batch number, expiry date, dose and route of administration were not reported) on an unspecified date in 2015. Patient''s medical history included chronic obstructive pulmonary disease, Diabetes mellitus, Blood cholesterol increased and Lung neoplasm malignant. Concomitant medication was not reported. On an unknown date, post vaccination the patient developed a serious pneumonia (unknown latency), squamous cell carcinoma of the lung (lung neoplasm malignant) and severe chronic obstructive pulmonary disease (chronic obstructive pulmonary disease) (unknown latency). The patient was hospitalized. The patient died on an unspecified date due to the events. It was unknown whether autopsy was performed. Patient''s lab data and corrective treatment was not reported. It was reported that a clear causal relationship with vaccination was unable to be determined due to confounding factors. List of the documents held by sender: none.; Sender''s Comments: This case concerns an elderly patient who presented with pneumonia, squamous cell carcinoma of the lung and severe chronic obstructive pulmonary disease. Patient''s medical history included chronic obstructive pulmonary disease, Diabetes mellitus, Blood cholesterol increased and malignant Lung neoplasm . The events are possibly related to disease progression with no relation to vaccination. Based upon the reported information, the role of the vaccine is unlikely.; Reported Cause(s) of Death: pneumonia; severe COPD; squamous cell carcinoma of the lung.


VAERS ID: 778763 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes (with multiple complications.for many years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC2018415405

Write-up: This is a spontaneous report from a non-contactable consumer or other non HCP via a sales representative. A 73-year-old male patient received PREVENAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history included ongoing diabetes mellitus with multiple complications for many years. The patient''s concomitant medications were not reported. The patient died on an unspecified date after several days after vaccination. It was not reported if an autopsy was performed. The patient''s wife stated she was convinced that the cause of her husband''s death was vaccination with PREVENAR 13. The woman asked for advice on her possible further actions in order to determine the true cause of death and its possible association with vaccination.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 778981 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-10-16
Entered: 2018-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201804441

Write-up: This spontaneous case, initially received from other non-health professional on 12-Oct-2018, concerns a 65-year-old, elderly male patient. The patient''s current condition included heart disease (reported as otherwise was well). On an unspecified date, the patient was administered FLUAD (TIV) [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On the following day of vaccine administration, the patient fell ill and was admitted to the hospital. Later that day, the patient passed away. It was unknown whether autopsy was performed. The cause of death was not reported. The reporter assessed the case as serious (death and hospitalization). Case Comment: A 65-year-old male patient with concurrent heart disease, passed away one day after receipt of FLUAD. Aside close temporal relationship, minimal information is available regarding the severity of concurrent heart disease, cause of death, medication history. Hence, company assessed the causality as unassessable. Further assessment will be done upon receipt of new information.


VAERS ID: 779279 (history)  
Form: Version 2.0  
Age: 1.58  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79293 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cough, Deafness, Empyema, Lethargy, Pleural effusion, Pneumococcal infection, Pulmonary congestion, Pulmonary oedema, Pyrexia, Rhinitis, Streptococcus test positive, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), 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: 2016-11-18
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: Cerebral abscess; Haemolytic uraemic syndrome; Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20161116; Test Name: Investigation; Result Unstructured Data: Test Result: pneumococcal infection, serotype 3
CDC Split Type: GBPFIZER INC2018404853

Write-up: This is a spontaneous report from a contactable healthcare professional via regulatory authority. A 4 year - old female patient started to receive PREVENAR 13 on following schedule: First dose on an unknown date, Second Dose on an unknown date, Third or Booster Dose on 03Sep2013 (From Batch: G79293) when the patient was 19 months old, all at single dose for immunization. With regards to the relevant medical history, it was noted that the patient did not have the following conditions: homozygous sickle cell disease and other disease, asplenia or splenic dysfunction, immunosuppression, malignancy, congenital anomaly, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease, diabetes, developmental health risk, cochlear implant, coeliac disease; Haemolytic Uraemic Syndrome and Cerebral Abscess status were noted as unknown. The relevant concomitant medications were unknown at the time of this report. On 16Nov2016, a specimen was taken. Based on this specimen, it was reported that the patient experienced a pneumococcal infection, serotype 3. The reporter said they considered this case as a vaccination failure. The patient was noted to be 57 months old at the infection. On an unknown date, the patient also experienced Empyema a large pleural effusion on right hand side, both lungs were oedematous congested. On 18Nov2016, the patient died due to pneumococcal infection, serotype 3. Post mortem report received on 14Aug2017 which said the following. The patient experienced 4 days of intermittent fever plus 2 days of cough, coryza, lethargy. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: pneumococcal infection, serotype 3.


VAERS ID: 779627 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Brain neoplasm, Death, Facial paralysis, Headache
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-15
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: FR0095075131810FRA007760

Write-up: This spontaneous report was received from a patient''s relative and refers to a 13 year old female patient. No information was provided regarding the patient''s medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 12-SEP-2016, the patient was vaccinated with her first dose of GARDASIL (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in 2016, (reported as "few days following the injection"), the patient experienced daily headaches and on 29-OCT-2016, the patient presented with facial paralysis on one side of her head. Subsequently on 17-DEC-2016, (reported as "on 17 or 19 December 2016"), a magnetic resonance imaging (MRI) was performed and the patient was diagnosed with a brainstem tumor. On 15-NOV-2017, the patient died from her brainstem tumor. It was unknown whether an autopsy had been performed or not. The reporter did not consider that the patient''s brainstem tumor and subsequent death was related to GARDASIL. Upon internal review, the patient''s brainstem tumor was determined to be a medically significant event. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the GARSASIL vaccine and the reported event brain neoplasm cannot be established. Information regarding prior neurological symptoms, concurrent conditions, medical history, concomitant medications is limited and would be relevant for the case. Company Comment- No changes to the GARDASIL product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of two countries, continues to monitor the safety profile of the product. Reported Cause(s) of Death: brainstem tumor.


VAERS ID: 780638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Agitation, Autopsy, Death, Gastric mucosa erythema, Incorrect route of product administration, Malaise
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Medication errors (narrow), 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: MXSA2018SA290013

Write-up: Initial information received on 18-Oct-2018 regarding an unsolicited valid serious case received from Consumer. This case involves a 2 months old male patient who experienced general malaise and agitation,unspecified stomach congestion while he received vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were unknown. On an unknown date, the patient received two doses of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE produced by unknown manufacturer lot number not reported via intramuscular and oral route (dose, expiry date and site of administration were unknown). On an unknown date, the patient developed a serious general malaise (malaise), agitation and unspecified stomach congestion (Gastric mucosa erythema) following the administration of DIPHTHERIA, TETANUS, AC PERTUSSIS and IPV AND HIB VACCINE. This event was leading to death. It was reported that, the autopsy confirmed as cause of death an unspecified stomach congestion. It was also case of actual medication error due to Wrong route of administration. Lab data was not provided. It was not reported if the patient received a corrective treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.; Sender''s Comments: A 2 months old male patient who presented with general malaise and agitation followed by death of unknown cause and reported as an unspecified stomach congestion after receiving vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE reported as produced by Sanofi''s generic ? via intramuscular and oral (out of label). The time to onset is unknown. Additional information regarding patient''s past medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: unspecified stomach congestion.


VAERS ID: 781000 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thymus enlargement
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZER INC2018428080

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 2-month-old patient of an unspecified gender received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included thymomegalia. Concomitant medications were not reported. The patient experienced sudden death 4 days after vaccination. It was unknown if an autopsy was performed. Infant mortality committee didn''t reveal causal relationship to PREVENAR 13. The medial history was reviewed by the lead of pediatric service of the hospital. Detailed information could be obtained by the request to hospital administrative department, where the medical history was stored.; Sender''s Comments: Sudden death is unlikely related to the vaccination with PREVENAR 13. The underlying medical condition might contribute to the infant''s death. More information such as complete medical history, concomitant medications, and death cause especially autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death.


VAERS ID: 781001 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cardiac arrest, Tachypnoea, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: increased
CDC Split Type: RUPFIZER INC2018428090

Write-up: This is a spontaneous report from a contactable physician (Head of the Department of Pediatrics and Neonatology) via a sales representative. An infant patient of an unspecified gender received PREVENAR 13 on an unspecified date (presumably in August or September, year unspecified) at single as vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced complication of vaccination, temperature increased, tachypnea and asystole. In the evening, after vaccination, patient''s temperature increased and the mother of the child decreased the temperature with NSAIDs. The medical nurse arrived in several hours and observed the child for an hour and assessed the condition as medium to severe. She called an ambulance. During transportation there was tachypnoea, pulse oximetry and measurement of blood pressure were not performed. Then asystole observed. The child died on an unknown date. In the pathologic anatomical diagnosis the cause of death was indicated as complication of pneumococcal 13-val conj vaccination. Complication of vaccination was fatal; outcome of the other events was unknown. An emergency notice was not sent to the Federal Service for Supervision of Consumer Rights Protection and Human Services.The commission in regards to the child death is scheduled for 11Nov2018. The medical records were requested for analysis by the Head of the Department of Pediatrics and Neonatology. Information on the batch number has been requested.; Sender''s Comments: Considering the plausible time association, the fatal vaccination complication, asystole and tachypnea might be attributed to the vaccination with PREVENAR 13; more information such as medical history and concomitant medications and the details regarding the death cause and autopsy results are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: complication of PREVENAR 13 vaccination.


VAERS ID: 781308 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Endotracheal intubation, Intensive care, Laboratory test normal, Pneumonia, Pyrexia, Streptococcus test positive, Thoracic cavity drainage
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: serotype 19
CDC Split Type: BRPFIZER INC2018425844

Write-up: This is a spontaneous report from a contactable physician. A female patient of unspecified age received 3 single doses PREVENAR 13 on unspecified dates, for immunization. The patient received 3 doses of the vaccine until the seventh month of life and she did not receive the booster dose later. Medical history was none. Concomitant medications were not reported. On an unspecified date the patient experienced a fatal invasive pneumonia, fever (hospitalization), difficulty to breathe (hospitalization). Clinical course of the events included the following information. The reporter informed that the patient died due to invasive pneumonia when she was 1 year and 11 months old, on 03Sep2018. She presented fever and she was hospitalized. The pediatrician took the appropriate actions according to the recommendation from the immunologist, but from one day to the other the patient had difficulty to breathe and later she was hospitalized in the intensive care unit. They performed drainage of the thorax and she was intubated but she died seven days later. They even collected the lung liquid and they sent to analysis in a different city, where it was verified the presence of serotype 19. They also performed an evaluation if the patient was immunosuppressed, but the result was all normal. The patient was healthy, she did not have any disease, nor any repeating disease, and she did not have the flu. Patient''s mother was a physiotherapist and they are looking for information to understand about seroconversion. They asked for clinical clarification, even though they knew that the patient received three doses of the vaccine until the seventh month of life and she did not receive the booster dose later. If needed, they had radiography images, lung liquid, and a little bit of the child''s blood. Invasive pneumonia had a fatal outcome. The outcome of the other events was unknown. It was unknown if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient towards the occurrence of fever, difficulty to breathe and the fatal invasive pneumonia with serotype 19 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: invasive pneumonia; invasive pneumonia


VAERS ID: 781846 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-09-27
Onset:2017-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPGLAXOSMITHKLINEJP2018JP

Write-up: This case was reported by a physician via licensee and described the occurrence of vomiting in a 3-month-old subject who received ROTARIX liquid formulation for prophylaxis. Concomitant products included ACTHIB, PREVENAR 13 and HEPATITIS B VACCINE. On 27th September 2017, the subject received the 1st dose of ROTARIX liquid formulation (oral). On 27th September 2017, less than a day after receiving ROTARIX liquid formulation, the subject experienced vomiting (serious criteria death). On 28th September 2017, the outcome of the vomiting was fatal. The subject died on 28th September 2017. The reported cause of death was vomiting. The reporter considered the vomiting to be unrelated to ROTARIX liquid formulation. Additional Details On 27 September 2017, the first doses of a rotavirus vaccine (the lot number: unknown), ACTHIB, a hepatitis B vaccine, a quadruple vaccine and PREVENAR 13 were simultaneously administered at Clinic B. At the night on the day, the subject vomited and was brought to Medical Center G. However, the hospital was changed to Hospital M since it was unable to receive the subject at the medical center. However, it was unable to receive the subject there, either. Therefore, the subject was brought to the other Medical Center S. On the way to the medical center, it was reported that the subject could be transported to the first Medical Center G. The subject was then transported to the medical center. On the way, the subject''s condition was suddenly changed. The procedure given at the medical center was unknown. On 28 September 2017, the subject was pronounced dead in the early morning. The reporting physician was neither a physician who gave vaccination nor a physician at the Medical Center G. The physician who gave vaccination explained to the subject''s guardian there was no causal relationship between the subject''s death and simultaneous vaccination and vaccines. Reported Cause(s) of Death: Vomiting.


VAERS ID: 782526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-04-12
Onset:2018-06-01
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2018-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T35168 / UNK - / SC

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Multiple organ dysfunction syndrome
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-07-17
   Days after onset: 46
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 coronary syndrome; Carotid endarterectomy (right); Coronary arterial stent insertion; Drug allergy (with cephalosporins); Drug intolerance (AUGMENTIN digestive intolerance); Hypertension arterial; Ischemic stroke; Osteoarthritis generalised; Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2018436693

Write-up: This is a spontaneous report from contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-BR20181262. A 90-year-old female patient received PREVENAR 13, (Lot # T35168) subcutaneous at single dose on 12Apr2018, PNEUMOVAX, (Lot # R008577) subcutaneous from 13Jun2018 to 13Jun2018 at 1 DF, both immunization (antibacterial prophylaxis). Medical history included osteoarthritis, carotid endarterectomy right, coronary arterial stent insertion from Dec2014 to an unknown date, AUGMENTIN digestive intolerance, hypertension arterial, acute coronary syndrome from Dec2014 to an unknown date, ischaemic stroke, drug allergy to cephalosporins, peripheral arterial occlusive disease. The patient''s concomitant medications were not reported. The patient experienced drug effect lack in Jun2018 and died from Multiorgan failure on 17Jul2018. It was not reported if an autopsy was performed. No follow-up attempts possible. Information about lot number already provided. No further information expected. Reported Cause(s) of Death: Multiorgan failure.


VAERS ID: 782532 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-09-12
Onset:2018-09-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X16195 / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose decreased, Death, Pallor, Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20180913; Test Name: Blood glucose; Result Unstructured Data: Test Result: 37.3; Test Date: 20180913; Test Name: Body temperature; Result Unstructured Data: Test Result: 31.8, Test Result Unit: Centigrade
CDC Split Type: ILPFIZER INC2018439156

Write-up: This is a spontaneous report from a physician received via the Health Authority (no regulatory number provided). A 9 weeks old female patient received PREVENAR 13 (lot/batch number: X16195), via an unspecified route of administration on 12Sep2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 13Sep2018, about 18 hours after receiving the vaccination, the patient died. The cause of death was unknown. An autopsy was not performed. The patient underwent resuscitation on 13Sep2018. Clinical course was as follows. The mother nursed at about 3 in the morning and when she woke up in the morning to nurse again, she found the girl death. According to the mother, from the moment she received the vaccine she did not observe any events that were out of the ordinary like fever, different alert levels. She nursed as usual and her hours of sleep were normal. The patient arrived at trauma room at 09:40 on 13Sep2018 she arrived by the mother and her brother wrapped in an infant seat. She was taken out of the infant seat in the trauma room. First impression: no reaction, not breathing and no pulse, limbs cold, pale. Beginning signs of "death stains" without external signs of injury. Resuscitation activities began at 09:40. I.O. Adrenalin 0.5 ML was administered at 09:50, 09:51 and 09:52. Death declared at 9:58. At 09:50 dex was 37.3, body temperature was 31.8 ?C. The police was called and she was sent to the investigation building. No follow up attempts possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 782539 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Crying, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: RUSA2018SA291926

Write-up: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious social media case received from a consumer. This case involves a six months old female patient who experienced sudden infant death syndrome and agitated and cried as never before while she received vaccine HEPATITIS B VACCINE, HIB and IMOVAX POLIO. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HIB not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, post vaccination, several days after, at night patient was very agitated and cried as never before. On an unspecified date, on Tuesday during the afternoon patient died due to sudden infant death syndrome. Patient was taken to local hospital, where death was confirmed. Other relevant tests included no lab data. Final diagnosis was sudden infant death syndrome. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for the event agitated and cried as never before. It is unknown if an autopsy was done. The cause of death was sudden infant death syndrome. Patient''s mother believes the reason of death was due to HIB while doctors say it was sudden infant death syndrome. Both HCPs and mother did not relate this event to use of IMOVAX POLIO. List of documents held by sender: none. Sender''s Comments: This case involves an infant who died after vaccination with IMOVAX POLIO. The time to onset is not known. Moreover, there is no information regarding patient''s medical condition at the time of vaccination, nor lab tests provided that rule out alternate etiologies. Sudden and unexplained deaths with respiratory abnormalities in this age group are commonly related to sleeping position, metabolic defects or cardiovascular causes. These alternate etiologies need to be ruled out. The reporting physician and patient''s mother consider the fatal outcome as being unrelated to vaccination and we agree with the assessment. Based upon the reported information, the role of the vaccine seems unlikely. Reported Cause(s) of Death: sudden infant death syndrome.


VAERS ID: 782576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-07-25
Onset:2018-08-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2018-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Blood iron abnormal, Exposure during pregnancy, Stillbirth, Ultrasound antenatal screen normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-08-01
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ferrous Sulphate; NATALIZUMAB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20180627; Test Name: Blood glucose; Result Unstructured Data: Test Result: Normal, Test Result Unit: unknown; Test Date: 20180627; Test Name: Blood test; Result Unstructured Data: Test Result: 28 Week blood test - only iron levels were a conce, Test Result Unit: unknown; Test Date: 20180312; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: 12 week scan - normal, Test Result Unit: unknown; Test Date: 20180503; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: 20 week scan - normal, Test Result Unit: unknown
CDC Split Type: GBGLAXOSMITHKLINEGB201819

Write-up: This retrospective pregnancy case was reported by a consumer via regulatory authority and described the occurrence of stillbirth in a female patient exposed to DTPa-IPV (DTPa-IPV) in utero. The mother received the product for product used for unknown indication. The parent''s medical history included multiple sclerosis, blood glucose normal and blood test (28 Week blood test - only iron levels were a concern). Concomitant product exposures included ferrous sulfate (Ferrous Sulphate) and natalizumab. On 25th July 2018, the mother received DTPa-IPV. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, at [weeks gestation], the patient was born via unknown delivery. The patient was diagnosed with stillbirth (serious criteria death, disability, GSK medically significant and other). On an unknown date, the patient experienced foetal exposure during pregnancy (serious criteria disability and other). On 3rd August 2018, the outcome of the stillbirth was fatal. On an unknown date, the outcome of the foetal exposure during pregnancy was unknown. The patient died on 1st August 2018. The reported cause of death was stillbirth. It was unknown if the reporter considered the stillbirth and foetal exposure during pregnancy to be related to DTPa-IPV. Additional information: The concomitant natalizumab was used for multiple sclerosis by patient''s mother. Initial information was reported by a consumer via regulatory authority on 24th October 2018. Stillbirth and foetal exposure during pregnancy.; Reported Cause(s) of Death: Stillbirth.


VAERS ID: 782775 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131810JPN003012J

Write-up: This solicited report has been received from the patient''s family via regulatory authority (NPAE-181025-001) on 25-OCT-2018. Information has been received from the patient''s family concerning an elderly male patient who was subcutaneously vaccinated with pneumococcal vaccine polyvalent (23-valent) injection (product name unknown) for prophylaxis (vaccination date, dose and lot number not reported). No concomitant medications were reported. On an unknown date, the patient and his wife were vaccinated with pneumococcal vaccine polyvalent (23-valent). On an unknown date, the patient who controlled the vaccination history, etc. died. The cause of death and whether an autopsy was performed were not reported. Reporter''s comment: Not provided. The reporter did not assess the relationship of death to pneumococcal vaccine polyvalent (23-valent). Company Causality Assessment: Based on the limited information currently available for this case, a reasonable causal association between therapy and the reported event cannot be established. Missing clinically important information includes Details of the cause of death. Reported Cause(s) of Death: Death.


VAERS ID: 782867 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-07-07
Onset:2018-10-01
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2018-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Bladder catheterisation, Cerebral haemorrhage, Death, Hyporesponsive to stimuli, Mobility decreased, Nuclear magnetic resonance imaging brain abnormal, Seizure, Urinary tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-01
   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: DUOLIN RC; COMBIMIST L; VENTIDOX BRO; STAMINA; NEWCOMIX; PULMOCLEAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure abnormal; Diabetes
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result: 190/90; Test Date: 2018; Test Name: MRI; Result Unstructured Data: Test Result: Internal brain hemorrhage
CDC Split Type: INPFIZER INC2018439652

Write-up: This is a spontaneous report from a contactable physician. An 82-year-old male patient received PREVENAR 13 (Batch# S50895), via an unspecified route of administration, on 07Jul2018, at single dose, for immunisation. Medical history included diabetes mellitus, blood pressure abnormal and asthma. He was never admitted to hospital in his life time (treated as an outpatient for medical history). Concomitant medications included ipratropium bromide, salbutamol sulfate (DUOLIN RC); ipratropium bromide, levosalbutamol sulfate (COMBIMIST L); ambroxol, doxofylline (VENTIDOX BRO); glucose, vitamin b nos (STAMINA); acetylcysteine, isoprenaline hydrochloride (NEWCOMIX); acetylcysteine, ambroxol acefyllinate (PULMOCLEAR). On 08Jul2018 the patient experienced mobility got reduced and not able to respond properly. On 09Jul2018, early morning, he developed seizure for the first time in his life. He never had any neurological problem in his life time. He was very fit and active. Then the patient was admitted to hospital and an MRI scan was performed. The doctor diagnosed internal brain hemorrhage that developed within 48 hours before. Blood pressure on unspecified date was 190/90. Hospital stay lasted for about two weeks and not much improvement was shown. The patient was discharged with medication at home. Then he was treated for urinary tract infection which developed due to the urine catheter insertion. He became completely bedridden and passed away on 01Oct2018. It was not reported if an autopsy was performed.; Sender''s Comments: All reported events occurred in the advanced old patient are not related to the vaccination with PREVENAR 13. Mobility got reduced and not able to respond properly and seizure are compatible with the typical symptoms of internal brain hemorrhage resulting from high blood pressure. Urinary tract infection represents the complication as a consequence of urine catheter insertion. Death is associated with the worsening of the cerebral hemorrhage. 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: passed away.


VAERS ID: 783202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131810FRA013225

Write-up: This spontaneous report was received from a physician via a lay press article concerning a female patient of unknown age who was reported to be an rowing champion. The report was also identified on the website of the physician in an article. Letter to the parliamentarians". The patient''s pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry, dose, frequency and route of administration unknown) for prophylaxis. On an unknown date, the patient died at 33 years of age from cervical cancer (cervix carcinoma). It was unknown if autopsy was performed. The reporter''s causality assessment was not provided. Upon internal review, the event cervix carcinoma was determined to be medically significant. Reported Cause(s) of Death: The patient who was an champion of rowing died at 33 years from cervical cancer after being vaccinated.


VAERS ID: 783274 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-07-29
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: AU0095075131810AUS011861

Write-up: Information was received from an publication and an online article. On an unknown date when the female patient was 23 years old, she received the GARDASIL (lot number, dosage and route of administration not provided). No information was provided concerning the patient''s past medical history, concurrent conditions, or concomitant medication. The patient was diagnosed with cervical cancer when she was 30 years old. The patient and her family "fought for years against a terminal diagnosis." The patient shared her story before she passed away on 29-JUL-2018 and had stated that she felt very passionately about spreading the word on the destruction that GARDASIL could cause. It is unknown if an autopsy was performed. The event of cervical cancer was considered to be related to GARDASIL. Upon internal review, cervical cancer was determined to be medically significant. Additional information is not expected. Reported Cause(s) of Death: Cervical cancer.


VAERS ID: 783320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-10-11
Onset:2018-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRPFIZERINC2018436209

Write-up: This is a spontaneous report from a contactable physician via Pfizer sales representative via Corporation, manufacturer control number 2018-10017, license party for PREVENAR 13. A 73-year-old patient was administered PREVENAR 13 intramuscular at single dose and influenza vaccine (3 valent) both on 11Oct2018 for immunization. Patient medical history and concomitant medications were not reported. On an unknown date in Oct2018, the patient experienced myocarditis, due to which died on Oct2018. It was unknown if an autopsy was performed. The patient went to a university hospital on 14Oct2018 and was confirmed as myocarditis. Since it was confirmed that the patient was administered 3-valent influenza vaccine and pneumococcal 13-val conjugate vaccine, the university hospital reported it to local government health center, who called the reporting physician, so the reporting physician got to know it. There was no special adverse events after the vaccines administrations. Follow-up (23Oct2018): This is a spontaneous report from a contactable physician via Corporation, manufacturer control number 2018-10017, license party for PREVENAR 13. The patient was administered PREVENAR 13 and influenza vaccine (3 valent) on 11Oct2018 together. About one week after the administration, local government health center informed the physician that the patient died due to myocarditis. The government health center told that the patient had been administered vaccines, so a related investigation might be conducted to the physician''s office. No follow-up attempts are possible; information about batch number cannot be obtained. Sender''s Comments: Fatal myocarditis occurred 3 days following the vaccination with both PREVENAR 13 and influenza vaccine (3 valent). There is no plausible mechanism to implicate PREVENAR 13 to the development of myocarditis. Given the patient''s old age, the underlying medical conditions most likely provided explanations for the onset of the event. More information especially medical history, concomitant medications and concurrent illnesses such as the predisposing factors including viral/bacterial infections are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: myocarditis.


VAERS ID: 783321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-09-19
Onset:2018-09-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD313A / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC101AC / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201819

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death syndrome in a 3-month-old male patient who received INFANRIX HEXA (batch number A21CD313A, expiry date 31st May 2020) for prophylaxis. Co-suspect products included ROTARIX liquid formulation (batch number AROLC101AC, expiry date 31st October 2020) for prophylaxis. On 19th September 2018, the patient received the 2nd dose of INFANRIX HEXA (intramuscular) .5 ml and the 2nd dose of ROTARIX liquid formulation (oral) 1.5 ml. On 20th September 2018 13:30, 1 days after receiving INFANRIX HEXA and ROTARIX liquid formulation, 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 20th September 2018. The reported cause of death was sudden infant death syndrome. An autopsy was performed. The reporter considered the sudden infant death syndrome to be possibly related to INFANRIX HEXA and ROTARIX liquid formulation. Additional details: The age at vaccination was not reported, however the patient could be 2 to 3 months old at the time of vaccination. The suspect product was reported ROTARIX upon batch number review AROLC101AC it was change to ROTARIX liquid formulation. The patient received INFANRIX HEXA on left thigh. Initial information was reported by a physician via regulatory authority on 30th October 2018: Sudden infant death syndrome. Sender''s comments: According to the information given by the reporting physician, the suspected cause of child''s death was cot death. This information was confirmed by the autopsy results. The reporting physician did not see a causal relationship between the administration of INFANRIX HEXA and ROTARIX, and the death of the child. This report from the reporting physician also confirmed the results of autopsy. The information given above indicates a possible temporal coincidence between vaccination and death of the child. Due to the report of the reporting physician confirmed by autopsy results, it was decided to exclude causal relationship between the administration of the vaccines and the death of the child. Reports were made on the basis of the definition of an adverse event following immunization, specified in the Act, on the prevention and control of infections and infectious diseases in humans, according to which, an adverse event following immunization is an undesirable disease symptom remaining in temporal relationship with the vaccination performed. In turn, the ordinance of the Minister of Health of December 21, 2010, on adverse events following immunization and the criteria for their diagnosis, states that unless otherwise stated and except for reactions after vaccination BCG, temporarily associated with vaccination are diagnosed health disorders that occurred within 4 weeks after vaccination. In accordance with the above-mentioned provisions, the time criterion retained (even with the simultaneous exclusion of causal relationship) is a sufficient criterion to qualify each health event that is in temporal relationship with vaccination as an adverse event following immunization. The reporter qualified AEFI as serious. Due to the assessment of the reporter and due to the child''s death, regulatory authority qualified AEFI as serious. Note: The regulatory authority reported causality for Sudden infant death syndrome was No relation from sender comment it was captured possible. Reported Cause(s) of Death: Sudden infant death syndrome.


VAERS ID: 783917 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-01
Onset:2018-10-09
   Days after vaccination:8
Submitted: 2018-10-29
   Days after onset:20
Entered: 2018-11-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251216C1A / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-09
   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: Levothyroxine sodium; Lansoprazole; ACCRETE D3; Glyceryl trinitrate; LAXIDO; Clopidogrel; Alogliptin; Folic acid; Cassia senna; Metformin; Simvastatin
Current Illness: 2004 Diabetes mellitus;
Preexisting Conditions: 1997 to Unknown, Myocardial infarction; 1998 to Unknown, Coronary artery bypass graft; 2008 to Unknown, Thyroidectomy partial; 2009 to Unknown, Pulmonary fibrosis; 2015 to Unknown, Pneumonia; NOV-2017 to Unknown, Gastrointestinal bleed; APR-2017 to Unknown, Pneumonia; 29-Oct-2018 14:20, Admitted
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201804803

Write-up: This spontaneous case, reported by other health professional to Agency and initially retrieved on 23-Oct-2018 by Seqirus from Agency (regulatory reference number: GB-MHRA-EYC 00187376), concerns an 80-year-old, elderly, female, patient of height 162 cm. The patient''s medical history included myocardial infarction on an unspecified date in 1997, coronary artery bypass on an unspecified date in 1998, thyroidectomy partial on an unspecified date in 2008, pulmonary fibrosis on an unspecified date in 2009, pneumonia on an unspecified date in 2015 and on an unspecified date in Apr-2017, gastrointestinal bleed on an unspecified date in Nov-2017. The patient''s current condition included diabetes mellitus since an unspecified date in 2004. The concomitant medications included Levothyroxine Sodium (100 ug), Lansoprazole (30 mg), ACCRETE D3, Glyceryl Trinitrate, LAXIDO, Clopidogrel (75 mg), Alogliptin (25 mg), Folic Acid (5 mg), Cassia senna (7.5 mg), Metformin (2 g), Simvastatin (40 mg) for unknown indications. On 01-Oct-2018, the patient was administered FLUAD (TIV), dose: 0.5 ml, route of administration: intramuscular, batch number: 251216C1A, anatomical location and expiry date: not reported]. On 09-Oct-2018, 8 days after the administration of the vaccine, the patient died. The cause of death was unknown (reported as death unexplained). It was unknown if autopsy was performed or not. The reporter assessed the case as serious (death and hospitalization).


VAERS ID: 783873 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-06-08
Onset:2018-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. N028295 / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR N1H20 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 17C02A / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: 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: 2018-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Weight; Test Result: 2700 g; Comments: At birth
CDC Split Type: JP0095075131810JPN003743J

Write-up: Information has been received for a direct report from the PMDA [V18100483] on 29-OCT-2018, regarding a case provided by the physician. Initial information has been received from the physician concerning a 2-month-old female infant patient. There were no special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination and disease within the recent 1 month, currently taken medications, past adverse reaction and growth status). The patient had no family history. On 08-JUN-2018, the patient was vaccinated with HEPTAVAX-II (lot number: N028295, lot number: 0000744708) (the first dose, volume: unknown, vaccination route: parenteral, site: unknown) for prophylaxis. Other suspect drugs included PREVENAR 13 (the first dose, day of inoculation: 08-JUN-2018, volume: unknown, indication: prophylaxis, vaccination route: parenteral, site: unknown) (lot number: 17C02A, lot number: 17C02A) and ACTHIB (the first dose, day of inoculation: 08-JUN-2018, volume: unknown, indication: prophylaxis, vaccination route: parenteral, site: unknown) (lot number: N1H20, lot number: N1H20). Other concomitant medications were not reported. On 08-JUN-2018, body temperature before vaccination: 36.9 degrees Celsius. At 9:30 the patient was vaccinated with hepatitis b vaccine (recombinant) (as stated above). Around 23:00 the patient was given the breast as usual. On 09-JUN-2018, around 5:00 the parents noticed a respiratory arrest and the patient was transferred to A hospital. Death was confirmed. Reporter''s comment: Although the patient''s general condition was good before vaccination, the patient died within 24 hours. Therefore, causal relationship with vaccination could not be ruled out. The reporting physician felt that causal relationship between death and hepatitis b vaccine (recombinant) was unknown, and considered causative factors could not be assessable. Lot number (lot number: N028295, lot number: 0000744708) has been verified to be a valid lot number for hepatitis b vaccine (recombinant). Reported Cause(s) of Death: Death.


VAERS ID: 783967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-10
Onset:2018-10-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Death, Myocardial infarction, Nasal congestion, Pyrexia, Respiratory tract infection bacterial, Respiratory tract infection viral, Rhinorrhoea, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-21
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia (hospitalized in a psychiatric clinic, treatment followed for years but not specified); Hypertension (hospitalized in a psychiatric clinic, treatment followed for years but not specified)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRGLAXOSMITHKLINEGR2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of respiratory tract infection viral in a 78-year-old male patient who received Flu Seasonal QIV Dresden (FLUARIX TETRA 2018-2019 season) for prophylaxis. Concurrent medical conditions included dementia (hospitalized in a psychiatric clinic, treatment followed for years but not specified) and hypertension (hospitalized in a psychiatric clinic, treatment followed for years but not specified). On 10th October 2018, the patient received the 1st dose of FLUARIX TETRA 2018-2019 season. On 12th October 2018, 2 days after receiving FLUARIX TETRA 2018-2019 season, the patient experienced respiratory tract infection viral (serious criteria death), runny nose, weakness, cough, nasal congestion and fever. In October 2018, the patient experienced heart attack (serious criteria death and GSK medically significant) and respiratory tract infection bacterial (serious criteria GSK medically significant). The patient was treated with DEPON, AVELOX, normal saline, Inhaler (Nos), medication unknown, Syrup (Nos) and Bronchodilator. On 21st October 2018, the outcome of the respiratory tract infection viral and heart attack were fatal. On an unknown date, the outcome of the respiratory tract infection bacterial was unknown and the outcome of the runny nose, weakness, cough, nasal congestion and fever were not recovered/not resolved. The patient died on 21st October 2018. The reported cause of death was respiratory infection and heart attack. An autopsy was performed. The reporter considered the respiratory tract infection viral and heart attack to be unrelated to FLUARIX TETRA 2018-2019 season. It was unknown if the reporter considered the respiratory tract infection bacterial to be related to FLUARIX TETRA 2018-2019 season. The reporter considered the runny nose, weakness, cough, nasal congestion and fever to be probably related to FLUARIX TETRA 2018-2019 season. Additional information was reported as follows: The patient was not vaccinated with FLUARIX TETRA before. On 12th October 2018, two days after vaccination with FLUARIX, the patient experienced viral infection like disease with symptoms runny nose, weakness, cough, nasal congestion and fever. On 15th October 2018, the patient experienced respiratory infection by ingestion. The patient was treated with DEPON for fever, syrup and inhaler for cough and normal saline for nasal congestion. The patient was also treated with AVELOX and unspecified Bronchodilator, but the patient still died on 21st October 2018. The autopsy report mentioned death cause heart attack and respiratory infection by ingestion. The physician correlated the occurrence of all the adverse events with FLUARIX except heart attack and respiratory infection. On the date of reporting, follow-up information was received from the Medical Department of the company and via another communication with the physician. The follow-up information clarified that the patient had experienced viral respiratory infection in the context to the viral infection like disease that was reported one day before the date of reporting. The respiratory tract infection caused by ingestion was of bacterial type. It was also stated that, regarding all the other adverse event, apart from respiratory infection and heart attack the reporter considered they are all related to FLUARIX TETRA and was not definite as reported before the date of reporting. Since, the patient''s vaccination took place in the context of vaccination of about 100 people within 2 days and therefore the reported considered the possibility of coincidence of vaccination with incubation period of the viral infection, due to the closed community of the clinic. This case was linked with case GR2018GSK196870, reported by the same reporter. Reported Cause(s) of Death: Respiratory infection by ingestion; Heart attack.


VAERS ID: 784001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S70877 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Septic shock, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Toxic-septic shock conditions (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2018446216

Write-up: This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. This is a report received from the Health Authority. The regulatory authority report number is DE-PEI-PEI2018003773. An 18-month-old male patient received the PREVENAR 13, on 09Jun2017 (Lot Number: S15844) and 04Aug2017 (Lot Number: S70877); both via unspecified routes of administration at single doses for immunization. The patient''s medical history and concomitant medications were not reported. On 13Oct2018, the patient experienced vaccination failure and septic shock, which required hospitalization, was life threatening, and caused death, per the reporting physician. Therapeutic measures were not taken as a result of the events, vaccination failure and septic shock. The clinical outcome of the events, vaccination failure and septic shock, was fatal. The patient died on an unspecified date due to septic shock and vaccination failure. It was not reported if an autopsy was performed. Sender''s Comments: "Patient died in septic shock. Was an outpatient treatment required? No". No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: vaccination failure; Septic shock.


VAERS ID: 784243 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC2018383804

Write-up: This is a spontaneous report from a non-contactable physician through the Vaccine Senior Associate Scientific Advisor. An adult male patient received PREVENAR 13, via an unspecified route of administration, on an unspecified date as a single dose for immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced heart attack, 4 days after the vaccination on an unspecified date. The clinical outcome of heart attack was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. It was reported that the physician considered the event unrelated to vaccination with PREVENAR 13. No follow-up attempts are possible; information about batch/lot number cannot be obtained. Follow-up (31Oct2018): New information received from the Vaccine Senior Associate Scientific Advisor includes: suspect product data (suspect product was updated from PREVENAR to PREVENAR 13). No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender''s Comments: Fatal heart attack is considered unrelated to the use of PREVENAR 13 in accordance with the reporting physician. More information such as medical history and concomitant medications needed for full medical assessment.; Reported Cause(s) of Death: heart attack.


VAERS ID: 784401 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV QUEBEC) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2018GS

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in an unspecified number of patients who received Seasonal Influenza vaccine unspecified for prophylaxis. On an unknown date, the patients received Seasonal Influenza vaccine unspecified. On an unknown date, unknown after receiving Seasonal Influenza vaccine unspecified, the patients 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. The reporter considered the unknown cause of death to be possibly related to Seasonal Influenza vaccine unspecified. Additional details were provided as follows: The case was reported via SHINGRIX page. The age at vaccination was not applicable. The reported stated that he /she knew too many people, seniors, who died after getting the flu shot. No lot number and expiry date were provided. No consent to healthcare professional (HCP) information for follow up. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 784426 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Amputation, C-reactive protein increased, Death, Disseminated intravascular coagulation, Intensive care, Meningitis, Pneumococcal infection, Pneumococcal sepsis, Renal failure, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious meningitis (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO0095075131811NOR002242

Write-up: Information has been received from the authors as stated above, regarding a 60-year-old female patient. The patient was given splenectomized and pneumococcal vaccine (manufacturer unknown) 1 year prior. The patient was involved in a combined retrospective and prospective cohort study of the most severe cases of pneumococcal sepsis admitted to a specified hospital. Inclusion criteria were respiratory failure, defined as treatment with invasive mechanical ventilation and growth of Streptococcus pneumoniae in blood cultures (confirmation of bacteriology). The patient did not show gastrointestinal symptoms and signs. The pneumococcal infection focused on meningitis. White blood cell count at primary admission and C-reactive protein at primary admission showed 11.6 x 10^9/l and 193 mg/L, respectively. SOFA, which meant Sequential [Sepsis-related] Organ Failure Assessment showed 12/15/3 at the stages of in, max and out, respectively. The patient presented the disseminated intravascular coagulation (also included in multiorgan failure (MOF)); MOF showed the result of 4 (max. 6) with renal failure. The patients'' complications included amputation. The patient was in medical intensive care unit for 40 days in a specified hospital for 40 days. The patient died in the end. The authors considered events to be related to pneumococcal vaccine (manufacturer unknown). Upon internal review, pneumococcal sepsis, renal failure and pneumococcal infection were determined to be medically significant. This is one of two reports received from same literature (MARRS# 1811NOR000472).


VAERS ID: 784764 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-23
Onset:2018-10-24
   Days after vaccination:1
Submitted: 2018-11-06
   Days after onset:13
Entered: 2018-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 251225C1A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown date, Myocardial infarcation acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201805125

Write-up: This spontaneous case, reported by other health professional (physician) to Regulatory Authority and initially retrieved on 02-Nov-2018 by Seqirus from Regulatory Authority (regulatory reference number: IT-MINISAL02-507702), concerns a 91-year-old, elderly, female patient. The patient''s historical condition included IMA (myocardial infarction acute). On 23-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml (1 DF), route of administration: intramuscular, batch number: 251225C1A, anatomical location and expiry date: not reported]. On an unspecified date in Oct-2018, the patient experienced ischemic heart disease. On 24-Oct-2018, one day after vaccination, the patient died. The suspected cause of death was reported as ischemic heart disease. It was unknown if autopsy was performed or not. The reporter assessed the case as serious (death). Case Comment: A 91-year-old female patient with previous history of acute myocardial infarction died, 1 day after receipt of FLUAD TIV vaccine. The cause of death was suspected as ischemic heart disease (IHD), an unspecified date after vaccination. The event IHD can be alternately explained by previous history of acute MI with possible existing myocardial ischaemia and the event death can be alternately explained by IHD, rather than the suspect vaccine. Also, there is no known biological plausibility between influenza vaccination and event IHD. Hence, the company assessed the causality of the events as not related. Progressive age of the patient is considered as risk/confounding factor.


VAERS ID: 784823 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-19
Onset:2018-10-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX728AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chronic respiratory failure, Death, Gastrostomy, Hyperthermia, Tachycardia paroxysmal, Terminal state, Tracheostomy
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (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: 2018-10-19
   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: NUSINERSEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT201820

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 4-year-old female patient who received BEXSERO (batch number ABX728AA, expiry date unknown) for prophylaxis. Concomitant products included nusinersen. On 19th October 2018, the patient received BEXSERO (unknown) 5 ml. On 19th October 2018 22:00, less than a day after receiving BEXSERO, the patient experienced hyperthermia (serious criteria death). On 19th October 2018 23:00, the patient experienced cardiac arrest (serious criteria death and GSK medically significant), death imminent (serious criteria death and GSK medically significant) and tachycardia paroxysmal (serious criteria death). On 19th October 2018, the outcome of the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia were fatal. The patient died on 19th October 2018. The reported causes of death were cardiac arrest, tachycardia paroxysmal, hyperthermia and death imminent. An autopsy was not performed. It was unknown if the reporter considered the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia to be related to BEXSERO. Additional information: The route of administration of BEXSERO was reported as Intravenous in the source document. Initial information was received from a physician via regulatory authority on 5th November 2018: Sudden hyperthermia at 10 PM, paroxysmal tachycardia followed by cardiac arrest and death at 11 PM. Reporter''s comments: Clinical report by the signaler: (as per regulations): ''The report refers to a four year old girl Patient affected by SMA Type 1, in integrated home care with chronic respiratory failure in VMI h 24, tracheostomy and PEG. Patient treated with NUSINERSEN given periodically by intrathecal route from 13/01/2017 at the hospital (last administration 14/07/2018). Administered to Patient (truncated sentence). Reported Cause(s) of Death: Cardiac arrest; Tachycardia paroxysmal; Hyperthermia; Death imminent.


VAERS ID: 785465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131811CAN003700

Write-up: This spontaneous report was received from a physician, via a company representative, and refers to a female patient of unknown age. No information was provided regarding the patient''s medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unknown date, (reported as "several years ago"), the patient was vaccinated with GARDASIL (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient died. The cause was unknown, as well as, if an autopsy was performed or not. It was stated that the reporter was looking for more information and whether the patient had any underlying conditions. The causal relationship between therapy with GARDASIL and the patient''s death was unknown. Reported Cause(s) of Death: deceased.


VAERS ID: 785469 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-10-30
Onset:2018-11-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W62466 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNPFIZER INC2018451241

Write-up: This report was received via a sales representative. A 3-months-old patient received PREVENAR 13; (Lot #W62466W07368) on 30Oct2018 via an unknown route of administration at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient''s condition was not good after receiving the product and was sent to hospital. The patient died at 3 AM on 01Nov2018 and was diagnosed as Asphyxia death by physician. The reporter didn''t give conclusion if it was related to PREVENAR 13. It was not reported if an autopsy was performed. Sender''s Comments: Based on the information currently available, Asphyxia leading to death more likely represents an intercurrent respiratory condition unlikely related to the vaccination with PREVENAR 13. More information such as medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Asphyxia.


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