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VAERS ID: 809552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-15
Onset:2019-01-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2019-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADRIGYL
Current Illness: Hypospadias
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2019150875

Write-up: sudden infant death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Agency-WEB [other manufacturer number FR-GLAXOSMITHKLINE-FR2019GSK036880]. A 2-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), intramuscular, on 15Jan2019, at single dose, for immunization and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA), intramuscular, on 15Jan2019, at an unspecified dose, for immunisation. Medical history included ongoing hypospadias. Concomitant medication included colecalciferol (ADRIGYL) from 06Nov2018 to 23Jan2019 for vitamin supplementation. The patient experienced sudden infant death on 23Jan2019 at 03:55 AM. The event was considered serious as fatal and medically significant. An autopsy was not performed. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: sudden infant death


VAERS ID: 809928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, 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: DE0095075131904DEU004855

Write-up: Anaphylactic shock; This spontaneous report was received from a physician via company representative referred to a female patient (reported as young girl) of unknown age. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot # and expiry date were not reported). On an unknown date (reported as within a few minutes after the vaccination), the patient passed away due to anaphylactic shock. It was also reported that she couldn''t remember the source document. It was unknown whether an autopsy was performed. The reporting physician did not provide any causality assessment. Upon internal review, the event anaphylactic shock was determined to be medically significant.; Reported Cause(s) of Death: Anaphylactic shock


VAERS ID: 810072 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2019-04-04
Onset:2019-04-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Regurgitation, Sudden infant death syndrome
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-05
   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: ITGLAXOSMITHKLINEIT2019GS

Write-up: death due to an unknown cause; fatal regurgitation; This case was reported by a non-health professional via other and described the occurrence of cot death in a 2-month-old male patient who received Rota (Rotarix) for prophylaxis. Co-suspect products included HEXYON for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) for prophylaxis. On 4th April 2019, the patient received Rotarix (oral), HEXYON and PREVENAR 13. On 5th April 2019, 1 days after receiving Rotarix, the patient experienced cot death (serious criteria death and GSK medically significant) and regurgitation (serious criteria death). On an unknown date, the outcome of the cot death and regurgitation were fatal. The patient died on 5th April 2019. The reported cause of death was cot death. An autopsy was not performed. The reporter considered the cot death to be possibly related to Rotarix. It was unknown if the reporter considered the regurgitation to be related to Rotarix. Additional details were provided as follows: This case was communicated to us by colleagues and it was news in the newspaper. On 5th April 2019, the patient died. Death cause was not clear. The patient the day before the death had been subjected to normal vaccinations: hexavalent and pneumococcal vaccine. The colleagues contacted the physician of the hospital and the physician said that the vaccines administered were Rotarix, probably Prevenar 13 and Hexyon (the two vaccines in the email have been partially canceled). In two other articles the cause of the death of the infant was reported as cot death, probably due to a fatal regurgitation in the cradle. The infant would not have had any health problems in the days before his death. On the date of reporting another newspaper reported that, the patient was found in a supine position by the parents who noticed that he was no longer breathing. The reporter considered the cot death to be possibly related to Prevenar 13 and Hexyon as well. It was unknown if the reporter considered the regurgitation and supine position to be related to Prevenar 13 and Hexyon as well. No further information available. Follow up had been requested.; Reported Cause(s) of Death: cot death


VAERS ID: 810393 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2019-03-30
Onset:2019-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R026358 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131904DEU006655

Write-up: SIDS; Information has been downloaded from regulatory authority (DE-PEI-PEI2019002076) This spontaneous report was received from a physician concerning a 8 week old male patient. The patient''s concurrent conditions and medical history, as well as concomitant medications were not reported. On 30-MAR-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and frequency were unknown) lot # R026358, expiration date 31-MAR-2020 dose 1, orally, hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) (strength, dose, frequency and expiration date were unknown) Lot # reported as N3P123V, intramuscularly and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (strength, dose, frequency and expiration date were unknown) lot# reported as AD6320, intramuscularly, all vaccines for prophylactic vaccination. On the same date, the patient experienced sudden infant death syndrome. The reporter stated that the patient died at home and with the arrival of the emergency doctor, the patient already certained death signs and no treatment was given to the patient. An autopsy was performed to the patient but the report was not yet available. The causality between sudden infant death syndrome and the suspect vaccines was unknown.; Reported Cause(s) of Death: SIDS


VAERS ID: 810541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2019146339

Write-up: pneumococcal bacteremia; pneumococcal bacteremia. This is a report from a Non-Interventional study source, IIR clinical trial, for Protocol ID WI180203 A 12-month-old female patient received 3 doses (lot# unknown) of pneumococcal 13-val conjugate vaccine (PREVENAR 13), administered respectively first dose at the age of 3 month, second dose at unknown age, third dose at 7 month, all on unspecified date at single dose, route of administration unknown for immunization. The patient medical history showed no chronic diseases, immune defects. The child was not a premature baby. Concomitant medication were not reported. The patient experienced pneumococcal bacteraemia without focus on an unspecified date in 2018 with fatal outcome. S. pneumoniae were detected by blood culture but a serotype was not evaluated. The reporter''s assessment of the causal relationship of the event pneumococcal bacteremia without focus with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; 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: Drug ineffective; Pneumococcal bacteremia


VAERS ID: 810653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: ITPFIZER INC2019161176

Write-up: Death; This is a spontaneous report received from a contactable Health Care Professional of Local Health Authority via MSD Company. A 2-month-old male patient received, on an unspecified date, pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) at single dose; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXYON) at single dose and rotavirus vaccine live oral 1v (ROTARIX) at single dose; all for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient died while sleeping in his crib. The cause of death was unknown at the time of the report. The prosecutor ordered an autopsy. At the time of the report it was unknown if autopsy was performed. The information on the lot number has been requested.; Sender''s Comments: There is limited information available at this point, based on the information available and known safety profile of the product it is unlikely that the reported event is related to the suspect product. Case reevaluated based on additional information received The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 810654 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2019-03-26
Onset:2019-03-01
Submitted: 0000-00-00
Entered: 2019-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER R009565 / 1 - / -
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNB062DE / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Crying, Death, Defaecation disorder, Fluid intake reduced, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131904NLD006440

Write-up: side effect on or around the injection site, little leg, pain; bijwerking op of rond de prikplaats, beentje, pijn; passed away; overleden; fever; koorts; changed defecation; veranderde ontlasting; crying a lot; veel huilen; badly drinking; slecht drinken; Information has been downloaded from regulatory authority (agency #NL-LRB-00327297). This spontaneous report as received from a physician refers to a 5 week old female patient. The patient''s concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2019, the patient was vaccinated with the first dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) lot # R009565, expiry date 31-JAN-2021, 1 dosage form, in leg for routine childhood immunisation. Other suspect therapies included given on the same date, the first dose of pneumococcal 10v conj vaccine (protein d/dip toxoid/tet toxoid)(SYNFLORIX) 1 dosage form, batch # ASPNB062DE , in leg as a part of the immunization program for babies and children. On unknown date in March 2019, the patient experienced badly drinking, crying a lot and changed defecation. On 26-MAR-2019, the patient experienced injection site pain and pyrexia. On 27-MAR-2019, the patient''s highest measured temperature was 38.7 degree Celsius. The outcome of injection site pain and pyrexia was reported as fatal. The outcome of badly drinking, crying a lot and changed defecation was unknown. The patient died on 03-APR-2019 (onset date reported as 26-MAR-2019). The cause of death was unknown. It was unknown if an autopsy was performed. The reporter considered injection site pain and badly drinking to be certainly related, death and abnormal feaces to be possibly related and fever and crying a lot to be probably related to both suspect therapies.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 811166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / UNK - / -
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoinflammatory disease, Blood culture negative, Blood immunoglobulin A normal, Blood immunoglobulin E, Blood immunoglobulin G increased, Blood immunoglobulin M normal, C-reactive protein increased, Chest X-ray abnormal, Condition aggravated, Death, Gene sequencing, Hepatosplenomegaly, Inflammation, Leukocytosis, Lymphocyte percentage, Mycobacterium tuberculosis complex test negative, Neutrophil percentage increased, Polymerase chain reaction, Pulmonary oedema, Pyrexia, Rash erythematous, Red blood cell sedimentation rate increased, Respiratory distress, Skin lesion, Skin mass, White blood cell count increased
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoinflammatory disease (OTULIN-related auto inflammatory syndrome); Gene mutation (OTULIN Mutation); Leukocytosis ((WBC: 35.7 x 10E6) (normal range: 5-21)); Neutrophilia (69 % (normal value: 45) elevated ESR, CRP, and total IgG); Nodule (Soon after birth and treated with broad-spectrum antibiotic therapy and with interferon-?)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: IgA; Result Unstructured Data: Test Result: 0.3, Test Result Unit: g/L; Test Name: IgA; Result Unstructured Data: Test Result: 0.38, Test Result Unit: g/L; Test Name: IgE; Result Unstructured Data: Test Result: 14, Test Result Unit: iu/ml; Test Name: IgE; Result Unstructured Data: Test Result: 11, Test Result Unit: iu/ml; Test Name: IgG; Result Unstructured Data: Test Result: 26, Test Result Unit: g/L; Test Name: IgG; Result Unstructured Data: Test Result: 22, Test Result Unit: g/L; Test Name: IgG; Result Unstructured Data: Test Result: 29, Test Result Unit: g/L; Test Name: IgM; Result Unstructured Data: Test Result: 0.30, Test Result Unit: g/L; Test Name: IgM; Result Unstructured Data: Test Result: 0.4, Test Result Unit: g/L; Test Name: Chest X-ray; Result Unstructured Data: Test Result: pulmonary edema, Test Result Unit: unknown; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 158, Test Result Unit: mg/L; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 132, Test Result Unit: mg/L; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 146, Test Result Unit: mg/L; Test Name: Gene sequencing; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Lymphocyte percentage; Test Result: 20 %; Test Name: Lymphocyte percentage; Test Result: 20 %; Test Name: Lymphocyte percentage; Test Result: 29 %; Test Name: Neutrophil percentage; Test Result: 77 %; Test Name: Neutrophil percentage; Test Result: 56 %; Test Name: Neutrophil percentage; Test Result: 76 %; Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 130, Test Result Unit: unknown; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 120, Test Result Unit: unknown; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 100, Test Result Unit: unknown; Test Name: White blood cells; Result Unstructured Data: Test Result: 18.4, Test Result Unit: x10E6/L; Test Name: White blood cells; Result Unstructured Data: Test Result: 24.4, Test Result Unit: x10E6/L; Test Name: White blood cells; Result Unstructured Data: Test Result: 20.6, Test Result Unit: x10E6/L
CDC Split Type: IRGLAXOSMITHKLINEIR2019GS

Write-up: exacerbation of OTULIN-related auto inflammatory syndrome; leukocytosis; exacerbation of lesions; recurrent erythematous rash; recurrent skin nodules; recurrent systemic inflammation; exacerbation of OTULIN-related auto inflammatory syndrome; pulmonary edema; highgrade fever; hepatosplenomegaly; respiratory distress; This case was reported in a literature article and described the occurrence of autoinflammatory disease in a 2-month-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included DTP (A or W not known) (DTP (A or W not known)) for prophylaxis, MMR (Measles mumps rubella vaccine) for prophylaxis, Polio Trivalent Inactivated (IPV) for prophylaxis and bcg vaccine for prophylaxis. Concurrent medical conditions included gene mutation (OTULIN Mutation), nodule (Soon after birth erythematous nodules treated with broad-spectrum antibiotic therapy and with interferon-?), leukocytosis ((WBC: 35.7 x 10E6) (normal range: 5-21)), neutrophilia (69 % (normal value: 45) elevated ESR, CRP, and total IgG) and autoinflammatory disease (OTULIN-related auto inflammatory syndrome). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, DTP (A or W not known) at an unknown dose, Measles mumps rubella vaccine at an unknown dose, IPV at an unknown dose and bcg vaccine at an unknown dose and frequency. On an unknown date, less than a year after receiving Hepatitis B vaccine, DTP (A or W not known), Measles mumps rubella vaccine and IPV, the patient experienced autoinflammatory disease (serious criteria death and hospitalization), pulmonary edema (serious criteria death and GSK medically significant), condition aggravated (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), skin lesion (serious criteria hospitalization), respiratory distress (serious criteria GSK medically significant), red rash (serious criteria hospitalization), skin nodule (serious criteria hospitalization), inflammation (serious criteria hospitalization), fever and hepatosplenomegaly. On an unknown date, the outcome of the autoinflammatory disease and pulmonary edema were fatal and the outcome of the condition aggravated, leukocytosis, skin lesion, respiratory distress, red rash, skin nodule, inflammation, fever and hepatosplenomegaly were unknown. The reported cause of death was autoinflammatory disease and pulmonary edema. The reporter considered the autoinflammatory disease, pulmonary edema, condition aggravated, leukocytosis, skin lesion, respiratory distress, red rash, skin nodule, inflammation, fever and hepatosplenomegaly to be possibly related to Hepatitis B vaccine, DTP (A or W not known), Measles mumps rubella vaccine and IPV. Additional information was provided. This case was reported in a literature article and described the exacerbation of OTULIN (Ovarian TUmor domain deubiquitinases with LINear linkage specificity)-related auto inflammatory syndrome (ORAS) in a 2-month-old female who was vaccinated with unspecified diphtheria, tetanus, and (acellular or whole cell) pertussis (DTP) vaccine, unspecified hepatitis B virus (HBV) vaccine, unspecified measles, mumps, and rubella (MMR) vaccine, unspecified inactivated poliovirus (IPV) vaccine and unspecified Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown for all) with for prophylaxis. The patient was an newborn child (gestational age 35 weeks) from consanguineous parents (first cousins). Soon after birth, she developed abscesses (erythematous nodules) without fever or sepsis and consequently was hospitalized. The lesions were scattered over the chest and both extremities. There was leukocytosis (WBC: 35.7 x 10E6) (normal range: 5-21), Lymphocytes: 27 % (normal: 41), especially neutrophilia: 69 % (normal value: 45) with elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP): 136 (mg/L) (normal value: less than 5), total IgG (13.8 g/L), IgA: 0.337 (g/L), IgM: 0.26 (g/L) and IgE: 12 (IU/mL). Other immunological tests, including opsonization, chemotaxis, phagocytosis, and oxidative burst (nitroblue tetrazolium and dihydrorhodamine), were normal. The patient was treated with broad-spectrum antibiotic therapy and with interferon-?, because the lesions pathologically resembled those found in phagocytic disorders. She remained well for 2 months. The patient''s parents were healthy. On unspecified dates, the patient received unspecified DTP, HBV, MMR, IPV and BCG vaccines (administration route and site unspecified, dosage unknown; batch number not provided for all). It was reported that the patient experienced an exacerbation of the previous lesions (at the same site, but more severe and outspread) at 2, 4, and 6 months of age (for which hospitalization was needed). These exacerbations coincided with the administration of routine vaccine injections (BCG, DTP, hepatitis B, MMR, and IPV). On an unspecified date at the age of 2 months, an unknown period after vaccinations, the patient experienced an exacerbation of ORAS (at the same site, but more severe and outspread). Subsequently, the patient was hospitalised. At the age of 2 months, laboratory data revealed: leukocytosis (WBC: 18.4 x 10E6) (normal range: 5-19.5), lymphocytes: 20 % (normal: 56), neutrophils: 77 % (normal value: 35), ESR: 130, CRP: 158 (mg/L) (normal value less than 5), and total IgG:26 (g/L) (normal range: 2.53-6.96), IgA: 0.3 (g/L) (normal range: 0.03-0.6), IgM: 0.30 (g/L) (normal range: 0.1-1); and IgE: 14 (IU/mL). At the age of 6 months, laboratory data revealed: leukocytosis (WBC: 24.4 x 10E6) (normal range: 6-17.5), lymphocytes: 29 % (normal: 61), neutrophils: 56 % (normal value: 32), ESR: 120, CRP: 132 (mg/L) (normal value less than 5), and total IgG:22 (g/L) (normal range: 0.29-1.39), IgA: 0.38 (g/L) (normal range: 0.14-0.86), IgM: 0.4(g/L) (normal range: 0.29-1.36); and IgE: 11 (IU/mL). Cultures of blood for Mycobacterium tuberculosis and of the lesions for gram negative and positive bacteria were negative at 2, 4, and 6 months. At the age of 8.5 months, the patient developed a high-grade fever with respiratory distress and mild hepatosplenomegaly. Laboratory data revealed: leukocytosis (WBC: 20.6 x 10E6) (normal range: 6-17.5), Lymphocytes: 20 % (normal: 61), neutrophils: 76 % (normal value: 32), ESR: 100, CRP: 146 (mg/L) (normal value less than 5), and total IgG: 29 (g/L) (normal range: 0.29-1.39). On an unspecified date, the patient died. Chest X-ray showed pulmonary oedema that led to her demise. It was unknown if an autopsy was performed. Whole-exome sequencing revealed a homozygous c.864 + 2T more than C variant in OTULIN. There was no other relevant homozygous mutation. Sanger sequencing confirmed the homozygous OTULIN mutation in the patient and revealed a heterozygous mutation in the parents. This variant was not present in the gnomAD and in 1785 controls. The effect of the variant on splicing of OTULIN mRNA by reverse transcriptase (RT)-PCR analysis of cDNA derived from fibroblasts of a heterozygous carrier (father) and healthy control. As the patient died, no cells from the patient were available for analysis. For detailed analysis of splicing of intron 5 - 6, we (i) performed a PCR with primers anchored in exon 4 and 7, (ii) separated the reaction products by gel electrophoresis, and (iii) sequenced individual clones after pJet1.2 cloning (Thermo Fisher Scientific). In addition to the fully spliced mRNA PCR fragment (also found in the control), different smaller bands were uniquely found in PBMCs from the heterozygous carrier. Sanger sequencing of individual clones revealed PCR fragments skipping exon 6, skipping exon 5 and exon 6, or retention of 17 nt between exon 4 and exon 5 followed by exon 6 skipping. Expasy translation software predicted that the observed in vivo splicing will result in a deletion of 90 amino acids, a deletion of 132 amino acids or a frameshift creating a stop codon (L157GfsX12), respectively. Surprisingly, expression of OTULIN protein in primary fibroblasts of the father was comparable to expression in control fibroblasts (data not shown). Authors hypothesized that the truncated protein was not stable and was degraded. IL-6 production of heterozygous carrier primary fibroblasts after 48 h stimulation with LPS (10 ?g/mL), IL-1 ? (50 ng/mL), Poly I:C (12.5 ? g/mL) and TNF- a (100 ng/ mL) was comparable to cytokine response of control primary fibroblasts (data not shown). Modelling of the different splice variants starting from the crystal structure of OTULIN [using the homology module in the Molecular Operating Environment suggests instable/ inactive OTULIN protein, which was in line with the observed clinical phenotype. Skipping of exon 6 results in the deletion of 90 amino acids. Such modification leaves the active site area intact, but it leaves a large portion of the hydrophobic protein core exposed to the hydrophilic solvent resulting in an unstable protein. Furthermore, a loop which was required for coordinating the peptide linker between the consecutive ubiquitin domains in the active site, and thereby allowing catalysis to occur, was absent. Both alterations would result in an inactive OTULIN protein. A similar effect was observed when exons 5 and 6 were skipped, leading to a loss of 132 amino acids from the core of the protein. Finally, OTULIN formed by retention of 17 nucleotides of the intron between exon 4 and 5 followed by skipping of exon 6 lacks the majority of the protein structure domain required for interacting with linear ubiquitins, resulting in an inactive protein. This case has been considered serious due to death/hospitalisation. The author stated, "She remained well for 2 months experienced an exacerbation of the previous lesions (at the same site, but more severe and outspread) at 2, 4, and 6 months of age (for which hospitalization was needed). These exacerbations coincided with the administration of routine vaccine injections (BCG, DTP, hepatitis B, MMR, and IPV)." The author conclusion, "we report a novel disease-causing variant in OTULIN that affected splicing. The patient suffered from re- current erythematous rash and skin nodules and systemic inflammation (resulting in fatal pulmonary edema). The diagnosis was made based on genetic evidence and RT-PCR analysis that confirmed the presence of multiple alternatively spliced transcripts in the father''s RNA sample. Functional analysis could not be performed, but the truncated proteins are predicted to be inactive. OTULIN deficiency is very rare and only 4 patients have been described in the literature. The phenotype is severe, potentially lethal and treatment with anti-TNF therapy is efficacious in controlling disease activity. Thus, it is critical to identify these patients early in life and treat them appropriately. This case highlights the burning need for early genetic diagnosis such that adequate therapy can be initiated timely." Lab Comments: Lab tests were performed on unspecified dates. Cultures of blood for Mycobacterium tuberculosis and of the lesions for gram negative and positive bacteria were negative at 2, 4, and 6 months (during hospitalizations). Whole-exome sequencing revealed a homozygous c.864 + 2T more than C variant in OTULIN (NM_138348). There was no other relevant homozygous mutation. Sanger sequencing confirmed the homozygous OTULIN mutation in the patient and revealed a heterozygous mutation in the parents. This variant was not present in the gnomAD and in 1785 controls. The effect of the variant on splicing of OTULIN mRNA by reverse transcriptase (RT)-PCR analysis of cDNA derived from fibroblasts of a heterozygous carrier (father) and healthy control. As the patient died, no cells from the patient were available for analysis. For detailed analysis of splicing of intron 5 - 6, we (i) performed a PCR with primers anchored in exon 4 and 7, (ii) separated the reaction products by gel electrophoresis, and (iii) sequenced individual clones after pJet1.2 clonin. In addition to the fully spliced mRNA PCR fragment (also found in the control), different smaller bands were uniquely found in PBMCs from the heterozygous carrier. Sanger sequencing of individual clones revealed PCR fragments skipping exon 6, skipping exon 5 and exon 6, or retention of 17 nt between exon 4 and exon 5 followed by exon 6 skipping. Expasy translation software predicted that the observed in vivo splicing will result in a deletion of 90 amino acids, a deletion of 132 amino acids or a frameshift creating a stop codon (L157GfsX12), respectively. Surprisingly, expression of OTULIN protein in primary fibroblasts of the father was comparable to expression in control fibroblasts (data not shown).; Reported Cause(s) of Death: exacerbation of OTULIN-related auto inflammatory syndrome; pulmonary edema


VAERS ID: 811479 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-06
Onset:2019-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Carotid aneurysm rupture, Condition aggravated, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery aneurysm (stable aneurysm of the intracranial internal carotid artery without op.-indication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201907

Write-up: Rupture of an aneurysm of the intracranial part of the internal carotid artery.; This case was reported by a consumer via regulatory authority and described the occurrence of carotid aneurysm rupture in a 45-year-old female patient who received Rabies NVS (Rabipur) for prophylaxis. The patient''s past medical history included carotid artery aneurysm (stable aneurysm of the intracranial internal carotid artery without op.-indication). On 6th April 2019, the patient received Rabipur (intramuscular). On 7th April 2019, 1 days after receiving Rabipur, the patient experienced carotid aneurysm rupture (serious criteria death, GSK medically significant and other: Serious as per reporter). On 7th April 2019, the outcome of the carotid aneurysm rupture was fatal. The patient died on 7th April 2019. The reported cause of death was carotid aneurysm rupture. It was unknown if the reporter considered the carotid aneurysm rupture to be related to Rabipur. Additional information: The age at vaccination was not reported however patient could be 44 or 45 years old at the time of vaccination. The time to event onset was reported as 2 days however, it was captured as 1 day as per reported vaccination and event onset date. The PEI assessment was reported as D.Unclassifiable. Initial information was received from a consumer via regulatory authority on 22nd April 2019: Rupture of an aneurysm of the intracranial part of the internal carotid artery. Sender''s comments: Stable aneurysm of the intracranial internal carotid artery without op.-indication.; Reported Cause(s) of Death: Carotid aneurysm rupture


VAERS ID: 812213 (history)  
Form: Version 2.0  
Age: 1.58  
Sex: Male  
Location: Foreign  
Vaccinated:2018-08-10
Onset:2019-04-14
   Days after vaccination:247
Submitted: 0000-00-00
Entered: 2019-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood culture negative, Blood sodium decreased, C-reactive protein increased, CSF test abnormal, Death, Inappropriate schedule of product administration, Polymerase chain reaction, Pyrexia, Rheumatoid factor negative, Septic shock, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sgpt; Test Result: 800 {DF}; Result Unstructured Data: almost 800; Test Name: sgot; Test Result: 800 {DF}; Result Unstructured Data: almost 800; Test Name: sodium; Test Result: 129 {DF}; Result Unstructured Data: 129; Test Name: C-reactive protein; Test Result: 253 {DF}; Result Unstructured Data: 253; Test Name: RA; Test Result: 10 {DF}; Result Unstructured Data: 10
CDC Split Type: LBSA2019SA119194

Write-up: septic shock; high grade fever; vomiting; on 10-aug-2018, the baby received his first dose/on 13-apr-2019, received the second dose; Initial information received on 25-Apr-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 19 months old male patient who experienced septic shock, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 10-Aug-2018, the patient received a first primary dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 13-Apr-2019 at 11:20am, he also received second primary dose of the same vaccine with an unknown batch number via intramuscular route in the right deltoid. (Information on the batch number was requested). On 14-Apr-2019, The patient experienced a serious septic shock with symptoms high grade fever (pyrexia) and vomiting 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These events were leading to death. The patient was hospitalized after this event occurred. Patient did not have any reaction post first dose. Patient died on 15-Apr-2019 at 07:50 am. It was of actual medication error case due to inappropriate schedule of vaccine administered. The patient should have received the doses atleast three months apart. Relevant laboratory test results included: Alanine aminotransferase - On an unknown date: 800 [almost 800]; Aspartate aminotransferase -: 800 [almost 800]; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture before antibiotic and PCR CSF resulted negative. Final diagnosis was (fatal) septic shock. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Septic shock. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s 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.; Sender''s Comments: This is a case involves a 19-month-old male who suffered Septic shock with symptoms Pyrexia and Vomiting next day following the second primary dose of MENACTRA. The patient was hospitalized and died on the same day due to Septic Shock. Patient tolerated the first dose about 8 months before the second primary dose which also led to the inappropriate schedule of the vaccine. It is always recommended to complete the primary immunization as per approved dosing schedule. Autopsy results are unavailable. Patient was not on any concomitant therapy. Time to onset is however compatible. It was not reported if any corrective therapies were taken. Lab investigations included: Alanine aminotransferase and Aspartate aminotransferase - almost 800; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture was negative. There is no information on patient''s infectious history, allergy to any product/food along with previous vaccination tolerance (if any). Reassessment with patient''s condition at the time of vaccination, medical history, co-founding factors and autopsy report will be requested to re-assess the role of vaccine.; Reported Cause(s) of Death: septic shock


VAERS ID: 812329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-23
Onset:2018-12-27
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2019-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA322CA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Cough, Death, Dependence on respirator, Influenza, Influenza A virus test positive, Polymerase chain reaction positive, Pyrexia, Respiratory disorder, Respiratory distress, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-16
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: Influenza A NA, Test Result Unit: unknown
CDC Split Type: DEGLAXOSMITHKLINEDE201907

Write-up: ARDS; respiratory disorder requiring ventilation; respiratory disorder requiring ventilation; Influenza A; Respiratory distress; fever; Dry cough; Vaccination failure; This case was reported by a physician via regulatory authority and described the occurrence of ards in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2018/2019) (batch number AFLBA322CA, expiry date unknown) for prophylaxis. On 23rd October 2018, the patient received Influsplit Tetra 2018/2019 (intramuscular). On 27th December 2018, 65 days after receiving Influsplit Tetra 2018/2019, the patient experienced influenza a virus infection, vaccination failure (serious criteria GSK medically significant), respiratory distress (serious criteria GSK medically significant), fever and dry cough. On an unknown date, the patient experienced ards (serious criteria death and GSK medically significant), respiratory disorder nos (serious criteria death) and dependence on ventilator (serious criteria death and GSK medically significant). On 16th January 2019, the outcome of the ards, respiratory disorder nos and dependence on ventilator were fatal. On an unknown date, the outcome of the influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough were unknown. The patient died on 16th January 2019. The reported cause of death was respiratory disorder, acute respiratory distress syndrome and dependence on ventilator. It was unknown if the reporter considered the ards, respiratory disorder nos, dependence on ventilator, influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough to be related to Influsplit Tetra 2018/2019. Additional details: Age at vaccination was not reported however patient could be 71 or 72 years old at time of vaccination. On an unknown date, PCR was performed with results Influenza A NA. PEI assessment of causality was reported as Unclassifiable. Batch number for Influsplit Tetra 2018/2019 was reported as ASLBA322CA however on batch number review it was corrected to AFLBA322CA. Initial information was reported by a physician via regulatory authority on 30th April 2019. ARDS , espiratory disorder nos, Dependence on ventilator,influenza a virus infection, vaccination failure, respiratory distress, fever and dry cough. Lab Comments: On an unknown date PCR was performed with result Influenza A NA.; Reported Cause(s) of Death: Respiratory disorder; Acute respiratory distress syndrome; Dependence on ventilator


VAERS ID: 812406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-30
Onset:2019-03-05
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2019-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA326AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac failure, Coma, Culture throat, Death, Influenza, Pneumonitis, Polymerase chain reaction, Respiratory failure, Sepsis, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-27
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Coumadin; Ramipril; Aliflus; Sertraline; HALCION; BRETARIS GENUAIR; BISOPROLOL FUMARATE; VASCOMAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: unknown, Test Result Unit: unknown
CDC Split Type: ITGLAXOSMITHKLINEIT201907

Write-up: Vaccination failure; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic hea; This case was reported by a physician via regulatory authority and described the occurrence of vaccination failure in a 74-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2018-2019 season) (batch number AFLBA326AA, expiry date unknown) for prophylaxis. Concomitant products included metformin hydrochloride (Metformin), warfarin sodium (Coumadin), ramipril, fluticasone propionate, salmeterol xinafoate (Aliflus), sertraline, triazolam (Halcion), aclidinium bromide (Bretaris Genuair), bisoprolol fumarate and manidipine hydrochloride (Vascoman). On 30th October 2018, the patient received Fluarix Tetra 2018-2019 season (unknown). On 5th March 2019, 126 days after receiving Fluarix Tetra 2018-2019 season, the patient experienced influenza a virus infection (serious criteria death), sepsis (serious criteria death and GSK medically significant), decompensation cardiac (serious criteria death and GSK medically significant), coma (serious criteria death and GSK medically significant), stemi (serious criteria death and GSK medically significant), respiration failure (serious criteria death and GSK medically significant) and pneumonitis (serious criteria death). On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). Fluarix Tetra 2018-2019 season was discontinued. On 27th March 2019, the outcome of the influenza a virus infection, sepsis, decompensation cardiac, coma, stemi, respiration failure and pneumonitis were fatal. On an unknown date, the outcome of the vaccination failure was unknown. The patient died on 27th March 2019. The reported cause of death was sepsis, decompensation cardiac, coma, stemi, pneumonitis, influenza a virus infection and respiration failure. It was unknown if the reporter considered the vaccination failure, influenza a virus infection, sepsis, decompensation cardiac, coma, stemi, respiration failure and pneumonitis to be related to Fluarix Tetra 2018-2019 season. Additional details: Age at vaccination was not reported however patient could be 73 or 74 years old at time of vaccination. On an unknown date PCR was performed with unknown results. Initial information was reported by a physician via regulatory authority on 1st May 2019. Severe sepsis with coma and global respiratory failure due to multiple outbreak pneumonia and influenza A (despite vaccination), complicated by Non-ST elevation myocardial infarction and diastolic heart failure. Reporter''s Comments: Laboratory tests performed: PCR on a throat swab. Sender''s Comments: "Waiting for the physician report." Lab Comments: On an unknown date, PCR was performed with unknown results.; Reported Cause(s) of Death: Sepsis; Decompensation cardiac; Coma; STEMI; Pneumonitis; Influenza A virus infection; Respiration failure


VAERS ID: 812552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asphyxia, Death, Malaise, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (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: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT0095075131904ITA011451

Write-up: patients mother found the infant bellied up in the cradle, but he did not move and breathe anymore; The most probable cause of death could be suffocation for regurgitation or malaise by Sids (Sudden Infant Death Syndrome); The most probable cause of death could be suffocation for regurgitation or malaise by Sids (Sudden Infant Death Syndrome); infant heart stopped beating (died); The most probable cause of death could be suffocation for regurgitation or malaise by Sids (Sudden Infant Death Syndrome); Information has been downloaded from regulatory authority (IT-SA-2019SA102097). This spontaneous report was received from an unspecified source, referring to a 2-month-old male patient. The patient''s historical drugs, medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dosage, route of administration, frequency, lot # and expiration date were not reported) as a Prophylactic vaccination. Other suspect therapies included hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) Suspension for injection, rotavirus g1 p1 vaccine live (89-12)(ROTARIX) and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13). On an unspecified date also reported as ("one day after vaccination"), the patient''s mother found the patient bellied up in the cradle, but he did not move or breath (respiratory arrest). The patient died due suffocation for regurgitation (asphyxia) or malaise caused by SIDS (Sudden Infant Death Syndrome). At the time of this report, no autopsy results were available. The causal relationship between vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and respiratory arrest, asphyxia, cardiac arrest, sudden infant death syndrome and malaise was not reported, However, it was reported that the unspecified reporter assessed the causality between events and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) as related.; Reported Cause(s) of Death: malaise; Sudden Infant Death Syndrome; Suffocation


VAERS ID: 812660 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2019-04-17
Onset:2019-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD296A / 1 RL / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W39727 / 1 LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC065BE / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bed sharing, Death, Decreased appetite, Irritability, Moaning, Pyrexia, Resuscitation, Skin warm, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190417; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.9, Test Result Unit: degree C; Test Date: 20190418; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.8, Test Result Unit: degree C
CDC Split Type: AUGLAXOSMITHKLINEAU2019GS

Write-up: Sudden infant death syndrome; Pushing away milk; Whingy; Temperature; This case was reported by a consumer via other and described the occurrence of sudden infant death syndrome in a 10-week-old male patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD296A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC065BE, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number W39727, expiry date unknown) for prophylaxis. On 17th April 2019, the patient received the 1st dose of Infanrix hexa (injection), the 1st dose of Rotarix liquid formulation (oral) and the 1st dose of PREVENAR 13 (injection). On 17th April 2019, less than a day after receiving Infanrix hexa and Rotarix liquid formulation, the patient experienced moaning and fever. On 18th April 2019, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant) and appetite lost. On an unknown date, the outcome of the sudden infant death syndrome was fatal and the outcome of the moaning, fever and appetite lost were not reported. The patient died on 18th April 2019. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, moaning, fever and appetite lost to be related to Infanrix hexa and Rotarix liquid formulation. Additional details were provided as follows: The patient received Infanrix hexa on right thigh and Prevenar 13 on left thigh. The reporter stated that, death occurred a day after we had immunized the child at a immunisation session on the Wednesday 17th April 2019. On 17th April 2019, the child was whingy, low grade temps to 37.9 (nothing above 38) yesterday afternoon. They did not used paracetamol well overnight. On 18th April 2019, the patient experienced whingy in evening, pushing away at milk, felt hot and took temp again 37.8this evening. - around 5ish pm put child to bed with mother next to her, on parent''s bed. Baby fell asleep within 15 to 30 minutes. The patient mother left room and reported that baby normally would cry after an hour. So was worried and sent 5 years old sibling up to check on baby, after 5 to 10 minutes possibly sibling said baby not moving and crying and so mother ran up the room and saw baby lifeless. The patient mother panicked and quickly ran to neighbors house and neighbor ran over and saw lifeless baby and rung. The neighbor then commenced cardiopulmonary resuscitation (CPR) until ambulance arrived. All correct vaccines administered at the correct age and administered at the correct site. Consent to vaccinate obtained from parent on the day. The patient remained at the venue for the 15 minutes post vaccination waiting period. All correct procedures or processes followed on the day. The police officer investigating requested contact details of the nurse immunizer on the day, so a statement can be obtained. From ED notes on 18th April 2019. Deceased baby in mother''s arms The immunisation officer team leader contacted by police Wednesday on 24th April 2019 in the afternoon advising they were investigating the sudden death of a 2-month-old infant on the 18th April 2019 for the Coroner''s report. No consent to follow up with the patient''s physician was provided.; Reported Cause(s) of Death: Sudden infant death syndrome


VAERS ID: 812798 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2019185133

Write-up: Death; This is a Spontaneous report from a contactable physician. This is a report received from the Health Regulatory Authority via an on-line database search. Regulatory authority report number [000670268]. This information was initially reported to Health regulatory authority on 07Dec2105 from an unknown Market Authorization Holder AER# 2015SA195057. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation, diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (manufacturer unknown, dosage form: liquid intramuscular) via an unspecified route of administration on an unspecified date at unknown dose for immunisation, hib vaccine polysacch (manufacturer unknown, dosage form: solution subcutaneous) via an unspecified route of administration on an unspecified date at unknown dose for immunisation, rotavirus vaccine live oral 1v (ROTARIX, dosage form: suspension intramuscular) via an unspecified route of administration on an unspecified date at unknown dose for immunisation, polio vaccine inact (manufacturer unknown) via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: unspecified cause of death


VAERS ID: 813028 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: CNGLAXOSMITHKLINECN2019AP

Write-up: death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a subject who received Hepatitis B vaccine for prophylaxis. On an unknown date, unknown after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death not otherwise specified (NOS) in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. The case corresponds to table 7 reported in this literature article. The patient was part of study that aimed to analyse the epidemiological characteristics of the adverse events following immunisation (AEFI) from 2015 to 2017 and to evaluate the situation of AEFI surveillance system operations, the safety of National Immunisation Program (NIP) and non-NIP vaccines. No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 2015 and 2017 an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The case was classified as coincidence. [In this study, Coincidence: The person being vaccinated happens to be in the latency period or prodromal period of a certain disease at the time of vaccination, and the disease coincidentally onsets after vaccination]. The author did not comment on relationship between the event of death NOS and unspecified HBV vaccine. The author concluded, "To sum up, the operation of the AEFI surveillance system is basically normal, and the vaccine safety and immunisation service quality are good. There is a need for the further improvement of AEFI reporting sensitivity as well as the timely reporting, timely investigation, and standardised disposition of AEFI cases in order to provide reliable surveillance data and scientific evidence for vaccine safety assessment. There is a need to strengthen immunisation personnel training and to standardize the operating procedures to improve vaccination service quality." This is 1 of the 2 valid cases reported in the same literature article. The article corresponding to this case is not available for submission to regulatory due to copyright restriction.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 813230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-17
Onset:2019-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER R019134 / 1 - / OT
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS A70CD310A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Enteritis (suspicion of); Comments: On 17-APR-2019 medical checkup U6 (performed at the age between 10 and 12 months): inconspicuous result and vaccination for prophylaxis of MMR and varicella. A chronic impairment is not known. ? no pre-existing illness, vaccination status according to age
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131905DEU001897

Write-up: child was found dead in parents'' bed, on 21-APR-2019 in the morning; diarrea; Fever 39.5?C; Vomiting; Information has been downloaded from Agency (DE-PEI-PEI2019002590). A physician refers to female child patient between 10 to 12 months old. The patient''s concurrent condition included enteritis. A chronic impairment was not known, no pre-existing illness and vaccination status according to age. On 17-APR-2019, medical checkup was performed with a inconspicuous result, therefore, the patient was vaccinated with dose 1 M-M-RVAXPRO lot # R019134 with expiration date on 30-JUN-2020, intramuscularly in the left upper leg (dose was not reported) and dose 1 varicella virus vaccine live (oka/rit)(VARILRIX) subcutaneously, with lot number A70CD310A in the left upper arm for prophylactic vaccination (dose was not reported). On 19-APR-2019, the patient experienced watery stools (diarrhea), vomiting and fever of 39.5C? and was hospitalized on an unknown date in April because of the events. On 21-APR-2019, the patient had 40C? and then, in the morning the child was found dead in her parent''s bed; the cause and if autopsy was performed were unknown. The outcome of diarrhea, vomiting and fever were unknown. The causal relationship between the events and vaccinations with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-RVAXPRO) and varicella virus vaccine live (oka/rit)(VARILRIX) were not reported.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 813669 (history)  
Form: Version 2.0  
Age: 1.42  
Sex: Female  
Location: Foreign  
Vaccinated:2019-03-01
Onset:2019-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR P1B76 / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W66850 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Antibody test negative, Autopsy, Blood immunoglobulin E normal, Cardio-respiratory arrest, Death, Febrile convulsion, Influenza, Norovirus test positive, Tryptase
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-05
   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: Cow''s milk allergy; Myocardial disorder; Protein allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion; Influenza
Allergies:
Diagnostic Lab Data: Test Name: IgE; Result Unstructured Data: Within the normal range; Test Name: Norovirus; Result Unstructured Data: Positive; Test Name: Tryptase; Result Unstructured Data: Within the normal range
CDC Split Type: JPSAKK2019SA125187AA

Write-up: Acute pulmonary oedema; ?????; Initial information received on 07-May-2019 regarding an unsolicited valid serious case received from Health Authorities under reference. This case involves a 17 months old female patient who experienced acute pulmonary oedema, while she received vaccine HIB (PRP/T) VACCINE [ActHIB] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVENAR 13]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Milk allergy, Food allergy and Cardiomyopathy. Body weight at birth: 3580 g Points to be noted in the medical interview sheet: milk allergy, ovalbumin allergy On 24-Jan-2019, febrile convulsion developed due to influenza A. On 01-Mar-2019, the patient received the 4th doses of ActHIB (dosage, unknown) and PREVENAR 13 (dosage, unknown) for prophylactic vaccination. On 05-Mar-2019, at 16:09, the patient was in a cardiorespiratory arrest. On the day, at 18:12, acute pulmonary oedema developed, leading to death. The patient died from acute pulmonary oedema. Autopsy was conducted: Acute pulmonary oedema and myocardial bridge (left anterior descending artery) was revealed. Tryptase and IgE were within normal ranges. A norovirus test showed positive (no diarrhoea and poor finding of enterocolitis). The patient developed a serious acute pulmonary oedema 4 days 18 hrs 12 mins following the first dose intake of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197). This event was assessed as medically significant and was leading to death. The patient developed a serious acute pulmonary oedema 4 days 18 hrs 12 mins following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant and was leading to death. Relevant laboratory test results included: Antibody test - On an unknown date: [within the normal range] Norovirus test - On an unknown date: [positive] Tryptase - On an unknown date: [within the normal range] Final diagnosis was (fatal) acute pulmonary oedema. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for acute pulmonary oedema. An autopsy was done. The cause of death was reported as Acute pulmonary oedema. Reporter comment: Causality with HIB (PRP/T) VACCINE: Unassessable. It was considered that the patient died finally due to acute pulmonary oedema. This case was reported because the patient died 4 days after the prophylactic vaccinations and the definite cause of death was unknown although it was suspected that acute pulmonary oedema was caused by endogenous illnesses such as fatal arrhythmia.; Sender''s Comments: This case concerns a young patient who presented with fatal acute pulmonary oedema after vaccination. The time to onset is compatible. There is, however, no information regarding patient''s condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious and cardiovascular. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Acute pulmonary oedema


VAERS ID: 813748 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2018-07-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Laboratory test abnormal, Pneumococcal infection, Serology 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: 2018-08-08
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: 20180813; Test Name: Laboratory test; Result Unstructured Data: Test Result: Pneumococal infection, serotype 3; Test Date: 20180813; Test Name: Serology test; Result Unstructured Data: Test Result: Serotype 3
CDC Split Type: GBPFIZER INC2019196184

Write-up: Vaccine failure/Pneumococcal infection/Serotype 3; Vaccine failure/Pneumococal infection/Serotype 3; This is a spontaneous report from a healthcare professional received via the contactable regulatory authority. A 2-month-old male patient received the 1st dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, batch unknown) via an unspecified route of administration at single dose on 24Jul2018 at 1 month (8 weeks) old for immunization. With regards to the relevant medical history, the following was noted: the patient was not born prematurely (birthweight 3.020kg). The patient did not have homozygous sickle cell disease and other disease details, history of previous invasive bacterial disease, asplenia or splenic dysfunction, Immunosuppression, malignancy, congenital anomaly, conditions associated with CSF leakage, chronic respiratory disease, cardiac, renal and liver disease, diabetes, empyema, haemolytic uraemic syndrome, cerebral abscess, cochlear implant, coeliac disease or other complications. Developmental health risk information was noted as none. The relevant concomitant medications were unknown at the time of this report. On 13Aug2018, a specimen was taken and the patient diagnosed with a pneumococcal infection, Serotype 3 from an unknown date. The patient died on 08Aug2018. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained. 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: Vaccine failure/Pneumococcal infection/Serotype 3; Vaccine failure/Pneumococcal infection/Serotype 3


VAERS ID: 813968 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R006069 / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Anaphylactic shock, Asthenia, Chest pain, Chills, Death, Dizziness, Encephalitis allergic, Haemolytic anaemia, Headache, Hypersensitivity, Hyperuricaemia, Intensive care, Nausea, Pyrexia, Vomiting
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131905CHN004395

Write-up: anaphylactic shock / headache, dizziness, chills, fever, accompanied with general asthenia, chest pain, nausea and vomiting; allergical encephalitis; hemolytic anemia; hyperuricemia; the patient died / unknown cause of death; This spontaneous report was received from the regulatory authority and refers to a 23-year-old female patient. The patient''s concurrent conditions and concomitant medications were not provided. The patient did not have a history of allergy. On unknown dates, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot # R006069, expiration date not reported but upon internal validation established as 27-SEP-2020) and had no adverse event. On 19-APR-2019, the patient was vaccinated with the third dose using the same lot number of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, for prophylaxis (strength, dosage schedule and route of administration were not provided). On the same day, 9 hours after vaccination, the patient had headache, dizziness, chills, fever, accompanied with general asthenia, chest pain, nausea and vomiting. It was specified that the patient experienced allergy after injecting with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The patient was hospitalized because of anaphylactic shock and she was transferred to ICU on 21-APR-2019 at 02:00. The admission diagnosis were anaphylactic shock, hemolytic anemia and hyperuricemia. On 22-APR-2019, the hospital organized an experts consultation and then, the patient took an improvement of the disease, and was transferred to common ward (general sickroom) on 24-APR-2019. On 30-APR-2019, the patient''s disease exacerbated, and the patient was transferred to ICU of a second hospital. On 04-MAY-2019, the patient was transferred back to the first hospital, critically ill with mortality risk. The discharge diagnoses included: allergical encephalitis, hemolytic anemia and hyperuricemia. At this time of the report, the outcome was reported as not recovered. On 07-MAY-2019, the relatives gave up the treatment because of no improvement of the disease, the patient was under critical condition and vital signs were extremely unstable. On 11-MAY-2019 at 21:00, the patient died due to unknown reasons and an autopsy had not been conducted. The reporter considered encephalitis allergic to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL); however, no assessment was provided for the patient''s death, anaphylactic shock, hemolytic anemia and hyperuricemia. It was reported that the relatives submitted "vaccine abnormal response" survey application and requested compensation as soon as possible. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 814566 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

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: BR0095075131905BRA007103

Write-up: patient died; This initial spontaneous report was received through the Company''s legal department (the case is in litigation) through a technical-legal adviser of the Ministry representing the Special Prosecutor''s Office for Public Health Defense. This case was initially reported by a consumer referring to a female patient of an unknown age (her daughter''s friend). On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) injection (exact dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. On an unknown date, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The causality assessment between the patient''s death and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was not provided. This is one of three reports received from the same reporter.; Sender''s Comments: BR-009507513-1905BRA007118: BR-009507513-1905BRA007149:; Reported Cause(s) of Death: death


VAERS ID: 815048 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-05-06
Onset:2019-05-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Streptococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190510; Test Name: Body temperature; Result Unstructured Data: Test Result: 39, Test Result Unit: Centigrade
CDC Split Type: CZPFIZER INC2019211368

Write-up: acute streptococcal sepsis; This is a spontaneous report from a contactable physician received via Pfizer Company Representative. A 5-month-old patient of an unspecified gender received a first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration on 06May2019 at single dose for vaccination, diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (DIPHTHERIA VACCINE TOXOID;HEPATITIS B VACCINE RHBSAG (YEAST);HIB VACCI, "HEXA") via an unspecified route of administration on 06May2019 at one dosage form single dose for vaccination. The patient medical history and concomitant medications were not reported. On 10May2019 after lunch patient''s temperature of 39 degrees appeared, hospitalization was required in the evening and the death at 11 PM. The patient died due to acute streptococcal sepsis on 10May2019. 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, the fatal acute streptococcal sepsis occurred 4 days following the first dose vaccination with PREVENAR 13 represents an intercurrent medical condition; not due to lack of effect with 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.; Reported Cause(s) of Death: acute streptococcal sepsis


VAERS ID: 815213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-11
Onset:2019-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R028276 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death, Dizziness, Endotracheal intubation, Feeling cold, Injection site pain, Muscular weakness, Peripheral coldness, Sensory loss, Shock, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-12
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131905CHN007162

Write-up: lower limb weakness; whole body cold; dizziness; sensory loss of lower limb; sudden death; she experienced shock; coma; coldness of lower extremities; injection site pain without red swelling; This spontaneous report as received from a regulatory authority refers to an adult, currently 37-years-old female patient. No information regarding the patient''s pertinent medical history, concomitant medication, drug reactions and allergies was provided. On 11-MAY-2019, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # R028276, expiration date 22-FEB-2021 (dose, frequency and route of administration were not provided) for prophylaxis. On 11-MAY-2019, reported as on the night of the vaccination, the patient experienced injection site pain without red swelling and coldness of lower extremities. On 12-MAY-2019 (reported as on the next day), around 17:00, the patient had lower limb weakness, dizziness, whole body cold and clear consciousness. She was sent to the hospital''s emergency department, where she had clear consciousness and lost sensory of lower limb. When the doctor took her a physical examination, she experienced shock and coma, then she was given an intubation, adrenaline hydrochloride injection, dopamine (reported as domamine) hydrochloride injection, a continuous infusion of sodium chloride through a syringe pump and sodium bicarbonate injection by intravenous drip for rescue. On 12-MAY-2019, at 19:00, the rescue was invalid and the patient died. The cause of death was reported as sudden death. It was unknown if the autopsy was performed. The outcome of the events of injection site pain, coldness of lower extremities, lower limb weakness, dizziness, whole body cold, sensory loss of lower limb, shock and coma was unknown. The relatedness between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided. Upon internal review, the events of shock and coma were determined to be medically significant.; Reported Cause(s) of Death: sudden death


VAERS ID: 815976 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-04-17
Onset:2019-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Body temperature decreased, Cyanosis, Death, Enterovirus infection, Ischaemic contracture of the left ventricle, Listless, Poor peripheral circulation, Respiration abnormal, Resuscitation, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Common cold; Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131905NLD009501

Write-up: tachycardia child, tachycardia got worse, child went into reanimation setting and passed away; tachycard kindje, tachycardie verergerde, kindje kwam in reanimatiesetting en is overleden.; small child, poorly circulated; kindje, slecht gecirculeerd; blue discoloration; blauw verkleurd; small child had decreased body temperature (35,??); kindje had ondertemp (35,??).; strange breathing; rare ademhaling; Listlessness; hangerig; Information has been downloaded (NL-LRB-00331133). Information has been received from a physician referring to a 13 month old patient of unknown gender. The patient''s concurrent condition included common cold. The patient''s medical history and concomitant medication were not provided. On 17-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-RVAXPRO) 0.5 ml (1 dosage form, route, batch/lot number and expiration date were unknown) and meningococcal acyw conj vaccine (tet toxoid) (NIMENRIX) (1 dosage form, route, batch/lot number and expiration date were unknown), both for national immunization program vaccination. On 17-APR-2019, the patient experienced listless. On 18-APR-2019 the patient experienced poorly circulated, strange breathing, decreased body temperature, tachycardia and tachycardia got worse and blue discoloration. The body temperature was tested and the result was 35 degree celsius. The patient was hospitalized due to all events except listless. On the same day(18-APR-2019), the patient went into reanimation setting and passed away. The outcome of tachycardia and tachycardia got worse was fatal. The outcome of other events was unknown. The cause of death was not provided. In April 2019, autopsy was performed and showed that enterovirus and severe ischemic outerwall of left ventricle were the causes of death. The causality assessment between all events and both suspect products were reported as possible related. Upon internal review, all events except listless were determined to be medically significant.; Reported Cause(s) of Death: Unknown cause of death; Autopsy-determined Cause(s) of Death: severe ischemic outerwall of left ventricle; enterovirus


VAERS ID: 816074 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2019SA143797

Write-up: died after a flu shot; Initial information received on 22-May-2019 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via Social Media. This case involves male patient (friends father/age not reported) who died after a flu shot, while he received vaccine INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (expiry date, dose and dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient died (death NOS) following the administration of INFLUENZA VACCINE (Flu Shot). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) died after a flu shot. It was not reported if the patient received a corrective treatment. It was unknown if an autopsy was done. The cause of death was reported as Death NOS. There will be no information available on the batch number for this case. Documents held by the sender: none.; Sender''s Comments: This is a poorly documented case extracted from Social media concerns an adult male patient who died after a Flu shot (INFLUENZA VACCINE). It was unknown if an autopsy was conducted. This case being insufficiently documented, further information on the condition/circumstances of the patient at the time of death, cause 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; Reported Cause(s) of Death: death nos


VAERS ID: 816176 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 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: ROPFIZER INC2019225844

Write-up: patient died at 24 hours after vaccination; This is a spontaneous report from a contactable physician. This report was received via two different sales representatives and a local Vaccines Regional Medical Director. A 2-months-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13; lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at single dose for vaccination and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXACIMA) via an unspecified route of administration on an unspecified date at unknown single dose for vaccination. Relevant medical history was not reported. The patient was clinically healthy before the vaccination. Concomitant medications were not reported. The patient died at 24 hours after vaccination on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The cause of death was still unknown. There was no media coverage of the topic yet. The information on the batch number has been requested.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. More information such as medical history, concomitant medications and event term details especially death cause and autopsy results are needed for meaningfully medical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: patient died at 24 hours after vaccination


VAERS ID: 816276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-25
Onset:2019-04-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD309A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX785BB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AA2786 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC064AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Epistaxis, Heart rate decreased, Hypopnoea, Loss of consciousness, Mydriasis, Pallor, Pulse abnormal, Rhinorrhoea, Skin discolouration, Sudden infant death syndrome, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-26
   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: BCG VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201909

Write-up: Sudden infant death syndrome; Loss of consciousness; Pale skin; Watery nasal discharge; Vomiting; Shallow breathing; Dilated pupils; Heart rate low; Watery nasal discharge; Pulse weak; Skin discoloration; This case was reported by a consumer via regulatory authority and described the occurrence of sudden infant death syndrome in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD309A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC064AA, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX785BB, expiry date August 2020) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AA2786, expiry date March 2021) for prophylaxis. Concomitant products included BCG VACCINE. On 25th April 2019, the patient received Infanrix hexa (parenteral) .5 ml, Rotarix liquid formulation (oral) 1.5 ml, Bexsero (parenteral) .5 ml and PREVENAR 13 (parenteral) .5 ml. On 26th April 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant), loss of consciousness (serious criteria GSK medically significant), pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration. On 26th April 2019, the outcome of the sudden infant death syndrome was fatal. On an unknown date, the outcome of the loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, nasal discharge watery excessive, pulse weak and skin discoloration were not recovered/not resolved and the outcome of the heart rate low was unknown. The patient died on 26th April 2019. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported, however the patient could be 7 to 8 weeks at the time of vaccination. The Infanrix hexa batch number was reported as A2HD309A . However based on a batch number review, it was change to A21CD309A. The Rotarix batch number was reported as AROLCO64AA. However based on a batch number review, it was change to AROLC064AA. Initial information was reported by a consumer via regulatory authority on 23rd May 2019: Sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration.; Reported Cause(s) of Death: Sudden infant death syndrome


VAERS ID: 816625 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-30
Onset:2018-11-21
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2019-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-12-27
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ramipril; BURINEX; bisoprolol fumarate; PLAVIX
Current Illness: Prophylactic vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Hypertension arterial; Lung lower lobectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131905FRA009341

Write-up: Syndrome Guillain-Barre; Information has been downloaded from Regulatory Authority (FR-AFSSAPS-TO20190763). This spontaneous report was received from a pharmacist concerning a 98 year old male patient. The patient''s concurrent conditions included hypertension arterial. The patient''s medical history included lung lower lobectomy and a cardiac pacemaker insertion. The patient''s concomitant therapies included ramipril (BIOGARAN), bumetanide, bisoprolol fumarate and clopidogrel bisulfate(PLAVIX). On 30-OCT-2018, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX), intramuscular for prophylactic vaccination (dose, frequency, anatomical location, lot number and expiration date were not provided). On 21-NOV-2018, the patient experienced guillain-barre syndrome. Due to guillain-barre syndrome, the patient died on 27-DEC-2018. It was unknown if an autopsy was performed. The reporting pharmacist did not provide any causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX) and guillain-barre syndrome.; Reported Cause(s) of Death: Syndrome Guillain-Barre


VAERS ID: 816690 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-03-01
Onset:2019-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR P1B76 / UNK - / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER W66850 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-05
   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: JPSAKK2019SA147651AA

Write-up: Cardio-respiratory arrest; ????; Initial information received on 29-May-2019 regarding an unsolicited valid serious case received from Health Authorities under reference . This case involves a 1 years old female patient who experienced cardio-respiratory arrest, while she received vaccine HIB (PRP/T) VACCINE [ActHIB] and while treated with PNEUMOCOCCAL VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Mar-2019, three o''clock in the afternoon,the patient received the 4th dose of ActHIB (dose, unknown) and the 4th dose of PNEUMOCOCCAL VACCINE (dose, unknown) as prophylactic vaccination. On 05-Mar-2019, at 13:10, the patient was last confirmed to be alive. At 16:19, the patient was found motionless. At 16:39, on arrival at the reporting medical center, the patient was in cardio-respiratory arrest. The patient did not respond to resuscitation. At 18:12, the patient was confirmed dead; the patient died of cardio-respiratory arrest. The patient developed a serious cardio-respiratory arrest 7 days following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) cardio-respiratory arrest. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on 05-Mar-2019 for cardio-respiratory arrest. It is unknown if an autopsy was done. The cause of death was reported as Cardio-respiratory arrest. Reporter comment: Not reported; Sender''s Comments: Company comment dated 29-May-2019: Infant patient died due to sudden cardio-respiratory arrest 4 days after vaccination. The time to onset is compatible. There is no autopsy report provided. 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. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 817651 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: BRPFIZER INC2019231427

Write-up: died; This is a spontaneous report from a contactable non-consumer (patient'' s daughter) from Pfizer medical information team. A daughter reported that her mother received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on Jan2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. The cause of death was not reported. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conjugate vaccine (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information expected. Information about lot number cannot be obtained; Reported Cause(s) of Death: died


VAERS ID: 818508 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-10-03
Onset:2019-03-20
   Days after vaccination:533
Submitted: 0000-00-00
Entered: 2019-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis, Neisseria test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-20
   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: Test Name: Serology test; Result Unstructured Data: Test Result: Serogroup B positive, Test Result Unit: unknown
CDC Split Type: IEGLAXOSMITHKLINEIE2019EM

Write-up: Vaccination failure; Meningitis B; This case was reported by a other health professional and described the occurrence of vaccination failure in a 19-month-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis and Men B NVS (Meningococcal B vaccine) for prophylaxis. On 3rd October 2017, the patient received the 1st dose of Meningococcal B vaccine. On 17th December 2017, the patient received the 2nd dose of Meningococcal B vaccine. On 3rd August 2018, the patient received the 3rd dose of Meningococcal B vaccine. On 20th March 2019, 1 year and 168 days after receiving Meningococcal B vaccine, 1 year and 93 days after receiving Meningococcal B vaccine and 229 days after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was fatal. The patient died on 20th March 2019. The reported cause of death was meningitis. It was unknown if the reporter considered the vaccination failure and meningitis to be related to Meningococcal B vaccine, Meningococcal B vaccine and Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not provided. There had been Men B vaccine failure reported recently this year till the day of reporting This case was linked to case IE2019EME102212 reporter by same reporter. Lab Comments: Lab test performed on an unknown date; Reported Cause(s) of Death: Meningitis


VAERS ID: 818537 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: Guillain Barre syndrome; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a adult subject who received Flu vaccine for prophylaxis. On an unknown date, less than a year after receiving Flu vaccine, the subject developed guillain barre syndrome. Serious criteria included death, hospitalization and GSK medically significant. The outcome of guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome. The investigator considered that there was a reasonable possibility that the guillain barre syndrome may have been caused by Flu vaccine. Additional information was reported. This case was reported in a literature article and described the occurrence of Guillain-Barre syndrome (GBS) in a patient aged between 13 and 51 years of unspecified gender who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of study that aimed to evaluate the results of clinical and laboratory features of cases of GBS that developed following immunization. The study was a retrospective review of additional epidemiological investigations for the expert committee between 2002 and 2014. No information on patient''s medical family history or concomitant medication were provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). Age at vaccination was not provided. [In this study, all had a history of influenza vaccination with either monovalent (n=35) or trivalent (n=13)]. On an unspecified date, within 43 days after vaccination, the patient developed GBS and subsequently hospitalised. On an unspecified date, the patient died due to GBS. It was reported the outcome at discharge was death. It was unknown if autopsy was performed. This case has been considered as serious due to death and hospitalisation. Treatment was unknown. The author stated, "The present study analyzed the clinical and laboratory characteristics of 48 cases of GBS that occurred after immunization between 2002 and 2014. The present study also found that 83.3% of the total GBS cases were associated with the monovalent influenza vaccine." The author concluded "The criteria are used worldwide for the evaluation of GBS following immunization. In order to increase diagnostic accuracy when symptoms develop within 6 weeks of immunization and in the absence of alternative diagnoses to explain the symptoms and clear causative factors such as previous infection, vaccine-related GBS should be suspected. Detailed tests should be subsequently performed to aid early diagnosis. Due to the nature of NCS and CSF tests, follow-up testing need to be performed 1-2 weeks after the presentation of symptoms. The article corresponding to this case is not available for submission due to copyright restriction.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 818784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-27
Onset:2017-06-08
Submitted: 0000-00-00
Entered: 2019-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Death, Magnetic resonance imaging, X-ray
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-09-04
   Days after onset: 453
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GARDASIL; DEPAKIN
Current Illness: Epilepsy grand mal; Papilloma
Preexisting Conditions: Medical History/Concurrent Conditions: Ewing''s sarcoma metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT0095075131906ITA003514

Write-up: pain in the left thing, which was mistaken for an encysted hematoma, no respondent to the non steroids anti-inflammatory drugs or massages prescribed by the physiatrist; eco-muscular x-ray, resonance and TC scan one month after the appearance of?; Information has been downloaded from regulatory authority (IT-MINISAL02-552746). Information has been received from a health professional referring to 16 years old male patient with Ewing''s sarcoma metastatic (start date: 08-JUN-2017). Information about concomitant therapy and medical history of the patient was unknown. On 25-NOV-2013, the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), interactive drugs, (0,5ml, single dose (inconformity information: date of last administration was 25-MAY-2014) lot # J004358; strength and expiration date were unknown) intramuscular for papilloma. On an unknown date, the patient started valproate sodium (DEPAKIN), interactive drugs, tablet (1500mg, daily; strength and expiration date were unknown) orally for epilepsy grand mal. On 08-JUN-2017, the patient experienced pain in the left thing, which was mistaken for an encysted hematoma, no respondent to the non steroids anti-inflammatory drugs or massages prescribed by the physiatrist; eco-muscular x-ray, resonance and TC scan one month after the appearance of (information incomplete) (encode as pain in limb by agency). The patient died on 04-SEP-2018 due to the event (date of end of event was also reported as 04-SEP-2018). It was unknown if autopsy was performed and what caused the death. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was dose not changed (inconformity information: date of last administration was 25-MAY-2014, before AE onset date). Action taken with valproate sodium (DEPAKIN) was withdrawn on 27-JUN-2017. Causality assessment was not provided. Reporter comment: seizures after the vaccination. Therapy with depakin crono and appearance of Ewing''s sarcoma which was reported in the Depakin SPC as rare adverse event as benign and malignant tumors of the muscle system.; Reported Cause(s) of Death: pain in the left thing, which was mistaken for an encysted hematoma, no respondent to the non steroids anti-inflammatory drugs or massages prescribed by the physiatrist; eco-muscular x-ray, resonance and TC scan one month after the appearance of?


VAERS ID: 819148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-29
Onset:2019-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD251A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX790AB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AD6190 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Death, Dyspnoea, Respiratory acidosis, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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: 2019-05-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine; Furosemide; Amiloride hydrochloride; Lactulose; Captopril
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiolitis (In February 2019); Cough (Predated vaccinations); Foramen ovale patent; Ventricular septal defect (Born with, was repaired at 4 months of age)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201910

Write-up: Condition aggravated; Cardiac arrest; Respiratory acidosis; Respiratory distress; Breathing difficult; This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 5-month-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD251A, expiry date unknown) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number ABX790AB, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AD6190, expiry date unknown) for prophylaxis. The patient''s past medical history included cough (Predated vaccinations), ventricular septal defect (Born with, was repaired at 4 months of age) and bronchiolitis (In February 2019). Concurrent medical conditions included foramen ovale patent. Concomitant products included ranitidine hydrochloride (Ranitidine), frusemide (Furosemide), amiloride hydrochloride, lactulose and captopril. On 29th April 2019, the patient received Infanrix hexa (intramuscular) 1 dosage form(s), Bexsero (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 1st May 2019, 2 days after receiving Infanrix hexa and Bexsero, the patient experienced respiratory distress (serious criteria GSK medically significant) and breathing difficult. On 4th May 2019, the patient experienced cardiac arrest (serious criteria death and GSK medically significant) and respiratory acidosis. On an unknown date, the patient experienced condition worsened. On 4th May 2019, the outcome of the cardiac arrest was fatal. On an unknown date, the outcome of the respiratory distress, condition worsened and respiratory acidosis were unknown and the outcome of the breathing difficult was not recovered/not resolved. The patient died on 4th May 2019. The reported cause of death was cardiac arrest. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Infanrix hexa and Bexsero. Additional information: The age at vaccination was not reported, however the patient could be 4 or 5 month old at the time of vaccination. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Prevenar 13. The concomitant product reported as Nutritional supplement. Initial information was reported by a physician via regulatory authority on 12th June 2019: Cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis. Note: The reported current condition Cough was changed to historical condition as the patient was died.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 819761 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131906DEU006907

Write-up: Information has been downloaded (DE-SA-2019SA150170) This spontaneous report was received from a physician concerning a neonate of unknown age and gender. The patient''s medical history, concomitant medications, concurrent conditions and past drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) suspension for injection and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) all therapies for prophylactic vaccination (strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiry dates were not reported). On an unknown date, the patient died due to unspecified reason, within 24 hours after vaccination with hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON). However, no conclusion on the cause of death was reported, no autopsy results were available. The causal relationship between the patient dead and rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not provided. The causality assessment between the event and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) was reported as related by the physician.; Reported Cause(s) of Death: death NOS


VAERS ID: 819851 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, 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: Medical History/Concurrent Conditions: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 30 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 819852 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, 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: Medical History/Concurrent Conditions: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 60 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 819891 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Community acquired infection, Death, Influenza, Polymerase chain reaction positive, Respiratory tract infection viral, 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: Medical History/Concurrent Conditions: Allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation)
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: ESGLAXOSMITHKLINEES2019GS

Write-up: Suspected vaccination failure; Suspected influenza; Community acquired respiratory virus; Community-acquired respiratory virus infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult subject who received Influenza vaccine for prophylaxis. (The subject''s past medical history included allogenic stem cell transplantation (Allogeneic Hematopoietic Stem Cell Transplantation). On an unknown date, less than a year after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included influenza with serious criteria of death, community acquired infection with serious criteria of death and respiratory tract infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal), community acquired infection (fatal) and respiratory tract infection (fatal). The reported cause of death was vaccination failure, influenza, community acquired infection and respiratory tract infection. The investigator considered that there was a reasonable possibility that the vaccination failure, influenza, community acquired infection and respiratory tract infection may have been caused by Influenza vaccine. Relevant Tests: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was see text . Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a patient aged more than 18-years of unspecified gender who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown) for prophylaxis. The patient corresponds to table 2 in this literature article. The patient was a part of a prospective, cross-sectional, observational epidemiological study of community-acquired respiratory virus (CARV) respiratory tract disease (RTD) in allo-HSCT recipients who developed upper RTD (URTD) and/or lower RTD (LRTD) symptoms after transplant. The study also reported the prevalence of influenza RTD according to the vaccination status over 5 consecutive influenza seasons in a consecutive series of allo-HSCT recipients with virologically-documented respiratory virus infections (RVIs). The patient was allo-HSCT recipients. No information on patient''s family history or concomitant medication was provided. On an unspecified date during the 5 influenza seasons (2013-2014, 2014-2015, 2015-2016, 2016-2017, 2017-2018) and at least 90 days after transplantation, the patient received unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between December 2013 and May 2018, an unknown period after vaccination, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. On an unspecified date and 90 days after infection, the patient died due to infection. It was unknown if an autopsy was performed. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection. The case has been considered as suspected vaccination failure being the TTO was unknown and lab confirmation of influenza was suspected. This case has been considered serious due to Suspected Vaccination failure/death. The authors did not comment on the relationship between the event of CARV infection and uunspecified seasonal trivalent inactivated influenza vaccine. The authors concluded, "we provide clinical evidence that influenza vaccination after allo-HSCT is associated with a lower prevalence of influenza RVI and a lower severity of the disease." The article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 3 valid cases reported in the same literature article. Lab Comments: Laboratory test was performed on unspecified date between December 2013 and May 2018, the patient developed virologically-documented respiratory virus infections (RVIs). Subsequently, the patient was diagnosed with community-acquired respiratory virus (CARV) infection by polymerase chain reaction (PCR) test. In this study, 15 out of 46 CARV episodes in vaccinated patients were diagnosed with influenza infection.; Reported Cause(s) of Death: suspected vaccination failure; suspected influenza; Community acquired infection; Respiratory tract infection


VAERS ID: 820153 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: CA0095075131906CAN007565

Write-up: cerebral haemorrhage; This spontaneous report was received from a pharmacist via regulatory authority (Agency number: E2B_02271205) refers to an 86 year old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX II 0.65 ML) single dose vial, refrigerator stable(dose and lot# were not reported) via intramuscular route for prophylaxis. On an unknown date, the patient experienced cerebral haemorrhage. The outcome of cerebral haemorrhage was reported as fatal. Cause of death was unknown and it was unknown if an autopsy was performed. The causal relationship between the event and the suspect therapy was not reported.


VAERS ID: 821315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: DEGLAXOSMITHKLINEDE2019GS

Write-up: patient died; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 day 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. It was unknown if the reporter considered the unknown cause of death to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. This patient died on the next day after receiving Shingrix. No further information was provided with the initial report. Follow up was requested regarding further details. This case has been linked with case DE2019GSK117421 reported by the same reporter.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 821316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-16
Onset:2019-05-01
Submitted: 0000-00-00
Entered: 2019-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-01
   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: DEGLAXOSMITHKLINEDE2019GS

Write-up: patient died; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 16th May 2019, the patient received Shingrix. In May 2019, several 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 patient died in May 2019. 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 Shingrix. Additional details were provided as follows: The age at vaccination was not reported. Few days after receiving Shingrix, the patient was found dead in his home. No further information was provided with the initial report. Follow up was requested regarding further details. This case has been linked with case DE2019GSK117420 reported by the same reporter.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 821744 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-06-01
Submitted: 0000-00-00
Entered: 2019-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Endotracheal intubation, Influenza, Intensive care, Malaise, Vaccination failure
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2019AP

Write-up: Influenza; very sick; suspected vaccination failure; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 43-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. In June 2019, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection (serious criteria death and hospitalization) and sickness. On 23rd June 2019, the outcome of the influenza a virus infection was fatal. On an unknown date, the outcome of the vaccination failure and sickness were unknown. The patient died on 23rd June 2019. The reported cause of death was influenza a virus infection. It was unknown if the reporter considered the vaccination failure, influenza a virus infection and sickness to be related to Influenza vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient was working with acute medical patients in the hospital unit and had a 3 and half year old son. The patient''s wife posted a heartfelt plea for support and pictures of patient on Facebook the day after he was rushed to hospital. The patient was following a battle with influenza A the last eight days. Unfortunately, it had hit him and his body was quite hard. In June 2019, the patient was admitted to the hospital. The patient was very sick. A specialized retrieval team was sent to provide cardiac and respiratory support (extracorporeal membrane oxygenation). The patient was intubated and they supported his heart. He was critical and they did not have any time frame for him. The patient''s wife asked to send their thoughts as the patient very much needed it that time. The patient was in intensive care unit when he passed away. It was unknown if an autopsy was done. The tribute was given to chief executive at hospital by patient''s grieving family, friends and colleagues and staff at hospital were in shock. The staff at hospital stated that the patient was with them for a short time, but had connected with so many of their staff who were understandably shocked that his life was taken away. The nurses who worked with the patient''s wife were equally upset, knowing how challenging a time this had been for her and their young son. The nurse and colleague had started a account to support the patient''s family and said she had kept the account open for donations to support. She also stated that the patient and his wife were very friendly and compassionate and always looked out for others. The hospital staff had banded together to collect food donations for bereaved family. A spokesman from Department of Health and Human Services said the flu could strike anyone in the community, even normally healthy people with no underlying health issues. The hospital''s staff were regularly informed about their risk from influenza and were encouraged to get immunized. They also offer a free flu immunization program to their staff and volunteers each year. Their staff were also educated in the correct hand hygiene techniques to reduce the risk of passing on or contracting infection. The hospital staff were encouraged to stay home if they were sick and advised to see their GP (general practioner), which had followed. There have been more than one and half times as many confirmed flu cases so far, this year than in the whole of 2018, as per new data. But despite the surge in early cases, experts said this year''s season was not worse than average, and an early start to flu season could mean an early end. This year to date, there were 97,920 laboratory confirmed cases of influenza, compared with 58,870 cases for the whole of 2018, according to the latest data from the National Notifiable Diseases Surveillance System (NNDSS). An infectious diseases expert at the hospital had said while a flu vaccine did not prevent people from getting influenza 100 percent of the time, it did make a difference, essentially the people could halve the risk of catching flu by vaccination. It was not perfect, but it was more than helpful. This case was considered as suspected vaccination failure as the details regarding time to onset for the event was unknown at the time of reporting.; Reported Cause(s) of Death: Influenza A


VAERS ID: 821836 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Endotracheal intubation, Ill-defined disorder, Influenza, Influenza A virus test positive, Intensive care, Malaise, Vaccination failure
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Influenza A; Result Unstructured Data: Positive foe Influenza A virus.
CDC Split Type: AUSEQIRUS201904062

Write-up: Influenza A; Was ill; Very sick; Flu shot not foolproof; Influenza A virus test positive; This is a spontaneous case, initially received from other non-health professional on 28-Jun-2019 processed together with follow up received from other health professional on 29-Jun-2019, concerning a 43-year-old, adult male patient. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for immunization. On an unspecified date, the patient experienced illness and felt sick. A specialized retrieval team was sent from hospital to place and the patient was put on a machine to provide cardiac and respiratory support (ecmo). He was intubated and they were supporting his heart. On an unspecified date, the patient was rushed to the hospital and was admitted to the intensive care unit (ICU). On an unspecified date, the patient was diagnosed with influenza A virus infection (influenza A virus test positive). It was reported that flu shot is not foolproof in fight (explicitly coded as vaccination failure). The patient was hospitalized for the duration of 8 days. On 23-Jun-2019 (reported as Sunday), the patient died in the ICU of the hospital following a battle with influenza A over several weeks. It was reported that the patient died from influenza despite being vaccinated (related). It was unknown whether the autopsy was done. The reporter assessed the case as serious (death and hospitalization).; Reporter''s Comments: A 43-year-old male patient experienced illness and felt sick and was diagnosed as influenza A virus infection (fatal), at unspecified time after receipt of INN Flu Vaccine (considered as vaccination failure). Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported event and details regarding vaccination failure/flu, the company assessed the causality as unassessable. The case will be reassessed upon receipt of follow-up information. The investigation Influenza A virus test positive supported the diagnosis. The company assessed the case as serious (medically significant).; Reported Cause(s) of Death: Influenza A


VAERS ID: 822509 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute motor-sensory axonal neuropathy, Areflexia, Blood glucose normal, CSF glucose decreased, CSF protein increased, CSF test abnormal, CSF white blood cell differential, Dysphagia, Encephalitis, Hyperintensity in brain deep nuclei, Loss of consciousness, Lyssavirus test positive, Magnetic resonance imaging brain, Magnetic resonance imaging brain abnormal, Muscular weakness, Nerve conduction studies, Paraesthesia, Paralysis, Pyrexia, Quadriparesis, Rabies, Respiratory distress, Urinary retention
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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: Rabies Vaccine; Rabies Vaccine; Rabies Vaccine; Rabies Vaccine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (a category-III dog bite in his right leg)
Allergies:
Diagnostic Lab Data: Test Name: Serum glucose; Test Result: 86 mg/dl; Test Name: Cerebrospinal fluid glucose; Test Result: 47 mg/dl; Test Name: Cerebrospinal fluid protein; Test Result: 122 mg/dl; Test Name: CSF test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Mononuclear cell count; Result Unstructured Data: Test Result: 850, Test Result Unit: cells/mm3; Test Name: Nerve conduction studies; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Neurological examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Neutralizing antibodies; Result Unstructured Data: Test Result: see texts, Test Result Unit: unknown; Test Name: Nuclear magnetic resonance imaging; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: Rabies; Paralytic rabies; rabies encephalitis; quadriparesis/flaccid quadriparesis mimicking Guillain-Barre syndrome; urinary retention; Unconscious; fever; tingling in the right leg; weakness in the right leg on the first day of illness followed by weakness of all four limbs; dysphagia; sensorimotor axonal neuropathy involving all four limbs; hyperintensity in bilateral basal ganglia, thalami, medial temporal lobes, mid-brain and dorsal pons on T2; respiratory compromise; areflexic; This case was reported in a literature article and described the occurrence of rabies in a 29-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (a category-III dog bite in his right leg). Concomitant products included Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, the patient received the 5th dose of Rabies Vaccine. On an unknown date, less than a month after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant), paralysis (serious criteria death and GSK medically significant), encephalitis (serious criteria death and GSK medically significant), quadriparesis (serious criteria GSK medically significant), urinary retention (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), fever, tingling sensation, weakness of limbs, dysphagia, sensory polyneuropathy axonal, hyperintensity in brain deep nuclei, respiratory disorder and areflexia. On an unknown date, the outcome of the rabies, paralysis and encephalitis were fatal and the outcome of the quadriparesis, urinary retention, unconscious, fever, tingling sensation, weakness of limbs, dysphagia, sensory polyneuropathy axonal, hyperintensity in brain deep nuclei, respiratory disorder and areflexia were unknown. The reported cause of death was rabies, encephalitis and paralysis. The reporter considered the rabies, paralysis, encephalitis, quadriparesis, urinary retention, unconscious, fever, tingling sensation, weakness of limbs, dysphagia, sensory polyneuropathy axonal, hyperintensity in brain deep nuclei, respiratory disorder and areflexia to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of paralytic rabies and rabies encephalitis in a 29-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for prophylaxis. The patient was a right-handed male. It was reported that the patient had suffered a category-III dog bite in his right leg. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On unspecified dates, the patient received 5 doses of unspecified rabies vaccine (administration site and route unspecified; dosages unknown; batch number not provided). The patient had not received rabies immunoglobulin. On an unspecified date, an unknown period after vaccinations, the patient presented with fever and quadriparesis of 5 days duration. It was reported that the patient suffered a category-III dog bite in his right leg 25 days before the onset of his illness. Along with fever, patient developed tingling followed by weakness in the right leg on the first day of illness followed by weakness of all four limbs and urinary retention over the subsequent 2 days. The classical symptom of hydrophobia was not present in the patient. On the sixth day of his illness, he developed dysphagia along with respiratory compromise requiring mechanical ventilation and became unconscious a day later. Neurological examination revealed an areflexic, flaccid quadriparesis mimicking Guillain-Barre syndrome. Nerve conduction studies revealed sensorimotor axonal neuropathy involving all four limbs. Cerebrospinal fluid showed 850 cells/mm3 (88% mononuclear), 122 mg/dl protein and 47 mg/dl glucose with corresponding serum glucose being 86 mg/dl. Magnetic resonance imaging of brain showed hyperintensity in bilateral basal ganglia, thalami, medial temporal lobes, mid-brain and dorsal pons on T2 and fluid-attenuated inversion recovery sequences favoured the possibility of rabies encephalitis. Neutralizing IgG antibody to rabies by Rapid Fluorescence Focus Inhibition Test technique in Cerebrospinal fluid and Serum was more than 2048 on day 14 and showed a steep rise to reach 32 768 on day 20 of illness, thereby confirming rabies encephalitis. Despite supportive treatment, the patient succumbed on day 33 of his illness. It was unknown if an autopsy was performed. The authors did not comment on the relationship between the event of paralytic rabies, rabies encephalitis and unspecified rabies vaccine. The authors stated, "Post-exposure prophylaxis with both rabies immunoglobulin and active immunization with anti-rabies vaccine was indicated for our case carrying a category-III dog bite, but he failed to receive rabies immunoglobulin. Incomplete post-exposure prophylaxis has been frequently reported in cases developing paralytic rabies. Paralytic rabies should be considered a Guillain-Barre syndrome mimic, especially in rabies endemic countries. Lab Comments: Neurological examination revealed an areflexic, flaccid quadriparesis mimicking Guillain-Barre syndrome. Nerve conduction studies revealed sensorimotor axonal neuropathy involving all four limbs. Cerebrospinal fluid showed 850 cells/mm3 (88% mononuclear), 122 mg/dl protein and 47 mg/dl glucose with corresponding serum glucose being 86 mg/dl. Magnetic resonance imaging of brain showed hyperintensity in bilateral basal ganglia, thalami, medial temporal lobes, mid-brain and dorsal pons on T2 and fluid-attenuated inversion recovery sequences favoured the possibility of rabies encephalitis. Neutralizing IgG antibody to rabies by Rapid Fluorescence Focus Inhibition Test technique in Cerebrospinal fluid and Serum was more than 2048 on day 14 and showed a steep rise to reach 32 768 on day 20 of illness, thereby confirming rabies encephalitis.; Reported Cause(s) of Death: rabies; Rabies encephalitis; paralytic rabies


VAERS ID: 822714 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-01
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: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZASA2019SA184025

Write-up: rabies was suspected; Initial unsolicited report received from the literature (Conference abstract) via other health care professional on 29-Jun-2019. This case is linked to case 2019SA153354 (same reporter). Abstract: In this edition, we pro-vide an update on rabies and de-scribe a probable case of rabies in a four-year-old. We issue an alert on two different strengths of equine rabies immu-noglobulin (ERIG) which will be available for use in the country. Healthcare workers are advised to check the package insert of all ERIG products to ensure that the right dosage and volume is adminis-tered. This case involves a four-years-old female patient for whom rabies was suspected and died while she received RABIES VACCINE. Past medical history: The patient was bitten by a stray dog on the face and leg in April 2019. Past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received four dose of suspect RABIES VACCINE produced by unknown manufacturer (There will be no information on the batch number of this case) via unknown route in unknown administration site for bitten by a stray dog on the face and leg. On an unknown date, the patient developed a serious rabies was suspected (rabies) following the administration of RABIES VACCINE. The patient was hospitalized for this event. This event was leading to death. Rabies immunoglobulin was not given. Other relevant tests included Lab data: Ante-mortem testing for this child was not confirmatory. Final diagnosis was (fatal) rabies was suspected. It was not reported if the patient received a corrective treatment. The patient died on an unspecified date of May-2019. Post-mortem investigations were not possible for this case. The cause of death was reported as Rabies. The reporter confirmed this case was classified as a probable rabies case in the absence of laboratory confirmation. Documents held by the sender: none.; Sender''s Comments: This case from a literature concerns a four-year-old female patient who died from suspected rabies approximately one month after being bitten by a dog on face and leg, and despite receiving on unknown dates four doses of Rabies vaccine from unknown manufacturer. Rabies immunoglobulin, which is a critical part of rabies post-exposure prophylaxis, was not administered. Wound care details and time between exposure and post-exposure prophylaxis was not reported. Ante-mortem rabies testing was not confirmatory (inconclusive) and post-mortem investigations were not possible; the case was classified as Probable rabies by the reporter. Based on available information the post-exposure failure is likely linked to deviation from post-exposure recommendations (lack of rabies immunoglobulin administration).; Reported Cause(s) of Death: Rabies


VAERS ID: 822931 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-04-29
Onset:2019-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital cytomegalovirus infection, Cytomegalovirus test positive, Exposure during pregnancy, Nasopharyngitis, Pyrexia, Stillbirth
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Cytomegalovirus antibody; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown
CDC Split Type: TWGLAXOSMITHKLINETW2019AP

Write-up: Stillbirth; Congenital cytomegalovirus infection; Blisters across skin; This retrospective pregnancy case was reported by a physician via sales rep and described the occurrence of stillbirth in a foetus exposed to DTPa (Reduced antigen) (Boostrix) in utero. The mother received the product for prophylaxis. On 29th April 2019, the 35-year-old mother received Boostrix. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The foetus was exposed to Boostrix during the third trimester of pregnancy. On an unknown date, at [weeks gestation], the foetus was born via unknown delivery. The foetus was diagnosed with stillbirth (serious criteria death and GSK medically significant), congenital cytomegalovirus infection (serious criteria death and GSK medically significant) and blister. On an unknown date, the outcome of the stillbirth and congenital cytomegalovirus infection were fatal and the outcome of the blister was unknown. The reported cause of death was cytomegalovirus infection. It was unknown if the reporter considered the stillbirth, congenital cytomegalovirus infection and blister to be related to Boostrix. See case TW2019APC102374 for details regarding the mother case. Additional information was provided as follows: The patient''s mother received Boostrix when she was 30 weeks pregnant. After 1 week, she experienced fever and symptoms like getting cold and the fetus was agitating in the womb. On an unknown date in 2019, the patient''s mother had Cytomegalovirus antibody test which came positive. The patient had blisters on skin and 2 weeks later fetus passed away. Lab Comments: On an unknown date in 2019, the patient''s mother had Cytomegalovirus antibody test which came positive.; Reported Cause(s) of Death: Cytomegalovirus infection


VAERS ID: 823129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: rabies; This case was reported in a literature article and described the occurrence of rabies in a 38-year-old female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant). On an unknown date, the outcome of the rabies was fatal. The patient died in 2009. The reported cause of death was rabies. It was unknown if the reporter considered the rabies to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a 38-year old female, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post exposure prophylaxis. This case corresponds page no.2 reported in this literature article. The patient was part of report that described how a modified protocol was implemented, that contributed to modification of the world health organization''s (WHO''s) global recommendations on rabies immunoglobulins (RIG) use. [deaths due to rabies were still being reported. The high cost of RIG, which is required for Type III bites, made it unaffordable for patients, and it was not routinely stocked in all government services]. The patient was bitten by dog. No information on patient''s medical history, family history, concurrent condition and concomitant medication were provided. On an unspecified date, the patient received full course of unspecified rabies vaccine (administration route and site unspecified; dosages unknown; batch number not provided). It was reported that the patient was well off and could have afford the cost of treatment however, the patient did not receive RIG (rabies immunoglobulin) as it was not available in the civil hospital. [the rabies vaccine can be given by either the intra-dermal (ID) or intramuscular (IM) route. ID administration needs one-fifth of the vaccine volume compared to when given IM, and has the same or superior efficacy. Though the WHO (world health organization) has, since 1992, endorsed ID administration, until 2006, continued with IM administration, requiring a larger quantity of the vaccine, and this led to frequent stockouts of the vaccine]. The age of vaccination was not provided. On an unspecified date in 2009, an unknown period after vaccination the patient died of rabies. It was unknown if an autopsy was performed. This case has been considered as serious due to death. Treatment was unknown. The author did not comment on the relationship between the event of rabies infection and unspecified rabies vaccine. The authors concluded, "we started our intervention in order to save patients in a crisis of RIG shortage. We had no idea of its potential global implications. Our initiative led to a major change in WHO guidelines on RIG use. It is evident that if creative minds are encouraged and supported by their superiors, they have the capacity to contribute to critical national and international policy decisions even while working in small institutions in resource-poor settings. It is also evident that when doctors are sensitive to the plight of poor patients and the circumstances that lead to such unnecessary deaths, they can be energized to challenge any protocol, to save lives not only in their own setting but even worldwide". This is 1 of the 3 valid cases reported in the same literature article. The article corresponding to this case is not available for submission due to copyright restriction.; Reported Cause(s) of Death: rabies


VAERS ID: 823162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rabies Vaccine; Rabies Vaccine; Rabies Vaccine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (bitten by suspected rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: rabies infection; This case was reported in a literature article and described the occurrence of rabies in a male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (bitten by suspected rabid dog). Concomitant products included Rabies NVS (Rabies Vaccine), Rabies NVS (Rabies Vaccine) and Rabies NVS (Rabies Vaccine). On an unknown date, the patient received the 4th dose of Rabies Vaccine. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant). On an unknown date, the outcome of the rabies was fatal. The patient died on unknown date. The reported cause of death was rabies. It was unknown if the reporter considered the rabies to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a male patient of unspecified age, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post exposure prophylaxis. This case corresponds page no.3 reported in this literature article. The patient was part of report that described how a modified protocol was implemented, that contributed to modification of the world health organization''s (WHO''s) global recommendations on rabies immunoglobulins (RIG) use. [deaths due to rabies were still being reported. The high cost of RIG, which is required for Type III bites, made it unaffordable for patients, and it was not routinely stocked in all government services. The patient was badly bitten by suspected rabid dog. No information on patient''s medical history, family history, concurrent condition and concomitant medication were provided. On unspecified dates, the patient received all 4 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided) as recommended by world health organization (WHO). The patient did not receive eRIG (equine rabies immunoglobulin) as it was not available in the market. [the rabies vaccine can be given by either the intra-dermal (ID) or intramuscular (IM) route. ID administration needs one-fifth of the vaccine volume compared to when given IM, and has the same or superior efficacy. Though the WHO (world health organization) has, since 1992, endorsed ID administration, until 2006, continued with IM administration, requiring a larger quantity of the vaccine, and this led to frequent stock outs of the vaccine]. The age at vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed rabies infection and succumbed to it. It was unknown if an autopsy was performed. This case has been considered as serious due to death. Treatment was unknown. The author did not comment on the relationship between the event of rabies infection and unspecified rabies vaccine. The authors concluded, "we started our intervention in order to save patients in a crisis of RIG shortage. We had no idea of its potential global implications. Our initiative led to a major change in WHO guidelines on RIG use. It is evident that if creative minds are encouraged and supported by their superiors, they have the capacity to contribute to critical national and international policy decisions even while working in small institutions in resource-poor settings. It is also evident that when doctors are sensitive to the plight of poor patients and the circumstances that lead to such unnecessary deaths, they can be energized to challenge any protocol, to save lives not only in their own setting but even worldwide". This is 1 of the 3 valid cases reported in the same literature article. The article corresponding to this case is not available for submission due to copyright restriction.; Reported Cause(s) of Death: rabies


VAERS ID: 823190 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2019GS

Write-up: rabies; This case was reported in a literature article and described the occurrence of rabies in a patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death and GSK medically significant). On an unknown date, the outcome of the rabies was fatal. The patient died in 2017. The reported cause of death was rabies. It was unknown if the reporter considered the rabies to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of rabies infection in a patient of unspecified age and gender, who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post exposure prophylaxis. This case corresponds page no.4 reported in this literature article. The patient was part of report that described how a modified protocol was implemented, that contributed to modification of the world health organization''s (WHO''s) global recommendations on rabies immunoglobulins (RIG) use. [deaths due to rabies were still being reported. The high cost of RIG, which is required for Type III bites, made it unaffordable for patients, and it was not routinely stocked in all government services. The patient had a dog bite. No information on patient''s medical history, family history, and concomitant medication were provided. On an unspecified date, the patient received unspecified rabies vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The patient did not receive RIG by private hospital. [the rabies vaccine can be given by either the intra-dermal (ID) or intramuscular (IM) route. ID administration needs one-fifth of the vaccine volume compared to when given IM, and has the same or superior efficacy. Though the WHO (world health organization) has, since 1992, endorsed ID administration,until 2006, continued with IM administration, requiring a larger quantity of the vaccine, and this led to frequent stock outs of the vaccine]. The age at vaccination was not provided. On an unspecified date in 2017, an unknown period after vaccination, the patient developed rabies infection and died. It was unknown if an autopsy was performed. This case has been considered as serious due to death. Treatment was unknown. The author did not comment on the relationship between the event of rabies infection and unspecified rabies vaccine. The authors concluded, "we started our intervention in order to save patients in a crisis of RIG shortage. We had no idea of its potential global implications. Our initiative led to a major change in WHO guidelines on RIG use. It is evident that if creative minds are encouraged and supported by their superiors, they have the capacity to contribute to critical national and international policy decisions even while working in small institutions in resource-poor settings. It is also evident that when doctors are sensitive to the plight of poor patients and the circumstances that lead to such unnecessary deaths, they can be energized to challenge any protocol, to save lives not only in their own setting but even worldwide". This is 1 of the 3 valid cases reported in the same literature article. The article corresponding to this case is not available for submission due to copyright restriction.; Reported Cause(s) of Death: rabies


VAERS ID: 823379 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: RELENZA; TAMIFLU
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2019AM

Write-up: patients died from some adverse effects of the medications; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received zanamivir (Relenza) unknown for drug use for unknown indication. Co-suspect products included oseltamivir phosphate (Tamiflu) for drug use for unknown indication and Flu unspecified (Influenza vaccine) for drug use for unknown indication. On an unknown date, the patient started Relenza at an unknown dose and frequency, Tamiflu at an unknown dose and frequency and Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Relenza and Influenza vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Relenza and Influenza vaccine. Additional Details: it is unknown if the patients died from influenza or if they died from some adverse effects of the medications. It was unknown if the reporter considered the unknown cause of death to be related to Tamiflu.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 823574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apoptosis, Bronchitis, Death, Haemophagocytic lymphohistiocytosis, Hypopnoea, Influenza, Leukocytosis, Nasopharyngitis, Pneumonia, Pulmonary oedema, Pyrexia, Serum ferritin increased, Splenitis, Streptococcus test positive, Sudden infant death syndrome, Tracheitis, Upper respiratory tract infection, White blood cell count increased
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ferritin level; Result Unstructured Data: increase; Test Name: a-hemolytic Streptococcus; Result Unstructured Data: a-hemolytic Streptococcus was detected in the lung section or in the blood; Test Name: white blood cell count; Result Unstructured Data: Leukocytosis
CDC Split Type: JPSA2019SA187260

Write-up: was died after 12 hours with little response to resuscitation; cold-like symptoms accompanied by fever; neutrophil infiltration in the spleen was evident, suggesting that the subjects were affected by hypercytokinemia deriving from an immunological reaction by some infection; extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes; cold-like symptoms accompanied by fever; interstitial pneumonia; upper respiratory infection; shallow breathing; partial patchy pulmonary edema; found limp in the evening; leukocytosis; acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen; lymphocyte apoptosis; mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis; mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis; Influenza Avirus was detected in our postmortem examination; Initial unsolicited valid serious case report received from the literature on 09-Jul-2019. This case is linked to cases 2019SA187262 and 2019SA187264 (same literature). The following is verbatim from the article: Introduction: Sudden infant deaths might be attributable to adverse reaction to vaccination, but separating them from coincidental occurrences is difficult. This study retrospectively investigated vaccination-related details and postmortem findings for 57 cases of sudden death in children 2 years or younger. Data were extracted from autopsy files at the Department of Forensic Medicine. Vaccination histories were available in 50 cases based on the maternity passbook. Of the 32 cases in which any vaccines were administered, 7 infants (21.9%) had received immunization within 7 days of death. The most frequent vaccine cited as the last immunization before death was Haemophilus influenzae B. Although a temporal association of vaccines with sudden death was present for two 3-month-old and one 14-month-old infants in whom death occurred within 3 days of receiving the H. influenzae type b and other vaccinations, a definitive relationship between the vaccine and death could not be identified. Histopathological examinations revealed pneumonia and upper respiratory infection as contributing to death in their cases. Moreover, all 3 cases showed hemophagocytosis in the spleen and lymph nodes, which are similar features to hemophagocytic lymphohistiocytosis. Judgment of the disorders as truly related to vaccination is difficult, but suspicious cases do exist. Forensic pathologists must devote more attention to vaccination in sudden infant death cases. This case involves a three months old female patient who experienced SIDS, cold symptoms, leukocytosis, shallow breathing, acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen, macrophage activation syndrome, lymphocyte apoptosis, fever, pneumonia and upper respiratory infection, tracheitis and bronchitis, influenza A virus infection and limp while she received vaccines HAEMOPHILUS TYPE B (HIB) VACCINE, DTP IPV VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported. On an unknown date at the age of 63 days, the patient received first doses of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur and suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur, lot number not reported via unknown route in unknown administration site. On an unknown date at age of 91 days, the patient received a first dose of suspect DTP IPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date at age of 98 days, the patient received second doses of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur and suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur, lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed cold symptoms (nasopharyngitis) (the day after the second combined immunization) and in the evening found limp (gait disturbance) following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. On an unknown date, the patient died (sudden infant death syndrome) within 3 days following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. The patient was transported by ambulance. On an unknown date, the patient developed leukocytosis, shallow breathing (hypopnoea), acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen (splenitis), extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes (haemophagocytic lymphohistiocytosis), lymphocyte apoptosis (apoptosis), fever (pyrexia), pneumonia and upper respiratory infection (upper respiratory tract infection) following the second dose administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and first dose following the administration of DTP IPV VACCINE. (latency not reported). shallow breathing (hypopnoea), limping pneumonia and upper respiratory infection (upper respiratory tract infection), cold symptoms with fever led to death of the patient. Laboratory test reveled mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis and whole lungs were congested, accompanied by partial patchy pulmonary edema (onset date and latency not reported). Neutrophil infiltration in the spleen was evident, suggesting that the subjects were affected by hypercytokinemia (onset and latency not reported) deriving from an immunological reaction by some infection. Hypercytokinemia and pulmonary edema were medically significant. for rest of the events seriousness not reported. The patient was died within 3 days after vaccination when she was 100 days old. Relevant laboratory test results included: Test: white blood cell count, result: 23,000/uL ( Leukocytosis) Test: ferritin level, result: 16,380 ng/mL (increased), a-hemolytic Streptococcus was detected in the lung section or in the blood. H. influenzae and S. pneumoniae were not detected in the bacterial culture. Final diagnosis was (fatal) upper respiratory infection, (fatal) pneumonia, (fatal) fever, (fatal) lymph nodes and bronchus-associated lymphoid tissue, (fatal) macrophage activation syndrome, (fatal) acute splenitis, infiltration of neutrophils and congestion within the red pulp of the spleen, (fatal) shallow breathing, (fatal) leukocytosis, (fatal) cold symptoms and (fatal) sids. It was not reported if the patient received any corrective treatment. An autopsy results shows the cause of death as Pneumonia or Upper respiratory tract infection. It was reported that the causal relationship of vaccination to the SID subjects was unknown. Outcome of shallow breathing (hypopnoea), limping pneumonia and upper respiratory infection (upper respiratory tract infection), cold symptoms with fever was fatal ad unknown for rest of the events. There will be no information available on the batch number for this case. List of documents held by sender: none.; Sender''s Comments: A 3-month-old female baby developed cold symptoms on the day after vaccination with HAEMOPHILUS TYPE B (HIB) VACCINE (unknown manufacturer), DTP IPV VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE. The infant was found limp in the evening and died despite resuscitative measures. The autopsy results show the cause of death as Pneumonia or Upper respiratory tract infection. Leukocytosis of 23,000/?L was also observed. Nasopharyngitis, leukocytosis (23,000/?L), hypopnea, splenitis, haemophagocytic lymphohistiocytosis (congenital), lymphadenopathy, fever and upper respiratory tract infection were also reported. However, the patient''s medical condition at the time of vaccination not reported and four different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed; Reported Cause(s) of Death: pneumonia; upper respiratory infection; was died after 12 hours with little response to resuscitation; sids


VAERS ID: 823575 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Haemophagocytic lymphohistiocytosis, Influenza like illness, Lymphadenopathy, Lymphoid tissue hyperplasia, Pneumonia, Pyrexia, Splenitis, Sudden infant death syndrome, Tracheitis, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (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: Test Name: tryptase; Test Result: 2.8 {DF}
CDC Split Type: JPSA2019SA187264

Write-up: Sudden infant death syndrome; pneumonia; upper respiratory infection; macrophage activation syndrome/hemophagocytic lymphohistiocytosis; Cold like symptoms; swollen lymph nodes; reactive follicular hyperplasia; splenitis; high fever of more than 38 degrees celsius; bronchitis; tracheitis; Initial information received on 09-Jul-2019 regarding an unsolicited valid serious case issued from a literature article. This case is linked to case ID: 2019SA187260 and 2019SA187262 same article. The following is verbatim from the article: Sudden infant deaths might be attributable to adverse reaction to vaccination, but separating them from coincidental occurrences is difficult. This study retrospectively investigated vaccination-related details and Postmortem findings for 57 cases of sudden death in children 2 years or younger. Data were extracted from autopsy files at the Department of Forensic Medicine. Vaccination histories were available in 50 cases based on the maternity passbook. Of the 32 cases in which any vaccines were administered, 7 infants (21.9%) had received immunization within 7 days of death. The most frequent vaccine cited as the last immunization before death was Haemophilus influenzae B. Although a temporal association of vaccines with sudden death was present for two 3-month-old and one 14-month-old infants in whom death occurred within 3 days of receiving the H. influenzae type b and other vaccinations, a definitive relationship between the vaccine and death could not be identified. Histopathological examinations revealed pneumonia and upper respiratory infection as contributing to death in their cases. Moreover, all 3 cases showed hemophagocytosis in the spleen and lymph nodes, which are similar features to hemophagocytic lymphohistiocytosis. Judgment of the disorders as truly related to vaccination is difficult, but suspicious cases do exist. Forensic pathologists must devote more attention to vaccination in sudden infant death cases. Key Words: Hib, Streptococcus pneumoniae, forensic autopsy, histopathology, hemophagocytosis. This case involves a 14 months old male patient who experienced sudden infant death syndrome, pneumonia, upper respiratory infection, macrophage activation syndrome/hemophagocytic lymphohistiocytosis, swollen lymph nodes, splenitis, bronchitis, tracheitis and high fever of more than 38 degrees celsius, while he received vaccine HAEMOPHILUS TYPE B (HIB) VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (reported as 422 day after birth), patient received a fourth dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious sudden infant death syndrome, pneumonia, upper respiratory infection (upper respiratory tract infection), macrophage activation syndrome/hemophagocytic lymphohistiocytosis (haemophagocytic lymphohistiocytosis), swollen lymph nodes (lymphadenopathy), splenitis, high fever of more than 38 degrees celsius (pyrexia), cold like symptoms (nasopharyngitis), tracheitis, bronchitis and reactive follicular hyperplasia (lymphoid tissue hyperplasia) following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE. This event was leading to death. Laboratory test included Tryptase was 2.8 mcg/L, indicating no anaphylactic reaction potentially related to the SID cases, Histopathological findings showed tracheitis and bronchitis. Acute splenitis characterized by infiltrationof neutrophils and congestion within the red pulp of the spleen. Moreover, extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes. Swollen lymph nodes were visible in the whole body such as cervical lymph nodes and mesentery lymph nodes. Histopathology showed reactive follicular hyperplasia. Final diagnosis was (fatal) Mild splenitis, (fatal) Mild swollen lymph nodes, (fatal) Mild macrophage activation syndrome/hemophagocytic lymphohistiocytosis, (fatal) Mild upper respiratory infection, (fatal) Mild pneumonia and (fatal) Mild sudden infant death syndrome. It was not reported if the patient received a corrective treatment. On an unknown date, the patient died due to upper respiratory tract infection, pneumonia and sudden infant death. An autopsy was done. The cause of death was reported as upper respiratory tract infection, pneumonia and Sudden infant death syndrome. There will be no information available on the batch number for this case. List of documents held by sender: none.; Sender''s Comments: This case concerns a 14-month-old boy, with underlying Haemophagocytic lymphohistiocytosis, who died suddenly 3 days post-vaccination with HAEMOPHILUS TYPE B (HIB) (Manufacturer unknown). The autopsy results revealed pneumonia and upper respiratory infection as a cause. Lymphadenopathy, splenitis, pyrexia, nasopharyngitis and lymphoid tissue hyperplasia, including tracheitis and bronchitis, were also reported to occur. However, there is no information regarding patient''s medical condition at the time of vaccination, concomitant medications rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed; Reported Cause(s) of Death: pneumonia; Upper respiratory tract infection; Sudden infant death syndrome


VAERS ID: 823712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Death, Haemophagocytic lymphohistiocytosis, Pneumonia, Splenitis, Tracheitis, Upper respiratory tract infection
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Test Name: Streptococcus; Result Unstructured Data: a-hemolytic Streptococcus was detected in the lung section or in the blood; Test Name: Tryptase; Test Result: 5.8 {DF}; Result Unstructured Data: 5.8 ?g/L, indicating no anaphylactic reaction potentially related to the SID cases
CDC Split Type: JPSA2019SA187262

Write-up: Hewas found dead in sleep; pneumonia; bronchitis; tracheitis; upper respiratory infection; Cold like symptoms; extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes; acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen; Initial information received on 09-Jul-2019 regarding an unsolicited valid serious case issued from a literature article. This case is linked to case ID: 2019SA187260 and 2019SA187264. The following is verbatim from the article: Sudden infant deaths might be attributable to adverse reaction to vaccination, but separating them from coincidental occurrences is difficult. This study retrospectively investigated vaccination-related details and postmortem findings for 57 cases of sudden death in children 2 years or younger. Data were extracted from autopsy files at the Department of Forensic Medicine. Vaccination histories were available in 50 cases based on the maternity passbook. Of the 32 cases in which any vaccines were administered, 7 infants (21.9%) had received immunization within 7 days of death. The most frequent vaccine cited as the last immunization before death was Haemophilus influenzae B. Although a temporal association of vaccines with sudden death was present for two 3-month-old and one 14-month-old infants in whom death occurred within 3 days of receiving the H. influenzae type b and other vaccinations, a definitive relationship between the vaccine and death could not be identified. Histopathological examinations revealed pneumonia and upper respiratory infection as contributing to death in their cases. Moreover, all 3 cases showed hemophagocytosis in the spleen and lymph nodes, which are similar features to hemophagocytic lymphohistiocytosis. Judgment of the disorders as truly related to vaccination is difficult, but suspicious cases do exist. Forensic pathologists must devote more attention to vaccination in sudden infant death cases. Key Words: Hib, Streptococcus pneumoniae, forensic autopsy, histopathology, hemophagocytosis. This case involves a three months old male patient who died suddenly due to upper respiratory tract infection and pneumonia and had cold like symptoms, extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes and acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen while he received vaccines DTP IPV VACCINE, HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and HAEMOPHILUS TYPE B (HIB) VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (reported as 63 day after birth), the patient received a first dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, ROTAVIRUS VACCINE (not produced by Sanofi Pasteur), DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE (not produced by Sanofi Pasteur, taken 107 days after birth), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (not produced by Sanofi Pasteur) and HEPATITIS B VACCINE (not produced by Sanofi Pasteur) lot number, route and administration site were not reported for all the vaccines. On an unknown date (reported as 107 day after birth), HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer, ROTAVIRUS VACCINE (not produced by Sanofi Pasteur), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (not produced by Sanofi Pasteur) and HEPATITIS B VACCINE (not produced by Sanofi Pasteur) lot number, route and administration site were not reported for all the vaccines. On an unknown date, the patient developed a serious upper respiratory tract infection, pneumonia (unknown latency) following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), HEPATITIS B VACCINE and DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE and ROTAVIRUS VACCINE.. On an unknown date, on third day the patient suddenly died (sudden infant death syndrome). This event was leading to death. On an unknown date, the patient developed a serious cold like symptoms (nasopharyngitis) (unknown latency, reported as continuously from the immunized day) following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), HEPATITIS B VACCINE and DIPHTHERIA VACCINE;PERTUSSIS VACCINE;POLIO VACCINE inact;TETANUS VACCINE and ROTAVIRUS VACCINE. This event was leading to death. On an unknown date, (latency unknown) laboratory findings reveled that the patent showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen. Moreover, extensive hemophagocytosis was visible in the spleen, liver, and lymph nodes (Haemophagocytic lymphohistiocytosis and splenitis). Relevant laboratory test results included: Streptococcus test positive - On an unknown date: [a-hemolytic Streptococcus was detected in the lung section or in the blood] Tryptase - On an unknown date: 5.8 [5.8 ?g/L, indicating no anaphylactic reaction potentially related to the SID cases] Histopathological findings: Mild inflammatory cell infiltration including neutrophils was visible around the tracheae and the bronchi, indicating tracheitis and bronchitis, showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen and lymphocyte apoptosis and abundant nuclear debris were found in the lymph nodes and bronchus-associated lymphoid tissue. Hematoxylin and eosin stained sections of spleen showed hemophagocytosis, as erythrocytes, leukocytes, and platelets were engulfed by activated macrophages in tissues of the spleen and the lymph node. Final diagnosis was (fatal) sudden infant death and (fatal) cold like symptoms. It was not reported if the patient received a corrective treatment. On an unknown date, the patient died due to upper respiratory tract infection, pneumonia and sudden infant death. An autopsy was done. The cause of death was reported as upper respiratory tract infection, pneumonia and Sudden infant death syndrome. The outcome of the events was unknown for Haemophagocytic lymphohistiocytosis and splenitis and fatal for rest of the events. Causality statement: However, we concluded that the causal relationship of vaccination to the SID subjects was unknown in the reports because of the unclear mechanism how the 2 nonactive vaccines affect the mortality of infants and because of the difficulty to exclude potential coincidental occurrence. It is therefore necessary to consider it carefully at postmortem, along with the circumstances of death and autopsy findings, as many forensic pathologists may overlook this potential contributing factor. There will be no information available on the batch number for this case. List of documents held by sender: none.; Sender''s Comments: This case concerns a 3-month-old boy who died suddenly 3 days post-vaccination with HAEMOPHILUS TYPE B (HIB) (manufacturer unknown), HEPATITIS B , PNEUMOCOCCAL CONJ 13V (CRM197) , and DIPHTHERIA-TETANUS-PERTUSSIS-POLIO (DTaP-IPV) combined vaccines. The autopsy results revealed pneumonia and upper respiratory infection as a cause. The infant had presented cold like symptoms the day after vaccination. He was found dead in sleep in the early morning of the third day. Laboratory test included Streptococcus test positive and Tryptase was 5.8mcg/L, indicating no anaphylactic reaction potentially related to the SID cases, Histopathological findings showed tracheitis and bronchitis, showed acute splenitis characterized by infiltration of neutrophils and congestion within the red pulp of the spleen and lymphocyte. However, there is no information regarding patient''s medical condition at the time of vaccination, concomitant medications rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be individually assessed; Reported Cause(s) of Death: pneumonia; sudden infant death syndrome; Upper respiratory tract infection


VAERS ID: 823798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-04-02
Submitted: 0000-00-00
Entered: 2019-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Influenza A virus test positive, Polymerase chain reaction, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20160404; Test Name: Influenza A virus subtype H1N1 test positive; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Date: 20160404; Test Name: Human respiratory syncytial virus test positive; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Date: 20160404; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2019GS

Write-up: Respiratory distress; Fever; Cough; Vaccination failure; Influenza A(H1N1)pdm09 infection; human respiratory syncytial virus infection; Severe acute respiratory infection; This case was reported in a literature article and described the occurrence of vaccination failure in a 14-month-old female subject who received Influenza vaccine for prophylaxis. On 2nd April 2016, 266 days after receiving Influenza vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included h1n1 influenza on 2nd April 2016 with serious criteria of death and hospitalization, respiratory syncytial virus infection on 2nd April 2016 with serious criteria of death and hospitalization, severe - grade 3 acute respiratory tract infection on 2nd April 2016 with serious criteria of hospitalization and GSK medically significant, fever on 2nd April 2016 with serious criteria of hospitalization, cough on 2nd April 2016 with serious criteria of hospitalization and respiratory distress with serious criteria of hospitalization and GSK medically significant. The subject was treated with antibiotics nos and oseltamivir. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included h1n1 influenza (fatal), respiratory syncytial virus infection (fatal), acute respiratory tract infection (unknown), respiratory distress (unknown), fever (unknown) and cough (unknown). The reported cause of death was h1n1 influenza and respiratory syncytial virus infection. The investigator considered that there was a reasonable possibility that the vaccination failure, h1n1 influenza, respiratory syncytial virus infection, acute respiratory tract infection, fever, cough and respiratory distress may have been caused by Influenza vaccine. Relevant Tests: 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols]. Diagnostic results (unless otherwise stated, normal values were not provided): On 4th April 2016, Influenza A virus test positive result was positive unknown, Pneumovirus test positive result was positive unknown and Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the vaccination failure in a patient of 1.2-year-old female, who was vaccinated with an unspecified trivalent influenza vaccine (TIV) (manufacturer unknown) for prophylaxis. The patient was a part of birth cohort study, which presented the clinical-epidemiological and molecular characteristics of the first documented influenza outbreak in indigenous peoples that occurred from 30th March to 14th April 2016. Acute respiratory infections were prospectively investigated [In this study, a trained health team visited the households weekly to allow early identification of ARI cases. In the last epidemiological week (EW) of March 2016 (EW 13/2016), a rapid increase in the number and severity of ARI cases was observed beyond the target birth cohort study population. The fieldworkers were supported by the technical section of the Agency, the municipal epidemiological surveillance service and by the research group in order to actively search for cases in all households, collect information on disease and laboratory samples, and help to control the outbreak.]. No information on patient''s medical history and family history or concurrent condition or concomitant medication were provided. On an unspecified date in 2015, the patient received unspecified TIV vaccine (administration route and site unspecified; dosages unknown, batch number not provided). The age at vaccination was not reported. On 2 April 2016, 266 days after vaccination, the patient developed severe acute respiratory infection (SARI). [In this study, SARI defined as the patient experienced Influenza-like illness (ILI) case plus respiratory distress with or without hospitalization. ILI cases were defined as fever measured or reported plus cough and/or sore throat, with onset within the last 7 days during an outbreak]. Subsequently, the patient was hospitalized. On 4th April 2016, 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols]. The patient received antibiotic, oseltamivir with symptomatic treatment. On an unspecified date, the patient died. The clinical outcome of the patient was death. It was unknown if an autopsy was performed. This case has been considered as vaccination failure case. This case has been considered as serious due to death, vaccination failure, hospitalization. The author did not comment on the relationship between the event of SARI and unspecified TIV. However, the authors stated, "Contrary to expectation, the village group has permanent contact with the surrounding non-indigenous population, so is probably not naive for influenza A (H1N1)pdm09 infection and other influenza strains. Additionally, the trivalent influenza vaccine (TIV), which has contained the influenza A(H1N1)pdm09 strain since 2010, is part of the Immunization Program, and had 86.3% vaccination coverage in the 2015 seasonal campaign. These findings revealed the susceptibility of the village to a respiratory outbreak, even though they are not isolated and have high vaccination coverage, and suggests that the population might have attenuated immunity against seasonal influenza, possibly due to influenza antigenic drifts and/or loss of vaccine-induced immunity over time. The A/California/07/2009-like (H1N1)pdm09 strain was integrated in the influenza vaccine for the southern hemisphere from 2010 to 2016. Since the emergence of the influenza A (H1N1)pdm09 strain in 2009, some mutations in HA and NA were gradually incorporated by the virus population over the seasons. This culminated in the emergence and spread of the genetic group 6B.1, characterized by the HA substitution S84N, S162N with the addition of a glycosylation site, and I233T, in the northern hemisphere during the 2015-2016 epidemic season. This genetic group, with important changes in antigenic sites in the HA protein, was introduced in 2016 and may be responsible for the severe epidemic season of this year and for the outbreak in the specific population." The authors concluded, "The results have shown an early arrival of the influenza season before the 2016 influenza vaccination campaign. At the same time, it was confirmed the emergence and spread of a new influenza genetic group not covered by the 2015 vaccine and an overlapping with the hRSV season. The confluence of those circumstances in an indigenous village where several risk factors for infection and severity are highly prevalent can explain the high attack rate of ARI even with a high rate of influenza vaccination, confirming the vulnerability of indigenous peoples to acute respiratory infections. Thus, effective surveillance of respiratory viruses, timely vaccination and controlling risk factors for infection and severity of ARI in the indigenous populations are key public health measures for monitoring and preventing disease and related deaths, particularly in children. Establishing sentinel units in strategic villages with greater demographic mobility can help to identify influenza, hRSV and other virus circulation, and also genetic virus mutations. Influenza vaccination of pregnant women, caregivers and household contacts of children too young to receive vaccine seems to be a reasonable preventive strategy for younger children, since a severe laboratory-confirmed case of influenza A(H1N1)pdm09 was seen in children under the vaccination age. Further studies on pathogen circulation in indigenous villages, and on maternal-infant passive protection, immune response to vaccination and vaccination effectiveness could bring new and robust evidence for indigenous health policy making and decisions regarding optimal timing for vaccination delivery." This is 1 of the 12 valid cases reported in the same literature article. Lab Comments: 2 days after onset of symptoms, the patient''s nasopharyngeal swab sample was collected for the detection of etiological agent. Real time-polymerase chain reactions (RT-PCRs) were conducted using Centers for Disease Control and Prevention (CDC) protocols for influenza A and B and human respiratory syncytial virus (hRSV) detection. The patient was found positive for influenza A(H1N1)pdm09 and hRSV pathogens. [In this study, the genetic sequencing steps were performed for influenza and hRSV positive samples with a cycle threshold (CT) lower than 32 in the real time RT-PCR protocols].; Reported Cause(s) of Death: H1N1 influenza; Respiratory syncytial virus infection


VAERS ID: 823842 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: DE0095075131907DEU009888

Write-up: Death NOS; Information has been downloaded from database (DE-GLAXOSMITHKLINE-DE2019EME118924). This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient''s pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis. On an unknown date, the patient dead of an unknown cause. It was unknown if an autopsy was reported. The causality assessment was not provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 824148 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: DE0095075131907HUN010863

Write-up: two children died 6 weeks after vaccination with an unspecified HPV vaccine; manufacturer origin unknown; This spontaneous report was received from a physician and refers to two child patients of unknown age and gender. There was no information about the patients'' concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as last 3 to 5 years), the patients were vaccinated with 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)(reported as HPV vaccine) for prophylaxis. On an unknown date (reported as 6 weeks after vaccination), the patients died. The reporter considered death to be related to suspect therapy.


VAERS ID: 824282 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute graft versus host disease, Acute graft versus host disease in intestine, Acute graft versus host disease in liver, Acute hepatic failure, Alanine aminotransferase increased, Allogenic stem cell transplantation, Aspartate aminotransferase increased, Aspiration bone marrow normal, Autopsy, Biopsy intestine abnormal, Blood bilirubin increased, Blood lactate dehydrogenase increased, Coagulopathy, Colonoscopy abnormal, Coma scale abnormal, Death, Depressed level of consciousness, Diarrhoea, Encephalopathy, Faecal volume increased, Gamma-glutamyltransferase increased, General physical condition abnormal, General physical health deterioration, Haemoglobin decreased, Hepatic function abnormal, Hepatic necrosis, Hyperammonaemia, Hypertension, Hypotension, Intestinal haemorrhage, Jaundice, Large intestinal ulcer, Photopheresis, Platelet count decreased, Polymerase chain reaction positive, Pyrexia, Rash, Renal failure, Respiratory failure, Rubella, Rubivirus test positive, Tachycardia, Thrombotic microangiopathy, Transfusion, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute myeloblastic leukaemia; Myelodysplastic syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131907ESP007071

Write-up: Acute liver failure (ALF) by rubella was probably the main cause of?death; microbiological analysis showed an isolated and surprising detection of rubella virus (RV) sequences of genotype 1A; Secondary infection from a newly vaccinated person remains the only possibility to explain the presence of RA27/3 in the patient; This literature marketed report was received from a physician and refers to a 12 year old male patient, who was diagnosed with acute myeloblastic leukemia (AML) secondary to myelodisplastic syndrome (MDS) in September 2008. On an unknown date, when the patient was 4 year old, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dosage, frequency, route, lot# and expiration date were not provided). In April 2019, the patient underwent to allogeneic hematopoietic stem cell transplantation (HSCT) from his haploidentical mother. It was stated that the patient had not received any vaccines since 1 year before because he was in the hospital as an inpatient during this time due to his poor social situation. However on day +31 post-transplantation, he was diagnosed with acute graft-vs-host disease (aGVHD) grade 2 with hepatic and intestinal involvement using compatible gut biopsy. Treatment with corticosteroids at 1 mg/kg/d was started, with good response. On day +60 post-transplantation, he was admitted to the emergency department. He presented in poor condition with a Lansky score of 60%. He had diarrhea, generalized cutaneous exanthema, and conjunctiva jaundice. Laboratory findings showed a hemoglobin level of 11 gr/dL, platelets of 42 ? 109/L, and white blood cells of 0.67 ? 109/L. A bone marrow aspirate was performed, and he was in complete remission. Blood chemistry showed abnormal liver function with an aspartate aminotransferase (AST) of 439 U/L, alanine aminotransferase (ALT) of 578 U/L, gamma glutamyl transferase (GGT) of 1108 U/L, and bilirubin of 6 mg/dL (direct bilirubin: 3.5 mg/dL). Because of suspicion of recurrent aGVHD, the dose of corticosteroids was increased to 2 mg/kg/d, and treatment with intravenous cyclosporine was started. Despite treatment, the patient progressively got worse, with the appearance of abundant intestinal bleeding. A colonoscopy was performed, and he was diagnosed with aGVHD grade 4 with the presence of ulcers throughout the colon mucosa. Third-line therapy with extracorporeal photopheresis and subcutaneous etanercept was started. Cyclosporine was stopped due to the suspicion of thrombotic microangiopathy with severe arterial hypertension and renal failure. Liver function progressively improved, but his stool volume increased to more than 3000 mL per day with daily need for transfusions. On day +80 post-transplantation, the patient''s clinical condition rapidly deteriorated, and he went into fulminant hepatic failure (AST: 5766 U/L; ALT: 1767 U/L; and lactic dehydrogenase: 17993 U/L). He developed severe and refractory coagulopathy, hyperammonemia, and clinical acute encephalopathy with a decreased level of consciousness (Glasgow score: 6). He started with fever, hypotension, tachycardia, exanthema, and respiratory insufficiency, and finally he died on day +82 after transplantation. The family authorized the necropsy, which determined as the cause of death severe zonal hepatic necrosis of hemodynamic etiology. There were no signs of active GvHD in the liver, and microbiological analysis showed an isolated and surprising detection of rubella virus (RV) sequences of genotype 1A, similar to the vaccine strain RA27/3 by reverse transcriptase? polymerase chain reaction (RT-PCR). Therefore, secondary infection from a newly vaccinated person remains the only possibility to explain the presence of RA27/3 in the patient. The authors also concluded that the patient showed an exanthema concomitant to the detection of RV RNA, which was accompanied by severe hemodynamic symptoms leading to acute liver failure (ALF) and death. ALF by rubella was probably the main cause of death. A copy of the published article is attached as further documentation of the patient''s experience. Upon internal review, the event Acute hepatic failure was considered to be medically significant.


VAERS ID: 824347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: INN Flu Vaccine Seasonal
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZSEQIRUS201904150

Write-up: [Passed away after receiving] flu vaccine as it had interacted with current meds; This is a spontaneous case, initially received from other non-health professional on 18-Jul-2019, concerning a female patient of unspecified age (reported as 60 plus). The patient was on unspecified concomitant medications. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication. On an unspecified date, after vaccination, it was reported that the patient passed away as INN Flu Vaccine Seasonal had interacted with the patient''s unspecified current medications (drug interaction). It was unknown, whether autopsy was performed. The reporter assessed the case as serious (death) and causality of the event as related to the suspect vaccine.; Reporter''s Comments: A female patient of unspecified age experienced death due to drug interaction, unspecified period after receipt of INN flu vaccine seasonal. Considering the lack of information regarding onset latency, details of concomitant medications and drug interaction, the company assessed the causality as unassessable.; Reported Cause(s) of Death: [Passed away after receiving] flu vaccine as it had interacted with current meds


VAERS ID: 824441 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Death, Foetal exposure during pregnancy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: HEPATITIS B IMMUNOGLOBULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis B (patient mother had chronic hepatitis B infection during pregnancy from 12 to 34 weeks of gestation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2019GS

Write-up: ruptured abdominal aortic aneurysm; This case was reported in a literature article and described the occurrence of aortic aneurysm rupture in a 8-day-old subject who received Hepatitis B vaccine for prophylaxis. The subject had a Family History of chronic hepatitis b (patient mother had chronic hepatitis B infection during pregnancy from 12 to 34 weeks of gestation). Previously administered products included telbivudine (the patient was exposed to telbivudine in utero). Concomitant products included immunoglobulin antihepatitis b (Hepatitis B Immunoglobulin). On an unknown date, 8 days after receiving Hepatitis B vaccine, the subject developed aortic aneurysm rupture. Serious criteria included death and GSK medically significant. The outcome of aortic aneurysm rupture was fatal. The reported cause of death was aortic aneurysm rupture. It was unknown if the investigator considered the aortic aneurysm rupture to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of ruptured abdominal aortic aneurysm in a 8 days old infant who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. The patient and his/her mother was part of the prospective, observational study that aimed to evaluate the efficacy and safety of using telbivudine treatment started at 12-34 weeks of gestation in HBeAg positive or negative chronic hepatitis B (CHB) mothers on mother to child transmission (MTCT) prevention, hepatitis B virus deoxyribonucleic acid (HBV DNA) suppression, and maternal and fetal safety including major birth defect rates. During pregnancy the patient''s mother received routine physical examination. The liver function, HBV markers, HBV DNA, routine blood test and renal function were assessed regularly. The patient''s mother had chronic hepatitis B infection. The patient''s mother belonged to telbivudine group. Patient''s mother renal function and creatine kinase (CK) were monitored every 2-4 weeks. The patient''s mother received 600 mg/d of telbivudine (Sebivo, Novartis Pharma) from 12 to 34 weeks of gestation. The patient''s mother had abnormal liver function and had received glycyrrhizin (Minophagen Pharmaceutical Co., Ltd.), Polyene Phosphatidylcholine (Essentiale, Sanofi Pharma Ltd.), ademetionine (Simeitai, Abbott Laboratories Ltd.) or other agents for improving liver function. On an unspecified date, the patient born via unknown delivery method. The patient''s mother continued to receive telbivudine after delivery. No information on patient''s medical or concomitant medication or concurrent condition was provided. On an unspecified date, within 12 hours of birth the patient received 10 ug unspecified HBV vaccine in the deltoid muscle (administration route; batch number not provided). the patient also received HBIG 100-200 IU in the gluteus maximums within 12 h of birth. The patient was exposed to telbivudine in utero. On an unspecified date, 8 days after vaccination (delivery), the patient died of ruptured abdominal aortic aneurysm at 8 days after delivery. It was unknown if autopsy was performed. This case has been considered as serious due to death. The author did not comment on the relationship between the event of ruptured abdominal aortic aneurysm and unspecified HBV vaccine. The authors stated, "The most common telbivudine-related adverse events was increased serum CK levels. In our study, CK levels was slightly increased in 7 cases from telbivudine group and spontaneously recovered without drug withdrawal. In telbivudine group, fetal malformation was found in two cases (1 case at antenatal examination after 4 weeks of treatment, and another newborn had a ruptured abdominal aortic aneurysm in the perinatal period), and it''s no statistically significant difference compared with that in control group". The authors concluded "The antiviral therapy in HBeAg positive women whose HBV DNA are more than 106 IU/mL was started at the third trimester to prevent MTCT is recommended. However, it''s still have failed immunoprophylaxis in some high viral load CHB mothers. Antiviral therapy start at a earlier time may be a solution, but we have insufficient data to prove that it is a safe method. In this study, we found that telbivudine treatment at 12-34 weeks of gestation in HBeAg positive or negative CHB mothers with serum HBV DNA more than 6.0 log10 IU/mL is well tolerance and safe in our limited data. Thus, telbivudine can safely reduce mother-to-child transmission in chronic hepatitis B women after 12 weeks of gestation." This is 1 of the 5 valid cases reported in this literature article.; Reported Cause(s) of Death: Aortic aneurysm rupture


VAERS ID: 824980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-07-12
Onset:2019-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Autopsy, Death
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201913

Write-up: Increased agitation; Exitus letalis unclear cause; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 2-month-old male patient who received Rota (Rotarix) for prophylaxis. On 12th July 2019, the patient received the 1st dose of Rotarix (oral). On 13th July 2019, 1 days after receiving Rotarix, the patient experienced unknown cause of death (serious criteria death, GSK medically significant and life threatening). In July 2019, the patient experienced agitation. On 13th July 2019, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the agitation was unknown. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death and agitation to be related to Rotarix. Additional details: Age at vaccination was not reported however patient could be 1 or 2 months old at time of vaccination. The child was found dead at 19:00 of 13th July 2019. Initial information was reported by a physician via regulatory authority on 19th July 2019. Exitus lethalis of unknown cause. Sender''s comment: On 12.07.2019 the complication-free, first-time vaccination of the child with Rotarix took place. On the afternoon of the following day, the child was put to sleep by the mother at 17.00 and found lifeless in bed at 19.00. No other abnormalities except increased agitation since vaccination were noticed Was an outpatient treatment required ?: No; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 824983 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: NZGLAXOSMITHKLINENZ2019AP

Write-up: death NOS; This case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient passed away after receiving Flu Vaccine as it had interacted with current medication (unspecified). There was no information about current medication and cause of death follow up request was raised. The reporter did not give consent to follow up.; Reported Cause(s) of Death: Death NOS


VAERS ID: 825666 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-07-12
Onset:2019-07-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 32D22 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Prostate cancer
SMQs:, Prostate malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Diabetes; Parkinsonism; Prostatic carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: Suspected pulmonary embolism; This case was reported by a physician via call center representative and described the occurrence of pulmonary embolism in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 32D22, expiry date unknown) for prophylaxis. Concurrent medical conditions included asthma, parkinsonism, diabetes and prostatic carcinoma. On 12th July 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, 3 days after receiving Shingrix, the patient experienced pulmonary embolism (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the pulmonary embolism was fatal. The patient died on 15th July 2019. The reported cause of death was pulmonary embolism. It was unknown if the reporter considered the pulmonary embolism to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported, however the patient could be 80 or 81 years. The patient received a dose of Shingrix in left upper arm. On the day of the vaccine, the patient''s general health was good, apart from the known accompanied comorbidities. He was not different than usual. It was not known to the female doctor, whether symptoms arose directly after the vaccination. She sees a temporary connection between death and vaccination, however no causality. The reported batch number was changed from CH 32D22 to 32D22 as per sales data sheet.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 825802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Death, Influenza, Influenza B virus test positive, Influenza like illness, Septic shock, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2017; Test Name: Influenza B virus test; Result Unstructured Data: Test Result: Influenza B (Phuket strain) positive, Test Result Unit: unknown
CDC Split Type: AUGLAXOSMITHKLINEAU2019GS

Write-up: Vaccination failure; Influenza B (Phuket strain) infection; Influenza-like illness; Acute Respiratory Failure; Septic Shock; This case was reported in a literature article and described the occurrence of vaccination failure in a 40-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis. On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, 122 days after receiving Fluarix Tetra, the patient experienced vaccination failure (serious criteria death and GSK medically significant), influenza b virus infection (serious criteria death), influenza like illness (serious criteria death), acute respiratory failure (serious criteria death and GSK medically significant) and septic shock (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure, influenza b virus infection, influenza like illness, acute respiratory failure and septic shock were fatal. The reported cause of death was influenza b virus infection, influenza like illness, acute respiratory failure, septic shock and vaccination failure. The reporter considered the vaccination failure, influenza b virus infection, influenza like illness, acute respiratory failure and septic shock to be related to Fluarix Tetra. Additional information provided as follows: This case was reported in a literature article and described the vaccination failure in a 40-year-old female patient who was vaccinated with Fluarix Tetra vaccine (GlaxoSmithKline) for prophylaxis. This case corresponds to page no. 20 (severity of outcomes) reported in this literature article. The patient was part of the Australian passive surveillance data for adverse events following immunization (AEFI) for 2017 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. The post-marketing surveillance of AEFI was particularly important to detect signals of rare, late onset or unexpected events, which are difficult to detect in pre-registration vaccine trials. No information on patient''s medical or family history or concurrent condition or concomitant condition was provided. On an unspecified date between 1st January 2000 and 31st December 2017, the patient had received Fluarix Tetra vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date between 1st January 2000 and 31st December 2017, 4 months after vaccination, the patient had an influenza-like illness for one week and presented to the emergency department in acute respiratory failure and septic shock. She was transferred to another hospital via ambulance but died on route. The patient tested positive for Influenza B (Phuket strain) found in the 2017, Fluarix Tetra. The patient was died on unspecified date. It was unknown if an autopsy was performed. This case has been considered as serious due vaccination failure and death. The author commented, "In summary, all deaths following immunization reported to the TGA were investigated by the TGA and where relevant, other relevant authorities, based on the information received from reporters. Two deaths were due to vaccine failure, not adverse events following immunization. Vaccine effectiveness varies by vaccine type, as well as vaccine recipient and pathogen characteristics." The author concluded, "The number of reported AEFI increased in 2017 compared with 2016 though the majority were non-serious transient events. The data reported here are consistent with an overall high level of safety for vaccines used when used according to clinical recommendations contained within the Immunization Handbook". The article corresponding to this case is not available for submission due to copyright restriction. This is 1 of the 4 valid cases reported in this literature article.; Reported Cause(s) of Death: Influenza B virus infection; Influenza like illness; Acute Respiratory Failure; Septic Shock; Vaccination failure


VAERS ID: 825899 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-01-23
Onset:2018-01-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3K531M / UNK - / OT

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: CNSA2019SA199967

Write-up: Suffocation death by quilt; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A 9 weeks old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV(Salk) [IPV (VERO)] , lot number N3K531M, manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 23-JAN-2018 at 15:30. Other primary diagnosis reported by the HA was "suffocation death by quilt" on 24-JAN-2018 at 01:00, 9 hours and 30 minutes post-vaccination Treatment date was reported as 24-Jan-2018 without further details. At the time of the report, the outcome was reported as fatal. The patient died on an unknown date. It was not reported whether autopsy was done. Cause of death was reported as suffocation death by quilt. AEFI category was reported as coincidence by the HA. List of documents held by the sender :none; Sender''s Comments: Sanofi company comment on 22-Jul-2019: 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: Suffocation death by quilt


VAERS ID: 825900 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-01-02
Onset:2018-01-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3C681M / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2019SA199994

Write-up: Acute interstitial pneumonia; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A 2 months old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV(Salk) [IPV (VERO)] , (lot number N3C681M, manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 02-Jan-2018 at 09:00 AM. Other primary diagnosis reported by the HA was acute interstitial pneumonia on 04-Jan-2018 at 16:00 PM, 2 days post-vaccination. This event led to death of the patient. Final diagnosis reported by the HA was others. Treatment date was reported as 04-Jan-2018 without further details. At the time of the report, the outcome was reported as fatal. The patient died on an unknown date. It was not reported if autopsy was performed. The cause of death was acute interstitial pneumonia. AEFI category was reported as coincidence by the HA.; Sender''s Comments: Sanofi company comment on 22-Jul-2019: 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: Interstitial pneumonia


VAERS ID: 825901 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-08-24
Onset:2018-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3N731M / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2019SA199995

Write-up: Sudden death syndrome; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. An eight weeks old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV Salk [IPV (VERO)] (lot number: N3N731M manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 24-Aug-2018 at 09:00 am. Injury degree was reported as Level-1A. Other primary diagnosis reported by the HA was sudden death syndrome (sudden infant death syndrome) on 24-Aug-2018 at 08:00 pm, 11 hours post-vaccination. This event led to death. No final diagnosis was reported by the HA. Treatment date was reported as 25-Aug-2018 without further details. At the time of the report, the outcome was reported as fatal. It was unknown if the autopsy was done. Cause of Death was reported as sudden death syndrome AEFI category was reported as rare adverse reaction by the HA.; Sender''s Comments: "Sanofi company comment on 22-Jul-2019: 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: Sudden death syndrome


VAERS ID: 825967 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-26
Onset:2018-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3N132M / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Metabolic 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: CNSA2019SA200002

Write-up: Hereditary metabolic diseases; Hereditary metabolic diseases; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A three months old male patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV(Salk) [IPV (VERO)] (lot number N3N132M, manufacturer reported as Pasteur, dose number, route and administration site not reported) on 26-MAR-2018 at 09:38 AM. Other primary diagnosis reported by the HA was hereditary metabolic diseases on 26-MAR-2018 at 06:33 PM, approximately 9 hours post-vaccination. This event led to death of the patient. Final diagnosis was reported by the HA as others. Treatment date was reported as 30-MAR-2018 without further details. At the time of the report, the outcome was reported as Fatal. The patient died on an unknown date and it was unknown if an autopsy was done. Cause of death was reported as hereditary metabolic diseases. AEFI category was reported as coincidence by the HA. List of documents held by the sender :none; Sender''s Comments: Sanofi company comment on 22-JUL-2019: 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: Hereditary metabolic diseases; Hereditary metabolic diseases


VAERS ID: 826032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-05-08
Onset:2019-05-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3F411M / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Death, Malaise
SMQs:, Depression (excl suicide and self injury) (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: CNSA2019SA200005

Write-up: death NOS; feeling unwell at 5:00; crying at 2:00 pm; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A 11 week-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV (VERO) [POLIOMYELITIS VACCINE (INACTIVATED)] (lot number N3F411M, manufacturer reported as "Pasteur", dose number and route and administration site not reported) on 08-May-2018 at 08:00 AM. Injury degree was reported as Level-1A. Other primary diagnosis reported by the HA was crying on 08-May-2018 at 02:00 PM, six hours following the vaccination and feeling unwell on 08-May-2018 at 05:00 PM, nine hours following vaccination. Final diagnosis reported by the HA was "others". The patient died on an unknown date (Death NOS). Treatment date was reported as on 08-May-2018 without further details. At the time of the report, the outcome was reported as unknown for crying and feeling unwell and death NOS was reported as fatal. It is unknown if an autopsy was done. The cause of death was not reported. AEFI category was reported as rare adverse reaction by the HA.; Sender''s Comments: Sanofi company comment on 22-Jul-2019: 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: death NOS


VAERS ID: 826033 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-07-31
Onset:2018-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3K362M / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Cardio-respiratory arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), 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: CNSA2019SA200007

Write-up: breathing, cardiac arrest; asphyxia; This unsolicited serious valid case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A nine weeks old male patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV(Salk) [IPV (VERO)] (lot number N3K362M, manufacturer reported as Pasteur, dose number, route and administration site not reported) on 31-Jul-2018 07:56 AM. No primary diagnosis was reported. The secondary diagnosis reported by the HA was breathing, cardiac arrest (Cardio-respiratory arrest) and asphyxia on 01-Aug-2018 at 07:30 AM, approximately 24 hours post-vaccination. Final diagnosis was reported as others by the HA. Treatment date was reported as 01-Aug-2018 without further details. At the time of the report, the outcome was reported as Fatal. The patient died on an unknown date and it was unknown if an autopsy was done. Cause of death was reported as breathing, cardiac arrest and asphyxia. AEFI category was reported as coincidence by the HA. List of documents held by the sender: none.; Sender''s Comments: Sanofi company comment on 22-JUL-2019: 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: Breathing, cardiac arrest; Asphyxia


VAERS ID: 826034 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-11-16
Onset:2018-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3K701M / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningoencephalitis viral
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2019SA200013

Write-up: Viral meningoencephalitis; This unsolicited valid serious case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities (HA) on 22-Jul-2019 in the format of line listing. A 10 weeks old female patient, whose medical history and concomitant therapies were not reported, had received a dose of IPV VERO (Inactivated poliomyelitis vaccine) (lot number: P3K701M manufacturer reported as "Pasteur", dose number, route and administration site not reported) on 16-Nov-2018 at 08:11 am. Other primary diagnosis reported by the HA was viral meningoencephalitis on 16-Nov-2018 at 04:00 am, approximately 20 hours post-vaccination. This event lead to death. Final diagnosis was reported as others. Treatment date was reported as 18-Nov-2018 without further details. At the time of the report, the outcome was reported as fatal. Cause of death was reported as viral meningoencephalitis. It was unknown if the autopsy was done AEFI category was reported as coincidence by the HA. List of documents held by the sender: none.; Sender''s Comments: "Sanofi company comment on 22-Jul-2019: 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: Viral meningoencephalitis


VAERS ID: 826536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1980-02-19
Onset:1980-03-19
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2019-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Meningococcal sepsis, Mobility decreased, Musculoskeletal stiffness, Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1980-03-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131907NLD013204

Write-up: Pyrexia; In the night he was completely stiff, it was difficult to move he had little red spots day after we call the GP. GP said his brother experienced chicken pox. Finally he passed away.; Information has been downloaded from regulatory authority (NL-LRB-00343964). This spontaneous report was received from a consumer and refers to a 15-month-old male child. The patient''s concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. On 19-FEB-1980, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), 1 dosage form, (exact dose, route of administration, lot # and expiration date were not reported) as vaccination as a part of the immunization program for babies and children (National Immunization Program).On 14-MAR-1980, the child''s body temperature was measured with a result of 39 Celsius degrees. On 19-MAR-1980, in the night, a day after a general practitioner (GP) was called, the child was completely stiff, it was difficult to move, had little red spots (meningococcal sepsis) and fever. It was also reported that GP said his brother experienced chicken pox. The events resulted in death on 21-MAR-1980. It was unknown if an autopsy was done. The relatedness between the events and the suspect vaccine was not reported.


VAERS ID: 827337 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-07-17
Onset:2019-07-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2019-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N035644 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Blood pressure immeasurable, Body temperature decreased, Cardiomegaly, Chest X-ray abnormal, Cyanosis, Death, Enterovirus test positive, Life support, Loss of consciousness, Neurological examination normal, Peripheral coldness, Polymerase chain reaction positive, Pulse absent, Pupil fixed
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-25
   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: Medical History/Concurrent Conditions: Diarrhoea; Head injury; Hospitalisation (Treatment during her hospitalization: Fluids IV and with polycutan topically for diaper rash.); Hospitalisation (On 25-JUN-2019, she was hospitalized for 3 days because of head trauma, there were 2 vomiting around the event with no loss of consciousness and kept for observation with no dynamic in her condition, with no red flags requiring further investigation and imaging. she was released n a good condition.); Rash maculo-papular; Temperature elevation
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL0095075131907ISR016789

Write-up: Death; Initial information has been received from the Authority concerning an 11-weeks-old baby girl, was received via medical records on 29-JUL-2019. The patient''s medical history included head trauma in the occipital area of the scalp (because her stroller where she laid down fell backwards) (hospitalized on 25-JUN-2019 for three days, diarrhea, maculopapular rash and temperature increase). There were two vomiting around the event with no loss of consciousness. She was hospitalized for observation with no dynamic in her condition, with no red flags requiring further investigation and imaging. She was released in a good condition. On 09-JUL-2019, the patient was hospitalized for two days because of temperature increase, diarrhea and maculopapular rash. She was treated with intravenous fluids (IV) and with polycutan topically for diaper rash. Later during her hospitalization, there was a gradual improvement in her condition under fluid support. Appetite improved, fever decreased, she gave urine in a good quantity, diarrhea resolved, rash regressed, and diaper rash significantly improved. She was discharged in a good condition. Information on concurrent condition, concomitant medications and drug allergies were not reported. On 17-JUL-2019, the patient was vaccinated with rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) with lot # N035644 expiry date not reported, but upon internal validation established as 30-SEP-2019, (dosing details were not reported) orally for prophylaxis. On the same day, she was vaccinated with hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (INFANRIX IPV + HIB) of batch # A20CB482C (strength, dose and expiry date were not reported) given via unknown route. On the same day, the patient was also vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR) of batch# AN3111 (strength, dose and expiry date were not reported) given via unknown route. On an unknown date in July 2019, enterovirus-PCR (polymerase chain reaction) in stool was done and the result was positive. On an unknown date in July 2019, neurological examination showed normal. On 25-JUL-2019, upon her admission, body temperature was low33 (units unspecified). No pulse palpated. Pupils equal but not reactive to light. Saturation and blood pressure could not be measured. After her arrival, no blood tests could be sampled (from any artery or Intraosseous infusion, due to problematic circulation. No signs of dysmorphism or protruding rash. No signs of injury. On 25-JUL-2019, chest X-Ray during life support was done and the results showed shadow of heart is slightly large, volume of right lung less than left, without infiltrate or collapse (asymmetry in pulmonary ventilation). Cardiothymic shadow per age. End of tube in right main stem bronchus (RMB), cannula in stomach. On the same day, physical examination was done which showed no heartbeat, apnea, cyanotic and cold to the touch, unconscious, heart rate: No heartbeat. Signs Q-flow result was 527. On the same day, neurological examination was done and face, coarse strength and phonation-could not be examined. On the same day, general examination tests were done which showed breathing rate at 3:25 am: 15, at 3:35 am and 3:41 am: 20, unconscious, heart rate: No heartbeat. On the same day, accessory studies showed left and right lung-clear, End-tidal CO2 (EtCO2): 1, heart rate-asystole, pupils equal, left and right pupil-nonresponsive. The patient was brought by the emergency services to the emergency room under full life support: ventilated by laryngeal mask, compressions and after adrenalin doses. According to the reports they were called by her parents who found her not breathing while asleep (she was laid to sleep at about 12:00 am. Shortly after 3:00 am). After her arrival we continued full life support for about 20 minutes, per Pediatric Advanced Life Support (PALS) protocol, including four adrenalin doses. Anesthesiologist inserted tube. After about 20 minutes it was decided that life support efforts had failed. On 25-JUL-2019, treatment included: Oxygen given by treatments provided: At 3:25 am: Ventilation blower, use of metronome, connection to monitor, heart compression At 3:35 am: Ventilation blower, connection to monitor, heart compression, capnography At 3:41 am: Ventilation blower, connection to monitor, heart compression The intraosseous (IO) infusion procedure was successful. There were two failed attempts of peripheral infusion. There were two failed attempts of intubation. The manner of ventilation was ventilator. At 3:35 am ventilator succeeded. There was one attempt for mask application through ventilator. On 25-JUL-2019, medications included were: At 3:25 am, the patient was treated with sodium chloride 0.9%- sodium chloride at a dose of 10.00 cc given via IO infusion. The patient administered adrenaline-epinephrine/ adrenaline twice at a dose of 0.10 mg given via IO infusion. At 3:35 am, the patient was treated with adrenaline-epinephrine/ adrenaline at a dose of 0.10 mg given via IO infusion. At 3:41 am, the patient was treated with adrenaline-epinephrine/ adrenaline at a dose of 0.10 mg given via IO infusion. The patient was unconscious with apnea and no pulse, her peripheral capillary oxygen saturation (SpO2) and End-tidal CO2 (EtCO2) was zero at the end of the incident. The authority noted that there was no evidence in the medical literature that vaccination with any vaccine increases the risk of sudden death among babies. The authority sent the report to the company because of the temporal association between the vaccination and the event and not because of suspected causal relationship. The patient''s condition was severe and was hemodynamically unstable. "Pediatric medical records were received and reviewed and the following experience was identified: On 25-JUL-2019, the patient died at 4:11 am (also reported as dead on arrival), eight days after receiving all the three vaccines. It was unknown if autopsy was done. The cause of death was unknown.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 827657 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-07-17
Onset:2019-07-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2019-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Capnogram abnormal, Cardiac arrest, Chest X-ray normal, Cyanosis, Death, End-tidal CO2 decreased, Endotracheal intubation, Loss of consciousness, Mechanical ventilation, Neurological examination abnormal, Ophthalmological examination abnormal, Peripheral coldness, Polymerase chain reaction, Pulse absent, Pupillary light reflex tests abnormal, Respiratory arrest, Resuscitation, Scan abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-25
   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: Diarrhea (hospitalization); Fever (hospitalization); Head injury (hospitalized for 3 days due to head trauma.); Maculo-papular rash (hospitalization); Vomiting (2 events of vomiting without loss of consciousness)
Allergies:
Diagnostic Lab Data: Test Date: 20190725; Test Name: Ophthalmological examination; Result Unstructured Data: Test Result: Not responding; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 0; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Physical examination; Result Unstructured Data: Test Result: unknown; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 201907; Test Name: PCR; Result Unstructured Data: Test Result: Enterovirus in faeces positive; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: PCR; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 15; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 20; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Respiratory rate; Result Unstructured Data: Test Result: 20; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Scan; Result Unstructured Data: Test Result: the shadow of the heart was slightly big; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Skin test; Result Unstructured Data: Test Result: Cold, cyanosis; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Auscultation; Result Unstructured Data: Test Result: Clean; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Auscultation; Result Unstructured Data: Test Result: Clean; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Auscultation; Result Unstructured Data: Test Result: Clean; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Auscultation; Result Unstructured Data: Test Result: Clean; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Blood pressure; Result Unstructured Data: Test Result: 0/; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Blood pressure; Result Unstructured Data: Test Result: 0/; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Blood pressure; Result Unstructured Data: Test Result: 0/; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Body temperature; Result Unstructured Data: Test Result: low fever (around 33); Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Breath sounds; Result Unstructured Data: Test Result: Not breathing; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Breath sounds; Result Unstructured Data: Test Result: Ventilated; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Breath sounds; Result Unstructured Data: Test Result: Ventilated; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Chest scan; Result Unstructured Data: Test Result: The edge of tubus on the RMB nasogastric tube in t; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: End-tidal CO2; Result Unstructured Data: Test Result: 1; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: End-tidal CO2; Result Unstructured Data: Test Result: 1; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: End-tidal CO2; Result Unstructured Data: Test Result: 1; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: End-tidal CO2; Result Unstructured Data: Test Result: 0; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Heart rate; Result Unstructured Data: Test Result: Asystole; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Heart rate; Result Unstructured Data: Test Result: Asystole; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Heart rate; Result Unstructured Data: Test Result: Asystole; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Pulse rate; Result Unstructured Data: Test Result: No pulse; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Pulse rate; Result Unstructured Data: Test Result: No pulse; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Pulse rate; Result Unstructured Data: Test Result: No pulse; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Investigation; Result Unstructured Data: Test Result: Unconsciousness; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Investigation; Result Unstructured Data: Test Result: Unconsciousness; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Investigation; Result Unstructured Data: Test Result: Unconsciousness; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 201907; Test Name: Neurological examination; Result Unstructured Data: Test Result: Normal for her age; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Neurological examination; Result Unstructured Data: Test Result: Face, Gross motor and Speech - Unable to check; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Neurological examination; Result Unstructured Data: Test Result: Face, Gross motor and Speech - Unable to check; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Neurological examination; Result Unstructured Data: Test Result: Face, Gross motor and Speech - Unable to check; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Eye exam; Result Unstructured Data: Test Result: Yes; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.; Test Date: 20190725; Test Name: Ophthalmological examination; Result Unstructured Data: Test Result: Not responding; Comments: Q-Flow(25Jul2019): 527 Chest radiography (25Jul2019 04:23): The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age.
CDC Split Type: ILPFIZER INC2019327355

Write-up: Dead on arrival; Found by the parents in her bed without breathing and without a pulse; Cardiac and respiratory arrest; Found by the parents in her bed without breathing and without a pulse; This is a spontaneous report from a contactable other HCP received from the health authority. An 11-week old female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, AN3111) at single dose, diphtheria vaccine toxoid, hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX IPV & HIB, Lot # A20CB482C) at an unspecified dose, rotavirus vaccine live reassort oral 5v (ROTATEQ, Lot # N035644) at an unspecified dose, all on 17Jul2019 for immunisation. Medical history: patient was healthy usually as reported by the parents. On 25Jun2019 she was hospitalized for 3 days due to head trauma. The carriage she layed in fell backward with injury in the in the occipital region of the scalp. In relatedness to the event there were 2 events of vomiting without loss of consciousness. According to medical summary: "patient was hospitalized for supervision without a dynamics of her situation without red flags which require further investigation and imaging, released in good condition." On 09July2019 she was hospitalized for 2 days due to due to increased fever, diarrhea and maculopapular rash. She was treated with fluids and local treatment of POLYCUTAN due to diaper rash. PCR of Enterovirus of feces is positive. During her stay she was under fluid support, an gradual improvement occurred in her situation. The appetite improved, the fever decreased, she gave a good amount of urine, the diarrhea stopped, the rash decreased and also the diaper rash was on significant improvement. A normal neurological examination for her age. She was released in good condition. The patient''s concomitant medications were none. The patient was dead on hospital arrival, she was found by the parents in her bed without breathing and without a pulse brought to the hospital by national rescuing organization in full CPR with outcome of unknown, cardiac and respiratory arrest, all on 25Jul2019 03:57 a.m. 8 days after immunization. The outcome of the events was unknown. Course of events: National rescuing organization: Medical report (ALS team): 25Jun2019: According to the father she was put to sleep around 00:00 o''clock. A little bit after 3:00 o''clock she was observed without breathing and blue. On rescuing organization arrival bls (Basic Life Support) resuscitation by staff on duty in place. On her examination without pulse without breathing, blue and cold to the touch. On monitor asystole. After starting ALS (Advanced Life Support) resuscitation evacuation to pediatric ER started while resuscitation. Notification was delivered telephonic notification. On 25Jun2019 the patient was brought by National rescuing organization on full CPR: ventilated by laryngeal mask, massage and after adrenalin doses. According to their reports they were called by her parents when she was found not breathing while sleeping. On ambulance on 25Jul2019: General examinations: examination 1 at 03:25, examination 2 at 03:35, examination 3 at 03:41: breathing: not breathing, ventilated, ventilated; breathing rhythm: 15, 20, 20; pulse: no pulse, no pulse, no pulse; consciousness: unconsciousness, unconsciousness, unconsciousness; skin and mucosa: cold and cyanosis. Neurological examinations: face: unable to check, unable to check, unable to check; gross motor: unable to check, unable to check, unable to check; speech: unable to check, unable to check, unable to check. Auxiliary examinations: left and clean lung: not done, clean, clean; end-tidal (ET) CO2: 1, 1, 1; Blood pressure: 0/, 0/, 0/; Heart rate: asystole, asystole, asystole; equal pupils: yes, not done, not done; Left pupil: not responding, not done, not done; Right pupil: not responding, not done, not done. Estimated diagnosis: Cardiac and respiratory arrest. Resuscitation began by MDA staff on duty. Oxygen was given by resuscitator on ambulance at 03:25, at 03:35, at 03:41. Treatments given on ambulance: the patient was connected to the monitor: at 03:25 using a metronome: compressions, at 03:35 compressions and capnography, at 03:41 compressions. Intraosseous infusion at 03:25 succeeded twice. Peripheral infusion at 03:25 failed twice. Intubation at 03:25 failed, at 03:35 succeeded. Medications given on ambulance via IO: sodium chloride 0.9% 10.00 cc at 03:25, epinephrine/adrenaline 10.00 cc at 03:35 and 0.10 mg at 03:41. Patient status while resuscitation actions: predicament unstable hemodynamically. Patient status at the end of the event: unconscious, no spontaneous breathing, no spontaneous pulse, Spo2: 0, Etco2: 0. On hospital admission: patient arrived with national rescuing organization in full CPR and was immediately admitted to room 6. Main complaint: CPR. CPR attempts were unsuccessful. On hospital acceptance on 25Jul2019: low fever (around 33). Pulse was not palpated. The pupils are equal but do not respond to light. Without the ability to measure saturation or blood pressure. Parameters on Acceptance on 25July2019 03:59: Q-Flow: 527. Chest radiography on 25July2019 04:23: The edge of tubus on the RMB nasogastric tube in the stomach. Asymmetry of the pulmonary ventilation, the volume of the right lung is small then something, the left side without infiltrate or atelectasis, cardiomyotic shadow as appropriate to age. After her arrival physicians continued with full CPR for about 20 minutes, according the protocol of PALS including four doses of adrenaline. It was no possible to sample any blood tests. Not from the IO or any other artery, possible that due to problematic Circulation. An anesthesiologist sat up Tubes. After about 20 minutes it was decided that the CPR attempts failed and her death was announced on 04:11. A message was given to the police. To be emphasized that no signs of injury were found. No signs of Dysmorphism or an prominent rash. On a scan during the CPR the shadow of the heart was slightly big. Diagnosis: Dead on arrival (DOA). Termination of treatment in Department of Emergency Medicine: passed away. The patient died on 25Jul2019. It was not reported if an autopsy was performed. In medical summery and report of the national rescuing organization it was mentioned: In medical literature there is no evidence that recipient of any vaccine raises the risk of sudden death among babies. This report was sent due to proximity of times of the recipient of the vaccine and the event and not because of suspicion of causal relationship.; Sender''s Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: Dead on arrival


VAERS ID: 827739 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-31
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: CO0095075131908COL001519

Write-up: On the day before the reporting time, she died. They attribute the reaction to the vaccine; the complications that caused her death; This spontaneous report was received from an unspecified reporter, via a company representative, referring to a 14 year old female patient. The patient''s pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. Approximately in 2014 (reported as "at the age of 9-year-old"), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient had an unspecified reaction which "they" attributed to the vaccine; the complications that caused her death (vaccination complication). She died on 31-JUL-2019 (reported as "on the day before the reporting time"). It was unknown if an autopsy was performed. The reporter considered vaccination complication to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).; Reported Cause(s) of Death: They attribute the reaction to the vaccinate; the complicalions that caused her death


VAERS ID: 827791 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-07-12
Onset:2019-07-01
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Death, General physical health deterioration
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UZ0095075131907UZB016699

Write-up: biological death; deterioration of the child?s condition; body temperature increased to 38 degrees; This spontaneous report was received from a reporter via Pfizer and refers to a 3-month-old patient. There was no information about the patient''s concurrent conditions, medical history or concomitant medication. On 12-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) orally, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOCOCCAL VACCINE, POLYVALENT (23-VALENT)) and with poliovirus vaccine (second generation) (POLIOVIRUS VACCINE (SECOND GENERATION)) for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not reported). Vaccination was carried out by a nurse. In July 2019, during two days after vaccination, the patient''s body temperature increased to 38 degrees (body temperature increased). After the deterioration of the child''s condition (condition aggravated) on 15-JUL-2019 at 3:00 - 5:00, the third day after the vaccination, baby died; an ambulance was called, when arrived they stated a biological death According to the preliminary conclusion of experts, vaccination was not the cause of death, a forensic medical examination was being carried out to determine the cause of death. It was unknown if an autopsy was done. According to the reporter, a temperature of 38 degrees was quite acceptable after vaccination and was not a critical and pathological temperature, which in rare cases can affect the central nervous system of a child. It was also noted that it was not known what actually happened to the child for 2-3 days at home, the conditions under which the child was taken care of and it was not yet established what additional side effects were observed with a child. The outcome of the events body temperature increased and condition aggravated, and the causal relationship between the events and the vaccines were not reported.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 827846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-14
Onset:2019-06-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2019-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS NO BATCH NUMBER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Death, Depressed level of consciousness, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Lumbar puncture, Magnetic resonance imaging, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-06-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cholecystectomy; COPD; Dyslipidaemia; Gastroesophageal reflux disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSEQIRUS201904251

Write-up: Obtunded; Ventilator-aquired pneumonia; Respiratory failure; Guillain-Barre syndrome; This is a serious spontaneous case reported from other health care professional to TGA (reference number: AU-TGA-0000469653) and initially retrieved on 26-Jul-2019, concerning an 80-year-old female patient. The patient''s medical history included dyslipidaemia, gastroesophageal reflux disease (GORD), chronic obstructive pulmonary disease (COPD), cholecystectomy and anaemia. On 14-May-2019, the patient administered Fluad [influenza virus haemagglutinin, dose reported as: 1 dose unspecified, route of administration intramuscular, anatomical location, batch number, expiry date: not reported] for vaccination. On 09-Jun-2019, the patient developed Guillain-Barre syndrome. On 12-Jun-2019, the patient was admitted to intensive care unit (ICU) with respiratory failure and was obtunded. The patient was intubated on admission and underwent on following procedures: chest x-ray, magnetic resonance imaging (MRI) and lumbar puncture, however results were not provided. During ICU admission the patient developed ventilator-acquired pneumonia and escalation of antimicrobial therapy. The patient died on 25-Jun-2019. As reported, nerve conduction studies were ordered but patient died before it was performed. The outcome of the events of respiratory failure, obtundation and ventilator-acquired pneumonia was unknown. The reporter assessed the case as serious (death, hospitalization) and possibly related to Fluad.; Sender''s Comments: The patient developed Guillain-Barre syndrome, respiratory failure, depressed level of consciousness and pneumonia bacterial after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient died due to Guillain-Barre syndrome. Medical history of chronic obstructive pulmonary disease and advanced age (80) may have contributed to development of the events. More information regarding autopsy and concomitant drugs is needed. Based on provided information, causality is assessed as related for all events except for pneumonia bacterial (reported as ventilator-acquired pneumonia).; Reported Cause(s) of Death: Guillain-Barre syndrome


VAERS ID: 828688 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Crohn's disease, Death, Epilepsy, Hypokalaemia, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Gastrointestinal premalignant disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Hypokalaemia (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: Medical History/Concurrent Conditions: Seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: seizure; potassium deficiency; Morbus Crohn; Epileptic seizure; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received HAB (HAB) for prophylaxis. The patient''s past medical history included seizure. Previously administered products included whooping cough vaccine (the patient had responded to the vaccine as a child). On an unknown date, the patient received HAB at an unknown dose. On an unknown date, less than 6 months after receiving HAB, the patient experienced seizure (serious criteria death and GSK medically significant), potassium deficiency (serious criteria death and GSK medically significant), crohn''s disease (serious criteria GSK medically significant) and epileptic seizure (serious criteria GSK medically significant). The patient was treated with loperamide. On an unknown date, the outcome of the seizure and potassium deficiency were fatal and the outcome of the crohn''s disease and epileptic seizure were unknown. The reported cause of death was potassium deficiency and epileptic seizure. It was unknown if the reporter considered the seizure, potassium deficiency, crohn''s disease and epileptic seizure to be related to HAB. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of hepatitis A and B as well as other vaccine. The patient should also not be vaccinated with the new vaccine, especially since the patient had a titer. The patient would not had to needed the vaccination. First the patient started to get seizures again but only small focal. The patient''s parents were stationary for 2 years at the Epilepsy center. The patient died of a massive potassium deficiency and a severe seizure. The patient could still be alive, the patient would have been taken seriously instead of coal and Loperamide, which did not help. The patient received one sick report after the next. However, the patient did not give them up and took overtime off in order not to stay away from the move of the company working as a computer scientist. From because the patient went to the physician, to get sick report so he had not to work. The patient had Crohn''s disease, like the sister of his grandmother. The patient''s parents were told this when the patient was already dead and buried. But, the potassium tablets could have saved his life however, it could not be ruled out that his heart did not stop due to the epileptic seizure, but one favors the other. The patient was died 6 months after vaccination. The patient''s mother got MS after Hepatitis A and B vaccination and she was top-fit before and in the country it was also recognized as vaccination damage. But it was also a side effect for the reporter. Sure, it may only be 1 in 10,000, but as one were on the one. Wheelchair, nursing level 3 and it was getting worse and worse for 30 years and the patient''s death had been completely unnecessary.; Reported Cause(s) of Death: massive potassium deficiency; epileptic seizure


VAERS ID: 828941 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-12-10
Onset:2019-01-21
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2019-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 254690 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-06
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SENNA [SENNOSIDE A+B]; CYANOCOBALAMIN; OMEPRAZOLE; FOLIC ACID; CALCIUM +VIT D; CETIRIZINE; TRIMETHOPRIM
Current Illness: Dementia; Gastrooesophageal reflux disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSEQIRUS201900716

Write-up: Patient died; Given 2nd Fluad vaccine; This is a serious spontaneous case, initially received from other health professional (registered nurse) on 21-Jan-2019, concerning a 95-year-old elderly female patient. The patient''s current condition included dementia (since 19-May-2015). The concomitant medications of the patient included omeprazole for gastro-oesophageal reflux disease (reported as GORD), trimethoprim for urinary tract infection (UTI) prophylaxis, Senna, cyanocobalamin, folic acid, vitamin D with calcium and cetirizine. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] as she was over 65 years. On 21-Jan-2019, 42 days after 1st administration, the patient was administered a second dose of Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 254690, expiration date: 30-Jun-2019 and anatomical location: left arm] (explicitly coded as extra dose administered) as she was over 65 years. At the time of reporting, it was unknown if the patient experienced any adverse event. It was reported that, there was not any planned surgery or any condition which required surgery. On 06-Feb-2019, 16 days after the administration of second dose of Fluad (TIV) the patient died. The cause of death was not reported. The autopsy was not performed. The reporter was unable to provide any information, as the notes did not belong to her, it belonged to GP surgery.Hence the case was considered as lost to follow-up. Follow up received from other health professional (lead nurse) on 01-Apr-2019: The case was upgraded from non-serious to serious, as new event ?death'' was added. Added primary reporter''s email address and secondary reporter (lead nurse) in the general tab. Added GORD (gastro-oesophageal reflux disease) as current condition and start date of dementia (19-May-2015) in the patient tab. Anatomical location of vaccination was added as left arm for both the regimens in the product tab. Indication of Trimethoprim (UTI prophylaxis) and omeprazole were (GORD) added in the product tab. It was unknown if the patient experienced any adverse event. It was reported that that the patient died on 06-Feb-2019. The cause was death was not reported. It was unknown if the autopsy was performed or not. Added new event, "patient died" in the event tab. The narrative was amended accordingly. Non-significant follow up received from other health professional (lead nurse) on 17-Apr-2019: The details of secondary reporter (first name, institution, city, county, postal code and phone number) were added in the general tab. No changes were made in narrative. Follow up received from the other health professional (nurse) on 03-May-2019: The secondary reporter''s information details were added in the general tab. The reporter confirmed the vaccination dates as 10-Dec-2018 (1st dose) and 21-Jan-2019 (2nd dose). It was reported that, there was not any planned surgery or any condition which required surgery. The autopsy information updated in patient tab (no autopsy was performed). At the time of this report, no cause of death was available. The narrative was amended accordingly. Non-significant follow up received from other health professional on 14-May-2019: No additional information was received; hence no changes were made in the narrative. Non-significant follow up received from other health professional (nurse) on 15-May-2019: The reporter stated that, she was unable to pass on the follow up information as these notes were no longer belong to us as her GP surgery. No new information was received, hence no changes were made in the narrative.; Reporter''s Comments: A 95-year-old, female patient was administered 2 doses of Fluad TIV 42 days apart (considered as extra dose administered). The patient died, 16 days after receipt of second dose of Fluad TIV. Considering the lack of information regarding cause of death and the events prior to death, the causality assessed as unassessable. The progressive age of the patient, underlying conditions (gastro-oesophageal reflux disease, dementia) are considered as known risk factors. The company assessed the causality of the event extra dose administered as not related considering the accidental nature of the event. The case will be further assessed upon receipt of follow up information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 829735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Disseminated varicella zoster vaccine virus infection, Haemophagocytic lymphohistiocytosis, Inflammatory bowel disease
SMQs:, Ischaemic colitis (broad), Sepsis (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: infliximab
Current Illness: Immunocompromised
Preexisting Conditions: Medical History/Concurrent Conditions: General symptom
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131908AUS006664

Write-up: death; disseminated varicella-zoster virus infection; An immunocompro?mised 24-year old male was on azathio?prine and had recently commenced high dose corticosteroids for a serious medical condition was administered the live varicella vaccine. This literature marketed report has been received from authors of the literature article entitled as stated above. This report summarized national passive surveillance data for adverse events following immunization (AEFI) reported to the agency by 28 February 2018. AEFI were notified to the agency by state and territory health departments, health professionals, vaccine companies and members of the public. All reports were assessed using internationally consistent criteria and entered into the database. Reports were used in data mining and signal detection activities conducted by the agency. Where there was insufficient information in a report to determine causality for a serious adverse event the agency would attempt to contact the reporter on up to three occasions to elicit further information. The report focused on AEFI reported for vaccines administered during 2017 and trends in AEFI reporting over the 18-year period 1 January 2000 to 31 December 2017. The majority of reported adverse events in 2017 were defined as ''non-serious'' (n=3430, 88%). Twelve percent (n=448) were defined as serious. This report refers to an immunocompromised 24 years old male patient, who was on azathioprine and had commenced high dose corticosteroids for a serious medical condition. On an unknown date, the patient was vaccinated with dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (dose, route, batch/lot# and expiration date were unknown) for prophylaxis (product use in unapproved population). Over the subsequent two weeks, the patient also received infliximab (entered as concomitant medication). On an unknown date (reported as 19 days after the vaccination), the patient experienced disseminated varicella-zoster virus infection (Oka strain). On an unknown date (reported as 3 months after the vaccination), the patient died. The causes of death included disseminated varicella-zoster virus infection, haemophagocytic lymphohistiocytosis (HLH) and complicated inflammatory bowel disease. The outcome of disseminated varicella-zoster virus infection was reported as fatal. The outcome of product use in unapproved population was unknown. It was unknown whether an autopsy was performed or not. The agency considered that the use of live attenuated varicella zoster virus (VZV)-containing vaccines in people who were immunocompromised was contraindicated due to the risk of unchecked vaccine virus replication causing serious disease. The Agency considered both the death and disseminated varicella-zoster virus infection to be causally related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). Upon internal review, disseminated varicella-zoster virus infection was considered to be medically significant. This is one of two reports obtained from the same literature. (Linked case# 1702AUS008565). A copy of the published article is attached as further documentation of the patient''s experience.; Sender''s Comments: AU-009507513-1702AUS008565:; Reported Cause(s) of Death: complicated inflammatory bowel disease; haemophago?cytic lymphohistiocytosis (HLH); disseminated varicella-zoster virus infection


VAERS ID: 830401 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Bronchitis, Cytokine abnormal, Death, Decreased appetite, Encephalopathy, Haemophagocytic lymphohistiocytosis, Interstitial lung disease, Pallor, Splenitis, Tonic convulsion, Tracheitis, Vomiting
SMQs:, Acute pancreatitis (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131908JPN002024J

Write-up: Information has been received from an other health professional concerning a 3-month-old female patient. The patient was vaccinated with rotavirus vaccine (manufacturer unknown) orally (the date of vaccination, dose, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies included haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) (ActHIB) (the date of vaccination,dose: not reported, reason for use: prophylaxis), and pneumococcus vaccine (the date of vaccination,dose: not reported, reason for use: prophylaxis). No concomitant medications were reported. On an unspecified date (2 days before death), the patient was vaccinated with haemophilus b conjugate vaccine (tetanus toxoid conjugate), pneumococcus vaccine and rotavirus vaccine (manufacturer unknown). On an unspecified date (day after vaccination), vomiting, complexion ill, decreased feeding were noted (vomiting, complexion ill, and decreased feeding developed). On an unspecified date, tonic convulsion occured during a hospital visit (tonic convulsion occured). Tracheitis/bronchitis, interstitial pneumonia, encephalopathy acute, acute splenitis, and haemophagocytosis were confirmed (tracheitis/bronchitis, interstitial pneumonia, encephalopathy acute, acute splenitis, and haemophagocytosis developed). Serum influenza virus A (HIN1) antibody titer: 40-fold. On an unspecified date (approximately 12 hours later), the patient died. The causes of death were interstitial pneumonia, encephalopathy acute, acute splenitis, haemophagocytosis, tracheitis/bronchitis, and high-cytokine state. An autopsy was performed. At the time of reporting, the outcomes of vomiting, complexion ill, decreased feeding, and tonic convulsion were unknown. Reporter''s comment: Acute pancreatitis and haemophagocytosis were noted in 3 cases in common, thus it was inferred that abnormal immune reaction was caused by some disease state, leading to high-cytokine state. Although the association between this and the vaccination was unclear, it seemed necessary to suspect the possibility. In particular, there were sudden deaths following Hib vaccination and the vaccination was temporarily discontinued in the past. We reaffirmed that careful pathomorphological evaluation is necessary while paying attention to the history of vaccination. The reporting other health professional considered that interstitial pneumonia, encephalopathy acute, acute splenitis, haemophagocytosis, tracheitis/bronchitis, and high-cytokine state, vomiting, complexion ill, decreased feeding, and tonic convulsion were related to rotavirus vaccine (manufacturer unknown). The reporting other health professional considered interstitial pneumonia, encephalopathy acute, acute splenitis, haemophagocytosis, tracheitis/bronchitis, and high-cytokine state to be serious (death), while did not assess the seriousness of vomiting, complexion ill, decreased feeing, and tonic convulsion. Upon internal review, interstitial pneumonia, encephalopathy acute, haemophagocytosis, and tonic convulsion were determined to be serious (medically significant). A copy of the published article is attached as further documentation of the patient''s experience. A copy of the translation will be provided when available. This is one of several reports received from the same reporter.; Sender''s Comments: JP-MSD-1908JPN002025J:; Reported Cause(s) of Death: Tracheitis/bronchitis; Encephalopathy acute; interstitial pneumonia; Haemophagocytosis; Acute splenitis; High-cytokine state


VAERS ID: 830486 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER NO BATCH NUMER / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram abnormal, Death, Encephalopathy, H1N1 influenza, Influenza A virus test positive, Laboratory test abnormal, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Mitochondrial encephalomyopathy, Scan with contrast abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (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: Comments: None
Allergies:
Diagnostic Lab Data: Test Name: Computered Tomography (CT); Result Unstructured Data: Remarkable imaging findings.; Test Name: SWI; Result Unstructured Data: necrotizing haemorrhagic encephalopathy; Test Name: Magnetic resonance imaging (MRI); Result Unstructured Data: Remarkable imaging findings.; Comments: MRI of brain and spine.
CDC Split Type: AUSEQIRUS201904445

Write-up: H1N1 positive Influenza-associated acute encephalopathy (IAE); H1N1 Influenza; Vaccination failure; This is a spontaneous case initially retrieved on 22-Aug-2019 reported by other health professional to Regulatory Authority (regulatory authority Reference number: AU-TGA-0000473586) and a literature article received on 23-Aug-2019 (being processed together), concerning a 7-year-old, patient of unspecified gender. On an unspecified date, the patient was administered Influenza vaccine [Influenza virus haemagglutinin, dose reported as 1 one dose unspecified, anatomical location, route of administration, batch number and expiration date: not provided] for vaccination. On an unspecified date, H1N1 influenza -associated acute encephalopathy (IAE) was confirmed. On unspecified date patient underwent urgent admission computed tomography (CT)followed by magnetic resonance imaging (MRI) of brain and spine. Contrast enhanced CT (CECT) and hi-resolution MRI was performed on both 1.5T and 3.0T MR scanners with contrast, MR spectroscopy was also obtained. On unspecified date patient had follow up MRI to assess the disease course and treatment response and results showed remarkable imaging findings on CT and MRI studies. H1N1 positive IAE was post-immunisation and demonstrated necrotizing haemorrhagic encephalopathy on suspectibility weighted imaging in basal ganglia and brain stem with tissue necrosis leading to demise. These imaging findings reflected the severity of disease from mild to severe. on unspecified date. Cause of death was not reported. It was unknown, whether autopsy was performed. Author stated: H1N1-positive IAE is severe haemorrhagic form causing basal ganglia and bran stem necrosis. This imaging signature is peculiar and helpful in differentiating herpes and other viral encephalopathies The reporter didn''t provide causality assessment. Company comment: This report is a case of a 7-years-old patient (reported by other health professional and detected in the literature at the same time) who experienced vaccination failure (considered listed per labelling conventions), H1N1 influenza with fatal outcome and encephalopathy with fatal outcome after exposure to the suspect INN Flu Vaccine. Chronology needs more clarification. Reportedly, H1N1 positive IAE (Influenza-associated acute encephalopathy ) occurred post-immunisation and demonstrated necrotizing haemorrhagic encephalopathy on susceptibility weighted imaging in basal ganglia and brain stem with tissue necrosis leading to demise. Relevant medical history and concomitant medications were not reported. Events and narrative points that vaccination failure resulted in reactivation of compound and H1N1 influenza infection which led in occurrence of encephalopathy with fatal outcome. On the other side, this product was made either with a) flu viruses that have been ?inactivated'' (killed) and that therefore are not infectious, or b) using only a single gene from a flu virus (as opposed to the full virus) in order to produce an immune response without causing infection (recombinant influenza vaccines). More information is needed (medical history prior to the event, clarification of chronology - onset dates/dates of administration of the product, other medications). Since both sources suggest a valid causal relationship, causality is set as related to the product for both events. Although source marks vaccination failure with the fatal outcome, this was changed during case processing since there it was no reasonable suggestion that vaccination failure resulted in death, but was a contributor in developing events which led to fatal outcome. Indication for the product regarding age varies - from 4 years old as a minim criteria to 9 years old. (possible off label use); Reporter''s Comments: This report is a case of a 7-years-old patient (reported by other health professional and detected in the literature at the same time) who experienced vaccination failure (considered listed per labelling conventions), H1N1 influenza with fatal outcome and encephalopathy with fatal outcome after exposure to the suspect INN Flu Vaccine. Chronology needs more clarification. Reportedly, H1N1 positive IAE (Influenza-associated acute encephalopathy ) occurred post-immunisation and demonstrated necrotizing haemorrhagic encephalopathy on susceptibility weighted imaging in basal ganglia and brain stem with tissue necrosis leading to demise. Relevant medical history and concomitant medications were not reported. Events and narrative points that vaccination failure resulted in reactivation of compound and H1N1 influenza infection which led in occurrence of encephalopathy with fatal outcome. On the other side, this product was made either with a) flu viruses that have been ?inactivated'' (killed) and that therefore are not infectious, or b) using only a single gene from a flu virus (as opposed to the full virus) in order to produce an immune response without causing infection (recombinant influenza vaccines). More information is needed (medical history prior to the event, clarification of chronology - onset dates/dates of administration of the product, other medications). Since both sources suggest a valid causal relationship, causality is set as related to the product for both events. Although source marks vaccination failure with the fatal outcome, this was changed during case processing since there it was no reasonable suggestion that vaccination failure resulted in death, but was a contributor in developing events which led to fatal outcome.; Reported Cause(s) of Death: H1N1 positive Influenza-associated acute encephalopathy (IAE)


VAERS ID: 830556 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-12
Onset:2014-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA803AA / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Bronchitis, Cyanosis, Death, Hyporesponsive to stimuli, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131908BRA008574

Write-up: death; bronchitis; cyanosis; apnea; pallor; decreased response to stimuli; Information has been downloaded from regulatory authority (report identification number BR-GLAXOSMITHKLINE-BR2015GSK075229). This spontaneous report was received from a health professional and refers to a 4 month old female patient. The patient''s medical history, concomitant medications, drug reactions or allergies were not reported. On 12-MAY-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) lot # 136VPN003A , intramuscularly; with rotavirus g1 p1 vaccine live (89-12) (ROTARIX) lot # QROLA803AA, orally (dose, expiration date, anatomical location not provided for both); and with hib conj vaccine (unspecified carrier), diphtheria toxoid, hepatitis b virus vaccine (unspecified), pertussis acellular vaccine (unspecified), tetanus toxoid (DTPA-HBV-HIB) (lot #, expiration date, dose, anatomical location and route of administration not provided), all asdministered as prophylaxis. On 13-MAY-2014, the patient experienced bronchitis, cyanosis, apnoea, pallor and decreased response to stimuli. On an unspecified date, the patient died. The cause of the death, source of notification and whether an autopsy was performed were not reported. At the time of the death, the outcome of bronchitis, hyporesponsive to stimuli, pallor, apnoea and cyanosis was unknown (conflicting information as death was reported as a seriousness criteria for all the events). The causality between all the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and hib conj vaccine (unspecified carrier), diphtheria toxoid, hepatitis b virus vaccine (unspecified), pertussis acellular vaccine (unspecified), tetanus toxoid (DTPA-HBV-HIB) was not reported. The causality between all the events and rotavirus g1 p1 vaccine live (89-12) (ROTARIX) was reported as unknown. The reporter considered the events of bronchitis, cyanosis, apnoea, pallor and decreased response to stimuli to be medically significant. Lot number 136VPN003A is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).; Reported Cause(s) of Death: Death


VAERS ID: 830615 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Bronchitis, Death, Encephalopathy, Haemophagocytic lymphohistiocytosis, Influenza virus test positive, Interstitial lung disease, Pallor, Poor sucking reflex, Splenitis, Tonic convulsion, Tracheitis, Vaccination complication, Vomiting
SMQs:, Acute pancreatitis (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Serum influenza A virus (H1N1) antibody titer; Result Unstructured Data: 40 folds
CDC Split Type: JPSAKK2019SA233387AA

Write-up: Suspected abnormal immunisation reaction; Vomiting; Complexion ill; Poor sucking; Tonic convulsion; Tracheitis/bronchitis; Tracheitis/bronchitis; Interstitial pneumonia; Encephalopathy acute; Acute splenitis; Haemophagocytosis; Initial information received on 20-Aug-2019 regarding an unsolicited valid serious case issued from a literature article. This case was issued in publication in which 2 other related cases were reported:2019SA233406 and 2019SA233253. This case involves a 3 months old female patient who experienced suspected abnormal immunisation reaction, tracheitis/bronchitis, interstitial pneumonia, encephalopathy acute, acute splenitis and haemophagocytosis, while she received vaccines ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HIB (PRP/T) VACCINE [ActHIB]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (2 days before death), the patient started receiving ActHIB, PNEUMOCOCCAL VACCINE, and ROTAVIRUS VACCINE (dosages, unknown) for prophylactic vaccination. On an unknown date (the day after the vaccination), vomiting, complexion ill, and poor sucking were observed. While the patient was seen in the hospital, tonic convulsion occurred. On an unknown date, about 12 hours later, the patient died. Abnormal immunisation reaction was suspected. On an unknown date, autopsy was performed, and tracheitis/bronchitis, interstitial pneumonia, encephalopathy acute, acute splenitis, and haemophagocytosis were observed. Serum influenza A virus (H1N1) antibody titer: 40 folds On an unknown date, outcome of the suspected abnormal immunisation reaction, poor sucking, vomiting, tonic convulsion, encephalopathy acute, acute splenitis, tracheitis/bronchitis, haemophagocytosis, interstitial pneumonia, and complexion ill were fatal. The patient died of abnormal immunisation reaction, tracheitis/bronchitis, interstitial pneumonia, encephalopathy acute, acute splenitis, and haemophagocytosis. The patient developed a serious suspected abnormal immunisation reaction. This event was assessed as medically significant and was leading to death. The patient developed a serious tracheitis/bronchitis (tracheitis). This event was leading to death. The patient developed a serious tracheitis/bronchitis (bronchitis). This event was leading to death. The patient developed a serious interstitial pneumonia. This event was assessed as medically significant and was leading to death. The patient developed a serious encephalopathy acute. This event was assessed as medically significant and was leading to death. The patient developed a serious acute splenitis. This event was leading to death. The patient developed a serious haemophagocytosis. This event was assessed as medically significant and was leading to death. The patient developed a serious vomiting. This event was assessed as medically significant and was leading to death. The patient developed a serious complexion ill. This event was assessed as medically significant and was leading to death. The patient developed a serious poor sucking. This event was assessed as medically significant and was leading to death. The patient developed a serious tonic convulsion. This event was assessed as medically significant and was leading to death. Relevant laboratory test results included: Influenza virus test - On an unknown date: [40 folds] Final diagnosis was (fatal) haemophagocytosis, (fatal) acute splenitis, (fatal) encephalopathy acute, (fatal) interstitial pneumonia, (fatal) tracheitis/bronchitis, and (fatal) suspected abnormal immunisation reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Fatal on an unknown date for suspected abnormal immunisation reaction, as Fatal on an unknown date for vomiting, as Fatal on an unknown date for complexion ill, as Fatal on an unknown date for poor sucking, as Fatal on an unknown date for tonic convulsion, as Fatal on an unknown date for tracheitis/bronchitis, as Fatal on an unknown date for tracheitis/bronchitis, as Fatal on an unknown date for interstitial pneumonia, as Fatal on an unknown date for encephalopathy acute, as Fatal on an unknown date for acute splenitis and as Fatal on an unknown date for haemophagocytosis. An autopsy was done. The cause of death was reported as Immunisation reaction, Tracheitis, Bronchitis, Interstitial lung disease, Encephalopathy, Splenitis and Haemophagocytic lymphohistiocytosis. Reporter comment: It was assumed that abnormal immunisation reaction was induced by some disease condition, which resulted in high cytokine levels, because acute splenitis and haemophagocytosis were observed. The relationship of the assumption to the vaccination was unknown, but suspecting the possibility was considered necessary.; Sender''s Comments: This literature case involves a 3 months old female patient who presented with suspected abnormal immunisation reaction with vomiting, ill complexion, poor sucking leading to death post vaccination with ACTHIB, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE. Autopsy result shows tracheitis/bronchitis, interstitial pneumonia, acute encephalopathy, acute splenitis and haemophagocytosis. Further information regarding patient''s medical history, condition at the time of vaccination, lab test excluding other infectious etiologies will be needed for complete assessment. Moreover, three different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: Abnormal immunisation reaction; Autopsy-determined Cause(s) of Death: Tracheitis/Bronchitis; Tracheitis/Bronchitis; Interstitial pneumonia; Acute encephalopathy; Acute splenitis; Haemophagocytosis image


VAERS ID: 830827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-12
Onset:2015-10-01
Submitted: 0000-00-00
Entered: 2019-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
BCG: BCG (MYCOBAX) / SANOFI PASTEUR 113047A / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Brain death, Cyanosis, Pulmonary hypertension, Restlessness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: Immunisation; Patent ductus arteriosus
Preexisting Conditions: Medical History/Concurrent Conditions: Intrauterine growth retardation; Meconium aspiration (She swallowed meconium and was ventilated at birth); Comments: Intrauterine Growth retardation, Patent ductus artheriosus (open heart valve at birth), swallowed meconium and was ventilated at birth.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA0095075131908ZAF008981

Write-up: Stopped breathing, respiratory arrest; Turned blue; Restless; The patient developed several apnoeas (3 times) within 24 hours of vaccination / Child had few apnoea attacks while under investigation; Feverish; Pulmunary hypertension; The brain dead was pronounced; Information has been downloaded from regulatory authority (ZA-SSI-DKSSI0111716). This spontaneous report was received from a healthcare professional and refers to a female infant patient. The patient''s historical conditions included meconium aspiration, which resulted in her being ventilated at birth, and intrauterine growth retardation. The patient''s historical diagnostic procedures included lumbar punction with an unknown result. The patient''s concurrent conditions included patent ductus arteriosus, also reported as open heart valve at birth. No details regarding the patient''s concomitant medications and drug reactions or allergies were provided. On 12-OCT-2015, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter, orally (dose number, lot # and expiration date were not provided). Other suspect vaccines, administered on the same date, were Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown), hib conj vaccine (tet toxoid) (+) diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 2-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (HEXAXIM), poliovirus vaccine live oral (OPV-MERIEUX) and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13). The indication for all suspect products was immunization. On 12-OCT-2015, within 24 hours of vaccination, the patient developed several apnoeas (3 times) (also reported as "child had few apnoea attacks while under investigation"). On the same date, the patient became feverish. On an unspecified date in October 2015, the patient experienced pulmonary hypertension. On 13-OCT-2015, the patient experienced restlessness. On the same date, the patient stopped breathing (also reported as respiratory arrest) and turned blue. On an unknown date in 2015, the patient was pronounced brain dead (reported as "the brain dead was pronounced"). All the events were considered fatal by the reporter. The outcome of brain death was reported as fatal. The outcome of apnea and restlessness was reported as not recovered/not resolved. For the remaining events, the outcome was reported as unknown. The causality assessment between the suspect products and the events was not provided.


VAERS ID: 831137 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-30
Onset:2016-04-07
   Days after vaccination:343
Submitted: 0000-00-00
Entered: 2019-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L00744 / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Autopsy, Blood albumin, Blood culture negative, Blood glucose decreased, Blood lactic acid increased, Blood potassium normal, Blood sodium decreased, Blood urea normal, Brain oedema, C-reactive protein increased, CSF red blood cell count positive, CSF white blood cell count positive, Chest X-ray abnormal, Computerised tomogram head abnormal, Death, Diabetes insipidus, Drug ineffective, Encephalitis meningococcal, Endotracheal intubation, Generalised tonic-clonic seizure, Haemoglobin decreased, Hypokalaemia, Hyponatraemia, Hypotension, Mechanical ventilation, Microbiology test normal, Otitis media, PCO2 decreased, Platelet count normal, Prothrombin time, Pupillary light reflex tests abnormal, Pyrexia, Respiratory failure, Staphylococcus test negative, Staring, Ultrasound Doppler abnormal, Urine analysis normal, Vaccination failure, Vomiting, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-04-17
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination; Respiratory syncytial virus bronchiolitis
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperbilirubinemia (postnatal phototherapy because of hyperbilirubinemia at the fourth day of life); Phototherapy (postnatal phototherapy because of hyperbilirubinemia at the fourth day of life); Recurrent infection
Allergies:
Diagnostic Lab Data: Test Date: 20160414; Test Name: Microbiology test; Test Result: Negative ; Test Date: 20160414; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 20160414; Test Name: Quick''s test; Test Result: 46 %
CDC Split Type: DE0095075131908DEU008914

Write-up: Meningococcal encephalitis; Tonic-clonic seizures; Brain oedema; Staring; Otitis media both sides; Vomiting; Central diabetes insipidus; Respiratory failure, global, requires ventilation; Hypokalaemia; Arterial hypotension; Hyponatraemia; Vaccination failure; Fever; Information has been downloaded from Regulatory Authority (DE-PFIZER INC-2016333552). This spontaneous report was received from a physician refers to a 13-month old male patient. The patient''s concurrent conditions included, respiratory syncytial virus bronchiolitis. The patient''s medical history included phototherapy, hyperbilirubinemia (postnatal phototherapy because of hyperbilirubinemia at the fourth day of life) and recurrent infection. Information on concomitant therapies was not reported. On 04-JUN-2015 and 27-JUL-2015, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 single dosage (strength, route, lot and expiry date were not reported) for prophylactic vaccination. Other suspect therapies included, pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) 0.5 ml, single solution for injection in pre-filled syringe (vaccinated on 30-APR-2015, 04-JUN-2015 and 27-JUL-2015 with lot numbers L00744, L48815 and L59072 respectively, expiration dates not reported) for prophylactic vaccination and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX HEXA) 1 single dosage form (vaccinated on 30-APR-2015, 27-JUL-2015 and 04-JUN-2015) for prophylactic vaccination. On 07-APR-2016, the patient experienced pyrexia. On 13-APR-2016, the patient experienced central diabetes insipidus, vaccination failure(drug ineffective), Otitis media both sides(otitis media), vomiting, hyponatraemia, arterial hypotension (hypotension), hypokalaemia and respiratory failure, global, requires ventilation (respiratory failure). On 14-APR-2016, the patient experienced brain oedema, tonic-clonic seizures (generalized tonic- clonic seizure) and staring. On an unknown date, the patient experienced meningococcal encephalitis. On an unknown date in April 2016, the patient was hospitalized due to the events. The patient had lab tests performed on 14-APR-2016 with following results: Alanine aminotransferase, Aspartate aminotransferase, Urea, Creatinine : normal blood levels, Albumin : 35 gram/liter, Glucose : 0.7 and 7.9 millimole per liter, Lactate : 3.91 and 8.5 millimole per litter, cerebrospinal fluid (CSF) protein : 13 gram per litter, Microbiology test : negative blood culture, negative MRSA (methicillin, Oxygen saturation : 95%, Quick''s test : 46 %, Pupillary light reflex tests : Abnormal, Sodium : 118 and 127, Potassium : 2.8, PH : 7.32, Heart Rate : 170, Leukocyte count : 12.4, Activated partial thromboplastin time : 34.7, Hemoglobin : 6, Carbon dioxide tension (PCO2) : 4.1, Thrombocyte count : 359, Body temperature : 36.8, Respiratory rate: 15, Blood pressure: 114/81, C-reactive protein: 339.1((units not reported for any), Chest X-ray: At status post intubation the foremost part of the spotty consolidation paramediastinal, Computerized tomogram (CT) head: Diminished density of both cerebral hemispheres, Ultrasound Doppler: vorhanden/present, Urine analysis : Number of cells in the patient urine inconspicuous and Cerebrospinal fluid (CSF) test: leukocytes 92 Mpt/l, erythrocytes 1248 Mpt/l, prot. The patient had Ultrasound Doppler on 16-APR-2016 and 17-APR-2019 with a result as cerebral circulation had discontinued. On 17-APR-2016, the patient died due to drug ineffective, diabetes insipidus, brain edema, vomiting, generalized tonic- clonic seizure, staring, respiratory failure, otitis media, encephalitis meningococcal, hypotension, hyponatremia, hypokalemia and pyrexia. An autopsy was performed, and the results were available. The causality assessment was not reported. The Agency considered all the events as life threatening.; Reported Cause(s) of Death: Drug ineffective; Fever; Hypokalaemia; Hyponatraemia; Hypotension; Otitis media; Respiratory failure; Staring; Tonic-clonic seizures; Vomiting; Brain oedema; Central diabetes insipidus; Autopsy-determined Cause(s) of Death: Meningococcal encephalitis


VAERS ID: 831139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1S12D / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W19703 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2019354059

Write-up: death; This is a spontaneous report from a contactable Other Health Professional from the local Regulatory Authority (Regulatory Authority ES-AEMPS-533524). A 4-month-old male patient received meningococcal group C tetanus toxoid conjugate vaccine (NEISVAC-C, lot#: VNS1S12D) and pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) (PREVENAR 13, lot#: W19703), both via an unspecified route of administration on an unspecified date at single dose for vaccination, and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA, lot#: A21CD077A), via an unspecified route of administration on an unspecified date at unspecified dose for vaccination. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date the night after vaccination. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: death


VAERS ID: 831490 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-30
Onset:2018-11-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W62466W07368 / UNK - / -

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

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 INC2019373498

Write-up: death; This is a spontaneous report received from Health Authority. The regulatory authority report number was not reported. A 3-month-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number: W62466W07368), via an unspecified route of administration at 11:00 on 30Oct2018 at a single dose for immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death at 03:35 on 01Nov2018. There were none of range of fever (axillary temperature), local redness (diameter cm), and local induration (diameter cm). Reaction type: coincidence reaction. No follow-up attempt is possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 832205 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-08-26
Onset:2019-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Injection site induration, Pupils unequal, Pyrexia, Shock symptom
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-08-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia Alzheimer''s type; Glaucoma; Hypertension; Reflux oesophagitis
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to drug
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131909JPN000075J

Write-up: Death; Left-right asymmetry of pupils; Suspicion of cerebrovascular disorder; Symptom of shock; Pyrexia; Injection site induration; Information has been received from a physician concerning a 90-year-old female patient with dementia Alzheimer''s type, hypertension, glaucoma, reflux oesophagitis, and a history of allergic reaction to piperacillin sodium, who on 26-AUG-2019 was subcutaneously vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP) injection for prophylaxis (lot number not reported). No concomitant medications were reported. On 26-AUG-2019 (the evening), injection site induration and pyrexia (38 degrees Celsius) developed. It was considered as adverse reactions, antibiotic was not used. On 27-AUG-2019, the patient had lunch, and then had a snack. At about 17:00, a nurse found the patient was being in a shock symptom and left-right asymmetry of pupils. It was suspected as cerebrovascular disorder, but imaging procedure was not performed. When the reporting physician arrived, the patient''s both pupils were open (the patient died). The time of death was confirmed at about 22:00. The cause of death and autopsy were not reported. Pyrexia and injection site induration had not resolved. The outcomes of symptom of shock, left-right asymmetry of pupils and suspicion of cerebrovascular disorder were unknown. Reporter''s comment: not provided. The reporting physician felt that pyrexia and injection site induration were related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP), did not assess the relationship of death, symptom of shock, left-right asymmetry of pupils and suspicion of cerebrovascular disorder to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP). The reporting physician did not assess the seriousness of pyrexia, injection site induration, symptom of shock, left-right asymmetry of pupils and suspicion of cerebrovascular disorder. Upon internal review, symptom of shock was determined to be medically significant.; Reported Cause(s) of Death: Death


VAERS ID: 832636 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Immunology test, Rotavirus test negative
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Allergies:
Diagnostic Lab Data: Test Name: Enzyme-linked immunosorbent assay; Result Unstructured Data: Test Result: rotavirus negative, Test Result Unit: unknown
CDC Split Type: ZWGLAXOSMITHKLINEZW2019GS

Write-up: Acute watery diarrhea; This case was reported in a literature article and described the occurrence of watery diarrhea in a child patient who received Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patient received Rotarix liquid formulation (oral). On an unknown date, 14 days after receiving Rotarix liquid formulation, the patient experienced watery diarrhea (serious criteria death and hospitalization). On an unknown date, the outcome of the watery diarrhea was fatal. The reported cause of death was watery diarrhea. The reporter considered the watery diarrhea to be related to Rotarix liquid formulation. Additional information was reported as follows: This case was reported in a literature article and described the occurrence of acute watery diarrhea in patient of aged less than 5 years old of unspecified gender who was vaccinated with Rotarix vaccine (GlaxoSmithKline) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was the part of the active surveillance that aimed to evaluate the performance of monovalent rotavirus vaccine under conditions of routine use. They conducted a case-control evaluation of rotavirus vaccine effectiveness (VE) in children with acute diarrhea at 2 surveillance sites, after vaccine introduction in May 2014. [In this study, children less than 5 years of age hospitalized or treated in the accident and emergency department (A&E) for acute watery diarrhea were enrolled for routine surveillance at 3 hospitals during 2012-2017. They estimated rotavirus VE using a test-negative case-control design with rotavirus-positive cases and rotavirus-negative controls identified through the surveillance platform. Children born on or after 1 March 2014 and who were at least 6 months of age at the time of the hospitalization were included in the analysis. Cases and controls enrolled at 2 Hospitals only were included in the VE analysis. The secondary analysis, they estimated 2-dose and any-dose VE against hospitalization or A&E admission for severe diarrhea, defined as a modified Vesikari score equal or less than 11]. The patient was from the control group (rotavirus negative). From the control group (2728-rotavirus negative) included the 6-11month (1093) and more than 12 month (1635)]. No information on patient''s medical or family history or concurrent condition or concomitant condition was provided. On unspecified date between 2014 and 2017, the patient had received oral 2 doses of Rotarix vaccine (administration route and site unspecified, dosage unknown; batch number not provided. The age of vaccination was not provided. [In this study, since 2009, the World Health Organization (WHO) has recommended that all countries introduce rotavirus vaccine into their national immunization programs to further reduce the burden of diarrheal disease. The country introduced a 2-dose live, oral, monovalent rotavirus vaccine (Rotarix) nationally in May 2014 as part of the routine infant immunization program and recommended the vaccine be administered at 6 and 10 weeks of age with oral polio vaccine, pentavalent vaccine (diphtheria-tetanus-pertussis, hepatitis B, and Haemophilus influenza), and pneumococcal conjugate vaccine. If a dose of rotavirus vaccine was administered at least 2 weeks before the onset of any symptoms, the child was considered vaccinated. They created an indicator variable for month of birth; children born in May through October, months with historically high rotavirus disease, were considered born during the rotavirus season and those born in November through April were considered born outside the rotavirus season. Of the 4338 children, who were age eligible to receive rotavirus vaccine (i.e, born between 1stMarch 2014 and 31st December 2017), 3643 met the inclusion criteria for this analysis. From the control group (2728-rotavirus negative) confirmed vaccine included the 6-11month (1069) and more than 12 month (1616)]. On an unspecified date, atleast 2 weeks after the vaccination, the patient had the onset of symptoms and had experienced the acute diarrhea. The patients stool sample collected with 48 hours of admission and tested by enzyme immunoassay, however the patient found to be rotavirus negative. On an unspecified date, the patient had died during the hospitalization. It was unknown, whether the autopsy was performed or not. [In this study, acute watery diarrhea was defined as equal or more than 3 loose stools within 24 hours lasting no more than 7 days. Stool specimens were collected from eligible children within 48 hours of admission and tested by enzyme immunoassay. Stunting, an indicator of chronic malnutrition, was defined as less than 2 standard deviations below the median height for age]. This case has been considered as serious due to hospitalization and death. The author commented, "A recent study found that naturally acquired immunity to rotavirus may somewhat reduce the calculated rotavirus VE in populations with high incidence of disease, especially in older age groups. In this population, we do not know how many children may have naturally acquired immunity; however, because of the high vaccination coverage and small number of unvaccinated children more than or equal than 12 months old (n = 86 rotavirus negative; n = 19 rotavirus positive), our estimated VE is susceptible to even minor changes in the distribution of unvaccinated children. While our findings suggest rotavirus vaccine may be less effective in preventing hospitalizations after the first year of life, we are unable to draw conclusions about the exact magnitude of, or reasons for, any difference between the 2 age groups. Evaluations of VE have also shown that rotavirus vaccination did not protect against hospitalizations in undernourished children and stunted children, respectively. Rotavirus positive children had more severe diarrhea than rotavirus-negative children; had a modified Vesikari score more than or equal than 11. However, the mortality rate was similar in both groups, with 0 percentage and 1 percentage cases and controls, respectively, who died during the hospitalization." The author concluded, "The results from this analysis show that monovalent rotavirus vaccine is effective in preventing hospitalizations due to severe rotavirus diarrhea among infants. While our VE is slightly higher than other estimates from neighboring countries, the findings of this analysis are consistent with a large ecological reduction in all-cause and rotavirus hospitalizations that have been previously reported. This evaluation provides additional evidence for countries considering rotavirus vaccine introduction that live, oral rotavirus vaccines are effective in settings of high child mortality." Lab Comments: On an unspecified date, lab test performed.; Reported Cause(s) of Death: Acute watery diarrhea


VAERS ID: 832744 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-06-03
Onset:2019-08-02
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2019-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD077A / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1S12D / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W19703 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Crying, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (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: VITAMIN D3; APIRETAL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZERINC2019354059

Write-up: fever; Persistent crying; This is a spontaneous report from a contactable Other Healthcare Professional (HCP) from the local Regulatory Authority and later downloaded from the Regulatory Authority (ES-AEMPS-533524). The Regulatory Authority report number is ES-AEMPS-533524. A 4-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) (lot# W19703, Exp date Sep2019) via an unspecified route of administration on 02Aug2019 at single dose for vaccination; meningococcal group C tetanus toxoid conjugate vaccine (NEISVAC-C) (lot# VNS1S12D, Exp date May2021) via an unspecified route of administration on 02Aug2019 at single dose for vaccination and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA) (lot# A21CD077A) via an unspecified route of administration on 02Aug2019 at unspecified dose for routine vaccination, Vitamin D3 pharma 2.000 UI/ml oral solution from 03Jun2019, paracetamol (APIRETAL 100 mg/ml oral solution) oral on 02Aug2019 for fever. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced fever from 02Aug2019 and persistent crying from 02Aug2019 that resulted in death. The patient was died on an unspecified date the night after vaccination (as reported). An autopsy was performed and results were not provided. Investigational results for Prevenar 13 lot# W19703 and NeisVac-C lot# VNS1S12D. Conclusion for Neisvac-C lot# VNS1S12D: there is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Conclusion for Prevenar 13 lot# W19703: Packed lot W19703 and associated bulk lot 930214, met all Quality and compliance requirements at the time of release. There is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Follow-up (19Aug2019): New information from the same contactable Other HCP received from local Product Quality Complaint group includes expiry date for the vaccine was provided. Follow-up (20Aug2019): New information from the same contactable Other HCP reported by the local Regulatory Authority included: the autonomous community code. Follow-up (23Aug2019, 23Aug2019): New information received from Product Quality Complaints Group includes: investigational results for Prevenar 13 lot# W19703, and NeisVac-C lot# VNS1S12D. No follow-up attempts are possible. No further information is expected. Follow-up (28Aug2019): New information from a physician downloaded from the Regulatory Authority (ES-AEMPS-533524) included: patient''s weight, reaction data (previously reported event "death" was deleted and replaced with new events fever and persistent crying, cause of death), and product details (vaccination date, additional suspect products Vitamin D3, paracetamol). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; Persistent crying


VAERS ID: 833135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-02-25
Onset:2015-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA14005 / 2 LL / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H23100 / 1 RL / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-27
   Days after onset: 1461
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: PLPFIZER INC2019388257

Write-up: Sudden death; This is a spontaneous report from a contactable physician received from the regulatory authority via agency. The Regulatory authority report number is PL-URPL-N701/2015. The reporter is contactable to HA only. A 4-month-old female patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number: H23100, expiry date: 31Dec2015) at thigh right and second dose of hepatitis b vaccine rhbsag (yeast) (EUVAX B, lot number: UFA14005, expiry date: 31Dec2016) at thigh Left, both intramuscularly on 25Feb2015 at 13:40 at 0.5 ml, single for routine childhood immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden death on 27Feb2015. It was not reported if an autopsy was performed. SENDER COMMENT: Child''s death took place two days after vaccine administration, until today''s date (26Aug2019) URPL didn''t receive any additional information for determination of cause-and-effect relationship. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 833192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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: Breast neoplasm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131909KOR003543

Write-up: teenage girl who died 75 minutes after being immunized against the virus was widely reported; the patient received HPVVaccine; Information has been received from an unspecified reporter via a company representative regarding an article published in website. The patient''s medical history and concomitant medication were not provided. On an unknown date the patient received human papillomavirus (HPV) vaccine for prophylaxis (product origin unknown). The HPV vaccine might be 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). The strength, dose, frequency, route, batch/lot number and expiration date were not provided for the product. 75 minutes after being immunized against the virus, the patient died. The cause of death was not provided. It was unknown if an autopsy was performed. The causality between the vaccine and the events was unknown. It was reported that although press vehicles automatically established the causality between the vaccine and death, it was soon discovered that the victim had a previously undiscovered breast tumor.


VAERS ID: 833393 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: NZ0095075131909NZL003087

Write-up: Death; Convulsing; This spontaneous social media report was received from a consumer (who read in an online article) via seqirus regarding unknown number of female patients. The patients'' concurrent conditions, medical history and concomitant medications were unknown. On unknown dates, the patients'' were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, lot number, anatomical location and expiration date were unknown) for prophylaxis. On unknown dates, the patients'' experienced convulsions (seizures). On an unknown dates some of the patients'' have died.The cause of death was unknown. It was unknown if an autopsy was performed. The outcome of seizures was unknown. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event seizures was determined to be medically significant. This is one of the 3 reports from the same reporter.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 833853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Lumbar puncture abnormal, Serology abnormal, Streptococcal infection
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Lumbar puncture; Result Unstructured Data: Test Result: streptococcus; Test Name: Streptococcus serology; Result Unstructured Data: Test Result: 13b
CDC Split Type: ZAPFIZER INC2019394645

Write-up: died of streptococcus confirmed by lumbar puncture and laboratory serotyping confirmed 13b as the serotype responsible; This is a spontaneous report from a non-contactable healthcare professional via a Pfizer sales representative. A 6-month-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at single dose for vaccination. The patient''s medical history and concomitant medications were not reported. The patient was up to date with all her routine vaccination including PREVENAR 13. The patient died of streptococcus confirmed by lumbar puncture and laboratory serotyping confirmed 13b as the serotype responsible on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on the batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, the association between the event fatal streptococcus 13b infection 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 of streptococcus confirmed by lumbar puncture and laboratory serotyping confirmed 13b as the serotype responsible


VAERS ID: 834217 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-06-25
Onset:2019-07-10
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2019-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Biopsy skin, Blister, Blood blister, Blood creatinine increased, Blood test abnormal, Cardiac failure, Chest X-ray abnormal, Cyanosis, Death, Dyspnoea, Fall, Glomerular filtration rate decreased, Hepatic enzyme abnormal, Intensive care, Lung consolidation, Musculoskeletal discomfort, Oxygen saturation decreased, Palliative care, Pallor, Pneumonia, Productive cough, Rash, Rash erythematous, Renal impairment, Soft tissue injury
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-07-19
   Days after onset: 9
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: ARATAC; albuterol sulfate; atorvastatin; bisoprolol fumarate; APO CLOPIDOGREL; doxycycline; escitalopram; ferrous fumarate; APO FRUSEMIDE; metformin hydrochloride; omeprazole; PANAMAX; PLAQUENIL; spironolactone; TRELEGY ELLIPTA; PANAFCORTEL
Current Illness: Allergy; Chronic obstructive pulmonary disease; Psoriatic arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Atrial fibrillation; End stage cardiac failure; Endocarditis infective; Septic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20190718; Test Name: oxygen saturation; Test Result: 63 %
CDC Split Type: AU0095075131909AUS004573

Write-up: Rash; Blister; blood blister; Musculoskeletal discomfort; Information was obtained on a request by the Company from the agency via a Public Case Detail (AU-TGA-0000473146) concerning a 77-year-old consumer regarding himself. The patient with a history of psoriatic arthritis on immunosuppressive treatment (hydroxychloroquine + prednisolone), chronic obstructive pulmonary disease (COPD), end-stage cardiac failure chronic (perivalvular leak), atrial fibrillation, aortic valve replacement (AVR) (aortic root abscess) with debridement, re-do for infective endocarditis and septic arthritis of the hip. The patient had a number of allergies, none known to tetracycline antibiotics. Concomitant therapies included amiodarone hydrochloride (ARATAC), albuterol sulfate (reported as asmol cfc-free/ salbutamol sulfate), atorvastatin, bisoprolol fumarate, clopidogrel bi-sulfate (APO-CLOPIDOGREL), doxycycline, escitalopram, ferrous fumarate (reported as ferro tab), apo-furosemide, metformin hydrochloride, omeprazole, acetaminophen (PANAMAX), hydroxychloroquine sulfate (PLAQUENIL), spironolactone and fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA). On 25-JUN-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 1 dose unspecified (strength, frequency, anatomical location, route, lot # and expiry date not reported) for vaccination. Other suspect therapies included prednisolone (PANAFCORTELONE) (strength, dose, frequency, route, indication, lot # and expiry date not reported). On 09-JUL-2019, the patient presented to hospital after a fall (tripped over his wheeled walker) sustaining minor soft tissue injuries. The patient told the staff that the shop keeper where he fell called the ambulance service, he also stated that if it was up to him, he would not have come to hospital. Incidentally on examination of a chest X-ray which revealed left lower lobe consolidation (lung infection) and was commenced on oral antibiotics doxycycline, 100 mg daily and discharged from emergency department (ED). On 10-JUL-2019, the patient experienced rash, musculoskeletal discomfort and blood blister. On 15-JUL-2019, the patient returned with a widespread truncal rash (described as red, blanching with central blistering) which he stated commenced soon after starting the doxycycline and he stopped these on day two. The patient was not constitutionally unwell, and his observations were normal. The patient was advised to cease the antibiotics (which already had done) and was discharged home. On 15-JUL-2019, the patient experienced blister. On 18-JUL-2019, the patient was re-presented with increased shortness of breath and work of breathing; unable to get off the toilet. The patient had reduced oxygen saturations, was cyanotic and coughing whitish phlegm. It was noted that the patient was known to palliative care and still had a widespread rash. A biopsy was taken. Blood test revealed an acute renal injury were performed which showed deranged liver enzymes as well as acute renal injury (Estimated glomerular filtration rate (eGFR) reduced to 27 from 62. Blood creatinine levels was 199) as well as deranged liver enzymes, and he had worsened left lower lobe consolidation on chest X-ray. The patient was admitted to hospital on azithromycin and moxifloxacin (antibiotics). The dose of prednisolone (PANAFCORTELONE) was increased due to the rash. At 3:40 pm, a medical emergency team (MET) call was made for reduced oxygen saturation (63%); The patient was given nebulised Ventolin/Atrovent and increased flow nasal prong oxygen. Intensive Care Unit (ICU) team review recorded that the Patient had several co-morbidities including heart failure, renal impairment, end stage airways disease and valvular heart disease. It was determined that he was not a candidate for ICU, resuscitation, intubation or MET calls. The Patient told treating staff that he was tired and "had enough". The patient was placed on the end-of-life pathway, a syringe driver commenced. Action taken of prednisolone (PANAFCORTELONE) was unknown. On the morning of 19-JUL-2019, the patient passed away. Cause of death was unknown. It was unknown if an autopsy was done. The reporter considered blister, rash, musculoskeletal discomfort and blood blister to be related to Zoster Vaccine Live (ZOSTAVAX). The causal relationship between the events and prednisolone (PANAFCORTELONE) was not reported.


VAERS ID: 834221 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MY0095075131909MYS004637

Write-up: death; terribly ill; This solicited report has been received from a physician regarding a group of children who were enrolled in an unknown study. The patient''s concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, sixteen thousand patients started therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, units, frequency, lot number, expiration date and route of administration were not specified) for prophylaxis. On an unknown date, out of sixteen thousand patients, many of them fell terribly ill and five among them were died. Outcome of the event terribly ill was unknown at the time of report. The investigator did not provide the causality of the events death and terribly ill with the suspect therapy. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil 4 vaccine and the reported event of Death cannot be established. Missing clinically important information includes subjects demographic detailed information, medical history, concurrent conditions, concomitant medications/vaccines, dates of vaccination, number of doses administered, detailed clinical course, diagnostic workup results, autopsy results and primary cause of death for all subjects. Company Comment- No changes to the Gardasil 4 vaccine product safety information are warranted at this time. Merck and Co., Inc., known as MSD, continues to monitor the safety profile of Gardasil 4 vaccine product.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 834298 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2019-02-26
Onset:2019-03-09
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2019-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AH2392 / 1 LL / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-09
   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: VIGANTOL [COLECALCIFEROL]
Current Illness: Scoliosis (suspected incipient, sent for rehabilitation)
Preexisting Conditions: Medical History/Concurrent Conditions: Apgar score (10-10-10); Hard of hearing (Father of mother); Normal birth; Otoacoustic emissions test (bilaterally ++); Pollinosis (Father and mother); Thrombosis (Mother''s sister)
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Histology; Result Unstructured Data: Test Result: Negative; Comments: Toxicologic test (2019): Negative (during autopsy).; Test Date: 2019; Test Name: Microbiology test; Result Unstructured Data: Test Result: Negative; Comments: Toxicologic test (2019): Negative (during autopsy).; Test Date: 2019; Test Name: Toxicologic test; Result Unstructured Data: Test Result: Negative; Comments: Toxicologic test (2019): Negative (during autopsy).
CDC Split Type: CZPFIZER INC2019398814

Write-up: death/ SIDS (Sudden infant death syndrome); This is a spontaneous report from a contactable physician downloaded from the Agency-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number is CZ-CZSUKL-19003209. A 3-month old female patient received first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number: AH2392) intramuscular into the left thigh anterolateral on 26Feb2019 at 0.5 ml, single, first dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXACIMA, lot number: N3P113V) intramuscular into the left thigh anterolateral on 05Feb2019 at 0.5 ml, single and first dose of rotavirus vaccine live reassort oral 5v (ROTATEQ, lot number: R005249) oral on 05Feb2019 at 2 ml, single all for routine childhood immunization. The patient was checked for 30 minutes after the administration of all vaccines and leaving healthy for immunization. It was reported that rotavirus vaccine live reassort oral 5v was voluntary. Medical history included delivery on 02Dec2018 in week 38 (spontaneous, head first, birth weight 2690g, length 48 cm, mother group B streptococcus positive (GBS) - antibiotic prophylaxis given), otoacoustic emissions test on an unknown date bilaterally ++, Apgar score on 02Dec2018 10-10-10 , ongoing scoliosis suspected incipient, sent for rehabilitation. The patient was healthy, tuberculosis prophylaxis not indicated, Kanavit i.m. Paternal family medical history included pollinosis from father and maternal family history included pollinosis from mother, screening for thrombotic illness was negative, father of mother was hard of hearing, mother''s sister experienced thrombosis. Concomitant medication included colecalciferol (VIGANTOL). The patient experienced death (sudden infant death syndrome) on 09Mar2019. The patient underwent lab tests and procedures which included histology that was negative on an unspecified date in 2019, microbiology test that was negative on an unspecified date in 2019, toxicologic test that was negative on an unspecified date in 2019 (during autopsy). The patient died on 09Mar2019. An autopsy was performed and results were not provided. However, it was reported that a forensic autopsy was performed and stated that the autopsy and available examinations without disease or complications explaining death and according to anamnestic data Sudden infant death syndrome (SIDS) suggested. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Forensic autopsy: The autopsy and available examinations without disease or complications explaining death and according to anamnestic data Sudden infant death syndrome (SIDS) suggested.; Autopsy-determined Cause(s) of Death: Forensic autopsy: The autopsy and available examinations without disease or complications explaining death and according to anamnestic data Sudden infant death syndrome (SIDS) suggested.


VAERS ID: 834299 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-03-27
Onset:2019-04-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2019-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS TD4DD / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Cerebrovascular accident, Death, General physical health deterioration, Herpes zoster, Loss of personal independence in daily activities, Palliative care, Urinary tract infection
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-05-01
   Days after onset: 30
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 pressure high; Diabetes; Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Basal ganglia hemorrhage (in 2015); Stroke (years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: death; Suspicion of Apoplex; sharp deterioration in the state of health/poor health/very limited in function; urinary tract infection; had very limited function; Herpes Zoster; This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number TD4DD, expiry date unknown) for prophylaxis. The patient''s past medical history included stroke (years ago) and basal ganglia hemorrhage (in 2015). Concurrent medical conditions included epilepsy, blood pressure high and diabetes. On 27th March 2019, the patient received the 1st dose of Shingrix. In April 2019, 28 days after receiving Shingrix, the patient experienced herpes zoster. In May 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced apoplexy (serious criteria GSK medically significant), general physical health deterioration, urinary tract infection and activities of daily living impaired. The patient was treated with brivudine (Zostex). In May 2019, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the apoplexy, herpes zoster, general physical health deterioration, urinary tract infection and activities of daily living impaired were unknown. The patient died in May 2019. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death, apoplexy, herpes zoster, general physical health deterioration, urinary tract infection and activities of daily living impaired to be related to Shingrix. Additional case details were reported as follows: The patient was in a nursing home and was in a wheelchair. The patient developed herpes zoster, which was not very pronounced. The patient was not hospitalized. Two weeks before death, there was a sharp deterioration in the state of health. The patient received palliative care and was bedridden. Less than 2 months after receiving Shingrix, the patient had very limited function, poor health, caused, among other things, by a urinary tract infection and suspicion of Apoplex. The cause of death was not reported to the doctor. According to the doctor, it was difficult to judge and she was surprised by the rapid deterioration of the state of health and sees the temporal relationship between vaccination and death. In mid May 2019, the patient died. The patient did not die suddenly. Questionnaire would be sent.; Reported Cause(s) of Death: Death


VAERS ID: 835259 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-08-09
Onset:2019-08-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. R031113 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2019-08-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131909DEU006121

Write-up: circulatory failure and death; death, most likely in consequence of an aspiration 2 days before vaccination with Pneumovax; death, most likely in consequence of an aspiration 2 days before vaccination with Pneumovax; Information has been downloaded from regulatory authority (DE-PEI-PEI2019005793). This spontaneous report was received from a physician and refers to a 5-year-old female patient. Her concurrent conditions, medical history and concomitant medications were not reported. On 09-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, intramuscularly in upper arm, lot # R031113, expiry date: 30-SEP-2020 (dose was not provided) for prophylactic vaccination. On 12-AUG-2019, the patient experienced circulatory failure, most likely in consequence of an aspiration 2 days before vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (onset date reported as 12-AUG-2019). The patient was hospitalized due to the events on 12-AUG-2019 and subsequently died. The cause of death was not provided. An autopsy was performed, but the results were not available. The outcome of aspiration was not provided. The outcome of circulatory failure was reported as fatal. The relatedness between circulatory failure, aspiration and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was reported as inconsistent casual association (unknown). The causality between death and suspected vaccine was reported as unclassifiable. The events were considered to be life threatening.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 835422 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumococcal infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131909CAN006961

Write-up: pneumococcal infection; This spontaneous report was received from other health professional via Health authority (Agency # E2B_02601677) referring to a 10-month-old patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with pneumococcal conj vaccine (manufacturer unknown) (strength, dose, route, lot/batch# and expiry date were unknown) for prophylaxis. On an unknown date, the patient was vaccinated with other suspect therapy which included pneumococcal 10v conj vaccine (protein d/dip toxoid/tet toxoid) (SYNFLORIX) suspension intramuscular (strength, dose, route, lot/batch#, expiry date were unknown) for prophylaxis. On an unknown date, the patient experienced pneumococcal infection and patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The causality assessment was not provided. The Agency considered the event pneumococcal infection to be fatal and medically significant.; Reported Cause(s) of Death: Unknown cause of death


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