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From the 9/17/2021 release of VAERS data:

Found 46 cases where Patient Died and Vaccination Date from '2020-01-01' to '2020-03-31'



Case Details

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VAERS ID: 864498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-02-29
Onset:2020-03-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Cyanosis, Death, Erythema, Gaze palsy, Haematocrit decreased, Inflammation, Jaundice, Myoclonic epilepsy, Respiratory arrest, Seizure, Stupor
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (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 (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LB0095075132003LBN001197

Write-up: CONVULSION; Stupor Cyanosis/blueish; Stupor Cyanosis/blueish; DEATH; REPIRATORY ARREST; Myoclonic status seizure; he had a red cheek on one side only; Possible inflammation; Prolonged jaundice; This spontaneous report was received from a healthcare professional regarding a 2 month old male patient. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On 29-FEB-2020 (reported as ''two days prior''), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ VACCINE, LIVE ORAL PENTAVALENT) via oral route (strength, dose, anatomical location, lot and expiry dates were not reported) for prophylaxis. On 01-MAR-2020 (reported as ''day before admission''), the child was close to heater where he had a red check on one side only and a possible inflammation (erythema and inflammation). On 02-MAR-2020, according to the mother''s explanation the temperature of the patient was reported as 36.6, peripheral capillary oxygen saturation (Spo2) was 85, heart rate was 140 and fixated eyes were observed. The patient''s mother explained that the child was normal at 04:00 a.m. where the patient was fed. Then at 08:00 a.m., the mother saw the patient in that condition (reported as ''seizure and blueish'') where she fed him again (cyanosis and myoclonic epilepsy). On the same day at 11:30 a.m., the patient was admitted to the emergency room. On the same day after admission, the patient underwent blood tests results showed hematocrit (HCT) was 25 with a prolonged jaundice and the patient didn''t do any screening test after being born. He was given IV NaCl, D10 and phenytoin (EPANUTIN). After treatment the patient opened his eyes and myoclonic epilepsy was decreased. The patient was transferred to a hospital, where he had another convulsion (epilepsy) and respiratory arrest and the patient died due to unknown reason. It was unknown if autopsy was performed. The outcome of respiratory arrest, seizure, inflammation, erythema, jaundice, stupor, and cyanosis were unknown. Upon internal review, the events respiratory arrest, myoclonic epilepsy and seizure were determined to be medically significant.


VAERS ID: 865886 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-02-07
Onset:2020-02-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER S009985 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Encephalitis, Loss of consciousness, Pyrexia, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PL0095075132003POL006489

Write-up: Diarrhoea; Fever lasting up to 72 hours; Encephalitis; Convulsions - first episode; Vomiting; Loss of consciousness; Information has been downloaded from Regulatory Authority (PL-URPL-3-284-2020). This spontaneous report was received from a physician regarding a 1-year-old patient of unknown gender. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On 07-FEB-2020, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-RVAXPRO) (recombinant human albumin (rHA)) at a dose of 0.5 milliliter via intramuscular route in the right arm for routine childhood immunization (lot # S009985, expiration date reported as March 2021, but upon internal validation was established as 31-MAR-2021). On 12-FEB-2020, the patient had body temperature from 39.5 to 39.9 degree Celsius and experienced fever lasting up to 72 hours (pyrexia), diarrhoea, loss of consciousness, vomiting, convulsion (first episode) (seizure) and encephalitis. On an unknown date in February 2020, the patient was hospitalized for the reported events. On an unknown date, the patient died. The cause of death was not reported, however the outcome of diarrhoea, loss of consciousness, vomiting, seizure, encephalitis and pyrexia was reported as fatal. It was unknown if an autopsy was performed. The causality of all the reported events were considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-RVAXPRO).


VAERS ID: 866321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-02
Onset:2020-03-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2020-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD582A / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CD1581 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-11
   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: Hospitalization; Intubation; Mechanical ventilation; Pneumonia; Premature baby (32+1 Pregnancy week)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2020127437

Write-up: Death; This is a spontaneous report downloaded from the Regulatory Authority [regulatory authority numberDE-PEI-PEI2020001427]. A 3-month-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number: CD1581), intramuscular in the thigh on 02Mar2020 at single dose for prophylactic 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 (INFANRIX HEXA, lot number: A21CD582A), intramuscular in the thigh on 02Mar2020 at unspecified dose and frequency for prophylactic vaccination. Medical history included pneumonia on 12Jan2020 to an unspecified date. The patient was a premarture baby (32+1 pregnancy week), inpatient due to RSV pneumonia from 12Jan2020 to 31Jan2020, ventilated from 12Jan2020 to 25Jan2020, intubated and ventilated from 19Jan2020 to 20Jan2020. The patient''s concomitant medications were not reported. Patient''s death on 11Mar2020 was reported. The patient died on 11Mar2020. It was not reported if an autopsy was performed. Causality assessment for Prevenar 13 and Infanrix Hexa/Death: Agency,,D. Unclassifiable Sender''s comment: Previous medical history: premature baby 32+1 pregnancy week due to premature labor and premature amniorrhexis, Complication-free course. From 12Jan2020 to 31Jan2020 inpatient due to RSV pneumonia. From 12Jan2020 to 25Jan2020 ventilated, thereby from 19Jan2020 to 20Jan2020 intubated and ventilated. Scheduled admission for the first vaccination from 02Mar2020 to 04Mar2020 (Prevenar 13, lot number CD1581 and Infanrix Hexa Lot number A21CD582A). No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 866582 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-19
Onset:2020-03-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2020-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AH5529AJ6040 / 1 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Decreased appetite, Mental disorder, Pneumonia, Pulmonary function test decreased, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNPFIZER INC2020132604

Write-up: respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; Decreased appetite; slight cough; poor mental state; This is a spontaneous report from a contactable physician via a sales representative. A 4-months-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot: AH5529AJ6040), on her first injection on 19Feb2020 at age of 3 months, on left thigh via muscle injection, at single dose for immunization. The medical history and concomitant medications were not reported. After injection, patient had decreased appetite gradually, poor mental state and sometimes slight cough in 2020. On 04Mar2020, patient went to hospital and was clinically diagnosed with severe pneumonia, respiratory failure and half of pulmonary function loss, patient died on that day. Community physician considered that the symptoms were not caused by PREVENAR 13, patient died of respiratory failure due to severe pneumonia. Physician considered that all events were possibly not related to PREVENAR 13. No autopsy was performed and the physician was not sure that whether the patient had congenital heart disease or not. The outcome of respiratory failure due to severe pneumonia was fatal. The outcome of other events was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia


VAERS ID: 867030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-16
Onset:2020-03-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2020-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Encephalitis viral, General physical health deterioration, Hallucination, Oropharyngeal pain, Pyrexia, Rabies
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   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: IMMUNOGLOBULIN ANTI-RABIES
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYSA2020SA078344

Write-up: rabies encephalitis; rabies encephalitis; fever; condition deteriorated; difficulty swallowing; hallucinations; sore throat; Initial information received on 30-Mar-2020 regarding an unsolicited valid serious case received from a consumer/non-hcp This case involves a five-years old female patient who died due to rabies encephalitis (encephalitis viral) with sore throat (oropharyngeal pain), fever (pyrexia), difficulty swallowing (dysphagia), hallucinations (hallucination) and condition deteriorated (condition aggravated), while she received vaccines RABIES VACCINE and TETANUS TOXOID and while treated with IMMUNOGLOBULIN ANTI-RABIES. The patient''s medical history included Animal bite on 08-MAR-2020. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received first and second dose of RABIES VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for post-exposure immunization. On 16-Mar-2020, the patient received a third dose of suspect RABIES VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for post-exposure immunization. On an unknown date, the patient received a dose of IMMUNOGLOBULIN ANTI-RABIES (rabies immunoglobulin Jab) not produced by Sanofi Pasteur via unknown route unknown and unknown administration site (with an unknown batch number) for Animal bite. On 23-Mar-2020, the patient developed a serious sore throat (oropharyngeal pain), difficulty swallowing (dysphagia) and hallucinations (hallucination) unknown latency following first two doses of Rabies vaccine and 7 days following third dose of rabies vaccine and unknown latency following intake of IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. On an unknown date, the patient experienced serious fever (pyrexia) and condition deteriorated (condition aggravated) unknown latency following vaccination with rabies vaccine, IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. On an unknown date, the patient developed rabies encephalitis (encephalitis viral) unknown latency following vaccination with rabies vaccine, IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. The patient was hospitalized for these events. These all events were medically significant and led to death of the patient. Case details: it was reported that the patient was bitten in the face by a stray dog on March 8, but the wounds were not immediately washed with running water and soap. She was brought to Hospital for treatment the same day. She received an anti-tetanus jab, a rabies immunoglobulin jab and two doses of anti-rabies vaccine. On March 13, she was discharged in healthy condition, said in a statement on Monday (March 30). The patient was given a third anti-rabies vaccine jab on March 16. On March 24, the patient was brought to a community clinic in for fever and to Hospital the next day after suffering a sore throat, difficulty swallowing and hallucinations. Her condition deteriorated and she died the following day. The cause of death was rabies encephalitis. No laboratory data reported. Final diagnosis was (fatal) rabies encephalitis. It was not reported if the patient received any corrective treatment. The event outcome was fatal and the patient died on 25-Mar-2020. It is unknown if an autopsy was done. The cause of death was reported as Encephalitis viral, Oropharyngeal pain, Pyrexia, Dysphagia, Hallucination and Condition aggravated. There will be no information available on the batch number for this case.; Sender''s Comments: This five-year-old patient bitten on the face by a rabid dog, developed rabies and died despite post-exposure prophylaxis including RABIES VACCINE (three doses), TETANUS TOXOID and IMMUNOGLOBULIN ANTI-RABIES, all from unknown manufacturer. Reportedly, immediate wound cleaning was not provided. Rabies post-exposure prophylaxis (PEP) was started on the day of exposure. Overall, the patient received 3 doses of rabies vaccine, last dose administered 8 days after exposure (exact schedule not reported). The details of Rabies immunoglobulin and vaccine (type, manufacturer, dose, route and site of administration) were not reported. Sixteen days after exposure, the patient developed clinical rabies (sore throat, fever, difficulty swallowing and hallucinations) and died the following day. The cause of death was reported as rabies encephalitis, although it is unknown whether the autopsy was done or not. Lack of immediate wound cleaning and bite on the face which is highly innervated area could have significantly contributed to PEP failure. Based on limited information provided on rabies vaccine and immunoglobulin administration, a detailed assessment on the role of vaccine is not possible.; Reported Cause(s) of Death: rabies encephalitis


VAERS ID: 867723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-17
Onset:2020-01-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2020-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Death, Incorrect route of product administration, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-01-28
   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: Medical History/Concurrent Conditions: Atrial fibrillation; Coronary heart disease (In May 2012); Hyperlipoproteinemia; Transient ischemic attack (In March 2012)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE202005

Write-up: cardiopulmonary shock; Ventricular fibrillation; Inappropriate route of vaccine adminstered; This case was reported by a physician via regulatory authority and described the occurrence of cardiogenic shock in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient''s past medical history included atrial fibrillation, transient ischemic attack (In March 2012), hyperlipoproteinemia and coronary heart disease (In May 2012). Previously administered products included Shingrix (On 11th September 2019). On 17th January 2020, the patient received Shingrix (subcutaneous). On 28th January 2020, 11 days after receiving Shingrix, the patient experienced cardiogenic shock (serious criteria death, hospitalization, GSK medically significant and life threatening) and ventricular fibrillation (serious criteria death, hospitalization, GSK medically significant and life threatening). On an unknown date, the patient experienced intramuscular formulation administered by other route. On 28th January 2020, the outcome of the cardiogenic shock and ventricular fibrillation were fatal. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. The patient died on 28th January 2020. The reported cause of death was cardiogenic shock. An autopsy was not performed. It was unknown if the reporter considered the cardiogenic shock and ventricular fibrillation to be related to Shingrix. Additional details: The age at vaccination was not provided but the patient could be 83 years old or less than 83 years old. Shingrix should be administered via intramuscular route. However the patient received shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Initial information was reported by a Physician via regulatory authority on 1st April 2020: Cardiogenic shock , ventricular fibrillation and intramuscular formulation administered by other route.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 869005 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-03-13
Onset:2020-03-01
Submitted: 0000-00-00
Entered: 2020-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B328DD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine increased, Death, Headache, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-17
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECOZYME
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (allergies to almonds); Nonsmoker
Allergies:
Diagnostic Lab Data: Test Date: 20200225; Test Name: Creatinine; Result Unstructured Data: Test Result: 79, Test Result Unit: unknown
CDC Split Type: CHGLAXOSMITHKLINECH202006

Write-up: Headache; Nausea; Tod; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 71-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number AC37B328DD, expiry date unknown) for prophylaxis. Previously administered products included Focetria (swine flu vaccine received in Oct 2009) and Boostrix (received In 2013). Concurrent medical conditions included nonsmoker and food allergy (allergies to almonds). Additional patient notes included no liver nor kidney disease. Concomitant products included vitamin B substances nos (Becozyme). On 13th March 2020 09:40, the patient received Boostrix (intramuscular). On 14th March 2020, 1 days after receiving Boostrix, the patient experienced headache and nausea. On 17th March 2020 11:00, 4 days 1 hr 20 min after receiving Boostrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 17th March 2020, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the headache and nausea were unknown. The patient died on 17th March 2020. The reported cause of death was death nos. An autopsy was not performed. The reporter considered the unknown cause of death, headache and nausea to be possibly related to Boostrix. Additional details: The age at vaccination was not provided but the patient could be 71 or less than 72 years old. On 25th February 2020, lab test included creatinine with result 79. The patients initials were reported. Boostrix Other assessment as per WHO showed possible to headache, nausea and death. Note the outcome of event nausea headache was reported as fatal, However was captured it as unknown as the cause of death was unknown. The onset date for Headache was reported as 17th March per as per narrative the patient experienced headache on 14th March 2020. Initial information was reported by a Physician via regulatory authority on 20th April 2020: The 72-year-old patient (weight: 73 kg) received an intramuscular booster vaccination with Boostrix (diphtheria / tetanus / pertussis vaccine; lot no.AC37B328DD) on March 13, 2020 at 9:40 a.m. The patient wished for this vaccination if the daughter-in-law had advanced pregnancy, although the last Boostrix vaccination was only in 2013. On March 14, March 15 and March 17, 2020 there was a brief headache and nausea in the morning. Neither vomiting nor fever occurred. No painkillers were taken. On March 17th, 2020 the patient was found dead by his wife. At 11:00 am, 144 and medical stopped the resuscitation. No autopsy was carried out. The patient also took Becozym forte (vitamins of the B complex) once a day. There was neither liver nor kidney disease (creatinine 2/25/2020: 79). The patient had allergies to almonds and a Focetria? vaccine (swine flu) in October 2009. The patient was a non-smoker. We have no further information on this case. Senders comment: The drug information from Boostrix ((diphtheria / tetanus / pertussis vaccine) describes the occurrence of headache as very common (17.7%) and nausea as common (1-10%) UAW. A fatal outcome after vaccination or the lethal outcome is not explicitly listed as UAW. According to the drug information from Becozym, headaches can occur with the B vitamin preparation without specifying the frequency. Since 2004, the WHO pharmacovigilance database lists a total of 20,649 individual case safety reports on Boostrix, 19 cases of "death", most of which were children. There is a temporal relationship between the use of Boostrix and the occurrence of headache, nausea with fatal outcome. A de-challenge cannot be assessed for the lethal outcome. Other causes of death such as B. Cerebral bleeding events with headache and nausea as possible indicative symptoms cannot be excluded. If the autopsy is not carried out, the etiology of the fatal outcome after vaccination has not been definitively clarified. In summary, we assess the causality between the use of Boostrix and the occurrence of headache, nausea with fatal outcome according to the WHO / based on the temporal relationship, the documentation in the drug information and in the databases, but possible other, non-excluded, non-medicinal causes. Regulatory Authority criteria formally possible.; Reported Cause(s) of Death: Death NOS


VAERS ID: 869903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-13
Onset:2020-04-03
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2020-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS T74L4 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-12
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE202007

Write-up: Guillain-Barre syndrome; Respiratory insufficiency; This case was reported by a physician via regulatory authority and described the occurrence of guillain-barre syndrome in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number T74L4, expiry date unknown) for prophylaxis. Previously administered products included Shingrix (received on 6th November 2019). On 13th February 2020, the patient received Shingrix (unknown). On 3rd April 2020, 50 days after receiving Shingrix, the patient experienced guillain-barre syndrome (serious criteria death, hospitalization and GSK medically significant). On 12th April 2020, the patient experienced respiratory insufficiency (serious criteria death and GSK medically significant). On 12th April 2020, the outcome of the guillain-barre syndrome and respiratory insufficiency were fatal. The patient died on 12th April 2020. The reported cause of death was respiratory insufficiency and guillain-barre syndrome. An autopsy was not performed. It was unknown if the reporter considered the guillain-barre syndrome and respiratory insufficiency to be related to Shingrix. Additional information: The age at vaccination was not reported, but the patient could be 76 or 77 years old at the time of vaccination. The patient received Shingrix in left deltoid. The reported time to event onset for the event of guillain-barre syndrome was 51 days. However as per reported vaccination date and event onset date it was captured as 50 days. The Agency assessment for the event of guillain-barre syndrome was reported as unclassifiable or unknown. The event of guillain-barre syndrome was also captured as cause of death as the outcome of the event was reported as fatal and respiratory insufficiency was also captured as an event as it was after receiving the suspect vaccine and also the onset date was captured as death date because the event of respiratory insufficiency is a sudden event because of which the patient died. Initial information was reported by physician via regulatory authority on 1st May 2020: Guillain-barre syndrome.; Reported Cause(s) of Death: Respiratory insufficiency; Guillain-Barre syndrome


VAERS ID: 879384 (history)  
Form: Version 2.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-29
Onset:2020-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Adenovirus infection, Arthropathy, Biopsy pharynx abnormal, Bronchoalveolar lavage abnormal, Cellulitis, Computerised tomogram abnormal, Cytomegalovirus infection, Cytomegalovirus test positive, Death, Endotracheal intubation, Epiglottic oedema, Epstein-Barr virus infection, Epstein-Barr virus test positive, Haemophagocytic lymphohistiocytosis, Herpes simplex, Human herpesvirus 6 infection, Immunodeficiency, Immunoglobulin therapy, Incisional drainage, Lymphadenitis, Measles post vaccine, Multinucleate cell angiohistiocytoma, Multiple organ dysfunction syndrome, Otitis media, Pharyngeal abscess, Pneumonia, Polymerase chain reaction positive, Post vaccination challenge strain shedding, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Roseolovirus test positive, Stridor, Urine analysis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (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), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-22
   Days after onset: 23
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: 2020; Test Name: PCR Adenovirus; Test Result: Positive ; Test Date: 2020; Test Name: HHV 6; Test Result: Positive ; Test Date: 2020; Test Name: PCR for RSV; Test Result: Positive
CDC Split Type: GB0095075132008GBR001917

Write-up: When measles result from NP/urine returned on 2/21 started oral ribavirin; Positive for vaccine-strain measles from nasopharynx and urine; Pneumonitis; Pneumonia; developed ARDS and multiorgan dysfunction; Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure; Cervical & retropharyngeal lymphadenitis; Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure; Evident epiglottic inflammation with "white dots" noted during intubation; HLH/MAS was considered and he met some criteria for this; become infected and die testing positive for [...] CYTOMEGALOVIRUS; Presented respiratory failure, then developed ARDS; Evidence of developing retropharyngeal phlegmon; Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects; become infected and die testing positive for ADENOVIRUS; become infected and die testing positive for [..] EPSTEIN-BARR VIRUS; become infected and die testing positive for [...] HERPES SIMPLEX; become infected and die testing positive for [...] RESPIRATORY SYNCYTIAL VIRUS; become infected and die testing positive for [...] ROSEOLOVIRUS.; Subsequently developed knee lesion; This spontaneous report was received from a consumer via other MAH concerning a 13-months-old male patient. The patient''s concurrent conditions, medical history, historical drug and concomitant therapies were not provided. It was reported that the patient was previously healthy. On 29-JAN-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 1 dosage form for prophylaxis; and with varicella virus vaccine live (oka/merck)(VARICELLA VIRUS VACCINE LIVE (OKA/MERCK)) for prophylaxis. (dosage regimen, route of administration, lot number and expiration date were not provided for both vaccines). On 30-JAN-2020, the patient initially experienced otitis media, and then he re-presented with stridor and rapid respiratory failure, the patient was intubated and evidence of epiglottic inflammation with "white dots" were noted, also cervical and retropharyngeal lymphadenitis. On an unknown date in 2020, the following laboratory test were performed: respiratory polymerase chain reaction (PCR) for adenovirus (respiratory) with a positive result; serum adenovirus positive (not remarkably high level); PCR for Respiratory Syncytial virus (RSV): positive; PCR for Epstein-Barr virus (EBV): positive in serum, low-level positive but a serology of OSH (unknown) was suggestive of a past infection; a culture of the incision and drainage of neck lymphadenitis was performed with a negative result; a computerized tomography that showed evidence of developing retropharyngeal phlegmon (cellulitis). Subsequently, the patient developed a knee lesion (knee arthropathy) on an unspecified date in 2020, this lesion was positive for Herpes Simplex Virus (HSV). A PCR for HSV on serum was performed, it showed a disseminated HSV infection at high viral levels. On an unknown date, additional viral test were performed, a unspecified Cytomegalovirus (CMV) test with a positive result at low levels; Human Herpes Virus 6 test was positive (likely reactivation in setting of severe illness). Moreover, based on multiple viral infections, on an unknown date in 2020, the immunology team was involved and as differential diagnosis (DDX) were listed immunodeficiencies (such as Toll-like receptors defects), hemophagocytic lymphohistiocytosis (HLH) and Macrophage activation syndrome (MAS), since the patient met some criteria for it (treatment with anakinra and intermittent steroid dosing (Unknown)). On 14-FEB-2020, a bronchoalveolar cytology (BAL) was performed which showed multinucleated giant cells. On 21-FEB-2020, results of a test in nasopharynx and urine for vaccine-strain measles which was positive (Post vaccination challenge strain shedding, measles post-vaccine), treatment with ribavirin oral started (while pursuing IV ribavirin), high dose vitamin A and redosed intravenous immunoglobulins (IVIG). The HSV levels continued to fall. It was unclear if the respiratory presentation was a prolonged shedding versus true pneumonia/pneumonitis. On an unspecified date in 2020, the patient experienced acute respiratory distress syndrome and multiorgan dysfunction while being on veno-arterial extracorporeal membrane oxygenation (VA ECMO), requiring vasoactive support and continuous renal replacement therapy. On 22-FEB-2020, the patient died of cytomegalovirus infection, acute respiratory distress syndrome, cellulitis, immunodeficiency, multiple organ dysfunction syndrome, respiratory failure, measles post vaccine, pneumonia, adenovirus infection, Epstein-Barr virus infection, Herpes simplex, respiratory syncytial virus infection, human herpes virus 6 infection, arthropathy, lymphadenitis and otitis media. It was unknown if an autopsy was performed. The outcome of the epiglottitis, Haemophagocytic lymphohistiocytosis and Post vaccination challenge strain shedding was not reported. It was unknown of the contribution of measles vaccine strain to respiratory presentation. The causal relationship between varicella virus vaccine live (oka/merck)(VARICELLA VIRUS VACCINE LIVE (OKA/MERCK) and the events was not provided. Upon internal review, the events of epiglottitis and haemophagocytic lymphohistiocytosis were considered to be medically significant.; Reported Cause(s) of Death: Presented respiratory failure, then developed ARDS; become infected and die testing positive for [...] CYTOMEGALOVIRUS; become infected and die testing positive for [..] EPSTEIN-BARR VIRUS; Cervical & retropharyngeal lymphadenitis; Multiorgan failure


VAERS ID: 882193 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-21
Onset:2020-08-28
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2020-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. R023497 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Chest discomfort, Death, Dengue virus test negative, Dizziness, Fall, Illness, Loss of consciousness, Malaise, Nausea, Pallor, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-08-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: GARDASIL SYRINGE (DEVICE)
Current Illness: Fever (High fever 39 degree Celsius); Illness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200829; Test Name: dengue fever; Test Result: Negative
CDC Split Type: TH0095075132008THA015004

Write-up: first dose of Gardasil on 21-FEB-2020, second dose on 28-AUG-2020; Physician tried to do CPR but could not help. The daugther died at 02:00am/ Patient''s father informed that she may die of hear failure; fell down; became unconscious.; It was believed that she may allergic to vaccine; she got pale on mouth and face; came back home and got sick; she had vomiting; chest tightness; Dizziness; Nausea; This spontaneous report was received from a consumer via company representative thru social media regarding a female patient who would be 11-year-old at the reporting time. The patient''s concurrent conditions include fever of 40 Celsius degrees and illness. There was no information about patient''s concomitant medications or pertinent medical history. On 21-FEB-2020, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route, anatomical location, lot number and expiration date were not reported) as vaccination against cervical cancer. On 28-AUG-2020 (reported as last Friday), the patient went to school and had fever if 39 Celsius degrees and illness. The patient''s teacher asked her to sleep for rest until around 14:00 hours. At that time, the patient was in a queue where the health worker provided her the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number R023497, expiration date not reported but upon internal validation established as 08-JAN-2021 (dose, route and anatomical location were not reported) as vaccination against cervical cancer. Until the evening, her uncle picked up her from school and went back home as usual. This patient stayed with uncle and grandmother due to parent were working. Around 16:00 hours, the patient''s mother picked up her to come back home at a different district. On 28-AUG-2020, the patient complained that she had nausea, dizziness and chest tightness (chest discomfort). The mother thought that this was normal sickness, so she gave to the patient an unspecified medicine and some rest. Mother had asked for her daughter''s symptom and the patient told that she was getting better. On 29-AUG-2020 (reported as Saturday), the patient went to school as normal until 8.00 hours; the patient was very sick (malaise), she got pale on mouth and face (pallor) and the teacher took the patient back home. Then, the patient was referred to see the physician at the hospital. After physician interviewed the patient''s history, the patient informed that the school had provided vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and the temperature was high around 39 Celsius. Then, a blood test for testing dengue fever was performed but the result was negative. Therefore, the physician prescribed unspecified medicine and the patient came back for rest at home. While resting at home, the patient had continuous vomiting and chest tightness. her parents took care of her and asked her for symptoms until midnight of 29-AUG-2020, the patient had heavy vomiting and vomited in the bathroom. The parents called her many times, but the patient did not reply. Therefore, when the parents opened the door and they saw that the patient felt down (fall) and became unconscious (loss of consciousness). They took the patient to the hospital. The physician tried a cardiopulmonary resuscitation (CPR) but could not help. The patient died on 30-AUG-2020 at 02:00 hours. The patient''s father stated that she might have died of heart failure. It was reported that an autopsy was performed, however the results were not provided. It was also reported that it was believed that the patient could be allergic to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (allergy to vaccine). At the time of the report, the outcome of loss of consciousness, vomiting, malaise, pallor, allergy to vaccine, nausea, dizziness, fall and chest discomfort was unknown. The event of allergy to vaccine was related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The relatedness between the events of cardiac failure, loss of consciousness, vomiting, malaise, pallor, nausea, dizziness, fall and chest discomfort and therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported. Upon internal review, cardiac failure and loss of consciousness were determined to be medically significant event. combinationproductreport: Yes; brandname: GARDASIL SYRINGE (DEVICE); commondevicename: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R023497; expirationdate: 08-JAN-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Reported Cause(s) of Death: heart failure


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