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From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1585932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101032022

Write-up: were vaccinated with the Corona vaccine and died a few days afterwards; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for two patients. This is the second of two reports. A 9-decade-old (reported as "over 80 years old") male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included chronic disease. The patient''s concomitant medications were not reported. The patient was vaccinated with the Corona vaccine and died a few days afterwards. Event took place after use of product. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event "death" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-202101031665 Same reporter, same product, same event, different patient; Reported Cause(s) of Death: were vaccinated with the Corona vaccine and died a few days afterwards


VAERS ID: 1585937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Diarrhoea, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021125628

Write-up: death after 6 hours; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-667618. A 42-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL1484), intramuscular on 07Jan2021 as DOSE NUMBER UNKNOWN, 0.3ML SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Jan2021 the patient experienced death after 6 hours and asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine. The outcome of event asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine was recovered on an unspecified date. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The signaler is contacted to get information about the concomitant diseases in which he suffers, and the date of the outcome (08.02.2021 still awaiting feedback) No Follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death after 6 hours


VAERS ID: 1586050 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Infantile cerebral palsy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-764973) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA and PYREXIA in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003655) for COVID-19 vaccination. The patient''s past medical history included Infantile cerebral palsy on 31-May-1968. On 15-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization) and PYREXIA (seriousness criteria death and hospitalization). The patient died on 30-Jul-2021. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided. Company''s comment: Company''s comment: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Upon follow-up received: Updated seriousness criteria to death.; Sender''s Comments: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected.; Reported Cause(s) of Death: Dyspnea; Pyrexia


VAERS ID: 1586117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Alanine aminotransferase, Aspartate aminotransferase, Blood bilirubin, Blood calcium, Blood creatinine, Blood glucose, Blood sodium, Blood testosterone, Blood urea, Bone scan, Cardiac arrest, Dyspnoea, Haematology test, Haematoma, Haemoglobin, Neutrophil count, Platelet count, Prostatic specific antigen, Sopor, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 3
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: PREDNISONE TEVA; ZYTIGA; VALSARTAN; HYDROCHLOROTHIAZIDE; METFORMIN; TICLOPIDINE; QUETIAPINE; LANSOPRAZOLE; DECAPEPTYL [TRIPTORELIN]
Current Illness: Diabetes mellitus; Hypertension; Mixed anxiety and depressive disorder (in psychiatric therapy); Neoplasm prostate (diagnosed with biopsy in 2016, treated with Casodex and Decapeptyl quarterly.)
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker; Surgical intervention (Cervical spine surgery with titanium plate implant.)
Allergies:
Diagnostic Lab Data: Test Name: Alanine Aminotransferase; Result Unstructured Data: Test Result:9; Test Name: Aspartate Aminotransferase; Result Unstructured Data: Test Result:22; Test Name: bilirubin; Result Unstructured Data: Test Result:0.31; Comments: total: 0.31 direct: 0.16 indirect: 0.15; Test Name: calcium; Result Unstructured Data: Test Result:10.5; Test Name: creatinine; Result Unstructured Data: Test Result:1.27; Test Name: blood glucose; Result Unstructured Data: Test Result:120; Test Name: sodium; Result Unstructured Data: Test Result:136; Test Name: testosterone; Result Unstructured Data: Test Result:0.03; Test Name: Blood Urea Nitrogen; Result Unstructured Data: Test Result:34; Test Date: 20210216; Test Name: Bone scintigraphy; Result Unstructured Data: Test Result:Numerous images of focal pathological hyperfixatio; Comments: Numerous images of focal pathological hyperfixation to be referred to secondary level at the level of the whole spine, shoulder blades, sternum, costal arches, pelvis and femurs; Test Date: 20210308; Test Name: Hematology test; Result Unstructured Data: Test Result:unknown results; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.5; Test Name: neutrophil; Result Unstructured Data: Test Result:7.67; Test Name: platelet count; Result Unstructured Data: Test Result:255; Test Date: 20210308; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:255 x10 3/mm3; Test Date: 20210308; Test Name: PSA; Result Unstructured Data: Test Result:4,567 iU; Test Name: white blood cell; Result Unstructured Data: Test Result:11.4
CDC Split Type: ITPFIZER INC202101032068

Write-up: Cardiac arrest; Hematomas in the posterior region of the thorax; Sleepy state; pasty abdomen; dyspnea; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Regulatory Authority Report number is IT-MINISAL02-768322. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY, EP9599) intramuscular at single dose for COVID-19 immunisation on 11Mar2021. Relevant history included ongoing mixed anxiety and depressive disorder, ongoing diabetes mellitus, ongoing neoplasm prostate since 2016, ongoing hypertension, surgical intervention (cervical spine surgery with titanium plate implant), non-smoker. Relevant concomitant drug included prednisone (PREDNISONE TEVA) orally, abiraterone acetate (ZYTIGA) orally at 1 DF for Carcinoma prostatic on 15Mar2021. Additional concomitant drugs included valsartan and hydrochlorothiazide, metformin, ticlopidine, quetiapine, lansoprazole, quarterly triptorelin (DECAPEPTYL), all received on 11Mar2021. Past drug included bicalutamide (CASODEX) for Neoplasm prostate, triptorelin (DECAPEPTYL) for Neoplasm prostate. The patient experienced sleepy state and dyspnea. Hematomas in the posterior region of the thorax and pasty abdomen since 15Mar2021 with fatal outcome. The clinical course was reported: From Apr2020 progressive Prostatic specific antigen rise, on the CT of the brain, thorax, abdomen of 15Dec2020 doubts at the skeletal level, at the scintigraphy of 16Feb2021 numerous images of pathological hyperfixation of a focal nature to refer to secondaryity in the whole spine, shoulder blades, sternum, rib arches, pelvis and femur. On 11Mar2021 access to Oncology, on a wheelchair due to walking difficulties arising from the previous month, administration of Pfizer vaccine and prescription of therapy with Deltacortene 5mg, 1 tablet x2 per day, and Zytiga 1000mg per day starting from 15Mar2021. Home therapy on 11Mar2021 included valsartan and hydrochlorothiazide, metformin, ticlopidine, quetiapine, lansoprazole, quarterly triptorelin (DECAPEPTYL). From the evening of 15Mar2021 onset of intense asthenia, urinary blockage and pain, with access to the Emergency Room on 17Mar2021, where a bladder catheter was placed, followed by home discharge. On 18Mar2021, hematemesis reported, next loss of consciousness, patient in a drowsy state, dyspnoic with hematomas in the posterior region of the thorax, urgently transported to a hospital, where he died, during hospitalization. Autopsy check requested and performed. White Blood cells: 11.4; Neutrophils: 7.67; platelets: 255; Haemoglobin: 13.5; Testosterone 0.03; Glucose level 120; Urea: 34; Creatinine: 1.27; Aspartate aminotransferase/Alanine aminotransferase 22/9; Calcium 10.5; Sodium 136; Bilirubin total: 0.31, direct: 0.16; indirect: 0.15; testosterone minor 0.03; PSA 4.567.0; Numerous images of focal pathological hyperfixation to be referred to secondary level at the level of the whole spine, shoulder blades, sternum, costal arches, pelvis and femurs. Reporter''s comment: Prostate cancer. Sender''s comment: Local Center of Pharmacovigilance 06Aug2021 Suspected Comirnaty vaccine. Adverse reaction after about 4 days. Booster dose number 1. 06Aug2021 updated clinical history and adverse reaction fields.; Reporter''s Comments: Prostate cancer.; Reported Cause(s) of Death: Haematoma; Haematoma; dyspnea; Abdominal distension; Sopor; Cardiac arrest; Autopsy-determined Cause(s) of Death: Cardiac arrest


VAERS ID: 1586121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Erythema, Pain in extremity, Peripheral swelling, Urinary tract obstruction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Retroperitoneal fibrosis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 88
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: Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:severe renal blockage
CDC Split Type: ITPFIZER INC202101032064

Write-up: severe twinges in the legs; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; Shortness of breath; renal blockage; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority report number is IT-MINISAL02-768544. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly in arm left (left shoulder) on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included cardiopathic. The patient''s concomitant medications were not reported. The patient experienced severe twinges in the legs, so much so that she could not sleep at night and then became profusely swollen and red, and shortness of breath on 20Mar2021. The patient was hospitalized from 10Jun2021 where she was treated with high dose of diuretic furosemide (LASIX) to try to reduce fluids and deflate her legs. Given the ineffectiveness of the therapy, a CT scan was performed, which found a severe renal blockage. The liquids had reached the lungs largely so that the patient had difficulty breathing and she was given oxygen. She was not even able to take breath to speak although she was unfortunately fully aware of what inevitable fate she would meet. The dosages of furosemide were further increased to try to unblock the situation but with no result. Finally, dialysis was attempted, but the same evening death occurred on 16Jun2021. Impact on quality of life (10/10). The patient died on 16Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: renal blockage; severe twinges in the legs; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; severe twinges in the legs, so much so that she could not sleep at night and they became p


VAERS ID: 1586129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Neck pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 3
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: ITJNJFOC20210831959

Write-up: 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, IT-MINISAL02-769620] concerned an 87 year old female patient of unspecified race and ethnic origin. The patient''s weight was 45 kilograms and height was 148 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 13-JUL-2021 for covid-19. No concomitant medications were reported. In the morning on 17-JUL-2021, the patient experienced little appetite, fever 37.2, pain in arm, shoulders and behind the neck. On the same date at 19:00, she visited emergency room. On 20-JUL-2021 at 06:00, she died from an unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 37.2, pains: arm, shoulders, behind the neck and little appetite was fatal. This report was serious (Death).; Reporter''s Comments: Ipertensione arteriosa controllata dalla terapia Nebivololo 28 unita 5 mg - uso orale 032210015 LOBIVON 28 CPR 5 MG -; Sender''s Comments: V0: 20210831959-covid-19 vaccine ad26.cov2.s -13/07/21 JANSSEN. 17/07/21 morning: fever 37,2. Pains: arm, shoulders, behind the neck. Little appetite. 7 pm Emergency room. Transferred. 20/07 at 6 death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1586201 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-05-12
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004272 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: ATMODERNATX, INC.MOD20212

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: 39245) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. G26761A and 30004272) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was SARS-CoV-2 infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Sender''s Comments: Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1586225 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Basilar artery thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: DEMODERNATX, INC.MOD20212

Write-up: Gestorben 10 Stunden nach der Impfung basilaris Thrombose; This case was received via Regulatory Authority Agency (Reference number: 202100153191) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) in a 90-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Basilar artery thrombosis. It is unknown if an autopsy was performed. Concomitant medications were not reported . Treatment information was not provided. Company comment This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender''s Comments: This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Basilar artery thrombosis


VAERS ID: 1586233 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Insulin-requiring type 2 diabetes mellitus
Preexisting Conditions: Comments: Insulin-dependent diabetes HTA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210832911

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-LL20215345] concerned an 85 year old female. The patient''s weight was 56 kilograms, and height was 155 centimeters. The patient''s concurrent conditions included: insulin-requiring type 2 diabetes mellitus, and hypertension arterial, and other pre-existing medical conditions included: Insulin-dependent diabetes HTA. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 31-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced death and the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210832911- covid-19 vaccine ad26.cov2.s - death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1586399 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bed rest, Cerebral haemorrhage, Dizziness, Haemorrhage, Hypoaesthesia, Nausea, Paralysis, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 31
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: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE, CEREBRAL HAEMORRHAGE and PARALYSIS in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214001) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIZZINESS, BED REST, NAUSEA and PYREXIA. On 30-Jun-2021, the patient experienced HYPOAESTHESIA. On 01-Jul-2021 at 4:00 AM, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant). On 02-Jul-2021, the patient experienced HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant) and PARALYSIS (seriousness criteria hospitalization and medically significant). The patient died on 02-Jul-2021. It is unknown if an autopsy was performed. At the time of death, PARALYSIS, DIZZINESS, HYPOAESTHESIA, BED REST, NAUSEA and PYREXIA had not resolved. No concomitant medication was received by the patient. No treatment information was received by the patient. This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. This case was linked to AT-BASGAGES-2021-40229 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received on 16-AUG-2021: Start date of first dose and batch number for dose 2 was updated.; Sender''s Comments: This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. AT-BASGAGES-2021-40229:


VAERS ID: 1588664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Hemiplegia, Pneumonia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immobile
Preexisting Conditions: Medical History/Concurrent Conditions: Urinary tract inflammation (antibiotics therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101046085

Write-up: Sudden death; Paralyzed of the left side of the body; Stroke; Pneumonia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority. An 89-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 01Jul2021 (30 sec) (Batch/lot number and expiration date unknown) as second dose, single for COVID-19 immunization. Medical history included urinary tract inflammation from Jun2021 (not ongoing), ongoing immobile. She was fine until the vaccination with the 2nd dose of Comirnaty, but she was immobile. She administered antibiotics for urinary tract infection. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021 (Batch/lot number and expiration date unknown) as first dose, single for COVID-19 immunization with no event. The patient became paralysed on the left part of the body - she fell to the left while getting dressed after the vaccination with COMIRNATY. She was transported to neurology - a stroke and pneumonia were found. She was transferred to the following care on the 26Jul2021, where pneumonia was again detected (cured according to the hospital, not cured according to the following care). She died on the 30Jul2021. The outcome of paralysis one side of body was not resolved, of events stroke and pneumonia was unknown. On the 06Aug2021: Agency contacted the home for the elderly, so far without new information. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiovascular disorder, General physical health deterioration
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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: METOPROLOL
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038936

Write-up: Acute myocardial infarction with subtotal occlusion of the Left anterior descending artery; Deterioration in general condition in the last 1-2 weeks in terms of circulatory problems.; Deterioration in general condition in the last 1-2 weeks in terms of circulatory problems.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority DE-PEI-202100161650. A 61-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunisation on 25Jun2021 (61-year-old at vaccination). Relevant history included arterial hypertension. Relevant concomitant drug included metoprolol. The patient experienced general physical condition decreased in Jul2021. In the last 1-2 weeks the patient''s general condition was worsening in the sense of "circulatory problems". On 22Jul2021 the patient experienced acute myocardial infarction. The patient died due to Acute myocardial infarction on 22Jul2021. Autopsy was done. The outcome of event General physical condition decreased was unknown. Cause of death: acute myocardial infarction with subtotal occlusion of the Left anterior descending artery; no meaningful correlation between vaccination and onset of death. Reactions / Events Assessed by regulatory authority, Result of Assessment "D. Unclassifiable". No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1588697 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Light headedness
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:myocardial infarction
CDC Split Type: DEPFIZER INC202101038977

Write-up: Subacute myocardial infarction of the SW in severe 3-vessel coronary artery disease; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is [DE-PEI-202100161660]. A 61 years old female patient received 1st dose of bnt162b2 (COMIRNATY) on 23Jul2021 single dose for COVID-19 immunisation at age of 61 years old. The patient''s medical history and concurrent conditions included: Arterial hypertension, Light headedness from Jul2021. Concomitant drugs were not provided. On 24Jul2021 the patient experienced Infarct myocardial. The patient died on 24Jul2021. The patient had subacute myocardial infarction of the SW in severe 3-vessel coronary heart disease; no meaningful connection between vaccination and onset of death. Autopsy was done and revealed myocardial infarction. Event outcome was fatal. This report was serious - death. The causality assessment for suspect drug to event was reported as follows: unclassifiable by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1588698 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Myocardial infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung inflammation (pneumonia); Swallowing impaired (swallowing disorder)
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: without pathological findings; Test Date: 20210117; Test Name: body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: without pathological findings
CDC Split Type: DEPFIZER INC202101038574

Write-up: Myocardial infarction with occlusion of the circumflex branch, possibly stress-related; Pyrexia/38.7 - 39.2 centigrade; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100161682. An 89-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at age of 89 years old (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included lung inflammation (pneumonia) and swallowing impaired (swallowing disorder), both from unknown date and unknown if it was ongoing. The patient''s concomitant medications were not reported. On 19Jan2021 the patient experienced Infarct myocardial. On 17Jan2021 the patient experienced pyrexia. The patient underwent lab tests and procedures which included body temperature: 38.7 - 39.2 centigrade on 17Jan2021 without pathological findings. Patient was died on 19Jan2021.An autopsy was performed that revealed cause of death: Myocardial infarction with occlusion of the circumflex branch, possibly stress-related. The outcome of Infarct myocardial was fatal and the outcome of pyrexia was unknown.The causality assessment from regulatory authority was D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1588699 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045257

Write-up: Sudden cardiac death; This is a spontaneous report downloaded from the Regulatory Authority-WEB WWID reported as Regulatory Authority Number DE-PEI-202100161882 from the Healthcare Authority. A 56 years old male patient received bnt162b2 (COMIRNATY, lot FE6975) on 20Jul2021 single dose for COVID-19 immunisation at the age of 55 years old. Medical history and concomitant drugs were not provided. The patient experienced Sudden cardiac death on unknown date. Outcome of the event was fatal. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1588700 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypercholesterolaemia; Hypertension; Type 1 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101046062

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100162527, from the Healthcare Authority. A 58-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot Number: FE8405) as dose 2, single at the age of 58-years-old for covid-19 immunization. Medical history included ongoing type 1 diabetes mellitus, ongoing hypertension, ongoing hypercholesterolaemia. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 24Jun2021 for covid-19 immunisation. The patient experienced unknown cause of death on 2021. It was not reported if an autopsy was performed. Reaction(s) / Event(s) Assessed by Regulatory Authority, Result of Assessment: Unclassifiable. No follow-up attempts possible. No further information expected. Information about batch number has been obtained; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588701 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiomyopathy (Grade 3); Liver fatty (Grade 3); Obesity (Grade 3); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045431

Write-up: Unknown cause of death; The 1. vaccination : Vaxzevria/ The patient was treated with Comirnaty; The 1. vaccination : Vaxzevria/ The patient was treated with Comirnaty; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB WWID reported as Regulatory Authority Number DE-PEI-202100162535 from the Healthcare Authority. A 60-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), dose 2, initial Pfizer dose via an unspecified route of administration on 27Jul2021 (lot Number: FE8405) (at the vaccination age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included Ongoing obesity (Grade 3), Type 2 diabetes mellitus, Cardiomyopathy (Grade 3), Liver fatty (Grade 3); Deep vein thrombosis (unknown the start date and unknown if ongoing). Historical vaccine included first dose of Vaxzevria on 04May2021 for Covid-19 immunisation (dose 1, single). The patient''s concomitant medications were not reported. As reported, the patient''s weight was 135 kg, and height was 189 cm. On 01Aug2021 the patient experienced unknown cause of death. Patient has been found dead in his home by the nursing service. The outcome of the event was fatal. It is unknown if autopsy was done. The causality of suspect product BNT162b2 and event unknown cause of death per Regulatory Authority, was reported as "D. Unclassifiable". No follow-up attempts are possible. No further information is expected. OR No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: Medical History/Concurrent Conditions: Arterial hypertension; Type II diabetes mellitus; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210835510

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report was received from a health care professional via the Regulatory Authority, case reference number DE-PEI-202100165005, and concerned a 52 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration, batch number and expiry date not reported), dose and vaccination date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-AUG-2021, the patient experienced thrombosis of venous sinuses and died the same day. The cause of death was reported as unknown. It was unknown if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.CoV2.S was reported as not applicable. This report was serious (death).; Sender''s Comments: V0:This spontaneous report was received from a health care professional, case reference number DE-PEI-202100165005, and concerns a 52 year-old male patient with unknown past medical history and concomitant medications experienced thrombosis of venous sinuses and died the same day at unspecified time post vaccination. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. No other pertinent details reported. Information is limited in this case, and the occurrence of thrombosis of venous sinuses could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1588844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-25
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Death, Pain, Psoriasis, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (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: 2021-05-03
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic pain; Diabetes; Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038899

Write-up: Unknown cause of death; Psoriasis on both elbows outside. Excruciating pain all over the body. Painkillers with no effect/ Arthralgia; Psoriasis on both elbows outside. Excruciating pain all over the body. Painkillers with no effect/ Rash; Psoriasis on both elbows outside; Excruciating pain all over the body; This is a spontaneous report from a non-contactable consumer received from regulatory authority downloaded from the Regulatory Authority. Regulatory authority report number is DE-PEI-CADR2021153367; Safety Report Unique Identifier is DE-PEI-202100154861. A 60-year-old male patient (weight: 120kg, height: 186cm) received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, strength: 0.3ml, Batch/Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included ongoing chronic pain, ongoing lung cancer, ongoing diabetes. There were no known allergies. The patient''s concomitant medications were not reported. The patient experienced "psoriasis on both elbows outside. excruciating pain all over the body. painkillers with no effect/ rash" on 25Apr2021, "psoriasis on both elbows outside. excruciating pain all over the body. painkillers with no effect/ arthralgia" on 25Apr2021, "unknown cause of death" on 03May2021. Case narrative: This report is serious - death. On 25Apr2021 the patient experienced rash and arthralgia. On 03May2021 the patient experienced unknown cause of death. Therapeutic measures were taken as a result of the events other than "unknown cause of death" and included painkillers. The outcome of "unknown cause of death" was fatal; outcome of other events was unknown. The patient died on 03May2021. No autopsy was performed. The cause of death was unknown. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-04-01
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: DEPFIZER INC202101038875

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority DE-PEI-CADR2021155583, Safety Report Unique Identifier DE-PEI-202100157851. A 83-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jan2021 as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cerebral haemorrhage in Apr2021. The patient died in Apr2021. It was not reported if an autopsy was performed. The outcome of event was fatal. Source of assessment Regulatory Authority Result of Assessment D. Unclassifiable No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1588850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038862

Write-up: Acute massive pulmonary embolism, pulmonary artery embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021156388. Safety Report Unique Identifier DE-PEI-202100158533. An 88-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 20May2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Information on risk factors or previous illnesses: None. The patient was very mobile. No medication or previous illness. Concomitant medications were not reported. The patient experienced acute massive pulmonary embolism, pulmonary artery embolism. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Acute massive pulmonary embolism, pulmonary artery embolism


VAERS ID: 1588851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cerebrovascular accident, Facial paralysis
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Photosensitivity reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038889

Write-up: Accident cerebrovascular; failure symptoms and paralysis of the Half of the face; failure symptoms and paralysis of the Half of the face; This is a spontaneous report from non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021156690, Safety Report Unique Identifier DE-PEI-202100158847. A 54-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), dose 2 via an unspecified route of administration on 12Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Sun allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jul2021 the patient experienced Accident cerebrovascular. Also reported failure symptoms and paralysis of the Half of the face. Ambulance Hospital. The patient died for Accident cerebrovascular on 13Jul2021, outcome of other events was unknown. It was unknown if an autopsy was performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Sun allergy / failure symptoms and paralysis of the Half of the face. Ambulance Hospital. Source of assessment regulatory authority. Result of. Assessment D. Unclassifiable. Dosage text: 2. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1588852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Multiple organ dysfunction syndrome, Myocardial infarction, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), 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), Embolic and thrombotic events, arterial (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: 2021-06-27
   Days after onset: 26
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: Ventricular fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: high fever; Result Unstructured Data: Test Result:39.5 Centigrade
CDC Split Type: DEPFIZER INC202101038992

Write-up: Multiple organ failure; Infarct myocardial/heart attack; sudden high fever (39.5); blood poisoning; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority DE-PEI-CADR2021157015, Safety Report Unique Identifier DE-PEI-202100159940. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: ER9480, strength: 0.3 ml) (mRNA tozinameran) on 18May2021 at single dose for COVID-19 immunisation. Medical history included ongoing ventricular fibrillation. The patient had no known allergies. The patient''s concomitant medications were not reported. On 18Jun2021, the patient experienced sudden high fever (39.5), infarct myocardial/heart attack. The patient also experienced blood poisoning and placed in an artificial coma within 3 days and the patient died 6 days later. On 27Jun2021, the patient experienced multiple organ failure. This report was serious - hospitalization. The patient underwent lab tests and procedures which included high fever: 39.5 centigrade on 18Jun2021. The patient died on 27Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to the events was assessed as D. Unclassifiable by Regulatory Authority. The outcome of event multiple organ failure was fatal. The outcome of events fever and infarct myocardial was not recovered. The outcome of event blood poisoning was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1588853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Chronic left ventricular failure; Hypertensive heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038882

Write-up: My patient died of sudden cardiac death 5 days after receiving a Pfizer vaccine.; general condition worsening with dyspnoea the day after vaccination, then progressing; general condition worsening with dyspnoea the day after vaccination, then progressing; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021157145. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100160016. A 71-years-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), via an unspecified route of administration on 29Jul2021 (Lot Number: FE8405) as SINGLE for covid-19 immunisation. Medical history included ongoing hypertensive heart disease, ongoing atrial fibrillation, ongoing chronic left ventricular failure, covid-19 from Oct2020 to Oct2020, cardiac failure on the basis of hypertensive heart disease. No known allergies. The patient''s concomitant medications were not reported. The patient died of sudden cardiac death 5 days after receiving a pfizer vaccinemon an 03Aug2021, general condition worsening with dyspnoea the day after vaccination, then progressing on 30Jul2021. The patient died on 03Aug2021. It was not reported if an autopsy was performed. General condition worsening with dyspnoea the day after vaccination, then progressing. no doctor consulted. The patient experienced also Sudden cardiac death. Relatedness of drug to reaction/event assessed by Regulatory Authority, Result of Assessment: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1588854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Mucormycosis, Septic shock, Swelling of eyelid, Visual impairment, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (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: Coronary heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045499

Write-up: Vomiting; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Septic shock; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021157327, Safety Report Unique Identifier DE-PEI-202100159987. A 66-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing coronary artery disease. The patient''s concomitant medications were not reported. The patient experienced Septic shock on 31Jul2021 with outcome as fatal, vomiting (hospitalization), eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor on an unspecified date with outcome of not recovered. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course as reported: On 31Jul2021 the patient experienced Septic shock. The patient experienced also Vomiting, Mucormycosis, Visual disturbance. Sender''s comment: expression of a full picture of a mucor with development of necrosis in the area of the nose, both eyes and forehead; antifungal therapy with isovuconazole and later liposomal amphotericin B; no surgical removal possible, patient dies in septic shock. Assessment: Comirnaty/ Visual disturbance / RA: D. Unclassifiable. Assessment: Comirnaty/ Vomiting / RA: D. Unclassifiable. Assessment: Comirnaty/ Mucormycosis / RA: D. Unclassifiable. Assessment: Comirnaty/ Septic shock / RA: D. Unclassifiable. Comirnaty''s Dosage text: "1". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Septic shock


VAERS ID: 1588855 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dizziness, Dyspnoea, Nausea, Tachycardia, Vaccination site haemorrhage, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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: Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038956

Write-up: Unknown cause of death; Tachycardia; nausea; could hardly breathe; pain in the chest area; Bleeding at the injection site; Bleeding at the injection site, pain; severe dizziness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021158100, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100160608. A 52-year-old female patient received BNT162B2 (COMIRNATY) at 52-year-old, via an unspecified route of administration on 02Jul2021 at single dose for COVID-19 immunisation. Medical history included hay fever. The patient''s concomitant medications were not reported. On 02Jul2021, the patient experienced light headedness, tachycardia, thorax pain, nausea, dyspnea, vaccination site pain, vaccination site hemorrhage, and unknown cause of death. Heavy bleeding after vaccination, doctor was surprised himself, dizziness shortly afterwards. Bleeding at the puncture site, pain, racing heart; before the ambulance came she was dead in the hallway. Patient experienced severe dizziness; pain in the chest area, nausea, could hardly breathe, this came the evening after the 2 vaccinations. This report was serious - hospitalization. Outcome of events was not resolved. The patient died on 02Jul2021. It was not reported if an autopsy was performed. Reactions / Events Assessed by RA, Result of Assessment: "D. Unclassifiable". No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Bacterial test, Confusional state, Cough, Depressed level of consciousness, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 11
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: Aortic valve replacement; Artificial cardiac pacemaker user; Depressed mood (Has recently expressed a lack of desire to live); Diabetes mellitus; Reduced general condition (Over the last 2-3 years loss of function, not able to have visitors or cook dinner)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Bacterial culture; Result Unstructured Data: Test Result:4 bacteria found
CDC Split Type: DKPFIZER INC202100996509

Write-up: Confused; Fever; Consciousness decreased; Bacterial infection; Cough; Difficulty breathing; This is a spontaneous report from a contactable consumer and from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0072640. An 87-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jan2021 (Lot Number: EJ6134) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing depressed mood (has recently expressed a lack of desire to live), ongoing aortic valve replacement, ongoing artificial cardiac pacemaker, and ongoing reduced general condition (over the last 2-3 years loss of function, not able to have visitors or cook dinner). The patient''s concomitant medications were not reported. There is no information regarding past medications. On 30Jan2021, 2 days after, the patient developed cough and difficulty breathing. On 06Feb2021, 9 days after, the patient was confused, developed fever, and consciousness decreased. On an unknown date in Feb2021, the patient developed bacterial infection. Bacterial culture on 06Feb2021 showed 4 bacteria found. The ADRs were by the relative reported as resulting in hospitalisation on 06Feb2021 and being fatal on 10Feb2021. No autopsy was performed. The patient was initial treated for a bacterial infection (not specified), but after cultivation of resistance, the treatment was changed to palliative treatment (not specified) by request from the patient. The patient was informed that it could be fatal to oppose the necessary treatment. Causality: The patient''s general practitioner stated that he believes this was an expected death, and it was not related to the vaccination with Comirnaty. The patient has recently expressed a lack of desire to live. The patient was informed that it could be fatal to oppose the necessary treatment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: difficulty breathing; cough; confused; fever; consciousness decreased; Bacterial infection


VAERS ID: 1588901 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Glycosylated haemoglobin, Investigation
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIX; CARDACE [RAMIPRIL]; ATORVASTATIN; ZOPITIN; TAMSULOSIN; PRADAXA; BETALOC ZOK; METFORMIN
Current Illness: Duodenitis; Gastritis; Hyperlipidemia NOS; Insomnia (non-organic); Non-insulin-dependent diabetes mellitus; Prostatic hyperplasia; Unspecified hypertensive heart disease without congestive heart failure
Preexisting Conditions: Medical History/Concurrent Conditions: Old myocardial infarction (2 infarctions); Prostatic cancer
Allergies:
Diagnostic Lab Data: Test Date: 20201208; Test Name: HbA1c; Test Result: 8.1 %; Test Date: 20201208; Test Name: tests; Result Unstructured Data: Test Result:in order
CDC Split Type: EEPFIZER INC202101054614

Write-up: Asthenia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number EE-SAM-46552107297. A 67-years-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FC8889) via an intramuscular route of administration on 10Jun2021 (at the age of 67 years) as dose 2, 0.3mL single for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus, ongoing duodenitis, ongoing hypertensive heart disease, ongoing insomnia, prostate cancer from an unknown date and unknown if ongoing, ongoing benign prostatic hyperplasia, myocardial infarction from an unknown date and unknown if on-going with description: 2 infarctions, ongoing hyperlipidemia, ongoing gastritis. Concomitant medications taken for an unspecified indication included spironolactone (SPIRIX) taken 50 mg 2 times/week oral, start and stop date were not reported; ramipril (CARDACE (RAMIPRIL)) 5 mg, daily oral, start and stop date were not reported; atorvastatin (ATORVASTATIN) 20 mg, daily oral, start and stop date were not reported; zopiclone (ZOPITIN) 7.5 mg, as needed oral , start and stop date were not reported; tamsulosin (TAMSULOSIN) 0.4 mg, daily oral, start and stop date were not re-ported; dabigatran etexilate mesilate (PRADAXA) 150 mg, daily oral, start and stop date were not reported; metoprolol succinate (BETALOC ZOK) 100 mg, daily oral, start and stop date were not reported; metformin (METFORMIN) 500 mg, 2 times/day oral, start and stop date were not report-ed. Patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/lot number: EW6126) via an intramuscular route of administration on 30Apr2021 as dose 1, 0.3mL single for COVID-19 immunization with no adverse event. On 10Jun2021, the patient experienced asthenia (death and medically significant). The patient underwent lab tests and procedures which included glycosylated hemoglobin: 8.1 percent on 08Dec2020, not specified investigations: in order as a result performed on 08Dec2020. The patient died on 21Jul2021. It was not reported if an autopsy was performed. The clinical outcome of the event fatal on 21Jul2021. Health Authority Comment: Serious, fatal adverse reaction, but sufficient data are lacking for evaluation. The relationship could not be assessed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588986 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Epilepsy; Hysterectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101038587

Write-up: Death unexplained; Inappropriate route of vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20213021. A 67-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intradermal on 10Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. Medical history included hysterectomy, cataract, epilepsy. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 26Feb2021. On 26Feb2021, patient found deceased, sudden death. The patient died on 26Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1588987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-30
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6789 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart valvular prosthesis wearer; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101038579

Write-up: CVA; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-BR20213052. A 97-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Feb2021 (Batch/Lot Number: EJ 6789) as Dose 2, single for covid-19 immunisation. Medical history included hypertension arterial, diabetes, heart valvular prosthesis wearer. The patient''s concomitant medications were not reported. The patient experienced CVA (cerebrovascular accident) on 30Apr2021. The event was serious per life threatening and death. The outcome of the event was fatal. The patient died on 30Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CVA


VAERS ID: 1589007 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-27
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Blood creatine, Blood creatine phosphokinase, Blood potassium, Blood urea, Brain natriuretic peptide, C-reactive protein, CSF cell count, Cardiac index, Chlamydia test, Coma scale, Computerised tomogram, Cytomegalovirus test, Echocardiogram, Electroencephalogram, Electrophoresis, HIV test, Haemoglobin, Lumbar puncture, Magnetic resonance imaging, Oxygen saturation, Polymerase chain reaction, Prothrombin level, Varicella virus test
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; ESOMEPRAZOLE; ALPRAZOLAM; GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]; PAROXETINE [PAROXETINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Depression; Fibromyalgia; Fracture of vertebra; GERD; Hypertension arterial; Hysterectomy; Renal impairment; Spinal operation
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: creat; Result Unstructured Data: Test Result:531; Test Date: 20210627; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:18000; Test Date: 20210627; Test Name: iono k; Result Unstructured Data: Test Result:5.1; Test Date: 20210627; Test Name: urea; Result Unstructured Data: Test Result:26; Test Date: 20210627; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:56000; Test Date: 20210627; Test Name: index cardiac; Result Unstructured Data: Test Result:49; Test Name: chlamydial serology; Test Result: Positive ; Comments: positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma neg; Test Date: 20210709; Test Name: glasgow scale; Result Unstructured Data: Test Result:5 at best; Test Date: 20210719; Test Name: glasgow scale; Result Unstructured Data: Test Result:E2M1V4 at best with eye wandering, reactive interm; Comments: E2M1V4 at best with eye wandering, reactive intermediate pupils.; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:Excavated pneumonia and polyviceral failure; Test Date: 20210627; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:possibly anoxic encephalopathy; Comments: found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia.; Test Date: 20210627; Test Name: crp; Result Unstructured Data: Test Result:332; Test Date: 20210709; Test Name: cerebrospinal fluid; Result Unstructured Data: Test Result:25 cells, 92% lympho, prot 0.44g / l no hypoglycor; Comments: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture neg,; Test Name: PCR CMV; Result Unstructured Data: Test Result:positive blood; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:formamen ovale permeable but no vegetation.; Test Date: 20210719; Test Name: EEG; Result Unstructured Data: Test Result:reactive with absence of epileptogenic activity.; Test Name: electrophoresis of serum proteins; Result Unstructured Data: Test Result:Globulinemia at 5g / l; Test Date: 20210627; Test Name: Hb; Result Unstructured Data: Test Result:11.9; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210627; Test Name: lumbar puncture; Result Unstructured Data: Test Result:without nucleated element; Comments: without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. no elements, prot at 0.42g / l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg,; Test Date: 20210709; Test Name: lumbar puncture; Result Unstructured Data: Test Result:brings back some elements in favor of an Inflammat; Comments: brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture.; Test Date: 20210628; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:large ischemic areas of the white matter on the up; Comments: large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type; Test Date: 20210719; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:decrease in edema and the pseudo-tumoral appearanc; Comments: decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other?; Test Date: 20210627; Test Name: oxygen saturation; Test Result: 60 %; Test Name: multiplex PCR; Test Result: Negative ; Comments: (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus); Test Date: 20210627; Test Name: prothrombin; Test Result: 61 %; Test Name: VZV; Test Result: Negative
CDC Split Type: FRPFIZER INC202101038943

Write-up: necrotico-hemorrhagic acute disseminated encephalomyelitis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LY20218843. A 64-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 09Jun2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, HTA (hypertension arterial), moderate renal impairment (creatinine 95umol/L), depressive syndrome, GERD with treated H Pylori, dorsal vertebrae fracture operated on L5-S1 in 2010, cholecystectomy and hysterectomy. Concomitant medications included paracetamol (DOLIPRANE), esomeprazole, alprazolam, calcium carbonate, sodium alginate (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]), paroxetine hydrochloride (PAROXETINE [PAROXETINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported. The patient experienced necrotico-hemorrhagic acute disseminated encephalomyelitis (ADEM) on 27Jun2021. Clinical course was reported as On 27Jun2021: patient was found unconscious in her bed with 60% saturation, vomiting and stools; coma of indefinite duration and undetermined etiology. Computed tomography thorax-abdomen-pelvis scans found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia. A lumbar puncture returns without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. Biology: Gds PH7 with PCO2 60mmHg, Hb: 11.9, prothrombin: 61%; iono k: 5.1, creatine: 531 and urea: 26. Major hepatic cytolysis, creatine phosphokinase 18000; Brain natriuretic peptide: 56,000, high index cardiaque: 49, CRP: 332. The patient also presented with multi-visceral failure after prolonged stationary ground secondary to impaired consciousness. (Following hospitalization, organ failures (hemodynamic, renal, respiratory and hepatic) have completely regressed and can be part of a table of significant dehydration + rhabdomyolysis linked to the ground station). Additional tests: Cerebral MRI (28Jun2021): large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type. Brain MRI (19Jul2021): decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other? Differential diagnosis: no detection of carbon oxide (CO) at the sensor, no gas heating, little argument for CO poisoning during treatment. In addition, on GDS entry on 27Jun2021 at 11 a.m., HbCO is dosed at 0.8. Negative toxic balance. Patient with intense relational life, no dark thoughts. Trans-thoracic echocardiography: formamen ovale permeable but no vegetation. Computed tomography thorax-abdomen-pelvis: Excavated pneumonia and polyviceral failure. Initial lumbar punction 27Jun2021: no elements, prot at 0.42g/l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg, PCR HSV VZV neg LBA and hemoc pos in strepto anginosus. HIV negative serology, electrophoresis of serum proteins hypogammaGlobulinemia at 5g/l, positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma negative, cerebrospinal fluid on 09Jul2021: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture negative, PCR Whipple negative, negative multiplex PCR (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus), PCR CMV positive blood. EVOLUTION: 09Jul2021: No neurological improvement, patient glasgow 5 at best. She remained non-stimulable despite stopping the sedations on 06/30. The 2nd lumbar puncture today brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture. 16Jul2021: Neuro opinion: The clinical picture is very suggestive of a necrotico-hemorrhagic type ADEM (form of HURST) whose prognosis is poor. It is an acute inflammatory disease with microvascular vasculitis. The etiology may be postinfectious or post vaccination. Corticosteroid therapy 1g / d in the event of an ADEM. 19Jul2021: patient glasgow E2M1V4 at best with eye wandering, reactive intermediate pupils. EEG appears to be reactive with absence of epileptogenic activity. Decrease in corticosteroid therapy to 2 mg/kg/day. 21Jul2021: Neurological opinion: extremely unfavorable neurological and functional prognosis without the prospect of recovery despite treatment, extensive necrosis lesions formed on MRI. In agreement with a discontinuation of active therapies. 23Jul2021: death of the patient. In total, a necrotico-hemorrhagic ADEM table whose etiology may be post-infectious or post-vaccination on D18 of D1 of the BNT162B2 vaccine. The patient died on 23Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected. ; Reported Cause(s) of Death: necrotico-hemorrhagic acute disseminated encephalomyelitis


VAERS ID: 1589015 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiovascular evaluation, Death, Electrocardiogram, Headache, Hypoaesthesia, Neurological examination, Ultrasound Doppler
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DARATUMUMAB; IBRUTINIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphoid leukaemia; Hypertension arterial (in partial remission)
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/95 mmHg; Comments: HTA 160/95 which justifies the initiation of treatment with BI TILDIEM LP 120, given a rather high heart rate and control of blood pressure are prescribed; Test Date: 20210505; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/90 mmHg; Test Date: 20210507; Test Name: hypertension; Result Unstructured Data: Test Result:hypertension was moderate at 16/9; Test Date: 20210504; Test Name: The cardiovascular assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210504; Test Name: ECG; Result Unstructured Data: Test Result:returns to a sinus rhythm of 95 / min; Comments: the transthoracic cardiac ultrasound is normal.; Test Date: 20210504; Test Name: Neurological exam; Result Unstructured Data: Test Result:normal; Test Date: 20210507; Test Name: Neurological exam; Result Unstructured Data: Test Result:had normalized after the onset of sensory disorder; Comments: had normalized after the onset of sensory disorders of the lower left hemiface, which resolved spontaneously.Bi Tildiem prescribed for hypertension protects rather than induces arrhythmias, making ventricular heart rhythm disturbances with ibrutinib very unlikely. there was no heart rhythm disturbances for that elsewhere.; Test Date: 20210505; Test Name: doppler ultrasound Doppler ultrasound of the supraortic trunks; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101038923

Write-up: a feeling of hypoesthesia of the lower half of the left hemiface; Unknown cause of death/death of the patient, recorded on 22May2021 at his home; headaches; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20213053. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Hypertension arterial (hypertension) and Chronic lymphoid leukaemia (in partial remission). Concomitant medications included daratumumab and ibrutinib, both for Chronic lymphoid leukaemia as part of a clinical trial. The patient previously took first dose of Comirnaty (lot number unknown) on 23Mar2021 for covid-19 immunisation. Patient experienced Unknown cause of death on 22May2021. Reported as history: death of the patient, recorded on 22May2021 at his home. Mentioned headaches during the last telephone contact with the patient around 11May2021. Consultation on 04May2021: The patient reports "a feeling of left "PFP", with a feeling of hypoesthesia of the lower half of the left hemiface. Neurological exam on 04May2021 is normal. The cardiovascular assessment too. The ECG returns to a sinus rhythm of 95/min, the transthoracic cardiac ultrasound is normal. blood pressure measurement is 160/95 mmHg. HTA 160/95 which justifies the initiation of treatment with BI TILDIEM LP 120, given a rather high heart rate and control of blood pressure are prescribed. On 05May2021, he saw his cardiologist, who performed a Doppler ultrasound of the supraortic trunks which was found to be normal. blood pressure measurement is 160/90 mmHg. The cardiologist confirmed on 07May2021 that the neurological examination had normalized after the onset of sensory disorders of the lower left hemiface, which resolved spontaneously. Bi Tildiem prescribed for hypertension protects rather than induces arrhythmias, making ventricular heart rhythm disturbances with ibrutinib very unlikely. there was no heart rhythm disturbances for that elsewhere. hypertension was moderate at 16/9. Patient also treated for chronic lymphoid leukemia in partial remission with ibrutinib and daratumumab in a therapeutic trial. The death was reported as part of the study as unrelated to the study drugs. The patient died on 22May2021. An autopsy was not performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death/death of the patient, recorded on 22May2021 at his home


VAERS ID: 1589021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Asthenia, Coordination abnormal, Fatigue
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL; FLECAINE; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Balance disorder; Cardiac arrhythmia (treated with medication); Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101045378

Write-up: acute lung oedema; Great fatigue; could not stand on his legs; intense asthenia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20213389. A 90-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on 24May2021 (lot number FC3558) in the left arm as single dose for COVID-19 immunization. Medical history included Cardiac arrhythmia treated with medication, Balance disorders, Osteoarthritis. Concomitant medications included atenolol, flecainide acetate (FLECAINE), paracetamol (DOLIPRANE). The patient experienced great fatigue in the following week on 31May2021, could not stand on his legs...until death a week later. Pulmonary oedema leading to death at home. The patient''s daughter reported that the patient had presented with an altered general condition in the week following the vaccination with intense asthenia on 31May2021. The patient was found deceased by the housekeeper on 31May2021 with a messy home. The doctor who pronounced the patient dead on 31May2021 did not make a diagnosis, and the death probably occurred on 30May2021. The patient''s daughter thought that her father died of acute lung oedema because she perceived, thanks to her magnetism, that her father had a lung problem. There was no medical confirmation of this hypothesis. The nursing team visiting the home had not noticed any new symptoms since the vaccination. A slowdown had been observed for a while, probably dating from before the vaccination. Outcome: fatal, death on 31May2021. Conclusion: Unexplained death one week after vaccination of a 90 year old patient. It was unknown if autopsy was done. The outcome of event acute lung oedema was fatal, outcome of other events were unknown.; Reported Cause(s) of Death: acute lung oedema


VAERS ID: 1589039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain, Pain in extremity, Pulmonary embolism, Ultrasound Doppler
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 11
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: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: echodoppler; Result Unstructured Data: Test Result:without abnormalities
CDC Split Type: FRPFIZER INC202101045346

Write-up: Embolism pulmonary; Cardio-respiratory arrest; sudden chest pain; Pain of lower extremities; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215300. This is a 44-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FF0688) at single dose intramuscular on 19Jul2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. No pathological history mentioned (no cardiovascular or other history). Patient was not an alcohol or tobacco user. Patient presented on 25Jul2021 with pain in the left lower limb, an echodoppler done without abnormalities. 05Aug2021 at 10pm, patient experienced onset of sudden chest pain followed by unrecovered cardiopulmonary arrest after cardiopulmonary resuscitation complicated by death. According to emergency doctor, suspected death from pulmonary embolism (not confirmed by biology or imaging). Outcome of Embolism pulmonary and Cardio-respiratory arrest was fatal. Outcome of pain in the left lower limb was not resolved. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Embolism pulmonary; sudden chest pain


VAERS ID: 1589040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Heart rate, Pyrexia, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; End stage COPD (after smoking); Exeresis; Fibrosis lung; Hypertension pulmonary; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: pulse; Result Unstructured Data: Test Result:quick, fast, regular; Test Date: 20210804; Test Name: fever; Result Unstructured Data: Test Result:37; Test Date: 20210804; Test Name: fever; Result Unstructured Data: Test Result:37.8; Test Date: 20210804; Test Name: respiratory rate; Result Unstructured Data: Test Result:20; Test Date: 20210804; Test Name: respiratory rate; Result Unstructured Data: Test Result:32
CDC Split Type: FRPFIZER INC202101045341

Write-up: Aggravation of existing disorder; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20215307. An 81-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number unknown) Intramuscular at single dose for COVID-19 immunisation on 04Aug2021. Relevant history included end stage COPD after smoking, ischemic heart disease, Multifactorial terminal respiratory failure (under O2 at home between 4 and 6l minutes), hypertension pulmonary, and fibrosis lung since May 2021, and post-lobectomy restriction. Relevant concomitant drug included paracetamol (DOLIPRANE) for pain. On 04Aug2021, in the morning, the patient was less well, more asthenic, more sleepy, but conscious, communicating, no sign of distress respiratory, respiratory rate 20. No sign of concern. The 2nd dose of Pfizer vaccine done at 11:45 am on 04Aug2021. Patient already on doliprane systematically for pain. No effect immediately after the vaccine. At 4.30 p.m, the patient had deterioration of his general condition. Afebrile 37. Cyanotic, gray complexion. Cool hands, no sweat, no marbling. Conscious and communicating patient. No signs of respiratory distress. Reassessed at 7 p.m. Patient always conscious. T = 37.8. Signs of shock. Pulse quick, fast, regular. Mottling+++. respiratory rate 32 without sign of distress, without indrawing. A few moans and sweats at the start of the night. Lightweight. Quiet night afterwards, patient not conscious. Death noted at 8:15 am on 05Aug2021. It is unknown if autopsy was done. No follow-up attempts are possible; no further information expected, information about lot/batch number cannot be obtained ; Reported Cause(s) of Death: Aggravation of existing disorder


VAERS ID: 1589101 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-07-26
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dilated cardiomyopathy (Rhythmic valvular cardiomyopathy); Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101038919

Write-up: COVID-19; cardiac decompensation; respiratory distress; vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RS20212588. An 81-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscularly, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ET3620) and second single dose intramuscularly, administered in Arm Left on 15Apr2021 (Batch/Lot Number: EW2246) for covid-19 immunisation. Medical history included Parkinson''s disease, dilated cardiomyopathy (Rhythmic valvular cardiomyopathy), and chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. About 3 months later, PCR positive on 26Jul2021. The next day 27Jul2021: the patient presented with cardiac decompensation as well as respiratory distress leading to death on 31Jul2021. Search for the variant: L452R mutation. Vaccine failure confirmed around 3 months after the D2 of the Comirnaty vaccine in an 81-year-old patient which led to his death. It was not reported if an autopsy was performed. Additional, investigational results reported from Product Complaint Team included: Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5882945 (see File attachment in this investigation record). The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW2246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5824348 (see File attachment in this investigation record). The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET3620. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Vaccination failure; covid-19; respiratory distress; cardiac decompensation


VAERS ID: 1589102 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-15
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation (Permanent AF under xarelto (stopped / repeated falls)); Cardiac valve disease (with preserved ejection fraction)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: L452R mutation
CDC Split Type: FRPFIZER INC202101038911

Write-up: acute respiratory distress; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RS20212589. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on 04Feb2021 (lot number: EK9788) Intramuscularly administered in arm right at single dose; the second dose of bnt162b2 (COMIRNATY) on 25Feb2021 (lot number: EM6950) Intramuscularly administered in arm left at single dose for COVID-19 immunisation. Medical Histories included Arterial hypertension, valvular heart disease with preserved ejection fraction, permanent Atrial Fibrillation under Xarelto (stopped / repeated falls). Concomitant medications were not reported. Covid history was not known. About 5 months later, SARS-CoV-2 PCR test was positive (Search for the variant was L452R mutation) on 15Jul2021. The next day, 16Jul2021, the patient presented with acute respiratory distress leading to death on 20Jul2021. Vaccine failure confirmed around 5 months after the D2 of the Comirnaty vaccine in a 91-year-old patient who resulted in her death. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; acute respiratory distress


VAERS ID: 1589610 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040500

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108111509374350-4VC9J, Safety Report Unique Identifier is GB-MHRA-ADR 25785192. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jun2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included clinical trial participant. Patient had not had symptoms associated with COVID-19. Concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number and expiry date not known), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced death on 08Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Case narrative: Death. Patient had not tested positive for COVID-19 since having the vaccine. Clinical trial participant No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1589611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101040978

Write-up: Heart failure (medical history of cardiac failure); This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108111615184330-3YGFF , Safety Report Unique Identifier GB-MHRA-ADR 25785352. A 91-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac failure. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication(s) included bisoprolol (BISOPROLOL) taken for an unspecified indication from 1993 to an unspecified stop date. The patient experienced heart failure (cardiac failure) (death) led to death 6 weeks later on 14Jan2021. The patient died on 02Mar2021. It was not reported if an autopsy was performed. No relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1589614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040715

Write-up: Death sudden; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108112122135440-FPD5H, Safety Report Unique Identifier GB-MHRA-ADR 25786827. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing suspected COVID-19 (unsure when symptoms started). She was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced death sudden on 02Aug2021. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The patient died on 02Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1589616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-16
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101040696

Write-up: Miscarriage/Missed miscarriage; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202108112216401540-RQHOR], Safety Report Unique Identifier [GB-MHRA-ADR 25787123]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Lot Number: ET8885) as dose 1, single for COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced Miscarriage/Missed miscarriage on 16Jul2021. The event was assessed as serious (fatal and Congenital anomaly). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 04Aug2021. The patient died on 16Jul2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Missed miscarriage of child confirmed on 16th July. Festus had stopped growing some weeks earlier. She was likely in week 1-2 of pregnancy at the time of being vaccinated. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Miscarriage/Missed miscarriage


VAERS ID: 1589620 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101047381

Write-up: Brain death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202108121906052060-KSIDE. Safety Report Unique Identifier GB-MHRA-ADR 25790882. A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Unsure if patient had had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced brain death on an unspecified date. The patient died on 14Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain death


VAERS ID: 1589657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
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: Covid-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101046217

Write-up: died having recently tested positive for COVID-19; died having recently tested positive for COVID-19; This is a spontaneous report from a contactable consumer via company representative. A non-pregnant female patient (reporter''s mother) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 (Batch/lot number and expiration date unknown) as dose 1, single, and her 2nd single BNT162B2 on an unspecified date (Batch/lot number and expiration date unknown) was understood to be delivered in line with UK guidance at the time for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Prior the vaccination, the patient wasn''t diagnosed with COVID-19. In the reporter''s own words, the patient had health issues (numerous underlying medical conditions). The patient died having recently tested positive for COVID-19 on 12Aug2021. 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.; Reported Cause(s) of Death: died having recently tested positive for COVID-19


VAERS ID: 1589676 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy, Coronary artery disease, Headache
SMQs:, Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101038746

Write-up: Headache; myocardial lessions; Coronary heart disease; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216582. A 51-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27May2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced headache (death, life threatening), myocardial lessions (death, medically significant, life threatening) and coronary heart disease (death, medically significant, life threatening) all on 27May2021. The patient (reporter''s husband) was a quite young and healthy man, he was working very hard, they walked too much in their free time so they did not realize that patient had a problem with his heart. Two days after patient followed the Pfizer vaccine he felt asleep on afternoon (29May2021) and patient never woke up. The death certificate states recent lessions on myocardium and coronary heart disease. They were waiting for toxicology. The patient died on 29May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Headache; myocardial lessions; Coronary heart disease


VAERS ID: 1589677 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: GRPFIZER INC202101045670

Write-up: Death (heart failure); Fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB GR-GREOF-20216686. A 89-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jul2021 at 89-year-old (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 from Dec2020. The patient''s concomitant medications were not reported. He did the first dose of the vaccine for covid-19 immunization on Jul2021 and had for 2 days fever. At 18:00 on 23Jul2021, the afternoon after a while, he developed again fever and the next day was found dead and issued from physician at home a death certificate. Cause of death was reported as heart failure. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Outcome of events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up; Reported Cause(s) of Death: fever; Heart failure


VAERS ID: 1589693 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-05-01
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Haemorrhagic cerebral infarction, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 53
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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Brain CT; Result Unstructured Data: Test Result:basal ganglia hemorrhage right side
CDC Split Type: HUPFIZER INC202101039648

Write-up: Hemorrhagic cerebral infarction; 23Mar2021 1st dose/ 13Jun2021 2nd dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-673421. This spontaneous, serious case was received via the Regulatory Authority on 26Jul2021, concerning hemorrhagic cerebral infarction after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 13Jun2021 at 8:00 a.m., the 69-year-old male patient received the second dose of COMIRNATY (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: FD1921). First dose was given on 23Mar2021, batch number: ET7205. On 01May2021 the patient was hospitalized due to stroke (hemorrhagic cerebral infarction) causing left hemiparesis and confusion. Cranial CT (Computed tomography) showed right basal ganglia hemorrhage. During his observation, his general condition continued to decline. No meaningful contact could be made with him. Comfort treatment was provided. On 23Jun2021 at 2:00 a.m., the patient died among the symptoms of stroke complications. Autopsy was not done. The cause of death was reported as hemorrhagic cerebral infarction. Medical history included hypertension, concomitant medicaton was not reported. No further information is expected. Sender Comment: The patient died 10 days after the second dose of Comirnaty vaccine. Cause of death was hemorrhagic cerebral infarction, which occurred before vaccination (5 weeks after the first dose). The reported death and Comirnaty is considered not related. The case is serious due to hospitalization and fatal outcome.; Reported Cause(s) of Death: Hemorrhagic cerebral infarction


VAERS ID: 1589720 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-30
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dilated cardiomyopathy; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101020610

Write-up: Acute heart failure to chronic; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the regulatory authority. The reugaltory authority number of the first case is [IS-IMA-4078]. A 69-years-old male patient received dose 1 of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 13Apr2021 as dose 1, single for covid-19 immunization. The medical history included congestive cardiomyopathy, cardiac failure. The patient concomitant medications were not reported. On 30Apr2021 the patient experienced acute heart failure to chronic. It was reported that 16 days after the first injection (30Apr2021) the patient heart failure gets worsened and was hospitalized. The outcome of the event was fatal. No follow-up attempts are possible, information on batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101010444 the same patient, different doses and events; Reported Cause(s) of Death: Acute heart failure to chronic


VAERS ID: 1589722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210836024

Write-up: DEATH; This spontaneous report received from a social media (twitter) via a company representative concerned a 30 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. In 2021, the patient died from unknown cause of death. The outcome was fatal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210836024-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1589795 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-06-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram, Computerised tomogram thorax, Coronary angioplasty, Echocardiogram abnormal, Endotracheal intubation, Interstitial lung disease, SARS-CoV-2 test
SMQs:, Angioedema (broad), Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 15
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: Acute interstitial pneumonitis
Allergies:
Diagnostic Lab Data: Test Name: Angiograph coronary; Result Unstructured Data: Test Result:no information; Test Name: chest CT; Result Unstructured Data: Test Result:Chest which documented unexplained interstitial-li; Comments: Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs); Test Name: Coronary angioplasty; Result Unstructured Data: Test Result:no information; Test Name: Echocardiogram abnormal; Result Unstructured Data: Test Result:FE VSn 30%; Test Name: Endotracheal intubation; Result Unstructured Data: Test Result:no information; Test Name: covid-19; Test Result: Negative
CDC Split Type: ITPFIZER INC202101045738

Write-up: Acute myocardial infarction; Pneumonia interstitial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [IT-MINISAL02-769011] A 77-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 (Batch/Lot Number: Unknown) (at the age of unknown) as Dose 2, single for COVID-19 immunisation. Medical history included acute interstitial pneumonitis unknown if ongoing. The patient''s concomitant medications were not reported. On 25Jun2021, the patient at hospital arrived for acute myocardial infarction and subsequent documentation (during hospitalization of interstitial-like pneumonia of nature to be determined). PTCA 1 o + 1 Medicated Stent on proximal VAT was effectively performed (chronic occlusive disease of Cx and Cdx with good collateral circulation remains. Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan - Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs) and worsened in the following days (various Molecular swabs x Covid-19: Neg) .. For the progressive worsening Clinical-Radiological on 03Jul2021 the Patient was transferred to Reanimation proceeding to IOT. Despite the various Interventional maneuvers no recovery of the clinical picture and on 10Jul2021 Cardio-respiratory arrest with Declaration of Death.) The patient underwent lab tests and procedures which included angiocardiogram: no information, computerised tomogram thorax: chest which documented unexplained interstitial-li on Chest which documented unexplained interstitial-like pneumonia (involving$g 50% of the lungs) ,coronary angioplasty: no information, echocardiogram abnormal: fe vsn 30% , endotracheal intubation: no information, sars-cov-2 test: negative. The patient died on 10Jul2021. It was unknown if an autopsy was performed. Reporter comment: Patient aged 77 arrives in the Hemodynamics Room for extended Anterolateral STEMI (HUB path). Effectively performed PTCA 1 o + 1 Medicated stent on proximal IVA (chronic occlusive disease of Cx and Cdx remains with good collateral circulation). At Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan which documented the picture of unexplained interstitial-like pneumonia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Patient aged 77 arrives in the Hemodynamics Room hospital PRIVACY for extended Anterolateral STEMI (HUB path). Effectively performed PTCA 1 o + 1 Medicated stent on proximal IVA (chronic occlusive disease of Cx and Cdx remains with good collateral circulation). At Echocardiogram FE VSn 30%. During the hospitalization it was not possible to wean the patient from the respirator, which is why he performed CT scan which documented the picture of unexplained interstitial-like pneumonia.; Reported Cause(s) of Death: Pneumonia interstitial; Acute myocardial infarction


VAERS ID: 1589798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Heart rate increased, Peripheral swelling, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Dehydration (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: CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary artery occlusion; Coronary stent placement (2); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101045763

Write-up: weight on the chest; swelling in the left leg; rapid heartbeats; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [IT-MINISAL02-769339]. An 83-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 29Apr2021 (Lot Number: Unknown) (at the age of unknown) as Dose 1, single for COVID-19 immunisation. Medical history included hypercholesterolemia, arterial hypertension with 60% occluded coronary arteries, 2 coronary stents. Concomitant medication included acetylsalicylic acid (CARDIOASPIRIN). On 02May2021, the patient reported swelling in the left leg, weight on the chest, rapid heartbeats; she did blood tests, ultrasounds. The patient was deceased; she in anamnesis she presented with hypercholesterolemia, arterial hypertension with 60% occluded coronary arteries, 2 coronary stents. She died in the house alone. The daughters had her cremated and did not even consider the autopsy. The patient died on an unspecified date in 2021. An autopsy was not performed. Sender Comment: 04Aug2021 Pharmacovigilance : requests for further information to the reporter such as lot, skin site, vaccination time, detailed clinical report, test reports performed with diagnosis, clinical history, concomitant drugs taken, any allergies. Reporter comment: High blood pressure, coronary occlusion one at 60%, put 2 coronary stents, high cholesterol. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reporter''s Comments: High blood pressure, coronary occlusion one at 60%, put 2 coronary stents, high cholesterol.; Reported Cause(s) of Death: rapid heartbeats; swelling in the left leg; weight on the chest


VAERS ID: 1589871 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage; Comments: (Aneurysm ruptured of the anterior communicating artery was suspected)
CDC Split Type: JPPFIZER INC202101002614

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21122476. The patient was a 52-year-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of subarachnoid haenorrhage in 2012. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 02Aug2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Aug2021 at around 17:00 (Estimated time, one day after the vaccination), the patient experienced subarachnoid haemorrhage. On 03Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Aug2021, 17:00, the patient was found dead in a prone position in the floor of the living room of her home. Although an autopsy was performed, CT showed subarachnoid haemorrhage (Aneurysm ruptured of the anterior communicating artery was suspected). In 2012, the patient had medical history of subarachnoid haemorrhage. She had no underlying diseases such as hypertension. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The event was unrelated to BNT162b2 vaccination. The police considered that the report was on a voluntary base of the medical institution. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the temporal association and known safety profile ,the fatal event subarachnoid hemorrhage was assessed unrelated to the suspect product BNT162B2 or comirnaty,patient had already relevant medical history of subarachnoid hemorrhage.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1589949 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Cholelithiasis, Coma scale, Coma scale abnormal, Computerised tomogram, Diverticulum intestinal, Dizziness, Dysstasia, Feeding disorder, Fibrin D dimer, Fibrin degradation products, Fibrinolysis increased, Haematochezia, Heart rate, Heart rate decreased, Hyperhidrosis, Intestinal dilatation, Intestinal ischaemia, PCO2, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Vestibular disorders (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:increased to 80s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:66/41 mmHg; Comments: at 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:40 to 50s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: blood pressure; Result Unstructured Data: Test Result:30s mmHg; Comments: after 23:05; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: at 10:00; Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: at 23:05; Test Date: 20210803; Test Name: CS; Result Unstructured Data: Test Result:300; Comments: at 23:05; Test Date: 20210803; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:no pulmonary thromboembolism.; Comments: no pulmonary thromboembolism. Significant expansion was observed from the ascending colon to the transverse colon. Thinning of the wall and poor perfused area were observed, and insufficient intestinal blood flow was suspected.; Test Date: 20210803; Test Name: ct; Result Unstructured Data: Test Result:no findings of acute period in the head; Comments: The findings for which aspiration was suspected were poor in the trachea and the lung field. No significant findings were observed except for the gallstones and the colon diverticulum.; Test Date: 20210803; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:81 ug/ml; Comments: after 23:05; Test Date: 20210803; Test Name: FDP; Result Unstructured Data: Test Result:426 ug/ml; Comments: after 23:05; Test Date: 20210803; Test Name: pulse rate; Result Unstructured Data: Test Result:110; Comments: at 23:05; Test Date: 20210804; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased; Comments: at 3:00; Test Date: 20210803; Test Name: PCO2; Result Unstructured Data: Test Result:100s mmHg; Comments: after 23:05
CDC Split Type: JPPFIZER INC202101024001

Write-up: heart rate decreased; a large amount of bloody stool; blood pressure was 66/41 mmHg; Coma Scale (CS) was 300; Cardio-respiratory arrest; vomiting; apnoea; pyrexia of 39 degrees Celsius; large amount of sweating; light-headed feeling; difficulty in standing; Meal intake was poor; gallstones; colon diverticulum; increased fibrinolytic system; Significant expansion was observed from the ascending colon to the transverse colon; insufficient intestinal blood flow was suspected; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122853. A 64-year-old and 6-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), dose 2 via an unspecified route of administration on 02Aug2021 15:00 at the age of 64 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. Body temperature before vaccination was unknown. The family history was not provided. The patient had medical history of dementia Alzheimer''s type. Concomitant medications were not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date not reported) for COVID-19 immunisation. On 03Aug2021 at 22:20 (one day and 7 hours, 20 minutes after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 02Aug2021 at 15:00, the patient received the second dose of BNT162b2 vaccination. On 03Aug2021, at 10:00, the patient had pyrexia of 39 degrees Celsius. She had a large amount of sweating. Since the patient had light-headed feeling, she had difficulty in standing. Meal intake was poor. At 20:30, the patient took a meal (jelly and others). At 22:05, no abnormalities were observed. At 22:20, the patient had vomiting and apnoea. At 22:35, the ambulance service arrived. The patient experienced cardio-respiratory arrest. The airway was secured with a laryngeal tube (LT). Although adrenaline a total of 2 mg was administered, the patient had asystole. At 23:02, the patient was transferred to the reporting hospital. Adrenaline 1 mg was administered. At 23:05, the heart rate returned. The blood pressure was 66/41 mmHg, the pulse rate was 110, Coma Scale (CS) was 300, and the body temperature was 36.2 degrees Celsius. The LT was removed, and tracheal intubation was performed. The course was observed with the blood pressure of 40 to 50s mmHg. When noradrenaline was intravenously injected by 0.2 mg, the blood pressure increased to 80s mmHg; however, it decreased in a short time. CT showed no findings of acute period in the head. The findings for which aspiration was suspected were poor in the trachea and the lung field. No significant findings were observed except for the gallstones and the colon diverticulum. A central venous catheter (CV) was placed, and continuous administration of noradrenaline (2 mg/hour) was initiated; however, the blood pressure was 30s mmHg. Although the frequency of breath and the amount of ventilation was increased, the PCO2 was 100s mmHg. The FDP was 426 ug/mL, and the D-dimer was 81 ug/mL, which showed increased fibrinolytic system. Contrast-enhanced CT was additionally performed, which showed no pulmonary thromboembolism. Significant expansion was observed from the ascending colon to the transverse colon. Thinning of the wall and poor perfused area were observed, and insufficient intestinal blood flow was suspected. On 04Aug2021, 02:10 (one day, 11 hours, and 10 minutes after vaccination), the patient had a large amount of bloody stool. At 03:00, the heart rate decreased. At 03:15, the patient had asystole. At 03:45, the patient died. It was not reported if an autopsy was performed. Therapeutic measures were taken as the result of Cardio-respiratory arrest and Blood pressure decreased. On 04Aug2021 (2 days after the vaccination), the outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were heat illness and intestinal ischaemia. The reporting physician commented as follows: Since the findings which was the cause of the sudden change could not be confirmed, extrinsic death such as heat illness could not be ruled out. Although the pathological condition was considered to occur secondary to intestinal ischaemia, it was judged by the physician that the possibility of secondary change due to prolongation of subsequent shock was suspected. In addition, since the patient had pyrexia and cardio-pulmonary arrest after the vaccination, the causality between the events and the vaccination could not be ruled out. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest; light-headed feeling; large amount of sweating; difficulty in standing; Meal intake was poor; vomiting; apnoea; blood pressure was 66/41 mmHg; Coma Scale (CS) was 300; gallstones; colon diverticulum; increased fibrin


VAERS ID: 1589953 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Computerised tomogram thorax, Headache, Hypophagia, Malaise, Oxygen saturation, Pneumonia, Pyrexia, Sepsis, Somnolence, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Escherichia sepsis
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: blood test; Result Unstructured Data: Test Result:no problem; Test Date: 20210530; Test Name: Chest x-ray; Result Unstructured Data: Test Result:ground glass opacity on both lung fields; Test Date: 20210527; Test Name: CT; Result Unstructured Data: Test Result:no problem; Test Date: 20210530; Test Name: chest CT; Result Unstructured Data: Test Result:bilateral diffuse nodular shadow and ground glass; Comments: opacity; Test Date: 20210530; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased %; Comments: in the middle of the night; Test Date: 20210530; Test Name: oxygen saturation; Test Result: 67 %; Comments: on three liters of oxygen, at 05:30; Test Date: 20210527; Test Name: x-ray; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101026332

Write-up: sepsis; severe pneumonia; impossible to take food and fluid; a tendency of somnolence; intense headache; malaise; pyrexia; This is a spontaneous report from a contactable pharmacist received from the Agency. Regulatory authority report number is v21123167. A 92-year and 2-month-old female patient received first dose of COVID-19 Vaccine (unknown manufacture, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on 18May2021 at unspecified time. Age at vaccination was 92-year and 2-month-old. Body temperature before vaccination was not reported. The patient family history was not reported. Medical history included sepsis due to Escherichia coli (hospitalized in Oct2020). Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) were unknown because the patient was hospitalized after vaccination at the another facility. On 19May2021 at unspecified time (one day after the vaccination), the patient experienced headache, malaise and pyrexia. On 29May2021, the patient experienced a tendency of somnolence and impossible to take food and fluid. On 30May2021 (twelve days after the vaccination), the patient experienced severe pneumonia. On 30May2021 (twelve days after the vaccination), the patient was admitted to the hospital. On 30May2021 (twelve days after the vaccination), the patient died. The course of the event was as follows: On 18May2021, the patient received the vaccination. After that, on 19May2021, the patient started to have intense headache, malaise and pyrexia. On 20May2021, the patient visited the hospital of the reporting pharmacist. Antipyretic analgesic was prescribed, and fever declined, but headache remained. On 27May2021, the patient visited another hospital. No problem on the examinations including blood test, x-ray and computerised tomogram (CT). On 29May2021, the patient became impossible to take food and fluid, and had a tendency of somnolence. On 30May2021 in the middle of the night, respiratory discomfort occurred, oxygen saturation decreased and sweating in the large amount. At 05:30, oxygen saturation decreased to 67 % on three liters of oxygen, therefore the patient was urgently transported to the hospital of the reporting pharmacist. Chest x-ray showed ground glass opacity on both lung fields and chest CT showed bilateral diffuse nodular shadow and ground glass opacity. The patient was hospitalized for severe pneumonia. The reporting pharmacist classified the event as serious (hospitalization) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: the patient was hospitalized for sepsis due to Escherichia coli before (in Oct2020) too. The patient was hospitalized for severe pneumonia and sepsis again this time, but presumably she was already in the state of disseminated intravascular coagulation (DIC) and did not recover. It looked vaccination had involved in that trigger. Outcome of pneumonia was fatal. Outcome of pyrexia was resolved. Outcome of headache was not resolved. Outcome of other events was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: severe pneumonia


VAERS ID: 1589954 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Body temperature, Gastrooesophageal reflux disease, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hostility/aggression (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: URSO [URSODEOXYCHOLIC ACID]; NOBELZIN; LANSOPRAZOLE; MYSLEE; HOCHUEKKITO [ANGELICA ACUTILOBA ROOT;ASTRAGALUS SPP. ROOT;ATRACTYLODES LANCEA RHIZOME;BUPLEURUM FALC; RISPERIDONE; TAZOPIPE
Current Illness: Pneumonia aspiration
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (hospitalized); Dementia (hospitalized); Diabetes mellitus (hospitalized); Hepatic cancer (hospitalized); Hepatitis C (hospitalized); Hospitalisation; Pressure sore (hospitalized); Reflux oesophagitis (hospitalized)
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101026440

Write-up: Asphyxia due to aspiration or gastrooesophageal reflux; Respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123522. And the follow-up was received from the same contactable physician via regulatory authority. The patient was a 74-year-old male. Body temperature before vaccination was 36.9 degrees centigrade. The patient had no family history. Medical history included dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux oesophagitis, cerebral infarction, and pressure sore (the patient was hospitalized in the reporting hospital due to dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux oesophagitis, cerebral infarction, and pressure sore). Concomitant medications included oral ursodeoxycholic acid (URSO), oral zinc acetate (NOBELZIN), oral lansoprazole, oral zolpidem tartrate (MYSLEE), oral HOCHUEKKITO, oral risperidone as needed, and piperacillin sodium, tazobactam sodium (TAZOPIPE) via a lateral injection tube for possibility of pneumonia aspiration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 06Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY5422, Expiration date 31Aug2021) intramuscular in arm left at 12:00, and experienced right sided complete paralysis due to cerebral infarction on 16Jul2021. On 27Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date: 30Sep2021) intramuscular in arm left as a single dose for COVID-19 immunization (74 years old at vaccination). On 28Jul2021 at 11:50 (20 hours and 20 minutes after the vaccination), the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration (or gastrooesophageal reflux). On 28Jul2021, the patient died. No autopsy was done. The cause of patient death was reported as follows: aspiration or gastrooesophageal reflux (swallowing ability was decreased due to dementia, reflux oesophagitis and cerebral infarction; thus, the patient was prone to aspiration). The patient has not been tested for COVID-19 since the vaccination. The physician classified the events as serious (death, prolonged hospitalization). The course of the event was as follows: The patient was in the reporting hospital due to dementia and reflux oesophagitis. On 06Jul2021, the patient received the first dose of BNT162b2. On 16Jul2021, the patient experienced right sided complete paralysis due to cerebral infarction. Afterwards, the symptom tended to improve. The patient was receiving tazobactam via a lateral injection tube for a possibility of pneumonia aspiration. Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed from a few days before and sputum increased. On 27Jul2021 at 15:30, the patient received the second dose of BNT162b2. On 28Jul2021 at 11:50, the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration. The reporting physician classified the event as serious (death) and assessed the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases reported as follows: The swallowing ability decreased due to symptoms such as dementia, reflux oesophagitis, and cerebral infarction; thus, the patient was prone to aspiration. The reporting physician commented as follows: Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed from a few days before and sputum increased. The reporting physician considered that the patient experienced asphyxia due to aspiration or gastrooesophageal reflux.; Sender''s Comments: Based on the close temporal relationship, the association between the events asphyxia due to aspiration (or gastroesophageal reflux) and respiratory arrest with COMIRNATY use can not be fully excluded. Advanced age and past medical history of reflux may have been contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-202101046489 Same reporter/patient/drug, Different event/dose; Reported Cause(s) of Death: respiratory arrest; Asphyxia due to aspiration or gastrooesophageal reflux; Asphyxia due to aspiration or gastrooesophageal reflux; Asphyxia due to aspiration or gastrooesophageal reflux


VAERS ID: 1589956 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Vaccination site pain
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: 2021-07-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic schizophrenia (the patient had been hospitalized for approximately 30 years for chronic schizophrenia.); Hospitalisation (the patient had been hospitalized for approximately 30 years for chronic schizophrenia.); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101029642

Write-up: Cardio-respiratory arrest; Vaccination site pain; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122885. A 69-year and 3-month-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 19Jul2021 15:00 (Lot Number: EW0207; Expiration Date: 30Sep2021, at the age of 69-year-old) as single dose for covid-19 immunisation. Medical history included chronic schizophrenia, cardiac failure chronic, and renal failure. Since 1989, the patient had been hospitalized for approximately 30 years for chronic schizophrenia. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade on 19Jul2021. After the vaccination on 19Jul2021, the patient had only vaccination site pain, and no significant changes were observed. On 23Jul2021 at 18:00 (4 days and 3 hours after the vaccination), the patient experienced cardio-respiratory arrest. No changes were observed until the evening. However, after supper, the patient was found to have cardio-respiratory arrest. The outcome of the event cardio-respiratory arrest was fatal, for event vaccination site pain was unknown. The patient died on 23Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac failure chronic and renal failure.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1589959 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body temperature, C-reactive protein increased, Delirium, Disseminated intravascular coagulation, Dyspnoea, Electrocardiogram ambulatory, Embolism, Erythema, Oxygen saturation, Pain in extremity, Platelet count, Purpura, Pyrexia, Thrombocytopenia, Thrombosis
SMQs:, Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FEBURIC; LIXIANA; TAKEPRON; MAGMITT
Current Illness: Hyperuricaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: creatinine; Result Unstructured Data: Test Result:1.70; Test Date: 20210805; Test Name: creatinine; Result Unstructured Data: Test Result:2.14; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210805; Test Name: CRP; Result Unstructured Data: Test Result:19.6; Test Date: 202006; Test Name: Holter ECG; Result Unstructured Data: Test Result:no onset of atrial fibrillation; Test Date: 20210805; Test Name: SpO2; Test Result: 98 %; Test Date: 20210728; Test Name: platelet count; Result Unstructured Data: Test Result:19.7; Test Date: 20210805; Test Name: platelet count; Result Unstructured Data: Test Result:10.7
CDC Split Type: JPPFIZER INC202101029915

Write-up: disseminated intravascular coagulation syndrome; Dyspnoea; Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest/purpura; Pyrexia of 39.3 degrees Celsius; Delirium nocturnal; Redness in left lower leg/Redness in buttock; Left lower leg pain; thrombosis; thromboembolism; thrombocytopenia; This is a spontaneous report from a contactable physician received via the Regulatory Authority. Regulatory authority report number is v21122960. The 98-year-old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC9880, Expiration date: 30Sep2021) via intramuscular route of administration on 30Jul2021 at 09:00 in the arm right for COVID-19 immunization at the age of 98 years old. The body temperature before the second vaccination was 36.5 degrees Celsius. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received oral medications febuxostat (FEBURIC), edoxaban tosilate hydrate (LIXIANA), lansoprazole (TAKEPRON), and magnesium oxide (MAGMITT) within 2 weeks of vaccination. The administration of oral edoxaban tosilate hydrate 30 mg was stopped on 28Jul2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included hyperuricaemia (underlying disease), transit ischaemic attack (past medical history), and atrial fibrillation paroxysmal (past medical history). The patient underwent ECG every 1 or 2 months since Apr2020. The Holter ECG showed no onset of atrial fibrillation in Jun2020. On 09Jul2021 at 09:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EW0203, Expiration date 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization at the age of 98 years old. On 30Jul2021 at 09:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FC9880, Expiration date: 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 04Aug2021 at 17:00 (5 days and 8 hours after the second dose of the vaccination), the patient experienced the events. On 04Aug2021 in the evening, the patient experienced thrombosis (including thromboembolism, and limited to those with thrombocytopenia). The description of the events were reported as follows: On 04Aug2021 in the evening (5 days after the second dose of the vaccination), the patient experienced left lower leg pain. On 05Aug2021 (6 days after the second dose of the vaccination), although the patient usually visited the reporting hospital on foot without assistance, he visited with a wheelchair. The redness and pain in the left lower leg were noted. At 12:45 (6 days, 3 hours, and 45 minutes after the second dose of the vaccination), the patient was admitted to the reporting hospital. At 19:00 (6 days and 10 hours after the second dose of the vaccination), although the patient had dyspnoea, the SpO2 was 98%. Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest. The patient experienced pyrexia of 39.3 degrees Celsius. The patient experienced delirium nocturnal. The platelet count was 10.7 (it was 19.7 on 28Jul2021), the CRP was 19.6, and the creatinine was 2.14 (it was 1.70 on 28Jul2021). On 06Aug2021, at 06:00 (6 days and 21 hours after the second dose of the vaccination), administration of oxygen 2 L was initiated. At 07:00 (6 days and 22 hours after the second dose of the vaccination), redness in the buttock which was not observed at night was confirmed. At 08:24 (6 days, 23 hours, and 24 minutes after the second dose of the vaccination), the patient died. At the time of death, well-defined purple areas, which were considered purpura, were found on the left lower leg, the posterior surface of both thighs, and the right sole. The imaging examination was not performed, and the blood examination (D-dimer, prothrombin time, fibrinogen) was not performed. The events resulted in doctor''s office/urgent care, hospitalization and death. The number of the hospitalization was reported as 2 days. Hospitalization prolonged was reported as "no". The outcome of the events was fatal with treatment including administration of oxygen 2 L. The reporting physician assessed the event as serious (death, hospitalization). The patient died on 06Aug2021. The cause of death was reported as disseminated intravascular coagulation syndrome. It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient was an elderly of 98-year-old, he was doing fine until the evening on 04Aug2021.; Sender''s Comments: The event of Disseminated intravascular coagulation, pain in extremity, erythema, dyspnoea, purpura, pyrexia, delirium, thrombosis, embolism, thrombocytopenia, is assessed as possibly related to the suspect drug "BNT162B2" based on strong temporal association but consider also possible contributory effects from patient''s medical history and/or concomitant medications. 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: Left lower leg pain; Redness in left lower leg/Redness in buttock; Dyspnoea; Several purple areas were observed in the both lower legs (the left lower leg, the posterior surface of both thighs, the right sole) and the chest/purpura; Pyrexia of 39.3 d


VAERS ID: 1589961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Computerised tomogram, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 202108; Test Name: Postmortem computerised tomogram (CT); Result Unstructured Data: Test Result:suspected pulmonary arterial thromboembolism
CDC Split Type: JPPFIZER INC202101030070

Write-up: Thrombosis; suspected pulmonary arterial thromboembolism; This is a spontaneous report from a contactable physician (coroner) received from the regulatory authority. Regulatory authority report number is v21123529. A 73-year-old female patient received 2nd dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) on 04Aug2021 at unspecified time via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. Medical history included parkinson''s disease. On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were unknown) for COVID-19 immunization. Concomitant drugs were not provided. On 05Aug2021 (one day after the vaccination), the patient experienced thrombosis. On 05Aug2021 at 10:34 (one day after the vaccination), the patient died. The course of the event was as follows: On 05Aug2021 at about 09:30 (one day after the vaccination), a home-visiting nurse visited the patient home and found the patient lost consciousness in the prone position. Medical team was called, and the patient was transported to the local hospital. At 10:34, the patient was confirmed dead. It was reported to the police as unusual death. On 06Aug2021, the reporting physician performed a postmortem inspection by request from the police. Postmortem computerised tomogram (CT) in Aug2021 showed the cause of death was suspected pulmonary arterial thromboembolism. The reporter did not receive the result of blood test from hospital. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was that the patient had the medical history of Parkinson''s disease. The reporting physician commented as follows: The patient died from pulmonary arterial thromboembolism on the next day of vaccination. The reporter thought there were different opinions if blood clot would be formed in a day after the vaccination, but the reporter could not judge, and the patient family desired to report the case to regulatory authority.; Reported Cause(s) of Death: suspected pulmonary arterial thromboembolism; thrombosis; Autopsy-determined Cause(s) of Death: suspected pulmonary arterial thromboembolism


VAERS ID: 1589962 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: Test Date: 20210725; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101030121

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122579. A 51-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 25Jul2021 11:00 (Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for covid-19 immunization at the age of 51 years old. The patient medical history and concomitant medications were not reported. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced death on an unspecified date. The course of the event was as follows: On 25Jul2021, the patient did not appear to have any particular abnormalities when he came to the reporting clinic for the second vaccination. The patient was vaccinated as usual. No particular abnormalities were observed at the time of the vaccination. However, the police contacted the reporting physician afterward that the patient had died. The physician did not examine the patient and did not have information. Therefore, the physician could not report on adverse reactions or the death. A separate report from the police would be made; however, the physician submitted the report with the information that the physician could confirm. The reporting physician did not classify the event and did not assess the causality between the event and BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: unknown at the reporting clinic. The patient underwent lab tests and procedures which included Body temperature before vaccination was 36.3 degrees centigrade on 25Jul2021. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death


VAERS ID: 1589963 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest X-ray, Computerised tomogram, Pneumonia, Pulmonary alveolar haemorrhage, Septic shock
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 46
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: Atypical mycobacterial lower respiratory tract infection; Bronchiectasis; Hemodialysis; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Blood pressure; Result Unstructured Data: Test Result:suddenly decreased; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade; Comments: from evening; Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 20210626; Test Name: Chest X-ray; Result Unstructured Data: Test Result:showed Pulmonary alveolar hemorrhage; Test Date: 20210626; Test Name: CT; Result Unstructured Data: Test Result:showed Pulmonary alveolar hemorrhage
CDC Split Type: JPPFIZER INC202101030759

Write-up: Septic shock due to pneumonia; Septic shock due to pneumonia; Pulmonary alveolar hemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122863. A 71-year and 1-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration 24Jun2021, at patient age of 71-year-old, as a single dose for COVID-19 immunization. Relevant medical history included Bronchiectasis, pulmonary non-tuberculous mycobacterial infection, and renal failure chronic (hemodialysis).There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The family history was not provided. Concomitant medications were not reported. Body temperature before vaccination was not provided. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2. On 24Jun2021 (the day of the vaccination), the patient experienced pulmonary alveolar hemorrhage. On 26Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. On 09Aug2021 (One month/16 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jun2021 (the day of vaccination), at night, the patient had pyrexia of 37s degrees Celsius. On 25Jun2021 (one day after vaccination), the patient had pyrexia of 38s degrees Celsius, bloody sputum, and dyspnea. On 26Jun2021 (2 days after vaccination), after the patient received hemodialysis at another hospital, she was emergently transferred to the reporting hospital. The patient was diagnosed with pulmonary alveolar hemorrhage on the chest X-ray and CT. The intubation was performed for respiratory failure. Artificial respiration was initiated. On 08Jul2021 (14 days after vaccination), the extubation was performed, and the patient was being treated for the primary disease. On 09Aug2021 (one month and 16 days after vaccination), the patient had sudden blood pressure decreased. Septic shock due to pneumonia was considerable. Although the patient was managed with an artificial ventilator again, oxygenation could not be maintained. On the same day, the patient was confirmed to die. It was not reported if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were Bronchiectasis, pulmonary non-tuberculous mycobacterial infection, and renal failure chronic (hemodialysis). The reporting physician commented as follows: Although the patient experienced pulmonary alveolar hemorrhage after the vaccination, it improved with treatment. It was considered that the patient died due to septic shock caused by pneumonia during the treatment of the primary disease. Thus, the causality between the event and the vaccination was considered unlikely.; Reported Cause(s) of Death: septic shock; pneumonia; Pulmonary alveolar hemorrhage


VAERS ID: 1589964 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101030762

Write-up: Death; This is a spontaneous case from a non-contactable physician received via a Pfizer colleague. An 8-decade-old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) in Jul2021 at single dose for COVID-19 immunisation. The patient was receiving dialysis and was orally taking a tranquilizer. The patient''s concomitant medications were not reported. On unknown date in Jul2021 (the day of vaccination), the patient received the first dose of BNT162B2. On unknown date in Aug2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in Aug2021 (unknown days after the vaccination), the outcome of the event was fatal. The patient died in Aug2021. It was not reported if autopsy was performed. The course of the event was as follows: Approximately 2 weeks ago, the patient received the first dose of BNT162B2 vaccination. Approximately 10 days later, the patient died. The patient lived alone. The cause of death and the situation were unknown. The causality between the event and BNT162B2 was unknown. The outcome of the event was fatal. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1589965 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Internal carotid artery stenosis (left)
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101030767

Write-up: cerebral haemorrhage; This is a spontaneous report from a contactable physician (inoculator) received from the regulatory authority. Regulatory authority report number is v21122942. The patient was an 89-year-old male. Age at vaccination was 89-year-old. Body temperature before vaccination was 37.0 degrees centigrade. The patient had no family history. Medical history included cerebral infarction and left internal carotid artery stenosis. On 28Jun2021 at 16:37 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jun2021 in the morning (one day after the vaccination), the patient experienced cerebral haemorrhage. On 29Jun2021 (one day after the vaccination), the patient died. The course of the event was as follows: The reporting clinic was the primary care clinic for the patient, and the patient came to the clinic to get vaccinated while he was in hospital for an orthopedic disorder. The patient returned to hospital soon after the vaccination. The following matter was told by the patient family when the family contacted to the reporter: There was no specific change on the day of vaccination. The next morning, since the patient was unawakened, various examinations were performed and the patient was diagnosed with cerebral haemorrhage. The death was confirmed. The attending physician explained to the patient family that the association could not be identified. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was reported that there was/were other possible cause(s) of the event such as any other diseases, but details were not reported. The reporting physician did not provide any further comment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cerebral haemorrhage


VAERS ID: 1589966 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: JPPFIZER INC202101030790

Write-up: Death; This is a spontaneous report from a contactable physician received from a Pfizer colleague. Information regarding the patient was not obtained. Body temperature before vaccination, family history, medical history, and concomitant medication were not reported. On an unknown date (the day of vaccination), the patient received the single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported) via an intramuscular route for COVID-19 immunization. On an unknown date (after the vaccination), the patient experienced death. The outcome of the event death was fatal. The course of the event was as follows: Around Jun2021 (approximately 3 days after the vaccination), the police told the reporting physician by phone that the patient died. It was not provided if autopsy was performed. The reporting physician did not classify the event and did not assess the causal relationship between the event and BNT162b2. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug cannot be assessed as related. The case will be reassessed once new information is available; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1589968 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Dehydration, Myocardial infarction
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination normal
CDC Split Type: JPPFIZER INC202101031862

Write-up: This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number is v21122933. A 78-year and 6-month-old female patient received 1st dose of BNT162B2 (COMIRNATY, Lot number: FD1945, Expiration date: 31Oct2021) at single dose via an unknown route on 26Jul2021 11:00 at 78-year-old for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade. Family history and concomitant medication were not reported. Medical history included diabetes mellitus. On 01Aug2021 or 02Aug2021 (6 or 7 days after the vaccination), the patient experienced cardiac failure. On 02Aug2021 (7 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jul2021, at the time of the medical interview, the reporter was concerned that the patient had a very quiet voice; however, the reporter confirmed with the patient that she had no abnormalities. The body temperature was also normal; thus, the reporter decided that the patient would be vaccinated. On the morning of Monday, 02Aug2021, Police Station contacted the reporter by phone that the patient had died at home, and the police asked about the date of vaccination and the patient''s condition on the day of vaccination. On Saturday, 07Aug2021, the patient''s daughter told the reporter by phone that the cause of death was cardiac failure. The vaccinating physician determined that the patient had cardiac failure due to other factors such as dehydration because the hot days continued from the day of vaccination to 02Aug2021 of the death. Just in case, this case was reported because of the death within one week after the vaccination. The reporting other health professional classified the event as serious (death) and assessed the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was suspected cardiac failure due to myocardial infarction. The reporting other health professional commented as follows: The vaccinating physician requested an investigation because the patient''s family was concerned about the causal relationship between the event and the vaccination.; Sender''s Comments: Based on the temporal relationship, the association between the fatal events cardiac failure, myocardial infaction, and dehydration with COMIRNATY use can not be fully excluded. Advanced age and risk factor such as a medical history of diabetes mellitus may have been contributory as well. 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: Cardiac failure; suspected cardiac failure due to myocardial infarction; dehydration


VAERS ID: 1589970 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood sodium, Body mass index, C-reactive protein, Computerised tomogram, Diarrhoea, Hepatic function abnormal, Pyrexia, Sepsis, Vasculitis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), 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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety neurosis; Depression; Emaciation (BMI 14, 14.8); Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Cr; Test Result: 2.5 mg/dl; Comments: at the time of hospitalization, advanced prerenal failure; Test Date: 20210807; Test Name: Blood sodium; Result Unstructured Data: Test Result:114 mmol/L; Comments: at the time of hospitalization, hyponatraemia; Test Name: BMI; Result Unstructured Data: Test Result:14; Test Name: BMI; Result Unstructured Data: Test Result:14.8; Test Date: 20210807; Test Name: CT; Result Unstructured Data: Test Result:advanced intestinal oedema and ascites; Comments: at the time of hospitalization; Test Date: 20210807; Test Name: CT; Result Unstructured Data: Test Result:showed advanced intestinal oedema and ascites.; Test Date: 20210807; Test Name: CRP; Test Result: 26 mg/dl; Comments: at the time of hospitalization, high; Test Date: 20210807; Test Name: white blood cell; Result Unstructured Data: Test Result:30000s /mm3; Comments: at the time of hospitalization, significant increase
CDC Split Type: JPPFIZER INC202101032265

Write-up: vasculitis; hepatic function disorder; sepsis; Acute renal failure; intense diarrhoea; pyrexia; This is a spontaneous report from a contactable attending physician received from the regulatory authority. Regulatory authority report number is v21122904. A 55-year and 11-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Aug2021 10:00 (vaccination at age of 55 years old) (Lot Number: FC9873; Expiration Date: 30sep2021) as dose 2, single for covid-19 immunisation. Medical history included emaciation (BMI 14, 14.8), depression, anxiety neurosis, hypothyroidism. On an unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FC8736, Expiration date 30Sep2021) for COVID-19 immunisation and experienced pyrexia. The patient''s concomitant medications were not reported. The patient experienced vasculitis, hepatic function disorder on 02Aug2021 21:00, and pyrexia on 02Aug2021 with outcome of unknown, intense diarrhoea on 05Aug2021 with outcome of unknown, sepsis and acute renal failure on an unspecified date. The patient was hospitalized for vasculitis and hepatic function disorder from 07Aug2021 to an unknown date, hospitalized for sepsis and Acute renal failure from 07Aug2021 to 10Aug2021. The patient died of Vasculitis, Hepatic function abnormal, sepsis and acute renal failure. The clinical course reported as below: On 02Aug2021 at 21:00 (eleven hours after the vaccination), the patient experienced vasculitis and hepatic function disorder. On 07Aug2021 (five days after the vaccination), the patient was admitted to the reporter hospital. On 10Aug2021 (eight days after the vaccination), the outcome of the event was fatal. The patient experienced pyrexia and diarrhoea after the first dose of vaccination, and improved. In the night of the day of the second vaccination, pyrexia similar to the first dose occurred. On the third day(05Aug2021), intense diarrhoea occurred. On the fifth day(07Aug2021), the patient was transported by ambulance due to worsened general condition and was admitted to hospital. At the time of hospitalization, significant increase of white blood cell (30000s /uL) and high blood C-reactive protein (CRP) (26 mg/dL), advanced prerenal failure (creatinine (Cr) at 2.5 mg/dL), hyponatraemia (114 mmol/L) and computerised tomogram (CT) showed advanced intestinal oedema and ascites. The patient was hospitalized for sepsis and acute renal failure. Although the patient was treated with antibacterial drugs and fluid infusion, exacerbation did not stop, and the patient died on the fourth day(10Aug2021) of hospitalization. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered as the vaccine-induced serious adverse reactions because similar symptoms to the first vaccination occurred again at the second vaccination. Underlying condition of emaciation (BMI 14.8) and the administration of psychiatric drugs for panic disorder affected in some way, plus, there was a possibility that the patient had conditions that have not been diagnosed. However, in any case, the events would not occur if the patient did not receive the vaccination.; Reported Cause(s) of Death: vasculitis; hepatic function disorder; sepsis; acute renal failure


VAERS ID: 1589971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]; MICOMBI COMBINATION; CARBAZOCHROME SULFONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101035424

Write-up: acute ischaemic myocardial infarction; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension, pulmonary fibrosis. Concomitant medications included prednisolone (PREDONINE); hydrochlorothiazide, telmisartan ; CARBAZOCHROME SULFONATe; all ongoing. On 04Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 28Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY). On an unknown date, the patient experienced acute ischaemic myocardial infarction due to coronary infarction. The patient lived alone, and she was not in contact, and thus, the situation was confirmed. On 18Jul2021 (20 days after vaccination), the patient was found to collapse at her home, and she was confirmed to die. Postmortem examination by the police was performed at her nearby hospital. It was not reported if an autopsy was performed (as reported). It was judged that the patient died due to ischaemic heart disease. Although the causality between the event and the vaccination was unknown, since the patient died after the vaccination, the family reported to the physician. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the plausible temporal relation, the association between the event of Acute myocardial infarction and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factors for the event are medical history of hypertension and pulmonary fibrosis and elderly age of the patient. 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 ischaemic myocardial infarction; Ischaemic heart disease


VAERS ID: 1589972 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101035641

Write-up: Deep vein thrombosis leg right; left and right pulmonary trunk thrombosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123005. A 61-year and 3-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021), via an unspecified route of administration, on 05Aug2021 (at the age of 61-year and 3-month-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. Family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously took first dose of BNT162B2 (COMIRNATY, Lot# EY5422, Expiration date 31Aug2021), via an unspecified route of administration, on 15Jul2021 (at the age of 61-year-old), at single dose, for COVID-19 immunization. On 06Aug2021 (one day after the vaccination), the patient experienced deep vein thrombosis leg right, and left and right pulmonary trunk thrombosis. The course of the event was as follows: On 15Jul2021, the patient received the first dose of BNT162b2 vaccination. On 05Aug2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 06Aug2021 (one day after vaccination), the patient had slight physical deconditioning and dyspnea on exertion. On 10Aug2021 (5 days after vaccination), the patient left home to visit a clinic by bicycle. On the way, the patient collapsed, and he was emergently transferred and was treated; however, he did not regain consciousness. Patient died on 10Aug2021. As proceedings of Act for Investigations, an autopsy was performed (on 11Aug2021). The causes of death were deep vein thrombosis leg right, and left and right pulmonary trunk thrombosis. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 was not provided. It was not reported whether there was any other possible cause of the event such as any other diseases. The reporting physician commented as follows: Thrombosis due to vaccination was strongly suspected. On 10Aug2021 (5 days after the vaccination), the outcome of the events was fatal.; Reported Cause(s) of Death: deep vein thrombosis leg right; left and right pulmonary trunk thrombosis


VAERS ID: 1589973 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 4
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: 20210806; Test Name: CT; Result Unstructured Data: Test Result:the cause of death could not be determined; Comments: after died
CDC Split Type: JPPFIZER INC202101035658

Write-up: the cause of death could not be determined; cardio-respiratory arrest; pyrexia for two days; This is a spontaneous report from a contactable attending physician received from the regulatory authority. Regulatory authority report number is v21123540. A 34-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 06Aug2021 at 06:50 (four days after the vaccination), the patient died. The course of the event was as follows: After the vaccination, the patient had the symptoms including pyrexia from 02Aug2021 for two days. On the third day, it improved. On the fourth day, the patient was found in the state of cardio-respiratory arrest and transported by ambulance to the reporter hospital. Autopsy was done and results was available. The patient did not react to resuscitation and was confirmed dead. The police performed postmortem examination and computerised tomogram (CT), but the cause of death could not be determined. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician did not provide any further comment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: the cause of death could not be determined; Autopsy-determined Cause(s) of Death: the cause of death could not be determined


VAERS ID: 1589974 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ammonia, Body temperature, Computerised tomogram head, Hepatic encephalopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalopathy/delirium (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic cancer (underlying disease); Hepatic cirrhosis; Psoriasis
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Ammonia; Result Unstructured Data: Test Result:90s; Comments: high; Test Date: 20210711; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210712; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101035714

Write-up: Hepatic encephalopathy; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123020. A 71-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021) via an intramuscular route on 11Jul2021 at 16:00 (the day of vaccination) (71-year-old at vaccination), as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. Family history and concomitant medication were not reported. Medical history included hepatic cancer (underlying disease), hepatic cirrhosis, and psoriasis. On 12Jul2021 at 04:00 (12 hours after the vaccination), the patient experienced hepatic encephalopathy. On 12Jul2021 (1 day after the vaccination), the patient was admitted to the hospital. On 26Jul2021 (15 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was regularly visiting the reporting hospital for hepatic cirrhosis and hepatic cancer (he had also psoriasis). On 11Jul2021, the patient received the vaccine. Afterwards, the patient drove a car and had no abnormalities. However, on 12Jul2021 at 04:00, the patient did something strange, such as sprinkling faeces and urine. On the same day at 08:00, the patient was taken to the hospital by ambulance. On admission, a detailed examination was performed; a head CT showed no abnormalities, and the ammonia level was high at 90s. On the same day, the patient was hospitalized and was treated for the hepatic encephalopathy. Although the encephalopathy was temporarily resolving, the general condition gradually deteriorated. On 26Jul2021 at 03:55, the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were hepatic cirrhosis and hepatic cancer aggravated. The reporting physician commented as follows: The causes of death were considered to be hepatic cirrhosis and hepatic cancer; however, it could not be ruled out that the vaccine would trigger the occurrence of encephalopathy.; Reported Cause(s) of Death: hepatic cirrhosis; hepatic cancer; Hepatic encephalopathy


VAERS ID: 1589977 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Antineutrophil cytoplasmic antibody, Body temperature, C-reactive protein, Glycosylated haemoglobin, Imaging procedure, Large intestine perforation, Neutrophil count, PO2, White blood cell count
SMQs:, Interstitial lung disease (broad), Gastrointestinal perforation (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (regularly went to hospital and received treatment); Cardiac failure chronic (regularly went to hospital and received treatment); Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: serum; Result Unstructured Data: Test Result:4.5 IU/ml; Comments: positive with low value, on hospitalization; Test Date: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Comments: before hospitalization; Test Date: 20210605; Test Name: CRP; Test Result: 6.20 mg/dl; Test Date: 20210605; Test Name: HbA1c; Test Result: 6.9 %; Test Date: 202102; Test Name: Chest image; Result Unstructured Data: Test Result:slightly showed infiltrative shadow and reticular; Comments: slightly showed infiltrative shadow and reticular shadow of bilateral pulmonary lower lobe periphery; Test Date: 20210605; Test Name: Chest image; Result Unstructured Data: Test Result:Chest image showed post-resection of left upper le; Comments: Chest image showed post-resection of left upper lob, decreased volume of bilateral lungs due to enlarged non-segmental infiltrative shadow and ground-glass opacity. Left atrial enlargement and a small amount of left pleural effusion were observed.; Test Date: 20210609; Test Name: Chest image; Result Unstructured Data: Test Result:abnormal shadow; Test Date: 20210620; Test Name: Image; Result Unstructured Data: Test Result:perforation of sigmoid colon; Test Date: 20210605; Test Name: Neut; Test Result: 90.5 %; Test Date: 20210605; Test Name: PaO2; Result Unstructured Data: Test Result:92 mmHg; Comments: (unit: torr)on O2 with 6 l/min., hypoxaemia; Test Date: 20210605; Test Name: WBC; Result Unstructured Data: Test Result:12920 /mm3; Comments: (unit /ul)
CDC Split Type: JPPFIZER INC202101036732

Write-up: acute respiratory distress syndrome; lower abdominal pain started to exaggerate/perforation of sigmoid colon; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21123031. The patient was a 77-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no specific family history. Medical history included cardiac disease (the patient regularly went to hospital and received the treatment for atrial fibrillation and chronic cardiac failure) and prostatic hyperplasia. The patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 28May2021 at 10:23 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. On 04Jun2021 (seven days after the vaccination), the patient was admitted to the reporter hospital. On 05Jun2021 at 12:13 (eight days after the vaccination), the patient experienced acute respiratory distress syndrome. On 25Jun2021 (twenty-eight days after the vaccination), the patient died and was discharged from hospital. The outcome of event Perforation colon was unknown. The patient died on 25Jun2021 due to acute respiratory distress syndrome. It was unknown if an autopsy was performed. The course of the event was as follows: In the morning of 04Jun2021, rapid chills, shivering and pyrexia occurred. On 05Jun2021, chills, dizziness and visual hallucination presented, and due to pyrexia at 40 degrees in Celsius, an ambulance was called. The patient was admitted to the reporter hospital. White blood cell (WBC) at 12920/ul (mm3), neutrophil (Neut) at 90.5 %, C-reactive protein (CRP) at 6.20 mg/dL, hemoglobin A1c (HbA1c) at 6.9 %, partial pressure of oxygen (PaO2) at 92 torr (mmHg) on oxygen (O2) at six liters per minute, and was hypoxaemia. Chest image showed post-resection of left upper lobe, decreased volume of bilateral lungs due to enlarged non-segmental infiltrative shadow and ground-glass opacity. Left atrial enlargement and small amount of left pleural effusion were observed. The patient was in the state of acute respiratory distress syndrome and received steroid pulse therapy. The patient became afebrile, but hypoxaemia exacerbated and on 07Jun2021, endotracheal intubation and respiratory management began. On 09Jun2021, the patient was on O2 at three liters per minute and weaned off the respiratory management. However, abnormal shadow on chest image waxed and waned and hypoxaemia prolonged. On 19Jun2021, lower abdominal pain started to exaggerate. Image on 20Jun2021 showed perforation of sigmoid colon. The patient was treated with antibacterial drugs. On 24Jun2021, chills and shivering became unstable and lung lesion exacerbated. On 25Jun2021, the patient died. The reporting physician classified the event as serious (hospitalization, death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was an old age male who had been aware of aspiration to some degree. Image in Feb2021 slightly showed infiltrative shadow and reticular shadow of bilateral pulmonary lower lobe periphery. On hospitalization in Jun2021, serum myeloperoxidase-anti-neutrophil cytoplasmic antibody was positive with low value of 4.5 (less than 3.5) IU/mL. The patient got acute respiratory distress syndrome seven days after the first dose of vaccination, had twenty-one days of hospitalization course and died. Other elements to cause acute respiratory distress syndrome were not identified. Inoculation of Comirnaty and exacerbation of lung lesion had an anteroposterior relation and it was necessary to consider as the adverse events.; Reported Cause(s) of Death: acute respiratory distress syndrome


VAERS ID: 1589978 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Depressed level of consciousness, Dysphagia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 7
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: Medical History/Concurrent Conditions: Gallbladder cancer (had been pointed out for some years); Senile dementia (SDAT4/B2(4:care required all the time, B2:bedridden,capable to ride a wheel chair with nursing care))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101037032

Write-up: depressed level of consciousness; Appetite completely lost; swallowing reflex also lost; This is a spontaneous report from a contactable physician received from the regulatory autority. Regulatory authority report number is v21123065. A 97-year and 1-month-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jun2021 13:00 (Lot Number: EY2173; Expiration Date: 31Aug2021, at the age of 97-year and 1-month-old) as single dose for covid-19 immunisation. Medical history included senile dementia of Alzheimer type (SDAT) 4/B2 (4: care required all the time, B2: bedridden, capable to ride a wheel chair with nursing care), gallbladder cancer (had been pointed out for some years). The patient''s concomitant medications were not reported. On 12Jun2021 at 17:10 (eight days after the vaccination), the patient experienced depressed level of consciousness, appetite completely lost and swallowing reflex also lost. The course of the event was as follows: Gallbladder cancer had been pointed out for some years, but there were no symptoms at all. On 12Jun2021, depressed level of consciousness. Appetite completely lost. Swallowing reflex also lost. The reporter (physician) convinced the patient family and performed (illegible) drip infusion, but no effect. Medications of magnesium oxide (MAGMITT) 2 tablets and alfacalcidol 1 tablet had been informed to administrate. On 19Jun2021 (fifteen days after the vaccination), the outcome of the events was fatal. The patient died on 19Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporter assumed that there was no other possible cause of the event such as any other diseases. The reporting physician did not provide any further comment.; Reported Cause(s) of Death: swallowing reflex also lost; Depressed level of consciousness; Appetite completely lost


VAERS ID: 1589980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Arthralgia, Body temperature, Brain natriuretic peptide, Brain natriuretic peptide increased, C-reactive protein, C-reactive protein increased, Decreased appetite, Dyspnoea exertional, Ejection fraction, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Hypoxia, Imaging procedure, Oxygen saturation, PaO2/FiO2 ratio, Pneumonia, Respiratory failure, Sputum purulent, White blood cell count, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (broad), Neuroleptic malignant 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (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: 2021-07-25
   Days after onset: 19
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: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: 1st dose, before vaccination; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3; Comments: 2nd dose, before vaccination; Test Date: 20210714; Test Name: BNP; Result Unstructured Data: Test Result:309.8 pg/mL; Test Date: 20210714; Test Name: CRP; Test Result: 25.61 mg/dl; Test Name: LVEF; Test Result: 20 %; Comments: Cardiac failure chronic; Test Date: 20210714; Test Name: HbA1c; Test Result: 6.6 %; Test Date: 20210714; Test Name: Chest images; Result Unstructured Data: Test Result:ground glass and infiltrative shadows; Comments: extensive non-segmented ground glass and infiltrative shadows in the bilateral lungs with a background of strong emphysematous changes and a strong tendency for contraction and collapse in the subpleural alveolar region; Test Date: 20210714; Test Name: SpO2; Test Result: 84 %; Comments: Hypoxaemia; Test Date: 202107; Test Name: SpO2; Result Unstructured Data: Test Result:less than 90 %; Comments: measured at home; Test Date: 20210714; Test Name: paO2/fiO2; Result Unstructured Data: Test Result:about 90; Comments: Acute respiratory distress syndrome; Test Date: 202107; Test Name: paO2/fiO2; Result Unstructured Data: Test Result:150; Test Date: 20210714; Test Name: WBC; Result Unstructured Data: Test Result:11660 /mm3
CDC Split Type: JPPFIZER INC202101037172

Write-up: This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21123032. The patient was an 81-year-old male. Body temperature before vaccination was 36.3 degrees centigrade on 05Jul2021, 36.4 degrees centigrade on 14Jun2021. Family history: no special notes. Medical history included heart disease (cardiac failure chronic with left ventricular ejection fraction (LVEF) of 20%). Concomitant medication included edoxaban tosilate (LIXIANA). On 14Jun2021 at 15:46, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY5420, Expiration date: 31Aug2021) for COVID-19 immunization. On 05Jul2021 at 14:55 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5829, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 14Jul2021 at 11:05 (8 days, 20 hours and 10 minutes after the vaccination), the patient experienced acute respiratory distress syndrome with paO2/fiO2 of about 90. On 14Jul2021 (9 days after the vaccination), the patient was admitted to the hospital. On 25Jul2021 (20 days after the vaccination), the outcome of this event was fatal. The course of the event was as follows: On 06Jul2021, shoulder pain and loss of appetite occurred, and dyspnoea on exertion gradually aggravated. On 14Jul2021, the patient was admitted to the reporting hospital from the emergency department of the hospital. The patient had hypoxaemia with SpO2 in room air of 84%. The patient had previously had cardiac failure chronic with LFEF of 20%. WBC was 11660/uL, CRP was 25.61 mg/dL, BNP was 309.8 pg/mL, and HbA1c was 6.6%. Chest images showed extensive non-segmented ground glass and infiltrative shadows in the bilateral lungs with a background of strong emphysematous changes and a strong tendency for contraction and collapse in the subpleural alveolar region. The patient had acute respiratory distress syndrome with paO2/fiO2 of about 90, and treatment was started with endotracheal intubation, respiratory management, and high-dose corticosteroid. Although the acute inflammatory findings improved, paO2/fiO2 did not improve from 150 in Jul2021. On the evening of 23Jul2021, sputum purulent sharply increased, and ventilator associated pneumonia occurred. The patient was treated with antibiotics; however, he did not respond to them. On 25Jul2021, the patient died. It was unknown if autopsy was done. The reporting physician classified the event as serious (hospitalization) and assessed the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was a late-stage elderly man, who apparently had never had aspiration. Immediately after the second vaccination, the patient experienced loss of appetite, and SpO2 measured at home was less than 90% in Jul2021. The patient was poorly responsive to medical treatment, high-dose corticosteroid, and experienced respiratory failure death on 25Jul2021 due to combined ventilator associated pneumonia while a respiratory management was being continued. In this clinical course, other factors contributing to acute respiratory distress syndrome were not identified. There was a temporal relationship between the vaccination and the symptoms, and it was necessary to consider them as adverse events. The outcome of events Acute respiratory distress syndrome, Ventilator associated pneumonia, Respiratory failure death were fatal, outcome of other events were unknown.; Reported Cause(s) of Death: Respiratory failure death; Acute respiratory distress syndrome with paO2/fiO2 of about 90; Ventilator associated pneumonia


VAERS ID: 1589981 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Aspiration, Blood creatinine, Body temperature, Brain natriuretic peptide, C-reactive protein, Imaging procedure, Neutrophil count, Oxygen saturation, PO2, White blood cell count
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Creatinine (CRTN); Test Result: 1.80 mg/dl; Test Date: 20210630; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before the first COVID-19 vaccination; Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before the second COVID-19 vaccination; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210801; Test Name: BNP; Result Unstructured Data: Test Result:541.2 pg/mL; Test Date: 20210801; Test Name: CRP; Test Result: 2.44 mg/dl; Test Date: 20210801; Test Name: Chest images; Result Unstructured Data: Test Result:extensive abnormal shadows; Test Date: 20210801; Test Name: Neut; Test Result: 86.6 %; Test Date: 20210801; Test Name: SpO2; Test Result: 70 %; Comments: aggravated hypoxaemia; Test Date: 20210801; Test Name: paO2; Result Unstructured Data: Test Result:58; Comments: torr; with oxygen given at 10 L per minute; Test Date: 20210801; Test Name: WBC; Result Unstructured Data: Test Result:1410 /mm3
CDC Split Type: JPPFIZER INC202101037854

Write-up: aspiration; Acute respiratory distress syndrome; This is a spontaneous report from a contactable physician. This is the 1st of 2 reports, for the second dose. The first report is received from the regulatory authority. Regulatory authority report number is v21123030. An 89-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration at age of 89 years old on 21Jul2021 (Lot Number: FC8736; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac disease. Body temperature was 36.6 degrees Centigrade before the first vaccination on 30Jun2021 and was 36.6 degrees before the second vaccination on 21Jul2021. The patient had no family history. Concomitant medication included oral rivaroxaban (XARELTO). On 30Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient developed pyelonephritis within 1 month of the first COVID-19 vaccination. The patient experienced acute respiratory distress syndrome on 01Aug2021 20:51, aspiration on an unspecified date. The patient was hospitalized for events acute respiratory distress syndrome and aspiration from 01Aug2021 to 03Aug2021. Therapeutic measures were taken. The patient died on 03Aug2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: On 26Jul2021 (5 days after the vaccination), (masking). On 01Aug2021 at noon (11 days after the vaccination), the patient presented with nausea, chest tightness and pyrexia of more than 37 degrees Centigrade (38.9 Centigrade on 02Aug2021), for which antimicrobial agent was administered via intravenous drip infusion. At approximately 17:00, the patient began to have increased dyspnoea, and aggravated hypoxaemia at 70% of oxygen saturation (SpO2). The patient was transported to emergency department of the reporting physician''s hospital and hospitalized there. Laboratory data included that on 01AUG2021: white blood cell count (WBC) was 1410/uL, neutrophils (Neut) 86.6%, C-reactive protein (CRP) 2.44 mg/dL, Creatinine (CRTN) 1.80 mg/dL, brain natriuretic peptide (BNP) 541.2 pg/mL, and partial pressure of arterial oxygen (paO2) 58 torr with oxygen given at 10 L per minute; that represented acute respiratory distress syndrome. Chest images showed extensive abnormal shadows. On 02Aug2021 (12 days after the vaccination), the patient was transferred to the respiratory medicine. He received methylprednisolone (mPSL) at 500 mg for steroid pulse therapy. Five hours later, the patient had chills, shivering and pyrexia of 38.9 degrees Centigrade. Without improvement, the patient died on 03Aug2021 (13 days after the vaccination). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101042398 same source and patient, different drug(1st dose) and event; Reported Cause(s) of Death: Acute respiratory distress syndrome; aspiration


VAERS ID: 1589982 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Discomfort, Electrocardiogram
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: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Initial rhythm showed asystole
CDC Split Type: JPPFIZER INC202101039136

Write-up: cardio-respiratory arrest; the left shoulder felt heavy; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21123064. A 57-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: FC3661, Expiration Date: 30Sep2021) at single dose on 06Jul2021 at the age of 57-year-old for COVID-19 immunization. Body temperature before vaccination was unknown. Medical history included hypertension. The patient had mother and younger brother. Concomitant medication was not reported. On 07Jul2021 (1 day of after the vaccination), sensation of heaviness of the shoulder appeared. On 08Jul2021 (2 days of after the vaccination), the patient developed cardio-respiratory arrest and died on 08Jul2021. The course of the events was as follows: On 07Jul2021, the patient complained that the left shoulder felt heavy and he wanted to apply a compress. On 08Jul2021 at 12:40, the patient''s mother confirmed that the patient returned home from outside. It was confirmed for the last time that he was fine. At 14:20, the mother found that the patient collapsed in a room and called an ambulance. At 14:53, the patient was transferred to the reporter''s hospital by an ambulance. Initial rhythm showed asystole on electrocardiogram. Adrenaline 8 ampules in total was administered. For 40 minutes, resuscitation was performed. However, spontaneous circulation was not returned. At 03:43, the patient''s death was confirmed. It was not reported if an autopsy was performed. The outcome of event cardio-respiratory arrest was fatal. The outcome of rest event was unknown. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. The seriousness assessment for the event was unknown. The reporting physician commented as follows: The patient was transferred to a hospital in a state of cardio-respiratory arrest, so the causal relationship with BNT162b2 was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1589983 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Dysphagia, General physical health deterioration
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGMITT; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Cerebral infarction; Senility (IV/C1); Uterine cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101039144

Write-up: appetite impaired; loss of swallowing reflex; Reduced general condition; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21123067. The patient was a 94-year and 9-month-old female (age at vaccination was 94-year and 9-month old). Body temperature before vaccination was 35.5 degrees centigrade on 11May2021. Family history was not reported. Medical history included cerebral infarction, operation for uterine cancer, and geriatric syndrome (IV/C1). Concomitant medication included oral magnesium oxide (MAGMITT) and oral warfarin 1 mg, taken for unspecified indications, started in May2020 and were ongoing. On 20Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunization. On 11May2021 at 13:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at around 11:00 (29 days 22 hours after the vaccination), the patient experienced appetite impaired and loss of swallowing reflex. On 09Jul2021 (59 days after the vaccination), the patient died. It was unknown if an autopsy was done. The course of the event was as follows: On 10Jun2021, the patient developed appetite impaired and loss of swallowing reflex. Terminal care and forced feeding were refused from the beginning, and the patient died of reduced general condition. Since May2020, the patient has been hospitalized and medications administered included MAGMITT (illegible) and WARFARIN 1 mg (illegible). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was presumably no other possible cause of the event such as any other diseases. The outcome of the events appetite impaired and loss of swallowing reflex was unknown. ; Reported Cause(s) of Death: Reduced general condition


VAERS ID: 1589984 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Chest X-ray, Depressed level of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphagia; Gavage (gastric tube); Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101039169

Write-up: Depressed level of consciousness; cardiac arrest; pyrexia at 38.3 degrees; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21123068. The patient was a 95-year and 5-month-old female. Age at vaccination was 95-year and 5-month-old. Body temperature before vaccination was 36.5 degrees centigrade on 02Jul2021. The patient family history was not reported. Medical history included senile dementia, senile syndrome, gavage by gastric tube, aphagia, 4/C2. On 10Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported) for COVID-19 immunization. On 02Jul2021 at 13:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jul2021 at 06:00 (six days after the vaccination), the patient experienced pyrexia. On 12Jul2021 (ten days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 08Jul2021, pyrexia at 38.3 degrees in celsius occurred. Penicillin was administered but no effect. Depressed level of consciousness. The patient got cardiac arrest. No problem on chest x-ray. Medication being taken was only magnesium oxide (MAGMITT) 2 tablets per day. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporter assumed that there was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient was fed by gastric tube due to aphagia, she could communicate on admission in Jun2021.; Reported Cause(s) of Death: Depressed level of consciousness; cardiac arrest; pyrexia


VAERS ID: 1589985 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Feeding disorder, Lethargy
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 7
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: Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101039184

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123066. The patient was a 90-year and 11-month-old female. Body temperature before vaccination was 35.6 degrees centigrade on 04Jun2021. Family history and concomitant medication were not reported. Medical history included senile dementia (SDAT) (IV/C1). On 04Jun2021 at 13:00 (the day of vaccination), the patient aged 90 received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY2173, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 at an unknown time (12 days after the vaccination), the patient experienced unable to ingest orally. On 19Jun2021 (15 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: On 12Jun2021 around 08:30, the patient experienced depressed level of consciousness and had an absent response to meal assistance. No pyrexia was noted. The patient progressed to a lethargic state. Oral intake continued to wax and wane. On 16Jun2021, eventually, the patient was unable to ingest orally. Forced nutrition was rejected. On 19Jun2021, the patient died. During the clinical course, only Pico sulfate was administered. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician assumed that there was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Unable to ingest orally; Depressed level of consciousness; Lethargic state.


VAERS ID: 1589986 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiac arrest, Cerebral arteriosclerosis, Emphysema, Fall, Pneumothorax, Traumatic haemothorax
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101042069

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123184. An 85-year-old male patient received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: EY3860, expiration date: 31Aug2021) via an unspecified route of administration on 30Jun2021 at age of 85-year-old for COVID-19 immunisation. Medical history and concomitant medications were not reported. Body temperature before vaccination and family history were unknown. It was unknown whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Jul2021 at an unknown time (6 days after the vaccination), the patient experienced pneumothorax resulting from emphysema. On 06Jul2021 at 10:27 (6 days after the vaccination), the outcome of the event was fatal. Autopsy was performed, and the cause of death was determined as haemopneumothorax due to rupture of emphysematous bulla. It was reported that the event pneumothorax resulting from emphysema required emergency room visit. The course of the event was as follows: On 30Jun2021 (the day of vaccination), the patient received a vaccination against the new coronavirus. On 06Jul2021 after breakfast (6 days after the vaccination), the patient was said to have suddenly fallen down while waiting at home for the daycare staff to pick him up. He was transported to the hospital but developed cardiac arrest. Resuscitation was unsuccessful, and he was confirmed dead. Unknown cause of death led to administrative autopsy done on 07Jul2021. Haemopneumothorax due to rupture of emphysematous bulla was diagnosed as the cause of death. Other findings included coronary arteriosclerosis and basilar arteriosclerosis (advanced). The reporting physician classified the event pneumothorax resulting from emphysema as serious (death) and assessed the causality between the event pneumothorax resulting from emphysema and BNT162b2 as unassessable. Other possible causes of the event pneumothorax resulting from emphysema such as any other diseases included coronary arteriosclerosis. The reporting physician commented as follows: Details about the causal relationship with rupture of bulla were unknown. Outcome of Pneumothorax resulting from emphysema/ Haemopneumothorax due to rupture of emphysematous bulla was fatal, of cardiac arrest was not recovered, of the other events was unknown.; Reported Cause(s) of Death: Haemopneumothorax due to rupture of emphysematous bulla; Haemopneumothorax due to rupture of emphysematous bulla; Autopsy-determined Cause(s) of Death: Haemopneumothorax due to rupture of emphysematous bulla; Haemopneumothorax due to rupture of emphysematous bulla; coronary arteriosclerosis; basilar arteriosclerosis (advanced)


VAERS ID: 1589988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101056638

Write-up: Ventricular tachycardia; ventricular arrhythmia; cardio-respiratory arrest; This is a spontaneous report from a contactable nurse received via Medical information group. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0843; Expiration Date: 31Oct2021), via an unspecified route of administration on 11Aug2021 (the day of vaccination), as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 15Aug2021 at 01:25 (4 days after the vaccination), the patient experienced ventricular tachycardia. The course of the event was as follows: On 11Aug2021, the patient received the vaccine. Subsequently, the patient had no marked adverse reaction. On 15Aug2021 at 01:25, the patient suddenly experienced ventricular tachycardia, which is a ventricular arrhythmia, resulting in cardio-respiratory arrest. One hour later at 02:35, death was confirmed. The cause of death was due to ventricular tachycardia, ventricular arrhythmia and cardio-respiratory arrest On 15Aug2021 (4 days after the vaccination) the events was fatal. The reporting nurse assessed that the causality between the event and BNT162b2 as unassessable. The reporting nurse commented as follows: According to the primary physician, it was not clear whether the event was caused by the vaccine. Complication involving cardiac muscle due to the vaccine could not be denied and causality was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events Ventricular tachycardia, Ventricular arrhythmia and Cardio-Respiratory arrest and the suspect drug BNT162B2. 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: ventricular arrhythmia; cardio-respiratory arrest; Ventricular tachycardia


VAERS ID: 1590098 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain herniation, Cerebral haemorrhage, Chills, Meningitis, Physical deconditioning, Restlessness, Thrombocytopenic purpura, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: 2021-08-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072379

Write-up: Meningitis (decerebrate rigidity); Thrombosis with thrombocytopenia; Brain herniation; Cerebral hemorrhage; Thrombocytopenic purpura; Restlessness; Physical deconditioning; Chills; This case was received via Regulatory Authority (Reference number: 2021TJP072379) on 11-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the RA (Ref, v21122858). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: Unknown. On 03-Aug-2021, the patient received the 2nd dose of this vaccine. On 04-Aug-2021, in the morning, the patient had physical deconditioning and rested at home. At 18:00, chills developed. At 20:00, the patient had restlessness and was taken to a hospital by ambulance. On arrival, JCS/100, BT: 38.3 degrees Celsius, and SPO2: 97% (10 L of O2 mask). Decerebrate rigidity was noted, and meningitis was suspected. Cerebrospinal fluid test showed no increase in cell count. Thereafter, bleeding tendency became significant. Platelets decreased. thrombosis with thrombocytopenia (TTS) after the vaccination was suspected. It was considered to be thrombocytopenic purpura. Steroid pulse IVIG and plasma exchange were performed, but no improvement was noted. Brain herniation due to cerebral hemorrhage was suspected. On 09-Aug-2021, the patient died. The outcome of physical deconditioning, chills, restlessness, meningitis (decerebrate rigidity), thrombosis with thrombocytopenia, thrombocytopenic purpura, brain herniation, and cerebral hemorrhage was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The causal relationship with the vaccine is questionable.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Additional information required.; Reported Cause(s) of Death: Physical deconditioning; Chills; Unrest; Meningitis; Thrombosis; Thrombocytopenic purpura; Brain herniation; Cerebral hemorrhage


VAERS ID: 1590108 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: breathing difficulty; thrombosis; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing difficulty) and THROMBOSIS (thrombosis) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced THROMBOSIS (thrombosis) (seriousness criteria death, hospitalization and medically significant). On 31-Jul-2021, the patient experienced DYSPNOEA (breathing difficulty) (seriousness criteria death and hospitalization). The patient was hospitalized on 31-Jul-2021 due to DYSPNOEA and THROMBOSIS. The patient died on 07-Aug-2021. The reported cause of death was breathing difficulty and Thrombosis. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: breathing difficulty; thrombosis


VAERS ID: 1590349 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038822

Write-up: Not feeling well; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00658355. An 86-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, on 06Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no Previous COVID-19 infection. Past drug therapy was unknown. On 08Feb2021 the patient was not feeling well following administration of covid-19 vaccine Pfizer. Onset latency: 2 days after start of vaccine. The patient was died on 13Feb2021. The cause of death was unknown. It was unknown if an autopsy was performed. Reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty); Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown, available: yes; Previous COVID-19 infection: No The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1590585 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 231C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, COVID-19, Cough, Decreased appetite, Malaise, Pyrexia, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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 Date: 20210801; Test Name: SARS-CoV-2 rapid antibody test; Result Unstructured Data: positive
CDC Split Type: PHJNJFOC20210824925

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300097137] concerned a 67-year-old male male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 231C21A and expiry: unknown) dose was not reported,1 total administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the patient already had fever. On 23-JUL-2021, the patient had cough and loss of taste. On 24-JUL-2021 (same day of vaccination), the patient had loss of appetite, and body malaise. On 01-AUG-2021, the patient tested covid-19 positive (SARS-CoV-2 rapid antibody test positive). On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19 positive, cough, loss of taste, loss of appetite, body malaise and fever on an unspecified date. This report was serious (Death); Sender''s Comments: V0: 20210824925-COVID-19 VACCINE AD26.COV2.S-COVID-19 positive, loss of appetite, body malaise. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210824925-COVID-19 VACCINE AD26.COV2.S-fever, cough, loss of taste. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1590609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Coronary artery thrombosis, Electrocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 3
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: Paroxysmal atrial fibrillation; Prostate cancer; Prostatectomy; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:revealed occlusions/ distal embolization in the di; Comments: revealed occlusions/ distal embolization in the distal part of the left anterior descending coronary artery, in the first diagonal branch, and in the distal part of the dominant right coronary artery, with large thrombus; Test Name: Coronary angiography; Result Unstructured Data: Test Result:What is noteworthy, full patency of the left anter; Comments: What is noteworthy, full patency of the left anterior descending coronary artery and first diagonal branch, and no signs of previous thrombus were observed in the control left coronary artery angiogram; Test Name: electrocardiogram; Result Unstructured Data: Test Result:acute ST-segment elevation myocardial infarction o; Comments: acute ST-segment elevation myocardial infarction of the inferior wall was diagnosed
CDC Split Type: PLPFIZER INC202101042391

Write-up: This is a literature report from JACC: Cardiovascular Interventions, 2021, vol 14 (9); pgs e103-e104 (DOI: 10.1016/j.jcin.2021.03.003) entitled Acute Coronary Tree Thrombosis After Vaccination for COVID-19. The author would like to present a clinical case of a serious adverse event, possibly linked to 1 of the vaccines for COVID-19. An 86-year-old man with a history of prostate cancer treated with prostatectomy and radiotherapy in 2006 and, until recently, with androgen receptor inhibitor (enzalutamide), had paroxysmal atrial fibrillation (treated with apixaban 2.5 mg twice a day), without any previous allergies to drugs or vaccines, was qualified to receive vaccination for COVID-19. On January 27, 2021, the patient received the first dose of Pfizer-BioNTech vaccine. Approximately 30 min after the injection, the patient collapsed. Based on electrocardiogram findings, acute ST-segment elevation myocardial infarction of the inferior wall was diagnosed (Figure 1A, Electrocardiogram (ECG) on admission) and was referred to the author''s center. On admission, the patient was unconscious, with clinical and hemodynamic signs of cardiogenic shock and recurrent bradyarrhythmias. Coronary angiography revealed occlusions/ distal embolization in the distal part of the left anterior descending coronary artery, in the first diagonal branch, and in the distal part of the dominant right coronary artery, with large thrombus (Figures 1B, initial left coronary artery angiography with occlusion of the left anterior descending artery and the first diagonal branch (arrows) and 1C, initial right coronary artery angiography with large thrombus (arrow)). The primary percutaneous coronary intervention of the right coronary artery with manual aspiration thrombectomy was performed, along with coronary balloon angioplasty and glycoprotein IIb/IIIa receptor inhibitor (eptifibatide) administration, resulting in coronary flow improvement (Figure 1D, right coronary artery after percutaneous coronary intervention). What is noteworthy, full patency of the left anterior descending coronary artery and first diagonal branch, and no signs of previous thrombus were observed in the control left coronary artery angiogram (Figure 1E, control angiography of the left coronary artery). This could be related to the very short time between the thromboembolic event and the treatment. Unfortunately, on January 30, 2021, the patient died. Although it is not possible to ascertain a causal relationship between vaccination and cardiac events, it is important to remember that that the mechanisms of thrombotic events in COVID-19 are still poorly understood. Moreover, the Kounis syndrome-as an adverse event after vaccination-may also be a possible explanation for the presented clinical situation. Therefore, the presented case of triple coronary artery thrombosis in a patient recently vaccinated against COVID-19 may provide a causative link between those facts. The study was approved by an appropriate Institutional Review Board. Information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available information, pathogenesis of disease and known product profile, the causal relationship between the reported Coronary artery thrombosis and the use of BNT162B2 is unlikely. The abrupt presentation of the triple coronary artery thrombosis after vaccination does not seem to be biologically plausible and may likely be due to some underlying condition which developed over time. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: triple coronary artery thrombosis


VAERS ID: 1590615 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dysarthria, Dyspnoea
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101038816

Write-up: ICD-10 I46 Cardiac arrest; R96 Other sudden death, cause unknown; Dyspnoea / shortness of breath; slurred speech; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PL-URPL-3-854-2021]. A 72-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 30Jun2021 at 11:54 (Lot Number: FD8274; Expiration Date: 30Oct2021) at the age of 72-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 02Jul2021 at 3:50 am, the ambulance doctor pronounced death. Cause of death I46 cardiac arrest, R96 other sudden death due to unknown cause. Call to the patient for shortness of breath and slurred speech. Dyspnoea, slurred speech, and cardiac arrest on the second post-vaccination day are unexpected side effects of the Comirnaty vaccine. An anaphylactic reaction cannot be ruled out, but it is unlikely to occur on the second day after vaccination (anaphylaxis usually occurs several to several minutes after vaccination). Due to the insufficient amount of information (including the unknown cause of death), a cause-and-effect relationship has not been assessed. Privacy was reported as death occurred less than 48 hours after vaccination. There was a time relationship between the administration of the vaccine and the onset of symptoms (which was the reason for the reporting of the event). The reporting person classified them as severe. URPL also classified the application as heavy. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ICD-10 R96 Other sudden death, cause unknown; ICD-10 I46 Cardiac arrest


VAERS ID: 1590617 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-01
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Angiogram, Arteriosclerosis, Arteriosclerosis coronary artery, Cardiac arrest, Coronary artery stenosis, Dyspnoea, Electrocardiogram, Left ventricular failure, Pulmonary oedema, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: AMOKSIKLAV 2S; NOVOMIX; EUTHYROX N; NEDAL; TORVACARD; GLUCOPHAGE FORTE; POLAPRIL; INDAPEN SR; STEPCIL
Current Illness: Arterial hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Hypothyroidism; Obesity; Surgery (state after thyroid surgery due to lump (goiter)); Surgery (resection of the lump of the left vocal fold); Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Angiography; Result Unstructured Data: critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions; Test Date: 20210602; Test Name: ECG; Result Unstructured Data: recent myocardial infarction
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe; LAD: severe calcifications; sudden cardiac arrest in the mechanism of asystole; LAD: disseminated critical atherosclerotic lesions; sudden cardiac arrest in the mechanism of asystole; critical coronary vasoconstriction; Pulmonary oedema; left ventricular damage; Kidney failure; Acute respiratory failure; This case was received via Regulatory Authority. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure), ACUTE RESPIRATORY FAILURE (Acute respiratory failure), ARTERIOSCLEROSIS (LAD: severe calcifications), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), LEFT VENTRICULAR FAILURE (left ventricular damage), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions), PULMONARY OEDEMA (Pulmonary oedema), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole), CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) and DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Thrombosis, Hypothyroidism, Arteriosclerosis, Obesity, Surgery (resection of the lump of the left vocal fold) in 2012 and Surgery (state after thyroid surgery due to lump (goiter)) in 1992. Concurrent medical conditions included Arterial hypertension and Type II diabetes mellitus. Concomitant products included RAMIPRIL (POLAPRIL) for Arterial hypertension, AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOKSIKLAV 2S) from 02-Jun-2021 to 08-Jun-2021 for Dyspnea, CILOSTAZOL (STEPCIL) for Thrombosis, INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) and METFORMIN HYDROCHLORIDE (GLUCOPHAGE FORTE) for Type II diabetes mellitus, LEVOTHYROXINE SODIUM (EUTHYROX N), NEBIVOLOL HYDROCHLORIDE (NEDAL), ATORVASTATIN CALCIUM (TORVACARD) and INDAPAMIDE (INDAPEN SR) for an unknown indication. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. In June 2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criteria death, hospitalization and medically significant), ACUTE RESPIRATORY FAILURE (Acute respiratory failure) (seriousness criteria death, hospitalization and medically significant), LEFT VENTRICULAR FAILURE (left ventricular damage) (seriousness criteria death, hospitalization and medically significant) and PULMONARY OEDEMA (Pulmonary oedema) (seriousness criteria death, hospitalization and medically significant). On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced ARTERIOSCLEROSIS (LAD: severe calcifications) (seriousness criteria death and hospitalization), the first episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant), ARTERIOSCLEROSIS CORONARY ARTERY (LAD: disseminated critical atherosclerotic lesions) (seriousness criteria death and hospitalization), the second episode of CARDIAC ARREST (sudden cardiac arrest in the mechanism of asystole) (seriousness criteria death, hospitalization and medically significant) and CORONARY ARTERY STENOSIS (critical coronary vasoconstriction) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Approximately 1 month after the 2nd dose of the vaccine - oppressive breathlessness; 22/06/2021 - exacerbation of shortness of breath, she could not breathe) (seriousness criteria death and hospitalization). The patient died on 23-Jun-2021. The reported cause of death was sudden cardiac arrest in the mechanism of asystole. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Electrocardiogram: abnormal (abnormal) recent myocardial infarction. On 23-Jun-2021, Angiogram: abnormal (abnormal) critical coronary vessel narrowing; LAD: severe calcifications; LAD: disseminated critical atherosclerotic lesions. Treatment medication was not provided by the reporter Company Comment: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of death of a 72-year-old female patient after receiving unknown dose of vaccine on 16-APR-2021 (Lot number 3001442). Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: sudden cardiac arrest in the mechanism of asystole


VAERS ID: 1590618 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; TELMISARTAN - TABLET
Current Illness: Allergy to venom (allergy to bee venom (swelling)); Benign spinal cord neoplasm NOS (benign tumor in the spinal cord (neck region)); Cholesterol high; Chronic obstructive pulmonary disease (in the past treated for chronic obstructive pulmonary disease); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Neurologist consultation
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210826949

Write-up: THE PATIENT DIED. SUDDEN CARDIAC ARREST OCCURRED; R.96. SUDDEN UNEXPLAINED DEATH; BRUISE AT THE VACCINATION SITE (DIAMETER 4 CM); This spontaneous report received from a consumer via a Regulatory Authority [PL-URPL-DML-MLP.4401.2.513.2021] concerned a 66 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: neurologist consultation, and concurrent conditions included: chronic obstructive pulmonary disease (in the past treated for chronic obstructive pulmonary disease), benign spinal cord neoplasm NOS (not otherwise specified) [benign tumor in the spinal cord (neck region)], allergy to venom [allergy to bee venom (swelling)], cholesterol high, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included Zahron (rosuvastatin) for cholesterol high, and Telmisartan for hypertension. On 09-JUN-2021, the patient experienced bruise at the vaccination site (diameter 4 cm). On 14-JUL-2021, the patient experienced sudden cardiac arrest and died on the same day. The cause of death was unknown at the time of report. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden cardiac arrest on 14-JUL-2021, and the outcome of bruise at the vaccination site (diameter 4 cm) was not reported. This report was serious (Death).; Sender''s Comments: V0; 20210764579-covid-19 vaccine ad26.cov2.- Sudden cardiac arrest, Death. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: CARDIAC ARREST; SUDDEN DEATH, CAUSE UNKNOWN


VAERS ID: 1591060 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bacteraemia, Endocarditis, Heart rate, Respiratory rate, SARS-CoV-2 test, Urosepsis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypothyroidism; Incontinence
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:Rapid; Test Name: breathing pattern; Result Unstructured Data: Test Result:rapid; Test Date: 20210120; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210128; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210205; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210210; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: CAPFIZER INC202101022572

Write-up: Diagnosed with urosepsis; bacteremia; infective endocarditis.; This is a spontaneous report from a contactable consumer (reported as "patient") and other health care professional. This 89- year-old female patient (not pregnant at time of Vaccination) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 15Jan2021 11:00 via an unknown route in left arm at 89- year-old for Covid-19 immunization. Medical history included hypothyroid, dementia, and incontinence. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant drug was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, but received other medications the patient within 2 weeks of vaccination. Past drug history included known allergies with codeine. Patient experienced onset of vomiting on 20Jan2021, then low-grade fever, rapid heart rate, rapid breathing pattern, steady decline in health, eventually leading to hospitalization on 05Feb2021 for duration of 13 days. Patient was diagnosed with urosepsis, bacteremia and eventually infective endocarditis. Treatment received included IV treatment and cardiac care. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No hospitalization prolonged applied. The event onset date was 20Jan2021. Lab data included Nasal Swab on 20Jan2021, 28Jan2021, 05Feb2021, 10Feb2021: all negative. Patient died on 17Feb2021. Outcome of the events was fatal.; Sender''s Comments: The events of Urosepsis, bacteremia and Endocarditis are assessed as possibly related to the suspect drugBNT162B2 based on temporal association, but consider also possible contributory effects from patient''s medical history and/or concomitant medications 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: urosepsis; bacteremia; infective endocarditis


VAERS ID: 1591118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute fatty liver; Enlargement heart (590 g); Extravasation blood (Hemorrhage under the dura mater right half of the cranial cavity, left temporal muscle, ...); Uterine myoma (Malignant neoplasm of uterine muscle (fibroid))
Preexisting Conditions: Medical History/Concurrent Conditions: Brain swelling (1260 g; with occipital pressure cone); Heart valve replacement; Ligament disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101038605

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number CZ-CZSUKL-21009282. A 47-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EY3014) intramuscular on 08May2021 at single dose for COVID-19 immunisation. Medical history - autopsy report included biological heart valve replacement (stopped), condition after surgical replacement of the crescent valve of the heart and part of the thoracic heart: ongoing extravasation blood (Hemorrhage under the dura mater in the right half of the cranial cavity (48 g), hemorrhage in the left temporal muscle, hemorrhages in the soft skulls (in the left parietal region and in the parietal occipital region in the midline) and subcutaneous hemorrhages on the trunk, upper and lower limbs), ongoing uterine myoma (Malignant neoplasm of uterine muscle (fibroid)), ongoing enlargement heart (Swelling and dilation of the heart (590 g)), swelling of the brain (1260 g) with occipital pressure cone stopped, ongoing acute fatty liver, and ligamentous adhesions of the left lung with the pleura. There were no concomitant medications. The patient experienced acute infectious inflammation biological replacement of the crescent valve (death, disability, medically significant, life threatening, congenital anomaly) on 24May2021. The outcome of the event was fatal. The patient died on 24May2021. An autopsy was performed that revealed acute inflammation of the biological replacement of the crescent-shaped heart valve. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute infectious inflammation Biological replacement of the crescent valve; Autopsy-determined Cause(s) of Death: acute inflammation of the biological replacement of the crescent-shaped heart valve


VAERS ID: 1592209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardiogenic shock, Echocardiogram, Fibrin D dimer, Hyperkalaemia, Interchange of vaccine products, Off label use, Pneumonia, Pulmonary embolism, Right ventricular failure, Septic shock, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: 20210810; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Right heart failure; Test Date: 20210809; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7.59 ug/ml; Test Date: 20210810; Test Name: Troponin T; Result Unstructured Data: Test Result:0.073
CDC Split Type: DEPFIZER INC202101054540

Write-up: This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100163909. A male patient of an unspecified age received bnt162b2 (COMIRNATY) (strength: 0.3 ml), dose 2 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. First vaccination was administered with covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) on 04Mar2021 (batch unknown). On 10Aug2021 the patient experienced lung embolism. Fibrin D Dimer 7.59 ?g/ml 09Aug2021; Troponin T 0.073 10Aug2021. Transthoracic echocardiography: Right heart failure 10Aug2021. Respiratory failure - pneumonia; Sepsis - septic shock; Cardiogenic shock; Hyperkalemia; Acute kidney failure; Lung embolism. Therapeutic measures included anticoagulation, high dose catecholamines, alteplase (ACTILYSE). Differential diagnosis excluded: pneumothorax, hypoxia, myocardial infarction. The outcome was fatal for lung embolism. The outcome of other event was unknown. This event lung embolism is serious due to death, hospitalization, life threatening. The patient died on 10Aug2021. It was not reported if an autopsy was performed. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592220 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 13
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: DEPFIZER INC202101056168

Write-up: Lung embolism; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; This is a spontaneous report from an other healthcare professional downloaded from the Regulatory Authority-WEB DE-PEI-202100164946. A 83-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 83-years-old on 28Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at the age of 82-years-old on 04Mar2021(Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 10Aug2021, the patient experienced lung embolism. This report was serious - death, hospitalization, life threatening. The outcome of the event lung embolism was fatal. The patient died on 10Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592223 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   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: Alcohol abuse; Nicotine abuse; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (10 years ago); Infarct myocardial (10 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101061861

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100165267. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 (Lot Number: FE9174) as dose 1, single for COVID-19 immunization. Medical history included ongoing nicotine abuse from an unknown date, apoplexy from 2011 (reported as 10 years ago) to an unknown date (not ongoing), ongoing obesity from an unknown date, ongoing alcohol abuse from an unknown date, infarct myocardial on an unknown date in 2011 (reported as 10 years ago) to an unknown date (not ongoing). The patient''s concomitant medications were not reported. On 07Aug2021, 2 days after vaccination, the patient had an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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: Unknown cause of death


VAERS ID: 1592409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056006

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021159793, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100163364. An 89-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 29Jul2021 (Lot Number: 1F030A) as dose 2, single for covid-19 immunisation. Medical history included ongoing dementia. There was no allergies. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 08Aug2021. The patient died on 08Aug2021. An autopsy was not performed. Sender''s comments: Are you or the person affected aware of any allergies? If yes, which ones? no Information on risk factors or previous illnesses Dementia, but otherwise fit in case of vaccination / death. Result of Assessment: Comirnaty/ event(s): Unknown cause of death/ PEI: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1592410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056011

Write-up: pneumonia; Pyrexia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021159893, Safety Report Unique Identifier DE-PEI-202100163459. This is first of two reports. A 78-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing Alzheimer''s disease; ongoing high blood pressure. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and 3 days after the first dose development of high fever, generalised muscle cramps as well as severe pneumonia with strong drop in oxygen saturation - after 14 days slow improvement of health condition. The patient experienced relapse/new pneumonia, hospitalisation with medication plus oxygen administration; pyrexia. The outcome of the event pneumonia was fatal, of the event pyrexia was not recovered. The patient died on 20Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101067461 same patient, different dose; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1592431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101048486

Write-up: This is a spontaneous report from a contactable physician via COVAES. A 39-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (COMIRNATY) dose 1, single for COVID-19 immunization. The patient had no medical history. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction 5 days after second dose (death, hospitalization) on 11Aug2021 01:30. The patient was hospitalized for 1 day due to myocardial infarction, 5 days after second dose. The patient received treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or used any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Aug2021 due to myocardial infarction and cardiogenic shock. An autopsy was performed, and results were not provided. Information on the lot/batch number has been requested.; Sender''s Comments: based on the available information the fatal events and the suspected vaccine cannot be completely ruled out; Reported Cause(s) of Death: Myocardial infarction; Cardiogenic Shock.


VAERS ID: 1592437 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1DO14A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
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: Cardiac arrhythmia; Pacemaker insertion (cardiac); Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC202101067542

Write-up: This is a spontaneous report from a contactable consumer received via COVAES portal. An 87-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: 1DO14A, expiration date unknown) via an unspecified route of administration on 02Jun2021 at age of 87-year-old for COVID-19 immunisation. Medical history (previous illnesses that were treated at the clinic in Mar2021) included pulmonary embolism, inserting a pacemaker because of abnormal cardiac arrhythmias, adjustment of blood pressure and heart rate by means of medication. Patient previously received 1st dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. On 01Jul2021, patient died of the consequences of a pneumonia. On 02Jun2021, she got her second Biontech vaccination. At the time of admission to the hospital, the corona test was negative. The reporter was afraid the second Biontech vaccination weaken patient''s immune system and so she had catch pneumonia in the summer. Until patient''s death, she was treated to the complete satisfaction. However, they refused an autopsy. Patient died on 01Jul2021. Autopsy was not performed.; Reported Cause(s) of Death: consequence of a pneumonia


VAERS ID: 1592438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: DEPFIZER INC202101067665

Write-up: This is a spontaneous report from a contactable physician based on the information received by Pfizer from Biontech [manufacturer control number: 80239], license party for COMIRNATY. A 16-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration in Mar2021 (lot number and expiry date: unknown) as dose 2, single; via an unspecified route of administration in Jan2021 (lot number and expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and patient''s concomitant medications were not reported. On unspecified date, the patient was found dead in bed at the age of 16. The autopsy did not reveal any cause. Presumably had a rhythmogenic event that led to death.; Sender''s Comments: The causal relationship between bnt162b2 and the event Arrhythmia (Fatal) cannot be assessed as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: rythmogenic event led to death


VAERS ID: 1592507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Blood bicarbonate, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Electrocardiogram, Fraction of inspired oxygen, Haemoglobin, Heart rate, Investigation, Laboratory test, Lumbar puncture, Meningoencephalitis viral, Meningoradiculitis, Neurological examination, PCO2, PO2, Pharyngitis, Physical examination, Platelet count, Procalcitonin, Protein total, SARS-CoV-2 test, Scan brain, White blood cell count, pH body fluid
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 11
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: 20210810; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result:Absence of opacification of the M3-M4 segment of b; Comments: Absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met.; Test Name: HCO3; Result Unstructured Data: Test Result:26; Comments: no units reported; Test Date: 20210810; Test Name: blood glucose; Result Unstructured Data: Test Result:good; Test Name: lactic; Result Unstructured Data: Test Result:0.9; Comments: no units reported; Test Name: K; Result Unstructured Data: Test Result:4.19; Comments: no units reported; Test Date: 20210810; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: Na; Result Unstructured Data: Test Result:124; Comments: no units reported; Test Name: ECG; Result Unstructured Data: Test Result:VIRAL ENCEPHALITIS. CHEYNE-STOKES. ATELCTASIA RIGH; Test Date: 20210810; Test Name: FiO2; Result Unstructured Data: Test Result:0.35; Comments: no units reported; Test Name: Hg; Result Unstructured Data: Test Result:14; Comments: no units reported; Test Date: 20210810; Test Name: heart rate; Result Unstructured Data: Test Result:85; Comments: bpm, no murmurs; Test Name: Radiology Image; Result Unstructured Data: Test Result:Infiltrate with laminar atelectasis in the right b; Comments: Infiltrate with laminar atelectasis in the right base; Test Name: tests; Result Unstructured Data: Test Result:without significant alterations except for lymphop; Test Date: 202108; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Comments: COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Test Date: 20210730; Test Name: magnetoencephalography; Result Unstructured Data: Test Result:Unknown Results; Test Name: pCO; Result Unstructured Data: Test Result:48; Comments: no units reported; Test Name: pH; Result Unstructured Data: Test Result:7.35; Test Date: 20210810; Test Name: physical examination; Result Unstructured Data: Test Result:Abdomen: globular, soft. without masses or megalie; Comments: Abdomen: globular, soft. without masses or megalies Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT; Test Name: platelets; Result Unstructured Data: Test Result:149000; Comments: no units reported; Test Name: pO2; Result Unstructured Data: Test Result:40; Comments: no units reported; Test Name: procalcitonin; Result Unstructured Data: Test Result:normal; Test Name: TP ratio; Result Unstructured Data: Test Result:1.16; Comments: no units reported; Test Date: 20210730; Test Name: COVID-19 virus test/antigen test; Test Result: Negative ; Test Date: 20210808; Test Name: CT with no contrast; Result Unstructured Data: Test Result:no pathologies; Test Name: leucocytes; Result Unstructured Data: Test Result:4820; Comments: no units reported
CDC Split Type: ESPFIZER INC202101055775

Write-up: This is a spontaneous report from a contactable Pharmacist downloaded from the Regulatory Authority-WEB ES-AEMPS-970838. A 28-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jul2021 (Lot Number: FC1435) as DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced viral meningoencephalitis (death, hospitalization) on 30Jul2021, meningoradiculitis (death, hospitalization) on 31Jul2021, acute pharyngitis (non-serious) on 31Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included angiogram cerebral: absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met on 10Aug2021, blood bicarbonate: 26 on an unknown date, blood glucose: good on 10Aug2021, blood lactic acid: 0.9 on an unknown date, blood potassium: 4.19 on an unknown date, blood pressure measurement: normal on 10Aug2021, blood sodium: 124 on an unknown date, electrocardiogram: viral encephalitis. cheyne-stokes. atelctasia righ on an unknown date, fraction of inspired oxygen: 0.35 on 10Aug2021, haemoglobin: 14 on an unknown date, heart rate: 85 bpm on 10Aug2021; Radiology - Image: Infiltrate with laminar atelectasis in the right base on an unknown date, a battery of tests: without significant alterations except for lymphop on an unknow date, lumbar puncture: compatible with viral meningoenephalitis in Aug2021, pco2: 48 on an unknown date, CT with no contrast: no pathologies on 08Aug2021. The clinical course reported as following: on 30Jul2021, patient started with headache, magnetoencephalography and fever and an antigen test was done at the pharmacy being negative. On 31Jul2021, it was assessed in health center where they advised sueroral and paracetamol. On 31Jul2021, patient experienced sore throat, non-thermometered fever, vomiting. On 02Aug21, it was reviewed in the health center with acute pharyngitis and they advised azithromycin. On 04Aug20021, telephone contact reported headache. On 06Aug2021 06:56 home assistance reported that the headache for a week of evolution accompanied by fever and vegetative symptoms, upon they arrival, patient sitting disoriented with disturbance of attention, agitated that didn''t cooperate. Family members reported that this condition has started abruptly and has recently been in the hospital less than an hour ago. On 06Jun2021 they observed a battery of tests performed recently without significant alterations except for lymphopenia without absolute leukocytosis with hypoxemia. It was decided to transfer to the hospital with a diagnosis of probable herpetic encephalitis hospital income. Lumbar puncture. Clear liquid with fast exit rate. CSF: compatible with viral meningitis. Psychomotor agitation persists that requires sedation cursing admission in intensive care unit. Intensive Care Unit evolution as of 10Aug2021 Exploration: Overall Impression: Severe Attitude: calm, Awareness: CGS Glasgow Coma Scale M4 O3 V2 Respiratory: Spontaneous with BIPAP IPAP 16 EPAP 10 FiO2 0.35. Presents Cheyne-Stone BMV pattern Circulatory: Rhythmic at 85 bpm no murmurs Hemodynamics: Blood pressure maintained without amines. Abdomen: globular, soft. without masses or megalies. Nervous System: CGS 9 (M4 O3 V2) with preserved trunk reflexes. Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT Kidney and Internal ennvironment: D 1535 BH +2573 blood glucose levels good. Supplementary tests: Analytical - Microbiology: pH 7.35 pCO48 pO2 40 HCO3 26 lact 0.9 Leuc 4820 sec 88% Hg 14 platelets 149000 TP 1.16 ratio 1.23 Frenal normal Na 124 K 4.19 procalcitonin normal. Radiology - Image: Infiltrate with laminar atelectasis in the right base. ECG: Other Explorations. Clinical Judgment: viral encephalitis. cheyne-stokes. atelctasia right. Clinical picture compatible with symptoms of meningoencephalitis after vaccination in the AESI window period but with clinical judgement of viral meningoencephalitis. Death on 10Aug2021 with clinical judgement of viral meningoencephalitis. Patient died on 10Aug2021, it''s known if the autopsy was conducted.; Reported Cause(s) of Death: viral meningoencephalitis; Meningoradiculitis


VAERS ID: 1592598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-03-20
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Motor dysfunction, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: Memory impaired
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis of liver; Hypertension; Mental disorder NOS; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101056109

Write-up: This is a spontaneous report from a contactable consumer (patient''s father) downloaded from the Regulatory Authority-WEB FI-FIMEA-20213931. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in Jan2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included cirrhosis of liver, mentally ill, hypertension, type 2 diabetes and ongoing memory disorder from 2017. Weak but stable condition and did well at home, but in January received the 1st coronary vaccination from which the downturn began. Concomitant medication was not reported. At first, the patient swallowing became more difficult. Before, even the big drugs had been swallowed well, now they got stuck in the palate, then the legs became weak and he was sometimes "petrified", no proper contact with him could be established. In 2021, the patient experienced musculoskeletal disorder. Condition fluctuated drastically in Feb2021. Sometimes he was at home until the legs became powerless again. Went back and forth 4-5 times between home and health station. In Mar2021, the feet ceased to function completely, thus went to the department. The right hand also stopped working and there was a fever all the time against which the wide-spectrum antibiotic did not help. Eventually, the ability to swallow was lost and no hydration was given anymore when the doctor said it would be prolonging the inevitable. On 20Mar2021, the patient died. Personally, the reporter would consider that the organism of a poor-condition elderly person failed as a result of the vaccine. Until then, though, the patient was just fine and suddenly this happened after the vaccination. The cause of death was unknown. Autopsy was unknown. The outcome of limbs stiffness and motor dysfunction was unknown. The outcome of other events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown.


VAERS ID: 1592628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-30
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Hypertension arterial; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: SARS-CoV-2 test; Test Result: Negative.
CDC Split Type: FRPFIZER INC202101056097

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20213096. A 91-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Feb2021 (Lot Number: EJ 6789) as single dose for covid-19 immunisation. Medical history included cardiac failure, atrial fibrillation, hypertension, myocardial ischaemia. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 30Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Dec2020. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: unexplained death.


VAERS ID: 1592634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Activated partial thromboplastin time ratio decreased, Alanine aminotransferase, Bacterial test positive, Blood creatine phosphokinase, Blood culture, Blood electrolytes, Blood fibrinogen, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Creatinine renal clearance, Culture urine, Fall, Lactobacillus test positive, Legionella infection, Legionella test, Platelet count, Prothrombin time, Red blood cells urine, SARS-CoV-2 test, Sputum culture, Troponin, Troponin I, Urine analysis, Vaccination failure, White blood cell count, White blood cells urine
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 7
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: KARDEGIC; SIMVASTATIN; GLICAZIDA; AMLODIPINE; FUROSEMIDE; LEVEMIR; METFORMIN; INEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Acromioplasty; Algodystrophy; Rotator cuff syndrome (left)
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.02; Test Date: 20210726; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:normal; Test Date: 20210726; Test Name: CPK; Result Unstructured Data: Test Result:1645 IU/l; Test Date: 20210726; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210726; Test Name: Ionogram; Result Unstructured Data: Test Result:normal; Test Name: fibrinogen; Result Unstructured Data: Test Result:$g9.0 g/l; Test Date: 20210727; Test Name: thoracic CT with contrast; Result Unstructured Data: Test Result:Covid 19 pneumonia with moderate involvement, no s; Comments: Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia; Test Name: CRP; Result Unstructured Data: Test Result:253 mg/l; Test Date: 20210726; Test Name: CRP; Result Unstructured Data: Test Result:206 mg/l; Test Date: 20210726; Test Name: Clearance; Result Unstructured Data: Test Result:71 ml/min; Test Date: 20210726; Test Name: Urine culture; Result Unstructured Data: Test Result:positive for lactobacillus sp 10 7 CFU / ml and Es; Comments: positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml; Test Date: 20210728; Test Name: Urine culture; Result Unstructured Data: Test Result:negative initially; Test Date: 20210728; Test Name: lagionella pneumophils PCR; Test Result: Positive ; Comments: results available on 10Aug2021, twice positive; Test Date: 20210726; Test Name: legionella urinary antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Platelets; Result Unstructured Data: Test Result:180 x10 9/l; Test Date: 20210726; Test Name: Prothrombin time; Test Result: 74 %; Test Date: 20210726; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:less or equl to 5; Comments: /mm3; Test Date: 20210726; Test Name: Covid-19 virus test; Test Result: Positive ; Comments: on nasopharyngeal swab: positive with the presence of the L452 R mutation; Test Name: long culture of the input sputum; Result Unstructured Data: Test Result:positive to Legionella whose final result; Comments: positive to Legionella whose final result and phenotype are pending; Test Name: Troponin; Result Unstructured Data: Test Result:decreasing; Test Date: 20210726; Test Name: Troponin I HS; Result Unstructured Data: Test Result:4959 ng/L; Comments: normal range: <47; Test Date: 20210726; Test Name: pneumococcal urinary Antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Leukocyte count; Result Unstructured Data: Test Result:6.87 x10 9/l; Test Date: 20210726; Test Name: White blood cells urine; Result Unstructured Data: Test Result:79; Comments: /mm3
CDC Split Type: FRPFIZER INC202101056092

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211531. An 83-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular in left arm on 26Apr2021 (Lot Number: ET6956), dose 2 intramuscular in left arm on 07Jun2021 (Lot Number: FC6984), all at single dose for COVID-19 immunisation. Medical history included algodystrophy, ongoing type 2 diabetes mellitus and ongoing hypertension arterial; Surgical history included rotator cuff syndrome left and acromioplasty. The patient had no history of COVID-19. No drug addiction. Lifestyle: lives alone at home with helpers, drives and does his shopping. Concomitant medications included acetylsalicylate lysine (KARDEGIC), simvastatin, gliclazide (GLICAZIDA), amlodipine, furosemide, insulin detemir (LEVEMIR), metformin, esomeprazole magnesium (INEXIUM), all taken for unspecified indication(s) from unspecified date(s). On Day 45, 25Jul2021 Hospitalization for mechanical fall with prolonged state of being on the ground. The assessment carried out on 26Jul2021 highlights: A dissociated inflammatory syndrome: leukocytes = 6.87 x10 9/ l [3.8 -10.0], CRP = 206 mg / l [0-5], PCT not specified; Coagulation: Prothrombin time = 74%, activated partial thromboplastin time ratio = 1.02, platelets = 180 10 9/l, fibrinogen not reported; Ionogram: normal; CPK = 1645 U / l [46-171], troponin I HS 4959 ng / L [<47]; Renal function: clearance = 71 ml / min; Normal ALAT (Alanine transaminase); A PCR test (26Jul2021) looking for coronavirus on nasopharyngeal swab: positive with the presence of the L452 R mutation; A bacteriological assessment: negative blood cultures, negative Legionella and pneumococcal urinary Ag, Urine examination: White blood cells (leucocytes) = 79 / mm3, red blood cells = <5 / mm3, Urine culture positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml, urine culture 28Jul2021 negative initially. The injected thoracic CT with contrast of 27Jul2021 shows Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia. From a therapeutic point of view, the patient benefited from: Antibiotic therapy with cefotaxime from 26Jul2021 to 01Aug for multi-sensitive urine test E Coli positive; preventive anticoagulation 26Jul2021 then curative from 27Jul2021; Oxygen therapy by nasal oxygen from 28Jul2021: 5 l/min on 28Jul, 10 l/min on 30Jul then 17 l/min with a high concentration mask; Treatment with dexamethasone (6 mg per day) started on 27Jul2021 and TOCILIZUMAB (2 doses of 600 mg given) from 28Jul2021. CRP was at this time at 253 mg/ml and fibrinogen$g9.0 g/l. The respiratory evolution is unfavorable with persistence and increase in hypoxia requiring an intensive care unit advice which does not retain any indication for high flow oxygen therapy or intensive care. The patient was found dead in his room on 01Aug2021. The department doctor contacted did not rule out a worsening of the COVID pneumonia. A pulmonary edema and / or a coronary syndrome seems excluded because the troponin was decreasing. However, he reported that a long culture of the input sputum returns positive to Legionella whose final result and phenotype are pending. On 10Aug2021, the National Research Center of Legionella biologist confirms that the Cytobacteriological examination of sputum of 28Jul2021 is twice positive for legionella pneumophila PCR, the long culture is in progress but will not be available for 8 days. In conclusion: vaccine failure at Day45 of a complete vaccination schedule complicated by a fatal SARS covid 19 pneumonia. The possibility of legionellosis is being considered due to the double positivity of legionella pneumophila PCR. Long pending culture result. The outcome of events vaccination failure, sars covid 19 pneumonia, and legionella pneumophila infection considered as fatal, the outcome of other events was unknown. The patient died on 01Aug2021. An autopsy was not performed.; Reported Cause(s) of Death: SARS covid 19 pneumonia; SARS covid 19 pneumonia; legionella pneumophila infection


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