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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 138 out of 172

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VAERS ID: 1477084 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (required regular visit to a hospital)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021799730

Write-up: sudden died; This is a spontaneous report from a contactable physician received via regulatory authority. The patient was a non-pregnant 74-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cardiac failure and for the treatment the patient was regularly visiting a hospital. On 17Jun2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), at the age of 74 years old via intramuscularly as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization at a mass vaccination site. On 20Jun2021 in the morning (3 days after the vaccination), the patient was found dead at home, the patient suddenly died at home. The outcome of the event was fatal without treatment. On the same day, an autopsy was performed by police (results not available). Since the patient had suffered from heart disease, it was considered to have caused the sudden death. However, the event occurred shortly after the vaccination, so this case was reported. Cause of death was unknown. The reporting physician considered the event to be serious (fatal outcome). Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts possible. No further information expected.; Sender''s Comments: The event sudden death of unknown cause in relation to suspected drug BNT162B2 is assessed as unrelated and could be due to a pre-existing heart disease based on report. ; Reported Cause(s) of Death: sudden died


VAERS ID: 1477091 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Oxygen saturation, Respiratory disorder, Vital signs measurement
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (condition was stable)
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:no problem was found in blood test or pathological; Comments: Prior to the vaccination; Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210618; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: at around 00:00; Test Date: 20210618; Test Name: SpO2; Result Unstructured Data: Test Result:did not improve with inhalation of 10 L oxygen; Comments: under Oxygen 10L inhalation; Test Name: vital signs; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC2021800565

Write-up: respiratory status aggravated; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116663. The patient was a 94-year and 0-month-old female. Body temperature before vaccination was 36.7 degrees centigrade. 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). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 16Jun2021 at 15:00 (the day of vaccination) (at the age of 94-year-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) unspecified route of administration as a DOSE 2, single dose for COVID-19 immunization. On 18Jun2021 at 00:30 (1 day 9 hours 30 minutes after the vaccination), the patient experienced respiratory condition aggravated. On 18Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Although the patient was bedridden, disease state was stable. There was no particular concurrent complication and vital signs were stable. On 16Jun2021, the patient received 2nd dose of COMIRNATY. On 18Jun2021 at around 00:00, SpO2 decreased (the patient had never used oxygen before) and respiratory status aggravated. The patient had no pyrexia. Oxygen 10 L was inhaled; however, SpO2 did not improve and aggravation of respiratory status continued. On 18Jun2021 at 10:50, the patient died. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was geromarasmus. The reporting physician commented as follows: Prior to the vaccination, no problem was found in blood test or pathological condition. Immediately after the vaccination, there was no particular change in condition and no other pathological condition that would lead to sudden turn for the worse was found; thus, causality between the event and the vaccine could not be denied.; Reported Cause(s) of Death: Respiratory condition aggravated


VAERS ID: 1477093 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: FUROSEMIDE; TADALAFIL; DUTASTERIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nasopharyngeal cancer; Vocal cordectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Chest X-ray; Result Unstructured Data: Test Result:revealed bilateral pneumonia
CDC Split Type: JPPFIZER INC2021800582

Write-up: Bilateral pneumonia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 95-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received furosemide (FUROSEMIDE), tadalafil (TADALAFIL), and dutasteride (DUTASTERIDE) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included vocal cord resection due to nasopharyngeal cancer. On 31May2021 at 09:45 (the day of vaccination) (at the age of 95 years old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the arm left as dose 1, single for COVID-19 immunization. On 01Jun2021 (1 day after the vaccination), the patient experienced bilateral pneumonia. The event resulted in hospitalization on 10Jun2021. The outcome of the event was fatal on 11Jun2021. It was unknown whether the patient received treatment. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: On 31May2021, the patient received the first dose of the vaccine and subsequently developed physical deconditioning. On 10Jun2021, the patient visited the hospital. Chest X-ray revealed bilateral pneumonia, for which the patient was hospitalized. On the following day (11Jun2021), the patient died. An autopsy was not performed. The reporting physician classified the event as serious (death).; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Bilateral pneumonia


VAERS ID: 1477094 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021800587

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21116665. The patient was a 78-year-old female. Body temperature before vaccination was 36.9 degrees centigrade. Family history and medical history were unknown. On an unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# and expiration date were not reported). On 24Jun2021 at 10:55 (reportedly; the day of vaccination) (at the age of 78-years-old), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a dose 2, single for COVID-19 immunization. On 26Jun2021 estimated at around 06:00 (2 days after the vaccination), the patient experienced unknown cause of death. On 26Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Reportedly, the patient lived alone but details were unknown. Estimated time of death was around 06:00 on 26Jun2021. Since this was forensic autopsy case, investigation was being conducted. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable (since investigation was being conducted, causality was unknown at the time of this report). Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: This was an autopsy case requested by the police according to the law on cause of death or identity examination of dead body that were handled by the police, etc.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1477095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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: Arrhythmia; Cardiac failure chronic; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021800590

Write-up: fatal arrhythmia; cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21116654. The patient was an 81-year-old male. Body temperature before vaccination was not reported. Medical history included cardiac failure chronic, arrhythmia and COPD (chronic obstructive pulmonary disease). Concomitant medications and family history were not provided. On 10Jun2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX3617, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at 06:00 (14 days after the vaccination), the patient experienced fatal arrhythmia. On 24Jun2021 at 09:48, he died. It was not reported if an autopsy was performed. The course of the events was as follows: He was a housebound patient and was receiving home oxygen therapy. On 10Jun2021, a physician made a home visit and gave the first dose of vaccination to the patient. No adverse reaction was seen during acute period. On 22Jun2021 (12 days after the vaccination), the patient looked fine when visiting nurse. On 24Jun2021 in early morning, the patient was found sitting on a seat chair in a state of cardio-respiratory arrest. At 09:48, the patient''s death was confirmed. The reporting pharmacist classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event was reported as follows: The patient had a medical history of cardiac disease, so the causal relationship with BNT162b2 was uncertain. The reporting pharmacist commented as follows: Although the causal relationship with BNT162b2 was uncertain, the event occurred within 2 weeks from the vaccination, therefore, this case was reported.; Reported Cause(s) of Death: fatal arrhythmia


VAERS ID: 1477096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Mitral valve incompetence, Urine output
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: HALFDIGOXIN; URSODEOXYCHOLIC ACID; TRAZODONE; MADOPAR; FUROSEMIDE; ELIQUIS; SODIUM CHLORIDE; MAGNESIUM OXIDE; PICOSULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: urine output; Result Unstructured Data: Test Result:increased; Comments: once; Test Date: 20210613; Test Name: urine output; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021800634

Write-up: Acute on chronic heart failure; mitral regurgitation; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21116664. The patient was a 90-year-old female. Body temperature before vaccination was not reported. Medical history included gastrostomy. Concomitant medications (administered via gastrostomy tube) included digoxin (HALFDIGOXIN) 0.125 mg, 0.5 tablet (after breakfast), ursodeoxycholic acid (URSODEOXYCHOLIC ACID) 100 mg, 3 tablets (after every meals), trazodone (TRAZODONE) 20 mg, 1 tablet (after dinner), levodopa/benserazide hydrochloride (MADOPAR) 1 tablet (after breakfast) and 1.5 tablet (after dinner), furosemide (FUROSEMIDE) 10 mg, 1 tablet (after breakfast), apixaban (ELIQUIS) 2.5 mg, 2 tablets (after breakfast and after dinner), sodium chloride (SODIUM CHLORIDE) 3 g (after every meals), magnesium oxide (MAGNESIUM OXIDE) 330 mg, 3 tablets (after every meals) and sodium picosulfate hydrate (PICOSULFATE Na) 0.75% 10 mL (as needed for constipation). The patient had no relevant family history (her oldest son and oldest daughter). On 09Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, 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 11Jun2021 (2 days after the vaccination), the patient experienced acute on chronic heart failure. On 13Jun2021 (4 days after the vaccination), the patient was hospitalized on that day. On 25Jun2021 at 08:13 (16 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 11 Jun2021, wheezing appeared. Since pneumonia aspiration was suspected, drip infusion of antibacterial agent was started. On 12Jun2021, as it was considered as asthmatic attack, IV drip of NEOPHYLLIN and SOLU-CORTEF was administered, but it did not work. On 13Jun2021, as dyspnoea was worsening, the patient visited the emergency department of the reporter''s hospital as an outpatient. This was considered as acute on chronic heart failure due to mitral regurgitation, she was emergently hospitalized. Once urine output increased with continuous infusion of diuretic and cardiotonic (DOBUTREX), but the urine output decreased. On 25Jun2021 at 08:13, the patient died. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: mitral regurgitation; Acute on chronic heart failure


VAERS ID: 1477100 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Respiratory distress, Urine output, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: Cerebral infarction; Diabetes mellitus; Nasogastric tube feeding
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210618; Test Name: Urine output; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021801038

Write-up: death; respiratory distress; Urine output decreased; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116662. The patient was an 81-year and 0-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade. Medical history included cerebral infarction and diabetes mellitus. The patient was receiving nasogastric tube feeding and he was being admitted to the long-term care ward. No information on concomitant medications and family history was not provided. On 15Jun2021 at 13:39 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 in the evening (3 days after the vaccination), the patient experienced urine output decreased On 19Jun2021 at 02:00 (4 days after the vaccination), the patient experienced respiratory distress. At 03:15, the patient''s death was confirmed. It was not reported if an autopsy was performed. The outcome of the events respiratory distress and urine output decreased was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. Cerebral infarction was considered as a possible cause of the events.; Reported Cause(s) of Death: death


VAERS ID: 1477101 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 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 INC2021801042

Write-up: Cardiac failure; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21116681. The patient was an 82-year and 8-month-old female. Body temperature before vaccination, family history, medical history, and concomitant medications were not reported. It was not reported 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 26Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as dose 1, single (at the age of 82 years old) for COVID-19 immunisation. On 26Jun2021 at 10:00 (after the vaccination), the patient experienced cardiac failure. The outcome of the event was fatal. It was not reported whether autopsy was done. The reporting pharmacist classified the event as serious (death). The causality of the event was not reported. It was not reported whether there was other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1477103 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Chest discomfort, Chest pain, Fall
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021801065

Write-up: Acute aortic dissection; Chest pain; Chest discomfort; developed chest pain and fell down; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116666. The patient was a 66-year and 2-month-old female. Body temperature before vaccination, family history, medical history, and concomitant medications were not reported. It was not reported 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 26Jun2021 around 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported), at the age of 66-years-old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Jun2021 around 22:00 (8 hours and 30 minutes after the vaccination), the patient experienced chest pain, chest discomfort, and acute aortic dissection. On 27Jun2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: The onset was about 8 to 9 hours after the vaccination. Chest symptoms included discomfort at first and improved temporarily with oral drugs, but 6 to 7 hours after the onset, the patient developed chest pain and fell down. The progression of the symptoms was relatively fast. There were no dermatologic/mucosal symptoms. When transported by the ambulance, the patient was almost in a state of cardio-respiratory arrest. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was acute aortic dissection. The reporting physician commented as follows: Reported this on behalf of the attending physician who was away. The causal relationship between the vaccination and death was unknown.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1477104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Drowning, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrosclerosis (There was acute aggravation following dehydration in the past); Renal failure chronic (There was acute aggravation following dehydration in the past)
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: CT; Result Unstructured Data: Test Result:only revealed findings of drowning; Comments: only revealed findings of drowning and could not point out a definite lesion that led to loss of consciousness
CDC Split Type: JPPFIZER INC2021801066

Write-up: Drowning while bathing; Transient ischaemic attack; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116685. The patient was an 82-year-old male. Medical history included chronic renal failure associated with nephrosclerosis (There was acute aggravation following dehydration in the past, and an internal shunt was already placed in preparation for dialysis. No dialysis was performed regularly). It was unknown how the underlying disease was written in the prevaccination screening questionnaire. Body temperature before vaccination, family history, and concomitant medications were not reported. On 25May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date not reported) as local group vaccination for the elderly for COVID-19 immunisation. On 15Jun2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 18Jun2021 at unknown time (3 days after the vaccination), the patient experienced drowning while bathing. The course of the event was as follows: On 21Jun2021 around 11:00, after receiving a call from the officer of the social welfare council saying that she/he visited the patient but there was no response, the police went to the site and found him drowning and lying on his left side in the bathtub water at home. The patient was living alone and receiving home-visit nursing service twice a week. At previous visit on 17Jun2021 (2 days after the second vaccination), the patient had no particular complaints of symptoms and was in good health. He was a user of emergency report system, and this communication device ran out of battery on 18Jun2021 (the system provider was also aware of this situation and said that they tried making calls via the social welfare council several times for 3 days before the corpse was discovered). On 21Jun2021 at 15:00, postmortem examination was performed by a regulatory authority of the reporting university. Computerised tomography (CT) taken at that time only revealed findings of drowning and could not point out a definite lesion that led to loss of consciousness. Considering the marked coronary/aortic calcification and the historical condition of aggravated renal failure following dehydration in the past, it was presumed that drowning was triggered by transient ischaemic attack while bathing. The post-mortem changes of the corpse were considered not unnatural in light of the death around 18Jun2021 when no contact was possible anymore. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases: Transient ischaemic attack (Transient hypotension was included. Any onset of some severe diseases like ischaemic heart disease or fatal arrhythmia was unlikely). The reporting physician commented as follows: Despite the information on the patient''s second vaccination against the novel coronavirus on 15Jun2021, the symptoms after the vaccination through the death was unclear. If there would have been pyrexia after the vaccination, loss of consciousness while bathing could have been the trigger. However, comprehensively considering the factors including the infrequent onsets of pyrexia after the vaccination in the elderly, the vigorous appearance seen by the visitor on 17Jun2021 (2 days after the vaccination and 1 day before the estimated death date), and many death cases while bathing in the elderly in general (86.6 percent in male and 93.1 in female both aged 65 or older in the autopsies of 1399 people who died while bathing during the 10-year period from 2010 to 2019 in the 23 wards in unlisted country according to the survey by a regulatory authority), we assessed that the causal relationship between the vaccination and the death was none or very unlikely. Information on the batch/lot number has been requested.; Sender''s Comments: There is no reasonable possibility that the event "drowning while bathing" was related to COMIRNATY use. This is more likely associated with an intercurrent condition that led to drowning. Postmortem findings presume that TIA may have led to drowning.; Reported Cause(s) of Death: Transient ischaemic attack; Drowning while bathing; Autopsy-determined Cause(s) of Death: drowning while bathing/only revealed findings of drowning


VAERS ID: 1477107 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 28
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: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021801138

Write-up: Acute cardiac insufficiency; malaise; headache; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116682. The patient was a 34-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. The family history was not provided. The medical history was not provided. The patient''s concomitant medications were not reported. On 30Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021). On 21May2021 (the day of vaccination, at the age of 34 years old), the patient received the second 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 29May2021 at 01:00 (8 days/1 hours after the vaccination), the patient experienced acute cardiac insufficiency. On 29May2021 (8 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21May2021 (the day of vaccination), after the patient received the second dose of BNT162b2 vaccination, he complained of malaise and headache (on May2021) for 2 to 3 days. From 25May2021 (4 days after vaccination) to 28May2021 (7 days after vaccination), the patient worked a regular schedule. The patient complained of no physical deconditioning. On 29May2021 (8 days after vaccination), in the morning, the patient was found to have cardio-respiratory arrest on the floor of his room. Although the patient was transferred to the hospital, resuscitation was not obtained. Since the cause of death was unknown, an administrative autopsy was performed on 30May2021 (9 days after vaccination). The macroscopic findings showed findings for which sudden death was suggested; however, no obvious diseases or damages which were the causes of death in the organs were observed. The histological findings showed lymphocyte accumulation in a part of the cardiac interstitium close to the ramus nodi sinuatrialis. Outcome of events malaise and headache was recovering. The patient died on 29May2021. An autopsy was performed that revealed acute cardiac insufficiency. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. Reporter comment: Based on the autopsy findings, the cause of death was assumed to be acute cardiac insufficiency. The details of the period of the onset of lymphocyte accumulation in a part of the cardiac interstitium were unknown.; Reporter''s Comments: Based on the autopsy findings, the cause of death was assumed to be acute cardiac insufficiency. The details of the period of the onset of lymphocyte accumulation in a part of the cardiac interstitium were unknown.; Reported Cause(s) of Death: Acute cardiac insufficiency; Autopsy-determined Cause(s) of Death: Acute cardiac insufficiency


VAERS ID: 1477131 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Respiratory arrest, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: COPD; Oxygen supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021802339

Write-up: Respiratory arrest; Vaccination site pain; Inappetence; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116782. The patient was an 87-year-old male. Body temperature before vaccination was 36.7 degrees centigrade. The family history was not provided. The patient had medical history of COPD, for which home oxygen therapy was introduced. On 28Jun2021 at 14:00 (the day of vaccination), the patient received the first 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 28Jun2021 (the day of vaccination), the patient experienced vaccination site pain and inappetence. On 29Jun2021 at 05:30 (15 hours/30 minutes after the vaccination), the patient experienced respiratory arrest. On 29Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28Jun2021 (the day of vaccination), after the vaccination, the patient complained of vaccination site pain and inappetence. Thereafter, the patient went to sleep. On 29Jun2021, at 05:30 (15 hours and 30 minutes after vaccination), the patient''s wife noticed that the patient had respiratory arrest. On the same day, at 06:46 (16 hours and 46 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute aggravation of COPD. The outcome of the event respiratory arrest was fatal while for the other events was unknown. The reporting physician commented as follows (Reporter comment): The patient''s family demanded a thorough investigation of the cause of death.; Reporter''s Comments: The patient''s family demanded a thorough investigation of the cause of death.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1477132 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Cerebellar haemorrhage, Hypertension, Nausea, Subarachnoid haemorrhage, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 degrees Centigrade; Comments: before the first dose vaccination; Test Date: 20210619; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 degrees Centigrade; Comments: before the second dose vaccination
CDC Split Type: JPPFIZER INC2021802357

Write-up: queasy/vomiting; queasy/vomiting; hypertension; cardio-respiratory arrest; Cerebellar haemorrhage; subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116783. The patient was 87-years and 0-month-old male. Body temperature before the second dose vaccination on 19Jun2021 was 36.1 degrees Centigrade. 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 had no relevant family history. The patient''s medical history and concomitant medications were not reported. On 29May2021 in the afternoon (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# EY2173, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before the first dose vaccination on 29May2021 was 36.2 degrees Centigrade. On 19Jun2021 in the afternoon (the day of vaccination), at the age of 87-years-old, the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) an unspecified route of administration as dose 2, single for COVID-19 immunization. On 20Jun2021(1 day after the vaccination), the patient experienced queasy/vomiting and he was hospitalized. On 21Jun2021(2 days after the vaccination), the events improved. On 22Jun2021 at 21:50 (3 days after the vaccination), the patient died of cerebellar haemorrhage and subarachnoid haemorrhage. AI (autopsy imaging) was performed. The cause of death confirmed by AI was cerebellar haemorrhage and subarachnoid haemorrhage. The course of the events was as follows: On 20Jun2021, the patient was hospitalized for queasy and nausea. On 21Jun2021, the symptoms improved. On 22Jun2021, diet was resumed. On the same day at 21:50, a nurse found the patient in cardio-respiratory arrest. From the result of AI, the cause of death was considered to be cerebellar haemorrhage and subarachnoid haemorrhage. The reporting physician classified the events as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Hypertension was considered as a possible cause of the events. Outcome of the events cerebellar haemorrhage and subarachnoid haemorrhage was fatal, for events queasy and vomiting was recovering, and for the remaining events was unknown.; Reported Cause(s) of Death: Cerebellar haemorrhage; subarachnoid haemorrhage; Autopsy-determined Cause(s) of Death: Cerebellar haemorrhage; subarachnoid haemorrhage


VAERS ID: 1477154 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina unstable; Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 degrees Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021803374

Write-up: Suicide; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116870. The patient was 78-years and 3-month-old male. Body temperature before vaccination on 23Jun2021 was 36.4 degrees Centigrade. Medical history included angina unstable and depression. Oral concomitant medications were reported; acetylsalicylic acid (BAYASPIRIN). He was also receiving oral tricyclic antidepressants (BZ [considered as benzodiazepine]). It was unknown if the patient had relevant family history. On an unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jun2021 at 17:20 (the day of vaccination), at the age of 78-years-old, the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single for COVID-19 immunization. On 28Jun2021 (5 days after the vaccination), the patient committed suicide and died on 28Jun2021. It was not reported if an autopsy was performed. The course of the events was as follows: On 23Jun2021 at 17:20, the patient received the vaccination and he was prescribed laxative (a 30 day course of MAGMITT 1g and PURSENNID 12 mg). On 28Jun2021, the patient jumped off the 10th floor of the building, and he was found dead. The possibility of foul play was denied. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162B2. Depression was considered as a possible cause of the event. Outcome of the event was fatal. The reporting physician commented as follows: The patient was receiving tricyclic antidepressants (BZ). The causal relationship with BNT162B2 was uncertain, but this was considered to be suicide caused by his current disease.; Sender''s Comments: The patient 78-year-old male had medical history included angina unstable and depression, and was receiving oral tricyclic antidepressants. The company concurs with the reporting physician that the fatal event suicide was not related to vaccine of BNT162B2 (COMIRNATY). Depression was considered as a possible cause of the event.; Reported Cause(s) of Death: suicide


VAERS ID: 1477179 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Oxygen supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: CT; Result Unstructured Data: Test Result:Severe pneumonia
CDC Split Type: JPPFIZER INC2021806018

Write-up: Severe pneumonia; This is a spontaneous report from a contactable physician received via the Agency. A 72-year-old male Patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) intramuscular in the arm left on 16Jun2021 at 14:30 as single dose for COVID-19 immunization. Medical history included originally receiving home oxygen therapy for chronic respiratory failure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 17Jun2021 (9 hours/30 minutes after the vaccination), the patient experienced severe pneumonia. The event resulted in death. Since the vaccination, the patient had not been tested for COVID-19. The reported event was as follows: The patient was originally receiving home oxygen therapy for chronic respiratory failure. On 17Jun2021 (9 hours and 30 minutes after vaccination), the patient had physical deconditioning. On 19Jun2021 (2 days, 9 hours, and 30 minutes after vaccination), an ambulance was called, and the patient was transferred to his primary medical institution. The patient was diagnosed with severe pneumonia on the CT, and he was admitted to the hospital on the same day. However, the patient was confirmed to die on 19Jun2021. The outcome of the event was fatal. It was unknown if treatment of AE performed or not. The reporting physician assessed the event as serious (death).; Sender''s Comments: Based on information provided, the event pneumonia more likely represents an intercurrent illness which is unrelated to BNT162b2 (COMIRNATY). The case will be reassessed once more information become 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: Pneumonia


VAERS ID: 1477187 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breath sounds abnormal, Pneumonia aspiration, Pyrexia, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:transient pyrexia Centigrade
CDC Split Type: JPPFIZER INC2021808299

Write-up: worsening of respiratory state; transient pyrexia; Potential Pneumonia aspiration; adventitious breath sounds; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21116944. An 86-year and 1-month old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY5423; Expiration Date: 31Aug2021), via an unspecified route of administration, on 21Jun2021 at 19:00 (at the age of 86-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were 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 experienced worsening of respiratory state on 24Jun2021 and potential pneumonia aspiration in Jun2021, which were reported as fatal. The patient also experienced transient pyrexia on 22Jun2021 (1 day after the vaccination) and adventitious breath sounds in Jun2021. The clinical course was reported as follows: The body temperature before vaccination was 36.8 degrees Centigrade on 21Jun2021. The patient was bedridden and had symptoms of aspiration at moments. On 21Jun2021 (on the day of vaccination), the patient had no pyrexia and it was considered possible for him to receive the vaccination and the reporter gave the vaccine to him. On 22Jun2021 (1 day after the vaccination), although body temperature showing transient pyrexia was noted, it subsided with cooling treatment. Thereafter, adventitious breath sounds persisted. On 24Jun2021 (3 days after the vaccination), respiratory state worsened, and he died. Therapeutic measures were taken as a result of transient pyrexia as aforementioned. The clinical outcome of worsening of respiratory state and potential pneumonia aspiration was fatal, of transient pyrexia was recovering, and of adventitious breath sounds was not recovered. The patient died on 24Jun2021 (3 days after the vaccination). The cause of death was reported as worsening of respiratory state and potential pneumonia aspiration. It was not reported if an autopsy was performed. The reporting physician assessed that the events were not related to BNT162B2. It was not provided if there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: Basically, it was considered that the event occurred due to potential pneumonia aspiration.; Reported Cause(s) of Death: Potential Pneumonia aspiration; worsening of respiratory state


VAERS ID: 1477201 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MENESIT; JUVELA N; LAC-B; FP-OD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hyperthyroidism; Parkinson''s disease; Simple goitre
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021809160

Write-up: Death; This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. This is a report received from a contactable physician the Agency Regulatory Authority. Regulatory authority report number is v21117062. A 68-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: FA5829; Expiration Date: 31Aug2021), intramuscularly on 24Jun2021 at 15:30 at a single dose for covid-19 immunisation. Medical history included Parkinson''s disease, simple goitre, hyperthyroidism, hypertension. Family history was unknown. Concomitant medications included carbidopa/levodopa (MENESIT); tocopheryl nicotinate (JUVELA N); bifidobacterium lactis (LAC-B); selegiline hydrochloride (FP-OD). The patient previously received the first dose of the bnt162b2 (Lot Number: FA5829; Expiration Date: 31Aug2021)) intramuscularly on 03Jun2021 for covid-19 immunisation. On 26Jun2021 in the morning, the patient died. The patient started to visit the intractable neurological disease department of the reporting hospital regularly since Mar2021 (referred from another hospital). On 26Jun2021 (2 days after the vaccination), the patient died at home (police station involved). The symptoms and other details after the vaccination were unknown. The patient was not transported to the hospital, and it was said that assessment was not possible because the police involved in this case. The seriousness and causality of the event were not reported. The patient underwent lab tests and procedures which included body temperature: 36.4 degrees Centigrade on 24Jun2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 26Jun2021 due to unknown cause. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unassessable. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. The case will be reassessed should additional information become 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any 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: 1477202 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram
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: 2021-06-29
   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: Atrial fibrillation (the patient was on oral medications); Hyperuricaemia (the patient was on oral medications); Renal failure chronic (the patient was on oral medications)
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210629; Test Name: Full-body CT; Result Unstructured Data: Test Result:revealed no obvious abnormality
CDC Split Type: JPPFIZER INC2021809277

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116993. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Jun2021 at 14:00 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) at 85-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included atrial fibrillation from an unknown date and unknown if ongoing (the patient was on oral medications), renal failure chronic from an unknown date and unknown if ongoing (the patient was on oral medications), hyperuricaemia from an unknown date and unknown if ongoing (the patient was on oral medications). Concomitant medications included unspecified oral medications for atrial fibrillation, renal failure chronic, and hyperuricaemia from an unknown date to an unknown date. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 29Jun2021 at 11:00, the patient experienced cardio-respiratory arrest (death, medically significant). The clinical course was reported as follows: The patient was an 85-year and 9-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. Family history was not reported. Medical history included atrial fibrillation, renal failure chronic, hyperuricaemia; the patient was on oral medications for these conditions. The patient had no asthma or allergy. Concomitant medications included oral medications. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 26Jun2021 at 14:00 (the day of vaccination), the patient received the second dose (also reported as: first dose) of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 29Jun2021 at 11:00 (3 days after the vaccination; as reported), the patient experienced cardio-respiratory arrest. On 29Jun2021 (3 days after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done (as reported). The course of the event was as follows: On 26Jun2021 (the day of vaccination), the patient received the second vaccination against the novel pneumonia. On 29Jun2021 at 08:00 (3 days after the vaccination), the patient was in a normal condition when his family went out. On the same day at 11:00, the patient was found in a state of cardio-respiratory arrest. Cardiopulmonary resuscitation was performed but spontaneous circulation did not return, and his death was confirmed on the same day. After the death confirmation, full body computerised tomography (CT) revealed no obvious abnormality, and it was said that hypochondriacal complaints had been notable since long before (as reported). The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The relation with the vaccine was unknown. The diseases on treatment had been relatively in a stable state, and the risk for sudden death had seemed to be not really high. The family said that there had been frequent hypochondriacal complaints recently. The patient underwent lab tests and procedures which included body temperature: 36.3 Centigrade on 26Jun2021 (before vaccination), computerised tomogram (Full-body CT): revealed no obvious abnormality on 29Jun2021. Therapeutic measures were taken as a result of cardio-respiratory arrest. The clinical outcome of the event, cardio-respiratory arrest, was fatal. The patient died on 29Jun2021 due to cardio-respiratory arrest. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1477203 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, 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: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Asystole
CDC Split Type: JPPFIZER INC2021809312

Write-up: Cardiopulmonary arrest (CPA); This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116997. The patient was an 81-year and 4-month-old male. Body temperature before vaccination was 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). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for covid-19 immunisation. On 27Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single (at the age of 81 years) for COVID-19 immunization. On 29Jun2021 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 29Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: A call for service was requested by fire department since the patient was in cardiopulmonary arrest (CPA). The patient lay on his back on a floor of a dining space and emergency medical technician was performing chest compression. Bag valve mask (BVM) ventilation was performed and intubation was prepared. Peripheral intravenous line was secured in the left forearm and bone marrow needle was concurrently placed in the left lower leg. Adrenaline was administered and advanced cardiac life support (ACLS) was initiated. Emergency medical technician wore LUCAS and continued chest compression. Intubation was conducted concurrently. After the patient was admitted to ambulance, the patient was transferred to the emergency room (ER) of the reporting hospital while undergoing continued ACLS. During the transfer, adrenaline 3 A was administered in total. Waveform was asystole the whole time. At 11:02, death was confirmed. The reporting physician classified the event as serious (death). Causality and other possible cause of the event such as any other diseases were not provided. Cause of death was cardio-respiratory arrest CPA. It was unknown if autopsy was performed. The case was reported since the event occurred 2 days after the vaccination.; Reported Cause(s) of Death: Cardiopulmonary arrest (CPA)


VAERS ID: 1477208 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Catheterisation cardiac, Computerised tomogram, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Interstitial pneumonia (Home oxygen therapy (HOT) was introduced); Oxygen therapy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Catheterisation cardiac; Result Unstructured Data: Test Result:no dominant stenosis was noted; Test Date: 20210625; Test Name: Abdominopelvic CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage and aortic dissection; Comments: were unlikely. No findings that were responsible for cardio-respiratory arrest were identified; Test Date: 20210625; Test Name: Head CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage and aortic dissection; Comments: were unlikely. No findings that were responsible for cardio-respiratory arrest were identified; Test Date: 20210625; Test Name: Chest CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage and aortic dissection; Comments: were unlikely. No findings that were responsible for cardio-respiratory arrest were identified; Test Date: 20210625; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:asystole; Comments: when emergency medical service arrived; Test Date: 20210625; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:asystole; Comments: when the patient arrived at the hospital at 10:58
CDC Split Type: JPPFIZER INC2021809562

Write-up: Cardio-respiratory arrest; Queasy; Vomiting; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority report number is v21116976. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FC3661; Expiration Date: 30Sep2021), via an unspecified route of administration, on 22Jun2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing interstitial pneumonia (home oxygen therapy (HOT) was introduced) and ongoing HOT. The patient''s concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 25Jun2021 at 10:13 (3 days after the vaccination), which required hospitalization from 25Jun2021 to 26Jun2021 and was reported as fatal. The patient also experienced queasy and vomiting on 25Jun2021. The clinical course was reported as follows: On 25Jun2021 since the morning, the patient was queasy and had vomiting; however, the patient went to driver''s license test site to renew driver''s license. The patient fell at the test site and was in cardio-respiratory arrest, for which ambulance was requested. When emergency medical service arrived, electrocardiogram showed asystole on 25Jun2021, for which laryngeal tube was inserted and the patient was transferred to the reporting hospital while receiving cardiopulmonary resuscitation (CPR). At 10:58, when the patient arrived at the hospital, electrocardiogram was asystole. Adrenaline (MANUFACTURER UNKNOWN) 3 tubes were administered and at 11:10, spontaneous circulation returned but hemodynamics was unstable. Subsequently, head, chest, and abdominopelvic computerized tomogram (CTs) were conducted on 25Jun2021; however, subarachnoid haemorrhage and aortic dissection were unlikely. No findings that were responsible for cardio-respiratory arrest were identified. For further examination, cardiac catheterization was conducted on 25Jun2021, but no dominant stenosis was noted. After the examination, at 12:55, the patient was admitted to intensive care unit (ICU). The reporting other health professional commented as follows: After the patient was admitted to ICU, unspecified vasopressor was administered continuously; however, hemodynamics was unstable. On 26Jun2021 at 07:07, death was confirmed. Since the patient died within 24 hours after coming to the hospital, a competent police station was contacted to collect the patient''s body. Thus, death certificate was not made at the reporting hospital and the possibility of other diseases was unknown. Therapeutic measures were taken as a result of cardio-respiratory arrest as aforementioned. The clinical outcome of cardio-respiratory arrest was fatal and of queasy and vomiting was unknown. The patient died on 26Jun2021 at 07:07 (4 days after the vaccination). The cause of death was reported as cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting healthcare professional assessed that the causality between the events and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1477211 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood lactate dehydrogenase, Blood pressure systolic, Blood pressure systolic decreased, Blood urea, C-reactive protein, Colitis ischaemic, Computerised tomogram, Computerised tomogram thorax, Flatulence, Gastrointestinal necrosis, Ileus, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA; DIART; SPIRONOLACTONE; FEBURIC; DILTIAZEM HYDROCHLORIDE R; LANSOPRAZOLE; DAYVIGO; LUNESTA
Current Illness: Hyperuricaemia; Reflux oesophagitis; Sleeplessness
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Atrial fibrillation; Cardiac failure chronic; Dementia; TAVI
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: Cr; Test Result: 2.5 mg/dl; Test Date: 20210617; Test Name: Blood LDH; Result Unstructured Data: Test Result:338 IU/l; Test Date: 20210617; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:50; Comments: 6:00; Test Date: 20210617; Test Name: BUN; Test Result: 44.2 mg/dl; Test Date: 20210617; Test Name: Abdominal CT; Result Unstructured Data: Test Result:suspected small intestinal necrosis; Comments: it was found small intestinal Ileus and images of portal, intestinal, and gas. it was suspected small intestinal necrosis.; Test Date: 20210617; Test Name: Chest CT; Result Unstructured Data: Test Result:pneumonia in the left lung; Test Date: 20210617; Test Name: Blood CRP; Test Result: 6.4 mg/dl; Test Date: 20210617; Test Name: SpO2; Test Result: 85 %; Comments: O2 1L/min started
CDC Split Type: JPPFIZER INC2021810305

Write-up: Ischaemic enterocolitis; small intestinal necrosis; small intestinal Ileus; SpO2 85 %; blood pressure systolic decreased to 50; Images of portal gas, intestinal gas, and intestinal lumen gas; Pneumonia in the left lung; vomiting; shock; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 89-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was included LIXIANA, DIART, Spironolactone, Feburic, Diltiazem, Lansoprazole, DAYVIGO. The patient was not diagnosed with COVID-19 prior to vaccination. The relevant medical history and concurrent conditions was provided as Aortic valve stenosis(after TAVI), Atrial fibrillation and Cardiac failure chronic. The patient had no allergies to medications, food, or other products. On 15Jun2021 at 13:30, the patient received BNT162B2 (COMIRNATY intramuscular injection, Lot number: EY5420, expiration date: 31Aug2021), via an intramuscular route of administration in arm left as DOSE 1, SINGLE for COVID-19 immunization. The adverse event onset date was reported as on 16Jun2021 at 20:45 (1 day after the vaccination). The course of the event was as follows: The patient started vomiting and the state of shock at the night of 16Jun2021. Through abdominal CT, it was found small intestinal Ileus and there had Portal gas image, it was suspected small intestinal necrosis. On 17Jun2021, the patient was transferred to PRIVACY hospital. The event resulted in Emergency room/department or urgent care. The outcome of the event was not recovered with treatment including Noradrenaline IV drip. Since the vaccination, the patient had not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination was included edoxaban tosilate (LIXIANA) orally from an unspecified date to 17Jun2021 for atrial fibrillation, (DIART) orally from an unspecified date to 17Jun2021 for cardiac failure chronic, spironolactone (SPIRONOLACTONE) orally from an unspecified date to 17Jun2021 for cardiac failure chronic, febuxostat (FEBURIC) orally from an unspecified date to 17Jun2021 for hyperuricaemia, diltiazem) orally from an unspecified date to 17Jun2021 for hyperuricaemia, diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE R) orally from an unspecified date to 17Jun2021 for atrial fibrillation, lansoprazole (LANSOPRAZOLE) orally from an unspecified date to 17Jun2021 for gastric ulcer prophylaxis (reflux oesophagitis), lemborexant (DAYVIGO) orally from 08May2021 to 17Jun2021 for sleeplessness, and eszopiclone (LUNESTA) orally from 08May2021 to 17Jun2021 for sleeplessness. The relevant medical history and concurrent conditions was provided as Aortic valve stenosis (after TAVI on 17Jan2020), Atrial fibrillation, Cardiac failure chronic, dementia, ongoing hyperuricaemia, ongoing reflux oesophagitis, and ongoing sleeplessness. It was unknown if the patient had family history. Relevant lab tests on 17Jun2021 included blood C-reactive protein (CRP) (mg/dL, reference range 0.0-0.3): 6.4, blood LDH (IU/L, reference range 110-220) 338, Blood urea (BUN) (mg/dL, reference range 8.0-20.0): 44.2, creatinine (Cr) (mg/dL, reference range 0.46-0.8): 2.5, Chest CT: pneumonia in the left lung, abdominal CT: images of portal gas, intestinal gas, and intestinal lumen gas. On 17Jun2021 (2 day after the vaccination), (the event term ischaemic enterocolitis with onset date 17Jun2021 was reported). The event ischaemic enterocolitis resulted admission to hospital (from 17Jun2021 to 24Jun2021) and intensive care unit (ICU). On 24Jun2021 (9 day after the vaccination), the patient died. It was unknown if an autopsy was performed. The outcome of ischaemic enterocolitis was fatal. The physician classified the event as serious (hospitalisation) and assessd that causality between the event ischaemic enterocolitis and BNT162B2 was unassessable (the patient was treated at another hospital). The following was added to the course: After admission, the patient sometimes vomited after meals. On 15Jun2021, the patient received the first dose of BNT162B2. On 16Jun2021 at around 20:00, the patient started vomiting. On 17Jun2021 at 6:00, the blood pressure systolic decreased to 50. O2 administration was started. On the CT test result, small intestinal necrosis was suspected, and the patient was emergently transferred to hospital. it was determined to conservative treatments were given (owing to the advanced age?). On 24Jun2021, the patient died. Follow up questions for the event: All the signs and symptoms of the event: Vomiting, shock (blood pressure systolic 50, SpO2 85 %, for which O2 started at 1L/min). The time course of the anaphylactic reaction: On 15Jun2021 at 13:45, the patient received vaccination of BNT162B2. On 16Jun2021 at 20:00, the patient vomited. On 17Jun2021, shock vitals were seen. The patient required medical intervention with corticosteroids, IV fluids, and oxygen. Details: On 16Jun2021 at around 20:00 IV fluids started. On 17Jun2021 at around 9:00, hydrocortisone, O2, and dopamine were given. It was unknown if multiorgan, cardiovascular, or other involvement was noted. Gastrointestinal involvement was seen. Vomiting Yes. Details: Ischaemic enterocolitis was complicated). There was no dermatological/Mucosal involvement. The outcome of the rest of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "Ischaemic enterocolitis", "small intestinal necrosis", "small intestinal Ileus", "shock", "Images of portal gas, intestinal gas, and intestinal lumen gas", "Pneumonia in the left lung", "SpO2 85 %" and "blood pressure systolic decreased to 50" cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Ischaemic enterocolitis


VAERS ID: 1477212 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Colitis ischaemic, Computerised tomogram
SMQs:, Ischaemic colitis (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: REZALTAS; BISONO; BUFFERIN [ACETYLSALICYLIC ACID]; TRAZENTA; AMLODIPINE; RISPERIDONE; MAGNESIUM OXIDE; ISOSORBIDE; LASIX [FUROSEMIDE]; SPIRONOLACTONE; BELSOMRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypertension; Late effects of cerebral infarction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Abdominal CT; Result Unstructured Data: Test Result:large amount of gas; Comments: large amount of gas in the portal vein and pneumatosis in the small intestine and the ascending colon
CDC Split Type: JPPFIZER INC2021810367

Write-up: Ischaemic enterocolitis; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 95-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received olmesartan medoxomil/azelnidipine (REZALTAS), bisoprolol (BISONO tape), acetylsalicylic acid (BUFFERIN), linagliptin (TRAZENTA), amlodipine, risperidone, magnesium oxide, isosorbide (ISOSORBIDE tape), furosemide (LASIX), spironolactone, and suvorexant (BELSOMRA) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included dementia Alzheimer''s type, type 2 diabetes mellitus, hypertension and late effects of cerebral infarction. On 15Jun2021 at 09:30 (the day of vaccination), at the age of 95 years old, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital. On 16Jun2021 at 13:30 (1 day after the vaccination), after lunch, vomiting was noted. Abdominal CT showed large amount of gas in the portal vein and pneumatosis in the small intestine and the ascending colon which suspected necrosis of the small intestinal and the ascending colon. The patient experienced ischaemic enterocolitis. Treatment including drip infusion and administration of antibiotic was performed. On 18Jun2021 (3 days after the vaccination), the patient died. The event resulted in prolonged hospitalization/death. The cause of death was ischaemic enterocolitis. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event ischaemic enterocolitis was fatal.; Sender''s Comments: Based on the close temporal relationship, the association between ischemic enterocolitis with COMIRNATY use can not be fully excluded. Advanced age 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: Ischaemic enterocolitis


VAERS ID: 1477214 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Gait disturbance, Pneumonia aspiration, Pyrexia, Renal disorder
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 16
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: Cardiac failure (regular visit to a hospital); Chronic kidney disease (regular visit to a hospital); Diabetes mellitus (regular visit to a hospital); Hypertension (regular visit to a hospital); Myocardial infarction old (regular visit to a hospital)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial operation NOS; Bladder cancer (regular visit to a hospital); Bladder operation; Carotid artery stenosis (regular visit to a hospital); Chemoembolisation (regular visit to a hospital); Hepatic cancer (regular visit to a hospital); Large intestine carcinoma (regular visit to a hospital); Large intestine operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021810755

Write-up: Pyrexia; difficulty in walking; aggravated renal disorder; pneumonia aspiration; cardiac failure; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117042. The patient was a 91-year and 7-month-old male. Body temperature before vaccination was not reported. The patient had an underlying diseases of myocardial infarction old, cardiac failure, diabetes mellitus, hypertension, all ongoing; status after surgery for large intestine carcinoma, the status after selective arterial chemoembolization for hepatic cancer, the status after surgery for bladder cancer, bladder operation, the status after surgery for carotid artery stenosis and ongoing chronic kidney disease, and for the treatment, the patient was regularly visiting a hospital. Concomitant medications and family history were not provided. On 10Jun2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COVID-19 vaccine, manufacturer was unknown, lot number and expiration date were unknown) an unspecified route of administration as DOSE 1, SINGLE (single dose) for COVID-19 immunization. On 13Jun2021 (3 days after the vaccination), the patient experienced pyrexia and difficulty in walking, and the patient was hospitalized on that day. On an unspecified date, the patient developed pneumonia aspiration, cardiac failure and aggravated renal disorder (as reported). On 29Jun2021 (19 days after the vaccination), the patient died of pneumonia aspiration and cardiac failure. It was not reported if an autopsy was performed. (The outcome of the events of pyrexia and difficulty in walking was not reported (Unknown)). The course of the events was as follows: On 10Jun2021, the patient received the vaccination, and afterwards pyrexia persisted and the patient had difficulty in walking. On 13Jun2021, the patient was hospitalized. After hospitalization, as the patient decreased strength, he developed pneumonia aspiration and cardiac failure, and aggravated renal disorder (for clarification). Antibacterial agents were administered but the symptoms did not improve. On 29Jun2021, the patient died. Therapeutic measures were taken as the result of the events. The reporting physician classified the events as serious (hospitalization, for clarification) and assessed the causality between the events and BNT162b2 as unassessable. Pneumonia aspiration and cardiac failure were considered as possible causes of the events. The reporting physician commented as follows: The reporter did not know about a type of the vaccination. The outcome of Pneumonia aspiration and cardiac failure was fatal; aggravated renal disorder was not recovered while the other events was unknown. Information about lot/batch number has been requested.; Reported Cause(s) of Death: pneumonia aspiration; cardiac failure


VAERS ID: 1477216 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic stenosis, Cardiac failure acute, Cardio-respiratory arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021810809

Write-up: severe AS (aortic stenosis); Cardio-respiratory arrest; suspected cardiac failure acute; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116996. The patient was an 85-year and 3-month-old male. Body temperature before vaccination was not reported. It was unknown if the patient had medical history and he was receiving concomitant medications. Family history was not provided. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, 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 28Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Jun2021 (the day of vaccination), the patient developed pyrexia. On 29Jun2021 at 03:30 (1 day after the vaccination), the patient developed cardio-respiratory arrest and died. The cause of death could not be identified but it was suspected to be cardiac failure acute. It was not reported if an autopsy was performed. The course of the events was as follows: The patient was admitted to a facility. On 28Jun2021 at night (the day of vaccination), pyrexia was present. On 29Jun2021 at 03:30, while changing the patient''s diaper, he developed cardio-respiratory arrest. The patient was transferred to a hospital, however, it was difficult to perform resuscitation and the patient''s death was confirmed. There was a finding suggestive of cardiac failure, but a definite cause of death could not be identified. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Cardiac failure acute due to severe AS (aortic stenosis) was considered as a possible cause of the event. The outcome of pyrexia and aortic stenosis was unknown. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest; cardiac failure acute


VAERS ID: 1477217 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 769 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia aspiration; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021810836

Write-up: Thoracic aortic aneurysm rupture; cardiac arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117065. The patient was a 91-year and 2-month-old female. Body temperature before vaccination was 36.9 degrees centigrade. The patient had no particular family history. On 20May2019, the patient was admitted to the reporting hospital for the treatment of aspiration pneumonia. In 2020, the patient had thoracic aortic aneurysm, and the family understood the risk of sudden change due to the disease. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 25Jun2021 at 14:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as DOSE 2, SINGLE (received at the age of 91-years-old) for COVID-19 immunization. On 27Jun2021 at 00:20 (one day/10 hours/5 minutes after the vaccination), the patient experienced thoracic aortic aneurysm rupture. Since 20May2019 (before the vaccination), the patient was admitting to the hospital due to treatment for aspiration pneumonia. On 27Jun2021 (2 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 27Jun2021, at 00:20 (one day, 10 hours, and 5 minutes after vaccination), when a staff member visited the patient''s room, she had haematemesis. The blood was sucked, and a monitor was attached, and then, the patient was confirmed to have cardiac arrest. The doctor on duty and the family were contacted. After the family members arrived at the hospital, the patient was confirmed dead at 01:40 (one day, 11 hours, and 15 minutes after vaccination). The reporting physician classified the event as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was the possibility of rupture of known thoracic aortic aneurysm. The reporting physician commented as follows: Since it was at night, an imaging examination could not be performed. However, it was considered that the patient died due to rupture of known thoracic aortic aneurysm (the disease was diagnosed in 2020, and at that time, the family was explained about the risk of sudden change due to the disease. In addition, the family understood the necessity of BNT162b2 vaccination, and thus, the vaccination was performed this time).; Reported Cause(s) of Death: Cardiac arrest; Thoracic aortic aneurysm rupture


VAERS ID: 1477234 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest
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: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; ALFACALCIDOL; IFENPRODIL; DONEPEZIL; PANTETHINE; FUROSEMIDE; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Denture wearer; Foreign body ingestion; Gastrostomy; Peritonitis; Small intestinal perforation; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021811577

Write-up: Cardio-respiratory arrest; This is a spontaneous report from received from the regulatory authority report number is v21117078. A contactable pharmacist reported that a 90-year and 9-month-old female patient BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in upper right arm on 23Jun2021 14:45 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) at 90-years-old, as dose 1, single for COVID-19 immunisation. Medical history included gastrostomy in 14May2021. On 17May2021, the patient underwent surgery for small intestinal perforation and peritonitis due to accidental ingestion of denture. Ongoing concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin, alfacalcidol, ifenprodil, donepezil, pantethine, and furosemide, and magnesium oxide (MAGMITT), all taken for an unspecified indication. On 23Jun2021 (the day of vaccination), at 14:45, the patient received the first dose of BNT162B2 vaccination in the right upper arm in the ward. For 15 minutes after the vaccination, the course was observed without particular abnormalities. At 18:00 (3 hours and 15 minutes after vaccination), the nurse confirmed that the patient''s consciousness was alert. At 18:50 (4 hours and 5 minutes after vaccination), when the nurse visited the patient''s room, the patient had cardio-respiratory arrest. Cardiac massage and an air-mask bag unit (AMBU-bag) were initiated; however, the patient did not recover. The patient died on 23Jun2021 at 19:54 (5 hours and 9 minutes after vaccination). It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: The causality between the event and BNT162B2 vaccination was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1477239 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Head injury, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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 INC2021812436

Write-up: Automobile accident; Crashed head-on into a wall; This is a spontaneous report from a contactable physician received via regulatory authority. The patient was an 81-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had medical history or allergies to medications, food, or other products. On 01Jun2021 (the day of vaccination) (at the age of 81 years), the patient received the first dose of BNT162B2 (COMIRNATY Solution for injection; Lot Number: EY0779, Expiration Date: 31Aug2021), intramuscular in left arm, as single dose, for COVID-19 immunization. It was unknown whether the patient has been tested for COVID-19 since the vaccination. On 21Jun2021 at 17:00 (20 days after the vaccination), the patient experienced automobile accident. The course of the event was as follows. On 21Jun2021, the patient died of automobile accident. After a scrape automobile accident, the patient probably felt panicked, hit the gas instead of the brake, and crashed head-on into a wall. The patient did not have seat belt on. It was unknown whether the patient received treatment. The outcome of the events was fatal. The patient died on 21Jun2021. After autopsy, this information was received from the patient''s family. The reporting physician classified the events as serious (death).; Sender''s Comments: Based on the information currently available, the reported events are due to an accident, but not related to 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Crashed head-on into a wall; Automobile accident


VAERS ID: 1477250 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris; Dementia; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 17:30; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 04:30
CDC Split Type: JPPFIZER INC2021815310

Write-up: chest pain; Myocardial infarction; Pyrexia; This is a spontaneous report from a contactable consumer and physician received via a sales representative. The patient was a 93-year-old female. Medical history included ongoing diabetes mellitus, ongoing angina pectoris, and ongoing dementia. On 04Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Lot number and expiration date were not reported) for COVID-19 immunisation. On 28Jun2021 (the day of vaccination) (at the age of 93-year-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, lot number, and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 30Jun2021 (2 days after the vaccination), the patient experienced myocardial infarction. The outcome of the event was fatal. The course of the event was as follows: On 28Jun2021, the patient was vaccinated. On 29Jun2021, the patient developed pyrexia. On 30Jun2021, the patient had myocardial infarction and died. The patient was being hospitalized in healthcare facility. On 29Jun2021 at 17:30, the patient developed pyrexia of 38.5 degrees centigrade. On the following day on 30Jun2021 at 04:30, body temperature was 36.8 degrees centigrade. At 06:53, the patient complained of chest pain. At 08:15, the patient was emergently transferred to another hospital. The patient died of myocardial infarction. It was unknown whether the patient died during the transfer or at the hospital. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. The outcome of the pyrexia was recovered on 30Jun2021 at 04:30, the outcome of the event chest pain was unknown and the outcome of the event myocardial infarction was fatal. It was unknown if an autopsy performed or not. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event myocardial infarction cannot be totally excluded. Chest pain was most likely secondary to myocardial infarction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1477255 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Loss of consciousness
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), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: ETIZOLAM; RIVOTRIL; SENNOSIDE [SENNOSIDE A+B]; AMLODIPINE; FUROSEMIDE; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Epilepsy; Hypertension; Insomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021815327

Write-up: Cardiac arrest; lost consciousness; This is a spontaneous report from a contactable physician received via regulatory authority. The patient was a non-pregnant 96-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received etizolam (ETIZOLAM) 0.5 mg, clonazepam (RIVOTRIL) 0.5 mg, sennoside 12 mg, amlodipine 2.5 mg, furosemide 40 mg and magnesium oxide (MAGMITT) 330 mg, 2 tablets within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension, epilepsy, insomnia and cardiac failure chronic. On 02Jun2021 at 16:00 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular in the right arm as dose 1, single at the age of 96 years old for COVID-19 immunization. On 23Jun2021 at 16:00 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) intramuscular in the left arm as dose 2, single at the age of 96 years old for COVID-19 immunization at a nursing home. On 30Jun2021 at 14:45 (7 days after the vaccination), while the patient was moving in a wheelchair by herself, she lost consciousness which resulted in cardiac arrest. At the time of examination, she had already died. The outcome of the event was fatal without treatment. The cause of death was Cardiac arrest. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1477264 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-22
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal necrosis, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Ischaemic colitis (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 2
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: Anaemia; Hypertension; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021815440

Write-up: Septic shock; Necrosis of intestinal tract; This is a spontaneous report from a contactable physician received via a regulatory authority. The patient was a non-pregnant 96-year-old female. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had allergies to medications, food, or other products. Other medical history included hypertension, renal failure, and anaemia. Since the vaccination, the patient has not been tested for COVID-19 On 14Jun2021 at 11:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 22Jun2021 at 07:00 (7 days 19 hours 30 minutes after the vaccination), the patient experienced septic shock. The event resulted in emergency room visit, hospitalization, and death. The course of the event was as follows: On 14Jun2021, the patient received the vaccine. On the same day of the vaccination, the patient had no problem. On 22Jun2021 in the morning, the patient was in a shock state and could not stand up, for which the patient was emergently transferred. However, on 24Jun2021, the patient died of septic shock. Family member reported that the patient had necrosis of intestinal tract. Physician of the hospital where the patient was transferred reportedly said that the event (septic shock) was probably unrelated to the vaccine. The reporting physician classified the event (septic shock) as serious (death and hospitalization). The outcome of the event (septic shock) was fatal, of other event was unknown. It was unknown whether the patient received treatment. An autopsy was not performed.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events necrosis of the intestinal tract and septic shock cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1477269 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Leukaemia, Pulmonary alveolar haemorrhage, Sepsis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Diabetes mellitus; Dyslipidaemia; Hypertension; Hyperuricaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021815469

Write-up: leukaemia; pulmonary alveolar haemorrhage; Disseminated intravascular coagulation; Sepsis; This is a spontaneous report from a contactable physician received via a regulatory authority. The patient was a 78-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus, dyslipidaemia, hyperuricaemia, chronic kidney disease and hypertension. On 07Jun2021 (the day of vaccination), the patient received the dose 1, single (at the age of 78 years old) of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) intramuscular in the left arm for COVID-19 immunization at a COVID-19 vaccine vaccination site. On 09Jun2021 (2 days after the vaccination), the patient experienced leukaemia. Disseminated intravascular coagulation, sepsis and pulmonary alveolar haemorrhage occurred concurrently. The events resulted in clinic visit/hospitalization and death. The patient was hospitalized for 3 days. The outcome of disseminated intravascular coagulation, sepsis was unknown. On 17Jun2021 (10 days after the vaccination), the patient died. The patient received the treatment of danaparoid sodium, antithrombin, antibacterial drugs and others for the events. The cause of death was leukaemia and pulmonary alveolar haemorrhage. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided. The reporter classified the events as serious (death and hospitalization).; Sender''s Comments: Based on limited information provided, the events of leukaemia. Disseminated intravascular coagulation, sepsis and pulmonary alveolar haemorrhage more likely represent intercurrent illnesses which are unrelated to BNT162b2 (COMIRNATY). The case will be reassessed once more information become 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: leukaemia; pulmonary alveolar haemorrhage


VAERS ID: 1477297 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Cardio-respiratory arrest, Computerised tomogram, Electrocardiogram, Pericardial effusion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: ELIQUIS
Current Illness: Angina pectoris; Aortic regurgitation; Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder (Family history of her biological mother); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: CT test; Result Unstructured Data: Test Result:Aortic dissection; Comments: Aortic dissection and pericardial effusion were present; Test Date: 20210619; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Waveforms of asystole and PEA
CDC Split Type: JPPFIZER INC2021816474

Write-up: Aortic dissection; Pericardial effusion; Cardiopulmonary arrest; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is v21117136. The patient was an 84-year and 6-month-old female. Body temperature before vaccination was not reported. Family history included cancer of her biological sister and heart disease of her biological mother. Medical history included hypertension, heart disease (on oral treatment with apixaban (ELIQUIS)) (family history: heart disease of her biological mother), ongoing atrial fibrillation (AF), ongoing aortic regurgitation (AR), and ongoing angina pectoris. Current medical history: regularly visiting another hospital for AF, AR, and angina pectoris. Concomitant medication included ongoing apixaban (ELIQUIS) oral for heart disease. On an unspecified date, the patient previously received the first dose of BNT162B2 (COMIRNATY; Lot Number and Expiration Date were not reported) for COVID-19 immunization. On 05Jun2021 at 16:45 (the day of vaccination) (at the age of 84 years), the patient received the second dose of BNT162B2 (COMIRNATY Solution for injection; Lot Number: EY5422, Expiration Date: 31Aug2021), via an unspecified route of administration, as single dose, for COVID-19 immunization. On 19Jun2021 at 18:30 (14 days after the vaccination), the patient experienced aortic dissection. The course of the event was as follows (according to the medical records). On 19Jun2021 around 18:30 (14 days after the vaccination), the patient experienced chest pain and was able to talk when meeting the ambulance crew. Transported by ambulance (emergency room visit). Chief complaint was cardiopulmonary arrest (CPA) on 19Jun2021 (unspecified time). The regular visiting hospital could not accept the patient, and CPA developed on the way to the reporting hospital. She was transported while having CPA in the moving ambulance. A route was secured inside the ambulance, and the patient was transported while receiving adrenaline 3A. After being transported, the electrocardiogram showed waveforms of asystole and pulseless electrical activity (PEA). Computerised tomography (CT) test: aortic dissection (Stanford A) and pericardial effusion were present (19Jun2021 at 18:30). At 20:09, death was confirmed. Cause of death: aortic dissection. On 19Jun2021 (14 days after the vaccination), the outcome of the events was fatal. The patient died on 19Jun2021 at 20:09. It was unknown if an autopsy was performed. The reporting pharmacist classified the events as serious (death) and assessed the causality between the events and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases was present. The reporting pharmacist commented that this case was reported at the family''s request.; Reported Cause(s) of Death: Cardiopulmonary arrest; Pericardial effusion; Aortic dissection


VAERS ID: 1477303 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

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

Life Threatening? 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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021816589

Write-up: Acute circulatory failure; This is a spontaneous report from a contactable other healthcare professional (nurse) received from a regulatory authority. Regulatory authority report number is v21117134. A 79-years-old female patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 25Jun2021 at 10:31 (Batch/Lot Number: EY5422; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient received first dose of comirnaty for covid-19 immunization on 04Jun2021 (Lot#EY0779, Expiration date 31Aug2021) and experienced feeling queasy, vertigo and vomiting on 07Jun2021 - 3 days after 1 st dose of Comirnaty (07Jun2021). On 25Jun2021 at 18:00 or later (at least 7 hours/29 minutes after the vaccination or later, actual time was unknown), the patient experienced acute circulatory failure. On 25Jun2021 (the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jun2021, the patient received the first dose of BNT162b2 vaccination. 3 days after the vaccination, the patient had feeling queasy and vertigo. The feeling bad improved after vomiting. On 25Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. After the vaccination, no symptoms were observed, and the patient went home 30 minutes later. At 17:30 (6 hours and 59 minutes after vaccination), the patient had dinner. At 18:00 (7 hours and 29 minutes after vaccination), the patient''s husband went to sleep (18:00 was the last time when the patient was in good condition). On 26Jun2021, at 05:26 (18 hours and 55 minutes after vaccination), when the husband woke up, his wife (the patient) did not wake up. Thus, the husband went to see how the patient was doing, and no response was obtained, and an ambulance was called. At 05:37 (19 hours and 6 minutes after vaccination), when the emergency medical assistance arrived, cardiopulmonary resuscitation (CPR) was initiated. At 06:01 (19 hours and 30 minutes after vaccination), after the patient arrived at the emergency room in the reporting hospital, CPR was continued and still no response; however, the dying declaration was made at 06:24 (19 hours and 53 minutes after vaccination). The family did not wish an autopsy (anatomization), and CT for an autopsy imaging (AI) and an autopsy (external examination) by the police were performed. However, the cause of death was unable to be specified on the CT. The direct cause of death was acute circulatory failure, and the period from the onset of the disease from death was diagnosed as several hours. The patient underwent lab tests and procedures which included body temperature: 36.4 centigrade on 25Jun2021 Before vaccination. Therapeutic measures were taken as a result of acute circulatory failure. The patient died on an unspecified date. An autopsy was performed that revealed acute circulatory failure. The reporting other healthcare professional (nurse) classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases (Since there was no history of screening, the details were unknown).; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2021822270 Same patient/drug, different dose/event; Reported Cause(s) of Death: Acute circulatory failure; Autopsy-determined Cause(s) of Death: Acute circulatory failure


VAERS ID: 1477309 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest
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: 2021-06-30
   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: COPD; Emphysema (endstage); Interstitial pneumonia; Oxygen supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021816650

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117135. The patient was a 72-year-old male. Body temperature before vaccination was 36.1 degrees centigrade. The family history was not provided. The patient received home oxygen therapy for COPD. On 25May2021, the patient was administered prednisolone 2 mg for interstitial pneumonia. After the prednisolone was discontinued, physical deconditioning and decreased SpO2 were observed. On 22Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jun2021 at 12:59 (7 days/22 hours/59 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 30Jun2021 (8 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: When the patient''s wife was absent, the patient fell at his home, and he had cardio-respiratory arrest. An ambulance was called, and the patient was confirmed to have cardio-respiratory arrest. After the patient arrived in the reporting hospital, while resuscitation was being tried, adrenaline 2A was intravenously injected, and resuscitation was performed; however, the patient died. 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 patient was in the end stage of emphysema. One and a half month had passes since the patient was discharged from the hospital for the treatment of interstitial pneumonia. After prednisolone 2 mg was discontinued, the patient had physical deconditioning. It was considered that the event was unrelated to BNT162 vaccination.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; 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: Cardio-respiratory arrest


VAERS ID: 1477334 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest
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: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERO-GRADUMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Haemorrhage of digestive tract
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021817163

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was an 88-year-old male at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ferrous sulfate (FERO-GRADUMET) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cardiac failure, atrial fibrillation, and haemorrhage of digestive tract. On 15Jun2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, solution for injection, lot number EY5420, expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization. On 18Jun2021 at 08:00 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. The event resulted in death. The outcome of the event was fatal without treatment. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death).; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the fatal event cannot be excluded. 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.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1477335 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Condition aggravated, Imaging procedure, Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Malignant lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood data; Result Unstructured Data: Test Result:aggravated; Comments: after the first dose; Test Date: 202106; Test Name: Blood data; Result Unstructured Data: Test Result:aggravated suddenly; Comments: after the second dose; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 2021; Test Name: Imaging data; Result Unstructured Data: Test Result:aggravated; Comments: after the first dose
CDC Split Type: JPPFIZER INC2021817210

Write-up: Malignant lymphoma aggravated; Malignant lymphoma aggravated; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 81-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included malignant lymphoma and chemotherapy since Sep2020. On 31May2021 at 15:15 (at the age of 81-year-old), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY0779, Expiration date 31Aug2021) intramuscular in the arm left. On 21Jun2021 at 15:15 (the day of vaccination) (at the age of 81-year-old), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the arm left as DOSE 2, SINGLE for COVID-19 immunization. On an unspecified day in Jun2021 (after the vaccination), the patient experienced malignant lymphoma aggravated. The event resulted in death. The outcome of the event was fatal. It was unknown whether the patient received treatment. The course of the event was as follows: The patient''s primary care physician judged that the patient could receive the vaccination and the patient was vaccinated twice. Since Sep2020, the patient has received chemotherapy for malignant lymphoma with improvement in data. Until May, the course was favorable and the patient received treatment regularly. On 31May2021, the patient received the first dose of COMIRNARY and aggravation was noted in blood data and imaging data. On 07Jun2021, family member was summoned and received an explanation. On 21Jun2021 in the afternoon, the patient was fit enough to come walking to receive the second vaccination, went shopping, and went to a bank and done arrangement. However, immediately after the vaccination, blood data and condition aggravated suddenly. Five days after the vaccination, on 26Jun2021 in the morning, the patient was critically ill and family member was summoned. On 29Jun2021, the patient could not get out of bed and the only reaction was nodding. On 01Jul2021 at 04:30, the patient died. 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). On 02Jul2021, additional information was received from the same contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117568. New information reported includes follows: Body temperature before vaccination was 36.6 degrees centigrade. Start and stop time of COMIRNATY was updated to 16:00 Event onset date was 22Jun2021. Seriousness criteria of hospitalization was added. The reporting physician assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was ongoing use of anticancer agent due to malignant lymphoma. The reporting physician commented as follows: There was improvement in malignant lymphoma with anticancer agent treatment. This time, the patient was hospitalized to receive anticancer agent treatment. While the patient was hospitalized, the patient went to receive COVID-19 vaccine. Immediately after the second vaccination, aggravation in blood data was noted and general condition aggravated suddenly. In a few days, the patient became critically ill. It was unassessable whether there was adverse reaction due to anticancer agent or some kind of influence of the vaccine; however, it was at least true that condition aggravated suddenly after the vaccination. Thus, it was suspected that there was some kind of causal relationship.; Reported Cause(s) of Death: malignant lymphoma aggravated; malignant lymphoma aggravated


VAERS ID: 1477346 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
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 cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021817524

Write-up: died; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117154. The patient was a 73-year-old male. Body temperature before vaccination was 37.1 degrees Centigrade. Medical history included lung cancer. Family history and concomitant medications were not provided. On 20Jun2021 at 09:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0779, Expiration date 31Aug2021) an unspecified route of administration as dose 1, single (at the age of 73 years old) for COVID-19 immunization. On 25Jun2021, the patient died. It was not reported if an autopsy was performed. The cause of death was not reported. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: The causal relationship with BNT162b2 was unknown but the patient had an underlying disease of lung cancer.; Reported Cause(s) of Death: died


VAERS ID: 1477347 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: Interstitial pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021817544

Write-up: Unknown cause of death; cardiopulmonary arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117190. The patient was a 75-year and 7-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. Medical history included interstitial pneumonia (IP). Concomitant medications and family history were not provided. On 29Jun2021 at 19:33 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EW0201, Expiration date 30Sep2021) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 30Jun2021 at around 01:00 (1 day after the vaccination), the patient collapsed at home and developed CPA (cardiopulmonary arrest). Resuscitation was performed but the patient did not respond to it. He was transferred to a hospital by an ambulance, and then his death was confirmed. This case was reported as abnormal death. The patient died on 30Jun2021 01:00. The cause of death was unknown. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Interstitial pneumonia was considered as a possible cause of the event. The outcome of the event cardiopulmonary arrest was unknown. The reporting physician commented as follows: The patient was transferred to the reporter''s hospital in cardiac and respiratory arrest. The patient died of unknown cause.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1477349 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest
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: 2021-06-24
   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: Parkinson''s disease (being treated for Parkinson''s disease on outpatient basis at Hospital Neurology Department)
Preexisting Conditions: Medical History/Concurrent Conditions: Balance difficulty; Dysphagia; Hallucination, visual; Muscular weakness; Myalgia; Somnolence; Trismus
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before the second vaccination
CDC Split Type: JPPFIZER INC2021817571

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician reported for a patient received from the Regulatory Authority. Regulatory authority report number is v21117189. The patient was a 78-year and 4-month-old male (Age at vaccination at 78 years old). Body temperature before vaccination was 36.6 degrees centigrade. Medical history included Parkinson''s disease that symptoms included muscular weakness, myalgia, body tilts, somnolence, visual hallucination, trismus, and dysphagia. Family history and concomitant medications were 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). On 02Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA7338, Expiration date 30Sep2021). On 23Jun2021 at 13:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscularly as a single dose for COVID-19 immunisation. On 24Jun2021 at 00:00 (the exact time was unclear), the patient experienced cardio-respiratory arrest. On 24Jun2021 (1 day after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The patient was being treated for Parkinson''s disease on outpatient basis at hospital Neurology Department. The symptoms associated with Parkinson''s disease had been unstable recently, and muscular weakness, myalgia, body tilts, somnolence, visual hallucination, trismus, and dysphagia had been notable. On 23Jun2021 at 13:00 (the day of vaccination), the patient received the second BNT162b2 vaccination intramuscularly. Shortly after this, the patient did not experience particular changes in his condition. He could not eat lunch and dinner afterwards because of somnolence, trismus, and dysphagia. At 20:00 and 22:00, the patient was sleeping and his respiration was confirmed. On 24Jun2021 at 00:00 (1 day after the vaccination, as reported), the patient was unresponsive and breathing was absent, due to which an ambulance was called. At 00:20, the emergency crew of the doctor car arrived and performed cardiopulmonary resuscitation, but there was no response. At 00:45, death was confirmed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Parkinson''s disease.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1477362 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021819383

Write-up: Completed suicide; 2021819383 The patient was a non-pregnant 86-year-old female. Concomitant medications and medical history were not reported. On 25Jun2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot# FA7338, Expiration date 30Sep2021, Dose number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. On 26Jun2021 (1 day after the vaccination), the patient experienced completed suicide. The event resulted in death (26Jun2021). It was unknown if an autopsy was performed. The causality assessment was not provided.; Sender''s Comments: 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: Completed suicide


VAERS ID: 1477363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
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: 2021-06-29
   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: Diabetes mellitus; Dialysis; Renal failure; Wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021819386

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician via company representative. The patient was a 48-year and 10-month-old male. Underlying disease/current condition included diabetes mellitus, renal failure, dialysis, and using a wheelchair in daily life. Other medications were not reported. On 27Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 29Jun2021 at unknown time (2 days after the vaccination), the patient experienced cardiac failure. On 29Jun2021 (2 days after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The patient had diabetes mellitus. He had renal failure and was on dialysis. He was using a wheelchair in daily life. On 27Jun2021 (Sunday) (the day of the vaccination), the patient received the first BNT162b2 vaccination at the reporting clinic. On this day, the patient had no problem during the 30-minute waiting time and went home. On 29Jun2021 (Tuesday) (2 days after the vaccination), the patient was found dead at the hotel (the cause of death was cardiac failure). On 01Jul2021 (4 days after the vaccination), his wife called about the patient''s death the attending physician of the reporting clinic. The attending physician considered that there was no relation with BNT162b2. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Information on the batch/lot number has been requested.; Sender''s Comments: There is not sufficient evidence to support a causal relationship between the event "Cardiac failure" and BNT162b2. Underlying disease diabetes mellitus, renal failure under dialysis and using a wheelchair in daily life with possible cardiac disease may be alternative explanations. This case will be re-assessed when 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1477372 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drowning, Electroencephalogram
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REFLEX (MIRTAZAPINE); PROTECADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety neurosis; Gait instability (no abnormalities on EEG); Neurogenic bladder
Allergies:
Diagnostic Lab Data: Test Name: electroencephalogram; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021822243

Write-up: Drowning; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 81-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), intramuscularly on 10Jun2021 at single dose for COVID-19 immunisation. Medical history included staggering of unknown cause (no abnormalities on electroencephalogram), anxiety neurosis, and neurogenic bladder. When the patient fell down due to staggering, electroencephalogram did not show abnormalities. As for staggering, various factors including medical history could be considered as a cause. The patient was receiving unspecified alpha blocker, mirtazapine (REFLEX), and lafutidine (PROTECADIN). On 19Jun2021 (9 days after the vaccination), the care attendant found the patient dead from drowning in a bathtub at home. The patient declined support for bathing by care attendant, so the patient had bathing alone frequently. It was not reported whether the patient received the treatment for the event or not. The outcome of the event was fatal. It was not reported if an autopsy was performed. The possibility of BNT162b2 being the cause of the event was low. Information on lot/batch number has been requested.; Sender''s Comments: A possible contributory role of the suspect drug to the reported event Drowning cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Drowning


VAERS ID: 1477387 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Chronic kidney disease, Computerised tomogram, Heart rate, Malaise, Oxygen saturation, Pneumonia aspiration, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: Dialysis; Feeling sick; Fever; Renal failure chronic; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: BP; Result Unstructured Data: Test Result:72/49; Comments: in the morning; Test Date: 20210630; Test Name: BP; Result Unstructured Data: Test Result:70/38; Comments: at 13:00; Test Date: 20210630; Test Name: CT; Result Unstructured Data: Test Result:revealed right pneumonia; Comments: revealed right pneumonia/there was right pneumonia aspiration; Test Date: 20210630; Test Name: HR; Result Unstructured Data: Test Result:105; Comments: in the morning; Test Date: 20210630; Test Name: HR; Result Unstructured Data: Test Result:112; Comments: at 13:00; Test Date: 20210630; Test Name: SAT; Test Result: 93 %; Comments: at 13:00
CDC Split Type: JPPFIZER INC2021822291

Write-up: been unwell; Death/death due to renal failure chronic; cardiopulmonary arrest (CPA); Vomited; right pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117574. An 86-year-old female patient received second dose of BNT162b2 (COMIRNATY, Lot number: FA5765, Expiration date: 30Sep2021) at the age of 86-years, via an unspecified route of administration on 29Jun2021 at 10:30 at single dose for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. Medical history included dialysis, renal failure chronic, type 2 diabetes mellitus, and had a fever or gotten sick in the last month. The following were the points to be considered on the vaccine screening questionnaire: Have you had a fever or gotten sick in the last month? yes (name of disease: blank), person 65 years or older, and person with an underlying disease of renal failure chronic and type 2 diabetes mellitus. Concomitant medications were not reported. The patient previously received the first single dose of BNT162b2 (COMIRNATY, lot number not reported, expiration date not reported) on an unknown date for COVID-19 immunisation. On 30Jun2021 (1 day after the vaccination), the patient vomited at 07:00 and experienced cardiopulmonary arrest (CPA) at 15:27 and death at 16:43. Computerised tomography (CT) revealed right pneumonia/there was right pneumonia aspiration for a few days at unknown time. On 30Jun2021 (1 day after the vaccination), the outcome of the event death was fatal. The outcome of the other events was not clearly reported. It was not reported whether autopsy was done. The course of the events was as follows: on 30Jun2021 in the morning (1 day after the vaccination), the patient vomited. The patient did not eat breakfast because she refused. The blood pressure (BP) was 72/49, and the heart rate (HR) was 105. In the morning, she visited the orthopedic surgery department. According to her son, the patient had been unwell since being vaccinated. She went home. At 13:00, 70/38, HR 112, jaw breathing, saturation (SAT) 93%. At 15:00, a house call was made. At 15:27, CPA occurred during transport. At 15:32, the emergency department of the reporting hospital accepted the patient. Cardiopulmonary resuscitation was continued. At 16:43, the patient was unresponsive despite resuscitation and was confirmed dead. Computerised tomography (CT) revealed right pneumonia. Death due to renal failure chronic was determined. There was right pneumonia aspiration for a few days. The provided information revealed that this happened the next day of the vaccination. The reporting physician classified the event death as serious (death) and assessed the causality between the event death and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible cause(s) of the event death such as any other diseases were pneumonia aspiration and dialysis patient with renal failure chronic. The reporting physician commented as follows: It was possibly death due to the underlying disease. Reported this case because it happened the next day of the vaccination. Outcome of pneumonia aspiration was fatal while of remain was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: right pneumonia aspiration; Death due to renal failure chronic


VAERS ID: 1477388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypertension; Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021822295

Write-up: Sudden death; The patient was found unconscious while bathing; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21117571. The patient was a 93-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. Medical history included hypertension, historical condition of cerebral infarction, and late effects of cerebral infarction. Concomitant medications included ongoing clopidogrel (CLOPIDOGREL) for Late effects of cerebral infarction and antihypertensives. Family history was not reported. On 25May2021 at 15:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY2173, Expiration date 31Aug2021) for COVID-19 immunisation. On 15Jun2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as dose 2, single for COVID-19 immunisation. On 29Jun2021 (14 days after the vaccination), the patient was found unconscious while bathing at unknown time and experienced sudden death at 22:00. On 29Jun2021 (14 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: After the second vaccination, the patient was in good health at revisit on 21Jun2021 (6 days after the vaccination). He also spent his days afterwards walking his dog or doing other things. On 29Jun2021 at night (14 days after the vaccination), the patient was found unconscious while bathing and was transported by ambulance. He was confirmed dead on arrival. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases were ongoing oral treatment with CLOPIDOGREL for late effects of cerebral infarction and oral treatment with antihypertensives for hypertension. The reporting physician commented as follows: The patient was at an old age of 93 but had been in good health and had always taken his dog for a walk without manifestation of dementia or late effects of cerebral infarction (details were unknown because the drug therapy was decided by the other hospital and there was no obvious paralysis and dyslalia). The patient was found unconscious while bathing, and it was unknown whether cerebral infarction, cerebral haemorrhage, cardiac failure, or drowning was involved. It seemed that the hospital where he was taken only determined the death, and we knew about the whole story when the police called.; Reported Cause(s) of Death: unconscious; Sudden death


VAERS ID: 1477389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7388 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Cardio-respiratory arrest, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified; Oxygen therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021822298

Write-up: Cardiac failure; Respiratory failure; Cardio-respiratory arrest; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21117576. A 75-years-old male patient received the first dose of BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jun2021 15:30 (Lot Number: FA7388; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included heart disease and ongoing use of home oxygen. Concomitant medication included acetylsalicylic acid (BAYASPIRIN). Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. The patient was a 75-year-old male. Body temperature before vaccination was 36.3 degrees centigrade. Family history was not reported. Medical history included heart disease. Concomitant medications included oral acetylsalicylic acid (BAYASPIRIN). On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). On 16Jun2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7388, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 19Jun2021 at 03:00 (3 days after the vaccination), the patient experienced cardiac failure, respiratory failure, and cardio-respiratory arrest. On 19Jun2021 (3 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 19Jun2021 late at night around 02:00, the patient had cold sweat and respiratory discomfort at home, and an ambulance was called. Cardio-respiratory arrest occurred inside the ambulance. He was transported to another hospital and was confirmed dead. The reporting nurse classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were the underlying heart disease and ongoing use of home oxygen. The reporting nurse commented as follows: Details were unknown because he was transported to another hospital. Outcome of events were fatal. Patient died on 19Jun2021. It was not reported whether autopsy was done.; Reported Cause(s) of Death: Cardio-respiratory arrest; Cardiac failure; Respiratory failure


VAERS ID: 1477390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal tenderness, Asthenia, Body temperature, C-reactive protein, C-reactive protein increased, Cardio-respiratory arrest, Coma scale, Decreased appetite, Encephalitis, Encephalopathy, Sepsis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Diabetes mellitus; Heart disease, unspecified; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 202106; Test Name: JCS; Result Unstructured Data: Test Result:III-100; Test Date: 20210622; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:High
CDC Split Type: JPPFIZER INC2021822299

Write-up: Encephalitis; Encephalopathy; lower abdominal tenderness; CRP level was high; feelings of weakness; vomiting; Sepsis; died due to cardiac arrest and respiratory arrest; inappetence; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was a 97-year and 2-month-old female. The reporter, the date and time of the vaccination (On 17Jun2021, at 12:47, the second dose, Lot#EY3860; On unknown date in 2021, the first dose, Lot#FA7338), the body temperature before vaccination (36.5 degrees Celsius), the medical histories (diabetes mellitus,heart disease, hypertension, dementia Alzheimer''s type), the concomitant medication (acetylsalicylic acid (BYASPIRIN)100 mg), the adverse events (On 20Jun2021, pneumonia and encephalopathy), and narrative were added. The event'' Encephalitis'' was reported. The course of the event was as follows: On 20Jun2021 (unknown days/hours/minutes after the vaccination), the patient experienced sepsis. On 26Jun2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: At the end of May2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. Although the event was possibly related to BNT162 vaccination, the causality between the event and BNT162b2 vaccination was unknown in the response. On 20Jun2021 (2 days, 11 hours, and 13 minutes after vaccination), around lunch time, the patient had inappetence. On 21Jun2021 (3 days, 11 hours, and 13 minutes after vaccination), the patient had vomiting. On 22Jun2021 (4 days, 11 hours, and 13 minutes after vaccination), since the patient had feelings of weakness and lower abdominal tenderness, she was admitted to the reporting hospital on the same day. Since the CRP level was high, the patient was treated with an antibiotic. No pneumonia or urinary tract infection was observed. The laboratory values tended to improve. However, the state of consciousness progressed from a Coma Scale III-100. On 26Jun2021 (8 days, 11 hours, and 13 minutes after vaccination), the patient died due to cardiac arrest and respiratory arrest. Outcome of sepsis, Encephalitis, Encephalopathy was fatal, the outcome of remaining events was unknown. The reporting physician classified the event as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: There was a possibility of the change associated with sepsis. The reporting physician commented as follows: Although the patient received treatment for sepsis, and it was significantly resolving, disturbed consciousness did not resolve.; Sender''s Comments: Based on a temporal association, a contributory role of BNT162B2 to the reported events cannot be completely excluded. Advanced age, medical histories of diabetes mellitus, heart disease, hypertension, and dementia Alzheimer''s type are considered as the essential contributory factors. 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: encephalitis; Encephalopathy; cardiac arrest and respiratory arrest; Sepsis


VAERS ID: 1477394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atypical pneumonia, White blood cell count
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: white blood cell count; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021822321

Write-up: Atypical pneumonia; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was an 80-year-old male. The medical history was unknown. Family history and concomitant medications were not reported. On 03Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular for COVID-19 immunization. On 18Jun2021 (15 days after the vaccination), the patient experienced atypical pneumonia. Since the patient suddenly became unable to take meals at an institution, he visited the reporting hospital on 18Jun2021. Since the white blood cell count was normal, the patient was diagnosed with atypical pneumonia. On unknown date in 2021, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of atypical pneumonia due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: Atypical pneumonia


VAERS ID: 1477399 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: Constipation; Essential tremor; Insomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021822368

Write-up: Death; This is a spontaneous report from a contactable physician received via the Agency. A 96-year-old male patient received BNT162B2 (COMIRNATY), second dose intramuscular in the left arm on 25Jun2021 at 15:30 at age of 96-years-old (Lot number EY0573, Expiration date 30Sep2021) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received several unspecified medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, or other products. Other medical history included essential tremor, constipation and insomnia. On 04Jun2021 at 15:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 25Jun2021 at 15:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a clinic/emergency room. On 30Jun2021 at 14:00 (5 days after the vaccination), the patient was found dead and no treatment was received. (The event resulted in death) The cause of death was unknown. It was unknown if an autopsy was performed. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided.; 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 for this 96 years old 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: Unknown cause of death


VAERS ID: 1477401 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Cardio-respiratory arrest, Computerised tomogram, Loss of consciousness
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210701; Test Name: CT of the whole body; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021822423

Write-up: Cardiac death; cardio-respiratory arrest; lost consciousness; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES), and a contactable physician of the same hospital as the previous reporter received from the regulatory authority report number is v21117239. A 71-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm on 29Jun2021 at 15:00 at single dose for COVID-19 immunization at a hospital. Medical history and concomitant medications were not reported. The did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. The patient had no relevant family history. Body temperature before vaccination was 36.6 degrees Centigrade on 29Jun2021. On 01Jul2021 at around 10:00 (2 days after the vaccination), the patient''s mother found that patient lost consciousness sitting on the floor leaning, and she called an ambulance. At 10:36, an emergency team arrived, and cardiopulmonary resuscitation was performed. At 10:58, the patient was transferred to the reporter''s hospital in a state of cardio-respiratory arrest. At the hospital, cardiopulmonary resuscitation was performed again, but it did not work. At 11:23, the patient''s death was confirmed. (The event resulted in death.) The cause of death was intrinsic cardiac death. CT of the whole body performed at the reporting hospital did not show obvious abnormalities. It was unknown if the patient has been tested for COVID-19 since the vaccination. The outcome of the events cardio-respiratory arrest and intrinsic cardiac death was fatal with treatment including cardiopulmonary resuscitation. Outcome of lost consciousness was unknown. Patient died on 01Jul2021. An autopsy was not performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was unknown if there was possible cause of the events such as any other diseases.; Sender''s Comments: Limited information can not support a complete medical assessment. A possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cardio-respiratory arrest, intrinsic cardiac death and lost consciousness due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: cardio-respiratory arrest; intrinsic cardiac death


VAERS ID: 1477408 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac output, Cardiac output decreased, Hypophagia, Pyrexia, Respiratory arrest
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Hypertension; Hypoalbuminaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: before vaccination; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: at supper time; Test Date: 20210630; Test Name: cardiac output; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021823137

Write-up: Respiratory arrest; Cardiac output decreased; the amount of meal intake decreased to about 20%; body temperature elevated to 37.6 degrees centigrade; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21117258. A 98-year and 9-month-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: FC3661; Expiration Date: 30Sep2021), intramuscularly, on 30Jun2021 at 14:07 (at the age of 98-years-old) as a single dose for COIVD-19 immunisation. Medical history included old cerebral haemorrhage, hypertension, and hypoalbuminaemia. The patient had no family history. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. The patient experienced respiratory arrest and cardiac output decreased on 30Jun2021 at 23:50 (9 hours 43 minutes after the vaccination), which were reported as fatal. The patient also experienced the amount of meal intake decreased to about 20% and body temperature elevated to 37.6 degrees centigrade on 30Jun2021. The clinical course was reported as follows: On 30Jun2021 in the morning, at the time of round on patients, there was no marked change or decrease in level. At 14:07, the patient received BNT162B2 intramuscularly. The body temperature before vaccination was 37 degrees centigrade on 30Jun2021. At supper time, the amount of meal intake decreased to about 20% and body temperature elevated to 37.6 degrees centigrade on 30Jun2021. On the same day at 22:30, when round of visits and postural change were done, there was no aggravation in respiratory status. However, at 23:50, an attending nurse found that the patient had respiratory arrest and cardiac output decreased on 30Jun2021. Because of do not resuscitate (DNR) policy, on 01Jul2021 at 00:35, physician on duty confirmed death. The clinical outcome of respiratory arrest and cardiac output decreased was fatal and of the amount of meal intake decreased to about 20% and body temperature elevated to 37.6 degrees centigrade was unknown. The patient died on 01Jul2021 at 00:35. The cause of death was reported as respiratory arrest and cardiac output decreased. It was not reported if an autopsy was performed. The reporting physician assessed that the events were related to BNT162B2. Other possible cause of the event, such as any other diseases was as follows: possibility of complication of pyelonephritis could not be denied. The reporting physician commented as follows: There was strong indication that the condition aggravated due to BNT162B2 intramuscular injection.; Reported Cause(s) of Death: Respiratory arrest; Cardiac output decreased


VAERS ID: 1477426 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood lactate dehydrogenase, Blood pressure measurement, Body temperature, C-reactive protein, Cerebral infarction, Coma scale, Computerised tomogram, Depressed level of consciousness, Lymphocyte percentage, Neutrophil percentage, Septic shock, White blood cell count
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Catheter placement; Chronic atrial fibrillation; Chronic kidney disease; Glomerulonephritis chronic; Glycogen storage disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: Blood culture; Result Unstructured Data: Test Result:S. epidermidis; Test Date: 20210611; Test Name: LDH; Result Unstructured Data: Test Result:292; Comments: increased; Test Date: 20210613; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:no improvement; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:39.6 Centigrade; Comments: at around 14:00; Test Date: 20210613; Test Name: JCS; Result Unstructured Data: Test Result:III-300; Comments: in the evening; Test Date: 20210613; Test Name: CT; Result Unstructured Data: Test Result:infarction in the MCA; Comments: infarction in the right middle cerebral artery (MCA); Test Date: 20210611; Test Name: CRP; Result Unstructured Data: Test Result:14.67; Test Date: 20210611; Test Name: Lym; Test Result: 9.9 %; Test Date: 20210611; Test Name: Neu; Test Result: 83.1 %; Test Date: 20210611; Test Name: WBC; Result Unstructured Data: Test Result:8700
CDC Split Type: JPPFIZER INC2021824530

Write-up: Septic shock; JCS decreased to III-300; infarction in the MCA; This is a spontaneous report from contactable physicians received from a regulatory authority. Regulatory authority report number is v21117303. A 83-year and 4-month-old male received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA4597, Expiration date: 31Aug2021) via an unspecified route of administration on 10Jun2021 (at the age of 83-year and 4-month-old) at 14:30 (the day of vaccination), as a single dose for COVID-19 immunisation. Medical history reported was chronic kidney disease GSD (glomerulonephritis chronic), chronic atrial fibrillation, and long-term catheter placement. Concomitant medication reported was acetylsalicylic acid (ASPIRIN). Body temperature before vaccination was not reported. Family history was not reported. On 11Jun2021 at 14:00 (23 hours 30 minutes after the vaccination), the patient experienced septic shock. The course of the event was as follows: On 11Jun2021 at around 14:00, the patient developed chills, shivering, and body temperature of 39.6 degrees centigrade. Lactate dehydrogenase (LDH) increased to 292, C-reactive protein (CRP) was 14.67, and white blood cell (WBC) was 8700, (Neu 83.1%, Lym 9.9%). Two sets of blood culture revealed Staphylococcus epidermidis (S. epidermidis). Treatment with vancomycin (VCM) was initiated. On 12Jun2021, catheter was withdrawn. Subsequently, the patient was continued to be in a state of septic shock. On 13Jun2021 in the evening, Coma Scale (JCS) decreased to III-300. Computer tomography (CT) revealed infarction in the right middle cerebral artery (MCA). There were no improvements in consciousness and blood pressure and dialysis became difficult. On 16Jun2021, after the dialysis, dialysis was withdrawn. On 22Jun2021 at 20:25, death was confirmed. The patient was admitted to the hospital from 11Jun2021 (1 day after the vaccination) to 22Jun2021. On 22Jun2021 (12 days after the vaccination), the outcome of the event septic shock was fatal and for remaining events its unknown. The reporting physician classified the event as serious (death and hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were catheter related bloodstream infection (CRBSI), chronic kidney disease GS (CKDGS), and atrial fibrillation (AF). The reporting physician commented as follows: Occasionally, there were SARS-CoV-2 vaccine cases in which infection was induced in patients without manifestation of infection or cerebral infarction occurred. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1477437 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021827494

Write-up: myocardial infarction; This is a spontaneous report from a contactable other healthcare professional received via representative and a contactable physician received via representative. The patient''s age and gender were not provided. The patient had underlying diseases of ongoing hypertension and rheumatoid arthritis, for which s/he was orally taking some drugs. The concomitant medications were not provided. On unknown date in 2021 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not provided) via an unspecified route of administration for COVID-19 immunization. On unknown date in 2021 (approximately 14 days after the vaccination), the patient died due to myocardial infarction. The causality between the event and BNT162b2 vaccination and the seriousness criteria of the event were not provided. The reported course was as follows: On an unknown date in 2021, the patient received a dose of BNT162b2 vaccination. Approximately 2 weeks later, the patient stopped breathing, and s/he was transferred to the hospital by an ambulance. On Day 14 after the patient received a dose of BNT162b2 vaccination, s/he had myocardial infarction, and died. The patient was being treated for hypertension at another hospital. Since the patient was being treated at another hospital, no additional information was obtained. Information on the lot/batch number has been requested.; Sender''s Comments: A possible contributory role of the suspect drug to the reported event "myocardial infarction" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1477444 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021828047

Write-up: Death on the same day of the vaccination in the afternoon; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 76-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), second dose at the age of 76-year-old (Lot number FA5765, Expiration date 30Sep2021) Intramuscularly in the arm left on 01Jul2021 at 10:30 as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was not reported whether the patient had allergies to medications, food, or other products. Other medical history included diabetes mellitus. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received bnt162b2 (COMIRNATY), first dose (Lot# EY5420, Expiration date 31Aug2021) intramuscular in the arm left on 10Jun2021 at 10:30 as single dose for COVID-19 immunisation. On 01Jul2021, the patient experienced death on the same day of the vaccination in the afternoon. The reporting physician classified the event as serious (death). It was unknown whether the patient received treatment. No Autopsy Done. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was fatal.; 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1477452 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: Decreased appetite; Strength loss of (lost physical strength); Vesical fistula
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021831441

Write-up: geromarasmus; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 89-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunisation on 30Jun2021. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunisation on unknown date with no adverse event. Medical history included ongoing vesical fistula, ongoing decreased appetite since the beginning of 2021, ongoing strength loss of (lost physical strength) since the beginning of 2021. Concomitant medications were not reported. On 30Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2. On 01Jul2021 (1 day after the vaccination), while the patient underwent procedure for vesical fistula, he died. The cause of death was considered to be geromarasmus and there was no causal relationship with BNT162b2. Geromarasmus was described as a cause of death on the death certificate as well. It was not reported if an autopsy was performed. The information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information and considering the nature of the event, there is not a reasonable possibility that the event geomarasmus is related to the suspect product BNT162b2 (COMIRNATY).; Reported Cause(s) of Death: geromarasmus


VAERS ID: 1477453 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
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: 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 INC2021831442

Write-up: Death; This is a spontaneous report from a contactable physician via a sales representative. A 96-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection) first dose at the age of 96-year-old (Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history, concomitant medications and family history were not reported. The patient was a resident of a nursing facility. On an unspecified date, 12 hours after the vaccination, the patient died. It was not reported whether an autopsy was performed not. The cause of death was not reported. The patient''s family did not wish to pursue causal relationship with BNT162b2. The reporting physician heard from the family and determined that the causality between the event and BNT162b2 was uncertain. The reporter refused to provide further information and stated that the investigation on this case has been completed with this report. The outcome of the event was Fatal.; Sender''s Comments: Though limited data is available, a temporal relation between the "Death" and the administration of the vaccine cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1477461 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021841643

Write-up: Death; This is a spontaneous report from a contactable physician received via representative. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Solution for injection), unknown number of dose (lot number, and expiration date were not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Family history, medical history, and concomitant medication were not provided. On an unspecified date (after the vaccination), the patient experienced death. The reporting physician classified the event as serious (death). Causality and other possible cause of the event such as any other diseases were not provided. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed once receiving additional information including underlying risk factors/predisposing condition, concomitant medications and event details. 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: Death


VAERS ID: 1477466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021848531

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unknown age and gender received BNT162b2 (COMIRNATY, Solution for injection), unknown number of dose (Lot number and Expiration date were not reported) on an unspecified date via an unspecified route of administration at single dose for COVID-19 immunisation. The patient''s medical history, concomitant medications and family history were not reported. On unspecified date, the patient died. It was not reported whether an autopsy was performed. The cause of death was not reported. The assessment of causality between the event and BNT162b2 and seriousness of the event were not provided. The outcome of the event was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed once receiving additional information including underlying risk factors/predisposing condition and 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death


VAERS ID: 1477471 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Debility
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021864979

Write-up: Pyrexia; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patients'' age and gender were not provided. The family history, concomitant medications were not provided. On unknown date in 2021 (the day of vaccination), the patient received bnt162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not provided) via an unspecified route of administration as dose number unknown, single dose for COVID-19 immunisation. On unknown date in 2021 (1 day after the vaccination), the patient experienced pyrexia. The pyrexia persisted for 3 days. Thereafter, the fever decreased. On unknown date in 2021 (9 days after vaccination), the patient had pyrexia again. The patient died on the same day. The patient had significant debility. Suggest medical history included significant debility. The family did not wish investigations such as a pathological autopsy. The causality between the event and BNT162b2 was not provided. The event resulted in death. The patient died on unknown date in 2021. It was not reported if an autopsy was performed. The cause of death was pyrexia. The outcome of event was fatal. Information on the Lot/Batch number has been requested.; Sender''s Comments: A causal association between administration of bnt162b2 and the onset of pyrexia cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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: Pyrexia


VAERS ID: 1477472 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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: Bronchial asthma; Cerebral infarction; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021866519

Write-up: Death; This is a spontaneous report from a contactable pharmacist received via a representative. An 85-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection), second dose at the age of 85-year-old (Lot number and expiration date were not reported) intramuscularly on 23Jun2021 as 0.3 mL single dose for COVID-19 immunisation. Medical history included hypertension, cerebral infarction, dyslipidaemia, and bronchial asthma. Concomitant medications were not reported. The patient previously received BNT162b2 (COMIRNATY), first dose (Lot# and expiration date were not reported) intramuscularly on 02Jun2021as 0.3 mL single dose for COVID-19 immunisation. On 29Jun2021 (6 days after the vaccination), on the day of home visit nursing care, the patient was dead. The cause of death was not reported. It was unknown if an autopsy was performed. The outcome of the event was fatal. Information on the lot/batch number has been requested.; 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 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: 1477488 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002181 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: JPTAKEDA2021TJP050779

Write-up: Acute aortic dissection; This regulatory authority case was reported by a physician and describes the occurrence of AORTIC DISSECTION (Acute aortic dissection) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002181) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced AORTIC DISSECTION (Acute aortic dissection) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was acute aortic dissection. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered AORTIC DISSECTION (Acute aortic dissection) to be unlikely related. No Treatment information was provided by the reporter. No concomitant medication was reported. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Although the event developed immediately after the vaccination, the event is unlikely related to the vaccine. However, a statistical investigation is considered necessary. This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death of a 55-year-old male patient, 1 day after receiving unspecified dose of vaccine (Lot number unknown). The patient expired from acute aortic dissection. Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1477526 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Computerised tomogram, Myocardial ischaemia, Nausea, Tryptase, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Hypertension; Large intestine polyp
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Whole-body CT scan of the cadaver; Result Unstructured Data: severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion.; Test Name: Tryptase; Result Unstructured Data: the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.
CDC Split Type: JPTAKEDA2021TJP057641

Write-up: Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Pain in the vaccinated arm; This case was received via a regulatory authority (Reference number: v21118572) on 09-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Large intestine polyp and Dementia. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION SITE PAIN (Pain in the vaccinated arm) (seriousness criterion death). On 10-Jun-2021, the patient experienced NAUSEA (Queasy) (seriousness criterion death), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) (seriousness criterion death) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) (seriousness criteria death and medically significant). The patient died on 10-Jun-2021. The reported cause of death was pain in the vaccinated arm, Queasy, coronary arteriosclerosis and Ischaemic heart disease. An autopsy was performed. The autopsy-determined cause of death was coronary arteriosclerosis and Ischaemic heart disease. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) severe calcification of the coronary artery and hypostasis in the dorsal side which was indicative of status post pulmonary congestion. On an unknown date, Tryptase (2.1-9.0): 1.6 mcg/l (Low) the patient was diagnosed with ischemic heart disease secondary to coronary arteriosclerosis.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain in the vaccinated arm), NAUSEA (Queasy), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary arteriosclerosis) and MYOCARDIAL ISCHAEMIA (Ischaemic heart disease) to be not related. Company comment: The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority(the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority. The reporting physician explained several times to the bereaved family members (first son and second son) that the patient had ischaemic heart disease secondary to coronary arteriosclerosis. The reporting physician also explained that the events did not meet "the criteria for Suspected Adverse Reaction Reporting established by a regulatory authority (the events occurred more than 4 hours after the vaccination)", but the reporting physician was unable to gain their understanding. The family members strongly requested to report this case because they believed that the events were associated with the coronavirus vaccination. Therefore, the reporting physician reported this case at the request of the bereaved family. The reporting physician hopes this is all right. The reporting physician will cooperate with the investigation upon request from destinations to report including a regulatory authority; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pain in the vaccinated arm; Queasy; Coronary arteriosclerosis; Ischaemic heart disease; Autopsy-determined Cause(s) of Death: Coronary arteriosclerosis; Ischaemic heart disease


VAERS ID: 1477527 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Pneumonia aspiration, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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 Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 36.7; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 37.8; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: 38; Test Date: 20210708; Test Name: percutaneous oxygen saturation (SpO2); Result Unstructured Data: 87 percent
CDC Split Type: JPTAKEDA2021TJP057666

Write-up: Sepsis; Aspiration pneumonia; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. Family history included Dementia Alzheimer''s type. Concurrent medical conditions included Dementia Alzheimer''s type. On 07-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant) and PNEUMONIA ASPIRATION (Aspiration pneumonia) (seriousness criteria death and medically significant). The patient was treated with ACETAMINOPHEN on 08-Jul-2021 for Pyrexia, at a dose of 100 mg. The patient died on 08-Jul-2021. The reported cause of death was Sepsis and aspiration pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 37.8 (High) 37.8 and 38 (High) 38. On 08-Jul-2021, Oxygen saturation: 87 (abnormal) 87 percent. On an unknown date, Body temperature: 36.7 (Inconclusive) 36.7. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and PNEUMONIA ASPIRATION (Aspiration pneumonia) to be possibly related. The patient''s body temperature before vaccination was 36.7 degree Celsius. On 08-Jul-2021, at 06:00 AM the patient had sputum sticking sensation. On 08-Jul-2021, at 07:00, the signs of circulatory failure were noted. At 08:25, the patient experienced pyrexia of 38.0 degrees Celsius and took antipyretic (acetaminophen 100 mg) through a gastric fistula. At 09:45, the sign of respiratory failure was noted with percutaneous oxygen saturation (SpO2) of 87 percent. At 11:25, the patient had cardiopulmonary arrest. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear. This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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. The patient had often had sputum sticking sensation due to juvenile dementia Alzheimer''s type, and thus was diagnosed with aspiration pneumonia and sepsis. The causal relationship of the events with the vaccine is unclear.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This a report of dead one day after receiving the product in a 60-years old patient with concomitant Dementia Alzheimer''s type 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: Sepsis; Aspiration pneumonia


VAERS ID: 1477531 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiac arrest, Cerebral haemorrhage, Computerised tomogram, Headache, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 20
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: Comments: The patient was healthy. The patient had no disease of fainting.
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: upto 38 degree; Test Date: 20210619; Test Name: CT scan; Result Unstructured Data: cardiac arrest, cerebral hemorrhage, arrhythmia
CDC Split Type: KRJNJFOC20210710044

Write-up: CEREBRAL HEMORRHAGE; CARDIAC ARREST; ARRHYTHMIA; EXCESSIVE DROP IN BLOOD PRESSURE; FEVER; HEADACHE; MUSCLE PAIN; This spontaneous report received from a contact via representative via social media concerned a 37-year-old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient was healthy. The patient had no history of fainting disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 10-JUN-2021 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. On FEB-2021, Laboratory data included: Blood pressure (NR: not provided) normal. On 10-JUN-2021, the day of vaccination patient experienced fever, headache and muscle pain. Took Tylenol(paracetamol) and went to work day after vaccination. Laboratory data included: Body temperature (NR: not provided) upto 38 degree. On 19-JUN-2021 morning the patient had sudden nosebleed and seizure, he was unable to breathe properly. His wife called emergency number and he received cardiopulmonary resuscitation(CPR) and transferred to nearby hospital. At hospital was diagnosed with cardiac arrest accompanied by arrhythmia, cerebral hemorrhage was found through computed tomography(CT). His blood pressure started to drop excessively and was declared dead on 21-JUN-2021. An autopsy was performed on 23-JUN-2021 and result were expected within 1 to 2 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arrhythmia, fever, headache, muscle pain and excessive drop in blood pressure was not reported. The patient died of cardiac arrest and cerebral hemorrhage. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210711385.; Sender''s Comments: V0; 20210710044-COVID-19 VACCINE AD26.COV2.S-cerebral hemorrhage, cardiac arrest, arrhythmia, excessive drop in blood pressure. 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: CARDIAC ARREST; CEREBRAL HEMORRHAGE


VAERS ID: 1477532 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
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: 2021-06-28
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: KRJNJFOC20210711385

Write-up: DEATH; This spontaneous report received from social media (news article) from consumer via a company representative concerned a 4 decade old patient of unspecified sex, race and ethnicity. The patient''s weight, height, medical history and concurrent conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiration date were unknown) dose was not reported,1 total, administered on 10-JUN-2021 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. On 28-JUN-2021, the patient died from unknown cause of death. It was investigated that there was no particular fainting disease. The case was currently undergoing autopsy and the propulsion group planed to make final evaluation after confirming the results of autopsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event death was fatal. This report was serious (Death).; Sender''s Comments: V0:20210711385-JANSSEN 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: 1477755 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Foaming at mouth, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Convulsions (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 (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830145

Write-up: Death; Unresponsive to stimuli; Vomiting; Frothing at mouth; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is 21-04-03091A. A 44-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via intramuscular on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. After 17 days form vaccinated, the patient experienced Vomiting, Frothing at mouth, Unresponsive to stimuli. After 18 days form vaccinated, the patient was death. All events assessed as serious, medically significant. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event death was fatal, outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1477759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Chills, 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: 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: MYPFIZER INC2021830156

Write-up: Acute myocardial infarction; Fever; Chills; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is 21-04-02948A. A 55-year-old female patient received bnt162b2(COMIRNATY, concentrate for dispersion for injection) via intramuscular on unspecified date at single dose for COVID-19 immunisation. Relevant medical history and relevant concomitant medication was not reported. On an unknown date, 3 day after the administration of the suspected drug, the patient experienced Fever and Chills; 25 day after the administration of the suspected drug, the patient experienced Acute myocardial infarction. The outcome of reaction was reported as unknown to Fever and Chills, fatal / death to Acute myocardial infarction. Patient died on unspecified date. It was unknown if autopsy was performed. Causality assessment of the reporter was probable to Fever, Seriousness was Yes; possible to Acute myocardial infarction, Seriousness was Yes; probable to Chills. Seriousness was Yes. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1477763 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Chest pain, Hyperhidrosis, Loss of consciousness, Myocardial infarction, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830160

Write-up: Myocardial infarction; Arteriosclerosis; Unconscious; Chest pain; Sweating; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is 21-04-02730A. A 34-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date, 10 day after the administration of the suspected drug, the patient experienced Chest pain, Sweating, Vomiting, Unconscious, Myocardial infarction and Arteriosclerosis. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events myocardial infarction and arteriosclerosis was fatal; of the events unconscious, chest pain, sweating, vomiting was not recovered. Causality assessment of the reporter was possible to Chest pain, Seriousness was Yes; possible to Sweating, Seriousness was Yes; possible to Vomiting, Seriousness was Yes; possible to Unconscious, Seriousness was Yes; possible to Myocardial infarction, Seriousness was Yes; possible to Arteriosclerosis, Seriousness was Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction; Arteriosclerosis


VAERS ID: 1477764 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Coronary artery disease, Hyperhidrosis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830161

Write-up: Coronary artery disease; Unconscious; Chest pain; Sweating; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is 21-04-02729A. A 56-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date, 6 hour after the vaccination, the patient experienced Chest pain, Sweating, Unconscious; unknown period after the vaccination, the patient experienced Coronary artery disease. The patient died on an unspecified date. The cause of death was Coronary artery disease. It was not reported if an autopsy was performed. Outcome of the event coronary artery disease was fatal, of the events unconscious, chest pain, sweating was not recovered. Causality assessment of the reporter was possible to Chest pain, Seriousness was Yes; possible to Sweating, Seriousness was Yes; possible to Unconscious, Seriousness was Yes; possible to Coronary artery disease, Seriousness was Yes. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Coronary artery disease


VAERS ID: 1477765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830163

Write-up: Unresponsive to stimuli; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is 21-04-02670A. A 55-year-old male patient started to receive bnt162b2 (COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION) as DOSE NUMBER UNKNOWN, SINGLE via intramuscular on an unknown date for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, 9 day after the vaccination, the patient experienced Unresponsive to stimuli and Death. The outcome of reaction was reported as fatal / death to Unresponsive to stimuli and Death. Causality assessment of the reporter was unclassifiable to Unresponsive to stimuli and Death. No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Unresponsive to stimuli


VAERS ID: 1477846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cerebral haemorrhage, Headache
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (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: AUPFIZER INC2021888442

Write-up: Cerebral haemorrhage; Back pain; Headache; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 580759. A 58-year-old female patient received bnt162b2 (COMIRNATY, COVID-19 vaccine (mRNA)), via an unspecified route of administration on 28Jun2021 (Batch/Lot number was not reported) as dose number unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cerebral haemorrhage, back pain, and headache on 01Jul2021. The events resulted in death. The patient died on an unknown date. It was unknown if an autopsy was performed. The cause of death were cerebral haemorrhage, back pain, and headache. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Back pain; Cerebral haemorrhage; Headache


VAERS ID: 1477900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Dyspnoea, Endotracheal intubation, Fatigue, Headache, Loss of consciousness, Movement disorder, Myalgia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
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: BEPFIZER INC2021817656

Write-up: had to be intubated; collapsed in our couch; difficult to move; Difficulty breathing; Myalgia; Headache; Fatigue; COVID-19; Fever; Arthralgia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-99235]. Reporter reported for her husband and herself. This case is for husband. A male patient of an unspecified age received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced collapsed in couch, difficult to move, difficulty breathing, myalgia, headache, fatigue, covid-19, fever, arthralgia, all on 11Apr2021 and had to be intubated on 19Apr2021. Therapeutic measures were taken as a result of the events. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course was reported as following the vaccination, in the afternoon, patient developed headaches, fever and pain all over. 2 days after the vaccination (reported as 11Apr2021), patient was even sicker. He was more and more difficult to move and to breathe. They contacted the doctor who confirmed that patient had caught a bacterium at the same time as the vaccine and that patient had to alternate between paracetamol (DAFALGAN) and Ibuprofen, patient was hospitalised and there a doctor told reporter that patient was very contagious, that he had the covid. On 19Apr2021, he had to be intubated and his fight against the disease lasted three weeks, ending in death. Patient had no symptoms before the vaccination, the big symptoms came 2 days after the vaccination. No follow-up attempts possible. Lot/Batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-2021833415 Same reporter, same product, different patients, similar events; Reported Cause(s) of Death: collapsed in couch; difficult to move; Difficulty breathing; Myalgia; Headache; Fatigue; COVID-19; Fever; Arthralgia; had to be intubated


VAERS ID: 1477922 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021830266

Write-up: had what seemed to be a heart attack and died.; inappropriate dosing schedule; This is a spontaneous report from a contactable consumer via the Agency. An 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 85-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Jun2021 10:00 AM (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The COVID-19 vaccine was administered in Other (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications (medications the patient received within 2 weeks of vaccination) included prescription anticoagulants. Historical Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 11Mar2021 at the age of 85-years-old (DOSE 1, SINGLE, time: 08:30 AM, Anatomical Location Arm left). The patient experienced inappropriate dosing schedule on 08Jun2021 10:00, on 19Jun2021 10:00 had what seemed to be a heart attack and died. Due to heart attack, treatment included CPR provided by family and by parademics. Date of death 19Jun2021, no autopsy was done. Since the vaccination, the patient has not been tested for COVID-19. Information about Batch/Lot number has been requested.; Reported Cause(s) of Death: heart attack


VAERS ID: 1477923 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Headache, Neck pain, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pulmonary oedema, Spinal cord infection, Swelling
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 36 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Down''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: oxygen; Result Unstructured Data: Test Result:low
CDC Split Type: CAPFIZER INC2021830493

Write-up: oxygen distress; Severe Headaches; Severe Neck Pain; Swollen Spine behind the Esophagas; Infection in Spine; fluid in lungs; Pneumonia; low oxygen; This is spontaneous report received via the Agency from a contactable consumer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), in arm right on 28Apr2021 at 15:00 (at 54 years) as single dose for covid-19 immunisation . Medical history included Downe Syndrome (as reported). Concomitant medication included risperidone taken for an unspecified indication, start and stop date were not reported. On 28Apr2021 at 15:00 patient experienced severe headaches, severe neck pain, swollen spine behind the esophagas, infection in spine, all this causing to be bedridden and then (date unspecified in 2021)fluid in lungs, causing pneumonia, then causing low oxygen and needing to be on oxygen 24/7 (as reported). Events required emergency room/department or urgent care. Patient was hospitalized for 36 days in 2021 due to the events, that are also serious as life threatening. On 02Jul2021 patient had oxygen distress serious per hospitalized and life threatening. Patient was treated with IV antibiotics, oxygen,steroid and puffers.Patient died on 02Jul2021 due to overloaded by medication and oxygen distress. Outcome of oxygen distress was fatal; outcome of the other events was not recovered. It was unknown if an autopsy was done. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: overloaded by Medication/oxygen distress/; overloaded by Medication/oxygen distress/


VAERS ID: 1477961 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824325

Write-up: Decompensated heart failure; Dyspnoea exertional; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100117203. A 77-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FC3095), via an unspecified route of administration on 10Jun2021 at age of 77-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration on 06May2021 at age of 77-year-old as single dose for covid-19 immunisation. The patient experienced decompensated heart failure and dyspnoea exertional on 11Jun2021, resulted to death on 11Jun2021. The patient died on 21Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/ events was indeterminate. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dyspnoea exertional; Decompensated heart failure


VAERS ID: 1477962 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intracranial aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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 INC2021824320

Write-up: Subarachnoid haemorrhage; Aneurysm intracranial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100117204. A 58-year-old male patient received BNT162B2 (COMIRNATY) (Lot Number: FC3095), at the age of 58-year-old, via an unspecified route of administration on 18Jun2021 at single dose (dose number unknown), for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced subarachnoid haemorrhage and aneurysm intracranial both on 21Jun2021. The outcome of the events was fatal. The patient died in 2021. It was unknown if an autopsy was performed. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as C, inconsistent causal association to immunization. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the events occurred has submitted the same information to his/her local agency. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Aneurysm intracranial


VAERS ID: 1477963 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Medical History/Concurrent Conditions: Adiposis; Aortic valve stenosis; Arterial hypertension; Below knee amputation; Cardiac hypertrophy; Cardiac insufficiency; Coronary disease; Diabetes mellitus; Hyperuricaemia; Lyme borreliosis; Mitral valve stenosis; Nosocomial pneumonia; Polyneuropathy; Sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824337

Write-up: Heart arrest; Acute decompensated heart failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100117206. A 66-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11May2021 (Batch/lot number: EX8680) as dose number unknown, 0.3 mL, single at the age of 66-years-old for covid-19 immunization. Medical history included coronary disease, cardiac insufficiency, sleep apnea, arterial hypertension, adiposis, cardiac hypertrophy, mitral valve stenosis, aortic valve stenosis, polyneuropathy, lyme borreliosis, diabetes mellitus, hyperuricaemia, below knee amputation, nosocomial pneumonia. The patient''s concomitant medications were not reported. On 16May2021 the patient experienced acute decompensated heart failure, heart arrest. The patient died on 16May2021. Outcome of the events was fatal. An autopsy was performed that revealed acute decompensated heart failure (cardiac failure acute). Result of Assessment: Comirnaty/ all event(s):/ Regulatory Authority: B. Indeterminate No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart arrest; acute decompensated heart failure; Autopsy-determined Cause(s) of Death: Acute decompensated heart failure


VAERS ID: 1477964 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, SARS-CoV-2 test, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Hypovolaemic shock conditions (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
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: Adenocarcinoma gastric; Arterial hypertension; Atrial fibrillation; Chronic coronary syndrome; Chronic renal insufficiency; Myocardial infarction (Non ST Segment Elevation Myocardial Infarction); Old cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: PCR Sars-Cov-19; Test Result: Positive ; Comments: B117 variant
CDC Split Type: DEPFIZER INC2021824333

Write-up: ARDS; SARS-CoV-2 pneumonia; Hemorrhagic shock; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100117207. A 76-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included myocardial infarction, chronic renal insufficiency, old cerebral infarction, chronic coronary syndrome, atrial fibrillation, arterial hypertension, adenocarcinoma gastric. The patient''s concomitant medications were not reported. The patient experienced acute respiratory distress syndrome (ARDS), SARS-CoV-2 pneumonia, hemorrhagic shock. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (B117 variant) on 10May2021. Outcome of the events was fatal. An autopsy was performed and results were provided. Reporter''s comment: The post-mortem examination of the 76-year-old deceased revealed a clinically indicated SARS-CoV-2 infection with pronounced fresh and partly haemorrhagic diffuse alveolar-capillary lung damage with alveolar epithelial cell proliferation and desquamation, as well as evidence of hyaline membranes and small-cell squamous metaplasia of the alveolar epithelium. Small squamous metaplasia of the alveolar epithelium, consistent with the diagnosis of COVID-19 pneumonia as a morphological correlate for clinically indicated ARDS. At the time of autopsy, there was approximately 1.5 litres of coagulated blood in the stomach and melena in the intestine. As an incidental finding, a still localised intestinal adenocarcinoma with bleeding stigmata was found in the area of the cardia with transition into the distal oesophagus. There were no lymph node or distant metastases. Further signs of haemorrhagic shock were shock-related changes in the kidneys, serous pleural effusions and a pericardial effusion. In addition, there was a not very fresh myocardial infarction in the anterior papillary muscle and an old myocardial infarction in the anterior wall of the left heart. In summary of all findings up to this point, the patient died primarily of haemorrhagic shock as a result of bleeding from the ulcerated tumour area, which was aggravated by the SARS-CoV-2 infection. There were no indications of a vaccination complication (e.g. thromboembolic event, myocarditis), thus a connection with the SARS-CoV-2 mRNA vaccine and the cause of death can be excluded. Reaction(s) / Event(s) Assessed by Regulatory Authority, Result of Assessment for all events: "C. Inconsistent causal association to immunization" Information about lot/batch number cannot be obtained. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The post-mortem examination of the deceased. In summary of all findings up to this point, the patient died primarily of haemorrhagic shock as a result of bleeding from the ulcerated tumour area, which was aggravated by the SARS-CoV-2 infection. There were no indications of a vaccination complication (e.g. thromboembolic event, myocarditis), thus a connection with the SARS-CoV-2 mRNA vaccine and the cause of death can be excluded.; Reported Cause(s) of Death: ARDS; SARS-CoV-2 pneumonia; Haemorrhagic shock; Autopsy-determined Cause(s) of Death: Haemorrhagic shock


VAERS ID: 1477965 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH B1D016A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Fall (with various hematomas); Hematoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824280

Write-up: Heart arrest; This is a spontaneous report from non-contactable physician downloaded from the Regulatory Authority-WEB number DE-PEI-202100117214. A 63-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Jun2021 (Lot Number: B1D016A) at the age of 63 years old, as single dose for covid-19 immunisation. Medical history included fall from 03Jun2021 with various hematomas. The patient''s concomitant medications were not reported. The patient experienced heart arrest on 08Jun2021. The patient died on 08Jun2021. An autopsy was not performed. The outcome of the event heart arrest was fatal. Event assessment: Comirnaty/ event/Regulatory Authority/Result of Assessment: Unclassifiable No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1477967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 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 INC2021824313

Write-up: Thrombosis of venous sinuses; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100117218. A 42-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombosis of venous sinuses on an unspecified date. Vaccination about 1.5 weeks before the reaction. The patient died on an unspecified date due to the event. An autopsy was performed, and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1477974 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210731702

Write-up: UNKNOWN CAUSE OF DEATH; GENERAL DEBILITY; This spontaneous report received from a physician via a Regulatory Authority concerned a 69 year old male. 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, and batch number were not reported) dose was not reported, 1 total administered on 28-MAY-2021 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. On 28-MAY-2021, the patient experienced general debility. The patient was hospitalized on an unspecified date. On 02-JUN-2021, 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. The patient died of general debility on 02-JUN-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210731702-COVID-19 VACCINE AD26.COV2.S.- Unknown cause of death, General debility. This events is considered unassessable. The events 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 events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; GENERAL DEBILITY


VAERS ID: 1478711 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-06-01
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Infection, Mesenteric haemorrhage, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: DEPEI202100129257

Write-up: Renal failure; Infection; Mesenteric bleeding; This regulatory authority case was reported by a physician and describes the occurrence of RENAL FAILURE (Renal failure), INFECTION (Infection) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) in a 72-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: MODERNA COVID-19 VACCINE on 21-Apr-2021. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria death, hospitalization and medically significant), INFECTION (Infection) (seriousness criteria death and hospitalization) and MESENTERIC HAEMORRHAGE (Mesenteric bleeding) (seriousness criteria death, hospitalization and medically significant). The patient died on 02-Jul-2021. The reported cause of death was Renal failure. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication and treatment medication were not provided. Very limited information regarding the event Mesenteric hemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Sender''s Comments: Very limited information regarding the event Mesenteric haemorrhage has been provided at this time. Case causality is confounded by advanced age for the event Renal failure which could have predisposed to infection.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1478859 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erysipelas, Loss of consciousness, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824435

Write-up: Suspicion pulmonary embolism; unconscious; Erysipelas; This is a spontaneous report from a non-contactable consumer downloaded from the WEB DE-PEI-CADR2021107326, Safety Report Unique Identifier DE-PEI-202100102343. A 70-year-old female patient received bnt162b2 (COMIRNATY) (Strength 0.3ml), via an unspecified route of administration on 04May2021 (Lot Number: EX8679) (at age of 70-year-old) as 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced suspicion pulmonary embolism (death, hospitalization) on 14May2021, unconscious (hospitalization) on 14May2021 with outcome of not recovered, erysipelas (hospitalization) on 11May2021 with outcome of not recovered. On 11May2021 the patient experienced Erysipelas. Patient developed erysipelas on the left upper arm with hyperthermia, redness, oedema from 11May2021. Treatment after presentation to the doctor symptomatic plus penicillin V 4x 1 mill units per os. On 14May2021, suddenly dyspnoea without previous symptoms. The grandson called the emergency doctor. The patient arrived unconscious at the hospital, resuscitation attempts were unsuccessful. On 14May2021 the patient experienced Lung embolism. The patient died on 14May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspicion pulmonary embolism


VAERS ID: 1478917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-14
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Hot flush, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021824432

Write-up: Infarct myocardial; Dyspnoea; Hot flush; Chest pain; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021111048, Safety Report Unique Identifier DE-PEI-202100106402. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14May2021 (Batch/Lot Number: EX8680) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension. No concomitant medication reported. On 14Jun2021 the patient experienced Dyspnoea, Hot flush, Chest pain, Infarct myocardial. Events resulted in Emergency Room Visit. The patient''s outcome was: not recovered for Dyspnoea, not recovered for Hot flush, not recovered for Chest pain, fatal for Infarct myocardial. Therapeutic measures were taken as a result of infarct myocardial included defibrillator. The patient died on 14Jun2021 due to Infarct myocardial. An autopsy was not performed. Sender Comment: "Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses. High blood pressure / emergency doctor, defibrillator". Result of assessment (all adverse events): UNCLASSIFIABLE.. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1478930 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021833572

Write-up: Death; fever; This is a spontaneous report from a non-contactable consumer. This is second case from two cases for same product, same adverse event, different patient. (This is father case). A male patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever on Apr2021 and death was reported on 25Apr2021. The patient died on 25Apr2021. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to reporter local agency. Reporter''s parents vaccinated with the first biontech vaccination on 07April2021 and both died on 25April2021 on the same day. They were very healthy and in good conditions until 13-14Apr2021. The father had a fever, last day mother had a very strong headache. There were complications after vaccination. Reporter wanted Pfizer to help him to investigate this case if he also agrees to the exhumation. It was reported that an incredible number of people die after vaccination. It was not reported if an autopsy was performed. Cause of the death was unknown. The outcome for the event was fatal and fever was unknown. Follow-up attempt are not possible. No expected further information.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021833570; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1479001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-07
Onset:2021-05-01
   Days after vaccination:572
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Immune-mediated myocarditis, Immune-mediated myositis, Troponin T
SMQs:, Cardiomyopathy (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: 2021-06-24
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUCREAS; HIDROFEROL; DIOVAN; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (chronic bronchitis type); Hypercholesterolaemia; Hypertension arterial; Hypertriglyceridaemia; Hyperuricemia; Pneumothorax (that required surgery by performing bullectomy); Pneumothorax spontaneous (that resolved with chest drainage with aspiration); Recovered smoker (ex-smoker since 17 years); Type II diabetes mellitus; Urothelial carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Creatine kinase; Result Unstructured Data: Test Result:4585 IU/l; Comments: Units:U/L (enzyme unit per litre); Test Date: 2021; Test Name: Creatine kinase; Result Unstructured Data: Test Result:around 5000 IU/l; Test Date: 20210622; Test Name: Creatine kinase; Result Unstructured Data: Test Result:10000 IU/l; Test Date: 20210624; Test Name: Creatine kinase; Result Unstructured Data: Test Result:9340 IU/l; Comments: Units:U/L (enzyme unit per litre); Test Date: 20200107; Test Name: Troponin T; Result Unstructured Data: Test Result:18 ng/L; Test Date: 20210604; Test Name: Troponin T; Result Unstructured Data: Test Result:313 ng/L; Test Date: 2021; Test Name: Troponin T; Result Unstructured Data: Test Result:around 500 ng/L; Test Date: 20210622; Test Name: Troponin T; Result Unstructured Data: Test Result:3000 ng/L; Test Date: 20210624; Test Name: Troponin T; Result Unstructured Data: Test Result:3029 ng/L
CDC Split Type: ESPFIZER INC2021824354

Write-up: Immune-mediated myocarditis; Myositis and myocarditis due to immunotherapy; This is a spontaneous report from a contactable pharmacist downloaded from the WEB ES-AEMPS-924411. A 64-year-old male patient received second dose of bnt162b2 (COMIRNATY), via unknown administration route, on 11May2021 (Lot Number: FA4598) as dose 2, single for covid-19 immunisation; atezolizumab (TECENTRIQ), iv drip from 07Oct2019 (Batch/Lot Number: Unknown) to 10May2021, at 1200 mg, every 3 weeks for urothelial carcinoma. Medical history included hyperuricaemia, hypercholesterolaemia, pneumothorax from Nov2008 to an unknown date (that required surgery by performing bullectomy), pneumothorax spontaneous from Dec2007 to an unknown date (that resolved with chest drainage with aspiration), type 2 diabetes mellitus, hypertriglyceridaemia, chronic obstructive pulmonary disease (COPD) (chronic bronchitis type), recovered smoker (ex-smoker since 17 years), hypertension arterial, urothelial carcinoma. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 20Apr2021 (batch: EW6326) for covid-19 immunisation. Concomitant medications included metformin hydrochloride, vildagliptin (EUCREAS) taken for type 2 diabetes mellitus, start and stop date were not reported; calcifediol (HIDROFEROL) taken for an unspecified indication, start and stop date were not reported; valsartan (DIOVAN) taken for arterial hypertension, start and stop date were not reported; allopurinol (ZYLORIC) taken for hyperuricaemia, start and stop date were not reported. The patient experienced immune-mediated myocarditis on May2021. Diagnosis: Myositis and myocarditis due to immunotherapy; atezolizumab with a total of 24 cycles. The event seriousness criteria was death. Treatment received included Prednisone 1 mg / kg, Methylprednisolone 500 mg, Mycophenolate from 17Jun2021, Intravenous immunoglobulins from 19Jun2021, Therapeutic plasma exchange from 24Jun2021. Additional information on adverse drug reactions (ADRs): 64-year-old patient with bladder neoplasia under treatment with atezolizumab without a history of previous autoimmune disease, who was in her baseline situation until 4 weeks ago, walking without problems up to 8 km a day. In May2021, atezolizumab was discontinued due to progression (total 24 cycles). About 4 weeks ago she started with severe myositis with symptoms of muscle weakness, dysphagia and dyspnea, with high creatinine phosphokinase (around 5000) in blood tests and also with myocarditis with high troponin (around 500). High-dose corticosteroids, mycophenolate, intravenous immunoglobulins, and plasmapheresis have been administered. During admission, creatinine phosphokinase and troponin levels improved, but from the 22nd elevation (creatinine phosphokinase 10,000 and Troponin T 3,000). The 24th is exitus. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 4585 iu/l on 04Jun2021, blood creatine phosphokinase: around 5000 iu/l on 2021, blood creatine phosphokinase: 10000 iu/l on 22Jun2021, blood creatine phosphokinase: 9340 iu/l on 24Jun2021, troponin t: 18 ng/l on 07Jan2020, troponin t: 313 ng/l on 04Jun2021, troponin t: around 500 ng/l on 2021, troponin t: 3000 ng/l on 22Jun2021, troponin t: 3029 ng/l on 24Jun2021. The action taken in response to the events for atezolizumab was permanently withdrawn on 10May2021. The patient died on 24Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myositis and myocarditis due to immunotherapy; Immune-mediated myocarditis


VAERS ID: 1479024 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood cholesterol, Blood triglycerides
SMQs:, Myocardial infarction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: Smoker (more than 20 cg/day since the age of 14)
Preexisting Conditions: Medical History/Concurrent Conditions: Mixed hyperlipidaemia; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 2016; Test Name: cholesterol; Result Unstructured Data: Test Result:around 250; Test Date: 2016; Test Name: triglycerides; Result Unstructured Data: Test Result:400-500
CDC Split Type: ESPFIZER INC2021824327

Write-up: STEACS; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB ES-AEMPS-927007. A 47-years-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscularly on 24Jun2021 at 0.3 ml single dose for covid-19 immunisation. The patient was a smoker ongoing (more than 20 cg/day since the age of 14). Medical history included Mixed hyperlipidaemia from 2006 (mainly based on TG; blood tests in 2016 TG between 400-500; cholesterol around 250), overweight and statin. The patient was being prescribed treatment with statin+ ezetimibe initially and then fibrates, but acknowledges in 2016 to be poorly compliant with treatment (there are no notes in the history after November 2016). No known hypertension (HTN) or diabetes mellitus (DM). No usual treatment. No known allergies. The patient''s concomitant medications were not reported. The patient experienced ST segment elevation acute coronary syndrome (STEACS) on 27Jun2021. Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number): 4 days. On 27Jun2021 at 3.33 AM, the emergency services receive a call to go to the factory to assess the patient with chest pain. On the way to the ICU another call from emergency number after receiving notification from the nurse that the patient had gone into CRA. On arrival we found the patient in cardiorespiratory arrest, with peribuccal cyanosis and medium pupils (I did not check whether they were reactive at the time). Advanced CPR manoeuvres were started immediately: the first rhythm recorded with patches was VF, so the VF and pulseless VT protocol was started: Defibrillation at 200Jul+ immediate CPR+ on three occasions+ adrenaline 1mg ev every approx. 3-5min + Amiodarone 300mg bolus 20SG after the 3rd shock+ amiodarone 150mg in 20SG after the 5th shock. IOT was performed. After the 8th shock, rhythm compatible with VT with pulse, so it was decided to transfer him to hospital (after 50min in the factory). During the transfer, peribuccal cyanosis was observed and AESP was detected and treated with massage and adrenaline 1mg every 3min. In hospital, advanced CPR manoeuvres were continued until 5:04 am, when exitus was confirmed. Diagnosis was CPR 2nd to STEACS with final result of exitus. The event resulted to death on 27Jun2021. A clinical autopsy was requested but unknown if performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death:


VAERS ID: 1479104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021824114

Write-up: Sudden death; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213401. A 60-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden death on 16Jun2021. The patient died unexpectedly on 16Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1479235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-06-19
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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: 2021-06-23
   Days after onset: 4
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: Arteriopathy; Chronic renal failure; COPD; Diabetes; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: COVID-19 test; Test Result: Positive ; Comments: delta screened
CDC Split Type: FRPFIZER INC2021824258

Write-up: Vaccination failure; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-BX20216177 and Safety Report Unique Identifier is FR-AFSSAPS-2021083114. An 88-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 12Feb2021 (Batch/Lot Number: EJ6795) as dose 2, single; and intramuscular on 14Jan2021 (Batch/Lot Number: EJ6788) as dose 1, single for COVID-19 immunisation. Medical history included diabetes, chronic renal failure, hypertension arterial, chronic obstructive pulmonary disease (COPD), and arteriopathy. The patient''s concomitant medications were not reported. Vaccine failure was confirmed. Patient had severe COVID infection with death more than 5 months after a complete vaccination by Comirnaty. Screening: Delta variant (C1). On 19Jun2021, the patient tested positive for COVID-19; delta screened. On 20Jun2021, patient was hospitalized with cough and asthenia. Time interval between beginning of drug administration and start of reaction/event was 157 days. Time interval between last dose of drug and start of reaction / event was 128 days. The patient died on 23Jun2021. 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: Infection COVID


VAERS ID: 1479236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-06-19
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Heart rate, Oxygen saturation, 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: 2021-06-26
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dementia; Depressive state; Endobrachyoesophagus; Hypertension; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: temperature; Result Unstructured Data: Test Result:38.1; Test Date: 20210621; Test Name: pulse; Result Unstructured Data: Test Result:150; Comments: bpm; Test Date: 20210621; Test Name: saturation; Test Result: 88 %; Comments: in ambient air
CDC Split Type: FRPFIZER INC2021824254

Write-up: vaccination failure; Covid-19 infection variant; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20216222 with Safety Report Unique Identifier FR-AFSSAPS-2021084244. A 76-year-old female patient received bnt162b2 (COMIRNATY) on 11Feb2021 (Batch/Lot Number: EJ6795) as dose 2, single, and on 14Jan2021 (Batch/Lot Number: EJ6788) as dose 1, single, intramuscular for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), hypertension, depressive state, endobrachyoesophagus, dementia, living in nursing home, all from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. Confirmed vaccination failure, transmitted by the health agency. On 19Jun2021, the patient experienced vaccination failure. Stated that more than 4 months after vaccination (on 19Jun2021), patient had COVID-19 infection variant. The patient underwent lab tests and procedures on 21Jun2021 which included temperature: 38.1, pulse: 150 bpm, saturation: 88 % in ambient air. On 22Jun2021, hospitalization for asthenia, cough, sputum. The patient was hospitalized from 22Jun2021 to an unknown date. The patient died on 26Jun2021. It was not reported if an autopsy was performed. Investigation report received from Regulatory Authority. For both Lot numbers it was stated that, 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. Further indicated that, 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. No root cause or CAPA were identified as the complaint was not confirmed. For Lot EJ6788, The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5674032. The complaint for PFIZERBIONTECH 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 EJ6788. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. For Lot EJ6795, The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5573939. The complaint for fatal outcome of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 EJ6795. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples.; Reported Cause(s) of Death: infection Covid


VAERS ID: 1479241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, C-reactive protein, Computerised tomogram head, Dermatologic examination, Haemoglobin, Herpes zoster meningoencephalitis, Lumbar puncture, Neurological examination, Polymerase chain reaction, Protein total, Scan brain, Urine analysis, White blood cell count, X-ray
SMQs:, Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 9
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: Arterial hypertension; Blind left eye (left blindness (haemorrhage)); Cholecystectomy; Deafness; Diabetes; Fahr''s disease; Hypercholesterolemia; Stroke (Stroke with sequelae left hemiparesis); Varicose veins stripping
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:96 umol/l; Test Name: glucose; Result Unstructured Data: Test Result:7.1 mmol/L; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:30 IU/l; Test Name: lactates; Result Unstructured Data: Test Result:2.7 mmol/L; Test Name: potassium; Result Unstructured Data: Test Result:4.2 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:135 mmol/L; Test Name: Brain CT scan; Result Unstructured Data: Test Result:Calcifications of the central gray nuclei suggesti; Comments: Calcifications of the central gray nuclei suggestive of Fahr syndrome. No intracranial bleeding or mass syndrome.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:33 mg/l; Comments: C reactive protein 33 mg / L (N <5mg / L ); Test Name: Dermatological examination; Result Unstructured Data: Test Result:lesion of multimetameric right lumbar shingles, T9; Comments: lesion of multimetameric right lumbar shingles, T9 to T12; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.5 g/dl; Test Name: lumbar puncture; Result Unstructured Data: Test Result:Biochemistry: 50 elements 1% neutro, 97% mononucle; Comments: Biochemistry: 50 elements 1% neutro, 97% mononuclear cell, direct examination negative; Test Date: 20210618; Test Name: lumbar puncture; Result Unstructured Data: Test Result:discovery of a varicella-zoster virus meningoencep; Comments: discovery of a varicella-zoster virus meningoencephalitis confirmed at the lumbar puncture on Day 9 of the vaccination; Test Name: Neurological examination; Result Unstructured Data: Test Result:G14; Temporal-spatial disorientation, psychomotor; Comments: G14; Temporal-spatial disorientation, psychomotor slowing down Cranial nerves: Deafness; left blindness. Dysarthria; central left facial paralysis (usual depending on the patient) No sensory disturbances No osteotendinous reflex; Absence of babinski; Test Name: PCR test; Result Unstructured Data: Test Result:Polymerase chain reaction in cerebrospinal fluid p; Comments: Polymerase chain reaction in cerebrospinal fluid positive for varicella-zoster virus; Test Name: protein level; Result Unstructured Data: Test Result:0.73 g/l; Comments: hyperproteinorachia; Test Name: brain scan; Result Unstructured Data: Test Result:not showing any encephalic morphological abnormali; Comments: a brain scan was performed not showing any encephalic morphological abnormality apart from calcifications of the basal ganglia, without intracranial bleeding or mass syndrome.; Test Name: cytobacteriological examination of the urine; Result Unstructured Data: Test Result:Leukocyturia 1586 00 / ml; secondarily positive fo; Comments: Leukocyturia 1586 00 / ml; secondarily positive for E coli; Test Name: leukocytes; Result Unstructured Data: Test Result:6.4 x10 9/l; Test Name: Pulmonary x-ray; Result Unstructured Data: Test Result:diffuse interstitial syndrome
CDC Split Type: FRPFIZER INC2021824251

Write-up: Herpes zoster meningoencephalitis; This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority report number is FR-AFSSAPS-CN20212069 and Safety Report Unique Identifier FR-AFSSAPS-2021080737 An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes, arterial hypertension, Stroke with sequelae left hemiparesis, Fahr''s disease, hypercholesterolaemia, deafness, left blindness (haemorrhage) from an unknown date and unknown if ongoing, cholecystectomy on an unknown date, stripping of varicose veins on an unknown date. The patient''s concomitant medications were not reported. The patient experienced herpes zoster meningoencephalitis on 17Jun2021. It was reported that onset of multimetameric shingles on Day 5 of vaccination. The next day, deterioration of the general condition, confusion, agitation, vomiting. Patient referred to the emergency department by her attending physician, discovery of a varicella-zoster virus meningoencephalitis confirmed at the lumbar puncture on Day 9 of the vaccination. Hospital report included; history: 89-year-old female patient referred by her attending physician for deterioration of general condition since Tuesday 15Jun in a context of discovery of shingles on 14Jun treated with Valaciclovir 500mg. Vaccination Pfizer on 09Jun (2nd dose). Her daughter describes a state of confusion since Tuesday, worsening during the week with an episode of vomiting on Tuesday and a fall from her bed without head trauma or loss of consciousness. On admission to the emergency room, the patient was conscious but presented spatiotemporal disorientation associated with meningeal syndrome characterized by stiff neck. In this context, a brain scan was performed not showing any encephalic morphological abnormality apart from calcifications of the basal ganglia, without intracranial bleeding or mass syndrome. Biology showed a discreet biological inflammatory syndrome. In this context, a lumbar puncture made it possible to demonstrate the presence of varicella zoster virus on the cerebrospinal fluid. Physical examination; Neurological examination: G14; Temporal-spatial disorientation, psychomotor slowing down, Cranial nerves: Deafness; left blindness. Dysarthria; central left facial paralysis (usual depending on the patient), No sensory disturbances, No osteotendinous reflex; Absence of Babinski, Dermatological examination: lesion of multimetameric right lumbar shingles, T9 to T12. Additional tests included biology: Na +: 135 mmol / L (N: 135-145 mmol / L); K +: 4.2 mmol / L (N: 3.5-4.5 mmol / L), creatinine 96 ?mol / L (N: 45-105 ?mol / L), C reactive protein 33 mg / L (N <5mg / L ), Hemoglobin 12.5 g / dL (N: 12-16 g / dL), leukocytes 6.4 G / L (N: 4-10 G / L). Pulmonary x-ray: diffuse interstitial syndrome, Brain CT scan: Calcifications of the central gray nuclei suggestive of Fahr syndrome. No intracranial bleeding or mass syndrome. Cytobacteriological examination of the urine: Leukocyturia 158600 / ml; secondarily positive for E coli, Lumbar puncture: Biochemistry: 50 elements 1% neutro, 97% mononuclear cell, direct examination negative; hyperproteinorachia 0.73 g / L (N: 0.15-0.45 g / L), glucose 7.1 mmol / L (N: 2.2-3.9 mmol / L), lactates 2.7mmol / L (N: 1.2-2.2 mmol / L), Lactate dehydrogenase at 30U / L (N20-40). Cerebrospinal fluid: Search for HSV1, HSV2, VZV, HHV6, Enterovirus, Parechovirus, cytomegalovirus. Polymerase chain reaction in cerebrospinal fluid positive for varicella-zoster virus. Treatment: Aciclovir 10 mg / kg every 8 hours IV (estimated weight 80 kg: 800 mg). In total, varicella-zoster virus meningoencephalitis + multimetameric shingles. Despite the treatments undertaken, the patient''s neurological condition gradually deteriorated with a coma of progressive worsening and secondary onset of tonicoclonic symptoms suggestive of epileptic disorders complementing this infection of the central nervous system. The course was complicated by the appearance of acute renal failure despite the volume maintenance therapies undertaken. Magnetic resonance imaging intra-cranial not performed. The patient died on 26Jun2021. In total: death from varicella zoster virus meningoencephalitis at day +17 of the 2nd dose of Pfizer vaccine in an 89-year-old female patient. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Herpes zoster meningoencephalitis


VAERS ID: 1479307 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amniotic cavity infection, Histology, Investigation, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGNESIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Foetopathological examination; Result Unstructured Data: Test Result:normal; Comments: male fetus, macerated, without apparent or visceral malformation detected, no dysmorphia of the face or extremities; Test Name: USG; Result Unstructured Data: Test Result:normal; Test Name: anatomopathological examination; Result Unstructured Data: Test Result:no abnormality on fetopathological examination; Comments: of the deceased twin; Test Name: Pathological examinations of the 2 placentas; Result Unstructured Data: Test Result:presence of stage 2 chorioamnionitis; Comments: with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin
CDC Split Type: FRPFIZER INC2021879459

Write-up: Maternal Exposure During Pregnancy, third trimester ; Chorioamnionitis; This is a spontaneous report from a contactable physician. This is the third of three reports. The first report is a report downloaded from the Agency Regulatory Authority-WEB [FR-AFSSAPS-TS20212485], Safety Report Unique Identifier [FR-AFSSAPS-2021078733]. This physician reported information for the mother and for the two fetuses. This is the report for one of the two fetuses. A fetus male patient received bnt162b2 (COMIRNATY, lot number and expiry date unknown), transplacental on 21May2021, dose 1, single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included magnesium (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. The patient was one of two twins in a twin chorionic, bi-amniotic twin pregnancy. The patient''s mother received the first dose of bnt162b2 on 21May2021 at 28 weeks (Maternal Exposure During Pregnancy, third trimester). The patient''s mother experienced premature rupture of the frank membranes of clear liquid, without fever or contraction. Emergency consultation on Saturday 05Jun2021 in the evening (D15 post-vaccine) for premature rupture of the membranes, spontaneous, without associated sign: frank rupture, clear liquid, no fever, no contraction, no other symptom. On ultrasound, fetal death in utero of one of the 2 twins (dating back several days, because signs of maceration and anamnios), good vitality of the other twin. The mother had not noticed any particular symptoms and felt her babies moving. Normal blood pressure and heart rate, no fever, no proteinuria. Start of amoxicillin (will not be not continued after birth). A few hours after admission, onset of contractions. Birth by cesarean on 06Jun2021 at 9:11 a.m., under cover of 2 g of cefazoline, of the first baby, alive, male, weighing 1.34 kg with normal pH then 1 minute later of the second baby (patient), deceased, weighing 1.16 kg, with clear signs of maceration. Obstetricians noted that each child''s umbilical cords were very large and very swollen. For the living baby, however, the fluid was clear and no other peculiarities were observed. Bacteriology on the placenta: rare leukocytes, direct negative examination, sterile culture. Pathological examinations of the 2 placentas: histological appearance in accordance with the term, presence of stage 2 chorioamonionitis with stage 3 funniculitis for the deceased twin, less intense chorioamnionitis without funniculitis for the other twin. In total, fetal death in utero of one of 2 twins in a twin chorionic, bi-amniotic twin pregnancy, discovered at 30 weeks on D15 of a first dose of Comirnaty, after premature rupture of the frank membranes of clear liquid, without fever or contraction. Aspect of maceration of the deceased twin suggesting a death dating back several days. Premature delivery in the following hours by Caesarean section of a live male child hospitalized for prematurity and of the deceased child. Chorioamnionitis for the 2 twins (stage 2 with stage 3 funniculitis for the deceased twin, less intense for the other) on anatomopathological examination of the placentas, no abnormality on fetopathological examination of the deceased twin. The outcome of the event Chorioamnionitis was fatal. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021770452 mother/child case;FR-PFIZER INC-2021879458 twins cases; Reported Cause(s) of Death: Chorioamnionitis


VAERS ID: 1479321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Intracranial aneurysm, Medication error
SMQs:, Drug abuse and dependence (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
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 INC2021843496

Write-up: Brain aneurysm; Medication error; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an parenteral route of administration; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number GB-MHRA-EYC 00254904. Sender Safety Report Unique Identifier GB-MHRA-ADR 25563338 . A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an parenteral route of administration, as dose number unknown, single on 21Apr2021 for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that patient did not had problems before the vaccine. The patient experienced Brain aneurysm, Medication error. The patient died on 27May2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Brain aneurysm; Medication error


VAERS ID: 1479673 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
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: FOLIC ACID; IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021892891

Write-up: congenital anomaly; Maternal exposure during pregnancy, first trimester; This is a solicited report from a contactable consumer. This consumer reported information for both mother and fetus. This is the second of 2 reports, the fetus report. The first report (the mother report) is received from the Regulatory Agency, regulatory authority report number is GB-MHRA-YCVM-202106061533299420-ANNEC, Safety Report Unique Identifier is GB-MHRA-ADR 25577703. A fetus of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via transplacental route of administration on 06Jun2021 (Batch/Lot Number: EW3143) as single dose for COVID-19 vaccination. The medical history of the patient''s mother included headache, folic acid supplementation, and details of previous pregnancies: miscarriage. Concomitant medications included folic acid via transplacental ; and ibuprofen via transplacental from 13Jun2021 to 13Jun2021. The mother was pregnant while taking bnt162b2 on 06Jun2021. The mother last menstrual period date was 20Apr2021 and the mother was due to deliver on 25Jan2022. The fetus was exposed to the vaccine first-trimester (1-12 weeks). On an unspecified date, the fetus had congenital anomaly. On 17Jun2021, the mother experienced miscarriage, which was recovered on 01Jul2021. The fetus died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of the event congenital anomaly was fatal. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available is limited.The etiology for the reported event of congenital anomaly could be multifactorial in nature. However based on an implied temporal relationship and noted transplacental exposure to the suspect drug bnt162b2 the contributory role of the suspect drug to the reported event cannot be completely excluded until more information is available to provide an alternate etiology. This case will be updated when more information is available.The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021829240 Mother case; Reported Cause(s) of Death: congenital anomaly


VAERS ID: 1479692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiogenic shock, Chest pain, Echocardiogram, Exercise electrocardiogram, Scan myocardial perfusion
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 14
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: CONCOR COR; NORMABEL
Current Illness: Anemia iron deficiency (sideropenic anemia); Anxiety (Anxiety); Arterial hypertension (Arterial hypertension); Cardiac arrhythmia (other cardiac arrhythmias); Fatty liver (Fatty liver); Gastritis (gastritis); Gout (Gout); Heart rate increased (Heart rate increased); Hyperlipidemia (Hyperlipidemia); Hyperplasia of prostate (Hyperplasia of prostate)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound of the heart; Result Unstructured Data: Test Result:unknown; Test Name: ergometry; Result Unstructured Data: Test Result:unknown; Test Name: perfusion scintigraphy of the myocardium; Result Unstructured Data: Test Result:unknown
CDC Split Type: HRPFIZER INC2021828169

Write-up: admitted to the hospital due to myocardial infarction, acute myocardial infarction; severe pains in chest; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the WEB regulatory authority number HR-HALMED-300048961. A 70-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 06May2021 (Batch/Lot Number: EX6537) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included ongoing anxiety, ongoing Fatty liver , ongoing gout, ongoing hyperlipidemia, ongoing Hyperplasia of prostate, ongoing other cardiac arrhythmias, ongoing gastritis, ongoing Arterial hypertension, ongoing Heart rate increased, ongoing Anemia iron deficiency/sideropenic anemia. Concomitant medication(s) included bisoprolol fumarate (CONCOR COR) taken for heart rate increased from 19May2020 to 15May2021; diazepam (NORMABEL) taken for anxiety from 15Feb2016 to 15May2021. On May2021 (also reported as 9th day after receiving the second dose of the vaccine and 11May2021) he was admitted to the hospital for severe chest pain (severe pains in chest) due to myocardial infarction/acute myocardial infarction. He had a stent implanted, but soon after that cardiogenic shock and death occurred. It was reported that patient had ultrasound of the heart, ergometry, perfusion scintigraphy of the myocardium. The patient died on 15May2021. It was not reported if an autopsy was performed. A casual relationship between Comirnaty and events Cardiogenic shock, Chest pain and Acute myocardial infarction was assessed: Source of assessment: HALMED, Method of assessment: Causality, Result of Assessment: Unassessable/Unclassifiable. Sender Comment: 28Jun2021. Reporter was contacted for additional information on the hospitalization data, information on the autopsy (including autopsy report), vaccine batch number. No information has been received so far. Causality assessment meeting is still awaited. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: admitted to the hospital due to myocardial infarction, acute myocardial infarction; severe pains in chest; Cardiogenic shock


VAERS ID: 1479700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-16
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Diabetes mellitus; Hypertension; Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021827754

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-508521. An 81-year-old female patient received bnt162b2 (COMIRNATY) dispersion for injection (MAH: BioNTech Manufacturing) first dose intramuscularly in the left arm on 18May2021 (batch number: FA4598, expiry date: not reported,) as 0.3 ml single dose for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus and ischaemic heart disease, all ongoing. The patient''s concomitant medicinal products were not reported. On 16Jun2021, the patient died/sudden death after the use of Comirnaty and was considered serious due to fatal. Death after vaccination with Comirnaty is not expected. TTO (Treatment) is 4 weeks and 1 day. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. It was unknown if Autopsy Done. The outcome of the event was Fatal. No follow-up attempts are possible; No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1479701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Diarrhoea, Dizziness, Fall, Hepatic enzyme increased, Hyperkalaemia, Investigation, Loss of consciousness, Myocardial infarction, Renal failure, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 17
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: MARFARIN; BISOPROLOL; DUCILTIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Bronchopneumonia; Cerebral atrophy; COPD; Dilated cardiomyopathy; Encephalopathy; Hypertension; Ischemic heart disease; Myocardial fibrosis; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: investigation; Result Unstructured Data: Test Result:Laboratory result showed kidney failure; Comments: Laboratory result showed kidney failure, hyperkalemia and elevated liver enzyme levels; Test Date: 20210508; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021827756

Write-up: recent myocardial necrosis/myocardial infarction; losing his consciousness; kidney failure; hyperkalemia; diarrhea; elevated liver enzyme levels; condition started to worsen; weakness; decreased appetite; felt dizzy; accident (fall); This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-510621. A 79-years-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly in the left arm on 20Apr2021 (Lot number: EW4815) as DOSE 2, 0.3ML SINGLE for COVID-19 immunisation. Medical history included severe atherosclerosis and cardiovascular diseases including dilative cardiomyopathy, hypertension, ischemic heart disease and myocardial fibrosis; encephalopathy, COPD, cerebral atrophy and bronchopneumonia; renal failure chronic; that all from unknown date and unknown if ongoing. Concomitant medications included warfarin sodium (MARFARIN), bisoprolol, duloxetine hydrochloride (DUCILTIA). 2 days after vaccination (on 22Apr2021) the patient felt dizzy and had an accident (fall) but with no major injury. The patient condition started to worsen around 30Apr2021 with symptoms of weakness, dizziness and decreased appetite. On 08May2021 the patient had diarrhea twice and was rushed to the hospital after losing his consciousness. Covid-19 antigen test was negative. Laboratory result showed kidney failure, hyperkalemia and elevated liver enzyme levels. On 09May2021, patient also experienced recent myocardial necrosis/myocardial infarction. After receiving therapy, the patient condition temporarily got better, but passed away on 09May2021 at 22:50. Autopsy had done with autopsy results available. Based on the autopsy report, the cause of death was a myocardial infarction. Lab data included Covid-19 antigen test was negative; investigation with laboratory result showed kidney failure, hyperkalemia and elevated liver enzyme levels on 08May2021. Treatment received for events. Outcome of the event myocardial infarction was fatal, while of the other events was unknown. This report was assessed by reporting physician as serious. Based on the autopsy, the event was related to the patient primary diseases, therefore the causal relationship was unlikely between the suspected drug and the adverse event myocardial infarction. Sender Comment: Based on the autopsy, the event is related to the patient primary diseases, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: There is not sufficient evidence to support a causal relationship between the event "myocardial necrosis/myocardial infarction" and BNT162B2. The patient''s medical history myocardial fibrosis, ischemic heart disease, hypertension and dilated cardiomyopathy provide plausible explanation.; Reported Cause(s) of Death: recent myocardial necrosis/myocardial infarction; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1479703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Circulatory collapse, Computerised tomogram, Left ventricular hypertrophy, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: Atrial fibrillation; Decompensation cardiac; Diabetes mellitus; Hypertension (untreated); Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea (On Nov2020 and in 2019, patient went to the hospital due to dyspnoea); Sputum bloody (patient went to the hospital due to bloody sputum and dyspnoea)
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:showed possible sarcoidosis but the patient refuse; Comments: showed possible sarcoidosis but the patient refused further examination.; Test Date: 20210604; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021827760

Write-up: circulatory failure; congestive heart failure; severe left ventricular hypertrophy; This is a spontaneous report from a contactable physician downloaded from the WEB HU-OGYI-519621. A 57-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly, in the left arm on 07May2021 (Lot number: FA5829) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing obesity, ongoing hypertension (untreated), ongoing diabetes mellitus, ongoing decompensation cardiac and ongoing atrial fibrillation. On Nov2020, the patient went to the hospital due to dyspnoea but refused treatment. In 2019, the patient went to the hospital due to bloody sputum and dyspnoea. CT showed possible sarcoidosis but the patient refused further examination. Concomitant medications were not provided. On 04Jun2021, the patient developed circulatory failure in her home, the patient was transported to the hospital. Despite medical treatment, the patient died in the hospital on 04Jun2021. Autopsy had done with autopsy results available. According to the autopsy report, cause of death was congestive heart failure. The primary disease was hypertension which led to severe left ventricular hypertrophy. Lab data included COVID-19 rapid POC test was negative on 04Jun2021; CT showed possible sarcoidosis but the patient refused further examination on unspecified date. Treatment received for circulatory failure. Outcome of events was fatal. This report was assessed by reporting physician as serious due to fatal outcome. The causal relationship between the suspected drug and the event was considered not related. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 4 weeks. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on information provided, the events more likely related to underlying disease but unrelated to BNT162B2 (COMIRNATY) in concur with the physician''s assessment.; Reported Cause(s) of Death: circulatory failure; severe left ventricular hypertrophy; Congestive heart failure; Autopsy-determined Cause(s) of Death: The primary disease was hypertension which led to severe left ventricular hypertrophy; Congestive heart failure


VAERS ID: 1479718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-23
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Myocardial necrosis marker, Oxygen saturation, Respiratory failure
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac enzymes NOS; Result Unstructured Data: Slight increase; Test Name: Oxygen saturation; Result Unstructured Data: Was improving when the patient had a PEA
CDC Split Type: ISJNJFOC20210722310

Write-up: CARDIAC ARREST; RESPIRATORY FAILURE; CHEST PAIN; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IS-IMA-3401] concerned a 73 year old male. 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, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 22-JUN-2021 for covid-19 immunisation. The drug start period was 1 day. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-JUN-2021, the patient died from cardiac arrest, respiratory failure and chest pain. It was unknown if autopsy was performed. Laboratory data (dates unspecified) included: Cardiac enzymes NOS (NR: not provided) Slight increase and Oxygen saturation (NR: not provided) was improving when the patient had a PEA. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210722310-COVID-19 VACCINE Ad26.COV2.S-Cardiac Arrest, Respiratory Failure, Chest Pain- These events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: CHEST PAIN; CARDIAC ARREST; RESPIRATORY FAILURE


VAERS ID: 1479746 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   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: Hypertension; IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021824189

Write-up: cardiac arrest in the car noted by emergency number.; This is a spontaneous report from contactable Physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-750517. A 64-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: Unknown), intramuscular on 20Jun2021 as 0.3 mL single dose for COVID-19 immunisation. The patient''s medical history included IHD and hypertension. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest in the car noted by emergency number on 21Jun2021. The event resulted in emergency room visit. Therapeutic measures were taken as a result of cardiac arrest and included adrenaline was infused according to protocol non-shockable rhythms and resuscitation was continued for 50 minutes. The patient died due to cardiac arrest on 22Jun2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Case narrative: Pharmacovigilance: 2nd dose of the vaccine Follow up of 28Jun2021 emergency number doctor''s report: On 21Jun2021 at 11.40 pm we were alerted by the emergency system of an event in locality per episode syncopal. Upon arrival, after a call to the company: for clarification of the location of the event, the patient who was in the driver''s seat of his car presented himself in cardiac arrest with abundant foamy secretions leaking out of the airways. The co-worker who was in the passenger seat with the victim reported coughing on leaving work after eating cheese. This symptomatology would improve after drinking liquids but, while driving, it would recur so much that she invited her colleague to stop at the side of the road. The patient would then lose consciousness and the lady alerted the rescue. After complex extrication (obese patient), cardiac arrest was found, obstruction of the upper airways was excluded (absence of material in the oral cavity) and cardiopulmonary resuscitation was started according to the Council protocol. The laryngeal tube was also positioned and given the difficulty of finding peripheral venous access, intraosseous access was performed. The analysis of the heart rhythm has always shown pulseless electrical activity (it should be noted that already upon arrival, there was no electrical heart activity but the presence of electrical isolation from onset). Adrenaline was infused according to protocol non-shockable rhythms and resuscitation was continued for 50 minutes. It should also be noted that the cardiac massage was performed mechanically with the aid of the LUCAS unit. At 00.52 on 22Jun2021 the death was confirmed. From an anamnesis collected in the place from acquaintances present, it became known of a history of hypertensive heart disease and that on 20Jun the patient would have carried out a second dose of Covid 19 vaccination with Pfizer. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1479783 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-17
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: 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: JPJNJFOC20210728330

Write-up: DEATH; This spontaneous report received from a company representative from social media by a Business partner on 09-JUL-2021 was received on 14-JUL-2021 and concerned multiple patients (480). 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, and batch number were not reported) dose, 1 total administered ,start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. It was unspecified 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: V0:20210728330-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


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