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

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1435337 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIART; ALDACTONE-A
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021699604

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician. The patient was a 78-year-old male. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical histories of hypertension, diabetes mellitus, and cardiac failure chronic. The concomitant medications included azosemide (DIART) and spironolactone (ALDACTON-A) within 2 weeks of vaccination, both ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient no known allergies. On 21May2021 at 10:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EX3617, Expiration date 31Aug2021) for COVID-19 immunisation. On 11Jun2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) (at the age of 78-year-old) Intramuscularly, administered in Arm Left, as single dose for COVID-19 immunization. On 12Jun2021 at 14:00 (one day and 4 hours after the vaccination), the patient experienced cardiac failure acute. On 12Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021, at 10:00, the patient received the second dose of BNT162b2 vaccination. After the vaccination, no anaphylactic symptoms were observed. Thereafter, the course was observed without particular abnormalities. On 12Jun2021, at around 14:00 (one day and 4 hours after vaccination), immediately after the patient moved from the bed to the wheelchair for eating between-meal snacks, he had loss of consciousness and his breathing became unstable. A staff member of the institution noticed this, and the patient was transferred to the hospital. At the hospital visit, the patient had cardio-respiratory arrest, pupils dilated, and pupillary light reflex lost. Although cardiac massage was performed, no response was obtained. At 14:48 (one day, 4 hours, and 48 minutes after vaccination), the patient was confirmed to die. The patient was diagnosed with cardiac failure acute. No autopsy was performed. The causality between the event and BNT162b2 was not provided. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the available information, the Company considers the reported event fatal cardiac failure acute is unrelated to BNT162b2 vaccination, but more likely due to underlying or an inter-current medical condition in this 78-year-old male with medical history of hypertension, diabetes mellitus, and cardiac failure chronic. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1435362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-02
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Intestinal obstruction; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021702686

Write-up: This is a spontaneous case from a contactable consumer or other non-healthcare professional. The patient was an 89-year-old female. Body temperature before vaccination was not provided. The patient family history was not provided. The patient had medical histories of dementia, myocardial infarction, and intestinal obstruction. On 20May2021 (the day of vaccination), the patient received unknown dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a unknown, single for COVID-19 immunization. On 02Jun2021 (13 days after the vaccination), the patient experienced myocardial infarction relapse. On 02Jun2021 (13 days after the vaccination), the outcome of the event was fatal. It was not reported if autopsy was performed The course of the event was as follows: On 20May2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. On 02Jun2021 (13 days after vaccination), the patient died. The reporting non-healthcare professional classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. There other possible cause of the event such as any other diseases was myocardial infarction. The reporting non-healthcare professional commented as follows: The myocardial infarction relapsed approximately 2 weeks after the vaccination, and thus, the causality between the event and BNT162b2 vaccination was unlikely.; Reported Cause(s) of Death: myocardial infarction relapse; myocardial infarction relapse


VAERS ID: 1435397 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Blood pressure systolic, Body temperature, Heart rate, Oxygen saturation, Pneumonia aspiration
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RADICUT; HEPARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ALS
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: BP; Result Unstructured Data: Test Result:142/80; Comments: at around 13:40; Test Date: 20210607; Test Name: BP; Result Unstructured Data: Test Result:60/49; Comments: at 16:55; Test Date: 20210607; Test Name: BP; Result Unstructured Data: Test Result:131/75; Comments: at around 17:25; Test Date: 20210607; Test Name: BP; Result Unstructured Data: Test Result:109/69; Comments: at around 17:40; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:around 100; Comments: after hospitalization; Test Date: 20210607; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:around 100; Comments: in ambulance; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: at around 13:40; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 16:50; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 16:55; Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Comments: at around 17:40; Test Date: 20210607; Test Name: pulse rate; Result Unstructured Data: Test Result:97; Comments: at around 13:40; Test Date: 20210607; Test Name: pulse rate; Result Unstructured Data: Test Result:124; Comments: at 16:55; Test Date: 20210607; Test Name: pulse rate; Result Unstructured Data: Test Result:136; Comments: at around 17:40; Test Date: 20210607; Test Name: SpO2; Test Result: 97 %; Comments: at around 13:40; Test Date: 20210607; Test Name: SpO2; Test Result: 82 %; Comments: at around 17:40; Test Date: 20210607; Test Name: SpO2; Result Unstructured Data: Test Result:85-89 %; Comments: in ambulance
CDC Split Type: JPPFIZER INC2021704269

Write-up: Anaphylactic shock; Pneumonia aspiration; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21114095. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 07Jun2021 13:15 (Batch/Lot Number: EY3860; Expiration Date: 31Aug2021) at 74-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included amyotrophic lateral sclerosis (ALS) from an unknown date and unknown if ongoing. Concomitant medications included edaravone (RADICUT Injection) taken for an unspecified indication, start and stop date were not reported; heparin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 07Jun2021 at 16:55 (3 hours 40 minutes after the vaccination), the patient experienced: anaphylactic shock (death, hospitalization, medically significant). On 09Jun2021 (1 day 10 hours 45 min after the vaccination) the patient experienced: pneumonia aspiration (death, medically significant). Both events required Emergency Room Visit. The patient was hospitalized for anaphylactic shock from 07Jun2021 to 11Jun2021. The clinical course was reported as follows: The patient was a 74-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Family history was not reported. Medical history included amyotrophic lateral sclerosis (ALS). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 07Jun2021 at 13:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jun2021 at 16:55 (3 hours 40 minutes after the vaccination), the patient experienced anaphylactic shock. On 07Jun2021 (on the same day of the vaccination), the patient was admitted to the hospital. On 11Jun2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: At around 13:15, body temperature before vaccination was 36.4 degrees Centigrade and the patient had no other problem. Since the patient could not move due to ASL, the patient received the second dose of the vaccine in the patient''s room. After the vaccination, the patient was placed under observation for about 20 minutes and had no particular problem. At around 13:40, body temperature was 36.6 degrees Centigrade, blood pressure was 142/80, pulse rate was 97, and SpO2 was 97%. There was no problem in general condition. An edaravone (RADICUT) Injection 60 mg was administered via CV port over 60 minutes (administration completed at 14:50). Heparin was used around this time and after the administration, the patient had no problem. At 16:50, a caregiver reported that the patient had pyrexia of 38.1 degrees Centigrade. At 16:55, the patient was visited to check the condition. The patient reacted when his name was called but had depressed level of consciousness. For respiration, home Noninvasive positive pressure ventilation (NPPV) therapy had been conducted. Body temperature was 38.1 degrees Centigrade; blood pressure was 60/49, and pulse rate was 124. It was considered as anaphylactic shock and epinephrine (EPIPEN) 1 tube 0.3 mg was intramuscularly injected. Infusion of calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (LACTEC G) 500 mL was initiated (at full) via CV port and hydrocortisone sodium succinate (SOLU-CORTEF) 200 mg was intravenously injected. Ambulance was requested to another hospital (where the primary care physician of ASL was). At around 17:25, blood pressure recovered to 131/75 and consciousness level increased. The patient complained of queasy. When the mask was off, SpO2 decreased. At around 17:40, just before the transfer, body temperature was 39.1 degrees centigrade, blood pressure was 109/69, pulse rate was 136, and SpO2 was 82%. The patient had queasiness. Emergency transport was conducted. While the patient was in ambulance, systolic blood pressure was around 100 and SpO2 was 85-89% (NPPV therapy was conducted via mask). As for consciousness level, the patient reacted to a call and complained of queasiness. The patient was brought to an emergency outpatient unit and subsequently admitted to the hospital. Attending physician where the patient was hospitalized reported that pyrexia resolved and systolic blood pressure stabilized at around 100; however, on 09Jun2021 and on 10Jun2021, respiratory condition aggravated (respiratory arrest? The patient developed pneumonia aspiration) and on 11Jun2021, the patient died of pneumonia aspiration. The patient was admitted to the hospital from 07Jun2021 to 11Jun2021. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was infusion of RADICUT (however, it was conducted once a month for several years). The reporting physician commented as follows: The patient had ALS. It was considered that anaphylactic shock due to the vaccine triggered pneumonia aspiration and resulted in death. The patient underwent lab tests and procedures which included blood pressure measurement (BP): 142/80 on 07Jun2021 at around 13:40, blood pressure measurement: 60/49 on 07Jun2021 at 16:55, blood pressure measurement: 131/75 on 07Jun2021 at around 17:25, blood pressure measurement: 109/69 on 07Jun2021 at around 17:40, blood pressure systolic: around 100 on an unspecified date after hospitalization, blood pressure systolic: around 100 on 07Jun2021 in ambulance, body temperature: 36.4 Centigrade on 07Jun2021 before vaccination, body temperature: 36.6 Centigrade on 07Jun2021 at around 13:40 , body temperature: 38.1 centigrade on 07Jun2021 at 16:50, body temperature: 38.1 centigrade on 07Jun2021 at 16:55, body temperature: 39.1 centigrade on 07Jun2021 at around 17:40, pulse rate: 97 on 07Jun2021 at around 13:40, pulse rate: 124 on 07Jun2021 at 16:55, pulse rate: 136 on 07Jun2021 at around 17:40 , oxygen saturation (SpO2): 97 % on 07Jun2021 at around 13:40, oxygen saturation: 82% on 07Jun2021 at around 17:40, oxygen saturation: 85-89% on 07Jun2021 in ambulance. Therapeutic measures were taken as a result of anaphylactic shock. The clinical outcome of the events was fatal. The patient died on 11Jun2021 due to pneumonia aspiration and anaphylactic shock. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: Anaphylactic shock; Pneumonia aspiration


VAERS ID: 1435405 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Diabetes mellitus, Diabetic coma, Multiple organ dysfunction syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021706168

Write-up: Diabetic coma; diabetes mellitus (worsening); Multi-organ failure; Inappetence; This is a spontaneous report from a contactable physician. This is a report received from the Agency. Regulatory authority report number is v21114184. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28May2021 14:13 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) at 92-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30May2021 (1 day 9 hours 47 minutes after the first dose), the patient experienced inappetence (non-serious). On 31May2021 (2 days 9 hours 47 minutes after the first dose), the patient experienced diabetic coma (death, hospitalization, medically significant) and diabetes mellitus (worsening) (death, hospitalization, medically significant), and multi-organ failure (death, hospitalization, medically significant); also required a physician office visit. The patient was hospitalized for diabetic coma, diabetes mellitus (worsening), and multi-organ failure from 31May2021 to an unknown date. The clinical course was reported as follows: The patient was a 92-year-old female. Body temperature before vaccination was 36.3 degrees Celsius. Family history, 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). On 28May2021 at 14:13 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617 Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 31May2021 at unknown time (3 days after the vaccination), the patient experienced diabetic coma and multi-organ failure. On 31May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 01Jun2021 (4 days after the vaccination), the outcome of the events diabetic coma and multi-organ failure was fatal. It was not reported whether an autopsy was performed. The course of the events was as follows: On 28May2021 at 14:13 (the day of vaccination), the patient received the first dose of BNT162b2. On 30May2021 at night (2 days after the vaccination) (as reported), the patient experienced inappetence. No pyrexia was noted. On 31May2021 (3 days after the vaccination) (as reported), with body pain and depressed level of consciousness, the patient visited the hospital and then was admitted the hospital. On 01Jun2021 (4 days after the vaccination) (as reported), the patient died. The reporting physician classified the events diabetic coma and multi-organ failure as serious (death) and assessed the causality between the events diabetic coma and multi-organ failure and BNT162b2 as unassessable. The seriousness and causality of the event inappetence were not reported. Other possible cause(s) of the events diabetic coma and multi-organ failure such as any other diseases was diabetes mellitus (worsening). The reporting physician commented as follows: Although the relationship was unlikely given the known side effects, we report this death case considering the timing of the onset. The patient underwent lab tests and procedures which included body temperature: 36.3 Centigrade on 28May2021 before vaccination. The clinical outcome of the event, inappetence, was unknown. The clinical outcome of the events: diabetic coma, diabetes mellitus (worsening), and multi-organ failure, was fatal. The patient died on 01Jun2021 due to diabetic coma, diabetes mellitus (worsening), and multi-organ failure. It was unknown if an autopsy was performed. ; Reported Cause(s) of Death: Diabetic coma; Multi-organ failure; diabetes mellitus (worsening)


VAERS ID: 1435406 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021706557

Write-up: This is a spontaneous report from a contactable pharmacist. An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly, on 25May2021 (at the age of 85-years-old) as 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 14Jun2021 (20 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: On 15Jun2021, the reporter attempted to contact the patient, but he could not reach the patient. Therefore, the reporter checked on what happened and found that the patient died on 14Jun2021. A facility member stated that the cause of death was uncertain at the time of reporting. The patient died on 14Jun2021. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The causal relationship with BNT162B2 was uncertain. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1435418 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: Aortic valve stenosis; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrointestinal disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021735203

Write-up: Geromarasmus; This is a spontaneous report from a contactable consumer (clerical staff) received from the Regulatory Authority, regulatory authority report number is v21115164 and another contactable physician via a sales representative. The patient was a 93-year and 0-month-old female. Body temperature before vaccination was 36.6 degrees centigrade on 29May2021. Medical history included gastrointestinal disorder, ongoing hypertension, and ongoing aortic valve stenosis. The patient''s family history was not reported. On 29May2021 at 10:00 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly at 0.3 mL as a single dose (at the age of 93-year-old) for COVID-19 immunization. The following were events all occurred on the same day (29May2021): The patient received?the first dose of BNT162b2. On the evening of that day, a family member felt something unusual and called an ambulance (details: the patient was resting home after the vaccination. Usually, the patient got out of bed, but the patient did not come on that day) (information the reporting physician heard from the family member). The patient was emergently transported to a medical center. On 29May2021 at 19:43 (9 hours 43 minutes after the vaccination), the patient died of geromarasmus at a medical center. It was unknown if an autopsy was performed. A physician (who made a certificate of death) 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. A physician of the medical center who made a certificate of death commented that there was no causal relationship between the cause of death and BNT162b2. A reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a role of BNT162B2 to the development of fatal event geromarasmus can 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: Geromarasmus


VAERS ID: 1435420 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TELMISARTAN; AMBROXOL; EVAMYL; ISOSORBIDE DINITRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Cardiac valvulopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021746727

Write-up: Loss of consciousness; This is a spontaneous report from a contactable physician received via the Agency. A 68-year-old female patient (It was unknown whether the patient was pregnant) received bnt162b2 (COMIRNATY), the first dose via intramuscular in left arm on 17Jun2021 at 16:45 (lot number: FC3661, expiration date: 30Sep2021) as single dose for COVID-19 immunisation. The relevant medical history included cardiac valvulopathy from unspecified date, cardiac failure chronic from unspecified date. Concomitant medications included telmisartan; ambroxol; lormetazepam (EVAMYL); isosorbide dinitrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 20Jun2021 (3 days after the vaccination), the patient experienced loss of consciousness. The clinical course was reported as follows: On 17Jun2021 (the day of vaccination), the patient received BNT162b2 in the afternoon, was followed up for 15 minutes and then returned home. On 20Jun2021 (3 days after the vaccination), the patient was found unconscious in a chair at the home. The patient was urgently transported to a hospital and her death was confirmed. An autopsy was not performed. The event resulted in death. It was unknown whether treatment was performed for the event. The patient died on 20Jun2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was fatal.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of LOC with fatal outcome due to temporal relationship. However, the reported event may possibly be associated with intercurrent medical condition in this elderly patient with history of cardiac valvulopathy and cardiac failure chronic. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results, EKG, echocardiogram, electrolytes, CBC and head CT/MRI counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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: Loss of consciousness


VAERS ID: 1435421 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: Angina pectoris; Artificial cardiac pacemaker user; Atrioventricular block complete; Cholesterol high; Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021749202

Write-up: Death from illness; This is a spontaneous report from a contactable nurse via a Pfizer employee. The patient was an 83-year-old female. Underlying disease/complication included hypertension, type 2 diabetes mellitus, angina pectoris, high cholesterol, atrioventricular block complete, and pacemaker implantation. Concomitant medications were not reported. On 04Jun2021 at unknown time (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) at 83-year-old at 0.3 ml intramuscularly as a single dose for COVID-19 immunisation. On 12Jun2021 at unknown time (8 days after the vaccination), the patient experienced death. On 12Jun2021, the outcome of the event was fatal. The cause of death was reported as death from illness. The course of the event was as follows: On 04Jun2021 (the day of vaccination), the patient received a BNT162b2 vaccination intramuscularly. The police informed that the patient had died at home on 12Jun2021. No pathological anatomy was performed, and it was considered as death from illness. Although the causal relationship with the patient vaccinated with BNT162b2 was unknown, there was a call from the nurse. The reporting nurse classified the event as serious (death). The causality of the event was not reported.; Sender''s Comments: The information provided is too limited for a reasonable medical assessment. There was no information provided regarding the specific cause of death, detailed medical history and counteractive treatment measures. As per company causality guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Death from illness


VAERS ID: 1435422 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiac arrest, Cardiac failure acute, Cyanosis, Depressed level of consciousness, Hypopnoea, Malaise, Oxygen saturation, Oxygen saturation decreased, Respiratory arrest, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   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 chronic (since about 8 months earlier); Pleural effusion (since about 8 months earlier)
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: Blood pressure; Result Unstructured Da1ta: Test Result:immeasurable; Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination; Test Date: 20210617; Test Name: SPO2 level; Result Unstructured Data: Test Result:was 72% for a moment; Comments: but immediately became immeasurable
CDC Split Type: JPPFIZER INC2021749312

Write-up: Respiratory arrest; Cardiac arrest; blood measurement was immeasurable; The respiratory was shallow and weak; Cyanosis of lip; Marked malaise; Depressed level of consciousness; Unresponsive to calls; The SpO2 level was 72% for a moment but immediately became immeasurable; Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21115279. The patient was a 92-year and 7-month-old female. Body temperature before vaccination was 37.1 degrees Celsius. Medical history included cardiac failure chronic and accumulated pleural effusion since about 8 months earlier. Family history and concomitant medications were not reported. There were no particular 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 25May2021 (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 15Jun2021 at 14:00 (the day of the second 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 a single dose for COVID-19 immunisation. On 17Jun2021 at 18:05 (2 days after the second vaccination), the patient experienced marked malaise, depressed level of consciousness, cyanosis of lip, "was unresponsive to calls", and "the SpO2 level was 72% for a moment but immediately became immeasurable". On 17Jun2021 at 18:10 (2 days after the second vaccination), the respiratory was shallow and weak, and blood measurement was immeasurable. On 17Jun2021 at 18:18 (2 days after the second vaccination), the patient experienced respiratory arrest and cardiac arrest, and died. The cause of death was reported as cardiac failure acute. It was not reported whether autopsy was done. The outcome was reported as fatal. The course of the events was as follows: On 25May2021 (the day of the first vaccination), the patient received the first vaccination and had uneventful course. On 15Jun2021 (the day of the second vaccination), the patient received the second vaccination and had experienced nothing such as pyrexia. On 17Jun2021 at 18:05 (2 days after the second vaccination), the patient started to have marked malaise at the midpoint of dinner. She chocked when drinking tea by herself. She seemed at her limit after eating one-ninth amount of the meal. During observation of her condition, the patient had depressed level of consciousness, developed cyanosis of lip, and was unresponsive to calls. Suctioning of sputum was done, but only a small volume was aspirated. The SpO2 level was 72% for a moment but immediately became immeasurable. At 18:10, the respiratory was shallow and weak, and blood measurement was immeasurable. At 18:18, respiratory arrest and cardiac arrest developed, and death was confirmed. Seriousness was reported as serious (death). The physician assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases were reported as cardiac failure chronic and accumulated pleural effusion. The reporting physician commented as follows: Cardiac failure chronic and accumulated pleural effusion had been present since about 8 months earlier, and cardiac failure acute was considered as cause of death. The causality with the vaccination was unknown.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1435423 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Imaging procedure, Pneumothorax
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dissecting aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: Imaging; Result Unstructured Data: Test Result:revealed pneumothorax
CDC Split Type: JPPFIZER INC2021749318

Write-up: Pneumothorax; This is a spontaneous report from a contactable pharmacist . The patient''s age and gender were not reported. Medical history included chronic obstructive pulmonary disease (COPD) and dissecting aortic aneurysm, both not ongoing. Concomitant medications were not reported. On 13Jun2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jun2021 (8 days after the vaccination), the patient experienced pneumothorax. The outcome of the event was fatal. The course of the event was as follows: On 13Jun2021 (on Sunday), the patient received the vaccine. On 15Jun2021, the patient visited outpatient department and at that time, the patient looked fine. On previous day, the patient was transferred to the reporting hospital due to cardio-respiratory arrest and died. Imaging revealed pneumothorax. The reporting pharmacist did not provided the seriousness, causality and other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: The patient had history of COPD and dissecting aortic aneurysm and there may be no direct causal relationship. It was probably not an adverse reaction to the vaccine. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the current available information the plausible drug event temporal association, a possible contributory role of the suspect product BNT162b2 to the development of pneumothorax with a fatal outcome cannot be totally excluded/assessed. 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: Pneumothorax


VAERS ID: 1435424 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Hepatitis acute
SMQs:, Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder; Hospitalisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021749439

Write-up: Hepatic function disorder (hepatitis acute); inappetence; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21115283. A 94-year-old (reported as 94-year and 3-month-old) male patient received the second dose of BNT162B2 (COMIRNATY, Pfizer vaccine against the coronavirus) at 94-year-old, via an unspecified route of administration on 08Jun2021 at single dose for COVID-19 immunization. Medical history included admitted to the reporting hospital because of heart disorder. Concomitant medications included oral medications prescribed from the neurology department and the cardiovascular medicine department. Body temperature before vaccination and family history 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). Patient previously received the first dose of BNT162B2 (Pfizer vaccine against the coronavirus) on 18May2021 for COVID-19 immunization. Thereafter, the patient was admitted to the reporting hospital because of heart disorder, but no apparent adverse reactions were noted. On 11Jun2021 (3 days after the second vaccination), the patient experienced hepatic function disorder (hepatitis acute). On 20Jun2021 (12 days after the second vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: On 09Jun2021 (1 day after the second vaccination), inappetence was noted. On 11Jun2021 (3 days after the second vaccination), the patient visited the reporting hospital and was admitted on the same day with a diagnosis of hepatitis acute. The reporting pharmacist classified the event as serious (life-threatening) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: In addition to the Pfizer coronavirus vaccine, there were other multiple drugs orally taken, and it could not be said that the coronavirus vaccine was the cause. Outcome of event inappetence was unknown. Patient died on 20Jun2021 due to hepatic function disorder (hepatitis acute). It was unknown if autopsy had been done. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Hepatic function disorder (hepatitis acute)


VAERS ID: 1435425 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Chronic obstructive pulmonary disease, Coma scale, Heart rate, Hot flush, Malaise, Oedema, Oxygen saturation, Respiratory failure, White blood cell count, X-ray
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 3
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; Lung cancer; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: BP; Result Unstructured Data: Test Result:129/66; Comments: after vaccination; Test Date: 20210617; Test Name: BP; Result Unstructured Data: Test Result:155/67; Test Date: 20210618; Test Name: BP; Result Unstructured Data: Test Result:139/72; Test Date: 20210617; Test Name: Blood collection; Result Unstructured Data: Test Result:''WPC'' and CRP were both normal; Test Date: 20210616; Test Name: BT; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: after vaccination; Test Date: 20210617; Test Name: BT; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210618; Test Name: BT; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210618; Test Name: BT; Result Unstructured Data: Test Result:68/39 Centigrade; Test Date: 20210618; Test Name: coma scale; Result Unstructured Data: Test Result:III-200; Test Date: 20210617; Test Name: CRP; Result Unstructured Data: Test Result:normal; Test Date: 20210616; Test Name: P/HR; Result Unstructured Data: Test Result:95; Comments: after vaccination; Test Date: 20210617; Test Name: P/HR; Result Unstructured Data: Test Result:109; Test Date: 20210618; Test Name: P/HR; Result Unstructured Data: Test Result:92; Test Date: 20210618; Test Name: P/HR; Result Unstructured Data: Test Result:30 to 50s; Test Date: 20210616; Test Name: SpO2; Test Result: 99 %; Comments: first measurement after vaccination; Test Date: 20210616; Test Name: SpO2; Result Unstructured Data: Test Result:88-89 %; Comments: second measurement after vaccination; Test Date: 20210618; Test Name: SpO2; Test Result: 90 %; Test Date: 20210618; Test Name: SpO2; Result Unstructured Data: Test Result:70% %; Test Date: 20210617; Test Name: ''WPC''; Result Unstructured Data: Test Result:normal; Test Date: 20210617; Test Name: X-P; Result Unstructured Data: Test Result:negative (-) to pneumonia findings
CDC Split Type: JPPFIZER INC2021749671

Write-up: Respiratory failure due to acute aggravation of COPD; Respiratory failure due to acute aggravation of COPD; Oedema of the bilateral feet, back, and face; Malaise was intensified; Hot flushes facial; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 82-year-old male (reported as 81-year-old, pending clarification). The most recent COVID-19 vaccine administered was received at the hospital. 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 included prescribed drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Other medical history included chronic obstructive pulmonary disease (COPD), prostate cancer, and left lung cancer. On 16Jun2021 at 13:30 (the day of vaccination), at age of 82-year-old, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization. On 16Jun2021 (the day of vaccination), the patient experienced hot flushes facial at 13:30 and malaise was intensified at 19:00. On 17Jun2021 at 05:00 (1 day after the vaccination), the patient experienced oedema of the bilateral feet, back, and face. On 18Jun2021 at 16:26 (2 days after the vaccination), the patient experienced death. The events resulted in death. The death cause was reported as respiratory failure due to acute aggravation of COPD. Autopsy was not performed. Treatment for AEs included oxygen administration at increased doses and fluid replacement. The reporting physician assessed the event as serious (death). The causality of the events was not reported. The course of the events was as follows: On 16Jun2021 at 13:30 (the day of vaccination), the patient was vaccinated. Right after this, hot flushes facial was present (+); the body temperature (BT) was 36.6 degrees centigrade, the pulse (P) 95, the blood pressure (BP) 129/66, the SpO2 99% (oxygen (02): 3L) (first measurement after vaccination). At 19:00, malaise was intensified, and the SpO2 was 88-89% (O2: increased from 3L to 4L) (second measurement after vaccination). On 17Jun2021 at 05:00 (1 day after the vaccination), oedema of the bilateral feet, back, and face was (+). The patient could not eat because of distressing condition; the BT was 37.3 degrees centigrade, the P 109, the BP 155/67, and X-ray photography (X-P) negative (-) to pneumonia findings. Blood collection was performed, and ''WPC'' and C-reactive protein (CRP) were both normal. On 18Jun2021 at 06:00 (2 days after the vaccination), the coma scale was III-200, the BT 36.9 degrees centigrade, the P 92, the BP 139/72, and the SpO2 90% (02: 8L). On 19Jun2021 at 15:15 (3 days after the vaccination), the HR was in 30 to 50s, the SpO2 70% (O2: 10L), and the ''BT'' 68/39 (as reported). At 16:26, death was confirmed. The outcome of the events was fatal.; Sender''s Comments: The events were considered intercurrent conditions and unrelated to BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021).; Reported Cause(s) of Death: Respiratory failure due to acute aggravation of COPD; Hot flushes facial; Malaise was intensified; Oedema of the bilateral feet, back, and face; Respiratory failure due to acute aggravation of COPD


VAERS ID: 1435426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-21
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

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

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: OLMETEC; FEBURIC
Current Illness: Gout (under treatment); Hypertension (under treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021749738

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21115396. The patient was a 77-year-old male. Body temperature before vaccination was 36.8 degrees centigrade on 08Jun2021. Family history was not reported. Medical history included ongoing hypertension and gout, for which the patient was under treatment. Concomitant medication included olmesartan medoxomil (OLMETEC) OD (20 mg) 1 tablet once daily in the morning and febuxostat (FEBURIC) (10 mg) 1 tablet once daily in the morning. On 08Jun2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jun2021 in the morning (13 days after the vaccination), the patient experienced death. On 21Jun2021 (13 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: It was reported to the reporting hospital that the patient died unexpectedly on 21Jun2021 in the morning. Cause of death was unknown. 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 could not be assessed at the time of this report. The reporting physician commented as follows: Details of the situation was unknown. ; Reporter''s Comments: Details of the situation was unknown.; Reported Cause(s) of Death: Death


VAERS ID: 1435428 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Disease recurrence, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Convulsion (the patient was taking anticonvulsant orally); Late effects of cerebral stroke (the patient was taking anticonvulsant orally); Pneumonia; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021750228

Write-up: Urinary tract infection; Urinary tract infection; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21115416. An 86-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 14Jun2021 14:38 (Lot Number: FA2453; Expiration Date: 31Aug2021) at the age of 86 years old, as single dose for covid-19 immunisation. The patient was an 86-year and 9-month-old male. Body temperature before vaccination on 14Jun2021 was 36.8 degrees Celsius. The patient had no family history. Medical history included prior convulsion due to late effects of cerebral stroke (for which the patient was taking anticonvulsant orally), prior pneumonia, and prior urinary tract infection. On 14Jun2021 at 14:38 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 (4 days after the vaccination), the patient experienced urinary tract infection. On 20Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 18Jun2021, the patient developed urinary tract infection, for which antibacterial agent and NSAID were administered. On 20Jun2021, the patient took a sudden turn for the worse and died. The patient had long been bedridden most of the time (nursing care level 4) and had history of pneumonia and urinary tract infection. The patient died on 20Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases included neurogenic bladder due to late effects of cerebral stroke. The reporting physician commented as follows: It was presumed to be unrelated to the vaccination.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a role of BNT162B2 to the development of fatal urinary tract infection can 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: Urinary tract infection; Urinary tract infection


VAERS ID: 1435429 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 RA / OT

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

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021750458

Write-up: Death; This is a spontaneous report from a non-contactable consumer received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 93-year-old male. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not provided. On 26May2021 at 10:15 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the right arm at age of 93 years for COVID-19 immunization at a nursing home. On 16Jun2021 at 10:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscular in the right arm at age of 93 years for COVID-19 immunization at a nursing home. On 18Jun2021 (2 days after the vaccination), the patient died (the event resulted in death/emergency room or emergency treatment). It was not reported if an autopsy was performed. It was unknown if the patient received the treatment. It was unknown if the patient had been tested for COVID-19 since the vaccination. The causal relationship with BNT162b2 was unknown.; Reported Cause(s) of Death: Death


VAERS ID: 1435431 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pain in extremity, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Haemodialysis (3 times every week)
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure chronic; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021751057

Write-up: Sudden death; pain of the right lower limb and plantar; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115535. The patient was a 70-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. The family history was not provided. The patient had medical histories of renal failure chronic, rheumatoid arthritis chronic. The patient was receiving haemodialysis 3 times every week. The patient was orally taking a steroid. The patient had concomitant drug. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 16Jun2021 at 08:25 (at age of 70 years old, the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jun2021 (5 days after the vaccination), the patient experienced sudden death. On 21Jun2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jun2021at 08:25 (the day of vaccination), the patient received the second dose of BNT162b2. In the evening on the same day, the patient developed pain of the right lower limb and plantar. The outcome of the event was unknown. On 19Jun2021 (3 days after the vaccination), the patient visited the reporting hospital and received dialysis as usual. On 21Jun2021 (5 days after vaccination), before dawn, the patient died at his home (the details were unknown). It was unknown if the autopsy done. The reporting physician classified the sudden death as serious (death) and assessed that the causality between the sudden death and BNT162b2 as unassessable. No information about other possible cause of the event such as any other diseases was reported.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1435433 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Carbohydrate antigen 19-9, Marasmus, Neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow)

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: ENALAPRIL; MAGNESIUM OXIDE; LINZESS; SOLDEM 3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Geromarasmus; Intestinal obstruction
Allergies:
Diagnostic Lab Data: Test Name: CA 19-9; Result Unstructured Data: Test Result:563; Comments: high level
CDC Split Type: JPPFIZER INC2021753737

Write-up: Geromarasmus; Carcinoma; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 91-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ongoing enalapril, ongoing magnesium oxide, ongoing linaclotide (LINZESS), and ongoing glucose, potassium chloride, sodium chloride, sodium lactate (SOLDEM 3) 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, geromarasmus, and postoperative intestinal obstruction. On 12Jun2021 at 16:00 (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) at 91-year-old via intramuscular route of administration in the arm left for COVID-19 immunization. On 20Jun2021 at 00:45 (7 days/8 hours/45 minutes after the vaccination), the patient died that might cause geromarasmus or carcinoma. The outcome of the event was fatal without treatment. Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: The patient had medical histories of dementia Alzheimer''s type, geromarasmus, and postoperative intestinal obstruction. The CA19-9 was high. Since 2 weeks before the vaccination, the patient could hardly take meals, and she was treated with a drip infusion. Since the CA19-9 was high as 563, and the family was consulted. However, since the patient had dementia and she was an elderly, the family did not wish to have detailed examination. However, the patient was able to take enteral nutrient such as ENSURE 2 to 3 cans per day. The cause of death was either geromarasmus or carcinoma; however, no detailed examination was performed. Patient died on 20Jun2021. The autopsy was not done.; 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 the events carcinoma and Marasmus can be fully excluded, and the causal factor to the reported events could be related to the patient''s Medical history of Geromarasmus and a relatively high count of CA-19-9 reported to have been detected 2 weeks prior to vaccination, until further information is received on the course of events leading to a fatal outcome. 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: Carcinoma; Geromarasmus


VAERS ID: 1435436 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Choking, Fatigue
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021754981

Write-up: when the patient was having a meal, she chocked on food; Fatigue feeling; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 64-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products were noted. Medical history included schizophrenia. On 25May2021 at 15:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital at age of 64-year-old (non-pregnant). On that day, fatigue feeling was noted, but the patient had a clear intention to receive the vaccination. On 09Jun2021 (15 days after the vaccination), the patient died. The reporter was informed of the suspicious death by police. The reporter could contact the patient''s husband on 14Jun2021, and according to him, when the patient was having a meal, she chocked on food. The results of the autopsy done by the police was uncertain. It was unknown whether treatment was provided to the patient. Food aspiration resulted in death and the physician classified it as serious (death). Outcome of the event and seriousness classification for the event, fatigue feeling, was not reported. The causality assessment between the events and BNT162b2 was not provided. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious event unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death, therefore the event does not meet reportability to the Agency. 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: when the patient was having a meal, she chocked on food


VAERS ID: 1435437 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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: 2021-06-21
   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: CARVEDILOL; FRANDOL; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Dementia; Infarction; Pneumonia; Sick sinus syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021756426

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115569. The patient was a 96-year and 5-month-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical histories of dementia, cardiac failure chronic, sick sinus syndrome, and after DMI (as reported). The concomitant medications included carvedilol, isosorbide dintrate (Frandol), and macrogol (Movicol). On 16Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jun2021 at 17:45 (5 days, 2 hours, and 45 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 21Jun2021 (5 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 unknown date in Jan2020, the patient was admitted to the medical facility for pneumonia. After the patient was discharged, the patient (masked characters) again. The course was observed without significant changes. According to the patient''s age, her family members wished to continue (masked characters) until the end. The patient was willing to receive the vaccination. On 21Jun2021, at 17:45 (5 days, 2 hours, and 45 minutes after vaccination), after supper, the patient suddenly had cardio-respiratory arrest. Treatments such as an automatic external defibrillator (AED) were performed; however, the patient died. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible causes of the event such as any other diseases were dementia, geromarasmus, and cardiac failure chronic.; Sender''s Comments: Based on the limited information in the case report and a plausible temporal relationship, A possible causal relationship between event Cardio-respiratory arrest and suspect drug BNT162B2 cannot be excluded. However, consider other contributory factors such as age and medical history. 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


VAERS ID: 1435438 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Ankle brachial index, Body temperature, Catheterisation cardiac, Computerised tomogram, Death, Endoscopy upper gastrointestinal tract, Gastrointestinal examination, SARS-CoV-2 test
SMQs:, COVID-19 (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: Anaemia; Appendicitis; Arterial haemorrhage; Atrial fibrillation paroxysmal; Bilateral pneumonia; Cardiogenic shock; Carotid arteriosclerosis; Cataract; Cataract operation (at age of 66); Catheterisation cardiac; Chest pain; Circumflex artery stenosis; Coronary artery calcification; Coronary artery occlusion; Coronary stent placement; Coronary vein stenosis; Drug-eluting stent placement; Dyspnoea; Femoral thromboendarterectomy; Fundic gland polyp; Gastric polyps; Gastritis atrophic; Gastrooesophageal reflux disease; Haemodialysis; Hepatic calcification; Hyperkalaemia; Hypertension; Irrigation therapy; Liver disorder; Numbness; Obstructive arteriosclerosis of lower extremities; Occult blood positive; Oesophageal hiatal hernia; Packed red blood cell transfusion; Percutaneous coronary intervention (between 25Dec2019 and 28Dec2019); Peritonitis; Pleural effusion; Pulmonary vein isolation; Pyrexia; Renal impairment; Stent placement (between 25Dec2019 and 28Dec2019); Stent placement; Surgery (at age of 18); Tachycardia; Tumour; Vascular catheterisation; Vascular cauterisation; Vasodilation procedure
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: coronary angiography; Result Unstructured Data: Test Result:revealed no significant stenosis in the left hepat; Comments: revealed no significant stenosis in the left hepatic artery and no stenosis in the stent. Chronic complete obstruction associated with marked calcification in the right hepatic artery was observed, but favorable collateral circulation from the left coronary artery was present, and there was no ischaemia in the left and right coronary arteries.; Test Date: 201903; Test Name: ABI; Result Unstructured Data: Test Result:0.92 in the right and 0.98 in the left; Test Date: 20210619; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20200528; Test Name: cardiac catheterisation; Result Unstructured Data: Test Result:significant stenosis in the left circumflex was no; Comments: significant stenosis in the left circumflex was noted; Test Date: 20200722; Test Name: CT; Result Unstructured Data: Test Result:showed bilateral pneumonia and accumulated pleural; Comments: showed bilateral pneumonia and accumulated pleural effusion; Test Date: 201706; Test Name: upper gastrointestinal tract endoscopy; Result Unstructured Data: Test Result:evealed duodenal submucosal tumour, fundic gland p; Comments: evealed duodenal submucosal tumour, fundic gland polyp, GERD, gastritis atrophic, carotid arteriosclerosis, and coronary artery calcification; Test Date: 20180804; Test Name: GIF; Result Unstructured Data: Test Result:revealed fundic gland polyp and duodenal submucosa; Comments: revealed fundic gland polyp and duodenal SMT; Test Date: 20190914; Test Name: GIF; Result Unstructured Data: Test Result:oesophageal hiatal hernia, gastric polyps, and duo; Comments: oesophageal hiatal hernia, gastric polyps, and duodenal SMT were suspected on GIF; Test Date: 20200722; Test Name: SARS-Cov-2-Ag; Test Result: Negative
CDC Split Type: JPPFIZER INC2021756432

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115533.The patient was a 73-year-old male. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included hypertension since the school age, surgery for appendicitis and peritonitis (at age of 18), a cataract operation was performed on the bilateral eyes (at age of 66), hypertension and renal impairment were pointed out (24Nov2011), numbness of hands and feet developed (Jan2012), haemodialysis was introduced because of hyperkalaemia (03Feb2012), anaemia and positive occult blood (Aug2017), duodenal submucosal tumour, fundic gland polyp, gastrooesophageal reflux disease (GERD), gastritis atrophic, carotid arteriosclerosis, and coronary artery calcification (Jun2017), occult blood was positive (Mar2018), atrial fibrillation paroxysmal (12Jul2018), fundic gland polyp and duodenal submucosal tumour (SMT) (04Aug2018), oesophageal hiatal hernia, gastric polyps, and duodenal SMT were suspected (14Sep2019), difficulty breathing (18Nov2019), chest pain (23Nov2019), emergency catheterization (23Nov2019), coronary stent placement and intra-aortic balloon pumping (IABP) were done for significant stenosis in left and right coronary arteries and cardiogenic shock (23Nov2019), tachycardia (03Feb2021), underwent percutaneous coronary intervention (PCI) and stent placement in the left anterior descending artery (between 25Dec2019 and 28Dec2019), chronic complete occlusion associated with marked calcification in the right hepatic artery (06Feb2021), obstructive arteriosclerosis of lower extremities (30Mar2020), right femoral thromboendarterectomy under general anaesthesia (31Mar2020), vasodilation procedure was performed for stenosis in the right common femoral artery and near the superficial femoral artery (28Apr2020), tachycardia (27May2020), significant stenosis in the left circumflex was noted (28May2020), drug-eluting balloon was used (28May2020), liver disorder (01Jul2020), pyrexia (22Jul2020), bilateral pneumonia and accumulated pleural effusion (22Jul2020), bilateral extensive pulmonary vein isolation and irrigation and cauterization on the tricuspid valve and the inferior vena cava isthmus (21Dec2020), tachycardia (30Dec2020), stent placement was performed in the stenosis area in the right superficial femoral artery (16Feb2021), bleeding was noted from the branch of the right superficial femoral artery (16Feb2021), red blood cell transfusion was performed at 6 units (16Feb2021), and occult blood was positive (Apr2021). Previously the patient received propafenone hydrochloride (PRONON), bisoprolol (BISOPROLOL) and calcium carbonate and experienced suspected drug-induced liver disorder. Previously the patient received aspirin (BAYASPIRIN), prasugrel hydrochloride (EFIENT), bisoprolol fumarate (MAINTATE), verapamil hydrochloride (VASOLAN) and levofloxacin hydrate (CRAVIT). Family 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 29May2021 (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported).On 19Jun2021 at unknown time (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7812, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.On 20Jun2021 at unknown time (1 day after the second vaccination), the patient experienced death.On 20Jun2021 (1 day after the second 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 hypertension since the school age, but it was left untreated. At age of 18, surgery for appendicitis and peritonitis was performed. At age of 66, a cataract operation was performed on the bilateral eyes. On 24Nov2011, hypertension and renal impairment were pointed out. In Jan2012, numbness of hands and feet developed. On 03Feb2012, haemodialysis was introduced because of hyperkalaemia (higher than 9). It was difficult to obtain consent for lowering the dry weight because of foot cramps. Despite anaemia and positive occult blood (Aug2017), lower gastrointestinal tract endoscopy was not performed because of no request. In Jun2017, upper gastrointestinal tract endoscopy revealed duodenal submucosal tumour, fundic gland polyp, GERD, gastritis atrophic, carotid arteriosclerosis, and coronary artery calcification. On 22Jan2018, after changing residence, the patient started haemodialysis at the reporting hospital. In Mar2018, occult blood was positive. On 12Jul2018, the patient visited the cardiovascular medicine department of another hospital because of suspected atrial fibrillation; atrial fibrillation paroxysmal was noted, and a follow-up approach was taken. A revisit would be made if atrial fibrillation occurred more frequently. On 04Aug2018, gastrointestinal fiberscope (GIF) revealed fundic gland polyp and duodenal SMT. In Mar2019, the ankle brachial pressure index (ABI) was 0.92 in the right and 0.98 in the left. On 14Sep2019, oesophageal hiatal hernia, gastric polyps, and duodenal SMT were suspected on GIF. On 18Nov2019, the patient complained of difficulty breathing, and the symptom was alleviated with dialysis. On 23Nov2019, the patient had chest pain and was urgently transported to the hospital after dialysis. The patient was hospitalized in the same hospital from the same day until 09Dec2019. On the same day, emergency catheterisation was performed, and coronary stent placement and IABP were done for significant stenosis in left and right coronary arteries and cardiogenic shock. The patient was discharged after rehabilitation, and BAYASPIRIN and EFIENT were added. The patient was hospitalized in the hospital from 25Dec2019 to 28Dec2019. He underwent PCI and stent placement in the left anterior descending artery. The patient was admitted to T. Hospital on 03Feb2021 because of tachycardia during the latter half of the dialysis and stayed in until 11Feb2021. On 06Feb2021, coronary angiography revealed no significant stenosis in the left hepatic artery and no stenosis in the stent. Chronic complete occlusion associated with marked calcification in the right hepatic artery was observed, but favorable collateral circulation from the left coronary artery was present, and there was no ischaemia in the left and right coronary arteries. MAINTATE was added. The patient was hospitalized in the hospital from 30Mar2020 to 05Apr2020 because of obstructive arteriosclerosis of lower extremities. On 31Mar2020, right femoral thromboendarterectomy under general anaesthesia was performed. The patient was hospitalized in the hospital from 27Apr2020 to 29Apr2020. On 28Apr2020, by left ''common aorta'' approach, vasodilation procedure was performed for stenosis in the right common femoral artery and near the superficial femoral artery. The patient was urgently transported and admitted to the hospital from 27May2020 to 31May2020 because of tachycardia attack during dialysis. Tachycardia attack improved with VASOLAN. On 28May2020, cardiac catheterisation was performed, and significant stenosis in the left circumflex was noted. Drug-eluting balloon was used, and the dose of MAINTATE was increased. The patient was hospitalized from 01Jul2020 to 18Jul2021 in the hospital because of liver disorder. Drug-related liver disorder was suspected; PRONON was discontinued, HISHIPHAGEN was administered, and BISOPROLOL and CALCIUM CARBONAE were stopped. On 22Jul2020, pyrexia occurred, and chest computerised tomography (CT) showed bilateral pneumonia and accumulated pleural effusion. At the hospital, SARS-Cov-2-Ag was negative, and CRAVIT was prescribed. The patient was hospitalized in the cardiovascular medicine department of the hospital from 20Dec2020 to 23Dec2020. On 21Dec2020, bilateral extensive pulmonary vein isolation and irrigation and cauterization on the tricuspid valve and the inferior vena cava isthmus were performed. Tachycardia settled down temporarily after discharge but started to be noted on 30Dec2020. The patient was hospitalized from 15Feb2021 to 16Feb2021 in the vascular surgery department of the Hospital. On 16Feb2021, stent placement was performed in the stenosis area in the right superficial femoral artery, and the guide wire (GW) could not pass the occluded area in the right popliteal artery. Bleeding was noted from the branch of the right superficial femoral artery, and red blood cell transfusion was performed at 6 units. In Apr2021, occult blood was positive. On 29May2021 (the day of the first vaccination), the patient received the first dose of BNT162b2. On 19Jun2021 (the day of the second vaccination), the patient received the second dose of BNT162b2. On 21Jun2021 (2 days after the second vaccination), the family called and reported the patient''s death. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unknown. Other possible cause(s) of the event such as any other diseases was present. The reporting physician commented as follows: There was also severe coronary events, and the sudden change could have occurred even if the vaccine had not been given.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1435439 (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: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Body temperature
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Medical History/Concurrent Conditions: Heart disorder; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021756434

Write-up: Aortic aneurysm rupture; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115562. An 81-years-old male patient received the second dose of BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Jun2021 09:30 (Lot Number: EY5423; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Medical history included heart disorder and hypertension. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 at single dose for covid-19 immunisation. The patient was an 81-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included heart disorder and hypertension. Concomitant medications and family history were not provided. 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 20Jun2021 at 09:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5423, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jun2021 at around 05:00 (1 day after the vaccination), the patient experienced aortic aneurysm rupture and died. It was not reported if an autopsy was performed. The course of the events was as follows: The patient had heart disorder and hypertension. On 20Jun2021 at 9:30, the patient received BNT162b2. On 21Jun2021 at around 05:00, the patient was found in cardio-respiratory arrest. He was transferred to a hospital and a diagnosis of aortic aneurysm rupture was made. Although a possibility of causal relationship with BNT162b2 was considered to be low, as the patient died on the following day of the vaccination, this case was reported. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Heart disorder and hypertension were considered as possible causes of the event. Patient died on 21Jun2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Aortic aneurysm rupture


VAERS ID: 1435441 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021756611

Write-up: This is a spontaneous report from a contactable physician. On 07Jun2021, a male patient in his 60s received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration at single dose for COVID-19 immunisation. The patient had underlying diseases of hypertension, hyperlipidaemia and diabetes mellitus. On 11Jun2021, when the patient was doing yard work on a garden, he fell down and he was transferred to a hospital by an ambulance. On the same day at 11:44, the patient''s death was confirmed. Outcome of event was fatal.The cause of death was acute myocardial infarction. It was not reported if an autopsy was performed. The causal relationship with BNT162b2 was unknown.; Sender''s Comments: Based on the limited information in the case report and a plausible temporal relationship, A possible causal relationship between event Acute Myocardial Infarction and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1435443 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP040352

Write-up: Subarachnoid haemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) in a 94-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 08-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 SUBARACHNOID HAEMORRHAGE (Subarachnoid haemorrhage) (seriousness criteria death, hospitalization and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Subarachnoid haemorrhage. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. ? No treatment information was provided. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) but details about other factors were not obtained. Action taken with mRNA-1273 in response to the event was not applicable On 09-JUN-2021, in the morning, the patient was urgently admitted to the hospital due to loss of consciousness, and diagnosed with subarachnoid haemorrhage. The patient died at 22:00. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1435507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Body temperature, Cardiac disorder, Cardiorenal syndrome, Heart rate, Pneumonia, Pulse absent, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypertension (narrow), Eosinophilic pneumonia (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: 2021-04-19
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bilateral pneumonia
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic cerebral ischemia; Chronic kidney disease stage 3; Delirium (active); Hypertensive heart disease (with congestive heart failure)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:160-170 mmHg; Comments: increased; Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Comments: decreased; Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 202103; Test Name: pulse; Result Unstructured Data: Test Result:imperceptible; Comments: impaired heart function
CDC Split Type: LTPFIZER INC2021751591

Write-up: 38.5C; 80/50mmHg; pulse was imperceptible; Pneumonia/Bilateral pneumonia; 160-170mmHg; impaired heart function; Cardiorenal failure; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Agency Regulatory Authority-WEB LT-SMCA-4159. A 91-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: asked but unknown), via an unspecified route of administration on 25Mar2021 (at an unspecified age) as dose 2, single for COVID-19 immunisation. Medical history included active delirium, chronic kidney disease stage 3, chronic cerebral ischemia, hypertensive heart disease with congestive heart failure, and underlying disease causes of death: Bilateral pneumonia. Concomitant medicine was not used. In Mar2021, a few days after vaccination the patient experienced blood pressure increased 160-170mmHg, later decreased 80/50mmHg, the pulse was imperceptible, impaired heart function and Ambulance called out. After weekend the temperature began to rise 38.5C, pneumonia started and the patient was hospitalized (the day not specified). The patient spent 10 days in the hospital, was discharged to the nursing hospital where he died on 19Apr2021. The outcome of the events was fatal. The patient died on 19Apr2021. Immediate cause of death was reported as cardiorenal failure. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia/Bilateral pneumonia; Cardiorenal failure; 38.5C; 80/50mmHg; pulse was imperceptible; 160-170mmHg; impaired heart function


VAERS ID: 1435517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dizziness
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. The patient''s past medical history included Dizziness. On 10-May-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 03-Jun-2021 The patient died on 03-Jun-2021. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug was reported. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: 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.


VAERS ID: 1435600 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Malaise, Nausea, Pyrexia, Respiratory failure, Somnolence, Urinary retention, Urinary tract infection, Urosepsis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LACTULOSE; GLICLAZIDE; METFORMIN; METOCLOPRAMIDE; PANTOPRAZOLE; BECLOMETASONE;FORMOTEROL; LEVOTHYROXINE; ACETYLSALICYLIC ACID; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder (cardiovascular history); Dementia; Diabetes mellitus; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021752733

Write-up: possibly urosepsis was (also) present; Patient died 4 days after vaccination: dehydration; Patient died 4 days after vaccination: respiratory failure; Nausea; Fever increase; Drowsiness; general malaise; Urinary tract infection; Urinary retention; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00579394. A 81-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jun2021 (Batch/Lot Number: FD0785) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dementia, diabetes mellitus, cardiovascular disorder, thyroid disorder. Patient previously received the first dose of Comirnaty (0.3 ml) on 07May2021 for covid-19 immunisation and experienced no adverse drug reaction.Concomitant medication(s) included lactulose taken for an unspecified indication, start and stop date were not reported; gliclazide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; metoclopramide taken for an unspecified indication, start and stop date were not reported; pantoprazole taken for an unspecified indication, start and stop date were not reported; beclometasone;formoterol (BECLOMETASONE;FORMOTEROL) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported. It is unclear whether death in this very frail patient with multi-morbidity occurred as a result of vaccination; possibly urosepsis was (also) present. 1 Day after vaccination, the patient suffered from nausea, general malaise, drowsiness and elevation; this revealed considerable urinary retention for which a CAD (Urinary catheter insertion) was placed. Urine strip was abnormal and possibly consistent with a urinary tract infection, but it was decided, in view of the extensive history, not to treat with antibiotics and to focus on comfort. Patient died 4 days after vaccination. The patient experienced urinary tract infection on 08Jun2021 , urinary retention on 08Jun2021 , patient died 4 days after vaccination: dehydration on 12Jun2021 , patient died 4 days after vaccination: respiratory failure on 12Jun2021. The patient died on 12Jun2021. It was not reported if an autopsy was performed.Outcome of all events was fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter''s comments: description of no ADR to 1st dose of Comirnaty, death details, description of adverse events and medical workup; Reported Cause(s) of Death: respiratory failure; dehydration


VAERS ID: 1435604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: NLPFIZER INC2021752010

Write-up: Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00580556. A 68-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Jun2021 (Batch/Lot Number: Unknown) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Past vaccine included COMIRNATY for injection 0,3ml, 1st dose, for covid-19 immunisation. The patient experienced death nos on 12Jun2021 morning. The patient died on 12Jun2021. It was not reported if an autopsy was performed. Health Authority Comment:- Death Additional information: Died the next morning. - Previous COVID-19 infection: No No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1435605 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ENALAPRIL; ATORVASTATIN; QUETIAPINE; ISOPROPANOL;MECETRONIUM ETILSULFATE;PROPANOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021753275

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00581672, Safety Report Unique Identifier NL-LRB-00582831. A 59-year-old male patient received bnt162b2 (COMIRNATY), second dose (lot: unknown) on 08Jun2021 as 0.3 ml single dose for covid 19 immunisation. No Previous COVID-19 infection. Medical history was not reported. Concomitant medications included amlodipine tablet 5mg, atorvastatin tablet 40mg, enalapril tablet 20mg, isopropanol/propanol/ mecetronium Cutaneous solution, quetiapine tablet modified-release 50mg. The patient previously took bnt162b2 (COMIRNATY) vaccine Pfizer solution for injection 0.3ml first dose (batch# unknown) for covid 19 immunisation and experienced no adverse reaction. The patient experienced Death with the latency of 7 days. Reporter couldn''t actually answer any of these questions because reporter didn''t know the patient. Have taken care of the patient as a resuscitator in the emergency room. Reporter would like to refer to the patient''s doctor for more information about the home situation and history/treatment. It was unknown if Autopsy Done. No diagnostic procedures. The outcome of death was fatal. Reporter''s Comments: -COVID19 -Previous COVID-19 infection: No-Other -diagnostic procedures: no-Follow-up-Dear Madam, I can''t actually answer any of these questions because I don''t know the patient. Have taken care of the patient as a resuscitator in the emergency room. I would like to refer to the patient''s doctor for more information about the home situation and history/treatment. If there are any questions please let me know. Kind Regards. No follow-up attempts possible. No further information expected.; Reporter''s Comments: -COVID19 -Previous COVID-19 infection: No-Other -diagnostic procedures: no-Follow-up-Dear Madam, I can''t actually answer any of these questions because I don''t know the patient. Have taken care of the patient as a resuscitator in the emergency room. I would like to refer to the patient''s doctor for more information about the home situation and history/treatment. If there are any questions please let me know. Kind Regards.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1435634 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Bacterial test, Bacterial test positive, Death, Influenza like illness
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEHEPAN [CYANOCOBALAMIN]; OXYNORM; LAXOBERAL; RELTEBON; ZOPICLONE ACTAVIS; VAGIFEM; DIVISUN; NEXIUM [ESOMEPRAZOLE SODIUM]; VENTOLINE [SALBUTAMOL]; IMIGRAN [SUMATRIPTAN]; SAROTEX; MUCOMYST [ACETYLCYSTEINE]; ALVESCO; DERMOVAT [CLOBETASOL PROP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue (disability benefits due to chronic fatigue); Cognitive impairment; Malnutrition; Migraine (disability benefits due to migraine); Mobility decreased (The patient has a stair lift in the home.)
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Bacteria urine; Result Unstructured Data: Test Result:positive
CDC Split Type: NOPFIZER INC2021753294

Write-up: DEATH ; delivered a urine sample that was positive for bacteria 09Jun2021; Flu-like symptoms; Abdominal and back pain; Abdominal and back pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uwzxjy. A 50 years old female patient received the 2nd dose of BNT162B2 (COMIRNATY, Batch/lot number: FC2336), Intramuscular at single dose for COVID-19 immunisation on 04Jun2021. The medical history included malnutrition, cognitive impairment, chronic fatigue, migraine, mobility decreased. Relevant concomitant medication included esomeprazole sodium (NEXIUM), paraffin (PARAFINEMULSJON NAF), sodium picosulfate (LAXOBERAL), colecalciferol (DIVISUN), cyanocobalamin (BEHEPAN), clobetasol propionate (DERMOVAT), estradiol (VAGIFEM), oxycodone hydrochloride (OXYNORM), oxycodone hydrochloride (RELTEBON) depot, zopiclone actavis, amitriptyline hydrochloride (SAROTEX), ciclesonide (ALVESCO), desloratadine (AERIUS), metoclopramide hydrochloride (AFIPRAN), sumatriptan (IMIGRAN), salbutamol (VENTOLINE), terbutaline sulfate (BRICANYL TURBUHALER), and acetylcysteine (MUCOMYST). The patient felt ill after vaccintion; flu-like symptoms with abdominal and back pain. No fever. Did not consult a doctor in the process, but delivered a urine sample that was positive for bacteria on 09Jun2021, and was put on Selexid. The outcome of events flu-like symptoms with abdominal, back pain and positive for bacteria was unknown. On 11Jun2021, the patient died without clear cause of death. Her husband stated that she previously talked about euthanasia. Reporter Comment: Additional information: Got 2nd dose Comirnity 04Jun2021, and since then felt ill; flu-like symptoms with abdominal and back pain. No fever. Did not consult a doctor in the process, but delivered a urine sample that was positive for bacteria 09Jun2021, and was put on Selexid since 10Jun2021. Died 11Jun2021 without clear cause of death. From previously pronounced sick with malnutrition and cognitive impairment; massively investigated/examined without findings of underlying cause. Social security due to chronic fatigue and migraines. Impaired function, has stair lift in the home. Her husband states that she previously talked about euthanasia. The Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Summary: Got 2nd dose Comirnity 04Jun2021, and since then felt ill; flu-like symptoms with abdominal and back pain. No fever. Did not consult a doctor in the process, but delivered a urine sample that was positive for bacteria 09Jun2021, and was put on selexid. Died 11Jun2021 without clear cause of death. From previously pronounced sick with malnutrition and cognitive impairment; massively investigated/examined without findings of underlying cause.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1435656 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
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: NZPFIZER INC2021739396

Write-up: death; This is a spontaneous report from a contactable other health professional . Regulatory authority report number is unknown. This is one death case. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reporting the death of one elderly individual this week. The death is considered medical staff involved to be unrelated to the administration of Comirnaty but was reported through an abundance of caution. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The information provided is too limited for a reasonable medical assessment. There was no information provided regarding the specific cause of death, detailed medical history and counteractive treatment measures. As per company causality guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: death


VAERS ID: 1435670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Decreased activity, Dysarthria, Dyspnoea, Haemorrhagic stroke, Pleuritic pain, Pneumonia, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PAPFIZER INC2021754280

Write-up: Pneumonia; Fever; Dyspnea; Cough; Hypoactivity; Somnolence; Pleuritic Pain; Dysarthria; hemorrhagic ECV; This is a spontaneous report from a non-contactable Other Health Professional, received from the Regulatory authority. The regulatory authority report number is ESAVI-PSE-M-21-513-0513. An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via intramuscular on 26Apr2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included HTA (Arterial Hypertension). The patient''s concomitant medications were not reported. The patient experienced serious pneumonia, serious fever, serious cough, serious dyspnea, serious somnolence, serious hypoactivity, serious pleuritic pain, serious dysarthria, and hemorrhagic ECV (cerebrovascular event) on 05May2021. Events were serious, medically significant. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia; Fever; Dyspnea; Cough; Hypoactivity; Somnolence; Pleuritic Pain; Dysarthria; hemorrhagic ECV


VAERS ID: 1435671 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0438 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoglycaemia, Hypotonia, Presyncope
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: Chronic kidney disease (Peritoneal dialysis); Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PAPFIZER INC2021754281

Write-up: Lipothymia or flaccidity/presyncope; Hypoglycemia; Lipothymia or flaccidity; This is a spontaneous report from a non-contactable other health care professional (HCP). This is a report received from the Regulatory authority, report number ESAVI-PSE-M-21-496-0496 . A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EX0438), intramuscular at the age of 70-year-old on 24Apr2021 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension, chronic kidney disease (Peritoneal dialysis). The patient''s concomitant medications were not reported. The patient experienced lipothymia or flaccidity, hypoglycemia on 24Apr2021. Who Art term presyncope, hypoglycemia. The events were serious for being medical significant and death. The outcome of events was fatal. The patient died on an unspecified date. 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: Lipothymia or flaccidity/presyncope; Hypoglycemia; Lipothymia or flaccidity


VAERS ID: 1435677 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-18
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Haematuria, Hyporesponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021752995

Write-up: Hematuria; non-ST elevation myocardial infarction; sudden deterioration of contact; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-730-2021. The report PL-URPL-3-730-2021 was sent to Office for Registration of Medicinal Products on 19Mar2021. The report concerns an 83-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: ER2659), dose 2 intramuscularly, administered in left arm on 04Mar2021 13:31 (at 83-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hematuria, sudden deterioration of contact, non-ST elevation myocardial infarction, death on 18Mar2021 at 08:45. Adverse reactions marked on the form: Complications: Other. The outcome of the events was fatal. The patient died on 18Mar2021. It was not reported if an autopsy was performed. The reporter assessed the side effects as severe. The Office for Registration of Medicinal Products also classified the report as serious (death). The data contained in the electronic report are all at the disposal of Office for Registration of Medicinal Products in case of obtaining additional information, the next version will be sent. Sender Comment: Haematuria, impaired consciousness and heart attack are unexpected side effects of Comirnaty vaccine There is a time relationship between the administration of the vaccine and the occurrence of complications. Due to the insufficient amount of information, a cause-and-effect relationship cannot be assessed. The reporting person assessed the side effects as severe. The agency for Registration of Medicinal Products also classified the report as serious (death). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: hematuria; non-st elevation myocardial infarction; sudden deterioration of contact


VAERS ID: 1435678 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Hypotonic-hyporesponsive episode, Loss of consciousness, Pulmonary embolism, Pulse abnormal, Syncope
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalisation; Pleural effusion; Tumor
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021753305

Write-up: weak pulse; Hypotonic-hyporesponsive episode; cardiac arrest; Syncope/fainting; Loss of consciousness; pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB PL-URPL-3-732-2021. The notification PL-URPL-3-732-2021 was sent to database on 02Jun2021. The notification concerns a 61 years old male patient received the 2nd dose of BNT162B2 COVID-19 vaccine (COMIRNATY, lot#FD0932), at the age of 61 years old, intramuscular on 02Jun2021 at 12:49 p.m in the left arm for covid-19 immunization. Post-vaccination reaction occurred. According to the information obtained from the reporting doctor on 02Jun2021: about 40 min after vaccination fainting. After 20 minutes cardiac arrest. Patient handed over to ambulance team with weak pulse, transported to the ED of the hospital where he was previously hospitalized in the internal ward for a tumor and pleural effusion. Patient previously hospitalized from 12May2021 to 26May2021 due to tumor, pleural effusion (cancer). On 02Jun2021 vaccinated with 2nd dose of Comirnaty at 12:49 p.m. Patient died at 14:25 p.m. On 04Jun2021, after a telephone consultation with the head of the emergency ward, the following was established: diagnosis pulmonary embolism, not associated with the 2nd dose of vaccination. An autopsy was ordered. The form indicates a hypotonic-hyporeactive episode, which by definition occurs in children under 2 years of age. The submission is for an adult. The episode was marked by the physician probably because on the form there is no possibility to select the corresponding symptoms occurring in adults. In an adult, a hypotonic-hyporeactive episode should not be considered for evaluation. Loss of consciousness was assessed in this case. The loss of consciousness, fainting, cardiac arrest, weak pulse (it is difficult to clearly assess whether the reporter meant a slow heart rate or a faint pulse indicative of low blood pressure) that occurred 40 min after vaccination may be related to an anaphylactic reaction, which is an expected adverse reaction of Comirnaty vaccine. According to information from the doctor of the hospital where the patient was hospitalized (both before and after vaccination), a pulmonary embolism was diagnosed, which according to the doctor''s assessment was not related to the vaccination. There are currently too few data to both confirm and exclude the influence of vaccination on the occurrence of symptoms. The cause and effect relationship is supported by the close temporal relationship between the administration of the vaccine and the occurrence of the complications. Only the association with the occurrence of pulmonary embolism was assessed as unlikely. The reporter assessed the adverse reactions as severe. Classified the report as severe (death). COMIRNATY: Events: ALL: Relatedness of drug to reaction(s)/event Source of assessment: expert; Method of assessment system for standardised case causality assessment; Result of Assessment Unassessable/Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: weak pulse; Hypotonic-hyporesponsive episode; cardiac arrest; Syncope/fainting; Pulmonary embolism; Loss of consciousness


VAERS ID: 1435679 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Cough, Dyspnoea, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: Body temperature; Result Unstructured Data: Test Result:38-38.4 Centigrade; Test Date: 20210306; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: PLPFIZER INC2021753388

Write-up: sudden cardiac arrest; loss of consciousness; dry cough; fever of 38.5 degrees Celsius/highest temperature: 38.0-38.4; shortness of breath/dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB PL-URPL-3-735-2021. A 71-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 05Mar2021 10:27 (Batch/Lot Number: ER2659; Expiration Date: 30Jun2021) as dose 1, 0.3 ml single at the age of 71-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Adverse reaction was reported as 06Mar2021 for 6 days - fever, dyspnoea; 11Mar2021 - dry cough, loss of consciousness, sudden cardiac arrest. On the report form the following was noted: fever (highest temperature: 38.0-38.4, duration of fever: longer - no further information provided). On 11Mar2021 the dyspnoea disappeared but a dry cough appeared and the patient went to the outpatient clinic where she started to lose consciousness as soon as she entered and then she had a sudden cardiac arrest. Despite 25 minutes of resuscitation (until the arrival of the ambulance), neither circulation nor breathing could be restored, and death was pronounced. On the day after vaccination, a fever of 38.5 degrees with shortness of breath appeared, the symptoms lasted 6 days, on 11Mar2021 the shortness of breath disappeared but she developed a dry, exhausting cough, then the patient went to the outpatient clinic, where she suffered a sudden cardiac arrest and despite resuscitation died. No post-vaccinal reaction in the patient''s history. The person making the report classified it as severe. Regulatory Authority classified the report as "severe" due to the reporter''s assessment, the nature of the adverse reaction and the patient''s death. Health outcome: death (cause: sudden cardiac arrest, date: 11Mar2021). The data contained in the electronic report are all those available to Regulatory Authority - a further version will be sent if additional information is obtained. Comirnaty is a mRNA vaccine against COVID-19 (with modified nucleosides). Fever is an expected side effect after administration of Comirnaty. The other side effects are unexpected. As of 08Jun2021 in the Regulatory Authority database, 5044 cases of dyspnoea, 2789 cases of cough and 246 cases of cardiac arrest have been reported Regulatory Authority does not have information on possible additional circumstances (drugs used, chronic diseases, allergies, etc.) that could have resulted in the described side effects. The temporal relationship argues for a cause and effect relationship. The reporting person classified the report as serious. Regulatory Authority classified the report as "severe" due to the reporter''s assessment, the nature of the adverse reactions and the death of the patient. The outcome of event shortness of breath/dyspnoea was recovered with sequelae. The outcome of event loss of consciousness, dry cough, fever of 38.5 degrees celsius/highest temperature: 38.0-38.4 was unknown. Death cause reported as sudden cardiac arrest. The patient died on 11Mar2021. It was not reported if an autopsy was performed. Cardiac arrest, Dry Cough, Resuscitation, Dyspnoea: Relatedness of drug to reaction(s)/event(s) Source of assessment: Regulatory Authority expert; Method of assessment: WHO system for standardised case causality assessment; Result of Assessment Possible Fever: Relatedness of drug to reaction(s)/event(s) Source of assessment: Regulatory Authority expert; Method of assessment: WHO system for standardised case causality assessment; Result of Assessment Probable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden cardiac arrest


VAERS ID: 1435748 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Benign prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: MASSIV CENTRAL LUNGEMBOLI; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (MASSIV CENTRAL LUNGEMBOLI) in a 76-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Benign prostatic hyperplasia since an unknown date. In May 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (MASSIV CENTRAL LUNGEMBOLI) (seriousness criteria death and medically significant). An autopsy was performed. The autopsy-determined cause of death was Pulmonary embolism. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This is a case of fatal outcome with event of pulmonary embolism Cause of death was assessed as due to pulmonary embolism. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of fatal outcome with event of pulmonary embolism Cause of death was assessed as due to pulmonary embolism. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1435769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021751595

Write-up: Found dead; This is a spontaneous report from a contactable physician downloaded from the WEB regulatory authority number SI-JAZMP-NCPHV-2021SI0697_0697. A 95-year-old female patient received BNT162B2 (COMIRNATY, concentrate for dispersion for injection, COVID-19 mRNA vaccine, nucleoside modified - Tozinameran) dose 2 intramuscular on 31Mar2021 (Lot Number: EW2239; Expiration Date: 31Jul2021) as dose 2, single for Covid-19 prophylactic vaccination. The patient medical history and concomitant medications were not reported. On 07Apr2021, the patient was found death. The outcome of event was fatal. The patient died on 07Apr2021. It was not reported if an autopsy was performed. This case report was assessed as medically significant. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: found death


VAERS ID: 1435771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Edema knees (had knee hydrops and was taking NSAIDs.); Myocarditis (20 years ago); Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021751598

Write-up: Stroke; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number SI-JAZMP-NCPHV-2021SI0703_0703, Safety Report Unique Identifier JAZMP-300013006. A 52-year-old male patient received first dose BNT162B2 (COMIRNATY, lot number FC8736, Expiration Date 30SEP2021), intramuscular on 28May2021 at single dose for COVID-19 immunisation. The medical history included psoriasis, myocarditis(20 years ago), had knee hydrops and was taking NSAIDs. The concomitant medications were not reported. On 02Jun2021, the patient experienced a stroke and died on 02Jun2021. The event was assessed as Medically Significant also. The patient died on 02Jun2021. It''s unknown if an autopsy was performed. The cause of death was Stroke. The outcome of the event was Fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1435776 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
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: TRPFIZER INC2021729231

Write-up: died 1 week after the vaccination; This is a spontaneous report based on information received by Pfizer from LLP Biontech SE [manufacturer control number 65670], license party for BNT162B2. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized in the intensive care unit and died 1 week after the vaccination on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested; Reported Cause(s) of Death: died 1 week after the vaccination


VAERS ID: 1436908 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-06
Submitted: 0000-00-00
Entered: 2021-06-30
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: 2021-06-06
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUJNJFOC20210661063

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority HU-OGYI-457021 concerned a 34 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, intramuscular, batch number: XD986 expiry: UNKNOWN) .5 ml, 1 total administered on 05-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 06-JUN-2021, the patient experienced death from an unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210661063-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: 1437081 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Brain herniation, Brain oedema, C-reactive protein, Cardiac arrest, Circulatory collapse, Computerised tomogram head, Dizziness, Headache, Hypertensive crisis, Lymphangioma, SARS-CoV-2 test, Subarachnoid haemorrhage, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), 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), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: TREMFYA
Current Illness: Hypertension arterial; Psoriasis vulgaris
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: RR; Result Unstructured Data: Test Result:200 mmHg; Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:33.4 Centigrade; Test Date: 20210614; Test Name: CT; Result Unstructured Data: Test Result:extensive subarachnoid haemorrhage; Test Date: 20210614; Test Name: CRP; Result Unstructured Data: Test Result:2.9 mg/l; Test Date: 20210614; Test Name: COVID-PCR nasopharyngeal; Test Result: Negative ; Test Date: 20210614; Test Name: Leukos; Result Unstructured Data: Test Result:23.4 g/l
CDC Split Type: ATPFIZER INC2021759207

Write-up: with diffuse cerebral oedema and incipient entrapment; incipient entrapment/brain stem entrapment; in CT extensive subarachnoid haemorrhage; Cardiac cresil arrest with prohasic resuscitation; unobserved syncope; circulatory arrest; Hypertensive crisis (RR around 200mmHg); Headache; Dizziness; Kaposiform lymphangiomatosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-32324. A 50-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EY7015) at single dose on 10Jun2021 at 50-year-old intramuscular for COVID-19 immunisation. Underlying diseases included ongoing psoriasis vulgaris and hypertension arterial with no regular oral therapy, both ongoing. Concomitate drug included guselkumab (TREMFYA Injection, reported as "13.4., 8.6."). Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) on 06May2021 for COVID-19 immunisation and no adverse reaction. On 10Jun2021 the patient experienced dizziness, headache, and hypertensive crisis (RR around 200mmHg); the events were serious with hospitalization. On 14Jun2021 the patient experienced brain stem entrapment, cardiac arrest death, hospitalization, in CT extensive subarachnoid haemorrhage, cardiac cresil arrest with prohasic resuscitation; the events were serious with hospitalization and death. The clinical course was reported as follows: On 10Jun2021 afternoon, patient experienced dizziness, headache, AD first aid provided. Patient also experienced adverse event of Kaposiform lymphangiomatosis (KLA): hypertensive crisis (blood pressure around 200mmHg). On 11Jun2021, ramipril 2,5mg 1-0-0 was prescribed (initial treatment in hospital) regarding signs of an infection: none clearly present. On 14Jun2021 noon, patient experienced unobserved syncope with circulatory arrest. Patient died on 14Jun2021 with cause of death of subarachnoid hemorrhage, cerebral edema with brain stem entrapment; autopsy was ordered. Lab data included CRP 2.9mg/l, leukocytes 23.4 G/l, body temperature 33.4?C. COVID-PCR nasopharyngeal negative. Outcome of cardiac arrest, subarachnoid bleeding, brain oedema, brain stem herniation was fatal. Outcome of lightheadedness, headache, hypertensive crisis was not resolved. Outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: with diffuse cerebral oedema and incipient entrapment; in CT extensive subarachnoid haemorrhage; incipient entrapment/brain stem entrapment; Cardiac cresil arrest with prohasic resuscitation


VAERS ID: 1437096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-31
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Dyspnoea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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: AUPFIZER INC2021710403

Write-up: Confusional state; Dyspnoea; Pain in extremity; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 566295. A 91-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), the second dose via unspecified route of administration on an unspecified date (reported as Suspect (6 days)) at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date (reported as Suspect (27 days)) for COVID-19 immunisation. On 31May2021, the patient experienced confusional state, dyspnoea and pain in extremity. The patient died on an unspecified date. It was unknown 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: Confusional state; Dyspnoea; Pain in extremity


VAERS ID: 1437156 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-26
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonia, Thrombosis
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), 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: 2021-06-22
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021766809

Write-up: he developed covid-19 after taking the Pfizer vaccine; he developed covid-19 after taking the Pfizer vaccine; thrombosis; pneumonia; This is a spontaneous report from a contactable other health care professional (unknown relationship with patient) received through Agency. A 66-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at age of 66 years old) as single dose for COVID-19 immunisation. Medical history included: diabetes. The patient''s concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient developed COVID-19 on 26May2021 after taking the Pfizer vaccine (date not informed). The patient was admitted to the ICU on 26May2021 but was not intubated. After 10 days he was recovered but he remained in the ICU because he had thrombosis and then he had pneumonia caused by a hospital bacterium. He was intubated, needed hemodialysis and died on 22Jun21. Cause of death was pneumonia. Treatment received for the adverse event (Anticoagulant, antibiotics). Physician office visit for all events. The patient died on 22Jun2021. An autopsy was not performed. The outcome of the events developed COVID-19 was recovered on 05Jun2021, thrombosis was unknown. information on the lot/batch number has been requested.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported events cannot be totally Additional information including date of vaccination, events onset dates, concomitant medications and their indications, concurrent medical conditions, complete medical history, diagnostic test results, is needed to better assess this report. 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: 1438116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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? 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: DEPFIZER INC2021759342

Write-up: fever 40 degree; This is a spontaneous report based on information received by Pfizer from Company [manufacturer reference number: 67285], license party for COMIRNATY. A non-contactable physician reported a 79-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) as single dose for COVID-19 immunisation. "Physician reported on a female patient (79 years old) who had to be admitted to hospital three days after the second vaccination with fever of 40 degrees, and then died there." The patient died on an unspecified date. Physician office for the event. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer drug 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: fever 40 degree


VAERS ID: 1438117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021760175

Write-up: Exertional dyspnea; This is a spontaneous report based on information received by Pfizer from company [manufacturer reference number: 67277], license party for COMIRNATY. A non-contactable physician reported a 74-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. "Physician reported on a male patient (74 years old) from a vaccination center who developed exertional dyspnea after 4-5 days. A week later he died suddenly." The patient died on an unspecified date. It was unknown if an autopsy was performed. 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 provided is very limited and does not allow for a complete medical assessment. Additional information including concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, autopsy report (if done) is needed to better assess this report. 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: Exertional dyspnea


VAERS ID: 1438144 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood gases, Blood test, Cardiac arrest, Cardiogenic shock, Chest pain, Echocardiogram, Troponin I
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder (Patient went to his own general practitioner about a heart related problem, not vaccine related)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:showed lactic acidosis and hypoxia; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Echocardiography; Result Unstructured Data: Test Result:showed decreased left ventricular function 30-40%,; Comments: showed decreased left ventricular function 30-40%, cardiac failure; Test Date: 2021; Test Name: Troponin I; Result Unstructured Data: Test Result:125000; Comments: normal value under 10
CDC Split Type: DKPFIZER INC2021759279

Write-up: Inferior STEMI with biventricular heart failure; Severe chest pain; cardiac arrest; Cardiogenic shock; This is a spontaneous report from contactable physicians downloaded from the Regulatory Authority-WEB regulatory authority number DK-DKMA-WBS-0070725. A 66-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 27May2021 (Batch/Lot Number: Unknown) as dose 2, single at the age of 66-year-old for covid-19 immunisation. Patient received the first dose on an unknown date for covid-19 immunisation and no side effects was reported after first dose of the vaccination with bnt162b2. Patient medical concurrent conditions included diabetes, hypertension and overweight, all ongoing. Medical history included cardiac disorder (Patient went to his own general practitioner about a heart related problem, not vaccine related). The patient''s concomitant medications were not reported. The physicians described the occurrence of chest pain (Severe chest pain) and STEMI (Inferior STEMI with biventricular heart failure) in this patient, vaccinated with bnt162b2. On the same day as the 2nd dose (27May2021), the patient developed chest pain and STEMI. The events were by the reporter reported as being life threatening and fatal. After the diagnosis with STEMI, the patient received thrombolysis, and developed cardiac arrest (in 2021), but is rescuciated. Reported cause of death was STEMI (STEMI with biventricular heart failure) and cardiogenic shock. Only normal confirmation of death was performed. Test results includes: Troponin I in 2021: TNI 125000, normal value under 10. Echocardiography in 2021: showed decreased left ventricular function 30-40%, cardiac failure. Arterial blood gases in 2021: showed lactic acidosis and hypoxia. Blood test in 2021: results not reported. The cardiac arrest was recovered, and chest pain was not recovered. The STEMI and cardiogenic shock was fatal on 05Jun2021. The patient died on 05Jun2021. An autopsy was not performed. Causality initial reporter: The initial reporter commented, that the patient was a "typical STEMI-patient" and was in risk of heart complications due to hypertension, diabetes and overweight. The initial reporter commented that no side effects was reported after first dose of the vaccination with bnt162b2. The patient had been in contact with his own physician regarding heart-related problems which have not been suspected in relation to the vaccine. Causality 2nd physician: Another physician stated, that the death was due to a major myocardial infarction with cardiogenic shock. The death has not been reported to the Police, since there is no suspicion of a relation to the vaccine. No follow-up attempts are possible; batch/lot numbers cannot be obtained.; Reported Cause(s) of Death: STEMI; Cardiogenic shock


VAERS ID: 1438337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-08
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Auricular fibrillation; Chronic renal failure; Diabetes mellitus insulin-dependent; Hypercholesterolaemia; Ischaemic heart disease; Sarcoidosis
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Notion of positive COVID antigenic test on 02/04/2021); Thrombosis venous deep
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20210661070

Write-up: CARDIO-RESPIRATORY ARREST; This spontaneous report received from a physician via a Regulatory Authority [FR-AFSSAPS-2021071748] concerned a 62 year old male. The patient''s weight was 101 kilograms, and height was 180 centimeters. The patient''s past medical history included covid-19, and thrombosis venous deep, and concurrent conditions included hypercholesterolaemia, ischaemic heart disease, chronic renal failure, arterial hypertension, diabetes mellitus insulin-dependent, auricular fibrillation, and sarcoidosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 210 10-02 and expiry: unknown) 0.5 ml, 1 total administered on 28-MAY-2021 for covid-19 vaccination. Drug start period 12 (days) and drug last period 12 (days). No concomitant medications were reported. On 02-APR-2021, Laboratory data included: SARS-CoV-2 test and result was positive. On 08-JUN-2021, patient had cardio-respiratory arrest and died from cardio-respiratory arrest. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of cardio-respiratory arrest on 08-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210661070-COVID-19 VACCINE AD26.COV2.S. Cardio-respiratory arrest. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: CARDIO-RESPIRATORY ARREST


VAERS ID: 1438354 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-27
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2425 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Echocardiogram, Ejection fraction, Electrocardiogram, Glomerular filtration rate, Glycosylated haemoglobin, Physical examination
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: ALLOPURINOL; KARDEGIC; COVERAM; LASILIX [FUROSEMIDE]; KAYEXALATE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic renal failure; Diabetes; Gout; Peripheral arterial occlusive disease; Unspecified hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:Left Ventricule not dilated,; Comments: Left Ventricule not dilated, not hypertrophic, LVEF 55%, aortic valve thickened without stenosis, aortic root not dilated; Test Name: LVEF; Test Result: 55 %; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm; Comments: sinus rhythm, without conduction or repolarization disorders; Test Date: 202012; Test Name: GFR; Result Unstructured Data: Test Result:40 ml/min; Test Date: 202012; Test Name: glycosylated hemoglobin; Test Result: 7 %; Test Date: 202012; Test Name: clinical examination; Result Unstructured Data: Test Result:dyspnea for moderate efforts; Comments: dyspnea for moderate efforts, absence of signs of heart failure, systolic ejection murmur, objectivation of a hanging ulcer of the right leg
CDC Split Type: FRPFIZER INC2021759239

Write-up: death; chest pain; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BX20215793, Safety Report Unique Identifier FR-AFSSAPS-2021077291. An 87-year-old female patient received bnt162b2 (COMIRNATY), the second dose via intramuscular on 14Apr2021 (lot number: EX2425) as single dose for COVID-19 immunisation. The relevant medical history included gout, diabetes, chronic renal failure, unspecified hypertensive heart disease, arterial hypertension, peripheral arterial occlusive disease. Concomitant medications included allopurinol; acetylsalicylate lysine (KARDEGIC); amlodipine besilate, perindopril arginine (COVERAM); furosemide (LASILIX); sodium polystyrene sulfonate (KAYEXALATE); metformin. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot number: EP9605) on 17Mar2021 for COVID-19 immunisation. Possible cardiovascular death at Day 71 (D71, as reported) of the 2nd dose of Comirnaty vaccine, after exercise, in a patient with a multiple history of cardiovascular risk. No information on history COVID. No information regarding the occurrence of adverse events post-vaccination. Last cardiological check-up in Dec2020 (5 months before) with clinical examination dyspnea for moderate efforts, absence of signs of heart failure, systolic ejection murmur, objectivation of a hanging ulcer of the right leg, GFR 40 ml/min, glycosylated Hb 7%. ECG on an unspecified date showed sinus rhythm, without conduction or repolarization disorders. Trans thoriacic echocardiography (TTE) on an unspecified date showed: LV not dilated, not hypertrophic, LVEF 55%, aortic valve thickened without stenosis, aortic root not dilated. On 27May2021, adverse event at Day 71 (D71, as reported) of the 2nd dose of the vaccine, during a physiotherapy session, chest pain, continuation of the session for 30-45 minutes. Death observed approximately two hours later. Cause of death not specified by the declarant. The patient died on 27May2021. It was unknown if an autopsy was performed. The outcome of the event death was fatal, for event chest pain was unknown.; Reported Cause(s) of Death: death


VAERS ID: 1438355 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardio-respiratory arrest, Cardiovascular function test, Electrocardiogram, Heart rate
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: 2021-05-12
   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: Crohn''s disease (Under Pentasa until 2004.); Dyslipidemia (Under Pravastatin 20 mg / day.); Dyslipidemia; Factor V deficiency; Hypertension; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 201810; Test Name: Blood pressure; Result Unstructured Data: Test Result:125/60 mmHg; Test Date: 201901; Test Name: Biological assessment; Result Unstructured Data: Test Result:normal; Test Date: 201810; Test Name: Cardiological examination; Result Unstructured Data: Test Result:regular heart sounds, normal auscultation; Comments: symmetrical pulses; Test Date: 201810; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm, repolarization normal; Test Date: 201810; Test Name: Heart rate; Result Unstructured Data: Test Result:56
CDC Split Type: FRPFIZER INC2021759205

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-CN20211990. Safety Report Unique Identifier: FR-AFSSAPS-2021076098. A 70-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 10May2021 (Batch/Lot Number: J07BX03) as dose 2, single for COVID-19 immunisation. Medical history dyslipidemia under pravastatin 20 mg / day, crohn''s disease (under mesalazine (PENTASA) until 2004), Minor congenital factor V deficiency. Family history: hypertension, stroke, dyslipidemia. History of COVID-19: unknown. PCR test history: unknown. Allergic history: no. Patient had normal biological assessment in Jan2019. Cardiological examination Oct2018: regular heart sounds, normal auscultation, symmetrical pulses, blood pressure 125/60. ECG: sinus rhythm, rate 56, repolarization normal. Overall, asymptomatic, no significant abnormality. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation and experienced pain in the chest and in the arm. The patient''s concomitant medications were not reported. The patient presented 3 weeks after his 1st vaccination with pain in the chest and in the arm, but which quickly passed. No medical consultation during this spontaneously resolved episode. On 10May2021 the patient receives his 2nd dose, no particular symptom during the course of the vaccination. Around 12:30 p.m. on 12May2021, he was found by his wife in cardio respiratory arrest on the ground. External cardiac massage. Call of the emergency medical services, Death. Treatment was received for the event. The patient died on 12May2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021769611 same patient, different dose and events; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1438645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-09
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 4
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: Test Date: 20210610; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021736593

Write-up: Pulmonary embolism; laboured breathing; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106151020223600-AFJV8, Safety Report Unique Identifier GB-MHRA-ADR 25476229. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15May2021 (Batch/lot number: Not known, Expiration Date: not reported), as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. On 09Jun2021, the patient experienced laboured breathing and pulmonary embolism. On the same day, 09Jun2021, doctor was called for laboured breathing. On 10Jun2021, COVID test was administered. On 12Jun2021, the doctor called and informed no obvious cause. An ambulance was called and patient was transported to (hospital name). On 13Jun2021, blood clots were identified in the lungs, confirmed by doctor on phone at 7 PM. Patient passed away between 9-9:30 PM (these dates were approximate, medical records to be checked for exact record). Suspected COVID-19 from 09Jun2021 to 13Jun2021 was also reported. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 10Jun2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event laboured breathing was not recovered. The patient died on 13Jun2021. Cause of death was reported as pulmonary embolism. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1438697 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain herniation, Cerebrovascular accident, Computerised tomogram head, Decerebrate posture, Dysarthria, Haemorrhage intracranial, Headache, Inappropriate schedule of product administration, Loss of consciousness, Muscular weakness, Pupil fixed, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Migraine; Obesity; Osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Head CT; Result Unstructured Data: Test Result:showed large intracranial haemorrhage; Test Date: 20210430; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021736141

Write-up: Haemorrhage/Intracranial haemorrhage; unconscious/collapsed; Stroke; Pupil fixed; extensor posturing; signs of coning; headache; left arm weaknes; slurred speech; BNT162B2 Dose 1 10Feb2021, Dose 2 28Apr2021; This is a spontaneous report from a contactable healthcare professional received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106151557548570-FFMIO. Safety Report Unique Identifier: GB-MHRA-ADR 25478162. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and on 28Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE; both via an unspecified route of administration (at the age of 71 years) for covid-19 immunisation. Medical history included osteoarthritis, hypertension, obesity and migraine. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included bendrofluazide taken for hypertension. On 30Apr2021, the patient presented headache, left arm weakness, slurred speech, and reduced conscious level. Found collapsed at home by husband, unconscious requiring paramedic attendance and insertion and tolerance of Guedel airway. Arrived in accident and emergency (A&E), intubated and ventilated to secure airway and facilitate a head computerised tomogram (CT) scan which showed large intracranial haemorrhage. This was discussed with neurosurgery team who did not feel surgical intervention was appropriate and advised conservative management with stroke input into her ongoing care. Team and family aware of likely poor prognosis, sedation hold the following day revealed clinical signs of coning, pupils fixed and dilated, extensor posturing. Direction of care then changed to end of life comfort care. The patient died due to intracranial haemorrhage. The events unconscious/collapsed, stroke, pupil fixed, extensor posturing and signs of coning were assessed as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 30Apr2021. The patient died on 01May2021. It was not reported if an autopsy was performed. The outcome of the event intracranial haemorrhage was fatal, the events headache, unconscious/collapsed, slurred speech and stroke was not recovered, while unknown for the rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Intracranial haemorrhage


VAERS ID: 1438764 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-03-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arteriosclerosis coronary artery, Left ventricular hypertrophy, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 66
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: Heart attack; Pulmonary embolism; Comments: Not on any medication Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021737996

Write-up: Coronary atheroma; Left Ventricular Hypertrophy; Angina pectoris; Myocardial infarction; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106171057392130-8B0JT, Safety Report Unique Identifier GB-MHRA-ADR 25490506. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided) via an unspecified route of administration at single dose on 20Feb2021 for COVID-19 immunisation. The patient''s medical history included pulmonary embolism and heart attack. There were no concomitant medications. Not on any medication. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced myocardial infarction and angina pectoris on 01Mar2021. It was reported that patient was hospitalized after suspected heart attack or pulmonary embolism on 01Mar2021 with diagnosis of angina. The patient died on 07May2021. Report indicated that patient died from myocardial infarction and coronary atheroma and left ventricular hypertrophy. Relevant investigations or tests conducted: Coroner''s post mortem. Autopsy was done. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism; Coronary atheroma; Left ventricular hypertrophy; Myocardial infarction


VAERS ID: 1438770 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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: GBPFIZER INC2021736062

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202106171957460990-1OQE9, Safety Report Unique Identifier: GB-MHRA-ADR 25494927. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 13May2021 (lot number and expiry date were not reported) as first dose, single for COVID-19 immunisation. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient medical history and concomitant medications were not reported. The patient experienced death on 17May2021. The patient died on 17May2021 (stop date also reported as 10Jun2021). An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1438780 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Organ failure
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), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021747246

Write-up: found the next day with his chin on his chest unresponsive; Organ failure; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202106201400050830-3OWZD], Safety Report Unique Identifier [GB-MHRA-ADR 25505955]. A patient of unspecified age and gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 22May2021 (Lot/batch number and expiry date not reported) at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced organ failure on 23May2021 and was assessed as serious-fatal. The patient died on an unspecified date. An autopsy was not performed. The outcome of the event ''found the next day with his chin on his chest unresponsive'' was unknown. The clinical course was reported as follows: was a healthy man. He had the second dose of his vaccine on 22May2021. He was found the next day with his chin on his chest unresponsive. GP was taken to hospital and died within one week. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about batch/Lot Number cannot be obtained.; Reported Cause(s) of Death: Organ failure


VAERS ID: 1438809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Cardiac arrest, Chills, Coma, Decreased appetite, Hypersomnia, Pain, Pneumonia, SARS-CoV-2 test, Sepsis, Somnolence, Thirst, X-ray
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), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart rate abnormal; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: bloodstream; Result Unstructured Data: Test Result:Bacteria staphylococcus found; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210526; Test Name: x-rays; Result Unstructured Data: Test Result:no causes found
CDC Split Type: GBPFIZER INC2021747242

Write-up: pneumonia; little brain activity lapsed into a coma; Heart stopped; drowsiness; Sepsis; extended sleeping period; rigor; pain in upper body; Loss of appetite; raging thirst; Loss of bodily strength unable to sit up or stand/problems with movement sitting up and standing; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106202125561590-QM3SC. A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 13May2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included pneumonia and heart rate abnormal. Nothing for immune response. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included bisoprolol taken for heart rate abnormal from an unspecified start date to 05Jun2021. The patient previously took the first dose of bnt162b2 for COVID-19 immunisation. On 19May2021, the patient experienced drowsiness, pneumonia, sepsis, extended sleeping period, rigor, pain in upper body, loss of appetite, raging thirst, loss of bodily strength unable to sit up or stand/problems with movement sitting up and standing. On 01Jun2021, the patient experienced heart stopped and little brain activity lapsed into a coma. The patient was hospitalized for pneumonia from 29May2021. The patient underwent lab tests and procedures which included blood test where bacteria staphylococcus found on 29May2021, COVID-19 virus test was no - negative COVID-19 test on an unspecified date, and x-ray with no causes found on 26May2021. Therapeutic measures were taken as a result of little brain activity lapsed into a coma and included life support and heart stopped and included resuscitation. The patient died on 05Jun2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Six days after 2nd vaccine, Drowsiness followed by extended sleeping period, rigor, pain in upper body, Loss of appetite, raging thirst, Loss of bodily strength unable to sit up or stand. Checked over in hospital with x-rays no causes found sent home 26May. Continued problems with movement sitting up and standing. Readmitted to hospital 29May suspected pneumonia. Bacteria found in bloodstream staphylococcus. 01Jun Transferred to different hospital. No proper contact with hospital. Didn''t know where he was. Mobile unanswered. Found in ICU. Heart stopped had to be resuscitated little brain activity lapsed into a coma. No contact with hospital for 3 days. Finally life support turned off on 05Jun. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: extended sleeping period; rigor; pain in upper body; drowsiness; pneumonia; sepsis; loss of appetite; raging thirst; Loss of bodily strength unable to sit up or stand/problems with movement sitting up and standing; Heart stopped; little brain activit


VAERS ID: 1438812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8713 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: DOXYCYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathlessness; Cardiac arrest; Difficulty in walking; Infection; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021774163

Write-up: Suspected PE; Cardiac arrest; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106211423555160-V8QDO.Safety Report Unique Identifier GB-MHRA-ADR 25511423. A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8713), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunisation. Medical history included cardiac arrest, suspected COVID-19 on 12Feb2021 (Unsure when symptoms stopped), infection, breathless on minimal exertion, and struggled to walk. Concomitant medication included doxycycline for infection from 18Feb2021. However it was also reported that patient was not on any regular medication. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced cardiac arrest on 20Feb2021. It was reported that patient had covid vaccine and same day called for phone consultation with GP. GP suspected covid as patient was breathless on minimal exertion. Said she struggled to walk to and from the car when she went to vaccination centre. Was given doxycycline. Then suffered cardiac arrest 20Feb2021 with suspected PE in report. However, it was also mentioned that report does not relate to possible blood clots or low platelet counts. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 20Feb2021. 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: Cardiac arrest; Suspected PE


VAERS ID: 1438817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 23
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; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lung cancer; Comments: Lung cancer burn not terminal Copd not a time end stages Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021765844

Write-up: Heart failure; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106221139205460-MRWLY, Safety Report Unique Identifier GB-MHRA-ADR 25519724. A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration as dose 2 single on 14Apr2021 for COVID-19 immunization. Medical history included Lung cancer burn not terminal, COPD not a time end stages and immunodeficiency (has an illness or condition, not listed above, which reduces the immune response. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced heart failure (death) on 15Apr2021. The eve It was reported that there was swelling from the ankles taking days to move up the legs (given antibiotics from gp) swelling to the thighs, abdomen and onto the breasts. Ambulance called and admitted to hospital and told of heart failure then sent home to die. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 08May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1438820 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive
CDC Split Type: GBPFIZER INC2021765691

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106221314357980-3SZLS. Safety Report Unique Identifier is GB-MHRA-ADR 25520448. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single for COVID-19 immunisation. Medical history included ongoing suspected COVID-19 (unsure when symptoms started). Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The consumer reported patient''s death on an unspecified date. The cause of death was unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1438833 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021783939

Write-up: Brain death/Brain Shutdown; This is a spontaneous report from a contactable Other Health Professional. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106250156576420-JRDL7, Safety Report Unique Identifier GB-MHRA-ADR 25539854. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 17May2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced brain death (brain shutdown) on 22May2021. The patient underwent laboratory test which included Sars-cov-2 test: No negative covid-19 test on unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Brain death


VAERS ID: 1438934 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
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: GBPFIZER INC2021770927

Write-up: died from your covid vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. The consumer reported similar events for three patients, this is the first of 3 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died from Pfizer COVID vaccine. The cause of death was not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021770937 same reporter/drug/event, different patient.;GB-PFIZER INC-2021770938 same reporter/drug/event, different patient.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1438935 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
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: GBPFIZER INC2021770938

Write-up: died from your covid vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. The consumer reported similar events for three patients, this is the third of 3 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died from Pfizer COVID vaccine. The cause of death was not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021770927 same reporter/drug/event, different patient;GB-PFIZER INC-2021770937 same reporter/drug/event, different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1438978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), 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: 2021-01-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Dementia with Lewy bodies; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: IEPFIZER INC2021758651

Write-up: broncho-pneumonia; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-073779. An 83-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 17Jan2021 (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. Medical history included hypertension, aortic stenosis, dementia with lewy bodies from Mar2020. The patient''s concomitant medications were not reported. On 19Jan2021, the patient experienced covid-19. On an unspecified date, the patient experienced broncho-pneumonia. The physician informed that the patient experienced COVID-19 and pneumonia following vaccination with Comirnaty for COVID-19 immunization. On 17Jan2021, the patient was vaccinated with Comirnaty and two days later (19Jan2021), the patient experienced bronchopneumonia and tested positive for COVID-19. The patient died due to the events on 23Jan2021 (also reported as seven days after vaccine). It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about batch no cannot be obtained.; Reported Cause(s) of Death: broncho-pneumonia; COVID-19


VAERS ID: 1438983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210647468

Write-up: SUSPICIOUS DEATH; This spontaneous report received via company representative (via social media) concerned a 48-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 not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, 1 total administered 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 an unspecified date, few days after vaccination, the patient had a suspicious death. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210647468-Covid 19 vaccine ad26.cov2.s- Suspicious 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: 1439026 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Cardiac failure, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; COSYREL; NEXIUM; FLEIDERINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma gastrointestinal; Hypertension arterial; Partial nephrectomy; Previous renal neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS, BEDRIDDEN, CARDIAC FAILURE and PARAESTHESIA in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The patient''s past medical history included Carcinoma gastrointestinal, Previous renal neoplasm, Hypertension arterial and Partial nephrectomy. Concomitant products included EDOXABAN TOSILATE (LIXIANA), BISOPROLOL FUMARATE, PERINDOPRIL ARGININE (COSYREL), NEXIUM and FLECAINIDE ACETATE (FLEIDERINA) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MUSCULAR WEAKNESS (seriousness criterion death), BEDRIDDEN (seriousness criterion death), CARDIAC FAILURE(seriousness criteria death and medically significant) and PARAESTHESIA (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was Paraesthesia hand, Decompensation cardiac, Bedridden and Hands weakness of. It is unknown if an autopsy was performed. No treatment medication was not reported. This is a case of death in a 67-year-old male subject with a history of Gastrointestinal Carcinoma, Renal neoplasia, Arterial Hypertension and Partial nephrectomy who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 67-year-old male subject with a history of Gastrointestinal Carcinoma, Renal neoplasia, Arterial Hypertension and Partial nephrectomy who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Paraesthesia hand; Decompensation cardiac; Bedridden; Hands weakness of


VAERS ID: 1439035 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral ischaemia, Platelet count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonitis
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: Unknown
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PERIPHERAL ISCHAEMIA in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Pneumonitis. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL ISCHAEMIA (seriousness criterion death). The patient died on 05-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Platelet count: unknown (Inconclusive) Unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information received and does not contain any new information.; Sender''s Comments: 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: Unknown cause of death


VAERS ID: 1439044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / 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: PANTOPRAZOLE; RIOPAN [MAGALDRATE]; LUXAZONE; KESTINE; RAMIPRIL; BRUFEN; GENTALYN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Gastritis; Hypertension; Osteoarthritis; Osteoarthrosis; Peptic ulcer; Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021759332

Write-up: UNEXPECTED DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-745386. A 57-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 02Jun2021 12:47 (Lot Number: FC1131; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing , psoriasis from an unknown date and unknown if ongoing , allergy from an unknown date and unknown if ongoing , osteoarthritis from an unknown date and unknown if ongoing, peptic ulcer from 01Dec2020 to 01Jan2021; gastritis, osteoarthritis. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; magaldrate (RIOPAN [MAGALDRATE]) taken for gastritis, start and stop date were not reported; dexamethasone (LUXAZONE) taken for allergy, start and stop date were not reported; ebastine (KESTINE) taken for allergy, start and stop date were not reported; ramipril (RAMIPRIL) taken for hypertension, start and stop date were not reported; ibuprofen (BRUFEN) taken for osteoarthritis, start and stop date were not reported; gentamicin sulfate (GENTALYN) taken for psoriasis, start and stop date were not reported. The patient experienced unexpected death (sudden death) on 16Jun2021. The patient died on 16Jun2021. It was not reported if an autopsy was performed. Reporter comment: Possible use of narcotic substances. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Possible use of drugs.; Reported Cause(s) of Death: UNEXPECTED DEATH


VAERS ID: 1439047 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chronic obstructive pulmonary disease, Incorrect route of product administration, Infection, Investigation, Respiratory fatigue
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), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC2021759368

Write-up: chronic obstructive pulmonary disease; He struggles to breathe infection in progress and then death from cardiocirculatory arrest; infection in progress; cardiocirculatory arrest; received BNT162B2 (COMIRNATY) dose 1 subcutaneous; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-745626. A 65-year-old male patient received BNT162B2 (COMIRNATY) dose 1 subcutaneous on 21Apr2021 (Lot Number: Ex0893) in right arm as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient struggled to breathe, infection in progress and then death from cardiocirculatory arrest on 24Apr2021. The patient had chronic obstructive pulmonary disease on an unspecified date. Impact on quality of life (10/10). The outcome of events struggled to breathe, infection in progress and cardiocirculatory arrest was fatal and other events was unknown. The patient died on an unspecified date. 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: cardiocirculatory arrest; infection in progress; struggled to breathe


VAERS ID: 1439051 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-06
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / 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: 2021-05-06
   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 (treated for diabetes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021759295

Write-up: died on 06May2021 of cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, the regulatory authority report number is IT-MINISAL02-745997. A 92-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EX0893), intramuscular on 17Apr2021 as dose 1, single for covid-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing, treated for diabetes. The patient''s concomitant medications were not reported. The patient experienced death on 06May2021. The patient died on 06May2021 of cardiac arrest. It was not reported if an autopsy was performed. Impact on quality of life (10/10). No treatment received. Reporters comment: The person received the Pfizer vaccine on 17Apr2021. He was being treated for diabetes but never suffered from heart problems. She died on 06May2021 of cardiac arrest. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The person received the Pfizer vaccine on 17Apr2021. He was being treated for diabetes but never suffered from heart problems. She died on 06May2021 of cardiac arrest.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1439099 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cyanosis, Death, Incontinence, Malaise, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: AMLODIPINE BESILATE; BLOPRESS
Current Illness: Hyperlipidaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021704295

Write-up: unknown cause of death; cyanosis condition; incontinence; Vaccination site pain; General malaise; Myalgia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21114096. A 47-year and 2-month-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration, on 14May2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing hyperlipidaemia. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN) taken for hypertension from an unspecified date and ongoing and candesartan cilexetil (BLOPRESS) taken for hyperlipidaemia from an unspecified date and ongoing. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously received the first dose of BNT162B2 (COMIRNATY) in 2021 for COVID-19 immunisation. The patient experienced unknown cause of death on 11Jun2021 at 08:30 (27 days and 18 hours after the vaccination), which was reported as fatal. The patient also experienced vaccination site pain, general malaise, and myalgia on 14May2021. The patient also experienced cyanosis condition and incontinence on 11Jun2021 at 08:30. The clinical course was reported as follows: The body temperature before vaccination was 36.1 degrees Centigrade on 14May2021. From 14May2021 (the day of vaccination) to 16May2021 (2 days after vaccination), the patient experienced vaccination site pain, general malaise, and myalgia (all symptoms were mild). On 11Jun2021, at 08:30 (27 days and 18 hours after vaccination), the patient stayed at his room in his working place from the previous day. In the morning, a staff member found the patient collapsed in the room. The patient was in cyanosis condition, and he had incontinence. No postmortem rigidity was observed. On the same day, from 08:38 (27 days, 18 hours, and 8 minutes after vaccination) to 09:46 (27 days, 19 hours, and 16 minutes after vaccination), the tracheal intubation was performed, and cardiac massage was performed; however, cardiopulmonary resuscitation was not confirmed. On the same day, at 09:46 (27 days, 19 hours, and 16 minutes after vaccination), the patient was confirmed to die. The obvious cause of death was unknown. The clinical outcome of unknown cause of death was fatal and of vaccination site pain, general malaise, myalgia, cyanosis condition, and incontinence was unknown. The patient died on 11Jun2021. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable. Other possible causes of the event, such as any other diseases, were as follows: The following information was confirmed by his wife: The patient had medical histories of hypertension and hyperlipidaemia, for which he was orally taking amlodipine besilate and candesartan cilexetil. There were no other possible causes. The reporting physician commented as follows: The vaccination was performed as a healthcare professional. At the follow up after the vaccination, no serious side reactions were observed. It was considered that the causality between the event and BNT162B2 vaccination was very unlikely. However, since no detailed information was obtained, it was considered that further consideration was extremely difficult.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1439283 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021753772

Write-up: Suspected cardiac failure acute; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 99-year-old female. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies or past drug history. Other medical history included hypertension. On 21May2021 at 09:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 28May2021 at 17:00 (7 days after the vaccination), the patient experienced suspected cardiac failure acute. The outcome of the event was fatal without treatment. On 28May2021 at 17:40, the patient died. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death). An autopsy was not performed. The cause of death was suspected cardiac failure acute.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cardiac failure acute with fatal outcome. The reported event may likely represent intercurrent medical condition in this elderly patient. There is limited information provided in this report. This case will be reassessed upon receipt of the follow-up information. 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: Suspected cardiac failure acute


VAERS ID: 1439284 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness, Magnetic resonance imaging, Pyrexia, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Headache; Hypertension; Reflux esophagitis
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210619; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: JPPFIZER INC2021756997

Write-up: Subarachnoid haemorrhage; Loss of consciousness; Pyrexia of around 38 degrees centigrade; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 85-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication 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, dyslipidaemia, and reflux esophagitis. On 26May2021 at 10:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA4597, Expiration date 31Aug2021) intramuscular in the arm left at the age of 85-year-old as single dose for COVID-19 immunization. On 16Jun2021 at 10:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the arm left at the age of 85-year-old as single dose for COVID-19 immunization. On an unspecified date, the patient experienced subarachnoid haemorrhage. The outcome of the event was fatal. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: On 10Jun2021, the patient had intense headache. On 16Jun2021, the patient developed pyrexia of around 38 degrees centigrade. On 19Jun2021, the patient experienced loss of consciousness while undergoing MRI and subsequently died. The patient died on 19Jun2021. The outcome of loss of consciousness and pyrexia was unknown. An autopsy was unknown performed and the reported cause of death was subarachnoid haemorrhage. The reporting physician classified the event as serious (death).; Sender''s Comments: Based on a plausible temporal association only, a causative role of BNT162B2 vaccine for the reported subarachnoid haemorrhage (fatal) and loss of consciousness cannot be completely excluded. The mentioned hypertension and the patient''s age are considered significant risk factors for the fatal event. 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: Subarachnoid haemorrhage


VAERS ID: 1439285 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021762878

Write-up: This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting. The patient was a non-pregnant elderly female aged 91 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination(details not reported). There was no relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. Other medical history included aortic aneurysm. On 24May2021 at 13:45 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization. On 14Jun2021 at 20:45 (21 days after the vaccination), the patient experienced death. The reporter stated that the adverse event resulted in emergency room/department or urgent care, death. The death cause was aortic rupture. Autopsy was not performed. Treatment was not given. The reporting physician assessed the event as serious (death). The causality of the event was not reported.; Sender''s Comments: Based on currently known drug safety profile, the reported event aortic rupture more likely represented intercurrent illness, 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: Aortic rupture


VAERS ID: 1439286 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021763996

Write-up: This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting and the same contactable physician who conducted autopsy. Regulatory authority report number is v21115859. The patient was a non-pregnant 91-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported whether the patient received any other medications within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Medical history was not reported. On 22Jun2021 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration for COVID-19 immunization at the age of 91-year-old. On 22Jun2021 (on the same day of the vaccination), the patient experienced acute myocardial infarction. The outcome of the event was fatal (death). It was unknown whether the patient received a treatment or not for the event. An autopsy was not performed. It was unknown whether the patient has been tested for COVID-19 since the vaccination. The reporting physician classified the event as serious (death) and the reporter stated the event result in death. The course of the event was as follows: On 22Jun2021 at 21:00 (estimated) the patient experienced sudden death while taking a bath. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute myocardial infarction. The reporting physician commented as follows: The patient died on the same day of the vaccination.; Reporter''s Comments: The patient died on the same day of the vaccination.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1439287 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Lung cancer stage IV; Metastatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021766910

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 68-year-old male. Medical history included lung cancer stage IV, emphysema, and metastatic carcinoma. On an unspecified date (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date (4 days after the vaccination), the patient experienced death. The outcome of the event was fatal. The course of the event was as follows: The patient had lung cancer stage IV but received COMIRNATY at the request of family member. Four days later, the patient died. It was not reported if an autopsy was performed. Seriousness criteria was not provided. The reporting physician assessed that the event was possibly related to BNT162b2. The reporting physician commented as follows: The condition of underlying disease was severe and causality between the event and the vaccination of COMIRNARY was considered less possibility.; Sender''s Comments: The causal relationship between BNT162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The causal role of the pre-existing medical conditions of the patient cannot be excluded. 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: Death


VAERS ID: 1439289 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neuralgia; Oedema
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021767364

Write-up: This is a spontaneous report from a contactable consumer received via COVID-19 Adverse Event Self-Reporting. The patient was a non-pregnant 81-year-old female. It was not reported whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Other medical history included oedema and neuralgia. On 02Jun2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration in the left arm for COVID-19 immunization. On 03Jun2021 (1 day after the vaccination), the patient experienced death. It was unknown if autopsy was done. The outcome of the event was fatal without treatment. It was unknown whether the patient the patient had been tested for COVID-19 since the vaccination.; Reported Cause(s) of Death: Death


VAERS ID: 1439379 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: Fatal brain haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Fatal brain haemorrhage) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Ex-smoker. On 15-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Fatal brain haemorrhage) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was brain haemorrhage . An autopsy was not performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided. Follow-up received on 15-Jun-2021 included no new information This is a case of sudden death in a 51-year-old female subject with past history of smoking, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Translation received on 15-Jun-2021 does not contain any new information. On 22-Jun-2021: Follow up was found to be significant: Medical history and Autopsy result was updated.; Sender''s Comments: This is a case of sudden death in a 51-year-old female subject with past history of smoking, who died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1439393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 13
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: Gout; Multinodular goitre (multinodular goiter); Osteochondrosis juvenilis (Scheuermann disease); Situs inversus (born with situs inversus); Suspected COVID-19 (episode with feeling unwell, no smell, no taste and sore leg, not confirmed with test.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021752027

Write-up: This is a spontaneous report received from a contactable physician, regulatory authority report number NL-LRB-00579885. A 57-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 (Lot Number: FD0785) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteochondrosis juvenilis Scheuermann disease, gout, multinodular goiter, born with situs inversus, and Possible COVID-19 in Spring 2020: episode with feeling unwell, no smell, no taste and sore leg, not confirmed with test. The patient''s concomitant medications were not reported. Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. The patient experienced death (sudden death) on 14Jun2021, 11 days after start. It was not reported if an autopsy was performed. Last week also sore leg. The outcome of sudden death is fatal. The outcome of sore leg was unknown. Additional information ADR: Died at 14Jun in the night. lay next to partner in bed, partner woke up, was cold. Out of nowhere, no complaints over the past few days. Confounding factors: Gout, Scheuermann disease, Multinodular goitre further born with situs inversus. Diagnostic procedures: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter''s comments: description of no past Comirnaty therapy, description of events, death details and description of medical history; Reported Cause(s) of Death: death (sudden death)


VAERS ID: 1439436 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cyanosis, Dysarthria, Dyskinesia, Fall, Haemorrhagic stroke, Hypertension
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ACENOCOUMAROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Prostatic hyperplasia; Varicose veins
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Blood pressure; Result Unstructured Data: Test Result:200/100 mmHg
CDC Split Type: PLPFIZER INC2021753324

Write-up: hemorrhagic stroke; Blue lips; high pressure 200 / 100mmHg; dropped corner of the mouth (right side); Landslide / fall; slurred speech; This is as spontaneous report received from a contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is PL-URPL-3-734-2021. An 81-year-old male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular in left arm on 14Apr2021 at 12:25 (lot number: EW9127, expiration date: 31Jul2021) as single dose for COVID-19 immunisation. The relevant medical history included arterial hypertension from unspecified date, varicose veins of the lower limbs from unspecified date and prostatic hyperplasia from unspecified date. Concomitant medications included acenocoumarol. The patient experienced hemorrhagic stroke, blue lips, high pressure 200 / 100mmHg, dropped corner of the mouth (right side), landslide / fall and slurred speech, all on 14Apr2021 at 12:35. The patient qualified for vaccination, did not report any complaints. About 10 minutes after vaccination on 14Apr2021 at 12:35, and entering the corridor, he slumped from the chair to the floor. After the staff intervention, an anesthesiologist was called and the pressure 200 / 100mmHg was placed in the office, the patient was circulatory and respiratory efficient, conscious, slurred speech, dropped corner of the mouth on the right side, blue lips. Captopril was administered under the tongue, oxygen and transported to the emergency room. Additional information: hemorrhagic stroke with death of the patient. The patient had not had a vaccine reaction in the past. On 16Jun2021, by e-mail, information was received from the sanitary and epidemiological station about the date of the patient''s death: 18Apr2021 Result: death (cause: hemorrhagic stroke, date of death: 18Apr2021) The reporting person (doctor) classified them as severe. Due to the nature of the side effects and the patient''s death, regulatory authority classified the report as severe. The data contained in the electronic report are all available to regulatory authority - in the case of obtaining additional information, another version will be sent. The patient died on 18Apr2021. It was unknown if an autopsy was performed. The patient underwent lab test included blood pressure: 200/100 mmHg on 14Apr2021. The outcome of the event hemorrhagic stroke was fatal, while the other events were unknown. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). The reported side effects are unexpected in the Summary of Product Characteristics. Symptoms observed in the patient immediately after vaccination could be the result of a developing, diagnosed, fatal hemorrhagic stroke. Moreover, it cannot be ruled out that the cardiovascular diseases mentioned by the reporting person and the use of the anticoagulant drug Acenocoumarol had an influence on the occurrence of the reported stroke. Until 12May2021 in the regulatory authority database, 16 cases of haemorrhagic stroke were reported with the result of the patient''s death. The report did not clearly state the date of the patient''s death. Regulatory authority asked for information by e-mail to the appropriate sanitary and epidemiological station. The close temporal relationship speaks for a cause-and-effect relationship. Due to the nature of the side effects and the patient''s death, regulatory authority classified the report as severe. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory authority expert; Method of assessment: regulatory authority system for standardised case causality assessment; Result of Assessment: Unlikely. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1439438 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac arrest, General physical health deterioration, Mobility decreased, Muscular weakness, Red blood cell sedimentation rate increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 34
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: Walking difficulty (he had not walked for a year earlier, required nursing services)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: blood test; Result Unstructured Data: Test Result:a high ESR index
CDC Split Type: PLPFIZER INC2021753016

Write-up: Cardiac arrest; the patient''s functioning clearly deteriorated; Mobility decreased/the patient lost the ability to change his body position; Generalised muscle weakness/Lower extremities weakness of/increasing limpness of the legs appeared; Raised ESR; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.382.2021. The report was sent to regulatory authority on 25May2021 by the patient''s daughter. A 90-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01Apr2021 (Batch/Lot Number: EW8904) (at the age of 90-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history included he had not walked for a year earlier, required nursing services. Concomitant medications were not reported. In Apr2021, the patient experienced mobility decreased, generalised muscle weakness, lower extremities weakness of, raised ESR. On an unspecified date, the patient experienced cardiac arrest. The above mentioned events were reported with fatal outcome (resulting in death). Additional clinical course was as follows: Approximately 2 weeks after receiving the first dose of the vaccine, the patient''s functioning clearly deteriorated - he had not walked for a year earlier, required nursing services, but could sat on the bed, could lift his hips when changing diaper pants; after vaccination, increasing limpness of the legs appeared, the patient lost the ability to change his body position, which he had no problems with before (for about 3 weeks he was lying on one side only), the blood results showed a high ESR index. The patient died on 05May2021. Also reported a cause of death as cardiac arrest. An autopsy was not performed. The reporting person indicated the criterion of severe report: death. Regulatory authority classified the report as severe. The data contained in the electronic report are all at the disposal of the regulatory authority in case of obtaining additional information, the next version will be sent. Sender Comment: Progressive muscle weakness and an increase in inflammatory markers are unexpected side effects of Comirnaty vaccine. Due to insufficient information (including the unknown nature of the symptoms), a causal relationship has not been established. There is a time relationship between the administration of the vaccine and the appearance of symptoms. The person submitting the report indicated the criterion of severe report: death. Regulatory authority classified the application as severe. Relatedness of drug to all events by source via method was Unclassified. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Cardiac arrest; Generalised muscle weakness/Lower extremities weakness of/increasing limpness of the legs appeared; Mobility decreased; Raised ESR


VAERS ID: 1439448 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-23
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fibrin D dimer, Haemoglobin, Pelvic venous thrombosis, Platelet count, Polymerase chain reaction, Renal vein thrombosis, Vena cava thrombosis
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Renovascular disorders (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: INDAPAMIDE; ALLOPURINOL; GABAPENTIN; PANTOPRAZOLE; PARACETAMOL; KAINEVER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mesenteric ischaemia (surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated); Short-bowel syndrome (surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated)
Allergies:
Diagnostic Lab Data: Test Name: D-dimers; Test Result: Positive ; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9 g/dl; Comments: 9 g/dl Iu international unit(s); Test Name: Platelet count; Test Result: 480000 uL; Test Name: PCR; Test Result: 8 mg/dl; Comments: 8 mg/dl Iu international unit(s)
CDC Split Type: PTPFIZER INC2021752289

Write-up: This is a spontaneous report from a contactable physician, regulatory authority number PT-INFARMED-T202105-3196. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Apr2021 (Batch/Lot Number: EY2172) as dose 2, 0.3mL single for covid-19 immunisation. Medical history included surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated. Concomitant medications included indapamide 2.5 mg; allopurinol 300 mg; gabapentin 400 mg; pantoprazole 40 mg; paracetamol; estazolam (KAINEVER) 2 mg. The patient previously took first dose of bnt162b2 (COMIRNATY, Batch/lot number: EW2239 ) at dose 1, 0.3mL single on 01Apr2021 for covid-19 immunization. The patient experienced iliofemoral venous thrombosis, vena cava and renal veins on 23May2021. The patient underwent lab tests and procedures which included fibrin d dimer: positive, haemoglobin: 9 g/dl Iu international unit(s), platelet count: 480000 ul, polymerase chain reaction: 8 mg/dl Iu international unit(s). Therapeutic measures were taken as a result of iliofemoral venous thrombosis, vena cava and renal veins, iliofemoral venous thrombosis, vena cava and renal veins, iliofemoral venous thrombosis, vena cava and renal veins. The patient died on 23May2021. An autopsy was not performed. The clinical course was reported as follows: Spontaneous notification refers to a case sent by a physician about an elderly male, 79 years old, who presented with a condition of "iliofemoral venous thrombosis, vena cava and renal veins" associated with the use of Comirnaty/mRNA vaccine against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml (lots EW2239 and EY2172), for "SARS-CoV-2 infection prophylaxis", with the dosage of 2 doses (0.3 ml each) IM with one 28-day interval between each dose. Referred clinical history of "of surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated". No information on previous occurrence of infection with SARS-CoV-2 virus. The adverse reaction (ADR) appeared 52 and 24 days after the administration, respectively, of the 1st and 2nd dose of the suspected drug, with unknown duration. According to the notifier, "the patient was sent to Emergency Service due to a condition of shock with acute kidney injury (apparently in context, or accompanied by diarrhea). She had neutrophilic leukocytosis and AKIN-3 acute kidney injury (pCr 9), PCR 8. He underwent body CT, for maintaining anuria after volume replacement, which documented extensive iliofemoral venous thrombosis, vena cava and renal veins. He died after less than 24 hours." There was no reduction in dosage, suspension or reintroduction of the suspected drug, since the vaccination schedule was already complete. There is no suspicion of drug interactions. There are no data on past reactions to other drugs/vaccines or allergies. Specific treatment of the adverse reaction was carried out with "heparin, prophylactic antibiotics, fluids". ADR did not improve with treatment.There is reference to the use of the following common medications: pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5 mg, gabapentin 400 mg, Estazolam 2 mg, paracetamol. Additional data: Platelet values 480.000/uL, Hemoglobin 9 g/dL, no clotting alterations, namely. hypofibrinogenemia, PF4 not assayed, positive D-dimers, PCR 8 mg/dl. According to the notifier "We think that the vaccination may have contributed to this patient''s venous thrombosis, in a favorable terrain." The cause of death was acute renal failure due to vena cava and renal thrombosis. The notifier considers that the autopsy will have been dispensed with. Evolution of ADR: death. Relatedness of drug to reaction(s)/event(s) for event: Source of assessment: Notifier; Method of assessment: Unknown; Result of Assessment: Possible. Product notes: SARS-CoV-2 infection prophylaxis. Reporter''s comments: Concomitant drug-pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5, gabapentin 400 mg, kainever 2 mg paracetamol Medication Error Occurred?-no No follow-up attempts needed. No further information expected.; Reporter''s Comments: Concomitant drug-pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5, gabapentin 400 mg, kainever 2 mg paracetamol Medication Error Occurred?-no; Reported Cause(s) of Death: Renal failure acute ischaemic


VAERS ID: 1439467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood alcohol, Blood creatine phosphokinase MB, Carboxyhaemoglobin, Death, Drug screen, Fibrin D dimer, Myoglobin blood, Polymerase chain reaction, Troponin
SMQs:, Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: blood alcohol level; Result Unstructured Data: Test Result:0; Test Date: 20210521; Test Name: CK-MB; Result Unstructured Data: Test Result:negative; Test Date: 20210521; Test Name: carboxyhemoglobin; Test Result: 64 %; Test Date: 20210521; Test Name: urine drug test; Test Result: Negative ; Comments: negative urine for amphetamines, barbiturates, benzodiazines, cocaine, methadone, opiates, THC, phencyclidines, tricyclic antidepressants, oxycodone, methamphetamines; Test Date: 20210521; Test Name: Fibrin D dimer; Test Result: Positive ; Test Date: 20210521; Test Name: myoglobine serology; Test Result: Negative ; Test Date: 20210524; Test Name: RT-PCR; Test Result: Negative ; Test Date: 20210521; Test Name: Troponin; Test Result: Positive
CDC Split Type: ROPFIZER INC2021759441

Write-up: Found dead; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB RO-NMA-2021-SPCOV11583. A 21-year-old male patient received first dose of bnt162b2 (COMIRNATY) on 14May2021 at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included obesity. The patient was found dead at home on 20May2021. At the request of the police, the body was transported to the forensic service. On 21May2021 a medical-legal autopsy was performed. The necroptic findings were: Anatomo-pathological diagnosis: obesity, intense purple lividity, cerebral edema and cerebral stasis, lung with the appearance of respiratory distress, hepatomegaly. hepatic steatosis, visceral stasis. Toxicology: zero blood alcohol level, carboxyhemoglobin 64%, negative urine for amphetamines, barbiturates, benzodiazines, cocaine, methadone, opiates, THC, phencyclidines, tricyclic antidepressants, oxycodone, methamphetamines. Serology: troponin positive, negative myoglobine serology, CK-MB negative, Fibrin D dimer positive. Test RT-PCR for SARS-CoV-2 infection on 24May2021 with negative result. Samples were collected for general toxicological examination (blood, liver, kidneys, gastric contents) and for histopathological examination (brain, lung, heart, liver, kidneys, pancreas, adrenal glands) which were sent to the [PRIVACY], following the release of the results to be communicated. Following investigation of the case by the Regulatory Authority, the conclusions were: coincidental AEFI. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Found dead; Autopsy-determined Cause(s) of Death: obesity; cerebral edema; cerebral stasis; lung with the appearance of respiratory distress; hepatomegaly


VAERS ID: 1440068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: 2021-06-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID; Test Result: Positive
CDC Split Type: USPFIZER INC2021763568

Write-up: He died 4 weeks later after his second dose. He died from COVID; He died 4 weeks later after his second dose. He died from COVID; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, on May2021 as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died from COVID and had full 2 doses from Pfizers COVID vaccine. He died 4 weeks later after his second dose. He died from COVID yesterday, 21Jun2021. The patient underwent lab tests and procedures which included COVID: positive on unspecified date. The patient died on 21Jun2021. It was not reported if an autopsy was performed. Information about lot/batch number has been requested. The event [he died 4 weeks later after his second dose. he died from covid] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.; Reported Cause(s) of Death: He died 4 weeks later after his second dose. He died from COVID; He died 4 weeks later after his second dose. He died from COVID


VAERS ID: 1440145 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3588/495/5 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic (on treatment); Hypertensive (on treatment); Venous ulceration (being treated 3 months before)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021709967

Write-up: Death; Not feeling well after receiving the vaccine; This is a spontaneous report from a contactable other healthcare professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: FC3588/495/5; Expiration Date: Sep2021) via an unspecified route of administration on 31May2021 at 12:06 as single dose for covid-19 immunisation. The patient''s medical history included diabetes mellitus, hypertension, was being treated for venous ulcer 3 months before. The patient''s concomitant medications were not reported. It was reported that patient was not feeling well after receiving the vaccine on 01Jun2021. The patient was died, date not specified. The family was said to have refused autopsy. The outcome of the event not feeling well was unknown. Follow-up (22Jun2021): New information reported from contactable other healthcare professional included reaction data (new event "died"), medical history (was being treated for venous ulcer 3 months before), autopsy information.; Reported Cause(s) of Death: died


VAERS ID: 1440147 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Disease recurrence, Dyspnoea
SMQs:, Anaphylactic reaction (broad), 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: 2021-06-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Feeling unwell; Shortness of breath (prior to vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021751105

Write-up: Chest pain; shortness of breath/had shortness of breath prior to vaccination; shortness of breath/had shortness of breath prior to vaccination; This is a spontaneous report from a contactable physician. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Jun2021 12:25 (Batch/Lot Number: FD0927; Expiration Date: 30Sep2021) as dose 1, single for covid-19 immunisation. Patient age at vaccination was 45-year-old. Medical history - the patient was reported to have had shortness of breath prior to vaccination and was not feeling well, date not specified. The patient''s concomitant medications were not reported. The patient experienced chest pain and shortness of breath, both on 11Jun2021, 12:00. The patient died on 13Jun2021. It was reported that autopsy was done but not reported if autopsy results were available or not.; Sender''s Comments: There are not sufficient elements supporting a causative role of BNT162B2 vaccine for the reported fatal events. The presence of shortness of breath prior to vaccination may suggest an intercurrent condition as possible cause of the events. 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: Chest pain; shortness of breath/had shortness of breath prior to vaccination; shortness of breath/had shortness of breath prior to vaccination


VAERS ID: 1440148 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, COVID-19, Death, Drug ineffective, Dyspnoea, Oxygen saturation, Pain, Physical examination, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN; DOXYCYCLINE; CLEXANE; TAMIFLU; ALLERGEX [CHLORPHENAMINE MALEATE]; CELESTONE [BETAMETHASONE ACETATE;BETAMETHASONE SODIUM PHOSPHATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive
Allergies:
Diagnostic Lab Data: Test Name: ABG; Result Unstructured Data: Test Result:Metabolic acidosis noted; Test Name: Sats; Result Unstructured Data: Test Result:52-63 %; Test Name: Sats; Result Unstructured Data: Test Result:88-92 %; Test Name: Chest; Result Unstructured Data: Test Result:bilateral crepitation''s; Test Name: COVID Ag test; Test Result: Negative ; Test Date: 20210613; Test Name: COVID PCR swab; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021751122

Write-up: Body pain; Dyspnea; COVID PCR swab positive; COVID PCR swab positive; Death; This is a spontaneous report from a contactable Other HCP (Other Health Professional). A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA5715; Expiration Date: 31May2021) at single dose on 27May2021 09:37 at age of 73-year-old for covid-19 immunization. Medical history included hypertensive. Concomitant medications included simvastatin, doxycycline, enoxaparin sodium (CLEXANE), oseltamivir phosphate (TAMIFLU), chlorphenamine maleate (ALLERGEX), betamethasone acetate/betamethasone sodium phosphate (CELESTONE). On 10Jun2021, the patient was reported to have experienced body pain and dyspnea and patient was hospitalized from 11Jun2021. Patient had COVID PCR swab positive on 13Jun2021. The patient died on 13Jun2021. An autopsy was not performed. Lab results included ABG: metabolic acidosis noted; chest presented bilateral crepitation''s; oxygen saturation: 52-63 %, 88-92 %; COVID Ag test negative. The outcome of event death was fatal. The outcome of rest events was unknown. The information on the lot/batch number has been requested.; Sender''s Comments: Based on information currently available a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information including the cause of death 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: Death


VAERS ID: 1440264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 6
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: IDDM; Comments: IDDM
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210655539

Write-up: UNOBSERVED CIRCULATORY ARREST, DEATH; SUBFEBRILE; FEELING SICK / FEELING UNWELL; This spontaneous report received from a physician via a Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-32463) concerned a 65 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included IDDM (Type 1 diabetes mellitus), and other pre-existing medical conditions included IDDM. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986, expiry: unknown) 1 dosage forms, frequency 1 total dose administered on 10-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 10-JUN-2021, the patient was subfebrile, feeling sick/feeling unwell. On 16-JUN-2021, the patient experienced unobserved circulatory arrest, and died. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unobserved circulatory arrest, subfebrile and feeling sick/feeling unwell on 16-JUN-2021. This report was serious (Death).; Sender''s Comments: V0:20210655539-COVID-19 VACCINE AD26.COV2.S- Unobserved Circulatory arrest death , subfebrile , feeling sick/ feeling unwell . 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: CIRCULATORY FAILURE; SUBFEBRILE; FEELING SICK/FEELING UNWEL


VAERS ID: 1440290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 210212 / 1 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal malformation, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), 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: 2021-06-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2021SA203771

Write-up: At birth, the stillborn newborn, with multiple malformations, softened cephalic pole, and no palpable bone structure, peeling skin on face and body, exophthalmic and umbilical cord calcification [fetal malformation]; serious adverse event after using the adsorbed vaccine covid-19 (inactivated) and TRIVALENT INFLUENZA VACCINE; Initial information was received on 15-Jun-2021 regarding an unsolicited valid serious case from the healthcare professional (physician) via business Partner - [(LP) BUTANTAN-BRA GSP-PCP] (under reference number: BR-SA-SAC20210618001124) and transmitted to Sanofi on 16-Jun-2021. On 15-Jun-2021 the a regulatory authority received through e-mail from the epidemiological surveillance center reporting a serious adverse event after using the adsorbed vaccine covid-19 (inactivated). The physician, reports that a newborn patient on 04-Jun-2021, stillborn, weight 3.110kg, male. The mother looked for medical help in the emergency room at Hospital, claiming she wasn''t feeling the newborn moving. Therefore, she underwent fetal heart rate tests, and it was inaudible, so she was referred for cesarean delivery. At birth, the stillborn newborn, with multiple malformations, softened cephalic pole, and no palpable bone structure, peeling skin on face and body, exophthalmic and umbilical cord calcification [fetal malformation]. Medication Details and reason for taking the medicine: No further information was provided Patient medical history, concomitant disease, risk factor: The reporter informed that the mother was diagnosed with covid-19 on 18-Mar-2021, and received on 25-May-2021 the first dose of vaccine batch: 210212, via intramuscular administration in the right deltoid at the central health unit It is unknown if the patient had any additional medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. It was also a case of maternal exposure during pregnancy. As per the report, the patient was Maternally exposed via mother due to vaccination received the adsorbed vaccine covid-19 (inactivated) and TRIVALENT INFLUENZA VACCINE and had serious adverse event (fetal malformation).; Sender''s Comments: This case involved 11-day old patient who had died due to fetal malformation after the receiving INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE INACT (not produced by Sanofi Pasteur) via Maternal exposure. Patient''s mother had a history of COVID-19. At the time of birth, the patient was stillborn, newborn, with multiple malformations, softened cephalic pole, and no palpable bone structure, peeling skin on face and body, exophthalmic and umbilical cord calcification. Further information regarding other concomitant risk factor, disease, concomitant medication received by patient''s mother or patient and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: At birth, the stillborn newborn, with multiple malformations, softened cephalic pole, and no palpable bone structure, peeling skin on face and body, exophthalmic and umbilical cord calcification [fetal malformation]; serious adverse event after using


VAERS ID: 1440303 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-04-16
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood culture, COVID-19, Chest X-ray, Computerised tomogram thorax, Deep vein thrombosis, Echocardiogram, Fibrin D dimer, Legionella infection, SARS-CoV-2 antibody test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 19
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: VOTUM [OLMESARTAN MEDOXOMIL]; BETMIGA; ZOLDORM
Current Illness: Arterial hypertension; Urinary incontinence
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (5/d stopped 50 years ago); Overactive bladder
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: angiological assessment; Result Unstructured Data: Test Result:Abnormal; Comments: DVT of the muscular veins of the right and left calves, without extension to the popliteal veins.; Test Date: 20210423; Test Name: Blood culture; Test Result: Negative ; Test Date: 20210426; Test Name: X-ray; Result Unstructured Data: Test Result:Abnormal; Comments: the poorly delineated, bibasal infiltrates in the right upper lobe are progressing, suggesting a progression of the pulmonary infectious process with possible bacterial superinfection. Blunting of the left costo-diaphragmatic sinus in relation to a possible pleural effusion. The rest is superimposable with respect to the comparative.; Test Date: 20210423; Test Name: Thoracic angio-CT; Result Unstructured Data: Test Result:Abnormal; Comments: Absence of pulmonary embolism visualized up to segmental. Ground glass infiltrates, subpleural reticulations and discrete bronchiectasis speaking primarily for fibrotic involvement of NSIP pattern. However, the radiological pattern may correspond to an infectious viral lung disease of the SARS-Cov-2 type; Test Date: 20210430; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal; Comments: LVEF 55%, no dilatation of the right chambers, no LV dysfunction, no indirect signs of PH (PAPs estimated at 35mmHg), IVC collapsed on inspiration; Test Date: 20210430; Test Name: D-dimer; Result Unstructured Data: Test Result:26793 ng/ml; Test Date: 20210426; Test Name: Legionella infection; Test Result: Negative ; Test Date: 20210404; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:345.8 IU/ml; Test Date: 20210430; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:100.4 IU/ml
CDC Split Type: CHPFIZER INC2021733451

Write-up: Severe ARDS to SARS-CoV-2 post vaccination; Severe ARDS to SARS-CoV-2 post vaccination; Severe ARDS to SARS-CoV-2 post vaccination; This is a spontaneous report received via medic, the regulatory authority. Regulatory authority report number CH-SM-2021-15474. A contactable physician reported that an 84-years-old male patient received his second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EL8723), via an intramuscular on 19Feb2021 (at the age of 84-years-old), as 1DF, single, dose 1, via an intramuscular route of administration on 22Jan2021 (Lot Number: E0477) as single for covid-19 immunisation. Medical history included Arterial hypertension, ongoing urinary incontinence, Ex-smoker (5 per day and stopped 50 years ago). The patient had no known allergies, not alcohol consumer, not hepatopathic. The patient had no renal disease, no kidney disease, and no liver disease. Concomitant medications included Olmesartan medoxomil (VOTUM [OLMESARTAN MEDOXOMIL]) taken for Arterial hypertension, start and stop date were not reported; mirabegron (BETMIGA) taken for overactive bladder, start and stop date were not reported; zolpidem tartrate (ZOLDORM) taken for an unspecified indication, start and stop date were not reported. On 16Apr2021, the patient experienced severe ARDS (Acute respiratory distress syndrome) to sars-cov-2 post vaccination. On 23Apr2021, the patient was NSIP (Nonspecific interstitial pneumonia) admitted because of hypoxemic respiratory failure on COVID-19 whose symptomatology begins on 16Apr2021. The patient was hospitalized for severe ARDS (Acute respiratory distress syndrome) to sars-cov-2 post vaccination on 23Apr2021. The patient underwent lab tests and procedures which included, blood culture: negative on 23Apr2021. X-ray thorax (26Apr2021): Compared to the X-ray of 23Apr2021, the poorly delineated, binasal infiltrates in the right upper lobe are progressing, suggesting a progression of the pulmonary infectious process with possible bacterial superinfection. Blunting of the left costo-diaphragmatic sinus in relation to a possible pleural effusion. The rest is superimposable with respect to the comparative. computerized tomogram thorax on 23Apr2021, showed absence of pulmonary embolism visualized up to segmental. Ground glass infiltrates, subpleural reticulations and discrete bronchiectasis speaking primarily for fibrotic involvement of NSIP pattern. However, the radiological pattern may correspond to an infectious viral lung disease of the SARS-Cov-2 type. Thoracic angio-CT 23Apr2021, X-ray of Acute respiratory distress syndrome, DVT of the muscular Bedside echocardiography on 30Apr2021, did not show indirect signs of pulmonary hypertension suggestive of pulmonary embolism with cardiac repercussion. The antilogical assessment on 30Apr2021 of the lower limbs shows a DVT (Deep vein thrombosis) of muscular veins of the right and left calves, indicating anticoagulation for 3 months. Legionella infection was negative on 26Apr2021. Pneumonia pneumococcal was negative. Echocardiogram on 30Apr2021 LVEF 55 percent, no dilatation of the right chambers, no LV dysfunction, no indirect signs of PH (PAPs estimated at 35mmHg), IVC collapsed on inspiration and fibrin d dimer: 26793 ng/ml. A treatment with Ceftriaxone from 26Apr2021 (dosage regimen unknown) and Dexamethasone from 25Apr2021, (dosage regimen unknown) is instituted. Due to an increase in oxygen requirements, the patient was transferred to the Intensive Care Unit at the hospital in the context of ARDS (Acute respiratory distress syndrome) on COVID-19 for further management on 29Apr2021. On admission, the patient was in respiratory distress and required high flow oxygen therapy and intermittent non-invasive ventilation. Antibiotic therapy was replaced by piperacillin - tazobactam from 30Apr2021 (dosage regimen unknown). Therapeutic anticoagulation (type of drug, posology, dosage unknown) was empirically introduced in view of very increased D-dimer 26793 ng/ml, making suspect a venous thromboembolic disease. A positivity for SARS-CoV-2 IgG antibodies with positivity threshold of greater than 33.8 BAU/ml was identified at the laboratory: 100.4 BAU/ml (30Apr2021) and 345.8 BAU/ml (04May2021). Virus variants were not researched by the infectiologists. The patient died on 05May2021 following the rapid deterioration of respiratory failure. It was not reported if an autopsy was performed. The outcome of all the events was fatal. A causal relationship between Comirnaty and COVID-19 respiratory infection and Deep vein thrombosis was assessed as being unlikely. A causal relationship between Comirnaty and Vaccination failure was assessed as being certain. Medic assessed this case as serious with fatal outcome. Sender comment (Medic): Pulmonary infection with Covid-19 ARDS (Acute respiratory distress syndrome) with admission to intensive care and subsequent death, deep vein thrombosis, in an 84-year-old patient in good general health except for an arterial hypertension and urinary incontinence who had received both doses of Comirnaty (22Jan201, 19Feb2021). In the Comirnaty monograph, it is reported that the duration of protection offered by the vaccine was unknown, as it was still being determined in ongoing clinical trials, and, as with any vaccine, vaccination with Comirnaty may not protect all recipients. In particular, it is reported that subjects may not be fully protected until 7 days after the second dose of the vaccine. In the case of this patient who finished his vaccination cycle on 19Feb2021 and develops the first symptoms of Covid-19 disease confirmed at the laboratory on 16Apr2021 we judge the ineffectiveness of the vaccine as certain. In order to increase the knowledge of the case it would have been interesting to determine the variant of the virus but the infectivologists involved did not consider necessary this additional analysis. Pulmonary infection with Covid-19 ARDS (Acute respiratory distress syndrome) that led to the death of the patient, this is not a side effect noted for Comirnaty. We therefore enter the causal role of the vaccine in Covid-19 infection as unlikely. Finally, with regard to the deep vein thrombosis manifested by the patient, they are not currently counted among the possible adverse events to Comirnaty either in the monograph or in the international literature. The literature reports a first case report of deep vein thrombosis diagnosed a few days after the second dose of Comirnaty in a 66-year-old woman. The authors hypothesize: the intense immunological response evoked by the second dose of vaccine could be a trigger for the thrombotic event described, a mechanism recognized in many clinical conditions (1). However, given the long temporal latency between vaccination and DVT, the other possible concomitant causes most likely Covid-19 disease, immobilization for hospitalization, we consider the causal role of the vaccine in the DVT presented by the patient as unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Severe ARDS to SARS-CoV-2 post vaccination; rapid deterioration of respiratory failure; Severe ARDS to SARS-CoV-2 post vaccination


VAERS ID: 1440320 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Blood pressure measurement, Body temperature, Cardiac failure, Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Dyspnoea, Electrocardiogram, Fibrin D dimer, Heart rate, International normalised ratio, Mean cell haemoglobin concentration, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Physical examination, Platelet count, Prothrombin time ratio, Red blood cell count, Respiratory rate, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 65
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; ZOCOR; ECOBEC; AFONILUM; FUROSEMID; TRITACE; KINITO; NOVALGIN [METAMIZOLE SODIUM]; KALNORMIN; VIGANTOL [COLECALCIFEROL]; INDOBENE [INDOMETACIN]; BETALOC ZOK; FURON [FUROSEMIDE]; OXAZEPAM; DIGOXIN
Current Illness: Cardiac insufficiency (left ventricle dysfunction with progression, left atrial dilatation with progression); Chronic atrial fibrillation; COPD (with chronic bronchitis of intermediate grade with no signs of acute exacerbation); Glucose tolerance impaired; Gonarthrosis (grade III lateris dextri); Hypertension (grade III (world health organization classification)); Hypertension pulmonary (indirect signs); Mitral regurgitation; Mobility decreased; Neurocirculatory asthenia; Vertebrogenic pain syndrome (lumbosacral spine)
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Breathlessness (breathlessness progression with cardial insufficiency); Bruising of leg (after fall); Chemotherapy; Cholecystectomy (when 54-years-old); Hysterosalpingo-oophorectomy (hysterectomy + bilateral adnexectomy, due to bleeding); Ischaemic heart disease (acute myocardial infarction with ST elevation of inferior wall); Mastectomy (mammary carcinoma left-side, left mamma ablation + left axilla exenteration, chemotherapy); Menopausal; Non-smoker; Parity 3; Pulmonary embolism (mother - died at 81 years); Testis cancer (dad - died at 73 years)
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Activated partial thromboplastin time; Test Result: 34 s; Test Date: 202105; Test Name: Activated partial thromboplastin time; Test Result: 31 s; Test Date: 20210427; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.37; Test Date: 202105; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.24; Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20210427; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/70 mmHg; Test Date: 20210412; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210412; Test Name: CXR; Result Unstructured Data: Test Result:new right shadow fluidothorax-like and atelectasis; Comments: like in lower fields, blood congestion smaller than during previous examination, big cardiomegaly; Test Date: 20210427; Test Name: CXR; Result Unstructured Data: Test Result:bigger shadow right side fluidothorax-like; Comments: bigger cardiomegaly; Test Date: 20210505; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:native acute; Comments: cannot differentiate between tiny subarachnoid bleeding and mere artefact left side highly parietally postcentrally; Test Date: 20210412; Test Name: electrocardiography; Result Unstructured Data: Test Result:atrial fibrillation; Comments: frequency 88/min, QRS 0.13 s, left bundle branch block; Test Date: 20210427; Test Name: electrocardiography; Result Unstructured Data: Test Result:heart rate irregular, atrial fibrillation; Comments: frequency 68/min, QRS 110 ms, ST isoelectric, repolarization without pathology; Test Date: 20210427; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2.36 mg/l; Test Date: 202105; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1.77 mg/l; Test Date: 20210412; Test Name: Heart rate; Result Unstructured Data: Test Result:88; Comments: Units:/min; Test Date: 20210427; Test Name: Heart rate; Result Unstructured Data: Test Result:80; Comments: Units:/min; Test Date: 20210427; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.4; Test Date: 202105; Test Name: international normalized ratio; Result Unstructured Data: Test Result:1.3; Test Date: 20210427; Test Name: MCHC; Result Unstructured Data: Test Result:310 g/l; Test Date: 20210427; Test Name: N-terminal prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:22553 pg/mL; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:82-86 %; Test Date: 20210412; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210427; Test Name: Oxygen saturation; Test Result: 84 %; Test Date: 20210412; Test Name: Physical examination; Result Unstructured Data: Test Result:no icterus and cyanosis, visually tired; Comments: orizontal position is tolerated shortly, breathing on the left side clear alveolar with no side phenomenons; Test Date: 20210412; Test Name: Platelet count; Result Unstructured Data: Test Result:145 nL; Test Date: 20210427; Test Name: Platelet count; Result Unstructured Data: Test Result:125 nL; Test Date: 202105; Test Name: Platelet count; Result Unstructured Data: Test Result:106 nL; Test Date: 202105; Test Name: Platelet count; Result Unstructured Data: Test Result:118 nL; Test Date: 202105; Test Name: Platelet count; Result Unstructured Data: Test Result:102 nL; Test Date: 20210427; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:1.4; Test Date: 202105; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:1.35; Test Date: 20210412; Test Name: erythrocytes; Result Unstructured Data: Test Result:4.86; Comments: Units:/pL; Test Date: 20210427; Test Name: erythrocytes; Result Unstructured Data: Test Result:5.09; Comments: Units:/pL; Test Date: 20210412; Test Name: Respiratory rate; Result Unstructured Data: Test Result:12; Comments: Units:/min; Test Date: 20210427; Test Name: Respiratory rate; Result Unstructured Data: Test Result:14; Comments: Units:/min; Test Date: 20210412; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.1 nL; Test Date: 20210427; Test Name: White blood cell count; Result Unstructured Data: Test Result:5.9 nL
CDC Split Type: CZPFIZER INC2021728616

Write-up: stroke suspected; breathlessness progression; decompensation of heart failure; This is as spontaneous report received from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is CZ-CZSUKL-21006893. This case is for the events of the second dose. An 84-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular on 18Mar2021 (at the age of 84-year-old) as dose 2, single for COVID-19 vaccination. Medical history breathlessness progression with cardial insufficiency from Oct2020 to Oct2020; ischemic heart disease, acute myocardial infarction with ST elevation of inferior wall from Sep2001 to Sep2001; ongoing left-sided cardiac insufficiency in Jan2019 - left ventricle dysfunction with progression, left atrial dilatation with progression, stationary dilatation of right ventricle, diffuse kinetic disorders of left ventricle up to akinesis ramus interventricularis anterior, ejection fraction 33 %; ongoing significant mitral regurgitation since Jan2019; indirect signs of significant pulmonary hypertension (ongoing); ongoing chronic atrial fibrillation; ongoing hypertension grade III (world health organization classification); ongoing impaired glucose tolerance, bruising of leg/after fall from Jul2020 to Jul2020; ongoing Vertebrogenic pain syndrome of lumbosacral spine; ongoing gonarthrosis of grade III lateris dextri in Jul2020; ongoing neurocirculatory asthenia; Mastectomy- mammary carcinoma left-side, left mamma ablation + left axilla exenteration from Nov2006 to Nov2006; chemotherapy; ongoing chronic obstructive pulmonary disease with chronic bronchitis of intermediate grade with no signs of acute exacerbation; cholecystectomy from 1991 to 1991 when 54-years-old; Hysterosalpingo-oophorectomy/hysterectomy + bilateral adnexectomy from 1993 to 1993 due to bleeding; ongoing mobility decreased. Epidemiologic: no tuberculosis, no COVID infection. Family history included: dad - died at 73 years due to testicle carcinoma, mother - died at 81 years due to pulmonary embolism. Allergy: no abuse: non-smoker, abstains from alcohol, gynecologic: 3 labours with no complications, menses till 1993. Concomitant medications included apixaban (ELIQUIS); simvastatin (ZOCOR); beclometasone dipropionate (ECOBEC); theophylline (AFONILUM); furosemide (FUROSEMID); ramipril (TRITACE); itopride hydrochloride (KINITO); metamizole sodium (NOVALGIN) for pain; potassium chloride (KALNORMIN); colecalciferol (VIGANTOL); indometacin (INDOBENE); metoprolol succinate (BETALOC ZOK); furosemide (FURON); oxazepam; digoxin. The patient previously took the first dose of bnt162b2 (COMIRNATY, lot number EK9788) via intramuscular on 25Feb2021 as single dose for COVID-19 immunization and experienced debility, Type II diabetes mellitus, breathlessness and not feeling well. The patient experienced decompensation of heart failure in Mar2021, stroke suspected on unspecified date, hypoxic-ischemic etiology is suspected on unspecified date and breathlessness progression on 18Mar2021. The patient was hospitalized from 27Apr2021 to 29Apr2021. Course of events as follows: On 18Mar the 2nd dose of COMIRNATY was applied and since then there is a shortness of breath progression. According to an ambulance crew there was a breathlessness, saturation 82-86 % which improved after oxygenation therapy. The patient suffers from breathlessness, she wakes up at night because she needs to sit, she does not tolerate horizontal position. Fluidothorax newly according to x-ray examination and auscultation, left-sided cardiac insufficiency. She was hospitalized at intern with a need of oxygenotherapy. She improves a lot after furosemid intravenous administration. She is cardiopulmonally compensated, normotense with no chest pain or breathlessness. She was taken to hospital for long-term sickness where a diuretic therapy, oxygenotherapy, inhalation therapy and Biseptol is continued. Overall bad state progresses, on 05/05 there is an impaired consciousness when hypoxic-ischemic etiology is suspected. On 27Apr2021 she was brought by ambulance, hospitalized till 29Apr2021. On 06May2021 at 4:10 she dies calmly. Tests: On 12Apr2021 - blood pressure 130/80 mmHg, temperature 36.5 C, heart rate 88/min, respiratory rate 12/min, oxygen saturation 90 %, physical examination - no icterus and cyanosis, visually tired, horizontal position is tolerated shortly, breathing on the left side clear alveolar with no side phenomenons, on the right side weakened at right basis, not regular heart rate, calm, heart sounds 2, bounded, legs without swellings and inflammatory changes, palpable peripheral pulse. On 12Apr2021: electrocardiography - atrial fibrillation, frequency 88/min, QRS 0.13 s, left bundle branch block; leukocytes 8.1/nl, erythrocytes 4.86/pl, platelets 145/nl. On 12Apr2021: x-ray of heart and lung - new right shadow fluidothorax-like and atelectasis-like in lower fields, blood congestion smaller than during previous examination, big cardiomegaly. On 27Apr2021 - blood pressure 130/70 mmHg, temperature 36.6 C, heart rate 80/min, respiratory rate 14/min. On 27Apr2021 - electrocardiography - heart rate irregular, atrial fibrillation frequency 68/min, QRS 110 ms, ST isoelectric, repolarization without pathology. On 27Apr2021 - N-terminal fragment brain natriuretic peptide 22 553.0 pg/ml, Oxygen saturation: 84%, international normalized ratio (INR) 1.4, prothrombin time ratio 1.4, activated partial thromboplastin time 34 s, activated partial thromboplastin time ratio - 1.37, D-dimers 2.36 mg/l, leukocytes 5.9/nl, erythrocytes 5.09/pl, mean cell hemoglobin concentration 310 g/l, Platelet count:125/nl. 27Apr2021 12:20 - chest x-ray - bigger shadow right side fluidothorax-like, bigger cardiomegaly. In May2021, INR 1.3, prothrombin time ratio 1.35, activated partial thromboplastin time 31 s, activated partial thromboplastin time ratio 1.24, D-dimers 1.77 mg/l, Platelet count: 118/nl, Platelet count: 106/nl, Platelet count: 102/nl. On 05May2021 computer tomography of brain - native acute - cannot differentiate between tiny subarachnoid bleeding and mere artefact left side highly parietally postcentrally. The patient died on 06May2021. Cause of death was cardiac decompensation, stroke suspected. An autopsy was not performed. The outcome of the event breathlessness progression was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac decompensation, stroke suspected; cardiac decompensation, stroke suspected


VAERS ID: 1440332 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D013A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021728715

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Regulatory Authority-WEB number DE-PEI-202100100827 from a non-contactable physician. A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: 1D013A) (at the age of 91 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of bnt162b2 (COMIRNATY), on 05May2021 (Batch/Lot Number: Unknown) (at the age of 90 years) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. This report is serious for death. On 10Jun2021 the patient experienced Unknown cause of death. The patient''s outcome was: fatal for Unknown cause of death. It was not reported if an autopsy was performed. Event assessment: Comirnaty/ event/Regulatory Authority/Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1440334 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021728777

Write-up: Thrombosis; Embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100100881. A 76-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose number unknown, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that the patient experienced embolism and thrombosis on unspecified date. The outcome of the event was fatal; it was unknown if an autopsy was done. No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Thrombosis; Autopsy-determined Cause(s) of Death: Embolism


VAERS ID: 1440337 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vasculitis
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of prostate; COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021770700

Write-up: Vasculitis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100108936. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Apr2021 (at the age of 59-year-old, Lot Number: EW8904) as single dose, and dose 2 via an unspecified route of administration on 28Apr2021 (at the age of 59-year-old, Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing Adenocarcinoma of prostate, ongoing chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. On 19Apr2021 the patient experienced Vasculitis.The patient''s outcome was: fatal for Vasculitis.The patient died on unknown date in 2021. This report is serious - death. The casual relationship of Comirnaty and event assessed as D. Unclassifiable by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number (the second dose)cannot be obtained.; Reported Cause(s) of Death: Vasculitis


VAERS ID: 1440339 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-11
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 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: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021770742

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100108941. A 79-year-old male patient received bnt162b2 (COMIRNATY, lot number: EX8679), via an unspecified route of administration on 05May2021 (at the age of 79-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Jun2021 the patient experienced Infarct myocardial. The patients outcome was: fatal for Infarct myocardial. The patient died on 11Jun2021. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and event assessed as D. Unclassifiable by the Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1440343 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Neurological symptom
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021770614

Write-up: Dyspnoea; Neurologic reaction; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100110000. A 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25May2021 (Batch/Lot Number: 1D012A) as single dose for covid-19 immunisation at the age of 83-year-old, dose 1 on 13Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation at the age of 82-year-old. Medical history included ongoing Arterial hypertension, Coronary disease. The patient''s concomitant medications were not reported. On 25May2021 the patient experienced Neurologic reaction, Dyspnoea. Outcome of the evens was fatal. The patient died on 26May2021 and unknown if autopsy was done. The casual relationship of Comirnaty and events assessed as D. Unclassifiable by the Regulatory Authority. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Neurologic reaction; Dyspnoea


VAERS ID: 1440359 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
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: DEPFIZER INC2021721513

Write-up: suddenly he was decompensated and died; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 65607], license party for Comirnaty. This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that, the reporter have lost his father directly after the first vaccination. The patient was not completely healthy, but fit. Suddenly he was decompensated and died on an unspecified date, 7 days after the vaccination. It was not reported if an autopsy was performed. The outcome for the event was fatal. Lot/batch number has been requested.; Reported Cause(s) of Death: suddenly he was decompensated and died


VAERS ID: 1440378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Suspected counterfeit product
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: DEPFIZER INC2021790857

Write-up: both parents died after first dose; suspicion on counterfeited vaccine has been used; This is a spontaneous report from contactable consumer. The consumer reported similar events for two patients (both her parents). This is the report for her mother. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (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 reporter stated both her parents have died on an unspecified date after first dose of bnt162b2, they received. The reporter complained on the health system and asked for support for further investigating the situation (if falsified or expired vaccines were used). It was not reported if an autopsy was performed. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021793654 Same reporter and event, different patient; Reported Cause(s) of Death: both parents died after first dose


VAERS ID: 1440379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Suspected counterfeit product
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: DEPFIZER INC2021793654

Write-up: both parents died after first dose; suspicion on counterfeited vaccine has been used; This is a spontaneous report from a contactable consumer. The consumer reported similar events for two patients (both her parents). This is the report for her father. A male patient of unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporting consumer stated both her parents had died on an unspecified date after first dose of bnt162b2, they received vaccine. The reporting consumer complained on the health system in Bulgaria and asked for support for further investigating the situation (if falsified or expired vaccines were used). Suspicion on counterfeited vaccine has been used on unspecified date. The outcome of the event "both parents died after first dose" was fatal, while of the other event was unknown. It was not reported if an autopsy was performed. The event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021790857 same reporter and event, different patient; Reported Cause(s) of Death: both parents died after first dose


VAERS ID: 1440380 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 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: 2021-05-27
   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: METHADONE; MOTIRON; VENLAFAXINE; DISULFIRAM; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Alcohol addiction; Depression; Drug withdrawal maintenance therapy; Fracture of ankle; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021728765

Write-up: Sudden death; This is a spontaneous report from two contactable physicians downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0069958. A 55-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 27May2021 (Batch/Lot Number: FA7812) (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fracture of ankle from 17May2021, hypertension, alcohol addiction, drug withdrawal maintenance therapy, attention deficit hyperactivity disorder (ADHD), and depression. Concomitant medications included methadone taken for drug withdrawal maintenance therapy from 16Dec2020; methylphenidate hydrochloride (MOTIRON) taken for ADHD from 05Oct2020; venlafaxine taken for depression from 12Mar2019; disulfiram taken for alcohol addiction from 28Nov2019; and amlodipine taken for hypertension from 07Feb2021. On 27May2021, the patient experienced sudden death. The patient died on 27May2021. An autopsy was performed on 03Jun2021 and results were not provided. There is no information regarding test results. Causality: Police finds patient dead and contacts the patient''s physician the initial reporter who informs the police that the death was unexpected in spite of known concurrent conditions. The police believe the death to be caused by heart failure, this has not been confirmed. The physician has not seen the patient during the last period. The physician at a Regulatory authority informs that there will be performed an autopsy on 03Jun2021 due to the timing between vaccination and patient death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1441154 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Akathisia, Increased bronchial secretion, Pyrexia, Restlessness, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (narrow), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PITAVASTATINA CINFA; URSOBILANE; EDOXABAN (9165A)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210641756

Write-up: BALSA; MOTOR RESTLESSNESS; INNER RESTLESSNESS; RAFT PRODUCTION; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-901825] concerned a 62 year old male. The patient''s weight was 85 kilograms, and height was 175 centimeters. The 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 17-MAY-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included pitavastatin 2 mg, ursodeoxycholic acid 300 mg and edoxaban used for unknown indication. On 2021, the patient experienced balsa. On 17-MAY-2021, the patient experienced raft production and fever. On 18-MAY-2021, he experienced inner restlessness. On 20-MAY-2021, the patient experienced motor restlessness. On an unspecified date, the patient died. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of inner restlessness, raft production, motor restlessness and fever on an unspecified date.The outcome of the balsa was not reported. This report was serious (Death, and Other Medically Important Condition). Additional information received from consumer on 23-JUN-2021. the following information was updated and incorporated into case narrative: Patient''s weight and height was added. Additional event Balsa.; Sender''s Comments: V1: Version created to update additional information received about patient demographics and events experienced. This updated information does not alter the prior causality assessment of previously reported events. 20210641756 -Covid-19 vaccine ad26.cov2.s-Inner restlessness, Raft production, Motor restlessness, Fever, Balsa. 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: INNER RESTLESSNESS; RAFT PRODUCTION; MOTOR RESTLESSNESS; FEVER


VAERS ID: 1441164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021728711

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213202. An 86-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21May2021 (Batch/Lot Number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient''s medical history were not reported. Concomitant medications includes unspecified antihypertensives and anticoagulants. The patient experienced cerebral haemorrhage on 24May2021. The patient died on 24May2021 due to the event. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about the batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


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