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

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



Case Details

This is page 136 out of 172

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VAERS ID: 1462796 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Body temperature, Restlessness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Gastric ulcer; Geromarasmus (the condition was close to geromarasmus); Prostatic hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021785390

Write-up: asphyxia due to vomit aspiration; asphyxia due to vomit aspiration; Tendency of unrest; Secondary unrest may have triggered vomiting; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21116266. The patient was a 94-year and 9-month-old male. Body temperature before vaccination was 37.0 degrees centigrade. Family history was not reported. Medical history included bronchitis chronic, gastric ulcer, and prostatic hypertrophy, and the condition was close to geromarasmus. Concomitant medication included bronchodilator and stomach medicine taken for unspecified indications, start and stop dates were not provided. On 24Jun2021 at 18:40 (the day of vaccination), the patient received the first 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 25Jun2021 (1 day after the vaccination), the patient experienced tendency of unrest, vomit and found with level decreased state, considered to asphyxia due to vomit aspiration. The outcome of the events was fatal. The course of the events was as follows: Prior to the vaccination, the patient had decreased food intake overall and the condition was close to geromarasmus; however, on the day of the vaccination, the patient sat and ate meal(s) on his own. During the nighttime, the patient showed tendency of unrest a little. Finally, the patient was found with level decreased in a toilet while sitting. Reportedly, there was vomit. Anaphylaxis was denied. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was asphyxia due to vomit aspiration. The reporting physician commented as follows: There was a possibility that the patient secondarily developed unrest, which induced vomiting. It was not reported if the autopsy was performed.; Reported Cause(s) of Death: asphyxia due to vomit aspiration; asphyxia due to vomit aspiration


VAERS ID: 1462807 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardio-respiratory arrest, Computerised tomogram thorax, 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), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: blood test; Result Unstructured Data: Test Result:suspected pulmonary embolism; Test Date: 20210617; Test Name: chest CT; Result Unstructured Data: Test Result:suspected pulmonary embolism
CDC Split Type: JPPFIZER INC2021786033

Write-up: Cardio-respiratory arrest; Pulmonary embolism; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting. The patient was a non-pregnant 90-year-old female. 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. Other medical history included dementia Alzheimer''s type. On an unspecified date (the day of vaccination) in Jun2021, the patient received single dose of BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number, and Expiration date were not provided) via an unspecified route of administration for COVID-19 immunization at a clinic/emergency room at the age of 90-year-old. On 17Jun2021 (1 week after the vaccination), the patient suddenly developed cardio-respiratory arrest. Based on the results of chest CT and blood test, pulmonary embolism was suspected as a cause of death. The event resulted in death/emergency room/department or urgent care. The outcome of the event was fatal without treatment. An autopsy was not performed. The reporting physician assessed the event as serious (death). The assessment of 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 information currently available, a causal association between the reported events suspected pulmonary embolism and subsequent cardio-respiratory arrest and BNT162B2 cannot be fully excluded. The patient''s advanced age and the underlying risk factors/predisposing condition dementia Alzheimer''s type have been assessed to have played a contributory role toward 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 RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest; Pulmonary embolism


VAERS ID: 1462810 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Death, Pyrexia, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blister rupture; Hospitalisation; Metastases to lung; Oedema lower limb; Pancreatic carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021786148

Write-up: the patient died; bilateral lower knee pain; pyrexia; the skin color of the lower legs turned dark red, and after that, it turned dark purple; Blood pressure decreased; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 81-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included pancreatic carcinoma, metastases to lung, oedema of both lower limbs, and blister rupture of both lower legs. The patient had admitted to the palliative care unit on 14Jun2021. There was no relevant past drug history. On 15Jun2021 at 13:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular route of administration in the left arm for COVID-19 immunization at the age of 81-year-old. On 16Jun2021 at 06:30 (1 day after the vaccination), the patient experienced adverse events. The patient developed bilateral lower knee pain and pyrexia. Thereafter, the skin color of the lower legs turned dark red, and after that, it turned dark purple. The blood pressure was decreased, and the patient died on 17Jun2021(2 days after the vaccination). The cause of death was reported as unknown. No autopsy was performed. The outcome the event was reported as fatal. Treatment provided included localized cooling and administration of an analgesic drug. The reporting physician classified the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event death and the suspect drug. 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: the patient died


VAERS ID: 1462825 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Imaging procedure
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: 2021-06-13
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: AI; Result Unstructured Data: Test Result:did not reveal any findings attributable to death
CDC Split Type: JPPFIZER INC2021791476

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 71-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration on 13Jun2021 at 10:30 (the day of vaccination) (at the age of 71-year-old) as dose 2, single for COVID-19 immunization. Relevant medical history included cardiac hypertrophy. Body temperature before vaccination was not reported. Family history was not reported. Concomitant medication was not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunisation on an unspecified date. On 13Jun2021 at 20:50 (10 hours 20 minutes after the vaccination), the patient experienced cardio-respiratory arrest. Family member noticed that the patient was unresponsive when he was watching TV while lying on the floor. Emergency medical technician confirmed cardio-respiratory arrest and asystole. The patient was unresponsive to resuscitation. On an unknown date in Jun2021, the patient autopsy imaging (AI) did not reveal any findings attributable to death. The reporting physician classified the event as serious (death) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was cardiac hypertrophy. The patient died on 13Jun2021 due to cardio-respiratory arrest. It was unknown if an autopsy was performed. The reporting physician commented: Although the patient had a history of cardiac hypertrophy, physical condition before vaccination was good and there was no chest symptom. It was unlikely that cardiac hypertrophy was the cause of sudden death. There were multiple reports in which similar cases of sudden death was reported due to COMIRNATY intramuscular injection.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1462863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830146

Write-up: Collapse; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. A 64-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), intramuscularly on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced collapse, death (death, medically significant) on an unspecified date. Onset of reaction was 2 days. The outcome of the event 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: Collapse


VAERS ID: 1462864 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood pressure decreased, Cardiogenic shock, Diarrhoea, Electrocardiogram ST segment elevation, Lethargy, Lip swelling, Periorbital swelling, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830148

Write-up: Cardiogenic shock; ST segment elevation; Blood pressure decreased; Diarrhoea; Vomiting; Abdominal discomfort; Lethargy; Periorbital swelling; Lip swelling; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. A 65-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), intramuscular on an unspecified date (at age of 65 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had Cardiogenic shock (onset: 4 Day, fatal), ST segment elevation (onset: 3 Day), Blood pressure decreased (onset: 3 Day), Diarrhoea (onset: 3 Day), Vomiting (onset: 3 Day), Abdominal discomfort (onset: 3 Day), Lethargy(onset: 3 Day), Periorbital swelling (onset: 1hr), Lip swelling (onset: 1hr). The patient died due to Cardiogenic shock on an unspecified date. It was unknown if an autopsy was performed. Seriousness for Periorbital swelling, Lip swelling was No. For all other events was Yes (medically significant). Relatedness: Possible. The outcome of the event Cardiogenic shock was fatal, for Periorbital swelling, Lip swelling was recovered on unknown date, for other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1462870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830162

Write-up: Myocardial infarction; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. A 42-year-old male patient started to receive bnt162b2 (COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION) as DOSE NUMBER UNKNOWN, SINGLE via intramuscular on an unknown date for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, 14 day after the vaccination, the patient experienced Myocardial infarction. The outcome of reaction was reported as fatal / death to Myocardial infarction. Causality assessment of the reporter was possible to Myocardial infarction, Seriousness was Yes. No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1462958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021797034

Write-up: Death; central chest pain radiating to neck and both arms; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FA8016), via an unspecified route of administration in May2021 at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EW4815) administered on 25Apr2021 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jun2021, 13 days after the second dose, the patient experienced death. The cause of death was unknown. According to healthcare records the previously healthy patient was found dead by ambulance staff. Relative report unclear information that the patient had suffered from central chest pain radiating to neck and both arms a few days after the vaccination. The patient did not contact healthcare about it but thought it might be from the vaccination. The outcome of chest pain at the time of death was unknown. Autopsy was requested but it was unknown if performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: death nos


VAERS ID: 1463936 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-29
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Embolism, Loss of consciousness, Malaise, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Past medical history included "homocysteinurie."
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: beeld van asystolie; beeld van embool; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; op 29/06 plots onwel; tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies; overlijden; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (overlijden), CARDIAC ARREST (beeld van asystolie), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies), EMBOLISM (beeld van embool), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) and MALAISE (op 29/06 plots onwel) in a 27-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Past medical history included "homocysteinurie.". On 25-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced DEATH (overlijden) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant), SEIZURE (tijdens hulpverlening convulsieve bewegingen en bewustzijnsverlies) (seriousness criteria death and medically significant) and MALAISE (op 29/06 plots onwel) (seriousness criterion death). On an unknown date, the patient experienced CARDIAC ARREST (beeld van asystolie) (seriousness criteria death and medically significant) and EMBOLISM (beeld van embool) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment was reported for the events. Translation is pending. Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1464081 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 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: DEPFIZER INC2021804259

Write-up: DEATH; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100049925. An 81-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 30Mar2021, dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The case was assessed as serious. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1465420 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021812977

Write-up: Reduced fetal movement the day after vaccination then no movement from the 3rd to 5th day after being vaccinated; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer. This is the second of second reports. This consumer reported for a patient (fetal) that: A patient of an unspecified age and gender (Date of LMP Nov2020) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via transplacental route of administration in left arm on 25May2021 (Lot Number: EW4109 Expiry date: UNKNOWN) as a single dose for COVID-19 immunisation. Date of LMP for mother was Nov2020. medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On an unspecified date the patient experienced reduced fetal movement the day after vaccination then no movement from the 3rd to 5th day after being vaccinated, maternal exposure during pregnancy, first trimester. The patient visited emergency room. The outcome of the events was unknown.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021676366 mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy, first trimester; Reduced fetal movement the day after vaccination then no movement from the 3rd to 5th day after being vaccinated


VAERS ID: 1465482 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Condition aggravated, Decreased appetite, Neoplasm progression
SMQs:, Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN; GASTER D; AMITIZA; GASMOTIN; MYSLEE; MAGMITT; ALOSENN [SENNOSIDE A+B]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial flutter; Cancer of head of pancreas metastatic (pT3N1bM0 pStageIIB); Hypertension; Hyperuricaemia; Metastases to liver
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021785922

Write-up: aggravation of underlying disease of cancer of head of pancreas (with metastases to liver).; Condition aggravated; Appetite impaired; This is a spontaneous report from a contactable physician received via the Agency. The patient was a 78-year and 8-month old male. Body temperature before vaccination was 37.0 degrees centigrade. The patient had no family history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received valsartan (DIOVAN) (40 mg) 1 tablet per oral once daily in the morning, famotidine (GASTER D) (20 mg) 1 tablet per oral once daily in the morning, lubiprostone (AMITIZA) (24 ug) 2 capsules per oral twice daily in the morning and evening, mosapride citrate (GASMOTIN) (5 mg) 3 tablets per oral once daily at night, zolpidem tartrate (MYSLEE) (5) 1 tablet per oral once daily before go to bed, magnesium oxide (MAGMITT) (330 mg) 3 tablets per oral once daily at night, and sennoside a+b (ALOSENN) granules 0.5 g per oral once daily before go to bed within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included cancer of head of pancreas (with metastases to liver, Stage IV), atrial flutter, hypertension, and hyperuricaemia. The patient had no allergies to medications, food, or other products. On 26May2021 at 15:50 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) (at the age of 78-years-old) intramuscular in the arm left for COVID-19 immunization. On 10Jun2021 (15 days after the vaccination), the patient experienced condition aggravated. The event resulted in death. The event resulted in department or urgent care. The outcome of the event was fatal. It was unknown whether the patient received treatment. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: On 26May2021, the patient received the first dose of coronavirus vaccine (COMIRNATY). There was no marked change in general condition and contraindications were not applicable. Vaccination was performed upon obtaining informed consent. On 31May2021, the patient visited the hospital again and requested to prescribe hypnotic since the patient ran out of it. Previously prescribed MYSLEE (5) 1 tablet once daily before going to bed was prescribed. The patient had appetite impaired and requested to receive infusion, for which BFLUID (500) was intravenously administered. On 10Jun2021 (day 15), although details were unknown, information was received from a staff of town office who was in charge of coronavirus vaccination that the patient died on 10Jun2021. Although causality between COMIRNATY vaccination and the death was unknown, the case was reported since the condition aggravated in relatively short time after the vaccination. The reporting physician classified the event as serious (death). Cause of death was reported as unknown. No autopsy was performed. 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 aggravation of underlying disease of cancer of head of pancreas (with metastases to liver). The reporting physician commented as follows: Although causality between COMIRNATY vaccination and the death was unknown, the case was reported since the condition aggravated in relatively short time after the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Condition aggravated; aggravation of underlying disease of cancer of head of pancreas (with metastases to liver).


VAERS ID: 1465510 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), 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), 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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021791336

Write-up: Myocardial infarction; Cardio-respiratory arrest; This is a spontaneous follow-up report from a physician via the Agency. The patient was a 79-year-old male. The most recent COVID-19 vaccine was administered at group vaccination site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks. 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. There was no other medical history. On 30May2021 at 15:30, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) (at the age of 79-years-old) intramuscularly in the left arm for COVID-19 immunisation. Reason why batch/lot is unknown: unable to locate or read the details. On 20Jun2021 at 15:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) (at the age of 79-years-old) intramuscularly in the left arm for COVID-19 immunisation. On 21Jun2021 (1 day after the vaccination), the patient experienced myocardial infarction. On 21Jun2021 in the morning, the family found the patient in a state of cardio-respiratory arrest. The police involved to handle this as unnatural death. It was reported that the death was due to myocardial infarction according to the postmortem examination done by the police. The death cause was myocardial infarction. It was unknown whether autopsy was performed. Treatment was not given for the event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1465511 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Computerised tomogram, Electrocardiogram
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Name: Whole body plain CT test; Result Unstructured Data: Test Result:could not identify apparent cause of death; Test Date: 20210624; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC2021791462

Write-up: Sudden death (asystole)/sudden death due to cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116517. The patient was a 90-year and 7-month-old male. Body temperature before vaccination was 36.0 degrees centigrade. Family history was unknown. Medical history included hypertension. Concomitant medication included acetylsalicylic acid (ASPIRIN) enteric-coated tablet taken orally for an unspecified indication, start and stop dates were not provided. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunization. On 22Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at around 07:00 (2 days after the vaccination), the patient experienced sudden death (asystole). On 24Jun2021 shortly after 07:00, family member found the patient lay on the bed and unresponsive, for which ambulance was requested. When emergency medical service arrived, electrocardiogram showed asystole. Chest compression, endotracheal intubation, and intravenous administration of adrenaline were performed. Cardiopulmonary resuscitation was continued after arriving at the reporting hospital but it was not successful. On 24Jun2021 at 08:44, death was confirmed. Whole body plain CT test and inspection by the police could not identify apparent cause of death. The patient had a history of hypertension and calcification was noted in coronary artery and aortic valve; thus, it was diagnosed as sudden death due to cardiac failure acute. However, it was 2 days after the vaccination and causality between the vaccine and the event could not be denied completely. Family member who lived together with the patient told that the patient had no change in physical condition on 22Jun2021 and on 23Jun2021. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was sudden death due to cardiac failure acute. The reporting physician commented as follows: It was sudden cardiac death occurred 2 days after the vaccination of COMIRNATY intramuscular injection. Although causality between the vaccine and the event could not be denied completely, it was likely that the patient had latent heart disease, which resulted in sudden death.; Reported Cause(s) of Death: Sudden death (asystole)/sudden death due to cardiac failure acute


VAERS ID: 1465521 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: AST/ALT ratio, Blood glucose, Blood lactate dehydrogenase, Body temperature, Cardiac arrest, Computerised tomogram, Loss of consciousness, Troponin I, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Cough (the symptoms had remained unchanged since before); Diabetes mellitus (permission was obtained from the family physician); Sputum (the symptoms had remained unchanged since before)
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: AST/ALT; Result Unstructured Data: Test Result:475/416; Test Date: 20210623; Test Name: Blood sugar level; Test Result: 547 mg/dl; Test Date: 20210623; Test Name: LDH; Result Unstructured Data: Test Result:1222; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210623; Test Name: CT as autopsy imaging; Result Unstructured Data: Test Result:revealed no clear cause of death; Test Date: 20210623; Test Name: TnI; Result Unstructured Data: Test Result:0.060; Test Date: 20210623; Test Name: WBC; Result Unstructured Data: Test Result:14260
CDC Split Type: JPPFIZER INC2021800029

Write-up: The wife found the patient lying in front of the wash basin; Asystole; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21116607. The patient was an 84-year and 2-month-old male. Body temperature before vaccination was 36.7 degrees centigrade on 22Jun2021. Family history was not reported. Medical history included diabetes mellitus (permission was obtained from the family physician) and cough and sputum symptoms (the symptoms had remained unchanged since before). Concomitant medications were not reported. On 22Jun2021 at 15:00 (the day of vaccination, at 84-year-old), the patient received the first 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 immunisation. On 23Jun2021 (1 day after the vaccination), the wife found the patient lying in front of the wash basin at 02:40, and the patient experienced asystole at unknown time. On 23Jun2021 (1 day after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 22Jun2021 after the vaccination, the patient said that he slightly felt dull. On 22Jun2021 around 24:00 (9 hours after the vaccination), the patient was last seen by his wife. On 23Jun2021 around 02:40 (1 day after the vaccination), the wife found the patient lying in front of the wash basin and called an ambulance. The patient was soaked in sweat. He was asystole when he was touched by the emergency crew. Cardiopulmonary resuscitation (CPR) was continued, but asystole had remained. At 15:33, death was confirmed. Computerised tomography (CT) as autopsy imaging revealed no clear cause of death. The blood test at hospital visit included blood sugar level 547 mg/dL, aspartate transaminase (AST)/alanine aminotransferase (ALT) 475/416, lactate dehydrogenase (LDH) 1222, white blood cell (WBC) 14260, and troponin I (TnI) 0.060. The outcome of the events was fatal. The patient died on 23Jun2021. The autopsy was performed. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: It was presumed that a certain time had passed after death, and the course of the symptoms was unknown. Therefore, they considered the relation as unknown.; Reported Cause(s) of Death: The wife found the patient lying in front of the wash basin; Asystole


VAERS ID: 1465526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-28
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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: 2021-06-28
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210710066

Write-up: SUDDEN DEATH; This spontaneous report received from a patient concerned a 3 decade 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) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-JUN-2021 (18 days after vaccination), the patient experienced sudden death. The patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the Others is linked to 20210710044.; Sender''s Comments: V0 : 20210710066-COVID-19 VACCINE JANSSEN-SUDDEN death. This event is considered unassessable. The event 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1465553 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiocardiogram, Cardiac failure, Ejection fraction, General physical health deterioration, Malaise, Physical examination
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESLORATADINE; AMLODIPINE; COLECALCIFEROL; EDOXABAN; TEMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (contrast); Aortic valve replacement (Family history: not present); Aortic valve stenosis (Family history: not present); Atrial fibrillation (Family history: not present); Fatigue (since October); Hypertension (Family history: not present); Lichen simplex chronicus (Family history: not present); Stent placement (abdominal Family history: not present)
Allergies:
Diagnostic Lab Data: Test Date: 2015; Test Name: CAG; Result Unstructured Data: Test Result:No significant coronary disease; Test Date: 20201110; Test Name: Left ventricular function; Result Unstructured Data: Test Result:70% LVH; Comments: 70 % with Teich, patient has LVH with good contractions (at least 60% EF); Test Date: 2021; Test Name: Physical examination; Result Unstructured Data: Test Result:Dyspnoeic; Comments: General impression: Dyspnoeic patient, clear and adequate. A: Free, inspiring peaks. B: AH: 28/min, sat: 90% at 6L O2. Pulmonary: Normally inbound wheezing with bibasal crepitation. C: Cap! Refill: 2sec. CVD not increased. RR: 125/83mmHg, Hf: 115/min Cor: S1S2 without Abdomen: Smooth abdomen, no pressure pain. Extremors: Odema peripheral edema, soft jaundice. D: EMV max, glucose: 6.6 E: temp: 36.5.
CDC Split Type: NLPFIZER INC2021400106

Write-up: Heart failure; malaise/Has not been pleasant; general physical health deterioration/Condition backwards; Abdominal pain; Malaise; This is a spontaneous report from a contactable physician reporting information for the same patient. This is the second of two reports. The first report is a report downloaded from the Agency Regulatory Authority-WEB manufacturer report number NL-LRB-00496928. An 83-years-old female patient received the first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 19Feb2021 (at the age of 83 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included aortic valve replacement, aortic valve stenosis, hypertension on unknown date in 2015, atrial fibrillation on unknown date in 2019, stent placement, lichen simplex chronicus, fatigue (since October) and allergy (contrast). Concomitant medications included desloratadine taken for pruritus, eczema and neurodermatitis, amlodipine taken for hypertension, edoxaban taken for atrial fibrillation, colecalciferol and temazepam taken for an unspecified indication, start and stop dates were not reported. On 19Feb2021, the patient experienced malaise. On 05Mar2021, the patient experienced malaise/Has not been pleasant, general physical health deterioration/Condition backwards and abdominal pain. On unspecified date the patient experienced heart failure. No previous covid-19 infection. No thrombosis suspicion. The patient already taking edoxaban at adequate dosage. The physician himself and therefore not the death certificates, leading cause of death, i.e. heart failure. Since October, more fatigue (when no cardiac origine can be found in physical research, lab and echocardiogram), true decline since 2-3 weeks, when, in addition to domestic help, a lot of help from her 3 daughters. Abdominal pain and general malaise appear at first sight to have little relationship to shortness of breath and heart failure. There''s no cause for this, general malaise can be felt with such a bad LVF. Difficult to assess, there was no evidence to show, especially feeling/observation. We had a lot of hospitalization after vaccination. In cardiology, for example, exacerbation heart failure. inflammation/ inflammation may worsen symptoms of heart failure. In addition to this, there is also a need to include in internal medicine. Malaise after vaccination. Healthy young people also have side effects from vaccinations such as fever. Young people who are healthy can handle this. Older people with already weak health are sometimes just too much for their pre-existing reduced physical condition that hospital admissions follow. We have not reported enough from the hospital, because of our own experience, all these hospital admissions after vaccination are not known to me. The patient died on 02Apr2021. The cause of death was cardiac failure and dyspnoea. The event cardiac failure was serious (fatal). The patient underwent lab tests and procedures which included angiocardiogram no significant coronary disease on unspecified date in 2015, ejection fraction 70% lvh on 10Nov2020 and physical examination dyspnoeic on unspecified date in 2021 (general impression: Dyspnoeic patient, clear and adequate. A: Free, inspiring peaks, B: AH: 28/min, sat: 90% at 6L O2, Pulmonary: Normally inbound wheezing with bibasal crepitation, C: Cap! Refill: 2sec, CVD not increased. RR: 125/83mmHg, Hf: 115/min Cor: S1S2 without Abdomen: Smooth abdomen, no pressure pain. Extremors: Odema peripheral edema, soft jaundice, D: EMV max, glucose: 6.6 E: temp: 36.5). Outcome of the event heart failure was fatal, for event malaise/Has not been pleasant, general physical health deterioration and abdominal pain was not recovered; for remaining event was unknown. Autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (30Apr2021): New information reported from a contactable healthcare professional from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00496928 (spontaneous report) includes a new reference number NL-LRB-00506252. Case has been upgraded from non-serious to serious case due to additional fatal event of cardiac failure. New information included: relevant medical history, lab data, dose description and indication for concomitant drugs, death and autopsy details updated, new events malaise and cardiac failure were added.; Reported Cause(s) of Death: Dyspnoea/shortness of breath; Heart failure


VAERS ID: 1466143 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SD0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, COVID-19, Confusional state, Death, Loss of consciousness, Muscular weakness, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: COVID PCR swab; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021804493

Write-up: Abdominal pain; Fever; Weakness of lower limbs; Confusion; COVID polymerase chain reaction (PCR) swab: positive; died; Collapsed / Falling; This is a spontaneous report from a contactable other hcp. A 66-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration on 24Jun2021 12:47 (Lot Number: SD0927; Expiration Date: Sep2021) as dose 1, single (at the age of 66-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Jun2021, the patient experienced abdominal pain on 25Jun2021 12:00, fever, weakness of lower limbs, confusion, collapsed/falling, the patient was reported to have died on 25Jun2021 while at home. Test COVID polymerase chain reaction (PCR) swab: positive on 25Jun2021. Outcome of abdominal pain, fever, weakness of lower limbs, confusion, collapsed/falling, COVID polymerase chain reaction (PCR) swab: positive was unknown. Autopsy was reported to have been performed, results were not made available. No further details were provided at the time of this report.; Sender''s Comments: The causal relationship between BNT162b2 and the events death, abdominal pain, pyrexia, muscular weakness, confusional state, loss of consciousness, and COVID-19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: died


VAERS ID: 1466175 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-21
Submitted: 0000-00-00
Entered: 2021-07-13
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: 2021-06-21
   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: Comments: Pacemaker wearer - Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210722300

Write-up: DEATH UNEXPLAINED; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-2021087227] concerned a 72 year old male of unknown ethnic origin and race. The patient''s weight was 95 kilograms, and height was 175 centimeters. The patient''s pre-existing medical conditions included pacemaker wearer - heart failure .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-02 expiry: UNKNOWN) frequency 1 total 1 dosage forms, administered on 21-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 21-JUN-2021, the patient experienced death which was unexplained. 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: 20210722300-COVID-19 VACCINE AD26.COV2.S- Death Unexplained. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1466290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-15
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebrovascular accident, Dysarthria, Dysphagia, Hemiparesis, Pulmonary oedema, Thrombosis
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021795165

Write-up: the liquid was passing through the lungs; CVA; Dysarthria; Hemiparesis (left); Unable to swallow; recurrence of atrial fibrillation; clot; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number BE-FAMHP-DHH-N2021-84740. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took anticoagulants and experienced cardiac fibrillation. The patient experienced CVA, hemiparesis (left), dysarthria, unable to swallow and death. In residence (MRS) and in a wheelchair; incontinent; can eat alone: needs help washing and using the toilet. On 15Jan2021 the patient had stroke within 48 hours of vaccination. According to the attending physician, stroke was due to a recurrence of atrial fibrillation which formed a clot and the lady had already had fibrillation with anticoagulant in time. Death on 23Jan2021 from the consequences of his stroke (impacts: total paralysis on the left side, inability to speak and swallow and inability to put an infusion since the liquid was passing through the lungs). The patient died on 23Jan2021. It was not reported if an autopsy was performed. Reporter comment: In residence (MRS) and in a wheelchair; incontinent; can eat alone: needs help washing and using the toilet. 15Jan2021: Stroke within 48 hours of vaccination. According to the attending physician, stroke is due to a recurrence of atrial fibrillation which formed a clot and the lady had already had fibrillation with anticoagulant in time. Death on 23Jan2021 from the consequences of his stroke (impacts: total paralysis on the left side, inability to speak and swallow and inability to put an infusion since the liquid was passing through the lungs). No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: In residence (MRS) and in a wheelchair; incontinent; can eat alone: needs help washing and using the toilet. 15Jan2021: Stroke within 48 hours of vaccination. According to the attending physician, stroke is due to a recurrence of atrial fibrillation which formed a clot and the lady had already had fibrillation with anticoagulant in time.; Reported Cause(s) of Death: stroke; Hemiparesis (left); Unable to swallow; Dysarthria


VAERS ID: 1466291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Fall, Fatigue, Malaise, Myalgia, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: LYRICA; TRADONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021795201

Write-up: Sudden death with no other explanation/Sudden death; Fall; Fatigue; fleeting thoracic D+/chest pain; Myalgia; Fever; shivering; Malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number BE-FAMHP-DHH-N2021-91187. A 48-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Batch/Lot Number: EX2405) as single dose for covid-19 immunisation. Medical history included tobacco. Concomitant medications included pregabalin (LYRICA) and tramadol hydrochloride (TRADONAL). On 03May2021, patient experienced fever, malaise, shivering, fatigue, myalgia, fall, chest pain, on 07May2021, patient experienced sudden death. Events was further described as follows: Sudden death with no other explanation, malaise, fall and death, failure to attend on 07May2021. No visible cause of death, no known vascular disease, general malaise since Monday 03May2021, did not consult (fleeting thoracic D+ on 03May2021, lasting about 1h, took Dafalgan 1g). For events fever, malaise, shivering, fatigue, myalgia, fall, sudden death, there was no treatment. The outcome of the events was fatal. The patient died on 07May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fleeting thoracic D+/chest pain; Myalgia; Fever; Sudden death with no other explanation/Sudden death; Fall; Shivering; Malaise; Fatigue


VAERS ID: 1466361 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-05-28
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

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

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: ASPIRIN CARDIO; PERINDOPRIL; AMIODARONE
Current Illness: Coronary disease (Date of diagnosis of stable coronary artery disease was unknown); Hypertension (Diagnosis date was unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Patient; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Patient .) in an 81-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001656 and 3000496) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Diagnosis date was unknown) and Coronary disease (Date of diagnosis of stable coronary artery disease was unknown). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), PERINDOPRIL and AMIODARONE for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 28-May-2021 The patient died on 28-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Patient.) to be unlikely related. The reporter stated that it was unknown whether the patient had any sort of allergy. On 28 May 2021 the patient collapsed in his backyard and was found dead by his wife. The face turned blue and was given futile cardiopulmonary resuscitation. The reporter assumed that the death may be due to sudden cardiac death or pulmonary embolism. No further treatment information was provided. Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Translation document was received on 07 Jul 2021. Patients medical history information and narrative was updated.; Sender''s Comments: Company comment: Very limited information regarding this event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1466381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 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: Adiposis; Chronic idiopathic pain syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021758621

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number DE-PEI-202100105615. A 62-year-old male patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included adiposis and chronic idiopathic pain syndrome both from an unknown date. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Lot number was not reported) on an unspecified date as 1st dose for covid-19 vaccination, and experienced no adverse event. The patient experienced sudden death unexplained on an unspecified date. The outcome of sudden death unexplained was fatal. The patient died on an unspecified date. An autopsy was not performed. Event Result of Assessment: UNCLASSIFIABLE. This report is serious - death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1466390 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cytokine release syndrome, Cytokine test, Disseminated intravascular coagulation, Multiple organ dysfunction syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cytokine; Result Unstructured Data: Test Result:increase; Comments: massive cytokine increase
CDC Split Type: DEPFIZER INC2021818098

Write-up: Disseminated intravascular coagulation; Multiple organ failure; Cytokine release syndrome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (RA)-WEB DE-PEI-202100116970. A 50-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection) (mRNA TOZINAMERAN), dose 2 intramuscular on 07Jun2021 (Batch/Lot Number: FA5833) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Previously patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Jun2021 (Batch/Lot Number: not reported) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. On 07Jun2021 the patient experienced cytokine release syndrome, disseminated intravascular coagulation and multiple organ failure. Lab investigations includes massive cytokine increase. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report is serious - death, hospitalization, life threatening. Outcome was reported as fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cytokine release syndrome; Disseminated intravascular coagulation; Multiple organ failure


VAERS ID: 1467239 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein, Death, Deep vein thrombosis, Fibrin D dimer, Full blood count, Metabolic function test, Pulmonary embolism, Renal function test, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Various asthma and anxiety medications
Current Illness: No
Preexisting Conditions: Emphysema, anxiety
Allergies: No
Diagnostic Lab Data: FBC, U&E, CMP, CRP, D-Dimer, Covid-19 PCR: 10/07/2021
CDC Split Type:

Write-up: Deep vein thrombosis and pulmonary embolisms 3 days after vaccine, and death 11 days after vaccine.


VAERS ID: 1467342 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Internal carotid artery stenosis (ACI-Stenosis); Intervertebral disc protrusion (discus protrusion L4/L5)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021804062

Write-up: Cardiopulmonary insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number AT-BASGAGES-2021-33611. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Jun2021 (Lot Number: FD0168) as single dose for COVID-19 immunisation. Medical history included ongoing carotid artery stenosis (ACI-Stenosis), ongoing dementia dementia, ongoing intervertebral disc protrusion (discus protrusion L4/L5). Concomitant medications were not reported. Previously the patient received the first dose of COMIRNATY (Lot # EY7015) on 07May2021 for COVID-19 immunisation. The patient experienced cardiopulmonary insufficiency (medically significant) on 24Jun2021. The patient died on 24Jun2021 from cardiopulmonary insufficiency. An autopsy was not performed. Sender''s comment: comment: No further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiorespiratory insufficiency


VAERS ID: 1467390 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021862462

Write-up: sepsis; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority (RA). Regulatory authority report number is 579102. A 67-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sepsis on 09May2021. The event was serious, 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: sepsis


VAERS ID: 1467391 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease progression
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: AUPFIZER INC2021862471

Write-up: concomitant disease progression; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority (RA). Regulatory authority report number is 579532. An 82-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on 02Jul2021. The event was serious, 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: concomitant disease progression


VAERS ID: 1467402 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Dyspnoea, Fatigue, General physical health deterioration, Headache, Hypokinesia, Myalgia, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 20
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 Name: sars-cov-2 test; Test Result: Positive
CDC Split Type: BEPFIZER INC2021795634

Write-up: Arthralgia; Myalgia; Headache; Difficulty breathing; COVID-19; General physical health deterioration; Fatigue; Movements reduced; Syncope; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-98133. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: Unknown) as Dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arthralgia, myalgia, headache, difficulty breathing, covid-19, general physical health deterioration, fatigue, movements reduced, syncope, fever all on 11Apr2021. The events resulted in Physician Office Visit, hospitalization and death. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Therapeutic measures were taken including dafalgan, ibrufen. The outcome was fatal. The patient died in May2021. It was not reported if an autopsy was performed. Reporter comment: Treatment - Yes dafalgan, ibrufen Evolution of the ADR - fatal Following the vaccination, that is to say in the afternoon, my husband triggered headaches, fever, pain all over. 2 days after the vaccination, my husband was sicker, more and more difficult to move and breathe. We contacted the doctor who confirmed to my husband that we had caught a bacteria at the same time as the vaccine and that it was necessary to alternate between Dafalgan and Ibrufen, which he did but day after day her condition was getting worse. On Sunday 18Apr2021 I found my husband collapsed on our couch, I had him hospitalized and there a doctor told me that he was very contagious, that he had covid. On 19Apr2021 he had to intubate him, his fight against the disease lasted 3 weeks to end in death. I think it was the vaccine that started it all and the death of my husband. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment Treatment - Yes dafalgan, ibrufen Evolution of the ADR - fatal I think it was the vaccine that started it all and the death of my husband.; Reported Cause(s) of Death: Arthralgia; myalgia; headache; difficulty breathing; covid-19; general physical health deterioration; fatigue; movements reduced; syncope; fever


VAERS ID: 1467403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Diarrhoea, Dyspepsia, Endoscopy upper gastrointestinal tract, Fatigue, Haemorrhage, Influenza like illness, Myalgia, Nasopharyngitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 25
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: Amyotrophic lateral sclerosis; Charcot''s syndrome; Diabetes (diabetes without being on insulin); Immune system disorder; Pacemaker syndrome (pacemaker for less than 5 months); Psoriasis
Allergies:
Diagnostic Lab Data: Test Name: gastroscopy; Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021795627

Write-up: COVID-19; Diarrhea; Fever; Two days after receiving the vaccine, she did not feel well, as if she was in a flu-like state.; Difficult digestion; Cold; giant fatigue; haemorrhage; muscle aches; Appetite lost; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB BE-FAMHP-DHH-N2021-98432. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY), intramuscularly on 12Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes without being on insulin, psoriasis, pacemaker for less than 5 months, charcot''s foot, immune system was poor due to amyotrophic lateral sclerosis(ALS). The patient''s concomitant medications were not reported. The patient experienced covid-19, diarrhea, fever, two days after receiving the vaccine, she did not feel well, as if she was in a flu-like state, difficult digestion, cold, giant fatigue, haemorrhage, muscle aches, appetite lost on 14Apr2021. Her doctor prescribed a gastroscopy to calm the diarrhoea, and a blood test was to be carried out within ten days. She was not well at all, so decided to admit her to hospital on 22Apr2021at around 7.30pm. The diagnosis was COVID. On May 3rd at 2.20pm the hospital announced that they had to intubate my mum, and despite the critical phase everything remained stable and controlled from the night of 08May2021 to 09May2021 at 2.22 am she died of a haemorrhage. The patient died on 09May2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; Diarrhea; Fever; Two days after receiving the vaccine, she did not feel well, as if she was in a flu-like state.; Difficult digestion; Cold; giant fatigue; muscle aches; Appetite lost; haemorrhage


VAERS ID: 1467489 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; Pyrexia; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 75-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and PYREXIA (Pyrexia). On 20-Jun-2021, PYREXIA (Pyrexia) had not resolved. The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. Full strength broad spectrum antibiotic was given as treatment. No relevant concomitant medications were reported. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Further information is not expected; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467492 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Post procedural haemorrhage, Vascular procedure complication
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus insulin-dependent; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021804139

Write-up: Heart attack (infarct myocardial); Bypass surgery complications; Post-operative bleeding; This is a spontaneous report from a non-contactable physician downloaded from the WEB. The regulatory authority report number is DE-PEI-202100062333. A 73-year-old female patient received BNT162B2 (COMIRNATY; Lot Number was not reported), via an unspecified route of administration, on 15Apr2021 (at the age of 73 years), as dose number unknown, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history included ongoing diabetes mellitus insulin-dependent, ongoing hypertension, and apoplexy. The patient''s concomitant medications were not reported. On 23Apr2021, the patient experienced heart attack (infarct myocardial). It was also reported that the patient''s causes of death included heart attack (infarct myocardial), bypass surgery (as treatment to heart attack), complications, and post-operative bleeding on an unspecified date in 2021. The outcome of the events was fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Per PEI, the relatedness of drug to reactions or events was indeterminate. No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack (infarct myocardial); Bypass surgery; Bypass surgery complications; Post-operative bleeding


VAERS ID: 1467497 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D013A / 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: DEPFIZER INC2021795813

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB number DE-PEI-202100113099. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: 1D013A) as dose number unknown, single for covid-19 immunisation. The patient was 81 years old at the time of vaccination. Medical history and concomitant medications were not reported. On an unspecified date, the patient had an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1467498 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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: Arterial hypertension; Atrial fibrillation; Coronary disease; Diabetes mellitus; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021795790

Write-up: Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number DE-PEI-202100113100. A 71-year-old male patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, 0.3 mL), via an unspecified route of administration on 10May2021 (Batch/Lot Number: EX8679) at the age of 71 years old as dose number unknown, single for COVID-19 immunisation. Medical history included diabetes mellitus, coronary disease, arterial hypertension, atrial fibrillation and renal insufficiency, all ongoing. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolus on 18May2021. The patient''s outcome was fatal for pulmonary embolus. The patient died on 18May2021. It was not reported if an autopsy was performed. This report is serious - death. Event assessment: Comirnaty/ event/Result of Assessment: B. Indeterminate. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1467500 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (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: DEPFIZER INC2021795798

Write-up: Acute circulatory failure; Dyspnea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number DE-PEI-202100113103. A 51-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: Unknown) as dose number unknown, single for Covid-19 immunisation. The patient''s weight and height were not reported. The patient medical history and concomitant medications were not reported. On 22Jun2021, five hours after vaccination the patient experienced dyspnea, acute circulatory failure, and had a resuscitation. The events were reported as fatal. The patient died on 22Jun2021. It was not reported if an autopsy was performed. Event assessment : Comirnaty/ all events/Result of Assessment: Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: dyspnea; Acute circulatory failure


VAERS ID: 1467502 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / -

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: 2021-06-23
   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: DEPFIZER INC2021795850

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the a regulatory authority-WEB, regulatory authority number DE-PEI-202100113119. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Jun2021 (Lot Number: FD5996) dose number unknown, as 0.3ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced acute myocardial infarction on 23Jun2021. Event serious due to death and hospitalization. The patient died on 23Jun2021. It was unknown if an autopsy was performed. Event assessment : Comirnaty/ event/PEI /Result of Assessment : B. Indeterminate No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1467505 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

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: Peripheral arterial occlusive disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021795906

Write-up: Left heart failure; This is a spontaneous report from the Regulatory Authority. The regulatory authority report number is DE-PEI-202100114215. A non-contactable physician reported that an 85-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: Unknown) at 85-years-old, as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing peripheral arterial occlusive disease. The patient''s concomitant medications were not reported. On 22Jun2021, the patient experienced left heart failure. The outcome of the event was fatal. The patient died on 22Jun2021. It was not reported if an autopsy was performed. This report is serious - death. Event assessment for Comirnaty for the event was Indeterminate. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected. Reported Cause(s) of Death: Left ventricular failure


VAERS ID: 1467558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   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: Back pain; Bursitis; Diabetes; Lung disease; Obesity; Smoker
Allergies:
Diagnostic Lab Data: Test Name: tested; Result Unstructured Data: Test Result:was not diagnosed with SARS or other coronavirus
CDC Split Type: BEPFIZER INC2021795171

Write-up: Died; Feeling unwell; Fatigue; Fever; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Authority-WEB, Regulatory Authority Number: BE-FAMHP-DHH-N2021-98095. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: FC8889) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes, bursitis hip, smoker, obesity, and back pain for which pain treatment were indicated to be started. Hospitalization/investigations (scans, etc.) were reportedly in progress because of back problems over the last few months. It was also reported that the patient did not go through COVID-19 infection, but had an unidentified, rare, severe lung disease once after a trip (in 2011? 2016? or earlier than that; not sure of the date/year). The patient was not diagnosed with SARS or other coronavirus, it was tested for at the time. Upon starting COVID, the patient''s family doctor informed the reporting consumer that he saw similarities to the reporter''s father''s illness years ago. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unknown date for COVID-19 immunisation and felt quite ill, the reporter thinks the patient also had fever and was short of breath for a few days. The patient''s concomitant medications were not reported. The patient experienced fever, malaise, and fatigue on 28May2021. Treatment for the events was reported as unknown. The patient died on 31May2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Unknown. Evolution of the ADR - Deceased.Did not go through Covid19 infection. Had an unidentified, rare, severe lung disease once after a trip in (2011? 2016? Or earlier than that? Am not sure). Was not diagnosed as Sars or other coronavirus, it was tested for at the time I believe). Upon starting Covid, his family doctor informed me that he saw similarities to my father''s illness years ago. Reaction after first dose? Yes, felt quite ill. I think fever and short of breath, few days. Health condition before 2nd dose: he was not sick, but had diabetes, inflamed bursa hip, back pain, for which pain treatment would be started soon. Hospitalization? Investigations (scans, etc.) were in progress because of back problems over the last few months.; Reported Cause(s) of Death: Fatigue; Fever; Feeling unwell


VAERS ID: 1467705 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CIRCULATORY COLLAPSE and CEREBRAL VENOUS SINUS THROMBOSIS in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Jun-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. On 23-Jun-2021, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant) and CEREBRAL VENOUS SINUS THROMBOSIS (seriousness criteria death and medically significant). The patient died on 25-Jun-2021. The reported cause of death was Thrombosis of venous sinuses. An autopsy was not performed. The concomitant medications were not reported. The treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 68-year-old male subject, who died 15 days after receiving second dose of vaccine. Very limited information has been provided at this time. Very limited information has been provided at this time. Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1467709 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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: Abdominal aneurysm; Hypertonus; Neurodermatitis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210721703

Write-up: DIED UNKNOWN; THORACIC PAIN; This spontaneous report received from a consumer via a Regulatory Authority [ DE-PEI-CADR2021124321] concerned a 69 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included neurodermatitis, abdominal aneurysm, and hypertonus. 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 04-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced thoracic pain. On 04-JUN-2021, the patient died from unknown cause of death. An autopsy was not performed. The action taken with covid-19 vaccine was not applicable. The patient died of died unknown on 04-JUN-2021, and had not recovered from thoracic pain. This report was serious (Death).; Sender''s Comments: V0:20210721703-COVID-19 VACCINE Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1467714 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021796223

Write-up: Heart attack; heart problems; This is a spontaneous report from a contactable physician. This report was received via Regulatory Authority. A 77-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was petite and very fit for her age and complained after the 2nd vaccination with BNT162B2 about "heart problems", occurred for the first time. Finally, she suffered a heart attack and died. The reporting physician did not carry out the vaccination and did not see the patient either but was informed by her partner. Suspicion of partner: Vaccine side effect. 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.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. The patient''s advanced age has been assessed to have played a contributory role toward the events.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, as appropriate. Reported Cause(s) of Death: Heart attack


VAERS ID: 1467850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood glucose increased, Blood potassium, Blood sodium, C-reactive protein, Carotid artery occlusion, Haematocrit, Haemoglobin, International normalised ratio, Ischaemic stroke, Lymphocyte count, Neutrophil count, Platelet count, Prothrombin time ratio, Red blood cell count, Scan brain, Thrombectomy, White blood cell count
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 2
Permanent Disability? Yes
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: Multinodular goitre
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:0.85; Test Date: 20210529; Test Name: GPT; Result Unstructured Data: Test Result:16 IU/l; Test Date: 20210529; Test Name: Creatinine; Test Result: 0.73 mg/dl; Test Date: 20210529; Test Name: Derived fibrinogen; Result Unstructured Data: Test Result:6 g/l; Test Date: 20210529; Test Name: Glucose; Test Result: 338 mg/dl; Test Date: 20210529; Test Name: Potassium; Result Unstructured Data: Test Result:3.5 mmol/L; Test Date: 20210529; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210529; Test Name: C-reactive protein; Result Unstructured Data: Test Result:11.4 mg/l; Test Date: 20210529; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.41; Comments: L/L; Test Date: 20210529; Test Name: Hemoglobin; Result Unstructured Data: Test Result:131 g/l; Test Date: 20210529; Test Name: INR; Result Unstructured Data: Test Result:1.05; Test Date: 20210529; Test Name: Lymphocytes; Test Result: 36.8 %; Test Date: 20210529; Test Name: Absolute neutrophils; Result Unstructured Data: Test Result:4.66 x10 9/l; Test Date: 20210529; Test Name: Neutrophils; Test Result: 52 %; Test Date: 20210529; Test Name: Platelets; Result Unstructured Data: Test Result:217 x10 9/l; Test Date: 20210529; Test Name: Prothrombin time ratio; Result Unstructured Data: Test Result:1.05; Test Date: 20210529; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.76 x10 12/l; Test Date: 20210529; Test Name: Brain computed tomography; Result Unstructured Data: Test Result:in notes; Comments: An extensive hypodensity is visualized with a triangular morphology with the base towards the cortex, with left frontoparietal involvement, compatible with an extensive ischemic lesion of subacute evolution in the left Middle cerebral artery territory. In its interior, areas of greater density correspond to areas of probable respect at the lenticular nucleus level. This ischemic lesion is causing an important mass effect, with effacement of the sulci convexity and causing collapse of the body and anterior horn of the left ventriculoperitoneal , with midline deviation, with data of subfalcial herniation of approximately 14.8 mm, also showing data of herniation transtentorial, with obliteration of perimesencephalic cisterns and incipient dilation of the temporal horn of the right ventriculoperitoneal . I do not appreciate evident data of hemorrhagic transformation, only visualizing small hyperdense images at the level of the sulci of the frontal and temporal convexity, in relation to small bleeding in the space. subarachnoid.; Test Date: 20210528; Test Name: CRANIAL Computed tomography WITHOUT CONTRAST; Result Unstructured Data: Test Result:in notes; Comments: Skull: Absence of intracranial bleeding. Mild collapse of brain sulci in left convexity due to cytotoxic edema without significant loss of differentiation between white-gray matter. Angio CT: Usual anatomy at the exit of the supra-aortic trunks from the arch. Absence of contrast filling in the left Internal carotid artery and ipsilateral M1 segment (probable carotid occlusion or "T" thrombus). Patency of the rest of the arteries of the polygon of Willis including arterial branches of the left M2 and M3 segments.; Test Date: 20210529; Test Name: Thrombectomy; Result Unstructured Data: Test Result:in notes; Comments: Left TICA mechanical thrombectomy compromised artery (TICI 3). Edema of the revascularized territory with gyriform enhancement of the left frontoparietal and gangiobasal territory; Test Date: 20210529; Test Name: Leukocytes; Result Unstructured Data: Test Result:8.97 x10 9/l
CDC Split Type: ESPFIZER INC2021795746

Write-up: Left MCA ischaemic stroke; Carotid occlusion; Glucose * 338 mg / dL (82 - 115); This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-899831. A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 27May2021 (Batch/Lot Number: FC1131) as dose 2, single for COVID-19 immunisation. Medical history included multinodular goitre from 1999 to an unknown date. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 administered in right arm on 05May2021 (Batch/Lot Number: EY7015) for COVID-19 immunisation. The patient was found by relatives at 7:00 p.m. on 28May2021 on the floor, was assessed by a doctor of 112, presenting right hemiplegia and global aphasia. She was transferred to the Hospital where she was admitted, drowsy with food remains, with a conjugate gaze deviation to the left, in addition to the clinic already described. A brain CT scan is performed where it is reported: Complete obstruction of the left Internal carotid artery functional Willis polygon. There was a slight collapse of the cerebral sulci in the left convexity due to cytotoxic edema without significant loss of differentiation between white-gray matter. Computed tomography angiography was performed that reported A: Absence of contrast filling in the left Internal carotid artery and ipsilateral M1 segment (probable carotid occlusion or "T" thrombus). Patency of the rest of the arteries of the polygon of Willis including arterial branches of the left M2 and M3 segments. It was decided to transfer to the interventional radiology room for endovascular treatment. Previous Orotracheal intubation, mechanical thrombectomy TICA left TICI 3 was performed. He goes to the intensive care unit for post-procedure management. Under effects of sedation and relaxation. Isochoric, pinpoint and hyporeactive pupils. No jugular engorgement. Rhythmic and regular heart sounds. Clear, hypophonic breath sounds. Globose abdomen, with abundant adipose panicle. No distal edema. No DVT signs. The patient was admitted for ischemic stroke of Internal carotid artery and left M1 Middle cerebral artery. Thrombectomy. TICI 3 despite which, torpid neurological evolution. After the thrombectomy procedure, the sedation was completely withdrawn, showing Glasgow coma scale 5-6p (O1V1M4-5) with right plegia. Cranial Computed tomography was performed confirming extensive left Middle cerebral artery infarction with perilesional edema that produces left ventriculoperitoneal collapse, midline deviation, and subfacial and transtentorial herniation. In the following hours, the patient evolves rapidly with progressive loss of reflexes, with evidence of intracranial hypension, presenting a clinical examination compatible with brain death, which is verified by means of a transcranial Doppler study, with death at 2:35 p.m. on 31May2021. Diagnostics: ischemic stroke left mca and exitus letalis The patient underwent lab procedures: Red blood cells 4.76 x10 ^ 12 / L (4 - 5.2), Hemoglobin 131.00 g / L (120 - 160), Hematocrit 0.41 L / L (0.36 - 0.46), Leukocytes 8.97 x10 ^ 9 / L (4.5 - 11), Neutrophils% 52.00%, Total neutrophils 4.66 x10 ^ 9 / L (1.8 - 8), Lymphocytes% 36.80%, Platelets 217 x10 ^ 9 / L (150 - 450), Prothrombin time ratio 1.05 (0.8 - 1.25), INR 1.05 (0.8 - 1.4), Activated partial thromboplastin time ratio 0.85 (0.8 - 1.2), Derived fibrinogen * 6 g / L (2 - 4), Glucose * 338 mg / dL (82 - 115), Creatinine 0.73 mg / dL (0.50 - 0.90), Sodium 139 mmol / L (132 - 146), Potassium * 3.50 mmol / L (3.7 - 5.4), GPT 16 IU / L (10 - 33), C-reactive protein * 11.4 mg / L (0 - 5). Brain computed tomography - An extensive hypodensity is visualized with a triangular morphology with the base towards the cortex, with left frontoparietal involvement, compatible with an extensive ischemic lesion of subacute evolution in the left Middle cerebral artery territory. In its interior, areas of greater density correspond to areas of probable respect at the lenticular nucleus level. This ischemic lesion is causing an important mass effect, with effacement of the sulci convexity and causing collapse of the body and anterior horn of the left ventriculoperitoneal , with midline deviation, with data of subfalcial herniation of approximately 14.8 mm, also showing data of herniation transtentorial, with obliteration of perimesencephalic cisterns and incipient dilation of the temporal horn of the right ventriculoperitoneal. It was reported as they do not appreciate evident data of hemorrhagic transformation, only visualizing small hyperdense images at the level of the sulci of the frontal and temporal convexity, in relation to small bleeding in the space. subarachnoid. Cranial Computed tomography without contrast - Skull: Absence of intracranial bleeding mild collapse of brain sulci in left convexity due to cytotoxic edema without significant loss of differentiation between white-gray matter. Vein Computed Tomography: Usual anatomy at the exit of the supra-aortic trunks from the arch. Absence of contrast filling in the left Internal carotid artery and ipsilateral M1 segment (probable carotid occlusion or "T" thrombus). Patency of the rest of the arteries of the polygon of Willis including arterial branches of the left M2 and M3 segments. Thrombectomy - Left TICA mechanical thrombectomy compromised artery (TICI 3). Edema of the revascularized territory with gyriform enhancement of the left frontoparietal and gangiobasal territory. The event was life-threatening led to hospitalization and disability. The patient died on 31May2021. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Carotid occlusion; Glucose * 338 mg / dL (82 - 115); Ischaemic stroke


VAERS ID: 1467951 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: FIPFIZER INC2021795820

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FI-FIMEA-20213350. A 42-year-old female patient received bnt162b2 (COMIRNATY. Batch/Lot number was not reported), intramuscular on 14Jun2021 (at the age of 42 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No known allergies or underlying diseases. The patient experienced sudden death at the workplace about 1-2 hours after a given vaccination. The autopsy did not reveal any clear explanations for the sudden death. Further research the matter is pending. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1468049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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: XARELTO; TERCIAN; FUROSEMIDE; ISOPTINE; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arrhythmia; Chronic respiratory failure; Nasal cannula oxygen therapy; Psychiatric disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021796007

Write-up: Sudden death unexplained; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number: FR-AFSSAPS-2021076271. An 81-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Jun2021 (Lot Number: FC3143) as single dose for COVID-19 immunisation. Medical history: atrial fibrillation (AFib), arrhythmia, chronic respiratory failure, psychiatric disorder, and nasal cannula oxygen therapy. Concomitant medications included rivaroxaban (XARELTO) for complete arrhythmia due to atrial fibrillation, cyamemazine tartrate (TERCIAN) for psychiatric disorder, furosemide for cardiac disorder, verapamil hydrochloride (ISOPTINE) furosemide for cardiac disorder, and mirtazapine for psychiatric disorder. On 10Jun2021, second injection of the vaccine. Good immediate tolerance. On 13Jun2021 patient was seen in the morning, in her usual state. At the end of the morning she was found asleep. Sudden unexplained death of the patient. No sign of struggle. Conclusion: sudden unexplained death of 81 year-old woman, long-term treated with XARELTO, furosemide, mirtazapine, ISOPTINE, three days after second injection of COMIRNATY vaccine. It was unknown if an autopsy was performed. Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Conclusion : sudden death of 81 year old women, long term treated with XARELTO, furosemide, mirtazapine, ISOPTINE, three days after second injection with COMIRNATY vaccine (lot FC3143).; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1468087 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration, SARS-CoV-2 test
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic alcoholism; End stage renal failure (with indication for dialysis for several months); Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: SARS-CoV-2 test; Test Result: Negative; Comments: Covid test (post-mortem, unspecified): negative
CDC Split Type: FRPFIZER INC2021795952

Write-up: Death; Route of administration noted intradermal; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-2021078873. A 52-year-old male patient received BNT162B2 (COMIRNATY), intradermal on 16Jun2021 (Batch/Lot Number: FA7812) as dose 1, single for COVID-19 immunisation. Medical history included Chronic alcoholism, End stage renal failure with indication for dialysis for several months (not started due to lack of follow-up), Ischaemic heart disease. No history of COVID (Test, not specified, on 17Jun2021). The patient''s concomitant medications were not reported. The patient experienced death on 17Jun2021 12:30. Route of administration noted intradermal. Also provided in report, Time Interval between Beginning of Drug Administration/ Last Dose of Drug and Start of Reaction/Event: 2 days. Death the day after Dose 1, in connection with the evolution of a chronic pathology already present before vaccination. The day after Dose 1 (on 17Jun2021), subject found in a state of apparent death. Resuscitation undertaken, unsuccessful, so death at 12:30 p.m. It was not possible to trace the medical history between the injection and death. In total, death within 24 hours following the 1st vaccine injection, of a 52-year-old man with multiple antecedents (end-stage renal failure, ischemic heart disease, chronic alcoholism) and without medical follow-up. No information available on possible reactogenicity or other symptoms between vaccination and death. Death in connection with the evolution of a chronic pathology present before vaccination according to the notifier (probably end-stage renal failure according to the elements communicated from the thanatological examination). Forensic autopsy performed. The thanatological examination highlights: major vasculopathy (major atheroma at the level of the polygon of Willis, a coronary, abdominal aorta); acute lung edema; pleural effusions, pericardial +/- peritoneal; suffering from small intestine, heterogeneous appendix; right pelvic vein thrombosis; COVID test (post-mortem, unspecified): negative. Reported Cause(s) of Death: Death; Autopsy-determined Cause(s) of Death: major vasculopathy (major atheroma at the level of the polygon of Willis, a coronary, abdominal aorta); acute lung edema; pleural effusions, pericardial +/- peritoneal; suffering from small intestine, heterogeneous appendix; right pelvic vein thrombo


VAERS ID: 1468123 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Antiphospholipid syndrome, Asthenia, Coagulation test, Deep vein thrombosis, Dizziness, HIV test, Headache, Interstitial lung disease, Oxygen saturation, Protein urine, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Interstitial lung disease (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Hypersensitivity (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 59
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: GLICAZIDA; CAPTOPRIL; CARBAMAZEPINE; EUTHYRAL; ALLOPURINOL; ESOMEPRAZOLE; ALFUZOSIN; TANGANIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Appendectomy; Benign prostatic hyperplasia; Benign prostatic hypertrophy; Bilateral cataracts; Bone fracture (not spontaneous); Cholecystectomy; Chronic gastritis; Dizziness; Epilepsy (3 seizures); Erectile dysfunction; Gout; Herniated disc; Hypertension arterial; Hypothyroidism; Left inguinal hernia; Non-insulin-dependent diabetes mellitus; Orchitis; Peptic ulcer perforation; Psoriasis; Sigmoid diverticulosis
Allergies:
Diagnostic Lab Data: Test Name: coagulation assessment; Result Unstructured Data: Test Result:normal; Test Name: HIV; Test Result: Negative ; Test Date: 20210517; Test Name: saturation; Test Result: 87 %; Test Name: 24h proteinuria; Result Unstructured Data: Test Result:0.35 g / 24h; Test Date: 20210517; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Test Date: 20210517; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:Doppler ultrasound of the lower limbs; Comments: found bilateral deep vein thrombosis.
CDC Split Type: FRPFIZER INC2021796202

Write-up: Interstitial lung disease; Thrombosis venous deep; Antiphospholipid syndrome; headaches; dizziness; Asthenia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-2021080259. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 01Apr2021 (Batch/Lot Number: ER9470) as dose 2, single for covid-19 immunisation. Medical history included epilepsy from 1986 to an unknown date 3 seizures, non-insulin-dependent diabetes mellitus, hypothyroidism, benign prostatic hyperplasia, psoriasis, sigmoid diverticulosis, peptic ulcer perforation in 2017, hypertension arterial, anxiodepressive syndrome, chronic gastritis in 2002, bilateral orchitis with chronic hydrocele in 2013, erectile dysfunction, dizziness, gout, herniated disc, petrous bone fracture, cholecystectomy in 1996, appendectomy, left inguinal hernia, cervico-prostatic incision for benign prostatic hypertrophy in 2004 and bilateral cataract in 2018. Non-steroidal anti-inflammatory drug and aspirin were contraindication due to history of perforated ulcer. The patient also has poor tolerance to zopiclone and hydroxyzine. Concomitant medications included gliclazide (GLICAZIDA); captopril; carbamazepine; levothyroxine sodium, liothyronine sodium (EUTHYRAL); allopurinol; esomeprazole; alfuzosin and acetylleucine (TANGANIL) all taken for an unspecified indication, start and stop date were not reported. The patient previously received Repevax in 2019. On 14Apr2021, the patient consults for the first time for asthenia associated with headaches and dizziness. There followed 3 or 4 consultations, the last on 17May2021 when 87% saturation was found where an emergency consultation was made. The patient was hospitalized in Pneumology for diffuse interstitial lung disease of subacute evolution on 17May2021. Doppler ultrasound of the lower limbs found bilateral deep vein thrombosis. Multiplex PCR and Covid are negative. On 21May2021, the patient was transferred to Intensive Care Unit due to increased oxygen requirements. Patient was intubated on 22May2021, curarization and prone position + test corticosteroid therapy with 1 g / d of methylprednisolone. Initially favorable evolution allowing a switch to spontaneous ventilation with inspiratory support + extubation on 30May2021, and relay by Optiflow. In terms of infection, antibiotic therapy with TAZOCILLINE + linezolid was started, then stopped on 25May2021 in front of negative samples (blood and lung). Immunologically: coagulation assessment and exploration of the complement: normal; cryoglobulinemia and dot-myositis + search for native anti-DNA antibodies and anti neutrophilic cytoplasm antibody: negative; 24h proteinuria: 0.35 g / 24h; negative HIV and Covid serologies; only anti-cardiolipin and anti-beta2GP1 IgM antibodies as well as a circulating lupus-type anticoagulant were found, allowing the diagnosis of antiphospholipid syndrome in Jun2021. After 4 boluses of 1g / d of methylprednisolone, decrease to the dosage of 90 mg / d, then to 60 mg / d on 04Jun2021. On 05Jun2021, further respiratory deterioration, patient reintubation, curarization, prone decubitus + nitrogen monoxide. Resumption of boluses of 1 g / d of methylprednisolone + 1 g of cyclophosphamide without any therapeutic efficacy being possible. Note the resumption of curative anticoagulation on 21May2021. The clinical situation has become that of a patient who can be inventoried due to a pulmonary inflammatory syndrome refractory to therapy. This therapeutic impasse results in the death of the patient on 12Jun2021. In total the patient with multiple comorbidities, 1 and a half months after a 2nd injection of the COMIRNATY vaccine, onset of acute respiratory distress in diffuse infiltrating pneumonia, suspected of lupus origin. Etiological assessment not allowing a definite conclusion to this diagnosis: only anti-cardiolipin and anti-beta2GP1 IgM antibodies, and a circulating lupus anticoagulant are found. Initially favorable outcome, but secondary deterioration with refractory acute respiratory distress syndrome despite corticosteroid therapy and immunosuppressive treatment. Death nearly one month from the onset of symptoms and two and a half months from the 2nd dose. This is a complex case which challenges the fact: the unexplained origin of the pneumopathy and the uncertain chronology of events: diagnosis of pneumonia established 1 and a half months after the 2nd injection, but this patient had already consulted 3 to 4 times since 14Apr2021 (i.e. 15 days after the 2nd injection). The outcome of event deep vein thrombosis, asthenia, headaches and dizziness were not recovered. The patient died on 12Jun2021 due to SDRA (acute respiratory distress syndrome). An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SDRA


VAERS ID: 1468137 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Coma scale, Computerised tomogram head, Electrocardiogram, Haemoglobin, Haemorrhagic stroke, Heart rate, Neurological examination, Oxygen saturation, Rheumatoid factor, SARS-CoV-2 test, Troponin
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 34
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: Speech impairment NOS; Stroke (4 hemorrhagic strokes (on anticoagulants, no other information))
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: blood glucose; Result Unstructured Data: Test Result:hypoglycemia; Test Date: 20210510; Test Name: blood pressure; Result Unstructured Data: Test Result:129/61 mmHg; Comments: right; Test Date: 20210510; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210510; Test Name: glasgow scale; Result Unstructured Data: Test Result:10; Test Date: 20210510; Test Name: brain CT; Result Unstructured Data: Test Result:left fronto-parietal-occipital hemorrhage; Comments: left fronto-parietal-occipital hemorrhage with mass effect; Test Date: 20210521; Test Name: brain CT; Result Unstructured Data: Test Result:a bleeding still active; Comments: a bleeding still active in the left fronto-temporoparietal lesion with increased edema and a small hemorrhagic focus beginning on the right.; Test Date: 20210510; Test Name: ecg; Result Unstructured Data: Test Result:regular sinus rhytm; Test Date: 20210510; Test Name: hemoglobin; Result Unstructured Data: Test Result:normal; Test Date: 20210510; Test Name: heart rate; Result Unstructured Data: Test Result:53; Test Date: 20210510; Test Name: neurological examination; Result Unstructured Data: Test Result:Glasgow 10, Broca''s aphasia; Comments: Glasgow 10, Broca''s aphasia, temporo-spatial disorientation, right hemiplegia; Test Date: 20210510; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210510; Test Name: rheumatoid factor; Result Unstructured Data: Test Result:16; Test Date: 20210510; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210510; Test Name: troponin; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021795903

Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority number is FR-AFSSAPS-2021080981. An 85-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 06May2021 (Batch/Lot Number: EX6537) as dose 2, single for COVID-19 immunisation. Medical history included stroke from 2014 to an unknown date: 4 hemorrhagic strokes (on anticoagulants, no other information), with speech impairment as the only sequela. Concomitant medications were not reported. The patient previously received the first dose of COMIRNATY on 06Apr2021 (lot number: EW2239) for COVID-19 immunisation. On 10May2021, the patient experienced hemorrhagic stroke. The event course was described as follows: Massive proportional right hemiplegia and aphasia. Blood pressure (BP) control. Corticoids. Left temporoparietal brain hemorrhage. Unfavorable prognosis on recovery. Summary made from additional information obtained from the patient file. On 10May2021, 4 days after the second injection, occurrence of a hemorrhagic stroke with right hemiplegia, deviation of the mouth to the right, aphasia, apraxia. Bilateral miosis, drowsiness, and intermittent snoring but eye opening to stimuli. Absence of cyanosis, mottling, hypoglycemia, apyretic patient. No information on long-term treatments, especially anticoagulants. On clinical examination: Glasgow 10, Broca''s aphasia, temporo-spatial disorientation, right hemiplegia, ECG: regular sinus rhythm (RS). Soft abdomen, Rheumatoid factor (FR): 16, Pulse (heart rate): 53, Pulse ox (oxygen saturation): 96%, Temperature 36.3 C, Right BP 129/61mm Hg. On biology: troponins and hemoglobin= Normal (N). On Brain CT: left fronto-parietal-occipital hemorrhage with mass effect. SARS-CoV-2 test was negative. No surgical indication. Symptomatic management with blood pressure control, treatment with Solu-Medrol, PPI (unspecified), Keppra (unspecified), and isotonic saline. The patient was admitted to palliative care on 20May2021 due to total loss of autonomy. On 21May2021, the brain scan (brain CT) showed a bleeding still active in the left fronto-temporoparietal lesion with increased edema and a small hemorrhagic focus beginning on the right. On 10Jun2021, clinical deterioration of the patient leading to the implementation of a light sedation for anxiolytic purposes and an analgesic treatment. The patient died on 13Jun2021. In total: occurrence of a hemorrhagic stroke with fatal outcome in a context of limitation of therapeutics, 4 days after a second dose of Comirnaty, in a patient with a history of 4 hemorrhagic strokes (under unspecified anticoagulant treatments) for whom the long-term treatments are not known. The events were considered serious (hospitalization and resulted in death) by the regulatory authority. The patient was hospitalized from an unspecified date and died on 13Jun2021 due to hemorrhagic stroke. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1468187 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Generalised oedema, Maternal exposure during pregnancy, Ultrasound foetal
SMQs:, Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Ultrasound; Result Unstructured Data: Test Result:growth preserved; Comments: a single right umbilical artery and a pelvis of the left kidney at the upper limit 6 mm; Test Date: 20210422; Test Name: Ultrasound; Result Unstructured Data: Test Result:no morphological anomaly; Comments: the single umbilical artery, the Left pelvis is measured between 3.4 and 4.4 mm, there is no morphological anomaly
CDC Split Type: FRPFIZER INC2021843042

Write-up: Anasarca; She was vaccinated on 25May2021 at 28 week of pregnancy.; This is a spontaneous report from a contactable physician. This is the report downloaded from the Regulatory Authority FR-AFSSAPS-MA20212455. Safety Report Unique Identifier FR-AFSSAPS-2021081867. This physician reported information for both mother and fetus. This is the fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 25May2021 (Batch/Lot Number: FC0681) as dose 1, single for covid-19 immunisation. No medical history and concomitant medications were reported. The fetus mother (33 years old), initially overweight, had her first pregnancy with live birth of healthy, eutrophic, full term child in 2018. She has psoriasis without chronic treatment. There was vomiting of pregnancy in early pregnancy. Monitoring in the city. Ultrasound of 22 amenorrhea weeks+ 3 days on 16Apr2021, growth preserved, a single right umbilical artery and a pelvis of the left kidney at the upper limit 6 mm, the control from 22Apr2021 confirms the single umbilical artery, the Left pelvis is measured between 3.4 and 4.4 mm. No morphological anomalies. The mother was vaccinated on 25May2021 at 28 amenorrhea weeks. Itchy erythematous macular rash was noted, with prescription of levocetirizine dihydrochloride (XYZALL) 5 and betamethasone dipropionate (DIPROSONE), no precise date of this rash. Diagnosis of an in-utero death in 29 amenorrhea week 17Jun2021. Non-contributory antiphospholipid test result. Serology of Parvovirus, Herpes old immunity, negative chickenpox. Delivery on 19Jun2021 of a female fetus weighing 2120 g and presenting anasarca of the cephalic pole and of the abdomen with the impression of a short cord. Fetal autopsy in progress. The outcome of event ''anasarca'' was fatal.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021868323 mother''s case; Reported Cause(s) of Death: Anasarca


VAERS ID: 1468258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Areflexia, Cardiac arrest, Cardio-respiratory arrest, Death, Dyspnoea, Mydriasis, Sputum discoloured, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute oedema of lung, unspecified; Diabetes; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021795745

Write-up: Death unexplained; cardio-respiratory arrest.; asystole; disturbances of consciousness; breathing difficulties with pink and foamy sputum; vomiting; pupils with areactive bilateral mydriases; breathing difficulties with pink and foamy sputum; No brain stem reflexes; This is a spontaneous report from a contactable physician from the Regulatory Authority FR-AFSSAPS-RN20211872, Safety Report Unique Identifier FR-AFSSAPS-2021079507. A 70-year-old female received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 25May2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included diabetes, heart failure, and history of PAO. No long-term treatments, no known allergy history. The patient''s COVID-19 history was not reported. Whether the patient had tested for COVID-19 was not reported. Concomitant medication was not reported. On 26May2021, at around 2:26 am, the patient called on the 15th for breathing difficulties with pink and foamy sputum. On arrival at the hospital: disturbances of consciousness, vomiting then cardio-respiratory arrest. They begin an external cardiac massage + Self-filling balloon with unidirectional valve (around 2:53 am). Installation of the semi-automatic defibrillator. The patient presented with asystole and pupils with areactive bilateral mydriases. 1st injection of adrenaline at 3:08 am then every 3 minutes. Difficult orotracheal intubation (IOT), at 3:08 a.m. Cardiopulmonary resuscitation for 30 minutes but absence of shockable rhythm. No brain stem reflexes and persistent asystole. The patient died at 3:38 am on 26May2021 and death unexplained. An autopsy was unknown performed. The outcome of death, cardio-respiratory arrest and systole was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest; asystole; Death unexplained


VAERS ID: 1468781 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: XARELTO; DEMENTIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Encephalopathy (degenerative encephalopathy); Hip fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius; Test Date: 20210625; Test Name: Oxygen saturation; Result Unstructured Data: 83
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Stupor; Fever; Consciousness decreased; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased), STUPOR (Stupor) and PYREXIA (Fever) in a 74-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Encephalopathy (degenerative encephalopathy) in November 2020, Hip fracture in December 2020 and Cardiac pacemaker insertion. Concomitant products included RIVAROXABAN (XARELTO) from 12-Aug-2020 to an unknown date and DONEPEZIL HYDROCHLORIDE (DEMENTIS) for an unknown indication. On 22-Jun-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. On 24-Jun-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Consciousness decreased) (seriousness criteria death and medically significant) and PYREXIA (Fever) (seriousness criteria death and medically significant). On 25-Jun-2021, the patient experienced STUPOR (Stupor) (seriousness criteria death and medically significant). On 26-Jun-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 26-Jun-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Body temperature: 38 degree Celsius (High) 38. On 25-Jun-2021, Oxygen saturation: 83 (abnormal) 83. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reporter''s Comments: Initial Report with additional information; Sender''s Comments: This is a case of death in a 74-year-old subject with a history of Encephalopathy and Cardiac pacemaker insertion, who died 5 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1468788 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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: HRPFIZER INC2021804718

Write-up: Instant death / Collapsed at the table; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number HR-HALMED-300049062. A 69-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FA7083) intramuscular on 20May2021 as dose number unknow, 0.3mL single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. A patient without previous significant ailments and diseases. There are no known previous reactions to other preparations or drugs, hypersensitivity reactions, epidemiological data etc. No illness at the time of vaccination. On 10Jun2021, the patient experienced instant death / collapsed at the table. It was reported that the patient collapsed at the table. On arrival of the emergency medical care with no signs of life. CPR was performed for 50 minutes, without re-establishment of circulation. Time Interval between beginning of drug administration and start of reaction / event: 21 days. The patient died on 10Jun2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Sender Comment: Causality assessment from the meeting is still awaited. Reporter Comment: Relationship between adverse reaction and drug according to the applicant assessment: possible No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Instant death / Crashed at table


VAERS ID: 1468790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Ascites, Bile duct stone, Cardiac failure, Cholangitis, Chronic kidney disease, Computerised tomogram abdomen, Death, Dehydration, Gastrointestinal disorder, Hepatic cirrhosis, Hepatic encephalopathy, Liver abscess, Peritonitis, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (narrow), Gastrointestinal perforation (narrow), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Gallstone related disorders (narrow), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 6
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: Alcoholic cirrhosis of liver; Alcoholic polyneuropathy; Appetite lost; Bile duct stent insertion; Cardiac pacemaker insertion; Chest pain (for four months); Hypertension; Lost weight; Obesity; Weakness
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Abdomen CT; Result Unstructured Data: Test Result:suspicion of hepatic metastasis in the liver; Comments: acute abdominal lesion was not confirmed, but lesions suspected of metastasis were described in the liver
CDC Split Type: HUPFIZER INC2021794937

Write-up: Parenchymal and vascularly decompensated cirrhosis hepatis; Encephalopathy hepatica; Ascites; Chronic kidney disease progression; Severe weight loss; Abdominal pain; Exsiccosis; Passage disorder; Death; Cardiorespiratory insufficiency; Acute peritonitis; Hepatic abscess; Bile duct stone; Bile duct inflammation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-456221. A 67-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 31Mar2021 15:34 (Batch/Lot Number: ET7205) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included alcoholic cirrhosis of liver, hypertension, cardiac pacemaker insertion in Nov2019, alcoholic polyneuropathy, obesity, and bile duct stent insertion in Mar2018. It was also reported that the patient has had tight chest pains for four months, which caused loss of appetite and made him feel weak and have lost weight. Concomitant medications were not reported. On 13Apr2021 the patient was hospitalized due to severe weight loss, abdominal pain, parenchymal and vascularly decompensated cirrhosis hepatis, encephalopathy hepatica, ascites, chronic kidney disease progression, exsiccosis, and passage disorder. Due to the patient''s condition and comorbidities, a detailed examination was not possible. His condition did not improve as a result of hepatoprotective therapy, diuretics, parenteral fluid replacement, and supportive therapy. On 19Apr2021, at 11:20 AM, the patient died among the symptoms of cardiorespiratory insufficiency. Autopsy was done, and the cause of death was acute peritonitis due to hepatic abscess and bile duct stone with bile duct inflammation. Based on the results of abdominal computed tomography (CT) on 13Apr2021, acute abdominal lesion was not confirmed, but lesions suspected of metastasis were described in the liver. The patient died on 19Apr2021. An autopsy was performed, and results were not provided. The outcome of other non fatal events was unknown. Sender''s Comments: The patient died 19 days after vaccination with Comirnaty due to acute peritonitis caused by hepatic abscess and bile duct stone with bile duct inflammation. The event and the suspect vaccine are considered not related. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on known disease pathophysiology, the events Death, Cardiac failure, Peritonitis ,Liver abscess, Bile duct stone, Cholangitis is assessed as not related to suspect drug BNT162B2, and more likely due to underlying medical condition of alcoholic cirrhosis of liver, hypertension.; Reported Cause(s) of Death: Hepatic abscess; Bile duct stone; Bile duct inflammation; Cardiorespiratory insufficiency; Acute peritonitis


VAERS ID: 1468814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
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: 2021-07-05
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: ITJNJFOC20210709306

Write-up: DEATH; This spontaneous report received from a company representative concerned a 22 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-JUL-2021, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). Sender''s Comments: V0 20210709306-COVID-19 VACCINE 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: 1468815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210723129

Write-up: DIED IN SLEEP AND IN SOLITUDE; This spontaneous report received from social media via consumer concerned a 48 year old male unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died in sleep and in solitude. The consumer did not know if there was correlation between patients death and vaccine. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). Sender''s Comments: V0;20210723129-COVID-19 VACCINE Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1468861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 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: 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: Colon cancer; Diabetes mellitus; Disability (severe disability (walked only at home with a walker)); Hypertension; Ischemic heart disease (being treated with apixaban); Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021796364

Write-up: Three days after the administration of the second dose, brain haemorrhage, death after 4 days of coma; This is a spontaneous report downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-747535. A contactable consumer or other non hcp reported a 83-year-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: Ex3599), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunization. Medical history included high blood pressure, previous colon cancer, diabetes mellitus, obese, ischemic heart disease (being treated with apixaban) and severe disability (walked only at home with a walker). The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration (Batch/Lot number : not reported) for covid-19 immunisation. On 25Apr2021, the patient experienced three days after the administration of the second dose, brain haemorrhage, death after 4 days of coma. It was reported that fragile patient being treated with NAO anti-Xa. Following a domestic fall, head trauma with cerebral haemorrhage. Actions taken (hospitalization) - impact on quality of life (10/10) - covid 19 comirnaty vaccine (pfizer): booster dose number two. After hearing the clinicians, they agree to rule out vaccine liability. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts needed, no further information is expected.; Reporter''s Comments: High blood pressure, previous colon cancer, diabetes mellitus, obese, ischemic heart disease (being treated with apixaban), severe disability (walked only at home with a walker); Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1468907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-05
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021796423

Write-up: death; This is a spontaneous report received from a contactable physician from the Regulatory Authority. The regulatory authority report number is IT-MINISAL02-747941. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 05Apr2021. The patient died on 05Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained. Reported Cause(s) of Death: death


VAERS ID: 1468911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-25
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral vascular disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021796356

Write-up: 10 days after inoculation of the Astrazeneca anticovid vaccine died suddenly of a thrombus / infarction in the stomach; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. The regulatory authority report number is IT-MINISAL02-747991. A 77-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number ET7205) via intramuscularly in left arm (as reported left shoulder) on 07Apr2021 as dose 1, single for COVID-19 immunization. Medical history included severe circulatory problems in her legs. Concomitant medication was not reported. It was reported that 10 days after inoculation of the Astrazeneca anticovid vaccine died suddenly of a thrombus / infarction in the stomach on 25Apr2021. The patient died on 25Apr2021. It was unknown if an autopsy was performed or not. Patient was hospitalized due to an event. The outcome of the event was fatal. Reporter''s comment: She suffered from severe circulatory problems in her legs Sender''s comment: Report made by a citizen who is acquainted with the patient, who is unable to provide clinical health data. Reporter''s Comments: She suffered from severe circulatory problems in her legs; Reported Cause(s) of Death: 10 days after inoculation of the Astrazeneca anticovid vaccine died suddenly of a thrombus / infarction in the stomach


VAERS ID: 1468920 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 61
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: 20210618; Test Name: Body temperature; Result Unstructured Data: increased
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: second dose Moderna (Covid19)17/06/2021. 18/06/2021 ; dyspnea; This regulatory authority case was reported by a physician and describes the occurrence of TERMINAL STATE 16 del 17/06/2021. 18/06/2021 and DYSPNOEA (dyspnea) in a 96-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021 at 4:00 PM, 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) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced DYSPNOEA (dyspnea) (seriousness criterion death). On 18-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced TERMINAL STATE . (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 18-Jun-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 18-Jun-2021, Body temperature: 39.5?c (High) increased. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported. The patient had the second dose of Moderna (Covid-19 vaccine) at 16:00 on June 17, 2021. At 05:00 on June 18, 2021 the patient had a body temperature of 39.5?C and dyspnea. At 06:50 the 118 physician declared the patient deceased. This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected. . Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Lab details updated.; Sender''s Comments: This is a case of death of a 96-year-old female patient, 1 day after receiving second dose of vaccine (Lot number unknown), and experienced fever and dyspnea. Very limited information regarding the clinical details pertaining to death, patient''s medical history, and concomitant medications were provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1468968 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Oedema peripheral, Pulmonary embolism, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), 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: 2021-06-13
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Specific allergy (drug) (Aspirin); Splenectomy; Thrombosis venous deep
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021796406

Write-up: After 2 days from vaccine: Edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways; After 2 days from vaccine: Edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways; After 2 days from vaccine: Edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways; After 2 days from vaccine: Edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways; After 2 days from vaccine: Edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, Safety Report Unique Identifier IT-MINISAL02-748699. A 54-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/ Lot Number: FC1526), via intramuscular route of administration on 05Jun2021 09:52 as 0.45ML single dose for covid-19 immunisation. Medical history included drug allergy: Aspirin from an unknown date and unknown if ongoing, deep vein thrombosis from 01Jan2013 to 31Jan2013, epilepsy from 01Jan1991 to an unknown date, splenectomy from 01Jan1991 to an unknown date. Concomitant medication included Keppra (levetiracetam) taken for epilepsy, start and stop date were not reported.The patient experienced after 2 days from vaccine: edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways on 07Jun2021. Therapeutic measures were taken with Aulin as a result of after 2 days from vaccine: edema right arm from armpit to wrist; 13Jun in the emergency room with respiratory failure and cardiac arrest, death from pulmonary thromboembolism sideways. The patient died on 13Jun2021.Autopsy was done. The outcome of the events was Fatal.; Reporter''s Comments: Patient in emergency room in cardiac arrest probably due to respiratory failure. ALS resuscitation for over an hour without ever Return to spontaneous circulation. Autopsy finding required, resulting in pulmonary thromboembolism in rider. Patient allergic to Aspirin; Reported Cause(s) of Death: Pulmonary thromboembolism


VAERS ID: 1469016 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Drowning, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Slow movement; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210529; Test Name: CT; Result Unstructured Data: Test Result: Accumulated intra-bronchial fluid was noted. Cardiac; Comments: (after vaccination) Accumulated intra-bronchial fluid was noted. Cardiac hypertrophy was present. Traumatic injury was absent. Haemorrhage was absent. Brain injury was absent.
CDC Split Type: JPPFIZER INC2021758499

Write-up: The patient had an attack of loss of consciousness while in the bathtub; in a state of cardiopulmonary function arrest; Drowning; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority (RA). Regulatory authority report number is v21115670. The patient was an 81-year and 3-month-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history was unknown. Historical vaccine included influenza vaccine (details unknown). Concomitant medications were not reported. On 29May2021 at 09:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 29May2021 at 21:00 (12 hours after the vaccination), the patient had an attack of loss of consciousness. On the same date, the patient was in a state of cardiopulmonary function arrest, and died in drowning. On 29May2021 (the day of vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: The patient always hated hospitals and had made no hospital visits. He seemed to speak of being tired, and he moved slowly. On 29May2021 around 09:00 (the day of vaccination), the patient was vaccinated with the coronavirus vaccine. On the same day at 21:00 (12 hours after the vaccination), the patient had an attack of loss of consciousness while in the bathtub. An ambulance was called at 22:19. It arrived at the scene at 22:24 and at the reporting hospital at 22:56. The patient had no pulse, no respiration, no consciousness, and was in a state of cardiopulmonary function arrest. Light reflex was absent, and the pupils were dilated. No traumatic injury was noted. ADRENALINE INJECTION 0.1% SYRINGE 1 mL was injected three times, but the waveform was flat without change. At 23:30, death was confirmed. Blood was collected and computerised tomography (CT) was taken. Accumulated intra-bronchial fluid was noted. Cardiac hypertrophy was present. Traumatic injury was absent. Haemorrhage was absent. Brain injury was absent. The death was due to drowning. The reporting classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was none (unknown). The reporting pharmacist commented as follows: Although the causal relationship was unknown, we made this report because of the death by drowning after the vaccination. Reported Cause(s) of Death: Drowning; The patient had an attack of loss of consciousness while in the bathtub; in a state of cardiopulmonary function arrest


VAERS ID: 1469048 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-16
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Fall, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Accidents and injuries (narrow), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021791452

Write-up: Cardio-respiratory arrest; recurrence of myocardial infarction; fallen from a bed; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116502. The patient was a 91-year-old male. Body temperature before vaccination and the family history were not reported. Medical history included myocardial infarction and dementia. On 31May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 at 04:20 (16 days after the vaccination), the patient experienced cardio-respiratory arrest and fall. On 16Jun2021 (16 days after the vaccination), the outcome of the event was fatal. The cause of death was not reported. It was not reported if an autopsy was performed. The course of the event was as follows: A staff heard the patient calling at the facility and ran to the patient. The patient was found to have fallen from a bed, for which ambulance was requested. The patient was in cardiopulmonary arrest with pulseless electrical activity (PEA). The patient was unresponsive to resuscitation and death was confirmed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was myocardial infarction. The reporting physician commented as follows: Considering age and medical history, risk of myocardial infarction was high. However, since there were multiple reports in which similar cases of myocardial infarction were reported, the possibility could not be denied that COMIRNATY was one of the causes of recurrence of myocardial infarction.; Reported Cause(s) of Death: recurrence of myocardial infarction; Cardio-respiratory arrest


VAERS ID: 1469049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-24
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021791487

Write-up: Death (no symptom); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116533. A 79-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 then via an unspecified route of administration on 23Jun2021 16:17 (Batch/Lot Number: FA7812; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. 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). Family history was not reported. On 23Jun2021 at 16:17 (the day of 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 immunization. The patient was placed under observation for 15 minutes and it was confirmed that there was no change in condition and then the patient returned home. On 24Jun2021 (1 day after the vaccination), the patient experienced death (no symptom). On 25Jun2021 in the morning, the reporting physician received a phone call from the police to ask about the situation because the patient died on 24Jun2021. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Death


VAERS ID: 1469057 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Hypercapnia, Pneumonia staphylococcal
SMQs:, Interstitial lung disease (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Femoral neck fracture; Osteoporosis; Overactive bladder; Paralysis of arms; Parkinson''s disease; Phrenic nerve paralysis; Prostatic hypertrophy; Respiratory failure type 2
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021796861

Write-up: Pneumonia MRSA; ARDS; Carbon dioxide narcosis; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 69-year-old male. The patient received pneumococcal vaccine polysacch 23v (PNEUMOVAX) within 4 weeks prior to the COVID vaccine. The patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, or other products. Other medical history included Parkinson''s disease, chronic type 2 respiratory failure, femoral neck fracture left, osteoporosis, paralysis of right upper extremity, phrenic nerve paralysis, prostatic hypertrophy, overactive bladder, and constipation. On unknown date in May2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) (at age of 69-year-old) via intramuscular route of administration in the arm left for COVID-19 immunization. The patient also received pneumococcal vaccine polysacch 23v (PNEUMOVAX) within 4 weeks prior to the COVID vaccine in unspecified date in May. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the patient experienced pneumonia MRSA, carbon dioxide narcosis, and ARDS. The event Pneumonia MRSA resulted in hospitalization (12 days) and death. The outcome of the event Pneumonia MRSA was fatal on unspecified date in Jun2021 and the treatment for the events included vancomycin (VCM), intubation, and management by artificial ventilator. The reporting pharmacist assessed the event as serious (hospitalization and death).It was not reported if autopsy was performed or not. Since the vaccination, the patient has not been tested for COVID-19: Unknown. The event outcome for carbon dioxide narcosis, and ARDS was unknown.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Pneumonia MRSA, ARDS resulted in hypercapnia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Pneumonia MRSA


VAERS ID: 1469069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; End stage renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021799516

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the a regulatory authority. Regulatory authority report number is v21116515. The patient was an 86-year-old female. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included end stage renal failure and cardiac failure chronic. Concomitant medications and family history were not provided. On 24Jun2021 at around 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5423, Expiration date 31Aug2021) an unspecified route of administration as the single dose for COVID-19 immunization at a nursing home. After the vaccination, there were no findings suggestive of anaphylaxis. At night, no problems were noted in her general condition. The final check was done at around 20:00. On 25Jun2021 at around 06:50 in the morning (1 day after the vaccination), the patient was found in cardio-respiratory arrest, then an emergency service was requested. The patient was transferred to the reporter''s hospital. On 25Jun2021 at 08:00, the patient''s death was confirmed. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. End stage renal failure and cardiac failure chronic were considered as possible causes of the event. The reporting physician commented as follows: The patient had suffered from end stage renal failure and cardiac failure chronic. Considering that the end stage renal failure was worsening, she had a high risk of developing sudden deterioration. It was difficult to prove a causal relationship between the event and BNT162b2.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1469071 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haemoglobin, Oxygen saturation, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SODIUM BICARBONATE; BAYASPIRIN; FEBURIC; AMLODIPINE; LANSOPRAZOLE; DIART; ADALAT L; LENDORMIN D; SEROQUEL; YOKUKANSAN; PURSENNIDE [SENNOSIDE A+B]; RISPERDAL; KREMEZIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Coronary stent placement; Hypertension; Hyperuricaemia; Nephrogenic anaemia; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Name: Hb; Result Unstructured Data: Test Result:5.7; Test Date: 20210625; Test Name: SpO2; Test Result: 73 %
CDC Split Type: JPPFIZER INC2021799567

Write-up: Severe renal failure; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116573. The patient was an 89-year-old female. Body temperature before vaccination was 36.2 degrees Centigrade (24Jun2021). Medical history included severe renal failure, severe nephrogenic anaemia, angina pectoris (the status after coronary stent placement), hypertension and hyperuricaemia. Concomitant medications included sodium bicarbonate (SODIUM BICARBONATE NikP) 1 g 2x/daily (after breakfast and before bedtime), acetylsalicylic acid (BAYASPIRIN 100MG) 0.5 tablet 1x/daily (after breakfast), febuxostat (FEBURIC 20MG) 1 tablet 1x/daily (after breakfast), amlodipine (AMLODIPINE O D 5MG) 1 tablet 1x/daily (after breakfast), lansoprazole (LANSOPRAZOLE OD 15MG) 1 tablet 1x/daily (after breakfast), azosemide (DIART 30 MG) 1 tablet 1x/daily (after breakfast), nifedipine (ADALAT-L 20MG) 1 tablet 1x/daily (before bedtime), brotizolam (LENDORMIN-D 0.25 MG) 0.5 tablet 1x/daily (before bedtime), quetiapine fumarate (SEROQUEL 25MG) 1 tablet 5x/daily (right after waking up, after every meals, before bedtime), ANGELICA ACUTILOBA ROOT, ATRACTYLODES LANCEA RHIZOME, BUPLEURUM FALCATUM ROOT, CNIDIUM OFFICINALE RHIZOME, GLYCYRRHIZA SPP. ROOT, PORIA COCOS SCLEROTIUM, UNCARIA SPP. HOOK (YOKUKANSAN Extract Granules for Ethical Use) 7.5 g/day (3x/daily, after every meals), sennoside AB (PURSENNID 12MG) 2 tablets 1x/daily (before bedtime), risperidone (RISPERDAL 1 mg/mL 0.1%) 0.5 mL (as needed), and KREMEZIN (tablet 500 MG) 8 tablets/day (2x/daily, between meals). Family history was not provided. On 24Jun2021 at 14:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5422, Expiration date 31Aug2021), at age of 89 years old, an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 at 16:00 (1 day after the vaccination), the patient experienced severe renal failure and she died. It was not reported if an autopsy was performed. The course of the events was as follows: After the vaccination, the patient was making a good progress without any adverse reactions and no symptoms were noted until 25Jun2021 at 16:00. From 16:00 to 17:00, there was a nurse call. A medical staff treated the patient. SpO2 (oxygen saturation percutaneous) was 73% and she became unconscious. An emergency service was requested. The emergency team arrived and resuscitative measures were performed. The patient was transferred to a hospital by an ambulance where the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Possible causes of the event was reported as follows: The patient had suffered from severe renal failure and severe nephrogenic anaemia. The intention for DNAR (Do Not Attempt Resuscitation) had already been confirmed. The hospital where the patient had been treated referred her to the reporter''s clinic. On 24Jun2021, the patient was visited by the physician for the first time and she received the vaccine. Hb (haemoglobin) 5.7 indicating anaemia had been noted since before referral. Blood transfusion was difficult to perform as she attempted to remove needle because she had dementia. The possibility of developing acute progression was explained several times. Acute progression and fatal outcome in this case were expected. The reporting physician commented as follows: The previous hospital informed the reporter of a diagnosis of severe renal failure but since the reporter had never examined the patient, the cause of death was uncertain. However, the patient had suffered severe renal failure and marked nephrogenic anaemia and the possibility of developing acute progression was sufficiently explained by the previous hospital several times. Therefore, the possibility of BNT162b2 being the cause of the fatal outcome was quite low. The causality was reported as unrelated for event severe renal failure. However, the event occurred 1 day after the vaccination, reporting this case was considered to be necessary.; Sender''s Comments: Based on known disease pathophysiology, the event of renal failure is assessed as not related to the drug BNT162B2 and more likely due to underlying medical condition of severe renal failure and marked nephrogenic anaemia. 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: Severe renal failure


VAERS ID: 1469073 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Decreased appetite, Heart rate, Hypersensitivity, Nausea, Oxygen saturation, Pneumonia, Pneumonia aspiration
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: LIXIANA; TEGRETOL; BELSOMRA; ALOSENN [SENNOSIDE A+B]; SEROQUEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Organic psychosis (required hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/82; Comments: around 12:00; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: around 12:00; Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: in the morning; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:37-38 Centigrade; Test Date: 20210531; Test Name: PR; Result Unstructured Data: Test Result:60; Comments: Unit: /min around 12:00; Test Date: 20210531; Test Name: SpO2; Test Result: 99 %; Comments: room air around 12:00; Test Date: 20210602; Test Name: SpO2; Test Result: 88 %; Comments: in the morning room air decreased
CDC Split Type: JPPFIZER INC2021799576

Write-up: pneumonia aspiration; Pneumonia; allergic reaction (abdominal symptom)/abdominal pain and small amount of watery vomit; appetite impaired; queasy/nausea; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21116516. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY) via unspecified route of administration on 31May2021 at 10:10 (Lot# EW4811, Expiration date 31Jul2021) at single dose for COVID-19 immunisation. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included organic mental disorder (the patient was hospitalized). Oral concomitant medications included edoxaban tosilate hydrate (LIXIANA), carbamazepine (TEGRETOL), suvorexant (BELSOMRA), sennoside A+B (ALOSENN), and quetiapine fumarate (SEROQUEL). It was unknown if the patient had relevant family history. On 31May2021 at 10:10 (the day of vaccination), the patient received the first dose of BNT162b2. On 31May2021 at 12:00 (1 hours and 50 minutes after the vaccination), the patient experienced allergic reaction (abdominal symptom), appetite impaired, and queasy/nausea. The event of queasy/nausea recovered on that day. On 02Jun2021 (2 days after the vaccination), the patient experienced pneumonia. On 07Jun2021(7 days after the vaccination), the event of pneumonia was recovering. On 21Jun2021 (21 days after the vaccination), the patient experienced pneumonia aspiration. On 28Jun2021 at 02:18 (28 days after the vaccination), the patient died without recovering from appetite impaired. It was not reported if an autopsy was performed. The cause of death was not reported. The outcome of the event of allergic reaction (abdominal symptom) was unknown. The course of the events was as follows: While the patient was being observed for 30 minutes after the vaccination, no abnormalities were noted. At around 12:00, the patient complained of abdominal pain and small amount of watery vomit was noted. BP (Blood pressure) was 140/82, PR (pulse rate) was 60/min, SpO2 (oxygen saturation percutaneous) was 99% (room air), body temperature was 36.0 degrees Centigrade. Since the abdominal symptom was considered to be due to allergic reaction, fexofenadine hydrochloride (ALLEGRA) (60 mg) 2 tablets x 2 was prescribed. At 14:45, queasy disappeared. His expression became calm. At around 18:00, although small amount of vomit was noted, he looked calm. On 01Jun2021, queasy and nausea were not noted, but he was not energetic. On 02Jun2021 in the morning, pyrexia of 39.2 degrees Centigrade was noted. SpO2 decreased to 88% (room air). Drip infusion and oxygen administration were started. A diagnosis of pneumonia was made. On 04Jun2021, the pyrexia abated. On 07Jun2021, administration of antibiotic was completed. Although pneumonia improved, dietary intake remained insufficient. Drip infusion was continued but he gradually weakened. On 21Jun2021, the pyrexia (37-38 degrees Centigrade) recurred. He received the treatment under diagnosis of pneumonia aspiration. However, he died at 02:18 on 28Jun2021. The reporting physician classified the event as serious (fatal outcome) and assessed that the events were related to BNT162b2. It was not reported if there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: After the vaccination, his dietary intake decreased.; Reported Cause(s) of Death: pneumonia aspiration


VAERS ID: 1469077 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SPIOLTO RESPIMAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Emphysema
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021799651

Write-up: The patient was found dead at home; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. The patient was an 80-year-old male. Medical history included cardiac failure and emphysema. Concomitant medications included olodaterol hydrochloride/tiotropium bromide monohydrate (SPIOLTO RESPIMAT, Inhalation) 20 inhalations a day from 07Aug2020 to 17Jun2020. On 06Jun2021 at unknown time (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported, dose number not reported) intramuscularly at 0.3 ml as an unknown single dose for COVID-19 immunisation. After the vaccination, the patient had checkups on 12Jun and 13Jun2021, but no obvious side effects were noted. On 17Jun2021 at unknown time (11 days after the vaccination), the patient was dead. It was not reported whether autopsy was done. On 21Jun2021 (15 days after the vaccination), the patient was found dead at home. The event was classified as serious (death). The reporting physician considered that the causal relationship with BNT162b2 was less possible. No follow-up attempts are possible. No further information is expected.; 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 fatal event cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: The patient was found dead at home


VAERS ID: 1469090 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic respiratory failure; COPD; Diabetes mellitus; Hypertension; Lung cancer; Oxygen therapy; Prostatic hyperplasia; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: SARS-CoV-2 (Media); Test Result: Negative
CDC Split Type: JPPFIZER INC2021799936

Write-up: Death; This is a spontaneous report from a contactable pharmacist via COVID-19 Self-Reporting. An 81-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021), intramuscularly in the left arm on an unknown date, at patient age of 81-year-old, at single dose for COVID-19 immunization. Medical history included lung cancer, atrial fibrillation, chronic respiratory failure (home oxygen therapy was introduced), chronic obstructive pulmonary disease (COPD), severe sleep apnoea syndrome (SAS), hypertension, diabetes mellitus, and prostatic hyperplasia. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no relevant past drug history. Since the vaccination, the patient has been tested for COVID-19 (SARS-CoV-2 (Media): negative in Jun2021). In Jun2021, the patient experienced death. The reporter stated that the adverse event resulted in death. It was unknown whether autopsy was performed. It was unknown whether treatment was given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the events "Death " and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1469094 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Shock haemorrhagic, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210627; Test Name: CT; Result Unstructured Data: Test Result:revealed abdominal aortic aneurysm rupture measuri; Comments: revealed abdominal aortic aneurysm rupture measuring 80 mm
CDC Split Type: JPPFIZER INC2021800005

Write-up: Shock haemorrhagic due to ruptured abdominal aortic aneurysm; Cardio-respiratory arrest; Shock haemorrhagic due to ruptured abdominal aortic aneurysm; The patient fainted; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116606. The patient was a 79-year-old female. Body temperature before vaccination was 36.0 degrees centigrade. The patient had no 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 27Jun2021 at 13:35 (at age of 79 years old, the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27Jun2021 at unknown time (after the vaccination), the patient fainted. On 27Jun2021 at 13:53 (18 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 27Jun2021 at unknown time (after the vaccination), computerised tomography (CT) revealed abdominal aortic aneurysm rupture measuring 80 mm. On 27Jun2021 (the day of vaccination), the patient was admitted to the hospital. On 28Jun2021 (1 day after the vaccination), the patient was discharged, and the outcome of the event fainted was unknown, for other events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 27Jun2021, after the vaccination, the patient fainted, and the physician confirmed cardio-respiratory arrest. The patient was urgently transported to the reporting hospital. CT revealed abdominal aortic aneurysm rupture measuring 80 mm. The reporting physician classified the event cardio-respiratory arrest as serious (death, hospitalization) and assessed that the event cardio-respiratory arrest was unrelated to BNT162b2. The seriousness and causality of the other events were not reported. Other possible cause(s) of the event cardio-respiratory arrest such as any other diseases was haemorrhagic shock due to abdominal aortic aneurysm rupture. The reporting physician commented as follows: We have no evidence that there was a direct effect on the abdominal aortic aneurysm rupture. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Shock haemorrhagic due to ruptured abdominal aortic aneurysm; Shock haemorrhagic due to ruptured abdominal aortic aneurysm; Cardio-respiratory arrest


VAERS ID: 1469096 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cholangitis, Hypophagia, Sepsis
SMQs:, Retroperitoneal fibrosis (narrow), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: Medical History/Concurrent Conditions: Insulin therapy; Type 2 diabetes mellitus (on insulin therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021800031

Write-up: Sepsis (calculous cholangitis); Sepsis (calculous cholangitis); dietary intake started to decrease; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116614. An 94-year-old (also reported as 94-year and 5-month-old) female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FA4597; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration on 01Jun2021 11:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus/type 2 diabetes mellitus and on insulin therapy. Family history was not reported. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.4 degrees centigrade. On 01Jun2021 at 11:00 (the day of vaccination), the patient received the first dose of BNT162b2. From around 06Jun2021 (5 days after the vaccination), dietary intake started to decrease. On 10Jun2021 at unknown time (9 days after the vaccination), the patient was admitted to another hospital; the reason was not reported. On 11Jun2021 at unknown time (10 days after the vaccination), the patient experienced sepsis (calculous cholangitis). On 11Jun2021 (10 days after the vaccination), the outcome of the events sepsis (calculous cholangitis) was fatal. It was not reported whether autopsy was done. Outcome of dietary intake started to decrease was unknown. The course of the events was as follows: The patient had type 2 diabetes mellitus and was on insulin therapy. On 01Jun2021 (the day of vaccination), the first vaccination was given. Thereafter, the dietary intake started to decrease from around 06Jun2021 (5 days after the vaccination). On 10Jun2021 (9 days after the vaccination), the patient was admitted to another hospital. On 11Jun2021 (10 days after the vaccination), the patient died of sepsis (calculous cholangitis). The reporting physician classified the events sepsis (calculous cholangitis) as serious (death) and assessed the causality between the events sepsis (calculous cholangitis) and BNT162b2 as unassessable. The seriousness and causality of the other event were not reported. It was not reported whether there was other possible cause of the events such as any other diseases. The reporting physician commented as follows: Made this report because of the death case despite the unknown causal relationship.; Reported Cause(s) of Death: Sepsis (calculous cholangitis); Sepsis (calculous cholangitis)


VAERS ID: 1469097 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Obturator hernia
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021800035

Write-up: shock death caused by acute obturator hernia; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116616. The patient was an 85-year and 9-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. The patient had no particular family history. The patient had ongoing heart disease as underlying disease. On 08Jun2021 at 09:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at around 20:00 (2 days after vaccination), the patient experienced acute obturator hernia. The outcome of the event was fatal. The course of the event was as follows: On 08Jun2021 (the day of vaccination) and 09Jun2021 (one day after vaccination), no particular abnormalities were observed. On 10Jun2021, at around 20:00 (2 days after vaccination), the patient''s condition suddenly changed in the restroom of her home. The family found this sudden change and called an ambulance. While the patient was being transferred to the emergency hospital by an ambulance, it was seemed to be no room for her to survive. The cause of death was shock death caused by acute obturator hernia, and the causality between the death and BNT162b2 vaccination was not asked. An autopsy by the police showed that there was no incidence. On the same day, at 20:52 (2 days, 11 hours, and 22 minutes after vaccination), the patient was confirmed to die (the above information was obtained from the patient''s first son). The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that the cause of death was unrelated to the BNT162b2 vaccination.; Sender''s Comments: Based on the available information, known product profile and the nature of the reported event , the causal relationship between the acute obturator hernia which resulted in death is unrelated to the use of the vaccine. This is in agreement with reporting physician.; Reported Cause(s) of Death: shock death caused by acute obturator hernia


VAERS ID: 1469099 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021800078

Write-up: Cardio-respiratory arrest/cardiopulmonary arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21116615. The patient was a 94-year and 5-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not provided. The patient had medical history of angina pectoris. On 22May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# and Expiration date not reported). On 12Jun2021 at 11:39 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 (one day after the vaccination), the patient experienced cardio-respiratory arrest. On 13Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient originally had chronic total occlusion (CTO) at left anterior descending artery (LAD)#7, and she had a bypass to the small left circumflex artery (LCX), and from the right coronary artery (RCA) to the LAD. The patient and her family members receive informed consent of the possibility of sudden death. This time, the preventive vaccination was performed on 22May2021 (the first dose) and on 12Jun2021 (the second dose) after the consent was obtained from the patient. On 13Jun2021 (one day after vaccination), before dawn, the patient had cardiopulmonary arrest (CPA), and this case was reported. It was unknown if Autopsy was Done. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The patient originally had chronic total occlusion (CTO) at LAD#7, and she had a bypass to the small left circumflex artery (LCX), from the right coronary artery (RCA) to the left anterior descending artery (LAD). The reporting physician commented as follows: The patient originally had a possibility of sudden death. Reported Cause(s) of Death: Cardio-respiratory arrest/cardiopulmonary arrest (CPA)


VAERS ID: 1469101 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Geromarasmus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021800128

Write-up: Queasy; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21116541. The patient was an 89-year and 2-month-old male. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 31May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration at 89 years old as a single dose for COVID-19 immunisation. The medical history included geromarasmus tendency. On 31May2021 (the day of the vaccination), the patient experienced queasy and vomiting. On 04Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. The patient was hospitalized due to the events from 04JUN2021 to 28JUN2021. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. From 31May2021 (the day of vaccination) to 06Jun2021 (6 days after vaccination), the patient repeatedly had queasy and vomiting. The patient died on an unknown date. It''s not reported if an autopsy was performed. The cause of death was queasy and vomiting. The outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: There was geromarasmus tendency as the patient''s background, and it was considered that the patient required hospitalization. Reported Cause(s) of Death: Queasy; Vomiting


VAERS ID: 1469109 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-27
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021800225

Write-up: she was dead in the bathroom; This is a spontaneous report from a contactable physician received via a Pfizer employee. A 76-year-old female patient received bnt162b2 (COMIRNATY), at same age, dose 1 intramuscular on 07Jun2021 09:20 as DOSE 1, SINGLE for covid-19 immunisation; donepezil hcl, oral from an unspecified date to an unspecified date, at unspecified dose for an unspecified indication. Medical history included dementia. The patient''s concomitant medications were not reported. On 27Jun2021 (20 days after the vaccination), the family member found that she was dead in the bathroom. The action taken in response to the event for donepezil hcl was not applicable. The patient died on 27Jun2021. An autopsy was not performed. The physician received the information because it was the day that the patient had appointment to receive the second vaccination. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Follow-up (28Jun2021&30Jun2021): This is a follow-up spontaneous report from a contactable physician, based on information received by Pfizer (manufacturer control number: EC-2021-095434), license party donepezil hydrochloride. This Physician report describes a 76 year old female who received DONEPEZIL for the treatment of an unknown indication and co-suspect drug COMIRNATY (BNT162B2) (tozinameran) for COVID-19 immunisation. Date Unknown: The patient began DONEPEZIL (dose and frequency unknown). Jun/07/2021: The patient received the first dose of co-suspect drug COMIRNATY (BNT162B2) at 0.3 (unit not provided) intramuscularly as a single dose. Jun/27/2021: The family member found that the patient was dead in the bathroom (DEATH), considered unrelated to COMIRNATY (BNT162B2) by the reporter. The physician received the information because it was the day that the patient had an appointment to receive the second vaccination. The cause of DEATH was not reported. It was unknown if an autopsy was performed. It was unknown if the patient was taking DONEPEZIL up to the time of DEATH. Further details not provided. Jun/28/2021: The Physician reports DEATH to the company. The seriousness and outcome of the event was classified as follows: DEATH : Serious : Death. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON JUN/30/2021 CONSISTED OF: added patient information (added patient date of birth), updated drug information (updated batch number/expiration date for co-suspect drug COMIRNATY), and case narrative. Jun/27/2021: The patient was found dead in the bathroom (DEATH); the cause of DEATH was unknown. An autopsy was not performed. Jun/30/2021: The physician reported additional information to the company. Product-Reaction level: Drug : DONEPEZIL(DONEPEZIL HYDROCHLORIDE). Causality for death (death); action(s) taken with drug: not applicable. Causality as per reporter (drug/vaccine) was possible. Rechallenge: Not Applicable. Drug: COMIRNATY (BNT162B2) (TOZINAMERAN), FA5765. Causality for death (death); action(s) taken with drug: not applicable; causality as per reporter (drug/vaccine): not related. rechallenge: not applicable.; Sender''s Comments: The information currently available is limited and does not allow a meaningful causality assessment for reported event death (unknown cause); however, based solely on implied vaccine-event chronological association a causal relationship between this event and BNT162B2 (COMIRNATY) and donepezil cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .; Reported Cause(s) of Death: she was dead in the bathroom


VAERS ID: 1469113 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: Catheterization study; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: JPPFIZER INC2021800689

Write-up: Myocardial infarction; This is a spontaneous report from a contactable other health professional received via a Pfizer sales representative. The patient was a female in her late 60s. Medical history included rheumatoid arthritis. Concomitant medication included methotrexate and steroids taken for rheumatoid arthritis, start and stop dates were not reported. The patient was normally taking methotrexate and steroids; however, the medications were temporarily withdrawn before the vaccination. On 24Jun2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) intramuscularly as 0.3 mL single dose for COVID-19 immunization. On 26Jun2021 (2 days after the vaccination), the patient experienced myocardial infarction. The patient complained of chest tightness and was emergently transferred to a hospital. It was confirmed that the patient had myocardial infarction. On 27Jun2021 (3 days after the vaccination), the patient died. Death was confirmed while the patient was undergoing catheterization study. Attending physician of the hospital commented that it was unlikely that the vaccination was the cause. The outcome of the event was fatal. It was not reported if autopsy done. The reporting other health professional classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known safety profile and available information the reported myocardial infarction with fatal outcome is assessed as an intercurrent medical condition and unrelated to BNT162b2. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1469128 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Body temperature, Chest pain, Physical deconditioning, Productive cough
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALSARTAN; ZYLORIC; CARDENALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic; Cigarette smoker; Hypertension; Hyperuricaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021802351

Write-up: Acute myocardial infarction; Chest pain; the patient''s condition suddenly changed; sputum occurred; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116793. The patient was a 65-year and 2-month-old female. On 25May2021 at 14:30 (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. The patient had medical histories of hypertension, hyperuricaemia, alcohol and cigarettes. The family history was not provided. Body temperature before vaccination was 36.3 degrees centigrade. The concomitant medications included valsartan 80 mg 1 tablet, allopurinol (Zyloric) 100 mg 1 tablet, and doxazosin mesylate (Cardenalin) 1 mg 1 tablet, each after breakfast. On 11Jun2021 at 15:00 (17 days/30 minutes after the vaccination), the patient experienced acute myocardial infarction and chest pain. On 12Jun2021 (18 days after the vaccination), the patient was admitted to the hospital. On 22Jun2021 (28 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 11Jun2021, at 15:00 (17 days and 30 minutes after vaccination), in the morning, chest pain persisted for approximately 3 hours. On 12Jun2021 (17 days, 9 hours, and 30 minutes after vaccination), sputum occurred. The patient visited hospital. The patient was diagnosed with acute myocardial infarction. On 22Jun2021 (27 days, 9 hours, and 30 minutes after vaccination), the patient''s condition suddenly changed, and he died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The outcome of the events sputum occurred and chest pain were unknown. Other possible causes of the event such as any other diseases were hypertension, hyperuricaemia, alcohol, and cigarettes. The reporting physician commented as follows: Since the patient had underling diseases, it was considered that the event was unrelated to BNT162b2 vaccination; however, the causality was unassesable. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: the patient''s condition suddenly changed; Acute myocardial infarction


VAERS ID: 1469131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210629; Test Name: CT; Result Unstructured Data: Test Result:cerebral haemorrahge; Comments: cerebral haemorrahge on the brain stem of the left cerebellum and on the right occipital lobe, and acute subdural haematoma right.
CDC Split Type: JPPFIZER INC2021803458

Write-up: cardio-respiratory arrest; Cerebral haemorrhage; vomiting; slight fever; queasy; feeling bad; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116876. The patient was an 83-year and 1-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA5829, Expiration date 31Aug2021). On 27Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jun2021 (two days after the vaccination), the patient experienced cerebral haemorrhage. On 29Jun2021 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 28Jun2021 (one day after vaccination), the patient had vomiting and slight fever. The fever decreased after the patient orally took an antipyretic. However, queasy persisted, and the patient had feeling bad, and she seemed to have fallen at the restroom. On 29Jun2021, at 06:00 (2 days and 6 hours after vaccination), the family member found that the patient had cardio-respiratory arrest. The patient was assumed to die at 05:00 (2 days and 5 hours after vaccination). CT showed cerebral haemorrahge on the brain stem of the left cerebellum and on the right occipital lobe, and acute subdural haematoma right. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was oral administration of clopidogrel sulfate (Clopidogrel).; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1469135 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021804599

Write-up: AMI; excessive haemorrhage during the procedures for AMI; This is a spontaneous report from a contactable nurse and other healthcare professional received via a regulatory authority. The patient was a non-pregnant 74-year-old female. On 24Jun2021 at 11:30 (the day of vaccination), (at the age of 74-year-old) the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular for COVID-19 immunization at a clinic/emergency room. Other medical history included rheumatoid arthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed medicine within 2 weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had allergies to medications, food, or other products. On 26Jun2021 at 21:00 (2 days after the vaccination), catheterization was performed for acute myocardial infarction (AMI) at a hospital and afterwards, haemorrhage occurred. On 27Jun2021, the patient died. The cause of death was excessive haemorrhage during the procedures for AMI. The event resulted in death/emergency room/department or urgent care/hospital visit. It was unknown if the patient received the treatment for the event. It was unknown if an autopsy was performed. It was unknown if the patient has been tested for COVID-19 since the vaccination. The assessment of causality between the event and BNT162b2 was not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Acute myocardial infarction and Haemorrhage and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: excessive haemorrhage during the procedures for AMI; AMI


VAERS ID: 1469138 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
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: Parkinson''s disease NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021807543

Write-up: Death; This is a spontaneous report from a contactable physician received via a company representative. An 84-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing underlying disease of Parkinson-like symptoms. On an unknown date (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY). On an unknown date (8 days after the vaccination), the patient experienced death. The outcome, seriousness, and causality of the event were not reported. It was not reported whether autopsy was done. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: death


VAERS ID: 1469146 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Angina pectoris
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: CT/AI; Result Unstructured Data: Test Result:revealed ascending aortic dissection; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021807612

Write-up: Cardio-respiratory arrest; Ascending aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21116931. The patient was an 85-year and 0-month-old female. Medical history included historical condition of angina pectoris and the patient was regularly visiting the clinic (not ongoing). Body temperature before vaccination, 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 an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY5420, Expiration date 31Aug2021). On 23Jun2021 at 15:30 (the day of vaccination, at age of 85-year-old), 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. Thereafter, the condition was uneventful. On 23Jun2021, the patient experienced ascending aortic dissection (at unknown time after the vaccination) and cardio-respiratory arrest at 17:54 (2 hours and 24 minutes after the vaccination). On 23Jun2021 at 17:54, the patient was in a state of cardio-respiratory arrest and was urgently transported to the reporting hospital. Cardiopulmonary resuscitation was performed but produced no recovery, and death was confirmed. Computerised tomography (CT)/autopsy imaging (AI) revealed ascending aortic dissection, which was considered as cause of death. It was not reported whether autopsy was done. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: Ascending aortic dissection; Cardio-respiratory arrest


VAERS ID: 1469148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Syncope; Terminal state
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021807618

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician received a company representative. The patient was an 83-year-old female. Medical history included dementia, hypertension, and occasional onsets of syncope, and she was dying of old age and was on end-of-life care. Concomitant medications were not reported. On 04Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 23Jun2021 at unknown time (19 days after the vaccination), the patient experienced aortic dissection. On 23Jun2021 (19 days after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: The patient had dementia, hypertension, and occasional onsets of syncope. She was dying of old age and was on end-of-life care. On 04Jun2021 (the day of vaccination), the patient received the first BNT162b2 vaccination. On 23Jun2021 (19 days after the vaccination), the patient''s condition suddenly changed during the meal, and she died at the hospital where she was transported. The cause of death was aortic dissection. It was said that the causal relationship could not be denied, but no further follow-ups could be accepted considering the end-of-life care and the privacy of the bereaved family. The seriousness of the event was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Aortic Dissection cannot be fully assessed/excluded. The case will be reassessed if 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1469154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021807666

Write-up: Sudden death (cause unknown); This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 94-year-old male. Medical history included chronic obstructive pulmonary disease (COPD) and other unspecified history. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for covid-19 immunisation. Concomitant medication included clopidogrel (CLOPIDOGREL) and other unspecified medication(s) taken for unspecified indications, start and stop dates were not provided. On 28Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jun2021 (1 day after the vaccination), the patient experienced sudden death (cause unknown). On 29Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28Jun2021, the patient received the second vaccination. On 29Jun2021, the patient died. It was sudden death (cause unknown and autopsy was being conducted at the time of this report). Seriousness criteria, causality, and other possible cause of the event such as any other diseases were not provided. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Sudden death and the suspect drug BNT162b2 (COMIRNATY) 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: Sudden death (cause unknown)


VAERS ID: 1469157 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021807715

Write-up: Pneumonia; Sudden death due to cardiac event; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a male in his 80s. Medical history and concomitant medication were not reported. 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) 0.3 mL via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date (2 weeks after the vaccination), the patient experienced sudden death due to cardiac event. The outcome of the event was fatal. The course of the event was as follows: On the day of the vaccination, the patient was vaccinated at group vaccination session even though the patient had low grade fever of 36.9 degrees centigrade. On the following day of the vaccination, the patient developed pneumonia and was subsequently admitted to a hospital. Two weeks after the vaccination, after the patient was discharged from the hospital, the patient experienced sudden death due to cardiac event at home. The reporting physician assessed that the causality between the event and BNT162b2 as unknown. Seriousness criteria and other possible cause of the event such as any other diseases were not provided.; Sender''s Comments: Based on very limited available information and the temporal relationship, the reasonable possibility of an association between pneumonia, sudden death due to cardiac event and suspect product BNT162b2 cannot be completely ruled out. Detailed information on patient''s medical history, concurrent medical condition, concomitant medication, lab results during hospitalization and treatment received will allow a medically meaningful assessment of the case. 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: Sudden death due to cardiac event


VAERS ID: 1469160 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Decreased appetite, Diarrhoea, Dyspnoea exertional, Myocardial infarction, Nausea
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Myocardial infarction (eldest son)
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021807745

Write-up: Myocardial infarction; chest pain; exercise-induced shortness of breath; Diarrhoea; Queasy; Inappetence; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21116875. The patient was a 93-year and 1-month-old female. Body temperature before vaccination was 36.2 degrees centigrade. The patient had a family history of myocardial infarction (patient''s eldest son). Medical history was not reported. Concomitant medication included antithrombotic drug taken orally for an unspecified indication, start and stop dates were not provided. On 05Jun2021 (the day of vaccination), the patient received the first 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 immunization at the age of 93-year-old. On 07Jun2021 (2 days after the vaccination), the patient experienced myocardial infarction. On 09Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. On 11Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 05Jun2021, the patient received the first dose of COVID-19 vaccine. On 07Jun2021 at around noon, the patient had subjective symptom of exercise-induced shortness of breath, followed by diarrhoea, queasy, and inappetence. On 09Jun2021, the patient developed chest pain, so visited a hospital. The patient was admitted to the hospital from 09Jun2021 to 11Jun2021. The reporting physician classified the event as serious (death and hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was arteriosclerosis. The reporting physician commented as follows: Causality between the event and the vaccine could not be denied.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1469163 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021807800

Write-up: Death; This is a spontaneous report from a physician received from the Regulatory Authority and also via the Agency. Regulatory authority report number is v21116954. The patient was a 74-year and 6-month-old male. Body temperature before vaccination was 36.0 degrees centigrade. Medical history included hypertension, diabetes mellitus, and atrial fibrillation. Family history was not reported. The patient had no drug or food allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Jun2021 at 14:30 (1 day after the vaccination), the patient experienced death. The course of the event was as follows: On 28Jun2021 at 12:00 (the day of vaccination), the patient received first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly in the left arm as single dose for COVID-19 immunization at the reporting hospital. During the 15-minute observation, the patient had no notable symptoms and went home. On 29Jun2021 at 14:30 in the afternoon (1 day after the vaccination), the patient was found dead. The Police Station contacted the hospital. The reporter stated that the adverse event resulted in death and assessed the event as serious (death). The death cause was unknown (under police investigation). It was unknown whether autopsy was performed. It was unknown whether treatment was given for the adverse event. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were atrial fibrillation, diabetes mellitus and hypertension. The reporting physician commented as follows: Reported this case because of the death within 24 hours after the vaccination despite the unknown causal relationship with the vaccination.; Reported Cause(s) of Death: Death


VAERS ID: 1469164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALTAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021807801

Write-up: Cardiac failure; This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. The patient was a 90-year-old female. Medical history was not provided. Concomitant medication included roxatidine acetate hydrochloride (ALTAT) capsules taken for an unspecified indication, start and stop dates were not provided. 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 provided) via intramuscular as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. On an unspecified date, the patient experienced cardiac failure. The outcome of the event was fatal. Cause of death was diagnosed as cardiac failure. The reporting healthcare professional classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Fatal vent cardiac failure more likely represents an intercurrent medical condition and unrelated to BNT162b2 for this 90 years old patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1469183 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021809134

Write-up: Death; This is a spontaneous report from a contactable nurse communicated via a company representative. The patient was an 89-year-old female. Medical history and concomitant medications were not reported. On an unknown date (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unknown date (about 10 days after the vaccination), the patient experienced death. The outcome of the event was not reported. The course of the event was as follows: About 10 days after the first vaccination, the patient died. The seriousness and causality of the event were not reported. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: Death


VAERS ID: 1469189 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Oxygen saturation, Pneumonia aspiration
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardiac failure; Dementia; Hypertension; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to the 70 range %
CDC Split Type: JPPFIZER INC2021809661

Write-up: Pneumonia aspiration; multi-organ failure; This is a spontaneous report from a non-contactable Health Professional received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 95-year-old female non-pregnant patient received bnt162b2 (COMIRNATY Solution for injection, Lot Number: Unknown) intramuscular on 22Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cardiac failure, renal failure chronic, hypertension, angina pectoris, dementia. 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. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. On 22Jun2021 (the day of vaccination), several hours after the vaccination, the patient had a meal. It was suspected that aspiration occurred afterwards. Pallor facial was noted, and SpO2 (oxygen saturation percutaneous) decreased to the 70% range. The patient was transferred to a hospital. At the time of hospitalization, her general condition was poor and she was in a state of multi-organ failure. On 24Jun2021, two days after the hospitalization, the patient died. The event resulted in hospitalization/death. The cause of death was pneumonia aspiration. An autopsy was not performed. The outcome of the events was fatal without treatment. The reporter stated that it was unknown if this was an adverse event, the possibility of the presence of an adverse event was fairly low. It was unknown if the patient has not been tested for COVID-19 since the vaccination.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. The patient''s advanced age has been assessed to have played a contributory role toward 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 RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: multi-organ failure; Pneumonia aspiration


VAERS ID: 1469235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-13
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Blood bicarbonate, Blood creatinine, Blood gases, C-reactive protein increased, COVID-19, Chest X-ray, Chronic obstructive pulmonary disease, Drug ineffective, Dyspnoea, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Infection, Lymphocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet disorder, Respiratory arrest, Respiratory rate, SARS-CoV-2 test, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: SALBUTAMOL; BUDESONIDE; SALMETEROL; UMECLIDINIUM; OMEPRAZOLE; BUMETANIDE
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; COVID-19 (symptoms: cough and shortness of breath); Heart disease, unspecified (Grade 1 Diastolic Dysfunction); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Bacteria; Result Unstructured Data: Test Result:No bacteria cultivated; Test Name: HcO3; Result Unstructured Data: Test Result:35.5; Test Date: 20210613; Test Name: creatinine; Result Unstructured Data: Test Result:135; Test Date: 20210613; Test Name: ABG on VM; Test Result: 28 %; Test Name: Chest x ray; Result Unstructured Data: Test Result:bilateral pleural effusions & overlying air space; Comments: bilateral pleural effusions & overlying air space shadowing; Test Date: 20210613; Test Name: CRP; Result Unstructured Data: Test Result:26.9; Test Date: 20210614; Test Name: D-dimer; Result Unstructured Data: Test Result:1039; Test Date: 20210613; Test Name: GFR; Result Unstructured Data: Test Result:47; Test Date: 20210613; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.5; Test Date: 20210613; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.74; Test Date: 20210613; Test Name: Neutophiles; Result Unstructured Data: Test Result:21.82; Test Name: SpO2; Result Unstructured Data: Test Result:65.9; Test Name: SpO2; Result Unstructured Data: Test Result:93 %; Test Name: pCO2; Result Unstructured Data: Test Result:113.5 mmHg; Test Date: 20210613; Test Name: pCO2; Result Unstructured Data: Test Result:99.7 mmHg; Test Name: pH; Result Unstructured Data: Test Result:7.1; Test Date: 20210613; Test Name: pH; Result Unstructured Data: Test Result:7.15; Test Date: 20210613; Test Name: Platelets; Result Unstructured Data: Test Result:269; Test Name: pO2; Result Unstructured Data: Test Result:114.4 mmHg; Test Date: 20210613; Test Name: pO2; Result Unstructured Data: Test Result:54.6 mmHg; Test Name: RR; Result Unstructured Data: Test Result:$g30 breaths/min; Test Date: 20210613; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Positive; Test Date: 20210613; Test Name: White blood cell count; Result Unstructured Data: Test Result:24.96 x10 9/l
CDC Split Type: MTPFIZER INC2021804068

Write-up: This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number MT-ADM-17062021. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ET6956) as dose 1, single; and dose 2 via an unspecified route of administration in left arm on 14May2021 (Batch/Lot Number: FD1921) as dose 2, single for covid-19 immunization. The patient''s medical history included ongoing chronic obstructive pulmonary disease, benign prostatic hypertrophy, hypertension, heart disease, unspecified (Grade 1 Diastolic Dysfunction), Covid-19 positive on 31Jan2021 (symptoms included cough and shortness of breath). Concomitant medications included salbutamol, budesonide, salmeterol, umeclidinium, omeprazole, and bumetanide, all were taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient had infection and COPD exacerbation. The patient who despite being fully vaccinated was COVID positive on 13Jun2021 (symptomatology for this second infection was SOB). Patient was admitted to hospital after suffering respiratory arrest (respiratory type 2 failure). Patient was found to be COVID POSITIVE [Detected]. Chest x-ray showed bilateral pleural effusions & overlying air space shadowing. The patient had concomitant severe COPD (chronic obstructive pulmonary disease), had a high RR ($g30 breaths/min) and SPO2 was less than 93%. Patient had hospital respiratory arrest (reason for admission). ABGs on NRM was pH7.1, pCO2 113.5, pO2 114.4, SpO2 65.9, HCO3 35.5. Patient started on NIV PINSP 15, PEEP 6, FIO2 40%. Over course of admission there was minimal improvement with deterioration despite maximal NIV settings. The patient received hydrocortisone 100mg tds iv given for COPD. Patient started on regular nebulization of salbutamol 2.5mg QDS plus Ipatromium Bromide 0.5mg QDS. Relevant laboratory analysis on 13Jun2021 includes, WCC 24.96, neutrophils 21.82, lymphocytes 0.74, haemoglobin 11.5, platelets 269, creatinine 135, GFR 47, CRP 26.9, ABGs on VM 28%: pH 7.15, pCO2 99.7 mmHg, pO2 54.6 mmHg. On 14 June 2021, D-Dimer was 1039, MSU for C/S: no bacteria cultivated. The outcome of the events was fatal. The patient died on 16Jun2021 in a hospital. The primary cause of death was chronic obstructive pulmonary disease exacerbation due to COVID-19 with other significant contributory causes being congestive heart failure and hypertension. It was not reported if autopsy was performed. Reported Cause(s) of Death: COPD exacerbation; He was found to be COVID POSITIVE [Detected]. Infection; dyspnea; respiratory arrest


VAERS ID: 1469318 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: DUSPATAL; OXAZEPAM; MOVICOLON; AMLODIPINE; PROPRANOLOL
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021796332

Write-up: possible brain haemorrhage, found dead; This is a spontaneous report from a contactable physician from the Regulatory Authority NL-LRB-00590047. A 73-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31May2021 (at the age of 73-year-old) as a dose 2, single for COVID-19 immunisation. The patient''s medical history included ongoing hypertension. Concomitant medication(s) included mebeverine hydrochloride (DUSPATAL [MEBEVERINE HYDROCHLORIDE]); oxazepam; macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON); amlodipine (AMLODIPINE); propranolol (PROPRANOLOL). The patient previously received BNT162B2 (COMIRNATY, Formulation: Solution for injection), via unspecified route of administration on 26Apr2021 as a dose 1, 0.3 mL, single for COVID-19 immunisation. ADRs were unknown after 1st dose. It was reported that, patient with previous COVID-19 was reported as none. The diagnostic procedures were reported as no. On 02Jun2021, the patient experienced possible brain haemorrhage, found dead following administration of covid-19 vaccine pfizer injectable solution 2 days after start. The cause of death was reported as possible brain haemorrhage, found deceased, no autopsy. Was familiar with hypertension requiring medication. patient died on 02Jun2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained. Reported Cause(s) of Death: possible brain haemorrhage, found deceased, no autopsy. Was familiar with hypertension requiring medication


VAERS ID: 1469319 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Death
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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: AMLODIPINE; THIAMIN [THIAMINE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021796264

Write-up: Three days later the patient passed away/ cause of death is unknown; abdominal pain, died 3 days later. a few hours after 2nd vaccination experienced tearing pain in upper abdomen. increasingly worse/sicker; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority report number: NL-LRB-00590315. A 59-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Jun2021 (batch/lot number was not reported) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has no previous COVID-19 infection. Patient previously received first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation and no side effect was reported. Concomitant medications included amlodipine; and thiamin [thiamine] (THIAMIN [THIAMINE]). The patient experienced ''abdominal pain, died 3 days later; a few hours after 2nd vaccination experienced tearing pain in upper abdomen, increasingly worse/sicker'' on 08Jun2021, and three days later the patient passed away/ cause of death is unknown on 11Jun2021.It was reported that several hours after vaccination patient got abdominal pain upper, which worsened over time. Three days later the patient passed away. No obduction was done, cause of death is unknown. The outcome of the event ''abdominal pain upper'' was fatal. It was also reported that the cause of death was unknown. The patient died on 11Jun2021. An autopsy was not performed. Case Summary and Reporter''s Comments Text: abdominal pain, died 3 days later Additional information ADR: a few hours after 2nd vaccination experienced tearing pain in the upper abdomen, getting worse/worse, died 3 days later in the morning on 11Jun2021. No autopsy took place, so unclear if there is indeed a link. COVID19: Previous COVID-19 infection: No Other diagnostic procedures: No No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: abdominal pain, died 3 days later Additional information ADR: a few hours after 2nd vaccination experienced tearing pain in the upper abdomen, getting worse/worse, died 3 days later in the morning on 11Jun2021. No autopsy took place, so unclear if there is indeed a link. COVID19: Previous COVID-19 infection: No Other diagnostic procedures: No; Reported Cause(s) of Death: Abdominal pain upper; Unknown


VAERS ID: 1469323 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-03
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood grouping, Cardiac failure acute, Thrombosis
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

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:
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:good cholesterol values/ good cholesterol; Test Name: Blood type; Result Unstructured Data: Test Result: negative.
CDC Split Type: NLPFIZER INC2021796302

Write-up: Sudden death in sleep. In good health, weight and no medication: There were no side effects. Clot in the heart, acute heart failure during sleep and death.; Cause of death was thrombus in/around the heart which caused acute heart failure.; This is a spontaneous report from a contactable consumer (patient) from the Regulatory Authority. The Regulatory Authority number NL-LRB-00591063. A 71-year-old male patient received BNT162B2 (COMIRNATY), at the age of 71-year-old, via an unspecified route of administration on 07May2021 at single dose (dose number unknown), for COVID-19 immunisation. The patient medical history was not reported. The patient has no previous COVID-19 infection. The patient was in good health, had good cholesterol values, ate healthy, and used no medication. According to the GP the patient''s body and heart were in a good shape. With good cholesterol, good exercise, a good diet, and no use of medicines. Heart and body were in good condition according to GP. Never used drugs and physically strong. The patient had sudden death in sleep. In good health, weight, and no medication: there were no side effects. clot in the heart, acute heart failure during sleep, and death on 03Jun2021, cause of death was thrombus in/around the heart which caused acute heart failure on 03Jun2021. The patient underwent lab tests and procedures which included cholesterol: good cholesterol values/ good cholesterol. The patient died on 03Jun2021. 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: Cause of death was thrombus in/around the heart which caused acute heart failure. Sudden death in sleep. In good health, weight and no medication: There were no side effects. Clot in the heart, acute heart failure during sleep and death.


VAERS ID: 1469328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021796405

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer or other non hcp NL-LRB-00592575. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot Number: FD0785) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 comirnaty (Batch/Lot Number: unknown) for covid-19 immunisation on 30Apr2021. The patient experienced cardiac arrest on 08Jun2021 with fatal outcome. The patient died on 08Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1469330 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery stenosis, Dyspnoea, Malaise, Myocardial infarction, Pneumonia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: PERINDOPRIL ERBUMINE; CLOPIDOGREL; SIMVASTATINE; SULFASALAZINE; HYDROXYCHLOROQUINE; PANTOPRAZOLE; ETORICOXIB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021804192

Write-up: right lung full of pneumonia; myocardial infarction//had had a heart attack at the emergency room; narrowing in coronary arteries, died the same night.; 2x VT (Ventricular Failure) greater than 2x electric shock; malaise within 13 hours, not good; stuffy within 13 hours; This is a spontaneous report from a contactable physician from the Regulatory Authority NL-LRB-00593642. A 70-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Jun2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The co-suspect medication included METHOTREXATE, via an unspecified route of administration from 2008 (Batch/Lot number: unknown) to an unspecified date, at 25 mg, weekly for rheumatoid arthritis. The patient''s medical history was not reported. The patient previously did not have COVID-19 infection. Concomitant medications included perindopril erbumine, clopidogrel, simvastatine, sulfasalazine, hydroxychloroquine, pantoprazole, etoricoxib all taken for an unspecified indication. The patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01May2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and experienced no adverse reaction. On 07Jun2021, patient experienced malaise, dyspnoea, myocardial infarct, pneumonia, coronary artery stenosis, ventricular tachycardia following administration of COVID-19 vaccine. Malaise within 13 hours, not feeling well, stuffy. On 06Jun2021 2x visit to the GP, admitted in the evening due to shortness of breath, 2x VT (Ventricular Failure) greater than 2x electric shock. Hospital. At the emergency room showed myocardial infarction//had had a heart attack at the emergency room, right lung full of pneumonia, narrowing of coronary arteries, died the same night. The patient died on 07Jun2021. It was not reported if an autopsy was performed. The outcome of the events coronary artery stenosis, dyspnoea, malaise, myocardial infarct, pneumonia, and ventricular tachycardia was fatal. Reported Cause(s) of Death: myocardial infarction, had had a heart attack at the emergency room; narrowing in coronary arteries, died the same night. right lung full of pneumonia; 2x VT (Ventricular Failure) greater than 2x electric shock; stuffy within 13 hours; malaise


VAERS ID: 1469333 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dilatation, Fatigue, Injection site discomfort, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021804282

Write-up: not feeling well; Other reaction at or around the injection site: Stiff; Acute dilated and leaky aorta; Fatigue; The contactable reporter described events for both doses of Comirnaty. This is the first of two re-ports and this report describes events for the second dose. This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB NL-LRB-00594208. A 78-years-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration, on 14May2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: unknown) for Covid-19 immunisation and experienced injection site discomfort, fatigue. Past drug therapy included covid-19 vaccine Pfizer solution for injection with injection site discomfort, covid-19 vaccine pfizer solution for injection with fatigue. On 27May2021, the patient had experienced not feeling well, other reaction at or around the injection site: stiff, acute dilated and leaky aorta and fatigue on 17May2021. Treatment included Aortic dilatation is treated with emergency surgery. Acute dilated and leaky aorta, injection site discomfort is treated with emergency surgery. Acute dilated and leaky aorta and malaise is treated with surgery on 27May. Dad became ill and was taken by ambulance for emergency surgery on his aorta. It was dilated and leaking. He did not survive this. The patient recovered from fatigue, the outcome of aortic dilatation is fatal, the outcome of injection site discomfort is fatal, and the outcome of malaise is fatal. Therapeutic measures were taken as a result of other reaction at or around the injection site: stiff, acute dilated and leaky aorta. The patient died on 27May2021. The cause of death was reported as Aortic dilatation. It was not reported if an autopsy was performed. The clinical outcome of the event fatigue recovered on 17May2021 and other events was fatal. Reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A stiff arm and very tired Date: 09Apr2021, BSN available: yes -COVID-19 -, Previous COVID-19 infection: No -Other - diagnostic procedures: No No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained. ; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: A stiff arm and very tired Date: 09Apr2021 BSN available: yes -COVID-19 - Previous COVID-19 infection: No -Other - diagnostic procedures: No; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021819112 same patient, different dose; Reported Cause(s) of Death: aorta Okay


VAERS ID: 1469334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021824342

Write-up: suddenly Unwell; acute cardiac death; Nausea; Vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority number NL-LRB-00594877. A 70-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Jun2021 as DOSE 2, SINGLE for covid-19 immunization. The patient recevied COMIRNATY, Solution injection, Lot number/Expiration date: Unknown). The patient medical history and concomitant medications were not reported. On 14Jun2021 the patient experienced vomiting and nausea. On 15Jun2021 the patient experienced suddenly unwell and acute cardiac death. It was reported that, 14Jun in the afternoon suddenly experiencing nausea and vomiting, not very sick. 15Jun in the morning suddenly unwell, resuscitated, died. No previous COVID-19 infection was reported. No Other diagnostic procedures were reported. The patient died on 15Jun2021. An autopsy was not performed. No follow-up attempts are possible,information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: no Date: 08May2021. acute cardiac death: Additional information adverse events: 14Jun in the afternoon suddenly experiencing nausea and vomiting, not very sick. 15Jun in the morning suddenly unwell, resuscitated, died. Previous COVID-19 infection: No. Other diagnostic procedures: no; Reported Cause(s) of Death: Unclear, acute cardiac arrest; no autopsy, wanted family


VAERS ID: 1469361 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Autopsy, Cardiac arrest, Dyspnoea, Echocardiogram, Electrocardiogram, Haemoptysis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CALCIGRAN FORTE; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; ENTOCORT; EXFORGE HCT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune hepatitis; Crohn''s disease; Hypertension; Infarct myocardial (Signs of sub acute (1-2 weeks old) infarction in posterior, septal and papillary muscle.); Old myocardial infarction (Findings of old infarction)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Autopsy; Result Unstructured Data: Test Result:sigificant coronary artery stenosis in both stem; Comments: sigificant coronary artery stenosis in both left and right main stem, with 2.5 cm long ruptured atherosclerotic plaque in right coronary artery. Signs of acute (1-2 days old), subacute (1-2 weeks old) and old infarction in posterior, septal and papillary muscle.; Test Date: 20210527; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Reduced contractility laterally and inferiorly; Comments: Reduced contractility laterally and inferiorly. Severe mitral regurgitation. No pericardial effusion or dilatation of ventricles.; Test Date: 20210527; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Findings compatible with infarction; Comments: Findings compatible with posterior ST elevation infarction
CDC Split Type: NOPFIZER INC2021796798

Write-up: STEMI; Cardiac arrest prehospital and inhospital; heavy breath; HEMOPTYSIS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U8e3x8. Safety Report Unique Identifier NO-NOMAADVRE-E2B_00032006. A 71-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25May2021 at age of 71-years-old as Dose 2, single for covid-19 immunisation. Medical history included myocardial infarction from May2021, myocardial infarction from 2021, hypertension, crohn''s disease, autoimmune hepatitis. Concomitant medications included calcium carbonate, colecalciferol (CALCIGRAN FORTE); cyanocobalamin, folic acid, pyridoxine (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]); budesonide (ENTOCORT) taken for crohn''s disease; amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for hypertension. On 25May2021, the patient developed hemoptysis, acute dyspnea. On 27May2021, the patient developed stemi, cardiac arrest. The patient did not seek medical attention until 27May2021, when she went to her local emergency room. Before she arrived the hospital she experienced sudden cardiac arrest. Cardiopulmonary resuscitation was performed, and ROSC was established. The patient was then hospitalized, and diagnosis of STEMI was established. She then had a new cardiac arrest before invasive coronary angiography was performed, and she then died on 27may2021. Relevant laboratory findings and investigations included in the report (electrocardiogram, 27May2021, Findings compatible with posterior ST elevation infarction)( echocardiogram, 27May2021, Reduced contractility laterally and inferiorly. Severe mitral regurgitation. No pericardial effusion or dilatation of ventricles.)( autopsy, 2021, Coronary artery stenosis both left and right main stem, with 2.5 cm long ruptured atherosclerotic plaque in right coronary artery, signs of acute (1-2 days old), subacute (1-2 weeks old) and old infarction in posterior, septal and papillary muscle.). An autopsy was performed and revealed signs of significant coronary artery disease, and findings consistent with acute, sub acute and old myocardial infarctions. Myocardial infarction was considered the cause of death by autopsy. The primary reporter considered that an immune response related to the vaccine might have contributed to the patient?s death, although it was not the direct cause of death. The patients outcome was Fatal. The case was considered to be Serious. This case was received from a Physician. The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporter Comment: 21Jun2021 Center: requested information about batch number, but the information was not registered in the Immunisation Registry. 23Jun2021 Center: requested information about batch number from the primary reporter. Information on batch/lot number has been requested.; Reporter''s Comments: 21Jun2021 Center: requested information about batch number, but the information was not registered in the Immunisation Registry. 23Jun2021 Center: requested information about batch number from the primary reporter.; Reported Cause(s) of Death: heavy breath; hemoptysis; cardiac arrest; Autopsy-determined Cause(s) of Death: STEMI


VAERS ID: 1469367 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-14
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: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]; ATACAND
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Hypertension; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM 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 Embolism pulmonary in 2014 and Prostate cancer in 2014. Concurrent medical conditions included Hypertension. Concomitant products included CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE (TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE]) and CANDESARTAN CILEXETIL (ATACAND) for an unknown indication. On 07-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant). The patient died on 30-Jun-2021. The reported cause of death was Embolism pulmonary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered PULMONARY EMBOLISM (to be possibly related. No treatment information was provided. 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: EMBOLISM PULMONARY


VAERS ID: 1469387 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-14
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 INC2021791030

Write-up: death; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is unknown. This one is the death cases. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s death was reported 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.; Reported Cause(s) of Death: death


VAERS ID: 1469435 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Drug ineffective
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021824785

Write-up: drug ineffective; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-2 interstitial pneumonia; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-2 interstitial pneumonia; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-2 interstitial pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-3-777-2021. A 96-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection), via intramuscular route of administration, administered in right arm (Batch/Lot Number: ER7812; Expiration Date: 06Jun2021) on 12Mar2021 08:16 as single dose for COVID-19 immunization. The patient medical history and patient''s concomitant medications were not reported. On an unspecified date, the patient experienced drug ineffective on an unspecified date, j84.8 / j96.0 / u07.1 acute respiratory failure in sars-cov-2 interstitial pneumonia. In the report, the doctor stated: J84.8 (Other specified diseases of interstitial lung tissue) /J96.0 (Respiratory failure not elsewhere classified) /U07.1 (Covid-19) Acute respiratory failure in the course of SARS-CoV interstitial pneumonia -2. An employee conducted a telephone conversation with the reporting doctor. The patient was hospitalized in a serious condition. The patient was hospitalized in the Pulmonology Department on: 25Mar2021 - 28Mar2021. Additional information: There is no post-vaccination reaction in the patient''s history. The reporting person classified them as severe. HA, due to the assessment of the reporting person, the nature of the side effects and the patient''s death, qualified the report as severe (hospitalization: 25Mar2021- 28Mar2021). Health result: death (date: 28Mar2021). The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. The outcome of events was fatal. Sender comments: Comirnaty vaccine is an mRNA vaccine against COVID-19 (with modified nucleosides) According to Comirnaty''s Summary of Product Characteristics, full protective efficacy of the vaccine should be achieved at least 7 days after the second dose. According to the reports provided in the report, the patient was diagnosed with respiratory failure caused by SARS-CoV-2 13 days from the date of the second vaccination. Summary of Products Characteristics of Comirnaty reports that, as with any vaccine, Comirnaty may not protect everyone who receives it. HA reported 82 cases of COVID-19-associated pneumonia (COVID-19 pneumonia) and 91 cases of respiratory failure following Comirnaty administration until June 16, 2021 (with fatal outcome). As required by the Risk Management Plan, a follow-up question form was sent to the reporting person via the sanitary and epidemiological station in order to obtain additional data in order to collect available clinical details on the nature and severity of the COVID-19 disease, especially with regard to potential cases vaccine effectiveness; and vaccine enhanced disease (VAED). If a response is obtained from the reporting person, it will be forwarded to HA follow-up. The temporal relationship speaks for a cause-and-effect relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, HA classified the report as severe. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: drug ineffective; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-2 interstitial pneumonia; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-2 interstitial pneumonia; J84.8 / J96.0 / U07.1 Acute respiratory failure in SARS-CoV-


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