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

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



Case Details

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VAERS ID: 1507380 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Myocarditis, Pericarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: BAYASPIRIN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021887961

Write-up: Cardio-respiratory arrest; suspected myocarditis and pericarditis; suspected myocarditis and pericarditis; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 67-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration 10Jul2021 between 14:00 to 17:00 at age of 67-year-old (the day of vaccination) at single dose for COVID-19 immunization. The patient had medical history of heart disease. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) orally for heart disease and warfarin. The historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. There was no problem when waiting after the vaccination. On 11Jul2021 in the middle of the night (1 day after the vaccination), the patient''s family found the patient with cardio-respiratory arrest and called for an emergency. The patient was transferred by ambulance and confirmed dead at 2:13 on 11Jul2021. The physician assessed the events cardio-respiratory arrest and death as probably related to BNT162b2. The physician considered the cause of death was suspected myocarditis and pericarditis (Jul2021) because the patient had heart disorder which was an underlying disease. The patient had an underlying disease, but as far as the family usually saw, the patient was healthy. The patient''s daughter contacted this situation. The family contacted the Regulatory Authority. The outcome of the events was fatal. It was unknown if an autopsy was performed. The date of death was 11Jul2021.; Sender''s Comments: Based on the plausible temporal relation, the association between the events of cardiorespiratory arrest, myocarditis and pericarditis and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: suspected myocarditis and pericarditis; suspected myocarditis and pericarditis; Cardio-respiratory arrest


VAERS ID: 1507386 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatine phosphokinase, Blood test, Body temperature, Cardiac failure, Decreased appetite, Nausea, Seizure
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: CPK; Result Unstructured Data: Test Result:High; Test Date: 20210713; Test Name: blood examination; Result Unstructured Data: Test Result:high creatinine phosphokinase; Test Date: 202107; Test Name: blood examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021887982

Write-up: Acute myocardial infarction; Cardiac failure; Seizure; Queasy; Inappetence; This is a spontaneous case from a contactable nurse received via a Pfizer sales representative and a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119233. A 72-year and 1-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 72 years on 08Jul2021 11:00 (Lot Number: EY0573; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. The patient had medical histories of hypertension, diabetes mellitus, and cerebral infarction. Since the patient had medical history of cerebral infarction, she was being admitted to a healthcare facility for the elderly. The concomitant medications were unknown. Historical vaccine included first dose of BNT162b2 (COMIRNATY, Lot# not reported, Expiration date not reported) for COVID-19 immunization. On 08Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY). After the patient received the second dose of BNT162b2 vaccination, she experienced queasy and inappetence. The dehydration was concerned, and a drip infusion was performed. The patient was transferred to the hospital for seizure. However, the patient also developed cardiac failure due to acute myocardial infarction, and she died. It was not reported if an autopsy was performed. The adverse events, Acute myocardial infarction and Cardiac failure were classified as serious (death) as per the reporting nurse. Seriousness classification for other events was not provided. The causality between the all of events and BNT162b2 was not provided. The physician further reported the body temperature before vaccination (on 08Jul2021, 36.5 degrees Centigrade), the date of onset of acute myocardial infarction and cardiac failure (on 13Jul2021), the date of death (on 13Jul2021). The course of the events was as follows: On 11Jul2021 and 12Jul2021 since the patient had queasy and inappetence, a drip infusion and a blood examination were performed (Jul2021). On 13Jul2021, the blood examination showed high creatinine phosphokinase (CPK), and emergently house visit by a doctor was planned. However, at 10:15 (4 days, 23 hours, and 15 minutes after vaccination), the contact was made. Since the patient had seizure, she was emergently transferred. Thereafter, at 11:30, it was contacted that the patient was confirmed to die at another hospital where she was transferred to. It was contacted that the cause of death was acute myocardial infarction. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases. The patient die on 13Jul2021. The outcome of events acute myocardial infarction and cardiac failure was fatal, other events was unknown. It was not reported if an autopsy was performed.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death, therefore the event does not meet reportability to Regulatory Authority. 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: Cardiac failure; Acute myocardial infarction


VAERS ID: 1507406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Cardio-respiratory arrest, Computerised tomogram thorax, Oxygen saturation
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), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple system atrophy; Parkinson''s syndrome; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210608; Test Name: Chest CT; Result Unstructured Data: Test Result:revealed a notable finding of endotracheal sputum; Comments: revealed a notable finding of endotracheal sputum and a high density suggestive of pneumonia aspiration in bilateral lobes; Test Date: 20210608; Test Name: SpO2; Test Result: 70 %; Test Date: 20210701; Test Name: SpO2; Test Result: 96 %; Test Date: 20210702; Test Name: SpO2; Test Result: 89 %; Comments: first measurement after vaccination; Test Date: 20210702; Test Name: SpO2; Result Unstructured Data: Test Result:gradually increased and recovered to 95% %; Comments: second measurement after vaccination; Test Date: 20210702; Test Name: SpO2; Test Result: 98 %; Comments: third measurement after vaccination; Test Date: 20210703; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC2021888134

Write-up: asphyxia due to saliva or sputum; Found in a state of cardio-respiratory arrest; This is a spontaneous report from a physician received from the Regulatory Authority. Regulatory authority report number is v21119097. A 87-year and 2-month-old male received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) On 02Jul2021 at 15:00 (the day of vaccination), at 0.3 ml via an unspecified route of administration as a single dose for COVID-19 immunisation.Body temperature before vaccination was 36.6 degrees centigrade. Family history was not reported. Medical history included pneumonia aspiration within a month, multiple system atrophy, and Parkinson''s syndrome.On 28May2021 at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation.On 03Jul2021 at 17:10 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest.On 03Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done.Summary (symptoms, signs, clinical course, diagnosis, examination, etc.) was as follows:The patient had multiple system atrophy.On 08Jun2021 around 08:00, the family found the patient distressed because of accumulated saliva inside the mouth and called a visiting nurse. The visiting nurse performed sputum suctioning, but the SpO2 was 70%, and the patient was urgently transported to the previous physician. Chest computerised tomography (CT) revealed a notable finding of endotracheal sputum and a high density suggestive of pneumonia aspiration in bilateral lobes. Administration of antibacterial drugs was initiated, and it was terminated on 11Jun2021. The patient received complete assistance for activities of daily living (ADL) was given meals of thickened food (there were no notes about the swallowing condition in the patient referral document and nursing summary, while records about weak cough reflex and a high risk of aspiration were included in the information provided by the rehabilitation department).On 01Jul2021, the patient was transferred to the reporting hospital in the afternoon and went up to the hospital ward at 15:00. The SpO2 was 96%, pulmonary murmur was heard in the right lung, pharyngeal stridor was noted, and a moderate amount of sputum was aspirated. At 16:00, a water swallowing test was performed by the speech-hearing therapist (ST) and was stopped because of choking on 3 ml of water. Dinner was skipped. At 18:00 and 22:00, a moderate amount of sputum was aspirated.On 02Jul2021 at 02:00 (the day of vaccination), a moderate amount of sputum was aspirated. At 06:00, the patient drank a spoon of thickened tea without chocking. He skipped breakfast. At 10:00, the breath sounds in the left lung were slightly weak. At 12:00, assisted by the ST, the patient had a dysphagia diet (60% of the main dish, 80% of the side dish), and chocking was noted. At 15:00, the patient received a vaccination against the new coronavirus, and during the 15-minute observation, no abnormality was found. At 18:00 (3 hours after the vaccination), pharyngeal stridor was noted, and a moderate amount of saliva-like sputum was aspirated, but the SpO2 was 89% and did not improve, and respiratory sounds in bilateral lungs decreased; oxygen inhalation (2L) was started, and the SpO2 gradually increased and recovered to 95%. At 20:00 and 21:00 (5 and 6 hours after the vaccination), sputum was aspirated. At 22:00 (7 hours after the vaccination), the SpO2 was 98%. Sputum was profuse and was aspirated, and respiratory sounds were not heard in the lower lobes of both lungs. On 03Jul2021 at 00:00 (1 day after the vaccination), sputum was aspirated. At 02:00, the SpO2 was 98%, and a large amount of sputum was aspirated. At 04:00, sputum was aspirated. At 04:30, the staff visited the patient''s room, talked to her, and sucked only a small amount of sputum. At 05:10, at visit to the room, the patient was found in a state of cardio-respiratory arrest with foaming at the mouth and was immediately started on cardiopulmonary resuscitation (CPR). At 06:04, his death was confirmed.Information on Prevaccination Screening Questionnaire for COVID-19 vaccine was as follows: Are you receiving the COVID-19 vaccine for the first time? No (If you have been vaccinated before, date of 1st time: 28May2021). Is the city, town, or village where you currently reside the same as the city, town, or village stated on the coupon? Yes. Have you read the "Instructions for the COVID-19 vaccine" and do you understand the effects and adverse side effects? Yes. Do you fall into one of the target groups that have a higher priority for this vaccine? Yes (person 65 years or older). Are you currently suffering from any kind of illness and receiving treatment or medication? Yes (other: Parkinson''s syndrome and multiple system atrophy). Has a doctor who is treating you for the disease told you that you can have the vaccine today? Yes. Have you had a fever or gotten sick in the last month? Yes (pneumonia aspiration). Are there any parts of your body that are not feeling well today? No. Have you ever had a convulsion (seizure)? No. Have you ever experienced severe allergic symptoms (such as anaphylaxis) from medications or foods? No. Have you ever been sick after receiving a vaccine? No. Is there any possibility that you are currently pregnant (for example, your period is later than expected) or are you breastfeeding? No. Have you had any vaccines within the last two weeks? No. Do you have any questions about the vaccine today? No.The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases included potential asphyxia due to saliva or sputum. The reporting physician commented as follows: The patient had poor swallowing condition and weak cough reflex and was likely to be at high risk of asphyxia due to saliva or sputum. However, in light of the death within 24 hours after the vaccination, we reported this case this time.; Reported Cause(s) of Death: asphyxia due to saliva or sputum; Found in a state of cardio-respiratory arrest


VAERS ID: 1507409 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210712; Test Name: CT; Result Unstructured Data: Test Result:CT revealed extensive infarction findings suggesti; Comments: CT revealed extensive infarction findings suggestive of old infarction (after vaccination); Test Date: 20210712; Test Name: Chest CT; Result Unstructured Data: Test Result:Chest CT showed findings suspected of pneumonia du; Comments: Chest CT showed findings suspected of pneumonia due to aspiration (after vaccination)
CDC Split Type: JPPFIZER INC2021888151

Write-up: Cardiac arrest; Respiratory arrest; The most suspicious death cause was asphyxia due to aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119232.A 98-year and 6-month-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) On 12Jul2021 at 10:00 (the day of vaccination), via an unspecified route of administration as a single dose for COVID-19 immunisation. Body temperature before vaccination was 36.6 degrees centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status).On an unknown date at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021).On12Jul2021, the patient experienced respiratory arrest at 12:10 (2 hours and 10 minutes after the vaccination) and cardiac arrest at 12:20 (2 hours and 20 minutes after the vaccination), and died. The most suspicious death cause was asphyxia due to aspiration. On 12Jul2021 (the day of vaccination), the outcome of the events was fatal. The course of the events was as follows: On 12Jul2021 in the morning (the day of vaccination), no abnormality was noted. Around 10:00, the patient received the second coronavirus vaccination. During the medical check before the vaccination, the patient was fine as usual and had normal body temperature. There were no unusual findings after the vaccination. Around 11:50 (1 hour and 50 minutes after the vaccination), tea was handed out before lunch. At 11:58 (1 hour and 58 minutes after the vaccination), it was reported that sputum seemed to be stuck, and suctioning was started, drawing a large amount of tea. At 12:10 (2 hours and 10 minutes after the vaccination), respiratory arrest developed, and intervention with an Ambu bag and cardiac massage was performed. No recovery was made. At 12:20 (2 hours and 20 minutes after the vaccination), respiratory arrest and cardiac arrest were noted, and a call was therefore made to the family. The patient was transported to the reporting hospital and arrived at 13:05. At 13:15, after the family was given an explanation, the patient was confirmed dead. Mainly in the head''s right-side cerebrum, computerised tomography (CT) revealed extensive infarction findings suggestive of old infarction. Otherwise, no evident haemorrhage was noted. Chest CT showed findings suspected of pneumonia due to aspiration. The most suspicious death cause was asphyxia due to aspiration. The reporting physician classified the events as serious (death) and assessed that the events was unrelated to BNT162b2. Other possible cause(s) of the events such as any other diseases dementia and late effects of cerebral infarction. The reporting physician commented as follows: The patient had shown signs of aspiration due to late effects of cerebral infarction and other conditions since before. The vaccination was unlikely to have a causal relationship with the present episode.; Sender''s Comments: Based on previous medical history of the patient and no evidence suggesting the role of the vaccine, a possible contributory role of the suspect BNT162B2 seems to be unrelated for the reported Aspiration, Respiratory arrest and Cardiac arrest.; Reported Cause(s) of Death: The most suspicious death cause was asphyxia due to aspiration


VAERS ID: 1507411 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebral haemorrhage, Computerised tomogram head, Respiratory disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Head computerised tomography (CT) test; Result Unstructured Data: Test Result:revealed extensive bilateral intraventricular haem; Comments: revealed extensive bilateral intraventricular haemorrhage also with significant cerebellar haemorrhage
CDC Split Type: JPPFIZER INC2021888164

Write-up: Consciousness disturbed; Declined respiratory condition; Cerebral haemorrhage found on CT test; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119246. A 95-years-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), on 24May2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced consciousness disturbed, declined respiratory condition , cerebral haemorrhage found on ct test all on 31May2021 03:00 with outcome of fatal. The clinical course was as follows: The patient was a 95-year and 7-month-old female. Body temperature before vaccination and family history were not reported. It was not reported whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 24May2021 at unknown time (the day of vaccination), the patient received an unknown dose of COVID-19 Vaccine (Manufacturer Unknown, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 31May2021 around 03:00-05:00 (7 days after the vaccination), the patient experienced consciousness disturbed, declined respiratory condition, and cerebral haemorrhage found on CT test; the outcome of the events was fatal. It was not reported whether autopsy was done. On 31May2021 around 05:00 (7 days after the vaccination), the patient was found to have decreased consciousness level and decreased respiratory status. Before this, there had been no problems or changes. An ambulance was called, and the patient was transported to the reporting hospital at 06:50. She had the first consultation at the reporting hospital and was noted have consciousness disturbed and marked decline in respiratory status. Head computerised tomography (CT) test revealed extensive bilateral intraventricular haemorrhage also with significant cerebellar haemorrhage. The family received a call and was asked to come. Considering factors including the advanced age and general condition, the family did not wish for emergency cardiopulmonary resuscitation. A wait-and-see approach was taken. The condition gradually declined, and respiratory arrest and cardio-respiratory arrest occurred. In the presence of the family, the patient was confirmed dead on 31May2021 at 08:24. The reporting physician classified the events as serious (death) and assessed the causality between the events and COVID-19 Vaccine unassessable. Other possible cause(s) of the events such as any other diseases included cerebral haemorrhage. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Consciousness disturbed; Cerebral haemorrhage; Declined respiratory condition


VAERS ID: 1507425 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
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: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021888834

Write-up: Death; This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration, on 06Jul2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 07Jul2021 (1 day after the vaccination), which was reported as fatal. The patient died on 07Jul2021. The cause of death was unknown. It was not reported if an autopsy was performed. The reporter explained to the patient''s family that the causal relationship with BNT162B2 could not be determined. The assessment of the causality and seriousness for the event was not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1507427 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardiac arrest, Cerebral infarction, Coma scale, Computerised tomogram, Investigation, Magnetic resonance imaging, Renal impairment, Respiratory arrest, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE [AMLODIPINE BESILATE]; BROMHEXINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral arterial aneurysm (in the right MCA); Dementia (level of care 3 needed. ADL- independent indoor walking possible.); Hypertension; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: blood test; Result Unstructured Data: Test Result:mild renal imapirment; Comments: No abnormalities other than mild renal impairment were noted; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210622; Test Name: JCS; Result Unstructured Data: Test Result:1-2; Test Date: 202107; Test Name: Postmortem CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage; Comments: due to ruptured aneurysm in the right MCA considering that multiple hematoma in the sylvian fissure was noted; Test Date: 20210622; Test Name: DWI; Result Unstructured Data: Test Result:new infarct lesions; Comments: new infarct lesions in the right corona radiata in two slices; Test Date: 20210622; Test Name: MRA; Result Unstructured Data: Test Result:thrombotic aneurysm; Comments: thrombotic aneurysm of around 9 mm in the right MCA arterial aneurysm; Test Date: 20210622; Test Name: NIHSS; Result Unstructured Data: Test Result:6; Comments: questions 2, left upper limb 1, left lower limb 2 and dyslalia 1; Test Date: 20210622; Test Name: Brain MRI; Result Unstructured Data: Test Result:new infarct lesions; Comments: new infarct lesions in the right corona radiata in two slices
CDC Split Type: JPPFIZER INC2021889095

Write-up: subarachnoid haemorrhage; Respiratory and cardiac arrest; Respiratory and cardiac arrest; mild renal impairment; cerebral infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119619. A 64-year and 11 month-old male patient received BNT162B2 (COMIRNATY; Lot Number: FC3661; Expiration Date: 30Sep2021), via an unspecified route of administration on 21Jun2021 10:30 (at the age of 64-years-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension, dementia, cerebral arterial aneurysm (in the right MCA [middle cerebral artery]) and pollinosis. The patient had no allergy to drug or food or any relevant family history. Concomitant medications included amlodipine besilate (AMLODIPINE OD) 2.5 mg and bromhexine hydrochloride 4 mg. Body temperature before vaccination was 36.8 degrees Centigrade. The course of the events was as follows: The patient had dementia. Level of care needed was 3. The patient was living with his sister and her husband. Regarding the level of ADL (activities of daily living), independent indoor walking was possible. On 21Jun2021 at around 10:30, the patient received the first dose of the vaccine at a clinic. Although he returned home, he looked sick. At noon, when he got out of a car, he stumbled over his left feet. Afterwards, it had gradually become difficult for him to move. On 22Jun2021, when visiting to the reporter''s hospital, (coma scale) was 1-2, dyslalia and hemiparesis except for the right face were noted. (health stroke scale) was 6 (questions 2, left upper limb 1, left lower limb 2 and dyslalia 1). Brain MRI (magnetic resonance imaging) and DWI (diffusion weighted image) showed new infarct lesions in the right corona radiata in two slices, and he was diagnosed with cerebral infarction (lacunar infarction in the right MCA occurred at around 12:00 on 21Jun2021), and was hospitalized. Also, MRA (magnetic resonance angiography) indicated thrombotic aneurysm of around 9 mm in the right MCA arterial aneurysm. After consulting the neurosurgery department, it was determined that the patient was not suitable for further examination and surgery considering low ADL. No abnormalities other than mild renal impairment were noted in particular on blood test performed on admission on 22Jun2021. After admission, ARGATROBAN and CLOPIDOGREL were used as treatment to prevent aggravation of cerebral infarction. Rehabilitation was recommended. For the purpose of reaching the ADL level enough to be able to do independent indoor walking, transferring to a nursing facility or a rehabilitation hospital was considered. On 10Jul2021 (19 day after the vaccination), at 04:00, when a nurse went round to the patient, no abnormality was seen, but at 05:00 he was found in respiratory and cardiac arrest. Cardiac massage was performed for 30 minutes but he did not react to it and spontaneous circulation was not returned. Therefore, resuscitation was stopped with the family''s consent. On 10Jul2021 at 05:50, his death was confirmed. Postmortem CT of the whole body indicated the presence of subarachnoid haemorrhage (which was considered to be due to ruptured aneurysm in the right MCA considering that multiple haematoma in the sylvian fissure was noted). The reporting physician classified the events as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. Possible cause of the event was reported as follows: The patient had suffered from arterial aneurysm in the right MCA, and it might have incidentally ruptured during the hospitalization. It was not reported if an autopsy was performed. The outcome of the event mild renal impairment was unknown. Reporter''s comment: The symptoms of cerebral infarction occurred about 1 hour and 30 minutes after the vaccination and within 3 weeks of the vaccination subarachnoid haemorrhage occurred which resulted in death. According to Regulatory Authority, the annual rate of rupture of MCA arterial aneurysm of 9 mm in size is 1.56 % (95% CI 0.74-3.2%) indicating not so high. Therefore, the causal relationship between the events of cerebral infarction and subarachnoid haemorrhage, and BNT162b2 could not be ruled out.; Reported Cause(s) of Death: subarachnoid haemorrhage; cerebral infarction; Respiratory and cardiac arrest; Respiratory and cardiac arrest


VAERS ID: 1507429 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-06-13
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Function kidney decreased; Hyperlipidaemia; Hypertension; Hyperuricaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021889134

Write-up: suspected cardiac failure acute; On 13Jul2021 in the morning, death was confirmed; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is V21119274. A 69-year and 11-month-old male patient received BNT162B2 (COMIRNATY; lot number: EY0572 and expiration date: 31Oct2021), via an unspecified route of administration on 12Jul2021 at 15:00 (the day of vaccination), at the age of 69-year-old, dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 Centigrade on 12Jul2021. Medical history included diabetes mellitus, hyperlipidaemia, hypertension, hyperuricaemia, function kidney decreased. The patient''s concomitant medications were not reported. On 13Jul2021 in the morning (1 day after the vaccination), the patient experienced suspected cardiac failure acute. The clinical course of the event was as follows: On 12Jul2021, the patient received the vaccine. On 13Jul2021 in the morning, death was confirmed. An autopsy was conducted on an unspecified date and cardiac failure acute was suspected. On 13Jul2021 (1 day after the vaccination), the outcome of the event was fatal. 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.; Autopsy-determined Cause(s) of Death: suspected cardiac failure acute


VAERS ID: 1507434 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aphasia, Blood potassium, Blood potassium increased, Blood test, Cough, Feeling abnormal, Melaena, Oxygen saturation, Physical examination, Respiratory arrest, Swelling, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulum
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: K level; Result Unstructured Data: Test Result:high; Test Date: 20210527; Test Name: blood examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210530; Test Name: SpO2; Test Result: 90 %; Test Date: 20210530; Test Name: SpO2; Result Unstructured Data: Test Result:70s %; Test Date: 20210530; Test Name: SpO2; Test Result: 86 %; Test Date: 20210526; Test Name: digital examination; Result Unstructured Data: Test Result:nothing was palpable; Comments: no haemorrhoids were observed
CDC Split Type: JPPFIZER INC2021889519

Write-up: respiratory arrest; Vomiting; cough 2 to 3 times; K level high; mild swelling on the both dorsum of feet and both forearms; No speech was observed; abdominal pain; fuzzy head; Melaena; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is V21119295. An 89-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration on 23May2021 at 09:00 at a single dose for covid-19 immunisation. Medical history included diverticulum haemorrhage. The patient''s concomitant medications were not reported. On 26May2021, the patient experienced melaena. On 26May2021, the patient experienced abdominal pain and fuzzy head. On 27May2021, the patient experienced mild swelling on the both dorsum of feet and both forearms and no speech was observed. On 28May2021, the patient experienced K level high. On 29May2021, the patient experienced vomiting and cough 2 to 3 times. On 30May2021 at 23:30, the patient experienced respiratory arrest, which was serious for death and medically significant. The course of the event was as follows: on 23May2021 at 09:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 26May2021 (3 days after the vaccination), the patient experienced melaena. Blood was found in the soft stool. Although a digital examination was performed, nothing was palpable, and no haemorrhoids were observed. When the patient was asked to have abdominal pain, she nodded her head; however, she had fuzzy head. Breakfast was discontinued, and oral administration was discontinued. The patient was able to take only fluid (KN NO.3 Injection 500 mL, carbazochrome sodium sulfonate hydrate (ADONA )1A, and tranexamic acid (TRANSAMIN) 1A. On 27May2021 (4 days after vaccination), additional blood examination was performed at home visited by a doctor (for inflammation, screening). In the afternoon, the patient took a sports drink with a drinking mug. The patient had mild swelling on the both dorsum of feet and both forearms. From 27May2021, no melaena was noted. No speech was observed. No swelling was noted. The patient did not complain of abdominal symptoms. On 28May2021 (5 days after vaccination), the patient did not respond to a questioning. On the same day, since the potassium (K) level was high, a drip infusion was changed. On 29May2021 (6 days after vaccination), KN NO.3 Injection was changed to SOLDEM 1 the following day. The melaena was stable. After the patient drank green tea, she had a small amount of bile-like vomiting. The patient had cough 2 to 3 times, thereafter, she had no queasy. Oral intake was discontinued until the morning. Addition of drip infusion of maintenance fluid (SOLDEM NO. 1,500) and metoclopramide hydrochloride (PRIMPERAN) 1A was instructed to add. Administration of domperidone (NAUZELIN suppository) was instructed if the patient continued vomiting. On 30May2021 (7 days after vaccination), the patient had vomiting. Since the SpO2 was 70s, an inhalation was tried; however, nothing was inhaled. Although the pulmonary sound was clear, the SpO2 did not return. Oxygen administration was initiated, and the SpO2 90% was tried to be maintained; however, it returned only to 86%. Thus, oxygen administration of 5 L/minute was administered. On 30May2021 at 23:30 (7 days after vaccination), respiratory arrest was noted. On 31May2021 at 00:27 (8 days after vaccination), the death was confirmed. It was unknown if an autopsy was performed. Therapeutic measures were taken as a result of melaena, K level high, and vomiting. The clinical outcome of the events, melaena, K level high, vomiting, abdominal pain, fuzzy head, mild swelling on the both dorsum of feet and both forearms, no speech was observed, and cough 2 to 3 times, was unknown. The clinical outcome of the event, respiratory arrest, was fatal. The patient died on 31May2021 due to respiratory arrest. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was not provided. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: respiratory arrest


VAERS ID: 1507437 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cardiac arrest, Cardio-respiratory arrest, Cerebral infarction, Computerised tomogram head, Hemiplegia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: SIGMART; ARTIST; NU-LOTAN; PLAVIX
Current Illness: Dialysis; Renal failure chronic (undergoing maintenance dialysis)
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Diabetic nephropathy
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before the first vaccination; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:35.1 Centigrade; Comments: before the second vaccination; Test Date: 20210617; Test Name: Head CT; Result Unstructured Data: Test Result:no cerebral haemorrhage
CDC Split Type: JPPFIZER INC2021889615

Write-up: ventricular tachycardia; asystole; Consciousness disturbed; paralysis of left upper and lower extremities; cerebral infarction; cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119288. A 76-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: FA2453; Expiration Date: 31Aug2021), via an unspecified route of administration, on 13Jun2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing renal failure chronic (undergoing maintenance dialysis), ongoing maintenance dialysis, angina pectoris, and diabetic nephropathy. The patient had no family history. Concomitant medications included nicorandil (SIGMART), carvedilol (ARTIST), losartan potassium (NU-LOTAN), and clopidogrel bisulfate (PLAVIX). The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EX3617; Expiration date: 31Aug2021) on 25May2021 for COVID-19 immunisation. The patient experienced consciousness disturbed, paralysis of left upper and lower extremities, and cerebral infarction on 17Jun2021 at 09:00 (4 days after the vaccination), which were reported as fatal. The patient also experienced cardio-respiratory arrest on 17Jun2021 and ventricular tachycardia and asystole on 27Jun2021. The clinical course was reported as follows: The body temperature before the second vaccination was 35.1 degrees centigrade on 13Jul2021 and before the first vaccination was 35.6 degrees centigrade on 25May2021. The patient was undergoing maintenance dialysis at the reporting hospital due to renal failure chronic caused by diabetic nephropathy. On 17Jun2021 in the morning, before dialysis, the patient had felt poorly, cold sweat, and vomiting, for which the patient received infusion and was placed under observation. During the observation, the patient had consciousness disturbed and paralysis of left upper and lower extremities. Head computerised tomogram (CT) revealed no cerebral haemorrhage on 17Jun2021. It was considered as cerebral infarction and the patient was transferred to another hospital. Before the transfer, the patient experienced cardio-respiratory arrest but resuscitation was successful. However, on 27Jun2021, the patient experienced ventricular tachycardia, followed by asystole, and the patient died at the hospital where the patient was transferred. Therapeutic measures were taken as a result of cardio-respiratory arrest as aforementioned. The clinical outcome of consciousness disturbed, paralysis of left upper and lower extremities, cerebral infarction, ventricular tachycardia, and asystole was fatal and of cardio-respiratory arrest was recovered on 17Jun2021. The patient died on 27Jun2021 (14 days after the vaccination). The cause of death was reported as consciousness disturbed, paralysis of left upper and lower extremities, cerebral infarction, ventricular tachycardia, and asystole. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162B2 as unassessable. Other possible causes of the event, such as any other diseases, were renal failure chronic, diabetes mellitus, arterial occlusion of lower extremities, and atrial fibrillation paroxysmal. The reporting physician commented as follows: The report was submitted since causality was unknown.; Reported Cause(s) of Death: ventricular tachycardia; asystole; Consciousness disturbed; paralysis of left upper and lower extremities; cerebral infarction


VAERS ID: 1507439 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood potassium, Blood pressure measurement, Blood urea, Dehydration, Glycosylated haemoglobin, Heart rate, Hyperglycaemia, Hyperglycaemic hyperosmolar nonketotic syndrome, Liver disorder, Platelet count, Platelet count decreased, White blood cell count, White blood cell count decreased
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Severe fever with thrombocytopenia syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Creatinine; Test Result: 1.05 mg/dl; Test Date: 20210705; Test Name: Blood glucose level; Test Result: 548 mg/dl; Test Date: 20210705; Test Name: Potassium; Result Unstructured Data: Test Result:5.5; Test Date: 20210705; Test Name: Blood pressure; Result Unstructured Data: Test Result:91/71 mmHg; Test Date: 20210705; Test Name: BUN; Test Result: 49 mg/dl; Test Date: 20210705; Test Name: HbA1c; Test Result: 12.3 %; Test Date: 20210705; Test Name: Pulse rate; Result Unstructured Data: Test Result:150; Test Date: 20210705; Test Name: Platelet; Result Unstructured Data: Test Result:decrease; Test Date: 20210705; Test Name: WBC; Result Unstructured Data: Test Result:decrease
CDC Split Type: JPPFIZER INC2021890149

Write-up: Hyperosmolar hyperglycaemic syndrome; hyperglycaemia; dehydration; WBC decreased; platelets decreased; mile liver disorder; This is a spontaneous report from a contactable health-care professional. This is a report received from the Regulatory Authority. Regulatory authority report number is v21119275. A 70-year-old male patient received the second dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Jul2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included severe fever with thrombocytopenia syndrome. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 12Jun2021 for COVID-19 immunisation. On 04Jul2021 at 11:45, the patient experienced hyperosmolar hyperglycaemic syndrome, hyperglycaemia, and dehydration which required emergency room visit, were serious for death, hospitalization from 05Jul2021 to an unknown date, and life-threatening. On 05Jul2021, the patient experienced white blood cell count (WBC) decreased, platelets decreased, and mile liver disorder. The clinical course was as follows: on 03Jul2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2. On 04Jul2021 at 11:45 (1 day, 1 hour 45 minutes after the vaccination), the patient experienced hyperosmolar hyperglycaemic syndrome, hyperglycaemia, and dehydration. On 12Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 03Jul2021, the patient received the second dose of bnt162b2. On 04Jul2021 at 11:45, the patient''s eldest son called the patient and noticed that the patient''s tone of voice was strange. Several hours later, the eldest son returned home and gave the patient oral rehydration solution and observed the patient but there was no improvement. On 05Jul2021 at 02:00, ambulance was requested. When arriving at emergency room (ER) on 05Jul2021, pulse rate was 150, blood pressure was 91/71 mmHg, blood glucose level was 548 mg/dL, blood urea nitrogen (BUN) was 49 mg/dL, creatinine was 1.05 mg/dL, potassium was 5.5, and HbA1c was 12.3%. Decrease in white blood cell (WBC), decrease in platelet, and mile liver disorder were noted. Investigation of the cause was ongoing. The clinical outcome of the events, WBC decreased, platelets decreased, and mile liver disorder, was unknown. The clinical outcome of the events, hyperosmolar hyperglycaemic syndrome, hyperglycaemia, and dehydration, was fatal. The patient died on 12Jul2021 due to hyperosmolar hyperglycaemic syndrome, hyperglycaemia, and dehydration. It was not reported if an autopsy was performed. The reporting other health-care professional classified the event as serious (death, life-threatening, 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 severe fever with thrombocytopenia syndrome. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Hyperosmolar hyperglycaemic syndrome; hyperglycaemia; dehydration


VAERS ID: 1507440 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Chronic respiratory failure (been using home oxygen therapy (oxygen 2 L/minute at all times)); Oxygen therapy
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dyspnoea exertional; Leg venous thrombosis; Lung cancer; Pneumonectomy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021890184

Write-up: Found dead; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119354. A 78-year and 11-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FA7338; Expiration Date: 30Sep2021), via an unspecified route of administration, on 29Jun2021 at 13:10 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia, chronic obstructive pulmonary disease (COPD), leg venous thrombosis, surgery for right lung cancer on an unspecified date, right lung total resection in 2007, ongoing chronic respiratory failure (been using home oxygen therapy (oxygen 2 L/minute at all times)), ongoing home oxygen therapy (oxygen 2 L/minute at all times), and dyspnoea exertional. Concomitant medications included apixaban (ELIQUIS) taken for improvement of leg venous thrombosis from an unspecified date and ongoing. The patient was found dead on 02Jul2021 at 04:00 (reported as: 2 days 10 hours 50 minutes after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.4 degrees centigrade on 29Jun2021. The patient had past history of surgery for right lung cancer (right lung total resection in 2007). Due to chronic respiratory failure, the patient had been using home oxygen therapy (oxygen 2 L/minute at all times) and the patient had dyspnoea exertional. At the time of vaccination, the patient had no particular subjective symptom and had grilled beef party. After that, the patient went to bed as usual. However, on the following day in the morning, the patient was found dead. The patient died on 02Jul2021 (reported as: 3 days after the vaccination). The cause of death was unknown. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event, such as any other diseases, was not provided. The reporting physician commented as follows: The patient received the vaccine at home at the strong request of the patient. The causality between the vaccine and the death was unknown.; Reported Cause(s) of Death: Found dead


VAERS ID: 1507443 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-04
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Circulatory collapse, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC2021891902

Write-up: cardiac sudden death; suddenly collapsed; sensation of squeezing in the chest; This is a spontaneous report from a contactable physician via a Regulatory Authority. A non-pregnant 68-year-old female patient received the first dose bnt162b2 (COMIRNATY; Lot Number: EW0207; Expiration Date: 30Sep2021), intramuscularly on 23Jun2021 at 16:00 at a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other oral 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. The patient had no other medical history. On 04Jul2021, the patient experienced sensation of squeezing in the chest. On 05Jul2021 at 17:30, the patient experienced cardiac sudden death, which was serious for death. On 05Jul2021 at 17:30, the patient experienced suddenly collapsed. The clinical course was as follows: on 23Jun2021 at 16:00 (the day of vaccination), the patient received the first single dose of BNT162b2. On 04Jul2021 in the evening (11 days after the vaccination), the patient experienced sensation of squeezing in the chest, but it improved. On 05Jul2021 at around 17:30 (12 days after the vaccination), while the patient was at work, she was standing, and then suddenly collapsed. While transferring to a hospital by an ambulance, cardiac massage was performed. After arriving at the hospital, the patient''s death was pronounced. The event resulted in death. The cause of death was cardiac sudden death. An autopsy was not performed. The outcome of the event was fatal without treatment. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided. The clinical outcome of the event, sensation of squeezing in the chest, was recovering. The clinical outcome of the event, suddenly collapsed, was unknown. The clinical outcome of the event, cardiac sudden death, was fatal. The patient died on 05Jul2021 due to cardiac sudden death. An autopsy was not performed. No follow- up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information and plausible temporal association, a possible contributory role of the suspect BNT162B2 (COMIRNATY) cannot be completely excluded for the reported the events chest tightness, collapsed and sudden cardiac death. Confounding factors include patient age. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac sudden death


VAERS ID: 1507445 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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: Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5; Comments: before vaccination; Test Date: 20210712; Test Name: CT scan; Result Unstructured Data: Test Result:subarachnoid haemorrhage
CDC Split Type: JPPFIZER INC2021894557

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21119359. A 93-year and 7-month-old female received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# FC5947, Expiration date 30Sep2021) via an unspecified route of administration on 11Jul2021 at 14:30 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. It was not reported if the patent had a family history. Concomitant medications were not reported. On 11Jul2021 at around 14:30 (the day of vaccination) the patient received the first dose of BNT162B2. On 12Jul2021 at around 06:50 (1 day after vaccination) the patient experience subarachnoid hemorrhage. At 09:36 the patient died. It was not reported if an autopsy was performed. On 12 Jul2021 at around 06:50 in the morning, the patient went to the bathroom. When she was changing clothes, she started to yawn frequently, and her reaction was getting slow. She was transferred to the reporter''s hospital by an ambulance. Computerize tomogram (CT) scan showed the presence of subarachnoid haemorrhage. Since her respiratory status was bad and there was heavy bleeding, emergency medical care was difficult to be performed. At 09:36 the patient''s death was confirmed. The reporting nurse classified the event as serious due to death and assessed the causality between the event and BNT162B2 as unassessable. It was not reported if there was possible cause of the event. The clinical outcome of subarachnoid hemorrhage was fatal on 12Jul2021; the outcome of yawn frequently was unknown.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1507446 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Computerised tomogram thorax, Vital signs measurement
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: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Lung cancer (Diagnosed 2018 on Chest CT)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 2018; Test Name: Chest CT; Result Unstructured Data: Test Result:lung cancer left; Test Date: 20210708; Test Name: vital signs; Result Unstructured Data: Test Result:No abnormalities
CDC Split Type: JPPFIZER INC2021894558

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119643. A 101-year and 2-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via unspecified route of administration on 08Jul2021 at 15:30 (at the age of 101-years-old) as a single dose for COVID-19 immunisation. Medical history included lung cancer left diagnosed in 2018 on the chest computerized tomogram (CT), and hypertension from an unknown date and unknown if ongoing. The patient''s family history was not provided. Concomitant medications included amlodipine taken orally from an unknown date for an unknown indication. Prior to vaccination the patient''s body temperature was 36.4 degrees Centigrade. On 22Jun2021, the patient was admitted to the reporting hospital for medical treatment. On 08Jul2021 the patient received the first dose of BNT162B2; on the same day, no abnormalities were observed in the vital signs and no particular changes were observed. On 09Jul2021 at 03:30 (12 hours after vaccination) the patient experienced cardiac arrest. On 09Jul2021 (one day after vaccination) the outcome of the event was fatal. The reporting physician classified the event as serious for death and assessed the causality between the event and BNT162B2 as unassessable. It was reported that other possible causes of the event such as any other diseases was as follows: the possibility of lung cancer was not zero, but it was unlikely. The clinical outcome of the event was fatal on 09Jul2021.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1507593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-04-08
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 8
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: GLICLAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture of ankle (broken ankle (3 years ago)); Hernia (at 45-years-old); Hip fracture (broken hip (about 15 years ago)); Macular degeneration; TIA (TIA (about 10 years ago),); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021874806

Write-up: Pneumonia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00613516 with Safety Report Unique Identifier: NL-LRB-00616303. A 90-year-old female patient received her second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EP2166) as DOSE 2, SINGLE for COVID-19 immunisation . Medical history included ankle fracture from 2018 to an unknown date broken ankle (3 years ago), broken hip from an unknown date (about 15 years ago), hernia from an unknown date and unknown if ongoing (at 45-years-old), type 2 diabetes mellitus (well controlled) from an unknown date and unknown if ongoing, transient ischaemic attack (TIA) from an unknown date and unknown if ongoing (about 10 years ago), and macular degeneration from an unknown date and unknown if ongoing. It was unknown to the reporter if the patient experienced side effects (right) after the vaccination. Patient normally would not complain very easily if she felt ill. Patient was perfectly healthy, lived independently, did everything herself, except for the major household chores and she became helped with showering once a week. The patient was a incredibly strong mother, perfectly healthy who was never ill/sick. There was nothing unusual to state. Patient had no previous COVID infection. Concomitant medication included gliclazide taken for type 2 diabetes mellitus, start and stop date were not reported. Historical vaccine included COMIRNATY on 01Feb2021 (lot number not reported) as DOSE 1, SINGLE for COVID-19 immunization and had no adverse reaction. On 08Apr2021, 29 days after administration of vaccine, the patient experienced pneumonia. The patient was hospitalized due to the event on unspecified date. Therapeutic measures were taken as a result of pneumonia which included three different kinds of antibiotics. No COVID test was done. The outcome of pneumonia was fatal. The patient died on 16Apr2021. Cause of death was pneumonia. An autopsy was no performed. Reporter comment: BioNTech/Pfizer vaccine (Comirnaty); Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse Drug Reactions: no Date: 01Feb2021; Death after pneumonia; Additional information Adverse Drug Reaction: My always incredibly strong mother, who was never ill, has broken like a matchstick; COVID-19: Previous COVID-19 infection: No; Other diagnostic procedures: no. Assessor Lareb: FU received. No autopsy. Hospital admission checked. Medical history added. Summary edited. Batch/lot number: EP2166 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: pneumonia


VAERS ID: 1507599 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chills, Faeces discoloured, Fatigue, Malaise, Nausea, Scan, Taste disorder
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 35
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: NIVOLUMAB
Current Illness: Mesothelioma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: various blood tests; Result Unstructured Data: Test Result:Unknown; Test Name: Scan; Result Unstructured Data: Test Result:Unknown
CDC Split Type: NLPFIZER INC202100915793

Write-up: Black stools; bad taste in mouth; Fatigue; Cold shivers; Not feeling well; Nausea; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00622565. An elderly male patient received unknown dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EX0893, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 22Apr2021 as single dose for COVID-19 immunisation. Medical history included ongoing mesothelioma from an unknown date. The patient had no previous COVID-19 infection. Concomitant medication(s) included nivolumab (NIVOLUMAB) 10mg/ml, taken for an unspecified indication from Oct2020 to an unspecified stop date. The patient experienced bad taste in mouth, not feeling well and nausea on 29Apr2021, black stools on 03May2021, cold shivers and fatigue on 29May2021. The patient underwent lab tests and procedures which included various blood test and scan; both results unknown on an unspecified date. The patient was admitted to hospital. The outcome of all events was reported as fatal on 03Jun2021. The patient died on 03Jun2021. It was not reported if an autopsy was performed. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no bad taste in mouth Additional information adverse drug reaction: 1 week after vaccination, bad taste day and night black stools Additional information adverse drug reaction: 2 x confounding factors confounding factors: mesothelioma COVID-19 Previous COVID-19 infection: No Other diagnostic procedures: hospital admission, various blood tests, scan.; Reported Cause(s) of Death: Adverse events of the vaccination


VAERS ID: 1507751 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Capillary leak syndrome, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 30
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: ELIQUIS; FURIX [FUROSEMIDE]
Current Illness: Artificial cardiac pacemaker user; Cardiac failure
Preexisting Conditions: Medical History/Concurrent Conditions: Shingles
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021908394

Write-up: Capillary leak syndrome; edema on both lower legs and in the feet; This is a spontaneous report received from a contactable nurse and a contactable other health professional. This is the second of two reports for the second dose. The first report was downloaded from the Regulatory Authority. The regulatory authority report number is SE-MPA-1617111898090, Safety report unique identifier SE-MPA-2021-024198. A 101-years-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on Mar2021 (Lot Number: EP2166) as dose 2, single for covid-19 immunisation. Medical history included ongoing artificial cardiac pacemaker user, ongoing cardiac failure, Shingles from 2009 to an unknown date (not continuing). Historical Vaccine included the first dose of BNT162B2 (COMIRNATY, lot: EP2166) on 09Mar2021 for covid-19 immunisation and experienced Swelling, Haematoma, Tiredness, Edema in the vaccinated arm, eating disorder/difficult to eat, Arm pain. Concomitant medications included apixaban (ELIQUIS, Film-coated tablet); furosemide (FURIX). On Mar2021, after dose 2 was aggravated by severe and untreatable edema on both lower legs and in the feet. Liquid flowed from the skin and formed puddles on the floor. The reporting nurse suspected that the edema may be capillary leakage syndrome. At the beginning of April, the man received home health care. Treatment received. Approximately one two weeks after the second dose, the patient was moved to short-term accommodation due to a deteriorating general condition. Two weeks later, the patient died on Apr2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. The case was deemed serious, death, life-threatening, hospitalized. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Capillary leak syndrome; edema on both lower legs and in the feet


VAERS ID: 1509222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Lower respiratory tract infection, Malaise
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100913717

Write-up: Passed away; Chest infection; Minor heart failure; Patient presented unwell; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 90-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration on 13Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On Tuesday 13Jul2021, the patient has received second Pfizer COVID vaccination. On 14Jul2021, patient presented unwell and was diagnosed with chest infection and minor heart failure and was treated with antibiotics. Condition deteriorated and on Sunday 18Jul2021, patient passed away. It was not reported if an autopsy was performed. Outcome for chest infection, minor heart failure and unwell was unknown.; Reported Cause(s) of Death: Passed away


VAERS ID: 1509223 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chronic obstructive pulmonary disease, Cough, Death, Dyspnoea, Dysuria, Heart rate, Oxygen saturation, Pain, Respiratory distress, Somnolence, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Coughing (1 week prior to vaccination); Shortness of breath (1 week prior to vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: BP; Result Unstructured Data: Test Result:135/79 mmHg; Comments: at 10hrs; Test Date: 20210713; Test Name: BP; Result Unstructured Data: Test Result:126/57 mmHg; Comments: at 10hrs30; Test Date: 20210713; Test Name: pulse; Result Unstructured Data: Test Result:73; Comments: bpm at 10hrs; Test Date: 20210713; Test Name: pulse; Result Unstructured Data: Test Result:56; Comments: bpm at 10hrs.30; Test Date: 20210713; Test Name: Spo2; Test Result: 90 %; Comments: at 10hrs; Test Date: 20210713; Test Name: Spo2; Test Result: 82 %; Comments: at 10hrs30
CDC Split Type: ZAPFIZER INC2021904470

Write-up: Death; Drowsy; COPD exarcebation; Respiratory distress; Shortness of breath; Wheezes; Coughing; General body pains; Pains when passing urine; This is a spontaneous report from contactable nurses. A 61-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FD0297; Expiration Date: Oct2021) dose 1 via an unspecified route of administration on 24Jun2021 14:14(at the age of 61 years old) as single for COVID-19 immunisation. Medical history included shortness of breath (1 week prior to vaccination), coughing (1 week prior to vaccination), and chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient experienced shortness of breath, wheezes, coughing, general body pains, pains when passing urine on 29Jun2021, drowsy, copd exarcebation, respiratory distress on 13Jul2021 12:24, death on 13Jul2021 13:06. The patient underwent lab tests and procedures which included blood pressure measurement: 135/79 mmhg on 13Jul2021 at 10hrs, blood pressure measurement: 126/57 mmhg on 13Jul2021 at 10hrs30, heart rate: 73 on 13Jul2021 bpm at 10hrs, heart rate: 56 on 13Jul2021 bpm at 10hrs.30, oxygen saturation: 90 % on 13Jul2021 at 10hrs, oxygen saturation: 82 % on 13Jul2021 at 10hrs30. The patient was reported to have died (death) on 13Jul2021 13:06. An autopsy was not performed. Outcome of events was fatal. No further information was available at the time of this report. ; Sender''s Comments: Based on possible temporality and known safety profile of drug the causal role of the BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Shortness of breath; Wheezing; cough; General body pains; Pains when passing urine


VAERS ID: 1509312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021894522

Write-up: died on unspecified date due to an unknown cause; Vaccination error; This is a spontaneous report from a contactable other health professional via Regulatory Authority. The regulatory authority report number is 582521. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination error on unspecified date. It was also reported that the patient experienced an unspecified adverse event following immunization. The patient died on unspecified date due to an unknown cause. Autopsy information was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1509313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Cough, Left ventricular failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021894524

Write-up: Left ventricular failure; Concomitant disease aggravated; Cough; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number 582868. An 82-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 number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30Jun2021, the patient experienced left ventricular failure, concomitant disease aggravated and cough. Outcome 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. No further information is expected.; Reported Cause(s) of Death: Left ventricular failure; Concomitant disease aggravated; Cough


VAERS ID: 1509314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-03
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021894525

Write-up: Adverse event following immunisation; Paraesthesia; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. The regulatory authority report number is 582919. A 57-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection), received on an unspecified date, as dose 1, single, for COVID-19 immunisation. On 03Jul2021, the patient experienced adverse event following immunisation (as reported) and paraesthesia. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation; Paraesthesia


VAERS ID: 1509324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
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: 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: BEPFIZER INC2021895883

Write-up: death 8 days after second dose injection; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-100863. A female patient of an unspecified age received the second dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was death 8 days after second dose injection on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1509344 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Hydrops foetalis, Maternal exposure during pregnancy, Ultrasound scan, Ultrasound scan vagina
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ultrasound (mother); Result Unstructured Data: Test Result:Absence of fetal heartbeat; Test Name: transvaginal ultrasound (mother); Result Unstructured Data: Test Result:fetal hydrops
CDC Split Type: BRPFIZER INC2021900344

Write-up: fetal hydrops; Absence of fetal heartbeat; Maternal exposure during pregnancy; This is a spontaneous report from a contactable pharmacist (patient''s mother) via COVAES. A fetus patient of an unspecified gender received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EW0195, Expiration Date was not reported) via transplacental on 19May2021 07:30 as dose 1, single for COVID-19 immunisation at public health center. The patient medical history and concomitant medications were not reported. It was reported that, absence of fetal heartbeat elucidated by ultrasound at 10 weeks and 2 days of gestation, due to non-evolving pregnancy, gestational age 9 weeks and 6 days with transvaginal ultrasound showing fetal hydrops. The patient chose to continue with surgical intervention (Manual intrauterine aspiration) for material retention and cytogenetic analysis. The patient''s mother was hospitalized for fetal hydrops for 2 days, hospitalized for absence of fetal heartbeat from 04Jul2021 to an unknown date for 2 days. The patient (fetus) died on 04Jul2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included ultrasound scan: absence of fetal heartbeat on an unspecified date, ultrasound scan vagina: fetal hydrops on an unspecified date.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events : Maternal Exposure during pregnancy, hydrops fetalis, fetal cardiac arrest and the administration of the vaccine 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: Hydrops fetalis


VAERS ID: 1509369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY00586 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021894529

Write-up: sudden death due to a cardiac event; This is a spontaneous report from three contactable consumer (patient''s godfather, patient''s father, and patient''s mother). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Jun2021 (Batch/Lot Number: EY00586) as DOSE 1, SINGLE for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient''s godfather indicated that he wanted to indicate a situation of a patient approximately 1.5 days after receiving the first dose of the Pfizer covid vaccine, although it was true that the consequence of the vaccine was not clearly attributable if the nexus of the vaccine was very evident and the consequence experienced a few hours later. The girl died of a sudden death due to a cardiac event on 29Jun2021 and given her young age it was fulminating. The patient''s father confirmed that the patient died on 29Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: sudden death due to a cardiac event


VAERS ID: 1509403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Magnetic resonance imaging head, Platelet count, Quadriparesis, Thrombotic cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 12
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: ANCOZAN; LANSOPRAZOL TEVA; FORMOTEROL EASYHALER; AMLODIPIN SANDOZ [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Esophageal acid reflux; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Blood test; Result Unstructured Data: Test Result:no other results provided; Test Date: 20210602; Test Name: MRI brain; Result Unstructured Data: Test Result:elongated infarct in medullamellem, btw. T1 and T3; Test Date: 20210602; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:normal
CDC Split Type: DKPFIZER INC202100915726

Write-up: Thrombosis and infarction in medulla (Thrombotic cerebral infarction); Tetraparesis, paresis of both arms and legs; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0070653, Safety Report Unique Identifier DK-DKMA-ADR 25429215. A 76-year-old female patient received bnt162b2 (COMIRNATY; Formulation: solution for injection; Lot Number: FC8889; Expiration Date: 30Sep2021) via intramuscular route of administration on 31May2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medications included losartan potassium (ANCOZAN) taken for hypertension from 23Jan2019; lansoprazole (LANSOPRAZOL TEVA) taken for gastrooesophageal reflux disease from 13Sep2018; formoterol fumarate (FORMOTEROL EASYHALER) taken for chronic obstructive pulmonary disease from 12Mar2019; amlodipine besilate (AMLODIPIN SANDOZ [AMLODIPINE BESILATE]) taken for hypertension from 23Jan2019; all to an unspecified stop date. There is no information regarding past medication. The patient previously received first dose of COMIRNATY (Batch number: EW6126, expiration date: 31Jul2021) on 10May2021 for COVID-19 immunization. On 02Jun2021 2 days after second vaccination, the patient experienced thrombosis and infarction in medulla (Thrombotic cerebral infarction); tetraparesis (paresis of both arms and legs). Adverse events caused of hospitalization from 02Jun2021 to an unknown date. No treatment due to the ADRs was reported. On 02Jun2021 the patient underwent lab tests and procedures which included blood test: no other results provided, magnetic resonance imaging head: elongated infarct in medulla, between T1 and T3, platelet count: normal. The patient died on 14Jun2021. Cause of death was COPD, Thrombotic cerebral infarction, and respiratory insufficiency. An autopsy was not performed; no police contacted and the patient is now buried. The clinical outcome of the events was fatal. Causality: Primarily the patient''s COPD is believed to have contributed to the fatal outcome. It is not possible to establish if the infarction in medulla with tetraparesis also have contributed to the death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Thrombotic cerebral infarction; Respiratory insufficiency; COPD


VAERS ID: 1509415 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-08
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood culture, Cardiac failure congestive, Computerised tomogram head, Computerised tomogram thorax, Culture urine, Echocardiogram, Magnetic resonance imaging head, Pneumonitis, Positron emission tomogram, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Interstitial lung disease (narrow), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified (25 years ago); Lymph node metastases; Neuroendocrine tumor (of unknown origin with lymph node metastases)
Allergies:
Diagnostic Lab Data: Test Name: blood culture; Test Result: Negative ; Test Name: Cranial CT; Result Unstructured Data: Test Result:Study without evidence of acute intracranial patho; Comments: Study without evidence of acute intracranial pathology or significant changes compared to the previous study; Test Name: CT scan of skull; Result Unstructured Data: Test Result:showing no acute alterations; Test Name: thoracic CT; Result Unstructured Data: Test Result:Congestive heart failure to be correlated with pa; Comments: Congestive heart failure to be correlated with patient data; Test Name: urine culture; Test Result: Negative ; Test Name: echocariogram; Result Unstructured Data: Test Result:Normal LVEF. Type I diastolic dysfunction. IAo mod; Comments: Normal LVEF. Type I diastolic dysfunction. IAo moderate II. Moderate MI II. HTP.; Test Name: brain MRI; Result Unstructured Data: Test Result:Cerebral atrophy according to the age group of t; Comments: Cerebral atrophy according to the age group of the patient. The ventricular system presents size and morphology within the normality. Correct differentiation between the gray and white matter. I do not observe intra or extraparenchymal expansive processes. No alterations in the basal ganglia. No alterations in the diffusion sequences. Left mastoidectomy cavity occupied by hyperintense material in T2, possibly inflammatory. Conclusion: Study artifacted by movement, without noteworthy findings.; Test Name: pet CT/PET PROTOCOL; Result Unstructured Data: Test Result:showing infiltrate; Comments: The study has been very limited by the marked alteration of the underlying lung parenchyma, although we did not identify clear images of a filling defect in the main pulmonary arteries or their lobar branches. Right supraclavicular lymphadenopathy as well as mediastinal lymphadenopathy persist, the most significant being the high right paratracheal lymph node of up to 2.1 cm in transverse diameter, as well as precarinal and subcarinals, all already visible on a previous CT, impressing the subcarinal with minimal non-significant growth.; Test Name: sars-cov-2 pcr test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021890422

Write-up: Pneumonitis; Congestive heart failure; Onset atrial fibrillation; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-938797. An 84-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Apr2021 (Batch/Lot Number: EW2239) as DOSE 2, SINGLE for covid-19 immunisation; and pembrolizumab (KEYTRUDA, strength: 25 mg/ml), intravenous from 17Mar2021 (Batch/Lot number was not reported) to 22Apr2021 at 200 mg, at unknown frequency for neuroendocrine tumor. Medical history included neuroendocrine tumor of unknown origin with lymph node metastases and chronic ischemic heart disease 25 years ago. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Batch/lot number: EW2239), intramuscular on 10Mar2021 for covid-19 immunization. On 08Apr2021, the patient experienced pneumonitis which resulted to hospitalization on an unspecified date and led to fatal outcome. On an unspecified date, patient was diagnosed with congestive heart failure and onset atrial fibrillation. It was further reported that patient was admitted due to fever with a personal history of neuroendocrine tumor of unknown origin with lymph node metastases and chronic ischemic heart disease 25 years ago. He was treated with CAET on 31Aug2020 according to age-adjusted doses. Immunotherapy treatment was started with a first cycle of pembrolizumab on 17Mar according to cutaneous biopsy. He was administrated with 2nd dose of the vaccine for Coronavirus on Monday 05Apr (3days before admission). He went to the emergency room due to fever with an increase in greenish expectoration with doubtful infiltration vs Congestive heart failure, so antibiotic treatment was started from the emergency room with Amoxicillin-Clavulanate, which was changed to Piperacillin-Tazobactam in addition to diuretic treatment on the first day of admission to the ward. Polymerase chain reaction (PCR) for coronavirus performed negative. Despite all the treatment, fever persisted, so on 11Apr it was changed to Meropenem. Given the situation of drowsiness and fever, a computerised tomogram (CT) scan of the skull was performed, showing no acute alterations, and a thoracic CT (Congestive heart failure to be correlated with patient data). Positron emission tomography (PET) protocol showing infiltrate. Given the lack of improvement with diuretic and broad-spectrum antibiotic treatment and with the suspicion of pneumonitis secondary to treatment with immunotherapy (the next cycle was suspended due to fever), treatment with Dexamethasone at a dose of 4 mg every 6h IV was started. With this, the fever disappears, persisting picture of syndrom. hypoactive confusional, which improves slightly at first with dexamethasone treatment. On the 21 a significant worsening of the respiratory situation with increased secretions and desaturation of up to 70%, requiring a mask with a reservoir, therefore, in agreement with the family, it was decided to adapt the therapeutic effort and symptomatic control. They notify to certify death on 22Apr2021. Cranial CT Conclusion: Study without evidence of acute intracranial pathology or significant changes compared to the previous study. PET protocol CT The study has been very limited by the marked alteration of the underlying lung parenchyma, although we did not identify clear images of a filling defect in the main pulmonary arteries or their lobar branches. Right supraclavicular lymphadenopathy as well as mediastinal lymphadenopathy persist, the most significant being the high right paratracheal lymph node of up to 2.1 cm in transverse diameter, as well as precarinal and subcarinals, all already visible on a previous CT, impressing the subcarinal with minimal non-significant growth. They visualize a discrete bilateral pleural effusion with fluid in fissures in relation to Congestive heart failure, visualizing extensive involvement of the pulmonary parenchyma mainly at the level of the right upper lobe, middle lobe and lower lobes that could be partly related to alveolar and interstitial edema, although given the peripheral distribution also suggests consolidation Parenchymal pneumonia. The patient had negative urine culture and negative blood cultures. Echocardiogram showed: Normal LVEF. Type I diastolic dysfunction. IAo moderate II. Moderate MI II. HTP; Brain magnetic resonance imaging (MRI) showed cerebral atrophy according to the age group of the patient. The ventricular system presents size and morphology within the normality. Correct differentiation between the gray and white matter. Reporter do not observe intra or extraparenchymal expansive processes. No alterations in the basal ganglia. No alterations in the diffusion sequences. Left mastoidectomy cavity occupied by hyperintense material in T2, possibly inflammatory. Conclusion: Study artifacted by movement, without noteworthy findings. Principal diagnostic includes: Congestive heart failure, Pneumonitis in relation to immunotherapy treatment, Onset atrial fibrillation, and Neuroendocrine tumor with high-grade lymph node metastases. The action taken in response to the events for pembrolizumab was permanently withdrawn on 22Apr2021. Therapeutic measures were taken as a result of pneumonitis. The outcome of the events congestive heart failure and onset atrial fibrillation. The patient died on 22Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonitis


VAERS ID: 1509423 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Deep vein thrombosis, Dyspnoea exertional, Electrocardiogram, Heart rate, Oxygen saturation, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: CITALOPRAM; LORAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: EKG; Result Unstructured Data: Test Result:without significant alterations; Comments: narrow QRS, no repolarization disorders, good vesicular murmur without pathological noises; Test Date: 20210707; Test Name: heart rate; Result Unstructured Data: Test Result:128; Comments: bpm; Test Date: 20210707; Test Name: o2 saturation; Result Unstructured Data: Test Result:no contribution 85/88% with 02 95% %; Test Date: 20210707; Test Name: Rapid antigen test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021890447

Write-up: Pulmonary thromboembolism; Venous thrombosis deep limb; Dyspnea/moderate dyspnea with an effort; Cardio-respiratory arrest; This is a spontaneous report from a contactable healthcare professional downloaded from the Medicines Agency (MA) -WEB, regulatory authority number ES-AEMPS-940805. A 40-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FC1439), via an unspecified route of administration on 25Jun2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included citalopram and lorazepam, both taken for unspecified indications, start and stop dates were not reported. The patient experienced pulmonary thromboembolism, venous thrombosis deep limb, dyspnea/moderate dyspnea with an effort and cardio-respiratory arrest on 07Jul2021. It was reported that the patient was attending the emergency room due to dyspnea. The patient is evaluated in the emergency room of the health center, and for this reason she has been referred to a hospital emergency room. Riding in her vehicle, she has started to get worse. She has had moderate dyspnea with an effort for 5 days, which has progressively worsened, which was why she went to the emergency room. The patient began to worsen in consultation, entering cardiorespiratory arrest at approximately 8.30 PM, beginning advanced CPR maneuvers. 061: Upon arrival of the emergency team, she did not present a pulse, did not present spontaneous breathing, CPR maneuvers were being performed by health personnel. Final CRP: 10:10 PM. Autopsy showed pulmonary embolism and deep vein thrombosis in the right lower limb. The patient underwent lab tests and procedures which included EKG: narrow QRS, no repolarization disorders, good vesicular murmur without pathological noises, heart rate: 128 bpm , oxygen (O2) saturation: no contribution 85/88% with 02 95% and rapid antigen test: negative, all on 07Jul2021. The outcome of all events was fatal. The patient died on 07Jul2021 due to all events. An autopsy was performed that revealed pulmonary thromboembolism and venous thrombosis deep limb. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Venous thrombosis deep limb; Pulmonary thromboembolism; Dyspnea/moderate dyspnea with an effort; Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: Pulmonary thromboembolism; Venous thrombosis deep limb


VAERS ID: 1509429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (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: ESPFIZER INC202100916221

Write-up: Ischemic stroke; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-942422. A 40-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 04Jul2021 (Batch/Lot Number: FE3065) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ischemic stroke on 10Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown


VAERS ID: 1509435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021893144

Write-up: the patient died the day after rececived the Pfizer vaccine; This is a spontaneous report from a contactable consumer received through Pfizer employee. A 46-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 13Jul2021, the patient died the day after received the Pfizer vaccine. It was unknown if an autopsy was performed. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed Covid-19 prior to vaccination. The lot number for the BNT162B2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: patient died the day after rececived the pfizer vaccine


VAERS ID: 1510280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acid base balance, Acute kidney injury, Asthenia, Blood lactic acid, Blood potassium, Blood pressure increased, Blood pressure measurement, C-reactive protein, COVID-19, Computerised tomogram thorax, Cyanosis, Heart rate, Hyperkalaemia, Inflammatory marker test, Lactic acidosis, Multiple organ dysfunction syndrome, Oxygen saturation, Oxygen saturation decreased, Pneumonia aspiration, Rales, Renal function test, Respiratory acidosis, Respiratory distress, SARS-CoV-2 test, Somnolence, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 13
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: PANTOPRAZOLE; TIAPRIDAL; IMOVANE; DUPHALAC [LACTULOSE]; NORSET; LASILIX [FUROSEMIDE]; SPIRONOLACTONE; KARDEGIC; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Angioplasty (with anterior ventricular stent); Aortic bypass; Arrhythmia; Coronary artery bypass; Dementia with Lewy bodies; Dyslipidaemia; Hypertension arterial; Myocardial infarction (1984); Stroke (2018); Swallowing disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: respiratory acidosis; Result Unstructured Data: Test Result:major mixed respiratory and hyperlactatemic acidos; Comments: major mixed respiratory and hyperlactatemic acidosis; Test Date: 20210409; Test Name: hyperlactatemic acidosis; Result Unstructured Data: Test Result:hyperlactatemic acidosis; Comments: hyperlactatemic acidosis; Test Date: 20210409; Test Name: hyperkalaemia; Result Unstructured Data: Test Result:hyperkalaemia; Test Date: 20210331; Test Name: Blood pressure; Result Unstructured Data: Test Result:190/80 mmHg; Test Date: 20210331; Test Name: Chest CT; Result Unstructured Data: Test Result:parenchymal focus of left lower lobe superinfecti; Comments: parenchymal focus of left lower lobe superinfection with pleural effusion and ventilatory disorders without evidence for COVID-19 pneumonia.; Test Date: 20210331; Test Name: CRP; Result Unstructured Data: Test Result:83 mg/l; Comments: without leukocytosis; Test Date: 20210331; Test Name: heart rate; Result Unstructured Data: Test Result:82; Comments: bpm; Test Date: 20210409; Test Name: inflammatory syndrome; Result Unstructured Data: Test Result:re-ascension of the inflammatory syndrome; Test Date: 20210331; Test Name: desaturation; Test Result: 79 %; Comments: after dinner, it shows a brutal 79% desaturation; Test Date: 20210409; Test Name: renal function test; Result Unstructured Data: Test Result:acute renal failure; Test Date: 20210328; Test Name: SARS-CoV2 PCR; Test Result: Positive ; Comments: British variant
CDC Split Type: FRPFIZER INC202100915546

Write-up: acute renal failure; mixed respiratory and hyperlactatemic acidosis; hyperkalemia; respiratory distress; non-communicating,drowsy; bilateral pulmonary crackles; mixed respiratory and hyperlactatemic acidosis; it shows a brutal 79% desaturation.; he is cyanotic with mottling; asthenic; Blood pressure 190/80 mmHg; Suspicion of aspiration pneumonia.; Vaccination failure; COVID-19; multiple organ failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the RA, regulatory authority number FR-AFSSAPS-AM20212000. An 88-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 via intramuscular route on 24Jan2021 (Batch/Lot Number: unknown) as dose 1, single and dose 2 via intramuscular route on 16Feb2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. The patient medical history included Alzheimer''s disease, hypertension arterial, complete arrhythmia by atrial fibrillation, myocardial infarction in in 1984, stroke in 2018, aortic bypass, dyslipidaemia, dementia with Lewy bodies, angioplasty, swallowing problems, and triple coronary artery bypass surgery. Concomitant medications included pantoprazole, tiapride hydrochloride (TIAPRIDAL), zopiclone (IMOVANE), lactulose (DUPHALAC), mirtazapine (NORSET), furosemide (LASILIX), spironolactone, acetylsalicylate lysine (KARDEGIC) and paracetamol (DOLIPRANE), all were taken for an unspecified indication. On 28Mar2021, the patient experienced SARS-CoV2 PCR had been positive (British variant). On 31Mar2021, after dinner, it showed a brutal 79% desaturation. At the end of March, he fell repeatedly while walking previously, indoors, independently. When he arrived at the hospital, he was cyanotic with mottling, very asthenic and his saturation was impregnable. The lab test includes blood pressure 190/80 mmHg, heart rate 82 bpm. Normalization of saturation under 6 L of oxygen. Biological inflammatory syndrome with CRP at 83 mg / l without leukocytosis. Chest CT images found a parenchymal focus of left lower lobe superinfection with pleural effusion and ventilatory disorders without evidence for COVID-19 pneumonia. Suspicion of aspiration pneumonia. Beginning of probabilistic antibiotic therapy with CEFOTAXIME - FLAGYL allowing a favorable clinical-biological evolution, with the possibility of oxygen withdrawal and return to nursing home on 07Apr2021. In the evening of 09Apr2021, the patient was referred to hospital emergency room for respiratory distress. He was non-communicating, drowsy with bilateral pulmonary crackles. The biological assessment showed a major mixed respiratory and hyperlactatemia acidosis with acute renal failure and hyperkaliemia with re-ascension of the inflammatory syndrome. NB: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Official Bulletin of the Ministry in charge of Health number 84/50, 24Jan1985. Published in Therapy 2011; 66 (6): 517-525. Progressive worsening of the clinical condition, implementation of comfort cares the patient died on 10Apr2021. The cause of the death was reported as multiple organ failure. It was unknown if an autopsy was performed. The outcome of the events vaccination failure, covid-19 and multiple organ failure was fatal, the event it shows a brutal 79% desaturation was resolved on 31Mar2021 and outcome of the other events was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1510286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-07-28
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: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of the cardia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210755868

Write-up: DEATH NOS; This spontaneous report received from a pharmacist via a Regulatory Authority [NLP, FR-AFSSAPS-BX20216776] concerned a 65 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included adenocarcinoma of the cardia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-02) 1 dosage forms, 1 total, administered on 16-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210755868-COVID-19 Vaccine Ad26.COV2.S-Death NOS-This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1510301 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   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: Medical History/Concurrent Conditions: Hypertension arterial; Peritonitis; Worry
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210755774

Write-up: HAEMORRHAGIC STROKE; This spontaneous report received from a physician via a Regulatory Authority [FR-AFSSAPS-PO20213720] concerned a 93-year-old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included worry, peritonitis, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1302 and expiry: Unknown) 0.5 ml, frequency 1 total, administered on 09-JUL-2021 for covid-19 vaccination. Drug start and end period was 4 days. No concomitant medications were reported. On 12-JUL-2021, the patient experienced Haemorrhagic stroke. On 20-Jul-2021, the patient died from hemorrhage intracerebral. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210755774-covid-19 vaccine ad26.cov2.s-Haemorrhagic stroke. 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: HEMORRHAGE INTRACEREBRAL


VAERS ID: 1510317 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Myocardial infarction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Diabetes; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021898900

Write-up: burning and pain in the chest; Nausea; Vomiting; Fatigue; Heart attack; This is a spontaneous report from a contactable consumer received from Regulatory Authority. An 80-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 13:30 as dose 1, single for COVID-19 immunisation. Medical history included diabetes, COVID-19 and thyroid. The patient''s concomitant medications included medications that the patient received within 2 weeks of vaccination. It was reported that 1 week after the first injection (May2021) the patient experienced burning and pain in the chest, nausea and vomiting, great fatigue. Heart attack 6 weeks after the 1st injection (2021) and death from the heart attack. The patient was hospitalized for the events for 7 days. Therapeutic measures were taken as a result of the events. The events resulted in Emergency room/department or urgent care visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events burning and pain in the chest, nausea, vomiting and fatigue was not recovered. The patient died on an unspecified date in 2021 due to heart attack. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1510509 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomegaly, Nephritis
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: ATPFIZER INC202100932055

Write-up: kidney inflammation; enlargement of the heart; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number AT-BASGAGES-2021-37455. A 38-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 14Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jun2021, patient experienced enlargement of the heart and kidney inflammation. The patient died on 28Jun2021. It was not reported if an autopsy was performed. Sender''s comments: The report is for a relative. No mail was sent to reporters. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: enlargement of the heart; kidney inflammation


VAERS ID: 1510529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-07-28
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 INC2021894523

Write-up: Concomitant disease progression; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 582846. An 82-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 number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced concomitant disease progression on 30Jun2021. The patient died on an unspecified date due to concomitant disease progression. 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: 1510571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-08-23
Onset:2021-07-09
   Days after vaccination:686
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, Cardio-respiratory arrest, Chest X-ray, Computerised tomogram, Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Hypertrophic cardiomyopathy, International normalised ratio, Lymphocyte count, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Platelet count, Protein total, Prothrombin level, Prothrombin time, Pulmonary embolism, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Thrombocytopenia, Troponin T, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: DEPAKINE [VALPROIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (taking oral contraceptives)
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: aPTT; Test Result: 102 s; Test Date: 20210709; Test Name: ALT; Result Unstructured Data: Test Result:234 IU/l; Test Date: 20210709; Test Name: AST; Result Unstructured Data: Test Result:310 IU/l; Test Date: 20210709; Test Name: Basophils; Result Unstructured Data: Test Result:0.1 x10 3/mm3; Test Date: 20210709; Test Name: Basophils; Test Result: 0.7 %; Test Date: 20210709; Test Name: Albumin; Result Unstructured Data: Test Result:2.6 g/dl; Test Date: 20210709; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:163 IU/l; Test Date: 20210709; Test Name: Bilirubin; Test Result: 0.1 mg/dl; Test Date: 20210709; Test Name: Calcium; Result Unstructured Data: Test Result:8.5 g/dl; Test Date: 20210709; Test Name: Chloride; Result Unstructured Data: Test Result:101 mEq/l; Test Date: 20210709; Test Name: CK; Result Unstructured Data: Test Result:221 IU/l; Test Date: 20210709; Test Name: Creatinine; Test Result: 1.4 mg/dl; Test Date: 20210709; Test Name: Fibrinogen (Coagulative); Test Result: 28 mg/dl; Test Date: 20210709; Test Name: Glucose; Test Result: 376 mg/dl; Test Date: 20210709; Test Name: LDH; Result Unstructured Data: Test Result:778 IU/l; Test Date: 20210709; Test Name: Phosphorus; Test Result: 13.5 mg/dl; Test Date: 20210709; Test Name: Potassium; Result Unstructured Data: Test Result:8.46 mEq/l; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210709; Test Name: Blood pressure; Result Unstructured Data: Test Result:80 mmHg; Test Date: 20210709; Test Name: Systolic lood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210709; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Date: 20210709; Test Name: Urea; Test Result: 42 mg/dl; Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:35.3 Centigrade; Test Date: 20210709; Test Name: chest x-ray; Result Unstructured Data: Test Result:without pleuroparenchymal alterations; Test Date: 20210709; Test Name: Computerized axial tomography; Result Unstructured Data: Test Result:Angio CT pulmonary arteries:...; Comments: ... bilateral PE with knobby thrombus in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobe, middle and partial lobe arteries of the LID with possible asitiated infarction in LII and signs of right cardiac overload; Test Date: 20210709; Test Name: CT angiopulmonary arteries; Result Unstructured Data: Test Result:bilateral PE with knobby thrombus...; Comments: ...in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobe, middle and partial lobe arteries of the LID with possible infarction asiaciated in LII and signs of right cardiac overload Fractures 2nd, 3rd, 4th and 5th right rib and 4th, 5th and 6th left. IOT progressed with extreme fondness (later withdrawn at 23cm).; Test Date: 20210709; Test Name: Cranial CT; Result Unstructured Data: Test Result:signs of diffuse cerebral edema...; Comments: ...suggestive of hypoxic-ischemic encephalopathy (loss of corticosubcortical and basal ganglia differentiation with slight effacement of sulci, centered midline).; Test Date: 20210709; Test Name: Cranial CT; Result Unstructured Data: Test Result:No signs of intra- or extra-axial bleeding...; Comments: .. Loss of corticosubcortical and basal ganglia differentiation with mild sulcus effacement suggestive of diffuse cerebral edema. Centered midline with adequate visualization of the basal cisterns. Ventricular system of normal size and morphology. CONCLUSION: Signs of diffuse cerebral edema suggestive of hypoxic-ischemic encephalopathy.; Test Date: 20210709; Test Name: Thoracic CT; Result Unstructured Data: Test Result:Extensive filling defect in the ...; Comments: ..pulmonary arteries compatible with acute PE with a knuckle thrombus in bifurcation of the main pulmonary artery with involvement of: - Left pulmonary artery with complete occlusion of the lower left lobar artery and the lingula artery of the LSI. - Right pulmonary artery with extension to the LM artery and partial occlusion of the right lower lobar artery. Signs of right cardiac overload with RV / LV ratio 1 (35 mm RV lumen and 12 mm LV) and slight rectification of the interventricular septum. Pulmonary artery of normal caliber (26 mm), however the Ao / Ap ratio is 1 so there is possibly an associated PHT. Lamellar thickness bilateral pleural effusion. Left ventricular hypertrophy. Peripheral and triangular ground glass opacities are observed in the lung parenchyma in LII that could be related to associated pulmonary infarction. Atelectasis is seen in both upper lobes in sloping areas due to hypoventilation. No radiologically significant lymphadenopathy. Anterior arch fracture of 2s, 3s, 4s and 5s right ribs and anterior arch fracture of 4s, 5s and 6s left ribs. Progressed IOT device with distal end in carina. Gastric tube. CONCLUSION: Bilateral PE with knuckle thrombus in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobar, middle lobe and partial LID arteries with possible associated infarction in LII and signs of right cardiac overload. Right rib fractures of 2s, 3s, 4s and 5s and left 4s, 5s and 6s. IOT progressed with end in carina.; Test Date: 20210709; Test Name: ECG; Result Unstructured Data: Test Result:with SR at 66 bpm; Test Date: 20210709; Test Name: Eosinophils; Result Unstructured Data: Test Result:0.2 x10 3/mm3; Test Date: 20210709; Test Name: Eosinophils; Test Result: 1.6 %; Test Date: 20210709; Test Name: Gamma-GT; Result Unstructured Data: Test Result:35 IU/l; Test Date: 20210709; Test Name: Glomerular Filtrate (ckd-epi); Result Unstructured Data: Test Result:47 ml / min / 1.73m2; Test Date: 20210709; Test Name: Hematocrit; Test Result: 34.1 %; Test Date: 20210709; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.2 g/dl; Test Date: 20210709; Test Name: heart rate; Result Unstructured Data: Test Result:66 bpm with ST descent in anterolateral aspect; Test Date: 20210709; Test Name: Heart rate; Result Unstructured Data: Test Result:67; Comments: bpm; Test Date: 20210709; Test Name: HCM; Test Result: 32.3 pg; Test Date: 20210709; Test Name: INR; Result Unstructured Data: Test Result:2.12; Test Date: 20210709; Test Name: Lymphocytes; Result Unstructured Data: Test Result:4.0x1000 x10 3/mm3; Test Date: 20210709; Test Name: Lymphocytes; Result Unstructured Data: Test Result:34 x10 3/mm3; Test Date: 20210709; Test Name: MCHC; Result Unstructured Data: Test Result:29.9 g/dl; Test Date: 20210709; Test Name: MCV; Result Unstructured Data: Test Result:107.9; Comments: fl; Test Date: 20210709; Test Name: MPV; Result Unstructured Data: Test Result:8.3; Comments: fl; Test Date: 20210709; Test Name: Monocytes; Result Unstructured Data: Test Result:0.2 x10 3/mm3; Test Date: 20210709; Test Name: Monocytes; Test Result: 1.6 %; Test Date: 20210709; Test Name: Neutrophils; Result Unstructured Data: Test Result:7.2 x10 3/mm3; Test Date: 20210709; Test Name: Neutrophils; Test Result: 62.1 %; Test Date: 20210709; Test Name: NT-proBNP; Result Unstructured Data: Test Result:713 pg/mL; Test Date: 20210709; Test Name: sO2; Test Result: 96 %; Test Date: 20210709; Test Name: Platelets; Result Unstructured Data: Test Result:115 x10 3/mm3; Test Date: 20210709; Test Name: Total Proteins; Result Unstructured Data: Test Result:4.5 g/dl; Test Date: 20210709; Test Name: Prothrombin Activity; Test Result: 35 %; Test Date: 20210709; Test Name: Prothrombin Time; Test Result: 24.6 s; Test Date: 20210709; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.16 x10 3/mm3; Test Date: 20210709; Test Name: RDW; Test Result: 14.2 %; Test Date: 20210709; Test Name: PCR for SARS-CoV-2; Test Result: Negative ; Test Date: 20210709; Test Name: Troponin T hs; Result Unstructured Data: Test Result:1209 ng/L; Test Date: 20210709; Test Name: Leukocytes; Result Unstructured Data: Test Result:11.6 x10 3/mm3
CDC Split Type: ESPFIZER INC202100927060

Write-up: Thrombocytopenia; Acute massive pulmonary embolism; Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-946744. A 42-years-old non-pregnant female patient received BNT162B2 (COMIRNATY; Solution for injection, Batch/Lot Number: FC1435), via an unspecified route of administration, administered in Arm Left on 08Jul2021 as dose 1, single for COVID-19 immunization; Drospirenone, ethinylestradiol (YASMIN), oral from 23Aug2019 (Batch/Lot number was not reported) to an unspecified date, at 1 DF, 1x/day for contraception. Medical history included obesity from an unknown date and unknown if ongoing taking oral contraceptives. Concomitant medication(s) included Valproic acid (DEPAKINE [VALPROIC ACID]) taken for Juvenile myoclonic epilepsy, start and stop date were not reported. The patient experienced Thrombocytopenia, Acute massive pulmonary embolism, cardio-respiratory arrest on 09Jul2021. Additional information on the ADRs: The adverse reaction was very rapid, the pfizer vaccine was administered on Thursday, 08Jul2021 in the afternoon and on Friday, 09Jul2021, at 8:00 a.m. she collapsed and was unconscious, to later be hospitalized in the emergency room. 41-year-old woman with no pathological history of interest (obesity, taking oral contraceptives) admitted to the multipurpose ICU after reception and initial care in the reanimation room:She came to the emergency room twice in the last 15 days for bilateral rib pain with mechanical haracteristics, being discharged with a musculoskeletal pathology (LAST VISIT 06Jul2021). She is found unconscious by her relatives at 8 am, so CPR is started with a total attendance count:- Basic CPR 7 + 8 min: total 15 min. Advanced CPR: 12 min (ventricular fibrillation, initial shock 200J + adrenaline) + 6 min (electrical activity without pulse, IV fibrinolysis) + 6 min: total 24 min. Total duration of stop: 39 min. Output Sinus rhythm 66 bpm with ST descent in anterolateral aspect. First recorded systolic blood pressure 80 mmHg.Transfer time 10 min. Upon arrival at reanimation room: A / B: isolated airway with tracheostomy 7.5, connected to mechanical ventilation 400 x 16 breaths per minute, PEEP (Positive end-expirative pressure) 5, FiO2 100%, thus spO2 96%. Symmetric ventilation of both hemithoraces. C: unstable with noradrenaline at 0.3 mcg / kg / min with weak central pulses, BP 80/40 mmHg. Sinus rhythm at 67 bpm. Capillary filling 3 seconds, lividity in the thorax, abdomen and extremities. D: GCS 3 without administration of sedation relaxation by out-of-hospital. Posteriorly she gasps during initial care. Mydriatic pupils R L (5mm 4mm) are reactive. No CPR. E: T 35.3C. Remains of epistaxis. No stigmata of trauma. Initially she carries a cardiocompressor that is withdrawn (not active). According to the above, noradrenaline is increased to 0.5 mcg / kg / min, initial GEM pH 7 is extracted, lactic 15 mmol / l, K + 8.5 meq / l, pCO2 86 mmHg, pO2 90, Hb 10 g / dl, Portable chest X-ray is realized without pleuroparenchymal alterations, ECG with SR at 66 bpm and echoscopy with RV dilation and dysfunction with bulging of the septum and paradoxical movement as well as little longitudinal contraction associating hypertrophic LV in a concentric manner without segmental alterations of contractility and without pericardial effusion. According to the above, invasive mechanical ventilation parameters are adjusted, fluid therapy (1,000 cm3 crystalloids) and bicarbonate are administered, and dobutamine is added at 6 mcg / kg / min, achieving systolic blood pressure 100 mmHg. After that, she was transferred to the CT room where angio-CT and cranial CT were performed: CT angiography of pulmonary arteries: bilateral pulmonary thromboebmolism with knobby thrombus in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobe, middle and partial lobe arteries of the right lower lobe with possible infarction asiaciated in left lower lobe and signs of right cardiac overload. Fractures 2nd, 3rd, 4th and 5th right rib and 4th, 5th and 6th left. Orotracheal intubation progressed with extreme fondness (later withdrawn at 23cm). Cranial CT: signs of diffuse cerebral edema suggestive of hypoxic-ischemic encephalopathy (loss of corticosubcortical and basal ganglia differentiation with slight effacement of sulci, centered midline). During imaging tests, she presented new instabilization, so resuscitation with fluid therapy was continued, noradrenaine increased to 1.2 mcg / kg / min and dobutamine to 9 mck / kg / min, vasopressin was associated at a dose of 0.04 IU / min and Evaluation by Cardiology was requested in order to propose introduction of rescue mechanical thrombendarterectomy, which they consider contraindicated given the instability of the patient. After that and after confirmation of previous negative PCR for SARS-CoV-2, we proceeded to transfer to a polyvalent ICU. Physical examination ON ADMISSION: A / B: isolated airway with tracheostomy 7.5, 95% spO2 under PEEP 5, FiO2 100% with difficulty in sensing pulse oximetry. Vesicular murmur preserved bilaterally. C: frank hemodynamic instability with a SAT of 60 mmHg under advanced life support with noradrenaline 1.2 mcg / kg / min, dobutamine up to 9 mck / kg / min and vasopressin at a dose of 0.04 IU / min. D: GCS of 3 with isochoric and slow reactive pupils. SUMMARY OF ADDITIONAL TESTS: HEMOGRAM: Red blood cells 3.16 xmill / ul, Hemoglobin 10.2 g / dl, Hematocrit 34.1%, MCV 107.9 fl, MCH 32.3 pg, MCHC 29.9 g / dl, RDW 14.2%, Platelets 115 x1000 / ul, MPV 8.3 fl, Leukocytes 11.6 x1000 / ul, Neutrophils 7.2 x1000 / ul, Neutrophils% 62.1%, Lymphocytes 4.0 x1000 / ul, Lymphocytes% 34.0%, Monocytes 0.2 x1000 / ul, Monocytes% 1.6%, Eosinophils 0.2 x1000 / ul, Eosinophils% 1.6%, Basophils 0.1 x1000 / ul, Basophils% 0.7% BIOCHEMISTRY: Glucose 376 mg / dl, Creatinine 1.40 mg / dl, Glomerular Filtrate (ckd-epi) 47 ml / min / 1.73m2, Sodium 139 mEq / l, Potassium 8.46 mEq / l, Chlorine 101 mEq / l, Total Proteins 4.5 g / dl, Albumin 2.6 g / dl, Calcium 8.5 mg / dl, ALT (GPT) 234 U / l, AST (GOT) 310 U / l Result interfered with by hemolysis. , Gamma-GT 35 U / l, Alkaline Phosphatase 163 U / l, LDH 778 U / l Result interfered with by hemolysis. , Bilirubin 0.1 mg / dl, CK 221 U / l, Urea 42 mg / dl, Phosphorus 13.5 mg / dl, Troponin T hs 1209.0 ng / l, NT-proBNP 713 pg / ml COAGULATION: Prothrombin Activity 35%, Prothrombin Time 24.6 sec, INR (Laboratory) 2.12, aPTT 102 sec, Fibrinogen (Coagulative) 28 mg / dl. CRANIAL CT: No signs of intra- or extra-axial bleeding. Loss of corticosubcortical and basal ganglia differentiation with mild sulcus effacement suggestive of diffuse cerebral edema. Centered midline with adequate visualization of the basal cisterns. Ventricular system of normal size and morphology. CONCLUSION: Signs of diffuse cerebral edema suggestive of hypoxic-ischemic encephalopathy. THORACIC CT: Extensive filling defect in the pulmonary arteries compatible with acute PE with a knuckle thrombus in bifurcation of the main pulmonary artery with involvement of: - Left pulmonary artery with complete occlusion of the lower left lobar artery and the lingula artery of the left upper lobe. - Right pulmonary artery with extension to the middle lobe artery and partial occlusion of the right lower lobar artery. Signs of right cardiac overload with RV / LV ratio 1 (35 mm RV lumen and 12 mm LV) and slight rectification of the interventricular septum. Pulmonary artery of normal caliber (26 mm), however the Ao / Ap ratio is 1 so there is possibly an associated pulmonary hypertension. Lamellar thickness bilateral pleural effusion. Left ventricular hypertrophy. Peripheral and triangular ground glass opacities are observed in the lung parenchyma in LII that could be related to associated pulmonary infarction. Atelectasis is seen in both upper lobes in sloping areas due to hypoventilation. No radiologically significant lymphadenopathy. Anterior arch fracture of 2s, 3s, 4s and 5s right ribs and anterior arch fracture of 4s, 5s and 6s left ribs. Progressed IOT device with distal end in carina. Gastric tube. CONCLUSION: Bilateral PE with knuckle thrombus in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobar, middle lobe and partial right lower lobe arteries with possible associated infarction in left lower lobe and signs of right cardiac overload. Right rib fractures of 2s, 3s, 4s and 5s and left 4s, 5s and 6s. IOT progressed with end in carina. PORTABLE CHEST X-RAY: Cardiothoracic index 50% without infiltrates or consolidations. Normally positioned devices. EVOLUTION AND COMMENTS: A Patient with history of obesity and taking oral contraceptives who was admitted to the polyvalent ICU after recovery of out-of-hospital cardiac arrest due to massive PTE with performance of intra-stop fibrinolysis with times: Basic CPR 7 + 8 min: total 15 min. Advanced CPR: 12 min (ventricular fibrillation, initial shock 200J + adrenaline) + 6 min (pulseless electrical activity, IV fibrinolysis) + 6 min: total 24 min. Total duration of stop: 39 min. Sinus rhythm 66 bpm output with anterolateral ST descent. As tests performed in reanimation room, a chest CT scan that confirms bilateral PE with a knuckle thrombus in bifurcation of the main pulmonary artery and extension of the lingula, left lower lobe, middle and partial lobe of the right lower lobe and cranial CT with diffuse cerebral edema suggestive of encephalopathy stands out. hypoxic-ischemic. Upon admission to the Unit, the analysis and microbiological cultures were monitored and extracted according to the protocol, highlighting in the initial assessment a situation of frank hemodynamic instability with threadlike central pulses and difficulty in acquisition of NIBP, so a femoral arterial catheter was channeled, confirming SAT 65 mmHg. Likewise, TTE is performed that confirms dilated RV with severe dysfunction that conditions septal displacement and compromises ventricular interdependence, with hypertrophic LV and whose filling is limited within the aforementioned and portable chest X-ray that rules out complications in this regard. Association of hemorrhagic diathesis within fibrinolysis with epistaxis, gingival hemorrhage and from venipuncture points. Accordingly, resuscitation with fluid therapy is continued, a transfusion of 2 red blood cell concentrates is started, vasoactive and inotropic support in an ascending manner are introduced with the addition of adrenaline up to 0.3 mcg / kg / min, and an assessment of mechanical circulatory support is requested by Cardiac Surgery. with logistical impossibility for the implementation of the same on their part. Evolution to a new CRP in electromechanical dissociation in which context, given the poor prognosis associated with prolonged CRP with semiology of hypoxic-ischemic encephalopathy in admission CT and the absence of effective therapeutic alternatives, death was certified on 09Jul2021 at 4:15 p.m. MAIN DIAGNOSIS: Massive pulmonary embolism. Therapeutic measures were taken for all the events. The patient died on 09Jul2021. It was not reported if an autopsy was performed. The outcome for all the events was Fatal.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1510579 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Coronary artery disease, Death, Hypertension, Inappropriate schedule of product administration, Magnetic resonance imaging head, Malaise, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Other ischaemic heart disease (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; PRIMASPAN; RENITEC COMP; ZANIDIP; SPESICOR DOS; ISMOX; EZETIMIBE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral atrophy; Coronary heart disease; Hypertension; Myocardial infarction; Ulcer; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: brain MRI; Result Unstructured Data: Test Result:vascular degeneration and temporomedial atrophy; Comments: in brain MRI
CDC Split Type: FIPFIZER INC202100939745

Write-up: Death; Coronary artery disease; hypertension with its complications proposed as a contributing factor; Malaise; Abdominal pain lower; Pain; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB FI-FIMEA-20213611. A 73-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC0681), dose 2 intramuscular on 26May2021 as Dose 2, single for covid-19 immunisation. The patient''s medical history included coronary heart disease, suffering from two myocardial infarctions, hypertension, ulcers, vascular degeneration and temporomedial atrophy in brain MRI. The patient''s concomitant medication included atorvastatin at a dose of 40 mg, daily, acetylsalicylic acid (PRIMASPAN) at a dose of 100 mg, daily, enalapril maleate, hydrochlorothiazide (RENITEC COMP, strength: 20/12 mg) at a dose of 1 DF, daily, lercanidipine hydrochloride (ZANIDIP) at a dose of 20 mg, daily, metoprolol succinate (SPESICOR DOS) at a dose of 95 mg, daily, isosorbide mononitrate (ISMOX) at a dose of 20 mg, daily and ezetimibe at a dose of 10 mg, daily. The patient previously received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EJ6790), dose 1, via unspecified route of administration, on 03Mar2021, as Dose 1, single for covid-19 immunisation. On 30May2021, 4 days after the vaccine, he started having symptoms lower abdominal pain, pain and malaise that led him to seek emergency care. 7 days after the vaccine, on Wednesday, 02Jun2021, he was found dead at home. Autopsy protocol summary: Cause of death coronary artery disease, hypertension with its complications proposed as a contributing factor. The patient had underlying illnesses, but the illnesses were treated with medication and the illnesses did not negatively affect his quality of life, e.g. pain or general pain. Deterioration in quality of life and onset of symptoms began only 4 days after the second dose of vaccine, eventually leading to death. The patient died on 02Jun2021. An autopsy was performed that revealed coronary artery disease (coronary artery disease, hypertension). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: hypertension; Autopsy-determined Cause(s) of Death: Coronary artery disease


VAERS ID: 1510602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-07-08
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic thrombosis, Computerised tomogram
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; ATENOLOL; COVERSYL [PERINDOPRIL ARGININE]; NICORANDIL; ROSUVASTATIN; SEROPLEX; LEVOTHYROX; EUPANTOL; TARDYFERON
Current Illness: Anaemia; Artificial cardiac pacemaker user; Ischaemic heart disease; Thyroidectomy NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder; TIA; Wrist fracture
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:occlusion of the abdominal sub-renal aorta; Comments: confirmed massive and complete occlusion of the abdominal sub-renal aorta
CDC Split Type: FRPFIZER INC202100948858

Write-up: Acute thrombosis abdominal aorta; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20215604. A 92-years-old female patient received bnt162b2 (COMIRNATY COVID-19 vaccine, Solution for injection, Batch/Lot Number: EW2239, Expiration date: Unknown), intramuscular on 08Apr2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing artificial cardiac pacemaker user, ongoing ischaemic heart disease, ongoing thyroidectomy NOS, ongoing anaemia, transient ischaemic attack, advanced cognitive disorder, wrist fracture. Concomitant medication(s) included acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported; atenolol taken for an unspecified indication, start and stop date were not reported; perindopril arginine (COVERSYL [PERINDOPRIL ARGININE]) taken for an unspecified indication, start and stop date were not reported; nicorandil taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (SEROPLEX) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (EUPANTOL) taken for an unspecified indication, start and stop date were not reported; ferrous sulfate (TARDYFERON) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (COMIRNATY COVID-19 vaccine, Solution for injection, Batch/Lot Number: ET3620, Expiration date: Unknown), intramuscular on 18Mar2021 as dose 1, single for covid-19 immunisation. On 08Jul2021, the patient experienced acute thrombosis abdominal aorta. The patient was hospitalized for acute thrombosis abdominal aorta (aortic thrombosis) from 08Jul2021 to an unknown date. The patient underwent lab tests and procedures which included computerised tomogram: occlusion of the abdominal sub-renal aorta confirmed massive and complete occlusion of the abdominal sub-renal aorta on an unspecified date. The patient died on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: NOS Death


VAERS ID: 1510831 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:health a baby and heartbeat; Comments: 7 week scan; Test Date: 2021; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:stopped growing, no heartbeat; Comments: by 10 weeks physical miscarriage
CDC Split Type: GBPFIZER INC202100933568

Write-up: Maternal exposure during pregnancy; baby stopped growing at 8 weeks; This is a spontaneous report from a contactable consumer (parent). This is the second of two reports. The first report is received from the regulatory authority. Regulatory authority report GB-MHRA-WEBCOVID-202107042334576040-BKZRY, Safety Report Unique Identifier GB-MHRA-ADR 25593298. This consumer reported information for both mother and fetus. This is the fetus report. The patient''s mother is a 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The fetus patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via transplacental. The patient medical history was not reported. The patient''s mother medical history included pregnant on an unknown date. The mother no longer pregnant at the time of reporting. The patient''s mother concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 04Jun2021 and stopped growing at 8 weeks in 2021. The event was reported as serious for death and medically significant. Mother accepted the vaccine at 5 weeks pregnant as told pros outweighs the risks. All seemed fine with the pregnancy however baby stopped growing at 8 weeks, this was discovered at the 10 week scan. Physical miscarriage. The patient underwent lab tests and procedures which included ultrasound scan: health a baby and heartbeat on 7 week, ultrasound scan: stopped growing, no heartbeat on by 10 weeks, both on unknown date in 2021. The outcome of the event was fatal. The patient died on an unspecified date in 2021. 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: Linked Report(s) : GB-PFIZER INC-2021854306 Maternal case; Reported Cause(s) of Death: baby stopped growing at 8 weeks; Maternal exposure during pregnancy


VAERS ID: 1510848 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: HOLISTEN; T4; HOLISTEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood glucose; Result Unstructured Data: Test Result:blood glucose curve; Comments: due to blood glucose disorder during fasting, without finding of type 2 diabetes mellitus; Test Date: 201712; Test Name: Blood glucose; Result Unstructured Data: Test Result:NORMAL: NO FINDING OF TYPE 2 DIABETES MELLITUS
CDC Split Type: GRPFIZER INC202100915645

Write-up: Death; Cardiac arrest during sleeping; heart failure; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) -WEB, GR-GREOF-20215700. A 50-year-old male patient received the second dose of the bnt162b2 (COMIRNATY), intramuscularly on 24Jun2021 at 13:20 at a single dose for covid-19 immunisation. The medical history was not reported. Concomitant medications included atorvastatin calcium (HOLISTEN) taken for hyperlipidaemia; levothyroxine sodium (T4) taken for hypothyroidism from May2017 to Mar2021; atorvastatin calcium (HOLISTEN) taken for cholesterol from an unspecified start date to Mar2021. On 29Jun2021, the patient experienced heart failure, cardiac arrest during sleeping, and death, which was medically significant and serious for death. The clinical course was as follows: the patient died suddenly on 29Jun2021 during sleeping. On 24Jun2021, he was vaccinated with the second dose of the vaccine at 13:20. On the death certificate was indicated the cause of death as heart failure, after visual examination by their family physician. No autopsy was performed. The date of burial was on 30Jun2021 at 11:00. The male patient who passed away had no history of heart disease. The patient underwent lab tests and procedures which included blood glucose: normal: no finding of type 2 diabetes mellitus in Dec2017 and blood glucose: blood glucose curve on an unknown date (reported as Dec2021) (due to blood glucose disorder during fasting, without finding of type 2 diabetes mellitus). The clinical outcome of the events, heart failure, cardiac arrest during sleeping, and death, was fatal. The patient died on 29Jun2021 due to heart failure, cardiac arrest during sleeping, and death. An autopsy was not performed. No follow-up attempts are possible; information on batch number cannot be obtained.; Reported Cause(s) of Death: Heart failure; cardiac arrest during sleeping; death


VAERS ID: 1510854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
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: HKPFIZER INC202100935429

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority department of health (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002754), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority department of health. The regulatory authority report number is not applicable. A 34-year-old male patient started to receive a dose of TOZINAMERAN (COMIRNATY) (lot number: unknown) on an unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There is no clinical evidence that the incident arose from vaccination. Upon receipt of the preliminary autopsy report, the case will be passed to the Expert Committee for the conducting of causality assessment. The event unknown cause of death was met the seriousness criterion of fatal. The action taken for TOZINAMERAN (COMIRNATY) regarding the event was not applicable. Patient died on an unknown date. preliminary autopsy report was done on an unknown date, autopsy result was not provided. Initial report was received on 14-Jul-2021. Follow-up closed, no further information is possible. Causality assessment: unknown cause of death pere reporter/company: unlikely/unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1510856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein, C-reactive protein increased, Chest X-ray, Death, Pneumonia, Renal function test, Renal impairment, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma gastric; Gastrectomy (with oesoph.-jejunost. sec. Roux); Pneumonia bacterial
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210629; Test Name: CRP; Result Unstructured Data: Test Result:elevated; Test Date: 20210629; Test Name: Kidney function; Result Unstructured Data: Test Result:narrowed; Test Date: 20210629; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021899423

Write-up: Pneumonia; Narrowed kidney function; Severe weakness; Elevated CRP; Death; This is a spontaneous report from a contactable physician downloaded from the Medicine Agency (MA) -WEB (Regulatory Authority Report Number: HU-OGYI-646821). An 80-year-old male patient received BNT162B2 (COMIRNATY; solution for injection), intramuscularly administered in the right arm on 24Jun2021 (lot number: FD0168) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included pneumonia bacterial, gastric adenocarcinoma diagnosed in Nov2018, and gastrectomy (with oesoph.-jejunost. sec. Roux) in Jan2019. Concomitant medications included unspecified oncological treatment. The patient previously received BNT162B2 (COMIRNATY) intramuscularly on 20May2021 (lot number: FA5829) as dose 1, 0.3 ml single for COVID-19 immunization. On 29Jun2021, the patient was hospitalized because of severe weakness. The patient''s COVID-19 antigen test was negative. His chest X-ray showed pneumonia. Laboratory results showed elevated C-reactive protein (CRP) and narrowed kidney function. The patient received liquids, antibiotics, and low-molecular-weight heparin (LMWH) therapy but passed away on 30Jun2021 at 06:40. According to the reporting physician, the patient''s condition gradually deteriorated after he was diagnosed with gastric adenocarcinoma. Based on the above, the causal relationship was not related between the suspected drug and the patient''s death. On 30Jun2021 at 06:40, the patient died due to an unknown cause. An autopsy was not performed. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information in the case, the causal association between the events pneumonia, renal impairment, asthenia, C-reactive protiein increased and the suspect drug BNT162B2 cannot be excluded. Based on the limited information pertaining to the specific details of death it cannot be ascertained with reasonable possibility that suspect therapy has caused, contributed to death of the patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1510857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Anaemia, Asthenia, COVID-19 pneumonia, Computerised tomogram thorax, Cough, Dyspnoea, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarct; Chronic renal failure; Diabetes mellitus; Heart insufficiency; Hypertension; Hypothyreosis; Myocardial infarct; Right bundle branch block; Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Chest CT; Result Unstructured Data: Test Result:Viral pneumonia; Test Date: 20210427; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC202100940484

Write-up: COVID-19 pneumonia; Dyspnoea; Stomach discomfort; Dry cough; Weakness; Nausea; Fever; Severe anemia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-650421. This spontaneous, serious case was reported by a physician on 07Jul2021, concerning COVID-19 pneumonia after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). A 81-year-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: ET6956 and Expiration Date: unknown), via an intramuscular route, administered in left arm on 24Apr2021 as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included cerebral infarct, hypertension, myocardial infarct, varicose vein operation, chronic renal failure in 2018, diabetes mellitus, heart insufficiency, hypothyreosis, and right bundle branch block. The patient''s concomitant medications were not reported. On 27Apr2021, the patient got hospitalized due to COVID-19 pneumonia, weakness, dyspnoea, stomach discomfort, nausea, dry cough, fever, and severe anemia. On 27Apr2021, the patient underwent lab tests and procedures included Chest CT with results of COVID-19 specific viral pneumonia and COVID-19 PCR test with negative results. In addition to elevated inflammatory values in laboratory tests, previously known end-stage renal failure and severe anemia were confirmed. The patient received COVID-19 protocol and antibiotic therapy. Severe anemia. The case was assessed as serious. The patient died on 29Apr2021 at 2:30 PM. An autopsy was performed, the cause of death was severe heart failure due to COVID-19 and the patient''s comorbidities, COVID-19 pneumonia, weakness, dyspnoea, stomach discomfort, nausea, dry cough, fever, and severe anemia. Sender Comment: COVID-19 pneumonia occurred after 5 days, and the patient died 7 days after the first dose of Comirnaty. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia; Weakness; Dyspnoea; Stomach discomfort; Nausea; Dry cough; Fever; Severe anemia; severe heart failure due to COVID-19 and the patient''s comorbidities.


VAERS ID: 1510858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-28
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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202100917637

Write-up: died; This is a spontaneous report received from the contactable consumer. This consumer reported similar events for four patients (his own mother, his colleague''s mother, his computer scientist colleague''s brother-in-law and computer scientist colleague''s neighbour). This is the 3rd of four reports, of the reporter''s computer scientist colleague''s brother-in-law. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient had a number of problems and died last week in Jul2021, received the 2nd vaccine 3 months prior 15Jul2021. 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: Linked Report(s) : HU-PFIZER INC-2021870291 same reporter and suspect product, different event and patient (case of the reporter''s mother); Reported Cause(s) of Death: died


VAERS ID: 1510874 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-08
Submitted: 0000-00-00
Entered: 2021-07-28
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: 2021-06-08
   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: SOLU MEDROL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INPFIZER INC2021900810

Write-up: death; This is a spontaneous report received from a contactable Pharmacist(Parent) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 62-year-old male patient received bnt162b2 (COVID 19), via an unspecified route of administration on an unspecified date at 62-year-old (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included methylprednisolone sodium succinate (SOLU MEDROL 500) taken for an unspecified indication, start and stop date were not reported. The patient experienced death (death, hospitalization) on 08Jun2021. The patient died on 08Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1510893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939398

Write-up: after experiencing symptoms of suffocation she died suddenly; after experiencing symptoms of suffocation she died suddenly; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency (MA) -WEB IT-MINISAL02-755116. A 73-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 27Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunization. The patient medical history and concomitant was not reported. The patient after suffering symptoms of suffocation, died suddenly on 30Jun2021. 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: suffocation


VAERS ID: 1510897 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Overdose
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Medication errors (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: Allergy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100926928

Write-up: administered DOSE 2, 3 mL, SINGLE; the patient was given a second dose of Comirnaty vaccine at 09:55; absolutely asymptomatic patient both before administration (observation 30 ''); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-755514. A 98-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD7959; Expiration Date: 31Oct2021) via intramuscular route of administration, administered in arm left on 05Jul2021 at 09:55 (at the age of 98-year-old) as dose 2, 3 ml, single for COVID-19 immunisation. Medical history included allergy NOS from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Clinical course: after contacting the doctor, he reiterated that: he made the report out of scruple, but in his opinion there was no relationship between death and vaccination. The elderly patient had a cardiac arrest while, supported by her daughter and caregiver, she was made to walk passively (only supported she was able to move a few steps): The arrest took place about an hour and a half after the vaccination (waited for half an hour). Now because the patient was allergic and he received the phone call, so adding the time elapsed between post-vaccination observation and transfer to privacy he calculated this time (as usual, he left his mobile phone to the families in order to be warned if some problems occur. The doctor also ruled out a causal link. He made the report for scruple, Reported on the advice of the hospital - Actions taken (Cardiac arrest while walking after more than an hour from the administration of the vaccine in complete well-being (daughter present); immediate activation 118; RCPA by 118 staff; upon their arrival the patient was already in gasping. The patient died on an unspecified date due to cardio-respiratory arrest. It was not reported if an autopsy was performed. The outcome of the other event overdose was unknown. Reporter''s comments: In my opinion, the administration of the vaccine had no role in the patient''s cardiac arrest; there is no evidence that she was taking any drugs. Half hour vaccination observation, arrest occurred one hour after vaccine administration while she was walking. Her daughter report no prodromal signs.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of cardiac arrest cannot be excluded. However, role of underlying medical conditions cannot be ruled out either. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1510903 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 08-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced RESPIRATORY FAILURE (seriousness criteria death and medically significant). The patient died on 10-Jul-2021. The reported cause of death was Respiration failure. 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 medication reported. No treatment information was provided. This case refers to an 87-year-old male patient who experienced serious unexpected event of respiratory failure 3 days after receiving the product mRNA-1273. Limited information regarding the patient''s medical history and underlying cause was reported for causality assessment at this time. Further information is expected.; Sender''s Comments: This case refers to an 87-year-old male patient who experienced serious unexpected event of respiratory failure 3 days after receiving the product mRNA-1273. Limited information regarding the patient''s medical history and underlying cause was reported for causality assessment at this time. Further information is expected.; Reported Cause(s) of Death: Respiration failure


VAERS ID: 1510930 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939493

Write-up: SARS-CoV-2 pneumonia; SARS-CoV-2 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [IT-MINISAL02-757242]. A 81-year-old male patient received first dose of bnt162b2 (COMIRNATY COVID-19 vaccine, Formulation: solution for injection, Lot Number: EP9598) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had sars-cov-2 pneumonia and drug ineffective on 10Mar2021. The patient received the treatment (hospitalization in resuscitation) for the event. The patient died on 08Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Sender''s comments: Death occurred at a time when the vaccine could not guarantee optimal vaccination coverage.; Reported Cause(s) of Death: SARS-CoV-2 pneumonia


VAERS ID: 1510946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Antinuclear antibody, Cardiogenic shock, Complement factor C3, Complement factor C4, Dyspnoea, Headache, Platelet count, Plateletcrit, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TEGRETOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder NOS; Epilepsy (in therapy with Tegretol); Thrombopenia
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Antinuclear antibody; Result Unstructured Data: Test Result:positive titre 1:320; Test Name: antibodies to platelet factor 4; Test Result: Negative ; Test Date: 20210702; Test Name: Complement factor C3; Test Result: 62 mg/dl; Test Date: 20210702; Test Name: Complement factor C4; Test Result: 4 mg/dl; Test Name: Thrombocyte; Result Unstructured Data: Test Result:130.00; Comments: thrombocytopenia of unknown origin (130.00 last known value); Test Date: 20210625; Test Name: Plateletcrit; Result Unstructured Data: Test Result:30.000
CDC Split Type: ITPFIZER INC202100948757

Write-up: Headache, dyspnoea. At diagnosis: massive pulmonary thromboembolism and cardiogenic shock.; Headache, dyspnoea. At diagnosis: massive pulmonary thromboembolism and cardiogenic shock.; Headache, dyspnoea. At diagnosis: massive pulmonary thromboembolism and cardiogenic shock.; Headache, dyspnoea. At diagnosis: massive pulmonary thromboembolism and cardiogenic shock.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-760012. A 58-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FA8016, Expiration date: 30Sep2021), via an intramuscularly on 24May2021 as dose 1, single for covid-19 immunization. The patient medical history included Epilepsy in therapy with Tegretol, thrombocytopenia of unknown origin (130.00 last known value), autoimmune disease of unknown origin from an unknown date and unknown if ongoing. The patient concomitant medications included carbamazepine (TEGRETOL) taken for epilepsy, start and stop date were not reported. On 24Jun2021, the patient experienced headache, dyspnoea and at diagnosis: massive pulmonary thromboembolism and cardiogenic shock. Patient had hospitalization from 25Jun2021 and died at 13.45 on 20Jul2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included Plateletcrit was 30.000 on 25Jun2021, antinuclear antibody: positive titre 1:320, complement factor c3: 62 mg/dl, complement factor c4: 4 mg/dl on 02Jul2021, antibodies to platelet factor 4 was negative, platelet count: 130.00 on thrombocytopenia of unknown origin (130.00 last known value) on unspecified date. Therapeutic measures were taken as a result of events performed thrombolysis, coagulation, mechanical ventilation/intravenous immunoglobulin/intravenous cortisone/plasmapheresis/ultrafiltration). The outcome of the events was fatal. Reporter''s comments: Epilepsy in therapy with Tegretol, thrombocytopenia of unknown origin (130.00 last known value), autoimmune disease of unknown origin. Death at 13.45 on 20Jul2021. Sender''s comments: Pending clinical report.; Reported Cause(s) of Death: Shock cardiogenic; Pulmonary thromboembolism


VAERS ID: 1511067 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (relevant past drug history/known allergies); Eosinophilic granulomatosis with polyangiitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021894655

Write-up: Chest distress; The consciousness also worsened; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 84-year-old female. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. List of any other/concomitant medications the patient received within 2 weeks of vaccination included regular medications without recent changes. Other medical history included eosinophilic granulomatosis with polyangiitis. Relevant past drug history/known allergies included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Jun2021 at unknown time (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) (at the age of 84 years old) intramuscularly in the left arm for COVID-19 immunisation at public office. Reason why batch/lot is unknown: not available/provided to reporter at the time of report completion. On 28Jun2021 at 22:00 (2 days after the vaccination), the patient complained of chest distress and the consciousness also worsened at home. She waited and saw her condition for a while but experienced aggravation. The patient therefore called her family, and an ambulance was called because the consciousness also worsened. Patient did not receive any treatment. She was dead on arrival at the hospital (28Jun2021). Autopsy was not permitted by the of family. The reporter stated that the adverse events resulted in death. No autopsy was performed. The causality of the events was not reported. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was fatal.; Reported Cause(s) of Death: The consciousness also worsened; Chest distress


VAERS ID: 1511069 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Femur fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021894657

Write-up: Sudden death; sepsis; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 89-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included dementia and femur fracture. On 08Jul2021 at 14:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a nursing home/senior living facility. On 11Jul2021 at 08:45 (3 days after the vaccination), the patient developed sudden death. The event resulted in fatal. The cause of death was sepsis. An autopsy was not performed. It was unknown if the patient received the treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided.; Sender''s Comments: A causal association between BNT162B2 and the reported serious unlisted events sudden death and sepsis cannot be excluded based on a compatible temporal relation. 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: Sepsis; Sudden death


VAERS ID: 1511077 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: Pulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021894830

Write-up: Atrial fibrillation; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient''s age and gender were unknown. Medical history included pulmonary hypertension. On an unspecified date (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date (after the vaccination), the patient experienced atrial fibrillation. The outcome of the event was fatal on an unspecified date. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162b2 and the event atrial fibrillation 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: Atrial fibrillation


VAERS ID: 1511118 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Cardiac failure congestive
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021895005

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119689. The patient was an 85-year and 4-month-old female. On 10Jul2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0572, Expiration date 31Oct2021) an unspecified route of administration as DOSE 2, SINGLE for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included heart disease (cardiac failure chronic, cardiac failure congestive and atrial fibrillation). Ongoing oral concomitant medications included rivaroxaban (XARELTO). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced the event. On 12Jul2021, the patient was found dead. Detailed information (including the cause of death) was unknown. The course of the events was as follows: The patient was admitted to a different hospital for the treatment of cardiac failure chronic, cardiac failure congestive and atrial fibrillation. On 30Jun2021, the patient visited the reporter''s hospital as outpatient. The same treatment as previous hospital was continued. On 10Jul2021, the patient received the vaccine and returned home. On 12Jul2021, the patient was found dead at home. As for this case, clinical autopsy was to be carried out, therefore, detailed information was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician considered that there was possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had heart diseases. The causal relationship with BNT162b2 was unknown.; Reported Cause(s) of Death: Death


VAERS ID: 1511142 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-13
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumour; Cardiac failure chronic; Hepatic cancer; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021895388

Write-up: Acute on chronic heart failure; cardio-respiratory arrest; Arteriosclerosis coronary artery; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 75-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 on 21Jun2021 (Lot number FA5765, Expiration date 30Sep2021), dose 2 on 12Jul2021 14:30 (Lot number FC5295, Expiration date 30Sep2021), both via intramuscular as single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination included ongoing prescribed oral medications. There was no relevant past drug history. There were no known allergies. Other medical history included cardiac failure chronic, hepatic cancer, myocardial infarction, and brain tumour. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Jun2021, the patient received the first single dose of bnt162b2. On an unspecified date (2021), the patient experienced acute on chronic heart failure. On 03Jul2021, the patient was admitted to the hospital because of acute on chronic heart failure. On 12Jul2021 at 14:30 (the day of vaccination), the patient received the second single dose of bnt162b2. On 13Jul2021 at 05:45 (1 day after the vaccination), the patient experienced arteriosclerosis coronary artery. On 13Jul2021 around 05:55 (1 day after the vaccination), during patient rounds, cardio-respiratory arrest was noted. Cardiopulmonary resuscitation was immediately started but was unsuccessful, and on the same day at 13:00, the patient''s death was confirmed. The death causes were acute on chronic heart failure and arteriosclerosis coronary artery. No autopsy was performed. Treatment given for the adverse events was cardiopulmonary resuscitation. The reporting physician assessed the events as serious (death). The causality of the events was not reported.; Sender''s Comments: While the reported events may be intercurrent conditions, a possible contributory effect of suspect BNT162B2 on the events 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: cardio-respiratory arrest; Acute on chronic heart failure; Arteriosclerosis coronary artery


VAERS ID: 1511152 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021895808

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician via a company representative. The patient was an 80-year-old male. Underlying conditions included concurrent arrhythmia/cardiac failure. On an unknown date at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported). On an unknown date at unknown time (the day of vaccination), the patient received the second 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 an unknown date at unknown time (3 days after the second vaccination), the patient experienced cardiac failure. Three days after the second vaccination, the patient fell down while working on the farm and was transported. The outcome of the event was fatal. It was unknown if autopsy was done. The death cause was cardiac failure, and it can be considered that there was no causal relationship with BNT162b2.; Sender''s Comments: Based on the information currently available, the reported event cardiac failure likely intercurrent and not related to BNT162B2. The patient''s underlying condition arrhythmia/cardiac failure and the advanced age of the patient have been assessed to have played a contributory role toward the event.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1511157 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: Bypass surgery; Diabetes mellitus (treating with oral medication); Hypothyroidism; Myocardial infarction (after bypass surgery); Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021896265

Write-up: Cardio-respiratory arrest; Pulmonary oedema; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120049. An 83-years-old (reported as 83-year and 9-month-old) male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Arm Left (reported as left shoulder) on 11Jul2021 14:30 (Batch/Lot number was not reported) at age of 83-years-old as single dose for COVID-19 immunisation. Medical history included diabetes mellitus treating with oral medication, myocardial infarction from 2001 to an unknown date (20 years ago, after bypass surgery), hypothyroidism, prostate cancer, bypass surgery was performed 20 years ago for myocardial infarction. The family history was unknown. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on an unspecified date for COVID-19 immunisation. Body temperature before vaccination was not provided. The patient experienced pulmonary oedema on 11Jul2021 15:00, cardio-respiratory arrest on 13Jul2021. The course of the event was as follows: On 11Jul2021 at 14:30, the patient received the second dose of BNT162b2 vaccination in his left shoulder at the mass vaccination site of the citizen center. The patient was followed up for 30 minutes in the citizen center, and no particular abnormalities were observed, and thus, he went home. After the patient went home, he lay down saying that he felt sick. The wife living together had dementia, and she was not interested in her husband''s abnormal change. On 13Jul2021, at 19:00 (2 days after the vaccination), the patient was found to have cardio-respiratory arrest by his daughter in other household. At 21:00 (2 days after vaccination), an inquest was performed by the officer and the reporting physician. On 14Jul2021 (2 days after vaccination), an administrative autopsy was performed at the forensic medicine class of the university. The cause of death was pulmonary oedema. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were heart disease, diabetes mellitus, thyroid disease, and prostate cancer. The reporting physician commented as follows: As of this date, the causality between the cause of death and BNT162b2 vaccination was unassessable. The patient died on 14Jul2021. An autopsy was performed that revealed pulmonary oedema. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest; Pulmonary oedema; Autopsy-determined Cause(s) of Death: Pulmonary oedema


VAERS ID: 1511158 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood potassium, Cardio-respiratory arrest, PCO2, PO2, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Large intestine carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: BS; Result Unstructured Data: Test Result:46; Test Date: 20210710; Test Name: Lactate; Result Unstructured Data: Test Result:196.1; Test Date: 20210710; Test Name: K; Result Unstructured Data: Test Result:12.71; Test Date: 20210710; Test Name: PCO2; Result Unstructured Data: Test Result:error value; Test Date: 20210710; Test Name: pH; Result Unstructured Data: Test Result:error value; Test Date: 20210710; Test Name: PO2; Result Unstructured Data: Test Result:error value
CDC Split Type: JPPFIZER INC2021896292

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119722. A 85-years-old (reported as 85-year and 8-month-old) female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 09Jul2021 (Batch/Lot number was not reported) at age of 85-years-old as single dose for COVID-19 immunisation. Medical history included dementia Alzheimer''s type and large intestine carcinoma from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on an unspecified date in 2021 for COVID-19 immunisation. Body temperature before vaccination was not provided. The patient experienced cardio-respiratory arrest on 10Jul2021. The course of the event was as follows: On 10Jul2021, at around 05:00 (one day after vaccination), the patient was found to have cardio-respiratory arrest, and she was emergently transferred. Although a life-saving measure was performed, the patient did not respond, and she was confirmed to die. The arterial blood gas measurement showed that pH, PO2, and PCO2 were error values, K was 12.71, lactate was 196.1, and blood sugar (BS) was 46, which showed significant changes. An autopsy imaging was not desired, and thus, the obvious cause of death was difficult to be judged. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 was not provided. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient was an elderly, she had medical history of only dementia Alzheimer''s type. Other conditions were stable, and the patient was able to eat and drink, and take a bath until the previous day. It was considered that the causality between the event and COVID-19 vaccination could not be ruled out. The patient died on 10Jul2021. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1511160 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-13
   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: Angina on exercise; Aortic regurgitation; Diabetes mellitus; Gangrene; Haemodialysis; Insulin therapy; Renal failure chronic; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: Test Result:38-40 Centigrade; Comments: after vaccination; Test Date: 20210709; Test Name: Coronavirus antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC2021896549

Write-up: Pyrexia; Malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119781. A 53-year and 6-month-old male patient received BNT162b2 (COMIRNATY, Solution for injection) first dose via an unspecified route of administration On 09Jul2021 at 11:10 (the day of vaccination) at the age of 53-year-old (Lot number FC8736, Expiration date 30Sep2021) as single dose for COVID-19 immunisation. Body temperature before vaccination was 36.7 degrees centigrade. Family history was not reported. Medical history included renal failure chronic (on haemodialysis), angina on exercise (after stent placement), aortic regurgitation, diabetes mellitus (on insulin treatment), and foot gangrene. Concomitant medications were not reported. On 10Jul2021at 08:00 (1 day after the vaccination), the patient experienced pyrexia and malaise. On 13Jul2021 in the morning (4 days after the vaccination), the patient was found lying down at home. The course of the events was as follows, On the next day of the vaccination, the patient experienced pyrexia (38-40 degrees centigrade) and malaise. An antipyretic was prescribed, and the patient went home after haemodialysis. The course was unknown since the following day because nobody met the patient. On 13Jul2021 in the morning (4 days after the vaccination), the patient was found lying down at home and was confirmed dead. The reporting physician classified the events (pyrexia and malaise) as serious (medically significant) and assessed the causality between the events (pyrexia and malaise) and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases included the underlying conditions above. The reporting physician commented it was not conceivable that the vaccination was the direct cause of death. Although there were serious underlying diseases that could lead to sudden death, the causal relationship with the vaccination could not be denied completely. It was not reported if Autopsy Done. Coronavirus antigen test was negative on 09Jul2021. On 13Jul2021 (4 days after the vaccination), the outcome of the events was fatal.; Reported Cause(s) of Death: Pyrexia; Malaise


VAERS ID: 1511162 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agonal respiration, Arrhythmia, Body temperature, Loss of consciousness, Urinary incontinence, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Hypertension; Stent insertion NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021897842

Write-up: Ventricular fibrillation (Lethal arrhythmia); Ventricular fibrillation (Lethal arrhythmia); Urinary incontinence; lost consciousness; agonal respiration; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number is v21119732. The patient was a 69-year-old male. Body temperature before vaccination was 35.9 degrees Centigrade on 04Jul2021. Medical history included angina pectoris and hypertension. Concomitant medications were not reported. The patient had experienced rash caused by levofloxacin (500) before. The patient underwent stent insertion (the reporter was informed of that by the patient''s wife after he died). It was uncertain if the patient had family history. On 04Jul2021 at 09:30 (the day of vaccination) at age of 69 years old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jul2021 at 09:40 (10 minutes after the vaccination), the patient experienced Ventricular fibrillation (Lethal arrhythmia). On 04Jul2021 at 11:55 (2 hours and 25 minutes after the vaccination), the patient died. The course of the events was as follows: On 04Jul2021, after the vaccination, the patient collapsed from the chair in the observation room. (Urinary incontinence was noted.) He lost consciousness. The reporter let him lay down on his back and maintained the patient''s airway. However, he had agonal respiration. He had weak radial pulse, but carotid pulse was not confirmed. Chest compression and manual ventilation were started to be carried out. Adrenaline 1ml/1g was administered twice. AED monitor showed VF (ventricular fibrillation) and electric shock treatment was attempted twice, but he did not recover. Pulseless electrical activity led to asystole. Electric shock by AED was not given because of asystole. IV route was secured, and he was transferred to a hospital at 10:00. At 10:12, the ambulance arrived at a medical facility. At 11:55, the patient''s death was confirmed. The outcome of Ventricular fibrillation (Lethal arrhythmia) was fatal, others was unknown. The patient died on 04Jul2021. It was not reported if an autopsy was performed. The reporter classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Lethal arrhythmia was a possible cause of the event. The reporter commented as follows: The causal relationship was uncertain, but it might be indirectly related to BNT162b2.; Reported Cause(s) of Death: Ventricular fibrillation (Lethal arrhythmia); Ventricular fibrillation (Lethal arrhythmia)


VAERS ID: 1511185 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein increased, Cardio-respiratory arrest, Coma, Pneumonia, Vomiting, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: MICAMLO; PROTECADIN; SODIUM BICARBONATE; DIART [AZOSEMIDE]; ADALAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Dialysis; Lung cancer; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210706; Test Name: CRP; Result Unstructured Data: Test Result:43.65; Test Date: 20210706; Test Name: WBC; Result Unstructured Data: Test Result:7700
CDC Split Type: JPPFIZER INC2021901715

Write-up: cardio-respiratory arrest; coma state persisted; Pneumonia; vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution, and also received from the Regulatory Authority. Regulatory authority report number is v21119866 from the same physician. A 66-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 02Jul2021 09:55 at his 66-year-old (Lot Number: EW0203; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. Medical history included renal failure chronic (Dialysis), chronic obstructive pulmonary disease (Home oxygen) , after radiotherapy for lung cancer. Ongoing concomitant medication included telmisartan amlodipine besilate [MICAMLO BP Tablet] at 1 Tablet, laftidine [PROTECADIN 10 Tablet] at 0.5 Tablet, sodium bicarbonate [SODIUM BICARBOBATE 500 Tablet] at 1 tablet x2, azosemide [DIART 60 Tablet] at 2 tablet, and nifedipine [ADALAT-CR 20 Tablet] at 1 tablet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Historical Vaccine included first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were unknown) for COVID-19 immunisation, and no adverse reaction was observed. The patient was a 66-year and 10-month-old male. On 02Jul2021 (the day of the vaccination), the patient experienced pneumonia. The event resulted in death. The outcome of the event was fatal with treatment including treatment with an antibiotic. The reporting physician assessed the event as serious (death). The cause of death was pneumonia. The patient died on 11Jul2021. Autopsy was not performed. It was reported that patient experience vomiting on Jul2021 with outcome of unknown , cardio-respiratory arrest and coma state persisted on 11Jul2021 with outcome of unknown. Therapeutic measures were taken as a result of all events. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 36.2 centigrade on 02Jul2021 Before vaccination, c-reactive protein increased: 43.65 on 06Jul2021, white blood cell count: 7700 on 06Jul2021. The course of the event was as follows: On 02Jul2021 (the day of vaccination), after the patient received the second dose of BNT162b2 vaccination, he had general malaise and dyspnoea. On 05Jul2021 (2 days, 14 hours, and 15 minutes after vaccination), the general malaise persisted, and no pyrexia was note. The blood examination was performed. On 06Jul2021 (3 days, 14 hours, and 15 minutes after vaccination), the results of the blood examination showed WBC of 7700 and CRP of 43.65, which showed high inflammatory reaction. The patient was referred to and was emergently admitted to another hospital. The patient was diagnosed with pneumonia, and the treatment with an antibiotic was initiated. Although the inflammatory reaction tended to improve, the patient repeatedly had vomiting. On 11Jul2021 (8 days, 14 hours, and 15 minutes after vaccination), in the morning, the patient had cardio-respiratory arrest after vomiting. Although the patient temporarily recovered with resuscitative measures, the coma state persisted. On the same day, at 17:42 (9 days, 7 hours, and 57 minutes after vaccination), the patient died. The reporting physician classified the pneumonia 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 not provided. ; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1511187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021901723

Write-up: Pyrexia; Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 73-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included lung cancer. The patient''s concomitant medications were not reported. The reason for unknown lot number was unable to locate or read the details. The patient experienced death on 14Jul2021 , pyrexia on 13Jul2021 with outcome of unknown. The patient was hospitalized for pyrexia from 14Jul2021 to 14Jul2021. Therapeutic measures were taken as a result of both event. The patient died on 14Jul2021. The clinical course was reported as follows: On 13Jul2021 (one day after vaccination), the patient experienced pyrexia. On 14Jul2021 (2 days after vaccination), the patient was admitted to the hospital. On the same day, in the afternoon, the patient died due to a sudden change, although life-saving measure was provide as treatment. No autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the limited information given, a causal association between the events "death", "fever" and bnt162b2 (COMIRNATY) cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1511228 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-12
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Malaise, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (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), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Arrhythmia; Pneumothorax
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: pyrexia in the 38 degrees Celsius range; Test Date: 2021; Test Name: SARS-COV-2 antigen test; Test Result: Negative ; Result Unstructured Data: nasopharyngeal swab was negative
CDC Split Type: JPTAKEDA2021TJP062969

Write-up: Injection site pain; Swelling; Generalized malaise; Cardio-respiratory arrest; Pyrexia; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Arrhythmia and Pneumothorax. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Pyrexia) (seriousness criterion death). On 13-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain) (seriousness criterion death), SWELLING (Swelling) (seriousness criterion death) and MALAISE (Generalized malaise) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Vaccination site pain, Swelling, Cardio-respiratory arrest, Pyrexia and General malaise. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) nasopharyngeal swab was negative. On 12-Jul-2021, Body temperature: 38 degrees celsius (High) pyrexia in the 38 degrees Celsius range. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter considered CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), VACCINATION SITE PAIN (Injection site pain), SWELLING (Swelling), MALAISE (Generalized malaise) and PYREXIA (Pyrexia) to be possibly related. After death, CT scan showed no findings of imaging abnormalities leading to death. No relevant concomitant medications were reported. No treatment information was provided. Case comment/sender''s comment: Since the patient had been in cardiac arrest for a long time at the time of the visit, sufficient examination could not be performed, and the apparent cause of death was unknown. It was considered that the possibility of vaccine-related death could not be ruled out in view of the sudden death of the young adult with no particular medical history and the occurrence of accompanying symptoms after the 2nd vaccination, followed by cardio-respiratory arrest. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Worldwide unique case identification number: 2021TJP062969; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Vaccination site pain; Swelling; Cardio-respiratory arrest; Pyrexia; General malaise


VAERS ID: 1511307 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Interchange of vaccine products
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), Medication errors (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021890414

Write-up: Cardiac arrest; Interchange of vaccine products; This is a spontaneous report from a contactable health professional downloaded from Regulatory Authority. (Regulatory Authority report number: NL-LRB-00598687). A 67-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: FC5089; Expiration date was not reported) on 24Jun2021 as dose 2, 0.3 mL, single, with route of administration unspecified, for COVID-19 immunization; and the first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have a previous COVID-19 infection. On 24Jun2021, the patient had received BNT162B2 (COMIRNATY) as the second dose; when the first dose was with covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) (interchange of vaccine products). On 24Jun2021, the patient had cardiac arrest following the administration of BNT162B2. The patient had died on 24Jun2021 due to cardiac arrest. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1511334 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Foetal exposure during pregnancy
SMQs:, Congenital and neonatal arrhythmias (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100949716

Write-up: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a fetus report. The mother report is a report downloaded from the Regulatory Authority NL-LRB-00616253. A fetus received BNT162B2 (COMIRNATY) dose 1 transplacental on 04Jul2021 (Batch/Lot Number: FE1573) as dose 1, single for covid-19 immunisation when patient mother had pregnant duration of 7 weeks and 3 days. The patient medical history and concomitant medications were not reported. The patient heart stopped shortly after vaccination on 06Jul2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021895854 mother/child case; Reported Cause(s) of Death: Heart stopped shortly after vaccination; received BNT162B2 (COMIRNATY) dose 1 transplacental


VAERS ID: 1511348 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021898383

Write-up: Loss of consciousness; Seizure; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300089813. A 67-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (Lot Number: FD5996) at 67 years old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loss of consciousness (death) on 01Jul2021 08:00, seizure (death) on 01Jul2021 08:00. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness; Seizure


VAERS ID: 1511349 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021898505

Write-up: body malaise; Dizziness; Headache; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory authority report number PH-PHFDA-300089917. A 69-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular on 28Jun2021 (at the age of 69years) as dose number unknown, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 02Jul2021, the patient experienced dizziness and headache. On an unspecified date, the patient experienced body malaise. The outcome of events dizziness and headache was fatal; outcome of body malaise was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dizziness; Headache


VAERS ID: 1511430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / 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: 2021-06-09
   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: TRIPLIXAM; NOLET; LIPANTHYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (second degree); Hypercholesterolemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100933255

Write-up: Sudden death; This is a spontaneous report from a contactable consumer (wife of patient) received from the Regulatory Authority-WEB, regulatory authority number RO-NMA-2021-SPCOV11955. A 50-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route of administration on 08Jun2021, as dose 2, single for COVID-19 immunisation. The patient''s medical history included second degree arterial hypertension and hypercholesterolaemia. Concomitant medications included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM) taken for arterial hypertension from 13Jan2020 to 09Jun2021; nebivolol (NOLET) taken for arterial hypertension from 13Jan2020 to 09Jun2021; fenofibrate (LIPANTHYL) taken for hypercholesterolaemia from 13Jan2020 to 09Jun2021. The patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EY2172), via intramuscular route of administration on 08May2021, as single dose for COVID-19 immunisation. On 09Jun2021, 1 day after the administration of second dose of vaccine, the patient experienced sudden death. It was not reported if an autopsy was performed. It was reported that during the next day after receiving the second dose of the Comirnaty vaccine, the patient experienced sudden death. The reporter noted that the event occurred instantaneously. The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. No result from the necropsy available in the present report. No other details available regarding this case. The clinical outcome of the event was reported as fatal. No follow-up attempts are possible. No further information expected. Information on 2nd dose batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : RO-NMA-2021-SPCOV11983 NMA; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1511435 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Myocardial infarction, Vaccination site pain
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), Cardiomyopathy (broad), Respiratory failure (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 INC2021895944

Write-up: HEART STOP; heart attack; PAIN AT THE VACCINATION SITE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-057296. This is the first of two reports for the same patient and it refers to the second dose of Comirnaty. A 66-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Jun2021 (Lot Number: EW6326), at the age of 66-years-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the man had pain in his arm for a couple of days even after the first dose. The second dose was given in Jun2021. Reported suspected side effects were pain at the vaccination site on the same day as the vaccination (Jun2021) and cardiac arrest approximately two weeks later. The patient experienced heart stop and heart attack in Jun2021. The events were reported as serious (death). The outcome of the event pain at the vaccination site was unknown. The outcome of the other events was fatal. The reporter stated that the man, according to doctors, died of a heart attack. Autopsy performed on unknown date and results were not provided. Procedure: Fatal. The case was judged to be serious, death. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021908347 Same reporter/patient/product, different dose/event; Reported Cause(s) of Death: heart attack


VAERS ID: 1511451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-23
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 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: Cerebral embolism (Previous event, date missing); Myocardial infarct (Previous event, date missing)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100940044

Write-up: CEREBRAL HAEMORRHAGE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-061918. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Apr2021, as single dose (Lot Number: ET7205) for covid-19 immunisation. Medical history included myocardial infarction and cerebral embolism (previous event, date missing) from an unspecific date and not ongoing. According to the reporter the patient medical history was more extensive, but no more details about other illnesses were provided. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021, as single dose (Lot number: EP2166) for covid-19 immunisation. The patient experienced cerebral haemorrhage on 23May2021 and had an onset of approximately 7 weeks and caused the patient death after some time in 2021. The outcome of event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1512092 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIAGLUCIDE; GLUCOPHAGE [METFORMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021892166

Write-up: Shortness of breath; Body aches; Died; This is a spontaneous report from a contactable other healthcare professional. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 11Jun2021 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date. Concomitant medication included gliclazide (DIAGLUCIDE) and metformin (GLUCOPHAGE) both taken for diabetes mellitus, start and stop date were not reported. On 23Jun2021, the patient experienced shortness of breath and body aches which led to hospitalization on 24Jun2021 and with an unknown outcome. The patient was reported to have died on 27Jun2021. It was not reported if an autopsy was performed. 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 events "death, dyspnoea and pain" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Died


VAERS ID: 1512109 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210756365

Write-up: RESPIRATORY CARDIAC ARREST; This spontaneous report received from a health care professional concerned an 18 year old male patient. 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 not reported, batch number: Unknown and Expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the patient suffered respiratory cardiac arrest and died. Legal medicine has not provided autopsy reports but family suspected that this might be related to the application of the vaccine. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine was not applicable. The patient died of respiratory cardiac arrest. This report was serious (Death). Sender''s Comments: V0: 20210756365-covid-19 vaccine. Respiratory cardiac arrest. 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: RESPIRATORY CARDIAC ARREST


VAERS ID: 1512126 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Diabetes.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Suddenly died at night after 11 days from the second dose. At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021 in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 01-May-2021. The reported cause of death was died suddenly at night after 11 days from the second dose to the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. second dose 05/31/2021.... It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received on 26 Jul 2021 included updates to patient''s medical history.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per IME list; Reported Cause(s) of Death: Suddenly died at night after 11 days from the second dose At the first dose diarrhea after 5 days and then dry but suffocating cough, unresponsive to antibiotic. Second dose taken on 05/31/2021.


VAERS ID: 1512142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: CLOPIDOGREL; SPIRONOLACTONE; METOPROLOL; ESOMEPRAZOLE; HYDROCHLOROTHIAZIDE; APIXABAN; ATORVASTATINE [ATORVASTATIN]; LANOXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210750739

Write-up: MR. DIED; This spontaneous report received from a physician via a Regulatory Authority [NL-LRB-00628059] concerned a 66 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 dosage forms, 1 total, administered on 06-JUL-2021 for covid-19 immunisation. Concomitant medications included apixaban, atorvastatin, clopidogrel, digoxin, esomeprazole, hydrochlorothiazide, metoprolol, and spironolactone. On 14-JUL-2021, the patient died from sudden cardiac death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210750739-covid-19 vaccine ad26.cov2.s -Mr. died. 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: SUDDEN CARDIAC DEATH


VAERS ID: 1512149 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Stroke; Urinary tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by an other and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stroke, Diabetes and Urinary tract infection. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Change of consciousness) (seriousness criteria death and medically significant). The patient died on 02-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided. Treatment information was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown


VAERS ID: 1512158 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 12-Jul-2021 The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Sender''s Comments: This is a case of sudden death of a 73yo F who died 4 days after receiving vaccine. Very limited information regarding the event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1512159 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Heart rate
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: Chronic obstructive pulmonary disease; Hypertension (Hypertension with Losartan control); Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control)
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (Stage IV with left side pleural effusi)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: BP; Result Unstructured Data: BP 158/91mmH; Test Date: 20210710; Test Name: body temperature; Test Date: 20210710; Test Name: heart rate
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (death) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lung cancer (Stage IV with left side pleural effusi). Concurrent medical conditions included Hypertension (Hypertension with Losartan control), Type 2 diabetes mellitus (Type 2 diabetes mellitus with Glibudon control) and Chronic obstructive pulmonary disease. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date 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 10-Jul-2021, Blood pressure measurement: (High) BP 158/91mmH. On 10-Jul-2021, Body temperature: 37.4. On 10-Jul-2021, Heart rate: 140. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Heart Rate 140 falling outside ER, initial rhythm bradycardia, no pulse. Company Comment This is a case of sudden death in a male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a male of unknown age with medical hx of stage 4 lung cancer, DM, HTN, and COPD, who died on unknown date after receiving the first dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: unknown cuase of death


VAERS ID: 1512222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cognitive disorder, Concomitant disease aggravated, Decreased appetite, Inappropriate schedule of product administration, Lethargy
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021894521

Write-up: 6 days (second dose), 65 days (first dose); Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 581649. A 60-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy on 24Jun2021 (onset 6 days (second dose), 65 days (first dose)). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cognitive disorder; Concomitant disease aggravated; Decreased appetite; Lethargy


VAERS ID: 1513233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident, Coma, Computerised tomogram, Diarrhoea, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: MELOXICAM; OMEPRAZOLE; LEDERTREXATE [METHOTREXATE]; SIMPONI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis; Rheumatism
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: ct scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: BEPFIZER INC202100932163

Write-up: artificial coma; Cerebral hemorrhage; Sepsis; Cerebral thrombosis; CVA; high fever; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-101066. A 51-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 25Jun2021 (Lot Number: Fe2090) as Dose 2, single for covid-19 immunisation. Medical history included psoriasis and rheumatism. Concomitant medications included meloxicam; omeprazole; methotrexate (LEDERTREXATE); golimumab (SIMPONI). The patient developed Cerebral thrombosis and CVA on 09Jul2021, Fever, Vomiting and Diarrhea on 07Jul2021, Coma, Cerebral hemorrhage, and Sepsis on unknown date. Treatment included Blood thinners and blood clot removal by interventional radiologist, artificial coma. Situations - Other: Immunosuppressant and Vaccine Combination. Examinations included Blood analysis, and CT scan. The outcome of the events was death. The patient died on 11Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Yes Blood thinners and blood clot removal by interventional radiologist, artificial coma Evolution of the ADR - death Situations - Other: Immunosuppressant and Vaccine Combination Examinations - Blood analysis, ct scan; Reported Cause(s) of Death: CVA; Fever; Vomiting; Diarrhea; Coma; Cerebral hemorrhage; Sepsis; Cerebral thrombosis


VAERS ID: 1513282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood creatine, Blood creatine phosphokinase MB, Blood glucose, Blood urea, C-reactive protein, Cardiac failure acute, Dyspnoea, Epistaxis, Fatigue, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypotension, N-terminal prohormone brain natriuretic peptide, Platelet count, Red blood cell count, Respiratory rate, Troponin T, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Arthritis (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ZOPICLONE; APIXABAN
Current Illness: Aortic aneurysm; Aortic valve insufficiency; Cardiac insufficiency; Chronic ischemic heart disease, unspecified; Hypertensive heart disease; Left ventricular failure
Preexisting Conditions: Medical History/Concurrent Conditions: TAVI
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Creatine; Result Unstructured Data: Test Result:213 umol/l; Test Date: 20210616; Test Name: CK-MB; Result Unstructured Data: Test Result:9.46 ug/L; Test Date: 20210616; Test Name: Fasting blood glucose; Result Unstructured Data: Test Result:8.8 mmol/L; Test Date: 20210616; Test Name: Urea; Result Unstructured Data: Test Result:7.3 mmol/L; Test Date: 20210616; Test Name: C-reactive protein; Result Unstructured Data: Test Result:23 mg/ml; Test Date: 20210616; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:0.83 mg/l; Test Date: 20210616; Test Name: Estimated GFR; Result Unstructured Data: Test Result:26; Comments: Units:mL/min/{1.73_m2}; Test Date: 20210616; Test Name: Hematocrit; Test Result: 33 %; Comments: Units:{ratio}; Test Date: 20210616; Test Name: Hemoglobin; Result Unstructured Data: Test Result:101 g/l; Test Date: 20210616; Test Name: NT-proBNP; Result Unstructured Data: Test Result:7327 ng/L; Test Date: 20210616; Test Name: Platelet count; Result Unstructured Data: Test Result:283 x10 9/l; Test Date: 20210616; Test Name: RBC count; Result Unstructured Data: Test Result:3.4 x10 12/l; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:on arrival at normal; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:122/81; Comments: Respiratory rate 122/81, frequency 129 x min; Test Date: 20210616; Test Name: Respiratory rate; Result Unstructured Data: Test Result:69/44; Comments: At 11:32 - Respiratory rate 69/44, frequency 109 x min; Test Date: 20210616; Test Name: Troponin T; Result Unstructured Data: Test Result:108.2 ng/L; Test Date: 20210616; Test Name: WBC count; Result Unstructured Data: Test Result:11.3 x10 9/l
CDC Split Type: EEPFIZER INC202100932399

Write-up: Acute decompensated heart failure; Hypotension; Fatigue; Arthralgia; Dyspnoea; Asthenia; Epistaxis; This is a spontaneous report from a contactable consumer (patient''s relative), downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-438621070521. This spontaneous case report from patient''s relative concerns a 70-year-old male patient who experienced adverse reactions after vaccination with COVID-19 mRNA vaccine. The patient was vaccinated with the second dose of Comirnaty vaccine (lot number FC8889) on 02Jun2021 (age at vaccination unspecified). One week later developed nosebleeds, weakness and tiredness, pain in the knees, difficulty breathing, very low blood pressure. The side effects did not go away, rather the patient felt weaker and weaker. On the morning of 16Jun2021, an ambulance was called and around the same day at noon the patient died in hospital. The patient had previously had an transcatheter aortic valve implantation on 14May2021, which was successful and the patient recovered very quickly after the operation and felt great. The patient was taking allopurinol, apixaban, zopiclone. Anamnesis. On 16Jun2021 08:54, the patient was brought by an ambulance: had heart palpitations for 3 days, shortness of breath, dyspnoea 30 x min. Upon arrival, the patient does not complain of pain, later begins to complain of pain in the right and left sides of the upper abdomen. Respiratory rate on arrival at normal, tachyfrequent. While in the emergency room, breathing became rumbling, on the right side of the lung crackles, respiratory rate decreased, the patient was covered with cold sweat. Asystole occured. Resuscitation was started + cardiac massage. Upon arrival of the anesthesiologist, the patient was intubated, subcutaneous Adrenaline 1 mg x 3, subcutaneous NaBic 8.4% 100.0 was administered. Restored sinus rhythm - after 10 min. Respiratory rate 122/81, frequency 129 x min. At 11:32 - Respiratory rate 69/44, frequency 109 x min. subcutaneous Atropin 1 mg, subcutaneous Adrenaline 2 mg was administered by an anesthesiologist. No respiratory rate, cardiac arrest. Circulation was not restored despite vasopressors and controlled breathing. Lethal outcome at 11:50. Underlying disease: heart failure, left ventricular failure. Concomitant conditions: hypertensive heart disease, chronic ischemic heart disease, aortic (valve) insufficiency; aortic aneurysm, presence of a heart valve prosthesis. Analyses on 16Jun2021: CK-Mbm 9.46 microg/l; CRP 23 mg/ml; D-dimers 0.83 mg/l; eGFR 26 ml/min/1.73 m2; fasting glucose serum/plasma 8.8 mmol/l; WBC 11.3*E9/l; RBC 3.4*E12/l; Hb 101 g/l; Hct 33%; Plt 283*E9/l; creatine 213 umol/l; Nt-proBNP 7327 ng/l; troponin T (hypersensitive) 108.2 ng/l; urea 7.3 mmol/l. On 09Jul2021 additional information from patient''s general practitioner. Cause of death: heart failure, left ventricular failure. Time Interval between Beginning of Drug Administration and Start of Reaction: 1 week for events: Hypotension, Fatigue, arthralgia, Dyspnoea, Asthenia, Epistaxis; 2 weeks for events: Acute decompensated heart failure, Death Sender Comment: Serious side effects, not listed. The causal relationship is considered doubtful because no autopsy was performed and the exact cause of cardiogenic shock is unknown. The patient also has a long-term heart disease, which better explains the decompensation of his heart failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Left ventricular failure; Heart failure


VAERS ID: 1513326 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Computerised tomogram head, Haemorrhagic stroke, SARS-CoV-2 test
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: 2021-07-13
   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: ADENURIC; CANDESARTAN CILEXETIL; LERCANIDIPINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: blood pressure; Result Unstructured Data: Test Result:157/78 mmHg; Test Date: 20210703; Test Name: cerebral CT; Result Unstructured Data: Test Result:objectifying a hematoma of the brainstem; Comments: with edema of 33x19mm in the axial plane, and 28mm in height, extended to the midbrain, the left cerebral peduncle and the left cerebral hemisphere.; Test Name: PCR COVID-19; Test Result: Negative
CDC Split Type: FRPFIZER INC202100932169

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20212038. A 44-year-old male patient received the 2nd dose of BNT162B2 (COMIRNATY, lot number: unknown) intramuscular on 03Jul2021 at age of 44 years old as single dose for COVID-19 immunisation. Medical history included hypertension arterial. The patient had no history of COVID-19. PCR COVID-19 negative. Concomitant medications included febuxostat (ADENURIC), candesartan cilexetil, lercanidipine HCL. The patient experienced hemorrhagic stroke on 03Jul2021. In the evening of the same day, altered consciousness with malaise, preceded by speech disturbances and facial paralysis. When help arrived, Glasgow 6, mydriasis on the left, miosis on the right. Orotracheal sedation and intubation. Persistent hypertension (blood pressure figures not provided), requiring 3 boluses of LOXEN. Blood pressure to 157 / 78mmHg thereafter. Hospitalization and performance of a cerebral computed tomography, objectifying a hematoma of the brainstem with edema of 33x19mm in the axial plane, and 28mm in height, extended to the midbrain, the left cerebral peduncle and the left cerebral hemisphere. No sign of engagement, no image of arterial addition suggesting an aneurysm. No surgical indication retained in this context of hemorrhagic stroke. Stop sedations on 05Jul2021. Glasgow at 4 on 08Jul. Evolution marked by Pneumopathy acquired under mechanical ventilation on 09Jul2021. Faced with the lack of improvement after stopping sedations, limiting and stopping active therapies on 12Jul2021. Death on 13Jul2021. In total, hemorrhagic stroke occurred on the same day as a 2nd dose of BNT162B2 vaccine on hypertensive flare, patient died on D + 10. It was unknown if autopsy was performed. The patient died on 13Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1513328 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Inappropriate schedule of product administration, Malaise, Myalgia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100932121

Write-up: Malaise; Death NOS; drowsiness; Chills; Fatigue; muscle pain; joint pain; First dose of bnt162b2 on 24May2021/ Second dose of bnt162b2 on 08Jul2021; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB FR-AFSSAPS-CF20212056. The reporter was report for the mother. A 71-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FC3558), second dose intramuscular on 08Jul2021 at the age of 71-year-old as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FE 1248) on 24May2021 for covid-19 immunization. The patient didn''t have long-term illness. The patient had no history of drug allergy. The patient experienced death nos on 12Jul2021, drowsiness, chills, fatigue, muscle pain, joint pain all on 08Jul2021, malaise on an unspecified date. The events were reported as serious per hospitalization. The mother died on 12Jul2021. From 08Jul2021 to 11Jul2021 chills, fatigue, muscle pain, joint pain, drowsiness. Death on 12Jul2021. Malaise on an unspecified date. The patient went to medical consultation. The patient died on 12Jul2021. It was not reported if an autopsy was performed. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1513330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-05-27
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, C-reactive protein, COVID-19, Culture stool, Diarrhoea, Fall, Glomerular filtration rate, Haemoglobin, Heart rate, Hyperhidrosis, Investigation, Oxygen saturation, Pain, Physical examination, Platelet count, SARS-CoV-2 test, Scan brain, Vaccination failure, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; DEXERYL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE;GUAIFENESIN;PHENYLEPHRINE HYDROCHLORID; INNOHEP; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NEO-MERCAZOLE; NORMACOL [SODIUM PHOSPH
Current Illness: Bipolar disorder (Manic-depressive illness (several hospitalizations in psychiatry)); Chronic renal failure (Chronic renal failure); Chronic venous insufficiency; Cyst ovary; Deafness (paired on the right); Dementia (Beginning neurocognitive disorders with probable vascular etiology); Elephantiasis; Essential hypertension (primitive); Lumbar spinal stenosis (level L4-L5 with history of sciatica); Uterine fibroid
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract (processed); Cholecystectomy; Constipation; Faecaloma; Hip prosthesis insertion; Inguinal hernia repair; Retention urinary (on fecal impaction (Indwelling urinary catheters removal)); Senile macular degeneration (Very disabling senile (atrophic) (exudative) macular degeneration); Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Creatinine; Result Unstructured Data: Test Result:326 umol/l; Comments: there is end-stage renal failure with creatinine at 326 umol/l; Test Date: 20210601; Test Name: serum potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:9/5; Test Date: 20210601; Test Name: CRP; Result Unstructured Data: Test Result:100 mg/l; Test Date: 2021; Test Name: stool culture; Result Unstructured Data: Test Result:absence of clostridium; Comments: Note the absence of clostridium in the stool culture; Test Date: 20210601; Test Name: GFR; Result Unstructured Data: Test Result:10 ml/min; Test Date: 20210601; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.4 g/dl; Test Date: 20210601; Test Name: pulse; Result Unstructured Data: Test Result:89; Comments: pulse 89 bpm; Test Date: 20210601; Test Name: serum content; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210528; Test Name: saturation; Test Result: 94 %; Test Date: 20210601; Test Name: saturation; Test Result: 97 %; Test Date: 20210601; Test Name: Physical examination; Result Unstructured Data: Test Result:does not present dyspnea; Comments: The patient does not present dyspnea and the pulmonary auscultation is unremarkable. She has mucus and smelly diarrhea.; Test Date: 20210601; Test Name: platelets; Result Unstructured Data: Test Result:273,000 /mm3; Test Date: 20210521; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210528; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Detection of the Spike N501Y mutation. Profile compatible with the English variant 501Y.V1.; Test Date: 20210601; Test Name: brain scan; Result Unstructured Data: Test Result:unremarkable; Comments: The brain scan performed in the hospital is unremarkable.; Test Date: 20210601; Test Name: leukocytes; Result Unstructured Data: Test Result:19,340 /mm3
CDC Split Type: FRPFIZER INC202100915606

Write-up: fall of mechanical origin; painful; sweats a lot; mucus and smelly diarrhea; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-DJ20212547. Verbatim: Statement from an ARS doctor in the context of a cluster of vaccine failures in nursing homes. Related cases: DJ20212545; DJ20212542; DJ20212584; DJ20212580; DJ20212572; DJ20212569; DJ20212564; DJ20212561; DJ20212559; DJ20212554; DJ20212551. A 97-years-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: EK9788; Expiration Date: 31May2021), via intramuscular route on 17Feb2021 as dose 2, single and received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: EJ6788; Expiration Date: 30Apr2021), via intramuscular route on 27Jan2021, as dose 1, single for covid-19 immunization. Medical history included Dementia: Beginning neurocognitive disorders with a probable vascular etiology, Senile (atrophic) (exudative) macular degeneration very debilitating, retention urinary (Urine retention on fecaloma (Indwelling urinary catheterization removal), Constipation and fecaloma, Chronic venous insufficiency with elephantiasis, chronic renal failure, Uterine fibroid, Cholecystectomy, Bipolar disorder (Manic-depressive illness (several hospitalizations in psychiatry), Cataract treatment, Primary essential hypertension, Hip prosthesis insertion, ovarian cyst, right-sided deafness, Lumbar spinal stenosis (Narrowing of the medullary canal in the lumbar region (level L4-L5 with history of sciatica), Treatment of a groin hernia (Inguinal hernia repair) and Varicose vein surgery. Concomitant medications included alprazolam (Strength: 0.25 mg, dose: 1 / -1 / 2-1); chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (DEXERYL); tinzaparin sodium (INNOHEP, Strength: 10000/0.5 mL, dose: 5000 iU, 1x/day in the evening); macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); carbimazole (NEO-MERCAZOLE, Strength: 5 mg, dose: 1 DF, 2x/day 1-0-1); sodium phosphate dibasic, sodium phosphate dibasic dodecahydrate (NORMACOL); morphine sulfate (ORAMORPH); paracetamol; ferrous sulfate (TARDYFERON, strength: 80 mg, 1 DF, 1x/day 0-1-0); lithium carbonate (TERALITHE, Strength: 400 mg, dose: 1 DF, 1x/day 0-0-1) and acebutolol (Strength: 200 mg, dose: 0.5 DF, 1x/day 0-0-1/2), all taken for unspecified indications, start and stop dates were not reported. On 27May2021, the patient fall of mechanical origin at her daughter''s place and the patient was transported to hospital. There was a fracture of the pelvis according to the emergency doctor with instructions not to take support for 15 days. The seriousness criteria captured as hospitalization. On 28May2021, the patient underwent a COVID-19 RT-PCR test which was positive (significant viral shedding). Detection of the Spike N501Y mutation. Profile compatible with the English variant 501Y.V1 (Vaccination failure). Clinically, pulmonary auscultation was unremarkable and 94% SaO2. COVID-19 isolation was done. On 31May2021, the patient was prostrate in her bed in opposition, she refused to eat, drink and take her treatments. On 01Jun2021, in the morning, the patient was not very reactive and her blood pressure was 9/5, pulse 89 bpm, SPO2 97%. The patient did not present dyspnea and the pulmonary auscultation was unremarkable. The brain scan performed in the hospital was unremarkable. She had mucus and smelly diarrhea. Biology showed hemoglobin at 8.4 g / dl, leukocytes at 19,340 / mm3, CRP was at 100 mg/l, platelets at 273,000/mm3, there was end-stage renal failure with creatinine at 326 umol/l and a GFR at 10 ml / min. The serum content is 139 mmol / l and the serum potassium 4.3 mmol / l. When her daughters were present, the patient managed to swallow, she drinks little. She agreed with her daughters on palliative care at the EHPAD and no hospitalization. Oral treatments were stopped except alprazolam as well as HBPM (clearance). The patient was infused with G5%. On 02Jun2021, the patient was painful during treatment and sweats a lot (suspected to be withdrawal from treatment), prompting the prescription of 2 drops of ORAMORPH before treatment and if necessary, every 4 hours. On 03Jun2021, the patient''s death was noted. Note the absence of clostridium in the stool culture. In total, 97-year-old patient who presented with a confirmed vaccine failure with the detection of the English variant in the RT-PCR test on D100 of a 2nd dose of COMIRNATY vaccine and who might have played a role in the patient''s death. The patient also underwent COVID-19 RT-PCR test on 21May2021, which case out to be negative. The outcome of the events: COVID-19 and vaccination failure were fatal and the outcome of rest of the events was unknown. Investigation conclusion: (Lot number: EK9788, Expiration Date: 31May2021) Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100915615 same reporter. different patient;FR-PFIZER INC-202100915619 same reporter. different patient;FR-PFIZER INC-202100921915 same patient, different dose, different events;FR-PFIZER INC-202100915193 Same reporter, different patient;FR-PFIZER INC-202100915253 Same reporter, different patient;FR-PFIZER INC-202100915233 Same reporter, different patient;FR-PFIZER INC-202100915226 Same reporter, different patient;FR-PFIZER INC-202100915221 Same reporter, different patient;FR-PFIZER INC-202100915870 Same reporter, different patient;FR-PFIZER INC-202100915259 Same reporter, different patient;FR-PFIZER INC-202100915861 Same reporter, different patient;FR-PFIZER INC-202100915239 Same reporter, different patient; Reported Cause(s) of Death: COVID-19


VAERS ID: 1513558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-07-11
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-29
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: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900255

Write-up: Sudden death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107141750038190-M84YD, and Safety Report Unique Identifier is GB-MHRA-ADR 25650882. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (batch/lot number: not known) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unsure if patient is enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The patient experienced sudden death on 11Jul2021 with outcome of fatal. The event was considered serious (fatal). The patient died on 11Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1513717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; EMPAGLIFLOZIN; NITROLINGUAL; RISPERIDONE; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906787

Write-up: Heart attack; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA).The regulatory authority report number is GB-MHRA-WEBCOVID-202107151400228600-UZ7JG Safety Report Unique Identifier GB-MHRA-ADR 25656841. The 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included allopurinol (ALLOPURINOL); empagliflozin (EMPAGLIFLOZIN); glyceryl trinitrate (NITROLINGUAL); risperidone (RISPERIDONE); sertraline (SERTRALINE). Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced heart attack on an unspecified date. On 15May2021 the patient died. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included Covid-19 virus test and results showed negative on No - Negative COVID-19 test. No follow-up attempts are possible, Information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1513830 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100918442

Write-up: Maternal exposure during pregnancy; passed fetus; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151745184040-DBXBI, Safety Report Unique Identifier GB-MHRA-ADR 25658593. This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via transplacental on 20Jun2021 (Lot Number: FC8289) as single dose for COVID-19 immunisation. The patient medical history included folic acid supplementation. The patient''s mother was 34-year-old female who received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FC8289) on 20Jun2021 for COVID-19 immunisation. The mother''s medical history included pregnancy and folic acid supplementation. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced passed fetus in 2021 and maternal exposure during pregnancy on 20Jun2021. Patient was exposed to the medicine first-trimester (1-12 weeks). The case was reported as serious due to other medically important condition. The patient died in 2021. It was not reported if an autopsy was performed. Outcome of events was fatal. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021906841 maternal case; Reported Cause(s) of Death: Maternal exposure during pregnancy; passed fetus


VAERS ID: 1513849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-20
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100932182

Write-up: Ischaemia cerebral; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number GR-GREOF-20216008. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced ischaemia cerebral (death, medically significant) on 20Jun2021. The patient died on 24Jun2021. Outcome of the event was fatal. 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: ischaemia cerebral


VAERS ID: 1513850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cerebrovascular accident
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100932198

Write-up: cardiac arrest; Stroke; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number GR-GREOF-20216011. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 11Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced stroke on 23Apr2021, cardiac arrest on an unknown date. The patient died on 28Apr2021. This report assessed as serious, medically significant and caused death. 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: Cardiac arrest; stroke


VAERS ID: 1513873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100962750

Write-up: brain hemorrhage; This is a spontaneous report from a contactable physician through another manufacturer (Bayer). The physician reported similar events for two patients. This is the first of two reports. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization and rivaroxaban (XARELTO), via an unspecified route of administration from an unspecified date for about 6 months (Batch/Lot number was not reported) to an unspecified date, at 20 mg for atrial fibrillation. Relevant medical history included atrial fibrillation from an unknown date. The patient''s concomitant medications were not reported. The patient received his rivaroxaban dose, and on that day 6 hours later got vaccinated with the first dose of bnt162b2. On an unknown date the patient experienced brain haemorrhage and passed away. The action taken with rivaroxaban was not applicable. The patient died on an unknown date. The cause of death was brain haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The association between the event fatal brain hemorrhage with COMIRNATY use can not be fully excluded based on the limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GR-PFIZER INC-202100965567 same reporter, drug,event, different patient; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1513874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100965567

Write-up: brain hemorrhage; This is a spontaneous report from a contactable physician through another manufacturer. The physician reported similar events for two patients. This is the second of two reports. An 80-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as Dose 2, single for COVID-19 immunization and rivaroxaban (XARELTO), via an unspecified route of administration from an unspecified date for about 2 years (Batch/Lot number was not reported), at 20 mg for atrial fibrillation. Relevant medical history included atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unknown date for COVID-19 immunization. The patient received his rivaroxaban dose, and 12 hours later got vaccinated with the second dose. On an unknown date the patient experienced brain haemorrhage and passed away. The action taken with rivaroxaban was not applicable. The patient died on an unknown date. The cause of death was brain haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The association between the event fatal brain hemorrhage with COMIRNATY use can not be fully excluded based on the limited information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GR-PFIZER INC-202100962750 same reporter, drug,event, different patient; Reported Cause(s) of Death: brain haemorrhage


VAERS ID: 1513918 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-05-11
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Diabetes mellitus; Hypertension; Ischemic heart disease; Kidney failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 antigen test; Test Date: 20210505; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 PCR test
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001650 and 3001946) for COVID-19 vaccination. The patient''s past medical history included Congestive heart failure. Concurrent medical conditions included Kidney failure chronic, Diabetes mellitus since 2010, Hypertension and Ischemic heart disease. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 11-May-2021 The patient died on 11-May-2021. The reported cause of death was Congestive heart failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 antigen test and negative (Negative) Negative COVID-19 PCR test. On 06-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 PCR test. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be not related. Concomitant product use was not provided by the reporter. No treatment information was provided. Sender''s comments: The reporter physician assessed the event as not related to the suspected vaccine. The case was considered serious because the outcome was fatal. Further information was not expected. This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Sender''s Comments: This a report of death 7 days after receiving the second dose of the product in a 54-years old multimorbidity patient. Although a temporal association exists, there are important confounders/co-suspects for the event, and death certificate states congestive heart failure (a pre-existing condition) as cause of death. Very limited information regarding the events has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: Congestive heart failure


VAERS ID: 1513940 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Hemiparesis, Infarction, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 42
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: ITPFIZER INC202100939373

Write-up: large brain hematoma; hemiparesis; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-755053. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL0725, Expiration date not reported), via intramuscular, administered in deltoid left on 17Feb2021 15:51 (at the age of 90-year-old) at 0.3 mL as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombotic events of the right middle cerebral artery and red infarction on 26Feb2021. According to the reporter (daughter), who lives in a nursing home reported that on 26Feb2021, the patient had a hemiparesis which required the patient to be admitted to the neurology department (for 3 weeks) and where large brain hematoma was diagnosed. Discharged at the end of March, the patient had registered a marked improvement in paresis. He contracted the covid in the facility where the patient was resided. He was hospitalized again. The duration of the symptoms manifested by the patient was 44 days. The patient passed away on 10Apr2021. It was not reported if an autopsy was performed. The outcome of the events likely thrombotic events of the right middle cerebral artery, red infarction was fatal. The outcome for other events was unknown. Sender''s comments: The reporter was contacted for further information. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ''... likely thrombotic events'' of the right middle cerebral artery; red infarct; ''... likely thrombotic events'' of the right middle cerebral artery; red infarct


VAERS ID: 1513946 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, 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: 2021-06-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Name: blood chemistry tests; Result Unstructured Data: Test Result:normal signs of inflammation and coagulation...; Comments: ...factors; Test Name: reports a temperature; Result Unstructured Data: Test Result:40.5 Centigrade; Comments: degrees
CDC Split Type: ITPFIZER INC202100948746

Write-up: index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-757692. A 78-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 intramuscular, administered in Deltoid Left on 22Jun2021 17:14 (at the age of 78 years old) (Batch/Lot Number: FC5089) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included ischemic stroke.The patient''s concomitant medications were not reported. On 22Jun2021, the same day of vaccination, the patient experienced hyperpyrexia (the reporter reports a temperature of 40.5 degrees) she does not respond to any antipyretic treatment. Index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy. The patient has undergone blood chemistry tests which reveal normal signs of inflammation and coagulation factors. On 25Jun the patient is transferred with 118 to the infectious diseases department and she dies the next day. The patient was staying in a rehabilitation center due to a previous ischemic stroke. Therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included blood chemistry tests: normal signs of inflammation and coagulation on an unspecified date, reports a temperature: 40.5 centigrade on an unspecified date. The outcome of the event was fatal. The patient died on 26Jun2021. It was not reported if an autopsy was performed. Reporter Comment: Vaccination in a patient with rehabilitation hospitalization code 56 for ischemic stroke outcomes. Sender Comment: The reporter has been contacted to find some information. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Vaccination in a patient with rehabilitation hospitalization code 56 for ischemic stroke outcomes; Sender''s Comments: The reported event ?hyperpyrexia'' was confirmed with temperature value below 41.5?C, a value which, from a medical point of view is not consistent with ?hyperpyrexia''. The Company therefore coded this event as ?pyrexia''.; Reported Cause(s) of Death: Unknown; index of inflammation and coagulation within the limits followed by sudden hyperpyrexia not responsive to therapy


VAERS ID: 1513947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-07-02
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Pneumonia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
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: DIBASE; DUOPLAVIN; EZEQUA; SINEMET; BIFRIL [ZOFENOPRIL]; CARDICOR; PEPTAZOL [PANTOPRAZOLE]; DIURESIX [TORASEMIDE]; DOMPERIDONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT scan; Result Unstructured Data: Test Result:not provided; Test Date: 20210706; Test Name: positive sarscov2 pcr swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202100948938

Write-up: Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; Covid-19; Fever, bilateral pneumonia, positive SarsCov2 PCR swab. Vaccination failure; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-757760. A 85-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection), intramuscular on 17Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) as dose 2, 0.3ml single and received first dose of intramuscular on 19Feb2021 (Batch/Lot Number: EJ790; Expiration Date: 31May2021) as dose 1, 0.3ml single for covid-19 immunization.Medical history was not reported.Concomitant medications included colecalciferol (DIBASE); acetylsalicylic acid, clopidogrel bisulfate (DUOPLAVIN) ;duloxetine hydrochloride (EZEQUA); carbidopa monohydrate, levodopa (SINEMET); zofenopril (BIFRIL [ZOFENOPRIL]); bisoprolol fumarate (CARDICOR); pantoprazole (PEPTAZOL [PANTOPRAZOLE]); torasemide (DIURESIX [TORASEMIDE]); domperidone (DOMPERIDONE). On 02Jul2021, the patient experienced Fever, Covid-19, bilateral pneumonia and vaccination failure. On 06Jul2021, patient had positive SarsCov2 PCR swab. It was reported that patient had close contact with confirmed case of covid19 on 28Jun2021 and had onset of fever on 02jul2021, positive swab for covid19 on 06jul2021. There was worsening of the clinical picture up to the need for hospitalization for reported bilateral pneumonia so far patient have not had access to the chest CT scan performed in the hospital and subsequent death on 14Jul2021. There was reporting on suspected therapeutic failure of the vaccine. Therapeutic actions taken included antipyretic and antibiotic therapy, then hospitalization required. On 14Jul2021, the patient died. It was unknown whether autopsy was performed or not. Reporter''s comment: chronic therapy: dibase, duoplavin, ezequa, sinemet, bifril, cardicor, peptazol, diuresix, domperidone, Sender''s comment: 20Jul: Sender''s comments: First dose batch: EJ790; Second dose batch: ET1831 No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: suspected bilateral pneumonia


VAERS ID: 1513951 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Troponin; Result Unstructured Data: Test Result:no results
CDC Split Type: ITPFIZER INC202100939315

Write-up: acute coronary syndrome Non-ST elevation myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority with regulatory authority number IT-MINISAL02-759111. A 59-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF0688) via intramuscularly administered in Arm Left on 10Jul2021 (Batch/Lot Number: FF0688) as Dose Number Unknown, 0.3 mL Single for covid-19 immunization. Medical history included diabetes mellitus from 12Jul2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced acute coronary syndrome non-st elevation myocardial infarction (death, medically significant) on 13Jul2021. The patient underwent lab tests and procedures which included troponin: no results provided on 14Jul2021. Therapeutic measures were taken as a result of acute coronary syndrome non-st elevation myocardial infarction. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute coronary syndrome Non-ST elevation myocardial infarction


VAERS ID: 1513955 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
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: ITPFIZER INC202100916408

Write-up: three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine; This is a spontaneous report from a contactable physician through a company representative. The physician reported safety information for three patients. This is the first out of three cases. A adult patient of an unspecified gender received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date, it was reported by the physician that in the last two weeks (the last case yesterday) three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine. The event occurred after using the product. They were waiting for the results of autopsies. The patient died on an unspecified date. The clinical outcome of the event was fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1513956 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
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: ITPFIZER INC202100916580

Write-up: three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine; This is a spontaneous report from a contactable physician via a company representative. The physician reported safety information for three patients. This is the third out of three cases. An adult patient of an unspecified gender received BNT162B2 (COMIRNATY, Solution for injection, Lot number- unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The physician reported that in the last two weeks, the last case yesterday (as reported) three people in apparent good health, about 50, died 24 hours after the administration of the Comirnaty vaccine. The event occurred after using the product. The patient died on an unspecified date and cause of death was unspecified. The autopsy was performed, and they were waiting for the results of autopsies. Nothing more than what was previously communicated to the reporter.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event of death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1513957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909766

Write-up: Myocardium color changed to white; This is a spontaneous report from a contactable physician received from a sales representative. A 59-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number was not reported, Expiration date was not reported) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Body temperature before vaccination and family history were not reported. Medical history included mild hypertension. Concomitant medications were not reported. On an unknown date at an unknown time (2 days after the vaccination), the patient experienced myocardium color changed to white. On an unknown date (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On an unknown date, the patient received the first dose of COMIRNATY at a mass inoculation venue. On the following day, the patient was well. On an unknown date (2 days after the vaccination), the patient did not wake up in the morning; therefore, his mother entered his room and found he died on his stomach on the desk. The patient was taken to hospital. As a result of autopsy, the cause of death was myocardium color changed to white. The reporting physician did not report seriousness of the event or causality between the event and BNT162b2. The reporter was the patient''s primary care physician, the information obtained was from the patient''s parent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender''s Comments: Based on the limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported fatal event of Myocardial Ischemia. 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: Myocardium color changed to white; Autopsy-determined Cause(s) of Death: Myocardium color changed to white


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