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

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



Case Details

This is page 145 out of 172

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VAERS ID: 1513984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100923780

Write-up: Subarachnoid haemorrhage; This is a spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was a female in her 60s. The body weight and height were unknown. The family history was not provided. The patient had medical history of hypertension. The patient''s concomitant drugs were not reported. The patient was working as a caregiver. She was working at night work. The patient''s concomitant medications were not reported. On unknown date in 2021 (the day of vaccination, at an unspecified age), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a unknown dose number, single for COVID-19 immunization. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced subarachnoid haemorrhage. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in 2021, several days after the patient received a dose of BNT162b2 vaccination, she experienced subarachnoid haemorrhage. After the whole day, the patient died. The causality between the event and BNT162b2 was not provided. The patient died on an unspecified date in 2021. It was unknown if the autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of fatal event subarachnoid hemorrhage cannot be excluded.But also consider relevant medical history of hypertension present.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1513989 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   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 FC5295 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Current Illness: Disuse syndrome (undergoing hospital treatment); Pneumonia aspiration (undergoing hospital treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100935477

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120777. The patient was a 95-year and 4-month-old male. Body temperature before vaccination was 37.2 degrees centigrade. The family history was not provided. The patient was undergoing hospital treatment for posttraumatic disuse syndrome and repeated episodes of pneumonia aspiration. On 06Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose, at age of 95-year-old of vaccination, for COVID-19 immunization. On 09Jul2021 at 23:47 (3 days/9 hours/47 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 09Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was being admitted to the hospital for undergoing medical treatment because he repeatedly had posttraumatic disuse syndrome and pneumonia aspiration. From 20Jun2021 to 03Jul2021, the patient was receiving oral administration for pneumonia. Although the patient had a large amount of sputum, the fever decreased, and thus, he received the first dose of BNT162b2 vaccination on 06Jul2021 (the day of vaccination). On 09Jul2021, at 23:47, the patient had respiratory arrest at the time of round. At the time of physical examination, the patient had cardiac arrest. At 23:52, the patient was confirmed to die. 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 pneumonia.; Reported Cause(s) of Death: pneumonia; Cardio-respiratory arrest


VAERS ID: 1513990 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-21
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy heart, Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Computerised tomogram, Echocardiogram, Procalcitonin, Urine analysis, Viral myocarditis, White blood cell count
SMQs:, Cardiomyopathy (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Myocardial biopsy; Result Unstructured Data: Test Result:the diagnosis of acute myocarditis was made; Test Date: 20210625; Test Name: blood pressure; Result Unstructured Data: Test Result:in 80s; Comments: In pre-shock state; Test Date: 20210625; Test Name: blood test; Result Unstructured Data: Test Result:Deviation of cardiac enzymes; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:went down temporarily during the day, but it went Centigrade; Comments: up in the evening, indicating no improvement; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210624; Test Name: CT; Result Unstructured Data: Test Result:None of origin of pyrexia; Test Date: 20210624; Test Name: CRP; Result Unstructured Data: Test Result:5.26; Test Date: 20210624; Test Name: echocardiography; Result Unstructured Data: Test Result:increase in echogenicity at a portion of mitral; Comments: valve; Test Date: 20210624; Test Name: procalcitonin; Result Unstructured Data: Test Result:0.79; Test Date: 20210624; Test Name: urine analysis; Result Unstructured Data: Test Result:No pyuria; Test Date: 20210624; Test Name: WBC; Result Unstructured Data: Test Result:7910
CDC Split Type: JPPFIZER INC202100935489

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120810. The patient was a 61-year and 7-month-old female. Body temperature before vaccination was unknown. The patient''s family history was unknown. Information was unknown reported 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 19Jun2021 (the day of vaccination), the patient received the first dose of COVID-19 Vaccine (Manufacturer Unknown, Lot number and Expiration date unknown) via an unspecified route of administration as a single dose, at age of 61-year-old of vaccination, for COVID-19 immunization. On 21Jun2021 (2 days after the vaccination), the patient experienced viral myocarditis. On 25Jun2021 (6 days after the vaccination), the patient was admitted to the hospital. On 30Jun2021, (11 days after the vaccination) the patient died. The outcome of the event was Fatal. The course of the event was as follows: On 19Jun2021 (the day of vaccination), the patient received the first dose of Coronavirus vaccination. On 21Jun2021 (2 days after the vaccination), pyrexia of 39 degrees Centigrade developed. In the observation, body temperature went down temporarily during the day, but it went up in the evening, indicating no improvement. On 24Jun2021 (5 days after the vaccination), as the patient was refused to be seen by a primary care physician, she visited the reporting physician''s hospital for initial consultation. No pharyngodynia, cough, diarrhoea or dysgeusia was present. The symptom of cystitis such as pollakiuria or feeling of residual urine was also absent. Body temperature was 39 degrees Centigrade at the time of awakening on the reporting hospital visit day. On blood test, white blood cell count (WBC) was not increased which was at 7910, but C-reactive protein (CRP) and procalcitonin levels were increased to 5.26 and 0.79, respectively. No pyuria was noted on urine analysis. Although computerised tomogram (CT) was also conducted, apparent origin of pyrexia was not found. However, on echocardiography, endocarditis infective or other disease was suspected because an increase in echogenicity was noted at a portion of mitral valve. The reporting physician recommended hospitalization to the patient for treatment on the same day, but the patient refused it. Instead of that, she was planned to be hospitalized on the next day (25Jun2021). On 25Jun2021 (6 days after the vaccination), the patient visited the reporting hospital on foot. However, blood pressure was in 80s, and the patient was in pre-shock state. Deviation of cardiac enzymes was found on blood test. Urgent catherization was thus performed. Coronary artery stenosis was not present. Myocardial biopsy was conducted. Then, the diagnosis of acute myocarditis was made. Since shock state persisted, intubation was conducted under the same state. Intra-aortic balloon pumping (IABP) and percutaneous cardiopulmonary support (PCPS) were carried out, and pacemaker was placed temporarily. Although the patient was also treated with supportive management of circulation dynamics in the intensive-care unit (ICU), myocarditis was deteriorated into the fulminant stage. On the same day, at night, the patient lost her own electrical activity of the heart, and went into A-systole entirely, which resulted in total dependence on artificial heart-lung machine. Systemic circulation could be barely maintained through intravenous drip infusion and blood transfusion; however, maintaining was difficult for this patient with no spontaneous circulation. On 29Jun2021 (10 days after the vaccination), the patient was transferred to another hospital for the purpose of Impella insertion, which was placed on the same day; nevertheless, circulatory maintenance was too difficult for her. On 30Jun2021 (11 days after the vaccination), the patient died. It was not reported that if an autopsy was performed. The reporting physician classified the event as serious (Death) and assessed the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Viral myocarditis


VAERS ID: 1513992 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-27
   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 EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy skin, Blood lactate dehydrogenase, Body temperature, C-reactive protein, Computerised tomogram, Haemoglobin, Investigation, Lymphoproliferative disorder, Myocardial ischaemia, Pancytopenia, Platelet count, Pyrexia, White blood cell count
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Other ischaemic heart disease (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Random skin biopsy; Test Result: Negative ; Test Name: LDH; Result Unstructured Data: Test Result:670 IU/l; Comments: High; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210526; Test Name: body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:splenic mass with the size of 22 mm; Comments: CT at hospitalization; Test Name: CRP; Test Result: 7.26 mg/dl; Test Name: Hb; Result Unstructured Data: Test Result:less than 6 g/dl; Comments: decreased; Test Name: soluble IL2R; Result Unstructured Data: Test Result:13,500 IU/ml; Comments: increased; Test Name: platelet; Result Unstructured Data: Test Result:48 x10 3/mm3; Test Name: platelet; Result Unstructured Data: Test Result:less than 10 x10 3/mm3; Test Name: white blood cell; Result Unstructured Data: Test Result:about 800-1,000; Comments: decreased
CDC Split Type: JPPFIZER INC202100935501

Write-up: possible myocardial ischaemia due to decreased hematocytes; possible lymphoproliferative disease including primary spleen malignant lymphoma and intravascular lymphoma; pancytopenia; Pyrexia; This is a spontaneous report from a contactable primary physician received from (PMDA). Regulatory authority report number is v21120780. The patient was a 92-year and 7-month-old female. On 26May2021 at 13:20 (the day of vaccination), the patient 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 at the age of 92-year-old for COVID-19 immunization. Body temperature before vaccination was 35.2 degrees centigrade on 26May2021. The patient had no specific family history. Medical history included hypertension. Concomitant medications included oral clopidogrel. On 27May2021 at unknown time (one day after the vaccination), the patient experienced pyrexia and pancytopenia. On 02Jun2021 (seven days after the vaccination), the patient was admitted to the hospital. On 03Jul2021 (one month and one week after the vaccination), the patient was died and discharged from the hospital. On 03Jul2021 (one month and one week after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27May2021, the patient started to experience Consciousness disturbed and Inappetence. On 02Jun2021, the patient was transferred by ambulance and admitted to the hospital. Pyrexia of 37.2 degrees Celsius, C-reactive protein was 7.26 mg/dL, high LDH (lactate dehydrogenase) of 670 U/L, low platelets of 48 x10 3/mm3 were noted. Computerised tomogram at hospitalization showed splenic mass with the size of 22 mm. Although antibacterial drug was administrated for the doubt of urinary tract infection, the symptoms did not improve. The decrease of hematocytes progressed to white blood cell about 800-1,000 (unit was no provided), hemoglobin less than 6 g/dL, platelet less than 10 x10 3/mm3, therefore red blood cell and platelet transfusions were performed appropriately. Soluble interleukin 2 receptor increased to 13,500 U/mL. Random skin biopsy was performed for the doubt of intravascular lymphoma, but the result was negative. The addition of detailed examination including bone marrow examination was considered for lymphoproliferative disease. However, it was discussed with the patient family, further examination was not performed because of the decrease of hematocytes and bad general physical condition. On 03Jul2021 (one month and one week after the vaccination), the patient died. Immediate cause of death was considered as possible myocardial ischaemia due to decreased hematocytes. Autopsy was suggested for detailed examination of pancytopenia and immediate cause of death, but the patient family did not desire that. The reporting physician classified the event as serious (death, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were possible lymphoproliferative disease including primary spleen malignant lymphoma and intravascular lymphoma. Outcome of the event pyrexia was unknown, of other events was fatal. The reporting physician commented as follows: Regarding the symptoms described above, the possibility of the relationship to the vaccination was not high at the present moment because there were no report found from clinical trials to the extent that we could search, no description in the package insert, no cohesive report at the present moment even though pancytopenia were found in the adverse event reports. However, it cannot be denied because other causes were not proved.; Reporter''s Comments: Regarding the symptoms described above, the possibility of the relationship to the vaccination was not high at the present moment because there were no report found from clinical trials to the extent that we could search, no description in the package insert, no cohesive report at the present moment even though pancytopenia were found in the adverse event reports. However, it cannot be denied because other causes were not proved.; Reported Cause(s) of Death: possible myocardial ischaemia due to decreased hematocytes; Pancytopenia


VAERS ID: 1513993 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Blood test, Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Bone marrow examination; Result Unstructured Data: Test Result:idiopathic thrombocytopenic purpura; Test Date: 20210715; Test Name: Blood test; Result Unstructured Data: Test Result:idiopathic thrombocytopenic purpura
CDC Split Type: JPPFIZER INC202100935506

Write-up: idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120811.?? The patient was an 80-year and 3-month-old male. On 25Jun2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at the age of 80-year-old for COVID-19 immunization. Body temperature before vaccination was unknown. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) for COVID-19 immunization. On 14Jul2021 (19 days after the vaccination), the patient experienced idiopathic thrombocytopenic purpura. On 19Jul2021 (24 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: From 12Jul2021, petechiae was noted on the body trunk and the upper and lower extremities. From 13Jul2021, haemorrhage from the tracheostomy stoma was noted. On 15Jul2021, the patient visited the reporting hospital, and idiopathic thrombocytopenic purpura (ITP) was diagnosed based on blood test and bone marrow examination. Treatment with intravenous dexamethasone at 1 g was ineffective. On 18Jul2021, pulmonary alveolar haemorrhage was found. Dexamethasone was switched to steroid pulse therapy and platelet transfusion was also performed, but they were ineffective. On 19Jul2021, the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. The reporting physician considered that other possible causes of the event such as any other diseases were unassessable. The reporting physician commented as follows: Since the event occurred after the vaccination, the event was considered related to BNT162b2. The patient''s serum was stored and can be provided as necessary.; Reporter''s Comments: Since the event occurred after the vaccination, the event was considered related to BNT162b2. The patient''s serum was stored and can be provided as necessary.; Reported Cause(s) of Death: Idiopathic thrombocytopenic purpura


VAERS ID: 1513994 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   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 EY0573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100935620

Write-up: Myocardial infarction; fell; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120839. An 89-year and 3-month-old female patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0573, Expiration date 30Sep2021) via an unspecified route of administration on 16Jul2021 at 10:15 (at 89-year and 3-month-old) as a single dose for COVID-19 immunization. The patient''s family history and medical history were not reported. Body temperature before vaccination was not reported. On 25Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EY0573, Expiration date 30Sep2021) for COVID-19 immunization. On 16Jul2021 at around 19:00 (0 day after the vaccination), the patient experienced myocardial infarction. On 16Jul2021 (0 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jul2021 at around 19:00, when the patient was about to go to toilet, she fell and was then urgently transferred to general hospital. Myocardial infarction was diagnosed and treatment was performed, but the patient died. The outcome of event fall at death time was unknown. It''s unknown if autopsy performed. The cause of death was reported as myocardial infarction. The reporting physician classified the event myocardial infarction as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not report other possible causes of the event myocardial infarction such as any other diseases.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1513997 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Head CT; Result Unstructured Data: Test Result:diagnosed as severe subarachnoid haemorrhage; Comments: diagnosed as severe subarachnoid haemorrhage due to right middle cerebral arterial thrombosed aneurysm ruptured
CDC Split Type: JPPFIZER INC202100935635

Write-up: severe subarachnoid haemorrhage; right middle cerebral arterial thrombosed aneurysm ruptured; consciousness disturbed; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121166. A 71-year and 7-month-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) on 19Jul2021 09:00 at single dose (at the age of 71-year and 7-month-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. The patient family history was not reported. On 19Jul2021 at 09:00 (the day of vaccination), the patient received COVID-19 Vaccine (Manufacturer, Lot number and Dose number unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jul2021 at 11:50 (2 hours and 50 minutes after the vaccination), the patient experienced subarachnoid haemorrhage. The course of the event was as follows: On 19Jul2021 before noon (the day of vaccination), after returning home, the patient suddenly experienced consciousness disturbed and was emergently transferred to a hospital. Head computerised tomogram was performed, and the patient was diagnosed with severe subarachnoid haemorrhage due to right middle cerebral arterial thrombosed aneurysm ruptured. Conservative treatment was chosen because it was judged to be difficult to save the life. On 21Jul2021 at around 03:00 (two days after the vaccination), the patient was discharged with death. The outcome of subarachnoid haemorrhage and right middle cerebral arterial thrombosed aneurysm ruptured was fatal. The outcome of consciousness disturbed was unknown. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It is said that the cause of cerebral arterial aneurysm is inflammation of arterial wall. Aneurysm was not originally indicated, and it was hard to consider that cerebral arterial aneurysm ruptured was due to the vaccination. However, vasculitis after vaccination was included in reactions to be reported, and the possibility was not completely denied that the vaccination evoked some kind of inflammation in artery and caused aneurysm ruptured in this case, therefore we report the event. Pfizer is marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: right middle cerebral arterial thrombosed aneurysm ruptured; Subarachnoid haemorrhage


VAERS ID: 1513998 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-19
   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 FC3661 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 1
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: Atrial fibrillation paroxysmal; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210719; Test Name: cardiac catheterization; Result Unstructured Data: Test Result:no significant findings; Test Date: 20210719; Test Name: Chest Abdominal CT; Result Unstructured Data: Test Result:no significant findings; Test Date: 20210719; Test Name: echocardiography; Result Unstructured Data: Test Result:no significant findings
CDC Split Type: JPPFIZER INC202100935999

Write-up: Myocarditis suspected; asystole; collapse without consciousness; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is V21120833. A 76-year and 2-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via intramuscular on 17Jul2021 at 10:00 at 76 years old as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. The patient family history was not reported. The patient had primary diseases of diabetes mellitus, hypertension, and atrial fibrillation paroxysmal. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On 19Jul2021 at 08:50 (2 days after the vaccination), the patient experienced myocarditis suspected. On 19Jul2021 (2 days after the vaccination), the patient was admitted to the hospital. On 20Jul2021 (3 days after the vaccination), the patient died. The course of the event was reported as follows: On 19Jul2021, in the morning, when a groan was heard from the bathroom at home, the patient''s family members went and saw what happened. There, they found the patient collapse without consciousness. An emergency service was required. When the medical services arrived, the patient was in asystole. With cardiopulmonary resuscitation, thoracoabdominal computerised tomography (Chest Abdominal CT), echocardiography and cardiac catheterization were performed to search for the cause of cardiopulmonary arrest (CPA); however, no significant findings were noted. As the patient was post-vaccinated for BNT162b2 intramuscular injection, the possibility of vaccine adverse reaction (arrhythmia caused by myocarditis) could not be denied. On 20Jul2021, the patient passed away. Pathological autopsy was conducted at this time. However, there were no macroscopical abnormalities on the heart. At the time of reporting, the reporter was waiting for final results of pathological autopsy. The outcome of the events was fatal. The reporting nurse classified the event as serious (hospitalization and fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were not reported. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: asystole; collapse without consciousness; Myocarditis suspected


VAERS ID: 1514025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-13
   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 EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2021-07-13
   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: DACTIL; FEBRICET; MYSLEE; LENDORMIN; AMLODIPINE OD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hyperuricaemia; Insomnia; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021894563

Write-up: Cardio-respiratory arrest; loss of consciousness while taking a bath; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119368. This physician reported different events for different doses. This is the first of 2 reports. This case is serious. The other case is non-serious. A 81-year and 10-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jul2021 09:50 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension, insomnia, hyperuricaemia, and osteoporosis from unspecified dates. Body temperature before vaccination was 36.9 degrees centigrade on 08Jul2021. The family history was not provided. Patient historically received first dose of COMIRNATY (Lot#FA2453, Expiration date 31Aug2021) on unspecified date in 2021 and experienced mild pain. Concomitant medications included piperidolate hydrochloride (DACTIL); paracetamol (FEBRICET); zolpidem tartrate (MYSLEE) 10 mg; brotizolam (LENDORMIN) 0.25 mg; amlodipine (AMLODIPINE OD) 2.5 mg taken for an unspecified indication, start and stop date were not reported. On 13Jul2021 at 17:15 (5 days after the vaccination), the patient experienced cardio-respiratory arrest. On 13Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in 2021, the patient experienced only mild pain as a side reaction after receiving the first dose of BNT162b2 vaccination. On 08Jul2021 (the day of vaccination), at the hospital visit, the patient''s condition was as usual without any changes . The patient was speaking loudly as usual. On 13Jul2021 (5 days after vaccination), the patient was found to have loss of consciousness while taking a bath (she had cardio-respiratory arrest). A phone call was received from the police. The patient died on 13Jul2021. 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 reported. The reporting physician commented as follows: There was only contact from the police.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2021896494 same patient, same drug, different dose and event; JP-PFIZER INC-2021896494 same patient, same drug, different dose and event; Reported Cause(s) of Death: loss of consciousness while taking a bath; Cardio-respiratory arrest


VAERS ID: 1514026 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
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 FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebrovascular disorder, Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), 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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Diabetes mellitus; Diabetic nephropathy; Dialysis (3 times per week, 4 hours per session); Haemodialysis; Hypertension; Old cerebral infarction; Renal failure; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021894565

Write-up: collapse; high risk of onset of cerebrovascular disorder; Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119322. A 59-year-old (also reported as 59-year and 10-month-old) male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FC3661, expiration date: 30Sep2021), via an unspecified route of administration on 09Jul2021 at 14:00 (at the age of 59-years-old -as reported) at dose 1, single for COVID-19 immunization. Body temperature before vaccination on 09Jul2021 was 36.9 degrees Centigrade. The patient''s family history was not provided. On 12Feb2014, he began to receive haemodialysis. On 02Sep2017, he started receiving maintenance dialysis 3 times per week, 4 hours per session at the outpatient department of the reporting hospital. The patient had underlying diseases such as diabetes mellitus, hypertension, angina pectoris, and old cerebral infarction. He had renal failure due to diabetic nephropathy according to the referral of the previous physician. The patient also had smoking history. The patient''s concomitant medications were not reported. On 09Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On Jul2021, reported as between 09Jul2021 and 12Jul2021 (between the day of vaccination and 2 days after the vaccination), the patient experienced unknown cause of death. On 12Jul2021 (reported as 2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 09Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2 vaccination before usual dialysis. Thereafter, dialysis was initiated. At 18:41 (4 hours and 41 minutes after vaccination), the patient went home without abnormalities after the completion of the dialysis. On 12Jul2021 (2 days and 10 hours after vaccination), since the patient did not visit the reporting hospital for dialysis, the physician contacted his family. Then, the patient was found to have collapsed at his home. Although cardiopulmonary resuscitation (CPR) was performed, return of spontaneous circulation was not obtained, and the patient was confirmed to have died. The patient died on 12Jul2021. The cause of death was unknown. As of this date, an autopsy was being performed. The outcome of all other events was unknown. The reporting physician classified the event "unknown cause of death" as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was as follows: It was considered that the patient had a high risk of onset of cerebrovascular disorder (Jul2021). The reporting physician commented as follows: It was considered that the patient had a high risk of onset of cerebrovascular disorder.; Reporter''s Comments: It was considered that the patient had a high risk of onset of cerebrovascular disorder.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514032 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-07
   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 EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Cytology, Decreased appetite, Drowning, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: Asthma; Chronic obstructive pulmonary disease; Lung neoplasm
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210709; Test Name: whole-body CT; Result Unstructured Data: Test Result:showed no obvious haemorrhage or infarction; Comments: showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea.; Test Date: 20201216; Test Name: Cytology of sputum; Result Unstructured Data: Test Result:class III B; Comments: lung cancer screening; Test Date: 20201216; Test Name: Imaging; Result Unstructured Data: Test Result:no problem was found; Comments: lung cancer screening
CDC Split Type: JPPFIZER INC2021894863

Write-up: lethal arrhythmia was considered likely; Drowning; Cardio-respiratory arrest; Appetite impaired; This is a spontaneous report from a contactable physician via a Pfizer sales representative and from the regulatory authority. Regulatory authority report number is v21119804. A 73-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Jul2021 16:09 (Lot Number: EY5423; Expiration Date: 31Aug2021) as dose 1, single (at the age of 73 years old) for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma and suspected pulmonary tumour; all from an unknown date. The patient''s concomitant medications were not reported. The patient previously took SYMBICORT and THEOPHYLLINE from 21Dec2020 to an unspecified date, CYLMIN from Feb2021 to an unspecified date. On 09Jul2021 (4 days after the vaccination), the patient experienced death. The course of the event was as follows: On 05Jul2021 (the day of vaccination), at 16:09, the patient received the first dose of COMIRNATY vaccination at the reporting hospital and the patient had no particular adverse reaction. On 07Jul2021 (5 days, 7 hours, and 51 minutes after vaccination), the patient had appetite impaired. On 08Jul2021, at 23:00 (7 days, 6 hours, and 51 minutes after vaccination, as reported) which was also reported as 09Jul2021 at around 23:00, the patient took a bath as usual. Although usually the patient got out of a bath in approximately 30 minutes, he did not. So at 23:50 (7 days, 7 hours, and 41 minutes after vaccination, as reported), his wife went to see how the patient was doing, and it was found that his face was in the bathtub (also reported that family member went to check the situation and found the patient sank in a bathtub), and an ambulance was called. When the ambulance service arrived, the patient had cardio-respiratory arrest. The patient was emergently transferred to the general hospital. The patient received treatments such as a vasopressor and others; however, he did not recover. It was reported that the patient was transferred to a nearby flagship hospital, in ambulance; however, death was confirmed. On 09Jul2021 at 00:55 (7 days, 8 hours, and 46 minutes after vaccination, as reported), the patient was confirmed to die. The whole-body CT showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea. On 12Jul2021, the patient''s wife contacted the reporting hospital about this, where the patient received COMIRNATY. The patient had underlying diseases of COPD and asthma and regularly visited the reporting hospital. On 16Dec2020, the patient visited the reporting hospital to undergo lung cancer screening. No problem was found with imaging and the result of cytology with sputum was class III B. Thus, the patient was advised to visit a nearby flagship hospital and the patient said he was going to visit in around March. During that period, on 21Dec2020, the patient visited the reporting hospital again and was diagnosed with COPD and asthma, for which budesonide (SYMBICORT) and theophylline were prescribed. In Jan2021, the patient visited the reporting hospital twice. In Feb2021, theophyline (CYLMIN) was prescribed and that was the last visit to the reporting hospital before the COMIRNATY vaccination. On unspecified date, lethal arrhythmia was considered likely. The patient underwent lab tests and procedures which included lung cancer screening on 16Dec2020, imaging: no problem was found and cytology with sputum: class III B; body temperature: 36.9 centigrade on 05Jul2021 before vaccination; whole-body computerised tomogram (CT): showed no obvious haemorrhage or infarction, and other significant findings. Water was found in the trachea on 09Jul2021. Therapeutic measures were taken as a result of drowning due to an accident and cardio-respiratory arrest. The outcome of the event appetite impaired was unknown while fatal for the other events. The patient died on 09Jul2021. There was no incidence by an autopsy by the police. An autopsy was performed that showed that the death was drowning due to an accident. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: Causality between the event and COMIRNATY was considered remotely related. Details of the cause of death were unknown. The causality between the event and BNT162b2 vaccination was unknown. The patient took a bath by himself, and it was unlikely that significant pathological condition occurred before taking a bath. Since no cerebrovascular disorder was observed, lethal arrhythmia was considered likely; however, it was not certain.; Sender''s Comments: The 73-year-old male patient had medical history included chronic obstructive pulmonary disease (COPD), asthma and suspected pulmonary tumour, and was given medications including budesonide (SYMBICORT) and theophyline (CYLMIN). Around 7 days after vaccination, it was found that his face was in the bathtub, and cardio-respiratory arrest was confirmed. An autopsy was performed that showed that the death was drowning due to an accident. Based on information available, the fatal event drowning was unrelated to BNT162B2 (COMIRNATY). The suspected lethal arrhythmia was more likely due to his underlying disease(s), and/or medication theophyline (CYLMIN), and unlikely causally related to vaccine of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest; lethal arrhythmia was considered likely; Autopsy-determined Cause(s) of Death: drowning due to an accident.


VAERS ID: 1514084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902730

Write-up: the patient died; This is a spontaneous report from a contactable healthcare professional via Medical Information Team. The patient was an 84-year and female. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were unknown). On 14Jul2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (2 days after the vaccination), the patient died. The outcome of the event was death. The course of the event was as follows: On 14Jul2021, the patient was vaccinated with the second dose of BNT162b2 by a healthcare professional who visited the facility where the patient lived. On 16Jul2021, in the morning, the patient died. The seriousness of the event was serious, and the causality between the event and BNT162b2 was unknown. Other possible cause of the event such as any other diseases was unknown. The reporter did not know the causality between the event and BNT162b2 and also did not know whether it should be regarded as an adverse event or just geromarasmus.; Sender''s Comments: The causal relationship between BNT162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. 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: the patient died


VAERS ID: 1514085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diabetes mellitus; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902731

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable consumer (patient''s brother) received via Medical information group. A 79-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus (the level was relatively high) and mild COPD (he was a smoker). The patient was receiving the drugs for diabetes mellitus. The patient''s concomitant medications were not reported. On an unspecified date (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (18 days after the vaccination), the patient suddenly died. It was not reported if an autopsy was performed. According to the death certificate, the cause of death was bacterial pneumonia. The reporter stated as follows: The death certificate said that the cause of death was bacterial pneumonia. The reporter asked the physician about the causality, but the physician said that it could not be said for certain because the vaccine case was the first one for the physician. The reporter could not understand that the patient died after the vaccination although the patient carried on a normal life. The patient was given a permission to receive the vaccination. The reporter considered that the vaccine might influence the event. Although the reporter attempted to contact Regulatory Authority, but it was not helpful. The reporter was informed of the phone number of the pharmaceutical company by the local government. As the vaccine has just started it was somewhat understandable, but the local government did not answer clearly saying if these cases become public people would not get vaccine (incomprehensible). The magazines said that around 300 people died. The reporter considered that it might be useless if the reporter reported this case to them, but would like them to record the case although the reporter might not be informed the result. Ultimately the case should be reported to Regulatory Authority but they have done nothing. The reporter would like to know if such cases have been reported before, and if COPD might influence the lung etc. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1514177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antipsychotic drug level, Blood calcium, Cardiac arrest, Muscular weakness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORAZEPAM; LEVOTHYROXINE; CINACALCET; OLANZAPINE; VALPROIC ACID; IRBESARTAN; LITHIUMCARBONAAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: lithium; Result Unstructured Data: Test Result:low reference values; Test Name: Calcium; Result Unstructured Data: Test Result:good
CDC Split Type: NLPFIZER INC202100932317

Write-up: Cardiac arrest; Muscle weakness; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number NL-LRB-00627422. A 60-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lorazepam taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; cinacalcet taken for an unspecified indication, start and stop date were not reported; olanzapine taken for an unspecified indication, start and stop date were not reported; valproic acid taken for an unspecified indication, start and stop date were not reported; irbesartan taken for an unspecified indication, start and stop date were not reported; lithium carbonate (LITHIUMCARBONAAT) taken for an unspecified indication, start and stop date were not reported. On 14May2021, 6 days after start vaccine, the patient experienced muscle weakness. The outcome of muscle weakness was fatal. It was reported muscle weakness throughout the body, however, predominantly in the lower extremities, developing over a few days, with inability to get up from a chair independently and fall next to the bed. Referred to by the general practitioner (GP) as not matching a hemi image. No additional confusion. To the best of our knowledge, the patient has not been previously aware of this complaint. About two weeks before death still in good health seen by doctor. Patient developed muscle weakness in his whole body, but the muscle weakness became severe in his lower extremities. Patient was not able to stand up from his chair on his own and fell next to his bed. Patient was in seemingly good health two weeks before his death. Cause of death was uncertain but reported as cardiac arrest. No autopsy was done. It was also reported cause of death was Unclear. Family didn''t want an autopsy. The physician considered a possible relationship with Covid vaccine. Forensic physician has been involved by telephone, however, considered the possibility that it would be a Covid side side effect small. The patient underwent lab tests and procedures which included lithium: low reference values on an unknown date; calcium: good on an unknown date. The patient died on 16May2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Muscle weakness; Unclear. Family did not want an autopsy. The GP took into account a possible relationship with the Covid vaccine. Forensic doctor has been involved by telephone, however, considered the chance that it would be a Covid side effect was


VAERS ID: 1514179 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
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: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100932342

Write-up: Death: Heart failure; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority, regulatory authority number NL-LRB-00628507. A 95-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 at the age of 95-years-old (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 10Jun2021 at 0.3 mL for COVID-19 immunisation. Previous COVID-19 infection was no. The patient''s concomitant medications were not reported. The patient experienced death: heart failure on 14Jul2021. The patient died on 14Jul2021. 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: Heart failure


VAERS ID: 1514180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-06-07
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Pemphigoid
SMQs:, Severe cutaneous adverse reactions (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bullous pemphigoid
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100932337

Write-up: itchy blisters; half coma; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00629717. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EMO477) as single dose for COVID-19 immunisation. Medical history included bullous pemphigoid from 28Jan2021. Previous COVID-19 infection was no. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 28Jan2021 for COVID-19 immunisation and experienced bullous pemphigoid. The patient''s concomitant medications were not reported. The patient experienced half coma (death) on 07Jun2021, itchy blisters (death) on an unspecified date. There was dermatologist consultation. The itchy blisters kept getting worse and opened and stronger drugs and ointments were used to suppress this. On 07Jun2021 there was a severe setback. In a sort of semi-coma ever since. Bullous pemphigoid was treated with prednisone, dermovate 2dd, pregabaline and paracetamol. The bullous pemphigoid became worse and the blisters kept opening up. Different medications were used to treat this. On 07Jun2021 patient''s condition worsened and she became comatose. She died weeks later. The outcome of bullous pemphigoid was fatal and the outcome of coma was fatal. The patient died on 29Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100935982 the same patient different dose and event; Reported Cause(s) of Death: half coma; itchy blisters


VAERS ID: 1514197 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FDS996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100930669

Write-up: fever; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091349. A 71-year-old female patient received bnt162b2 (COMIRNATY) at the age of 71-year-old, intramuscular on 25Jun2021 (Batch/Lot Number: FDS996) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever on 08Jul2021 11:30. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event died was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever


VAERS ID: 1514198 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FDS996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100936038

Write-up: Fever; Flank pain; Urine copper; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091368. A 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 25Jun2021 (at age of 71-year-old, Batch/Lot Number: FDS996) 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 fever (death) on 08Jul2021, flank pain (death) on 08Jul2021, urine copper (death) on 08Jul2021. 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: Fever; Flank pain; Urine copper


VAERS ID: 1514199 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Chills, Guillain-Barre syndrome, Nausea, Pyrexia, Throat irritation
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100936039

Write-up: CHILLS; FEVER; THROAT ITCHINESS; NAUSEA; EPIGASTRIC PAIN; WEAKNESS; ASCENDING PARALYSIS; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300091403. A 40-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 30Jun2021 (Batch/Lot Number: FD5996) as single dose for covid-19 immunization at age of 40-year-old. The patient''s medical history and concomitant medications were not reported. The patient experienced chills, fever, throat itchiness, nausea, epigastric pain, weakness and ascending paralysis (death) on 01Jul2021 at 06:00. The patient dead on unspecified date because of the events. 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: CHILLS; FEVER; THROAT ITCHINESS; NAUSEA; EPIGASTRIC PAIN; BODY WEAKNESS; ASCENDING PARALYSIS


VAERS ID: 1514200 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Pallor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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 INC202100936040

Write-up: Dizziness; DOB; body weakness; Vomiting; Pale lips; This is a spontaneous report from a contactable other health care professional received from the regulatory authority. Regulatory authority report number PH-PHFDA-300091979. A 62-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Jun2021 (Batch/Lot number was not reported) as dose number unknown, single at the age of 62-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body weakness, vomiting, and pale lips, all on 26Jun2021 16:05, dizziness and DOB (difficult of breathing) both on 05Jul2021 10:00. 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: Dizziness; DOB; body weakness; Vomiting; pale lips


VAERS ID: 1514202 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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: PHPFIZER INC202100936042

Write-up: body malaise; Sore throat; Dyspnea; This is a spontaneous report from a contactable other Health Professional (hcp). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300092307. A 73-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Jun2021 (Batch/Lot Number: FD5996) (at the age of 73-years-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sore throat on 01Jul2021, dyspnea on 01Jul2021, body malaise on an unspecified date. The patient died on an unspecified date. The outcome of the event body malaise was unknown. The outcome of other events 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: Sore throat; Dyspnea


VAERS ID: 1514203 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: PHPFIZER INC2021898507

Write-up: Headache; Dizziness; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. (Regulatory Authority report number: PH-PHFDA-300090419). A 77-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FD5996; Expiration date was not reported), intramuscular on 29Jun2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Jul2021 (10:50), the patient had headache and dizziness. The patient had died in Jul2021 due to headache and dizziness. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: headache; dizziness


VAERS ID: 1514207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100913794

Write-up: the death of a 21-year-old girl the day after receiving the vaccine.; This is a spontaneous report from a contactable consumer received by e-mail. Based on this source document 3 cases have been created. This is case 3 out of 3 for the patient number 3. A 21-years-old (pregnant: unknown) female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection), 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 medical history was not reported. The patient''s concomitant medications were not reported. It was heard about a death of a 21-year-old girl the day after receiving the vaccine. The patient died on an unspecified date. In addition, reporter was asking for new data on serious post-vaccination reactions occuring at later time from vaccination. was there also information available where it had been confirmed that vaccination had an effect on death. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-202100913796 same reporter, different patient;PL-PFIZER INC-202100913797 same reporter, different patient; Reported Cause(s) of Death: the death of a 21-year-old girl the day after receiving the vaccine.


VAERS ID: 1514265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100937252

Write-up: "it seems that" 2 days after immunisation died; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 14-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "it seems that" 2 days after immunisation patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. The information about lot number and expiration date cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available limited information in the case provided, the causal association between the event of Death due to unknown cause and the use of suspect product BNT162B2 cannot be fully assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authority, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514301 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021904974

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority; SK-SUKLSK-20217167. A 48-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac failure with fatal outcome on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causality assessment assessed by the pathologist is not yet available. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1514320 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-07
   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: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported by the reporter. No treatment information is provided. This is a case of death in a 71-year-old male subject, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 71-year-old male subject, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514321 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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: 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: TWMODERNATX, INC.MOD20212

Write-up: Myocarditis; This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myocarditis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant). The reported cause of death was Myocarditis. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 70-year-old male subject, who died 3 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1514322 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939697 / 1 - / OT

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

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: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939697) for COVID-19 vaccination. No Medical History information was reported. On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 11-Jul-2021 The patient died on 11-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown death


VAERS ID: 1514323 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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:
Current Illness: Hypertension
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 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600CDC) for COVID-19 vaccination. Previously administered products included for Influenza immunization: influenza vaccine (Patient had no history of injections or adverse drug reactions.); for an unreported indication: Streptococcus pneumoniae (Patient had no history of adverse drug reactions.). Concurrent medical conditions included Hypertension. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. 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. The concomitant medication use was not provided. Treatment information was not provided by the reporter. This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Sender''s Comments: This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and died on the same day. Very limited information regarding this event has been provided at this time. No detailed information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age and medical history of hypertension.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514324 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-09
   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:
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 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications on use were not provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514326 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 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 78-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 10-Jul-2021 The patient died on 10-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 products were not provided. Treatment medication were not reported. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514327 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ill-defined disorder
SMQs:

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:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: ill-defined disorder; This regulatory authority case was reported by an other and describes the occurrence of ILL-DEFINED DISORDER (ill-defined disorder) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ILL-DEFINED DISORDER (ill-defined disorder) (seriousness criterion death). The patient died on 14-Jul-2021. The reported cause of death was Ill-defined disorder. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company Comment: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Sender''s Comments: This is a case of sudden death in a 79-year-old female subject, who died 5 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: ill-defined disorder


VAERS ID: 1514328 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Other; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Other) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-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 medications were not provided. Treatment information was not provided. Company comment:This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Sender''s Comments: This is a case of an 81-year-old female patient who died after vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. The patient''s advanced age and underlying medical history of Chronic obstructive pulmonary disease significantly confound causality. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514329 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

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

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? 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 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Company comments:This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Sender''s Comments: This is a case of a 74-year-old female patient who died 8 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514330 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: other; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (other) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. Death occurred on 03-Jul-2021 The patient died on 03-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment for the events were not provided. Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514331 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-07
   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: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 07-Jul-2021 The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Sender''s Comments: This is a case of a 56-year-old female patient who died 5 days following vaccination with mRNA-1273. Very limited information regarding this event has been provided at this time. No information regarding patient''s medical history nor concomitant medications was provided. Furthermore, the exact cause of death was not provided. It is also unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514334 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Peritoneal dialysis; Renal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Renal disease and Peritoneal dialysis. Concurrent medical conditions included Diabetes and Hypertension. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 06-Jul-2021 The patient died on 06-Jul-2021. The cause of death was not reported. An autopsy was not 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 product was not provided by the reporter. A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: A 74-year-old female patient who received mRNA-1273 died the same day after the first dose of vaccine. Medical history included RENAL DISEASE undergoing PERITONEAL DIALYSIS, DIABETES AND HYPERTENSION. Patient''s comorbidities may confound the event. The cause of death was not reported. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514335 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: UNEVALUABLE EVENT; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (UNEVALUABLE EVENT) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 09-Jul-2021 The patient died on 09-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 medications were not reported. Treatment medications were not reported. An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: An 80-year-old male patient who received mRNA-1273 died three days after the first dose of vaccine. No medical history or conmeds were provided. Patient''s advanced age could carry with it some comorbidities which may confound the event. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1514336 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carbon dioxide, Death, Echocardiogram, Vaccination complication
SMQs:

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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CO2; Test Result: Inconclusive ; Result Unstructured Data: 21; Test Name: Echocardiogram; Test Result: Inconclusive ; Result Unstructured Data: No pericardial effusion
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; Vaccination adverse reaction; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Unknown cause of death) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 11-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced DEATH (Unknown cause of death) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (Vaccination adverse reaction). The patient died on 11-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Carbon dioxide: 21 (Inconclusive) 21. On an unknown date, Echocardiogram: no pericardial effusion (Inconclusive) No pericardial effusion. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was no concomitant medication reported. CPR was performed. Asystole throughout the clinical course was noted. This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Sender''s Comments: This is a case of Death in a 69-year-old female patient with a medical history of hypertension who died 1 day after receiving the dose 1 of the product mRNA-1273. Very limited information regarding the event (cause of death and clinical and diagnostic information) has been provided at this time insufficient for causality assessment. Additional information (translation) is awaited.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
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: 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: TWMODERNATX, INC.MOD20212

Write-up: death; This regulatory authority case was reported by an other and describes the occurrence of DEATH (death) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information may be provided after translation.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514338 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-04
   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:
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 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 04-Jul-2021 The patient died on 04-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter. No treatment medication information was mentioned by reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514340 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Headache. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Action taken with vaccine was not applicable. This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Sender''s Comments: This is a case of a 90-year-old male patient who developed headache six days following the administration of mRNA-1273 (Moderna COVID-19 Vaccine). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history, concomitant medications or autopsy results is available at this moment. The translation of the source document has been requested.; Reported Cause(s) of Death: Headache


VAERS ID: 1514341 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-30
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: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 05-Jul-2021 The patient died on 05-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product was not provided. Treatment medication was not reported. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514343 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (Medical history not reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Lethargy; This regulatory authority case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and LETHARGY (Lethargy) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 09-Jul-2021. The reported cause of death was Fatigue and Lethargy. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided.; Sender''s Comments: This is a case of sudden death in a 88-year-old male subject, who died 6 days after receiving the dose of vaccine. Very limited information has been provided at this time. Awaiting case translation.; Reported Cause(s) of Death: Fatigue; Lethargy


VAERS ID: 1514345 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-30
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
   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: TWMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 66-year-old male 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. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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 medication was not provided by the reporter. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1514347 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: TWMODERNATX, INC.MOD20212

Write-up: fatigue; Diarrhea; This regulatory authority case was reported by an other and describes the occurrence of FATIGUE (fatigue) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and DIARRHOEA (Diarrhea) (seriousness criterion death). The reported cause of death was Fatigue and Diarrhea. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a 69-year-old female patient, 8 days after receiving an unspecified dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to death, medical history, and the concomitant medications was provided at this time. No further information is expected.; Reported Cause(s) of Death: Fatigue; Diarrhea


VAERS ID: 1514357 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Pyrexia, Vaccination complication
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: 2021-07-13
   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: TWMODERNATX, INC.MOD20212

Write-up: Fever; Loss of appetite; Other; This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), DECREASED APPETITE (Loss of appetite) and VACCINATION COMPLICATION (Other) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death), DECREASED APPETITE (Loss of appetite) (seriousness criterion death) and VACCINATION COMPLICATION (Other) (seriousness criterion death). The patient died on 13-Jul-2021. The reported cause of death was Fever and loss of appetite. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information not provided. No concomitant medication not provided.; Sender''s Comments: This fatal case concerns a 77-year-old male with serious unexpected events of pyrexia, decreased appetite, and vaccination complication. Event latency 10 days after mRNA-1273. Cause of death reported as fever and loss of appetite. Based on 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: Fever; Loss of appetite


VAERS ID: 1514824 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 antibody test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: ZAPFIZER INC202100909552

Write-up: Death; Covid-19 test positive; This is a spontaneous report received from a contactable other health care professional. A 69-years-old female patient received first dose of BNT162b2 (COMIRNATY, Batch/Lot Number: FE2090, Expiration Date: Oct2021), via unspecified route of administration on 12Jul2021 18:21 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. The diluent batch details Batch: S9846D, expiry date May2023. The vaccine was reconstituted on 12Jul2021. Medical history included hypertension. The patient concomitant medications were not reported. The patient was reported to had tested positive for COVID-19 and died on 13Jul2021. The event death assessed as serious (death) and while other event was non-serious. It was not reported if an autopsy was performed. The outcome of the event death was reported as fatal and while for other was unknown. No further details was available at the time of this report.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug BNT162b2 cannot be excluded. The 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: 1514883 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, Malaise, Pneumonia, Unresponsive to stimuli, Vascular dementia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 44
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 INC202100908577

Write-up: Pneumonia; vascular dementia; bottom half of her body was severely bruised; headaches; generally feeling sick; became totally unresponsive; This is a spontaneous report from a contactable consumer or other non hcp reporting on behalf of the patient. A 83-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 83-year-old), via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation administered in Facility. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination but was not too sure. On 10Apr2021, the patient experienced headaches and generally feeling sick and stated that she was dying constantly, shortly after receiving the injection up until she became totally unresponsive which was approximately 10 days after receiving the injection. She had signs of blood clotting as the bottom half of her body was severely bruised for a short period prior to her eventual death at just after midnight on the 15-May-2021 and cause of death was due to pneumonia and vascular dementia. An autopsy was not performed. All the events were life threatening. No treatment was received for the events. The outcome of pneumonia and vascular dementia was fatal and all other events was unknown.; Reported Cause(s) of Death: Pneumonia; vascular dementia


VAERS ID: 1514946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-15
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210760742

Write-up: UNSPECIFIED CARDIAC ARREST; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity unknown. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered on 13-Jul-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-Jul-2021, at night, the patient died from an unspecified cardiac arrest. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 15-Jul-2021. This report was serious (Death).; Sender''s Comments: V0:20210760742-JANSSEN COVID-19 VACCINE Ad26.COV2.S- unspecified cardiac arrest with fatal outcome- 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: UNSPECIFIED CARDIAC ARREST


VAERS ID: 1514957 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-05-17
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200527; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: CAPFIZER INC202100923666

Write-up: Patient developed acute leukemia which was only diagnosed May 27 after a brain hemmorhage.; Patient developed acute leukemia which was only diagnosed May 27 after a brain hemmorhage.; This is a spontaneous report received from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 25Mar2021 at 09:15 (at the age of 65-year-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 17May2021 at 06:00, the patient developed brain haemorrhage and on 27May2021, the patient diagnosed with acute leukaemia. The adverse events resulted into emergency room/department or urgent care. The patient was hospitalized for 2 days. Treatment included for adverse event was blood cleaning machine. The patient underwent lab tests and procedures which included nasal swab: negative on 27May2020. The patient died on 29May2021. The cause of death was brain haemorrhage resulting from acute leukaemia. 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: Brain hemmorrhage resulting from acute leukemia


VAERS ID: 1514977 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC202100933372

Write-up: Covid; This is a spontaneous report from a non-contactable consumer or other non hcp received from a Pfizer colleague. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter shared he was aware of someone who had died of Covid despite receiving the Pfizer Covid vaccine, reporter informed that he was aware of someone who had died of Covid following the vaccination with the Pfizer vaccine. He stated the death had been reported via local channels. The patient was died due to Covid. It was unknown if the patient was tested for COVID-19 prior vaccination. It was unknown if an autopsy was performed to the patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid


VAERS ID: 1515811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery stenosis; Coronary sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939680

Write-up: fresh myocardial infarction in the posterior wall of the left ventricle; first dose on 06May2021; second dose on 17Jun2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 55-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD4555) as dose 2, single for covid-19 immunisation. Medical history included ongoing Coronary sclerosis and Coronary artery stenosis. The patient''s concomitant medications were not reported. Patient received first dose of bnt162b2 on 06May2021 with Batch/lot number: EY7015. On 24Jun2021 the patient experienced Acute myocardial infarction, true posterior wall infarction death. The patient died on 24Jun2021 from Acute myocardial infarction, true posterior wall infarction. The autopsy determined cause of death was reported to be: Acute myocardial infarction, true posterior wall infarction. Post-mortem findings: Cause of death: Fresh myocardial infarction pathology. Fresh myocardial infarction in the posterior wall of the left ventricle. Acute pulmonary congestion. First degree hepatic congestion. External description of corpse: A 180 cm tall corpse in normal DC. The skin is pale greyish-white, with blotchy blue-violet death marks on the back. Lying venous catheter in the left lateral neck region. The skin of the thorax shows some current marks (after resuscitation). Sender''s comments: No further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fresh myocardial infarction in the posterior wall of the left ventricle


VAERS ID: 1515822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

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: Mitral valve insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve prolapse (no regular medication use).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939704

Write-up: death NOS/ lifeless in bed; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 33-years-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: FD6840), via an unspecified route of administration on 06Jul2021 at single dose for COVID-19 immunisation. Medical history included mitral valve insufficiency (continuing) and mitral valve prolapse (no regular medication use). Concomitant medications were not reported. The patient previously received first single dose of COMIRNATY on 08Jun2021 for COVID-19 immunisation. On 17Jul2021 the patient experienced death NOS. Found lifeless in bed on 17Jul2021, autopsy ordered. Autopsy report pending for cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death NOS/ lifeless in bed


VAERS ID: 1515829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963299

Write-up: Cerebrovascular accident; Herpes zoster; This is a spontaneous report from a contactable other health professional via the Regulatory authority report number is 588772. A 90-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident and herpes zoster on 05Jun2021. Onset Time in Days: 10 days. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident; Herpes zoster


VAERS ID: 1515830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100963302

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Regulatory Authority report. A 64-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on 13May2021. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1515849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Bacterial test positive, Blood creatinine, Blood creatinine increased, Blood urea, Blood urea increased, Cardiac arrest, Dermatitis allergic, General physical health deterioration, Hepatitis A, Malaise, Mycobacterium tuberculosis complex test, Platelet count, Platelet count decreased, Rash, Red blood cell count, Red blood cells urine, Red blood cells urine positive, Sepsis, Somnolence, Urinary sediment present, Urine analysis, White blood cell count, White blood cell count increased, White blood cells urine, White blood cells urine positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver infections (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 34
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIGANTOL [COLECALCIFEROL]; ALLERGO-COMOD; FRAXIPARINE MULTI; NOLPAZA; ZODAC; CALCICHEW D3
Current Illness: Alzheimer''s disease (according to Mini-Mental State Exam - moderate dementia); Asymptomatic bacteriuria (with identification Klebsiella Pneumoniae); Cerebral atherosclerosis; Hypertension arterial (that time without therapy); Incontinence of urine; Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); Non-smoker; Omalgia (according to X-ray, sclerotic focus in the great tubercle of humerus (14x8.5 mm)); Sinus bradycardia (with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Cholecystectomy; Choledocholithiasis (state after endoscopic retrograde cholangiopancreatography March 2016); Conjunctivitis allergic; Delivery; Endoscopic retrograde cholangiopancreatography (with the extraction of concrement); Gastric ulcer surgery; Humerus fracture; Hysterectomy; Myocardial infarction; Osteoporosis; Urinary infection
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: ASAT; Result Unstructured Data: Test Result:0.67 ukat/L; Test Date: 20210304; Test Name: ASAT; Result Unstructured Data: Test Result:1.68 ukat/L; Test Date: 20210301; Test Name: Creatinine; Result Unstructured Data: Test Result:104 umol/l; Test Date: 20210304; Test Name: Creatinine; Result Unstructured Data: Test Result:198 umol/l; Test Date: 20210301; Test Name: Urea; Result Unstructured Data: Test Result:7 mmol/L; Test Date: 20210304; Test Name: Urea; Result Unstructured Data: Test Result:17.5 mmol/L; Test Name: infectious hepatitis; Test Result: Negative ; Test Name: TBC; Test Result: Negative ; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:149 x10 9/l; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:246 x10 9/l; Test Date: 20210304; Test Name: Platelet count; Result Unstructured Data: Test Result:45 x10 9/l; Test Date: 20210301; Test Name: RBC count; Result Unstructured Data: Test Result:4.95 x10 12/l; Test Date: 202103; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:11-20; Test Date: 202103; Test Name: Epithelial cells urine; Result Unstructured Data: Test Result:5-10; Test Date: 202103; Test Name: Urine analysis; Result Unstructured Data: Test Result:3; Comments: identification of bacteria; Test Date: 20210301; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.8 x10 9/l; Test Date: 20210304; Test Name: White blood cell count; Result Unstructured Data: Test Result:15.3 x10 9/l; Test Date: 202103; Test Name: White blood cells urine; Result Unstructured Data: Test Result:21-40
CDC Split Type: CZPFIZER INC2021905564

Write-up: condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema; allergic facial exanthema; Sepsis; Heart arrest; sleepy; malaise; white blood cell count: 15.3 on 04Mar2021; Creatinine: 198 umol/l on 04Mar2021; urea: 17.5 mmol/l on 04Mar2021; Platelet count: 45 x10 9/l on 04Mar2021; Red blood cells urine: 11-20 in Mar2021; Urine analysis: 3 identification of bacteria; White blood cells urine: 21-40 in Mar2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Lot Number: EJ 6797) as single dose for covid-19 immunisation. Medical history included Endoscopic retrograde cholangiopancreatography with the extraction of concrement from Mar2016 and not ongoing; Cholecystectomy from an unknown date and not ongoing (state after cholecystectomy); ongoing arterial hypertension III. grade according to WHO, that time without therapy; ongoing brain atherosclerosis; Appendicectomy (state after appendectomy) not ongoing; ongoing Omalgia on the right side, according to X-ray - state after surgical neck fracture in the past, sclerotic focus in the great tubercle of humerus (14x8.5 mm), sharply defined, analgetics with effect; state after surgery of stomach from 2011 and not ongoing; ongoing Alzheimer''s disease according to Mini-Mental State Exam - moderate dementia; ongoing Incontinence of urine; 3 childrens, deliveries without complications and not ongoing; ongoing Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); ongoing Sinus bradycardia with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes, probably due to therapy with beta-blocators in Apr2019; Hysterectomy (state after hysterectomy) not ongoing; choledocholithiasis, state after endoscopic retrograde cholangiopancreatography in March 2016 with the extraction of concrement and not ongoing; ongoing Non-smoker; ongoing Asymptomatic bacteriuria with identification Klebsiella Pneumoniae from Mar2019; not ongoing Urinary infection etiology - e.coli; Osteoporosis; Conjunctivitis allergic; she did not drink alcohol. Concomitant medications included colecalciferol (VIGANTOL [COLECALCIFEROL]) taken for osteoporosis from 19Mar2020 to 26Feb2021; cromoglicate sodium (ALLERGO-COMOD) taken for Conjunctivitis allergic from 12Jan2021 to 16Feb2021; nadroparin calcium (FRAXIPARINE MULTI) taken for Ischaemic heart disease from 30Mar2019 to 01Mar2021, then from 01Mar2021 to 04Mar2021; pantoprazole sodium sesquihydrate (NOLPAZA) taken for Gastric ulcer surgery from 01Oct2010 to 28Feb2021; cetirizine hydrochloride (ZODAC) taken for Allergic conjunctivitis from 14Nov2020 to 17Feb2021; calcium carbonate, colecalciferol (CALCICHEW D3) taken for osteoporosis from 08Apr2020 to 28Feb2021. The patient experienced condition aggravated (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021, allergic facial exanthema (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021. The patient experienced Sepsis (death) and Heart arrest (death) on an unspecified date. It was reported that: the patient experienced the following adverse reaction after the administration of the 1st dose of COMIRNATY vaccine: allergic exanthema on the face, generalized worsened health condition. On 29Jan2021, it appeared allergic exanthema on the face with no reaction on antihistaminics, the patient received Prednison. The next days she still had exanthema, she was malaise and sleepy. On 18Feb2021 it had to be given the second dose, but the patient''s health condition was worsened, so the second dose was not administrated. The health condition was still worsening during the next few days and the patient died on 04Mar2021. An autopsy was not performed. The patient underwent lab tests and procedures which included aspartate aminotransferase (ASAT): 0.67 ukat/l on 01Mar2021, 1.68 ukat/l on 04Mar2021; Creatinine: 104 umol/l on 01Mar2021, 198 umol/l on 04Mar2021; urea: 7 mmol/l on 01Mar2021, 17.5 mmol/l on 04Mar2021; infectious hepatitis: negative on an unspecified date; Platelet count: 149 x10 9/l on 01Mar2021, 246 x10 9/l on 01Mar2021, 45 x10 9/l on 04Mar2021; red blood cell count: 4.95 x10 12/l on 01Mar2021; Red blood cells urine: 11-20 in Mar2021; Epithelial cells urine: 5-10 in Mar2021; Urine analysis: 3 identification of bacteria in Mar2021; white blood cell count: 8.8 x10 9/l on 01Mar2021, 15.3 on 04Mar2021. White blood cells urine: 21-40 in Mar2021; TBC negative on an unspecified date. Therapeutic measures were taken as a result of allergic facial exanthema. The outcome of events condition aggravated/ generalized worsened health condition/ health condition was worsened, allergic facial exanthema, Sepsis and Heart arrest was fatal; of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Heart arrest; allergic facial exanthema; condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema


VAERS ID: 1515872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100941122

Write-up: sudden death due to cardiac arrest; This is a spontaneous report received by Pfizer from Biontech (manufacturer for bnt162b2 (COMIRNATY), from a non-contactable physician. A 52-year-old male patient received bnt162b2 (COMIRNATY) on an unspecified date as single dose (lot: unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has died due to sudden cardiac arrest 5 weeks after COMIRNATY administration. According to the physician no autopsy was performed, thus causal relation could hardly be assessed. The outcome of the event was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the temporal relationship, the association between the fatal event sudden cardiac arrest with COMIRNATY use can not be fully 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: Cardiac arrest


VAERS ID: 1515899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-28
Onset:2021-05-01
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER GR26607 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, C-reactive protein, Circulatory collapse, Computerised tomogram, Computerised tomogram thorax, Confusional state, Cyanosis, Dizziness, Dyspnoea, Heart rate irregular, Muscular weakness, Pneumocystis jirovecii pneumonia, Pneumocystis test, Renal failure, Respiratory failure, Sepsis, Septic shock, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 18
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: ANAFRANIL; ANAFRANIL; FOLIMET; LITAREX [LITHIUM CITRATE]; METHOTREXATE PARANOVA; TRUXAL [CHLORPROTHIXENE HYDROCHLORIDE]
Current Illness: Fall (Acute admission due to fall at home)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic depression; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:No results reported; Test Date: 20210503; Test Name: Blood test; Result Unstructured Data: Test Result:Affected infection count; Test Name: CT scan; Result Unstructured Data: Test Result:Bilateral infiltration; Test Date: 20210503; Test Name: Computerized tomogram thorax; Result Unstructured Data: Test Result:Multiple infiltrates. Signs of pneumonia.; Test Date: 20210503; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 20210507; Test Name: Pneumocystis test; Result Unstructured Data: Test Result:Positive for Pneumocystis pneumonia
CDC Split Type: DKPFIZER INC202100915827

Write-up: Sepsis; Respiratory failure. The patient was intubated; Confused; Heart rate irregular; Shaking; Pneumocystis jiroveci pneumonia; Blue around the lips (sign of cyanosis); Difficulty breathing; Dizziness; Muscle weakness; Kidney failure; Circulatory failure; Septic shock; This is a spontaneous report from a contactable physicians and consumer downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0072312. A 74-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER2659) as dose 2, single for COVID-19 immunization; adalimumab (IMRALDI), subcutaneous from 28Oct2020 (Batch/Lot Number: GR26607) to 22Apr2021, at 40 mg, once every 14 days for rheumatoid arthritis. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: ET3674) as dose 1, single for COVID-19 immunization. Medical history included fall (had acute admission due to fall at home), chronic depression and rheumatoid arthritis. No medical history of pneumonia has been described in the last 10 years. Concomitant medications included clomipramine hydrochloride (ANAFRANIL) taken for depression from 2016 to 2021; clomipramine hydrochloride (ANAFRANIL RETARD) taken for depression from 1988 to 2021; folic acid (FOLIMET) taken for rheumatoid arthritis from 2005 to 2021; lithium citrate (LITAREX) taken for depression from 2019 to 2021; methotrexate (METHOTREXATE PARANOVA) taken for rheumatoid arthritis from 2005 to 2021; and chlorprothixene hydrochloride (TRUXAL) taken for depression from 1988 to 2021. On 02May2021 the patient developed Pneumocystis jiroveci pneumonia together with Blue lips, Difficulty breathing, Dizziness and Muscle weakness. On 03May2021 the patient was confused, had an irregular heart rate and was shaking. On 07May2021 the patient developed respiratory failure and on 16May2021 the patient developed sepsis. In May2021, at unknown date, but after 14 days of treatment at the hospital, the condition of the patient got worse with beginning kidney failure and circulatory failure. At admission there was sign of pneumonia and the patient was started up with tazocin (PIPERACILLIN and Tazobactam). Despite treatment, progression in the condition was observed and the patient became increasingly oxygen-demanding. The patient was transferred to intensive department and had to be intubated. Changed to treatment with Sulfotrim (SULFAMETHOXAZOLE AND TRIMETHOPRIM) (intravenous) as usual instructions, but the patient was still oxygen-demanding and on a respirator. After 14 days of treatment the patient developed kidney failure. She shows no signs of waking up despite that she had come out of sedation after tracheostomy. There was circulatory failure and she was given increasing doses of Noradrenaline. The treatment seems hopeless due to the severely affected patient and prolonged treatment. Active treatment was discontinued after conversation with the patient''s daughter. Reported causes of death: Pneumocystis jiroveci pneumonia, Kidney failure, Circulatory failure, Septic shock, sepsis. Only normal confirmation of death was performed postmortem. The other physician stated that no autopsy has been performed and he didn''t think that an inquest had been performed. The death has not been reported to the police, as the vaccine was first suspected of causing the events on 17Jun2021, approximately 1 month after the death. Tests results: Pneumocystis test (07May2021): Positive for Pneumocystis pneumonia (Pneumocystis (DNA) detected from oral mouthwash samples), Computerized tomogram thorax (03May2021): Multiple infiltrates. Signs of pneumonia. C-reactive protein (03May2021): increasing, Blood test (03May2021): affected infection count, arterial blood gases (May2021): No result reported, CT scan: Bilateral infiltration. The patient died on 19May2021. An autopsy was not performed. The ADRs were by the reporter reported as resulting in hospitalization on 03May2021 and being life-threatening and then fatal on 19May2021. Causality: Both drugs were reported as being suspected of causing the ADR. The other physician stated that the most obvious explanation for the pneumonia would be due to treatment with Imraldi. He believes that there is no causal relationship between the vaccine and the pneumonia and death. Additionally, he stated that healthy people very rarely get this type of pneumonia and underlined that the patient was on this immunosuppressive medication (Imraldi). On the other hand, the original reporter (physician) had another opinion. The fact that the patient has been vaccinated against covid-19 came out of a conversation on 17Jun2021, after the patient''s death. Hereafter, the original reporter (physician) reported Comirnaty as suspect drug as well - even though she was not convinced about a causal relationship between the vaccine and ADR. As a causal relationship between the vaccine and the ADR cannot be ruled out, the case is medically confirmed. Sender Comment: COMMENT FROM DKMA: Duplicate case DK-DKMA-WBS-0075521 (DK-DKMA-ADR 25575778) has been merged with this master case before submission to EV.; Reported Cause(s) of Death: cyanosis; Difficulty breathing; Dizziness; Muscle weakness; irregular heart rate; shaking; respiratory failure; sepsis; confused; Septic shock; Pneumocystis jiroveci pneumonia; Circulatory failure; Kidney failure


VAERS ID: 1515916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: SELO-ZOK; ALPRAZOLAM KRKA; OLANZAPIN ACCORD; ATORVASTATIN 1A FARMA; QUETIAPIN ACCORD; MIRTAZAPIN
Current Illness: Depression; Hypercholesterolemia; Hypertension; Paranoid type schizophrenia; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis.); Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202100939670

Write-up: cardiac arrest; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB [DK-DKMA-WBS-0078255]. The case was received from a contactable physician via The Danish Medicines Agency (DKMA). A 68-year-old female patient received first dose of bnt162b2 (COMIRNATY,(tozinameran (INN), Batch number: FC1433) via intramuscular on 04Jul2021 as dose 1, single for COVID-19 immunisation. There is no information regarding past medication. Patient concurrent conditions included smoker, depression, hypertension, hypercholesterolemia and paranoid type schizophrenia. Patient medical history included heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis). Concomitant medication included metoprolol succinate (SELO-ZOK) tablet at 100 mg, 1x/day for hypertension from 06Nov2014; alprazolam (ALPRAZOLAM KRKA) tablet at 0.5 mg, 1x/day for mental disorder from 24Mar2021; olanzapine (OLANZAPIN ACCORD) tablet at 20 mg, 1x/day for an unspecified indication from 24Mar2021; atorvastatin calcium trihydrate (ATORVASTATIN 1A FARMA) tablet for hypercholesterolaemia from 07Oct2015 at 135 mg, 1x/day; quetiapine fumarate (QUETIAPIN ACCORD) tablet for schizophrenia from 24Mar2021 at 300 mg, 1x/day; mirtazapine (MIRTAZAPIN "2CARE4") tablet for depression from 22Sep2015 at 7.5 mg, 1x/day. On 14Jul2021 the patient developed cardiac arrest. The patient died on 14Jul2021. An autopsy was not performed. The ADRs were by the reporter reported as being fatal. No treatment or medical procedure due to the ADR was reported. The ADR cardiac arrest was fatal. Reported cause of death: cardiac arrest. There is no information regarding test results. Causality: The reporter states that it was not known that the patient has a heart disease, however the reporter has found it stated in an anamnesis.Brighton scale criteria: time onset first reaction was 10 day. acute reaction was no. rapid progression was no. duration of reaction was no answer. Skin and mucous membrane symptoms was none. Airway symptoms was none. Cardiovascular symptoms was none. Gastrointestinal symptoms was none. Blood pressure: min. no value. max. no value. S-tryptase, acute: no value. S-tryptase, base: no value. Temperature, max: no value. Sender Comment: Version 001 was not submitted to EV. Version 002, should be considered as version 1 No follow-up attempts possible. No further information expected. =; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1515976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, 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: 2021-07-03
   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: Diabetes mellitus; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypothyroidism; Traffic accident
Allergies:
Diagnostic Lab Data: Test Date: 20200630; Test Name: CRANIAL Computerised tomogram; Result Unstructured Data: Test Result:without ventricular septal defects...; Comments: ...according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time.
CDC Split Type: ESPFIZER INC2021905384

Write-up: Death sudden; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm on Thursday 01Jul2021 (Lot Number: FC3098) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Hypertension arterial, ongoing diabetes mellitus, hypothyroidism from an unknown date, dyslipidaemia from an unknown date, road traffic accident on 30Jun2020. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) Lot number: FC3098 for covid-19 immunisation on 10Jun2021, pitavastatin calcium (ALIPZA 2mg, film-coated tablets), insulin glulisine (APIDRA 100iu/ml SOLUTION INJECTABLE IN CARTRIDGE), ramipril 2,5mg tablets and acetylsalicylic acid (ADIRO 100mg tablets gastro-resistant). The patient experienced death sudden on Saturday 03Jul2021.it was unknown whether an autopsy was done. It was reported that he was found dead in his home, discarding the suicide. At the date of notification (05Jul2021) the pharmacist was unaware of the causes of death as no access to the data related to the autopsy performed. He had a traffic accident the day before vaccination with a computed tomography, which results are: cranial Computerised tomogram WITHOUT / WITH CONTRAST: Description of the Exploration: Findings: A head Computerised tomogram is performed without ventricular septal defects according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1516030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-20
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Capillary leak syndrome
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 24
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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210759328

Write-up: CAPILLARY LEAK SYNDROME; This spontaneous report received from a physician via a Regulatory Authority concerned a 50 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C14-04 expiry: UNKNOWN) 0.5 ml, 1 total administered on 17-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. The drug start period (latency) was 4 days. On 20-JUN-2021, the patient experienced capillary leak syndrome, and was hospitalized (date unspecified). On 14-JUL-2021, the patient died from capillary leak syndrome. It was unknown if autopsy was performed. Action taken with covid-19 vaccine ad26.cov2.s was not applicable This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: This spontaneous report received from a physician via a Regulatory Authority concerns a 50-year-old female patient who developed capillary leak syndrome 4 days after receiving the Janssen COVID-19 vaccine. She died 24 days after the hospitalization. It was unknown if autopsy was performed. The patient''s past medical history included covid-19. No additional information is provided. Information regarding other potential etiologies was insufficient; considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CAPILLARY LEAK SYNDROME


VAERS ID: 1516032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210761689

Write-up: DEATH; This spontaneous report received from a health care professional concerned a 33 year old male of unknown race and ethnicity The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter heard from a lady during break in the store that the patient died after receiving vaccine, on an unspecified date. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210761689-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1516064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Fluid retention, Pneumonia, Pulmonary oedema, Renal failure, Skin weeping
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Severe cutaneous adverse reactions (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100939759

Write-up: Pneumonia; Kidney failure; Blister; Skin oozing; Pulmonary oedema; Fluid retention; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. A 76-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blister, skin oozing, pulmonary oedema, fluid retention, kidney failure, and pneumonia in Jun2021. All considered serious due to death. The patient died on 06Jul2021. It was not reported if an autopsy was performed. 08Jul2021 initial consumer: 16Jun2021 received the 2nd dose of Comirnaty (Pfizer-BionTech) vaccine. Large cellular fluid blotch on left footpad after a few days. Was sent home, despite a leak of cell fluid in his system, treatment error. Followed up a few days later with a similar, but larger, right tibial plateau. Delivered to hospital 27Jun2021 by ambulance as person was bleeding heavily with cell fluids out of body in the morning. Cellular fluids spread throughout the body, lungs and abdomen. It is not known what caused it, according to doctors. Pneumonia and loss of kidney function. Person died 06Jul2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: blister; skin oozing; pulmonary oedema; fluid retention; kidney failure; pneumonia


VAERS ID: 1516066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery occlusion, Hyperhidrosis, Myocardial infarction, Palpitations, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100939771

Write-up: Myocardial infarction; Palpitations; Left anterior descending coronary artery occlusion; Visual disturbance; sweating; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20213648. A 64-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included antihypertensive (name unknown) for hypertension. Patient experienced palpitations, sweating, visual disturbance which, however, were not considered as requiring first aid, experienced left anterior descending coronary artery occlusion, myocardial infarction, symptoms began approximately 5 days after vaccination, on 10May2021. The patient died on 16May2021. An autopsy was performed that revealed a rupture of the fatty plaque of the left protruding coronary artery and a blockage of the fat and blood in the vein, which was likely to cause myocardial infarction. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: myocardial infarction; Palpitations; Left anterior descending coronary artery occlusion; Visual disturbance; sweating; Autopsy-determined Cause(s) of Death: A rupture of the fatty plaque of the left protruding coronary artery and a blockage of the fat and blood in the vein, which was likely to cause myocardial infarction


VAERS ID: 1516099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Bradypnoea, Cerebellar haemorrhage, Coma, Decreased appetite, Gait disturbance, Headache, Hydrocephalus, Malaise, Nausea, Retinal haemorrhage, Scan brain, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: URAPIDIL; ESIDREX; METFORMINE [METFORMIN]; INDAPAMIDE; PERINDOPRIL; LERCANIDIPINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Brain scan; Result Unstructured Data: Test Result:Evidence of a left cerebellar intra-parenchymal ha; Comments: Evidence of a left cerebellar intra-parenchymal haemorrhage with tetraventricular flooding causing hydrocephalus with compression of the pre-pontic cistern and onset of tonsillar involvement. Terson''s syndrome with left retinal haemorrhage. No haemostasis disorder on the biological assessment.
CDC Split Type: FRPFIZER INC202100915625

Write-up: Cerebellar haemorrhage; acute hydrocephalus; difficulty walking and speaking/dysphasia; difficulty walking and speaking.; comatose state; bradypnoea; left retinal haemorrhage; Asthenia; visual disturbances; headache; Malaise; Nausea; loss of appetite; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 64-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left deltoid on 11Jun2021 (Batch/Lot Number: FC1526) as dose 2, single for COVID-19 immunisation. Medical history included diabetes and hypertension arterial. Concomitant medications included urapidil; hydrochlorothiazide (ESIDREX); metformin (METFORMINE); indapamide; perindopril; lercanidipine hydrochloride; all taken for an unspecified indication, start and stop date were not reported. From 12Jun2021, feeling of malaise with nausea, loss of appetite. On 13Jun2021, persistence of symptoms with asthenia, intermittent visual disturbances, headache. The patient also had difficulty walking and speaking (also reported as dysphasia). The patient was admitted to the emergency department due to the onset of a comatose state. A brain scan was carried out because of the appearance of bradypnoea and the absence of neurological improvement: Evidence of a left cerebellar intra-parenchymal haemorrhage with tetraventricular flooding causing hydrocephalus with compression of the pre-pontic cistern and onset of tonsillar involvement. Terson''s syndrome with left retinal haemorrhage. No haemostasis disorder on the biological assessment. Collegial decision not to operate due to poor prognosis. In total, cerebellar haemorrhage and acute hydrocephalus following the second injection of Comirnaty. Outcome of events was fatal. The patient died on 18Jun2021. 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: acute hydrocephalus; difficulty walking and speaking/dysphasia; difficulty walking and speaking; left retinal haemorrhage; malaise; nausea; loss of appetite; Asthenia; visual disturbances; headache; comatose state; Bradypnoea; Cerebellar haemorrhage


VAERS ID: 1516226 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-06
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Lung cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100939827

Write-up: CVA; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority report. A 75-years-old male patient received BNT162B2 (PFIZER), dose 1 intramuscular, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EW2239) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Lung cancer metastatic, atrial fibrillation.The patient''s concomitant medications were not reported. Appearance on 06May2021, i.e. 28 days after his first injection, of a superficial and deep left sylvian infarction, in a context of atrial fibrillation and metastatic pulmonary cancer, whose thrombotic phenomena were rather attributable to paraneoplastic hypercoagulability. He presented a sudden severe neurological aggravation evoking a cerebrovascular recurrence in the basilar territory. Hospitalized from 06May2021 to 23May2021 in the neurological department. Outcome of event was fatal.The patient died on 23May2021. It was not reported if an autopsy was performed.Conclusion: Sylvian stroke at Day 28 (D28) post-vaccination in a 75-year-old patient in a context of atrial fibrillation and metastatic lung cancer. Hospitalization and death of the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Deep and superficial left sylvian stroke


VAERS ID: 1516253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium, Blood electrolytes, Blood parathyroid hormone, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging head, Oxygen saturation, Renal function test, Vitamin D
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: 2021-07-03
   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: LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (reduced by Cordarone); Cardiogenic shock; Dyslipidemia; Epilepsy; Hashimoto''s disease; Heparin-induced thrombocytopenia type II; Hypercalcemia; Ischemic stroke; Myocardial infarction; TSH increased
Allergies:
Diagnostic Lab Data: Test Name: calcium; Result Unstructured Data: Test Result:2.77; Test Date: 20210701; Test Name: calcium; Result Unstructured Data: Test Result:2.63; Test Name: Ionogram; Result Unstructured Data: Test Result:normal; Test Name: PTH; Result Unstructured Data: Test Result:normal; Test Date: 20210703; Test Name: blood pressure; Result Unstructured Data: Test Result:11/7; Test Name: TSH; Result Unstructured Data: Test Result:17; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:37.2; Test Date: 20210623; Test Name: Computed tomography thorax-abdomen-pelvis; Result Unstructured Data: Test Result:disappearance of pulmonary condensations; Comments: disappearance of the previously described pulmonary parenchymal condensations and a right trochanteric fracture sequela.; Test Date: 20210624; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:inferolateral wall akinesia with LVEF at 27 percen; Comments: inferolateral wall akinesia with (ejection fraction )LVEF at 27 percent and dilated (left atrium) OG. Non-dilated Left Ventricule (LV), no pulmonary arterial hypertension (PAH), no peri-cardiac effusion and no valvulopathy.; Test Date: 2008; Test Name: lvef; Test Result: 40 %; Test Name: electrocardiogram; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm without repolarization disorder.; Test Date: 20210629; Test Name: brain MRI; Result Unstructured Data: Test Result:ischemic sequelae of the left sylvian territory; Comments: ischemic sequelae of the left sylvian territory, posterior junctional territories and cerebellar hemispheres. Post-traumatic sequelae of the left anterior temporal pole, lacunar leukopathy of the corona radiata and stability of the lateral ventricles volume.; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210703; Test Name: oxygen saturation; Test Result: 98 %; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Name: Vitamin D; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202100939791

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 59-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included Dyslipidemia, AC/FA in 2008 reduced by Cordarone, Hospitalization in intensive care unit in 2008 for 3 months for cardiogenic shock with functional myocardial infarction (MI) secondary to anemia and Atrial fibrillation (AF) with left atrial and left ventricle (LV) thrombus responsible for other embolic complications =$g digestive, cerebral, splenic, lower limbs and left parieto-occipital ischemic stroke secondary to hemorrhage due to HIT type 2. Ejection fraction (LVEF) of 2008 40%. Substituted Hashimoto''s hypothyroidism. Epilepsy sequelae of the stroke. Recurrent ischemic stroke corona radiata in Mar2009. HIT type 2 diagnosed on hemorrhagic transformation of the ischemic stroke and parietal hematoma of the small intestine. Autoimmune test performed in 2009 negative. History of the adverse event: Control brain MRI is performed on 29Jun2021 showing ischemic sequelae of the left sylvian territory, posterior junctional territories and cerebellar hemispheres. Post-traumatic sequelae of the left anterior temporal pole, lacunar leukopathy of the corona radiata and stability of the lateral ventricles volume. A Computed tomography thorax-abdomen-pelvis (TAP CT) scan was performed on 23Jun2021 showing disappearance of the previously described pulmonary parenchymal condensations and a right trochanteric fracture sequela. A cardiac ultrasound was also performed on 24Jun2021 showing inferolateral wall akinesia with (ejection fraction )LVEF at 27 percent and dilated (left atrium) OG. Non-dilated Left Ventricule (LV), no pulmonary arterial hypertension (PAH), no peri-cardiac effusion and no valvulopathy. The electrocardiogram remained in regular sinus rhythm without repolarization disorder. On the biological level, taking into account an elevated TSH of 17, Levothyrox is increased to 150 microg/day (usual dose of the patient at home) with weekly control of the thyroid balance. Biological workup also revealed hypercalcemia at 2.77 corrected with ionogram and normal renal function. PTH normal. Vitamin D normal. After endocrine advice, hypercalcemia possibly related to hypothyroidism: an increase in IV hydration was instituted, which led to a decrease in corrected calcemia to 2.63 on 01Jul2021. A pic line was placed on 02Jul2021 in order to continue IV hydration more easily. Concomitant medication included levothyroxine sodium (LEVOTHYROX). The patient experienced cardio-respiratory arrest 48 hours after vaccination on 03Jul2021. Vigilance also improved as well as interactions with the entourage. Bronchial secretions remain clear and fluid. Saturation remains above 96% in room air. However, on 03Jul2021 at 23:45, while the patient was seen and aspirated at 23H00 with a saturation of 98%, a temperature of 37.2, and a BP of 11/7, the patient was found in cardiorespiratory arrest who despite intensive resuscitation of 45 min did not recover. The patient died on 03Jul2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1516303 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100940268

Write-up: death; This is a spontaneous report from a non-contactable consumer via medical information team. A (young) patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Relevant medical history was none. Concomitant medications were not reported. Patient died on unspecified date. It was not reported if an autopsy was performed. Death cause was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1516304 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-06-21
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE 2296 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100940736

Write-up: Maternal exposure During Pregnancy; Death; This case is a spontaneous report from a contactable physician. This physician reported information for both mother and baby. This is a baby report. A 39-year-old pregnant female received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FE 2296), Intramuscular administered in right arm on 12Apr2021 as dose 1, single for covid-19 immunization. Medical history included neonatal resuscitation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The female was pregnant when received the vaccine and give birth to a baby on 11May2021. The 5-weeks-old male baby experienced death on 21Jun2021. The pregnant female delivery by emergency caesarean section in a context of severe pre-eclampsia 1 month after vaccination on 11May2021 at 25 weeks + 1 day, child of 650 grams, 34 cm, deceased on 21Jun2021 despite neonatal resuscitation. Birth on 11May2021 of a male child, weighing 655 g. The patient died on 21Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021896158 mother case; Reported Cause(s) of Death: death


VAERS ID: 1516316 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7141 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Haemorrhagic stroke, Hypertension, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZEROCREAM; FYBOGEL; THEICAL D3; ATORVASTATIN; LEVOTHYROXINE SODIUM; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Thyroid stimulating immunoglobulin (two TSI''s (diagnosed around three years or so ago))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934471

Write-up: Haemorrhagic stroke; frailty; hypertension; Dose 1 on 18Dec2020/ Dose 2 on 23Feb2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority report. A 92-year-old male patient (reporter''s father) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Batch/ Lot Number: ER7141), at the age of 92-year-old, as single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and thyroid stimulating immunoglobulin (TSI) from 2018. Do note he had had at least two TSI''s (diagnosed around three years or so ago) and there might have been more (but symptoms of migraine overlapped with TSI symptoms). Consultant had asked the reporter on more than one occasion how reporter differentiated - knew one to be different from the other given the overlap - when caring for reporter''s father. Concomitant medications included paraffin, liquid, white soft paraffin (ZEROCREAM); plantago ovata (FYBOGEL); calcium carbonate, colecalciferol (THEICAL D3); atorvastatin; levothyroxine sodium; lansoprazole and nutritional supplement (Vitabiotics Ultimate Vitamin C, 500mg). The patient previously received first dose of BNT162B2 on 18Dec2020 (Batch no. EJ0553-L450) for COVID-19 immunization. After the first vaccine the patient had chills, leg cramps and headache which lasted a couple of days. After the second vaccine the patient did not complain of side effects. On 25Feb2021, the patient experienced haemorrhagic stroke, frailty and hypertension with fatal outcome. The patient died on the 25Feb2021. Cause of death was brainstem haemorrhagic stroke and hypertension and frailty. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Frailty; Hypertension


VAERS ID: 1516521 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Test Date: 20210512; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100908770

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority report. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 12May2021 (at the age of 67-year-old) as dose 2, single for COVID-19 vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Unsure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 12May2021, the patient experienced sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 12May2021. The patient died on 16May2021. Death 4 days after second dose SARS-CoV-2 infection. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1516673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-08-01
Onset:2021-04-02
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100908975

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161731524740-OWTKX, Safety Report Unique Identifier GB-MHRA-ADR 25665364. The 32-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on Aug2020 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. It was unsure if patient was enrolled in clinical trial. On 02Apr2021 the patient experienced death. The patient died on 02Apr2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on No - Negative COVID-19 test. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: The patient died on 02Apr2021


VAERS ID: 1516862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Dyspnoea, Fibrin D dimer, Myocardial infarction, Platelet count, Pulmonary embolism, Suicide attempt, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Suicide/self-injury (narrow), Systemic lupus erythematosus (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:UNKNOWN; Comments: results currently pending; Test Date: 20210717; Test Name: platelet counts; Result Unstructured Data: Test Result:Normal; Test Name: Thombocytopenia; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: GBPFIZER INC202100908737

Write-up: shortness of breath; resuscitation attempts; chest pain; myocardial infarction; Pulmonary embolism; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171520080490-HFPSV. A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thrombosis. The patient''s concomitant medications were not reported. Patient previously took first dose of BNT162B2 for COVID-19 immunisation. The patient experienced shortness of breath, resuscitation attempts, pulmonary embolism, chest pain, myocardial infarction on an unspecified date, cardiac arrest on 17Jul2021. Patient suffered acute onset shortness of breath and chest pain one week post vaccine. Quickly collapsed and was found to be in VF cardiac arrest. Resuscitation attempts unsuccessful and patient died shortly afterwards. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Report was related to possible blood clots or low platelet counts. Patient had acute shortness of breath and chest pain followed by cardiac arrest. (out of hospital cardiac arrest) differential diagnosis includes myocardial infarction and PE". "Not yet diagnosed, will be referred to coroner. Platelets normal" and no platelet count <150 - 109/L on 17Jul2021 was platelet count measured. D-dimer $g4000 was unknown dimer measured but results currently pending. Anti-PF4 antibodies identified reported as unknown. The patient underwent lab tests and procedures which included fibrin d dimer: unknown results currently pending, platelet count: normal on 17Jul2021, thrombocytopenia: unknown. The patient died on 17Jul2021 and cause was unknown. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517007 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 39
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUOXETINE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Folic acid supplementation; Pregnancy (2 previous successful pregnancies carried to full term)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scans; Result Unstructured Data: Test Result:all fine
CDC Split Type: GBPFIZER INC202100934473

Write-up: Late miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107211054152390-AX5K3, Safety Report Unique Identifier GB-MHRA-ADR 25685292. A 40-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on 10Jun2021 (Lot Number: Fc8289) at the age of 40-year-old as single dose for COVID-19 immunisation. Medical history included pregnancy (2 previous successful pregnancies carried to full term), anxiety, folic acid supplementation. Scans were completed for this pregnancy prior to vaccine where all fine. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included fluoxetine taken for anxiety; folic acid taken for folic acid supplementation. The patient experienced late miscarriage on 19Jul2021, maternal exposure during pregnancy 10Jun2021. Patient was exposed to the medicine second-trimester (13-28 weeks). The case was reported as serious due to hospitalization, disability, medically significant, and death. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unspecified date. The patient died on 19Jul2021. It was not reported if an autopsy was performed. Outcome of events was fatal. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Maternal exposure during pregnancy; Late miscarriage


VAERS ID: 1517009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-06-01
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: GBPFIZER INC202100934286

Write-up: Heart attack; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107211240582940-VR6I8, Safety Report Unique Identifier GB-MHRA-ADR 25688638. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EM4965), via an unspecified route of administration on 30Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced heart attack on 01Jun2021 with outcome of fatal. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow up attempts are possible. No further information is expected. Reported Cause(s) of Death: Heart attack


VAERS ID: 1517015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Cardiomegaly, Cerebral haemorrhage, Coma, Hypertension, SARS-CoV-2 test, Thrombosis
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934035

Write-up: coma; blood off her brain; high blood pressure; blood clots; Brain death; Heart enlarged; This is a spontaneous report from a contactable consumer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107220650206510-T4DO4. Safety Report Unique Identifier: GB-MHRA-ADR 25690667. A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration on 16Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had no medical history and concomitant medications, nothing and no medications. Patient had not had symptoms associated with COVID-19. The patient experienced coma on an unspecified date, heart enlarged on 23Jun2021, brain death on 18Jul2021. Colapsed into a coma, fighting for her life, had received neurosurgery to drain blood off her brain, high blood pressure abd blood clots and swollen heart muscles. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 14Jul2021 No - Negative COVID-19 test. Case was reported as serious, life threatening. Outcome of Heart enlarged was not recovered and the other events were unknown. Patient had brain death on 18Jul2021. 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: Brain death


VAERS ID: 1517023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-05-15
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100941407

Write-up: Malaria; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221531222680-IV3NF, Safety Report Unique Identifier GB-MHRA-ADR 25693504. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient experienced malaria (death) on 15May2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on an unspecified date. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: malaria


VAERS ID: 1517066 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia foetal
SMQs:, Congenital and neonatal arrhythmias (broad), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100942017

Write-up: Bradycardia foetal; This is the second of two reports. This is a fetus report. The first report was received from the regulatory authority. Regulatory authority report number is GB-MHRA-ADR 25687333.Safety Report Unique Identifier: GB-MHRA-ADR 25687333. A contactable consumer reported that the pregnant mother of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 15May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The fetus medical history was not reported. The fetus concomitant medications were not reported. The mother received the second vaccine on 15May2021, to which she was pregnant at the time, and shortly after having this vaccine, the fetus died of bradycardia. It was first noted on 25May2021 that the fetus was dying due to this heart condition, subsequently death was then confirmed on 09Jun2021, with indications that this had taken place within days of 25May2021. The mother stated that she felt that it was too coincidental, considering the fact that the baby suddenly died of heart problems after having this vaccine, which left the mother in a situation where she had to have the child removed due to the fact that she had not miscarried, which has left her extremely traumatized. The patient died on 09Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : 202100934067 Maternal case; Reported Cause(s) of Death: Bradycardia foetal


VAERS ID: 1517093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-04-26
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Death, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: HRPFIZER INC202100917799

Write-up: without symptoms of COVID-19 disease; without symptoms of COVID-19 disease; death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HR-HALMED-300047831.A 96-years-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EJ6796 and Expiry date: Unknown), via an intramuscularly on 31Dec2020 at a dose of 0.3 ML, single dose, second dose intramuscularly on 21Jan2021 (Lot Number: EJ6134 and Expiry date: Unknown) at a dose of 0.3 ML single dose for COVID-19 immunization. The patient''s medical history included living in nursing home. The patient''s concomitant medications were not reported. On 26Apr2021, the patient experienced without symptoms of COVID-19 disease, vaccination failure and hospitalized. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Apr2021.The patient died on 30Apr2021. The outcome of event death was fatal and rest all other events was unknown. F/U (20Jul2021): Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Colon neoplasm (colon tumor); COVID-19 (hospitalized); Deep vein thrombosis; Diabetes; Hypertension; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202100922300

Write-up: On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; This is a spontaneous report from a contactable physician from the regulatory authority, regulatory authority number HU-OGYI-602521 A 87-years-old female patient (resident of a social care institute) received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 21Apr2021 09:00 (Batch/Lot Number: ET6956) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included Deep vein thrombosis, Diabetes, Hypertension, Atrial fibrillation, COVID-19 from Mar2021 to Mar2021 hospitalized, Colon neoplasm/colon tumor, Pulmonary embolism; all not ongoing. The patient''s concomitant medications were not reported. On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea where the symptoms were no longer observed. On 28Apr2021, the patient was transported to the social care institute, where she died on 03May2021. Autopsy was requested, further information is expected about the cause of death. According to the reporter, the patient death could be related to the the patient underlying diseases, age, and consequences of the recent coronavirus infection. Sender Comment: The 87-year-old patient died 12 days after the second dose of Comirnaty. Autopsy was requested, further information is expected about the cause of death. The causal relationship between the reported death and Comirnaty is not assessable due to lack of information. The case is serious due to hospitalization and fatal outcome. Batch/Lot Number: ET6956 No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and dia


VAERS ID: 1517100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac insufficiency; Decompensation cardiac; Erysipelas; Hypertension; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021906474

Write-up: Death; Marasmus; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number HU-OGYI-650721. A 84-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 15Jun2021 (Lot Number: FD1921) as 0.3 ml single dose for covid-19 immunisation. Medical history included hypertension, vertebrobasilar insufficiency, atrial fibrillation and cardiac insufficiency. The patient was already receiving treatment in the hospital from 09Apr2021 for erysipelas and cardiac decompensation. As her general condition gradually deteriorated, they decided to transfer the patient to the comfort care. The patient''s concomitant medications were not reported. The patient took the first dose of Comirnaty on 11May2021 (lot/batch no: FA5829) for Covid-19 immunisation. On 24Jun2021 at 00:30 the patient passed away among the symptoms of marasmus. The patient died on 24Jun2021. An autopsy was not performed. Sender Comment: As the event is related to the patient''s primary cardiovascular diseases, the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information expected. Sender''s Comments: Based on the information currently available,the relation between suspect product BNT162B2 or comirnaty and the events death were unrelated because of patient had history of serious cardiovascular disorders. Reported Cause(s) of Death: Death


VAERS ID: 1517129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Multiple organ dysfunction syndrome
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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VESITIRIM; AMLODIPINE; NASOFAN; SALAMOL EASI-BREATHE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Hypertension; Interstitial lung disease; Overactive bladder; Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100920525

Write-up: Multi organ failure; Increased breathlessness; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number IE-HPRA-2021-079310, Safety Report Unique Identifier IE-HPRA-2021-079310. This is a report received from the Regulatory Authority (RA). A 71-year-old male patient received first dose BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Apr2021 (Lot Number: EW8904) as 0.3ml single dose for COVID-19 immunisation. Medical history included permanent pacemaker from 2017, interstitial lung disease, hypertension, allergic rhinitis, and overactive bladder. Concomitant medications included VESITIRIM (Manufacturer Unknown) taken for hypertonic bladder from 15Jan2021 to 03Jun2021; GENERIC (Manufacturer Unknown) taken for hypertension from 15Jan2021 to 03Jun2021; NASOFAN NASAL SPRAY (Manufacturer Unknown) taken for rhinitis allergic from 15Jan2021 to 03Jun2021; SALAMOL EASI-BREATHE CFC-FREE INHALER (Manufacturer Unknown) taken for interstitial lung disease from 15Apr2021 to 03Jun2021. On 18Apr2021, the patient experienced increased breathlessness. On 13May2021, the patient was admitted to hospital. Following admission to hospital, the patient was treated with intravenous antibiotics and steroids but deteriorated further. The patient was subsequently admitted to the intensive care unit (ICU) with eventual multi organ failure. The patient died on 03Jun2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Multiorgan failure; Increased breathlessnes


VAERS ID: 1517130 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100915945

Write-up: COPD; cardiac failure; renal failure; Felt unwell after the second dose; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority number IE-HPRA-2021-079416. An 87-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Mar2021 (lot number and expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient was taking unspecified concomitant medications (patient was taking many different medicines). The patient previously received first dose of BNT162B2 (COMIRNATY) in Feb2021, for COVID-19 immunisation. On 29Mar2021, after the second dose, the patient felt unwell and was seen by his General Practitioner. It was reported that the patient was well before vaccination. On 31Mar2021, the patient passed away at home. No autopsy was performed. The cause of death in the death certificate included COPD, cardiac failure, and renal failure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: COPD; cardiac failure; renal failure


VAERS ID: 1517151 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Hyperpyrexia, Sopor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939291

Write-up: Therapy-resistant hyperpyrexia sleepy state up to coma; Therapy-resistant hyperpyrexia sleepy state up to coma; Therapy-resistant hyperpyrexia sleepy state up to coma; This is a spontaneous report from a contactable Physician from the Regulatory Authority IT-MINISAL02-753463. A 75-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the right arm on 24Jun2021 at 20:08 (Batch/Lot Number: FC3098; Expiration date:30Sep2021) at the age of 75-year-old as 0.3 mL dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 24Jun2021, the patient who had manifested therapy-resistant hyperpyrexia sleepy state up to coma. On an unspecified date, the patient died. The events of sopor, hyperpyrexia and coma caused death. An autopsy was unknown performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Therapy-resistant hyperpyrexia sleepy state up to coma.


VAERS ID: 1517156 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Decreased appetite, Fatigue, Leukaemia, Motor dysfunction, Nausea, Pain in extremity, Pyrexia, Speech disorder, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939391

Write-up: He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-753682. A 72-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: Unknown) as Dose 1, 0.3 mL single for covid-19 immunisation. Medical history included diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced he started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia. Events onset date was reported as 13Apr2021. additional information reported: Actions taken (First aid and hospitalization with death 10 days after hospitalization) - Impact on quality of life (10/10) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (right shoulder) Booster dose number (1). 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 expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaus


VAERS ID: 1517179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-28
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Vertebrobasilar stroke
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral pneumonia; Chronic cor pulmonale; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939416

Write-up: Stroke basilar artery which caused irreversible coma; Stroke basilar artery which caused irreversible coma; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-755100. An 88-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 12May2021 11:46 (Lot Number: FA5831) as 0.3 ML, single for covid-19 immunisation. Medical history included chronic cor pulmonale, bilateral pneumonia, hypertensive heart disease, all above from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke basilar artery (vertebrobasilar stroke) which caused irreversible coma on 28May2021, the events caused patient death. The patient died on 04Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke basilar artery which caused irreversible coma; Stroke basilar artery which caused irreversible coma


VAERS ID: 1517180 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Blood culture, Body temperature, Candida sepsis, Candida test, Coagulopathy, Computerised tomogram head, Dysphagia, Haematology test, Haemoglobin, Haemoglobinuria, Hemiparesis, Investigation, Ischaemic stroke, Pancytopenia, Platelet count, Prothrombin time, Speech disorder, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Proteinuria (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRAZODONE; TIROSINT; IRON; DIBASE; LANSOPRAZOLE; CONTRAMAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Duodenoenterostomy; Hypothyroidism; Parenteral nutrition; Trisomy 21; Ulcer (Appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy)
Allergies:
Diagnostic Lab Data: Test Name: PTT; Result Unstructured Data: Test Result:never had changes in coagulation; Comments: much less thromboembolic episodes; Test Date: 20210513; Test Name: PTT; Result Unstructured Data: Test Result:1.58; Comments: impaired; Test Name: blood culture; Result Unstructured Data: Test Result:confirmed a Candida plus a bacterium; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210506; Test Name: Candida Albicans; Test Result: Positive ; Test Date: 20210530; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:stroke was documented; Test Date: 20210506; Test Name: hematochemicals; Result Unstructured Data: Test Result:pancytopenia; Test Date: 20210513; Test Name: hematochemicals; Result Unstructured Data: Test Result:worsening of pancytopenia; Test Date: 20210513; Test Name: hemoglobin; Result Unstructured Data: Test Result:36; Test Date: 20210513; Test Name: GB; Result Unstructured Data: Test Result:3.32; Test Date: 20210513; Test Name: GR; Result Unstructured Data: Test Result:2.46; Test Date: 20210513; Test Name: Platelet count; Result Unstructured Data: Test Result:66,000; Test Name: PT; Result Unstructured Data: Test Result:never had changes in coagulation; Comments: much less thromboembolic episodes; Test Date: 20210506; Test Name: Urine analysis; Result Unstructured Data: Test Result:hyperchromic urine; Comments: hyperchromic urine
CDC Split Type: ITPFIZER INC202100939419

Write-up: CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; impaired coagulation; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-755208. A 49-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscularly on 23Apr2021 (Batch/Lot Number: EX3599) for covid-19 immunisation. Medical history included trisomy 21 from an unknown date and unknown if ongoing, parenteral nutrition from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, duodenoenterostomy from an unknown date and unknown if ongoing , ulcer from an unknown date and unknown if ongoing (Appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy). Concomitant medications included trazodone hydrochloride; levothyroxine sodium (TIROSINT); ferrous gluconate (IRON); colecalciferol (DIBASE); lansoprazole; tramadol hydrochloride (CONTRAMAL). The patient previously took ceftriaxone sodium (ROCEFIN) and experienced allergy, azithromycin and experienced intolerance, metoclopramide (PLASIL) and experienced oculogyric crisis. The patient experienced candida sepsis, impaired speech and swallowing, hemoglobinuria, acute renal failure and pancythopenia (death) on 06May2021. The patient experienced ischemic stroke with hemiparesis days before death on unspecified date. The patient experienced impaired coagulation on 13May2021. The patient received treatment for the events. The patient died on 06Jun2021. The autopsy was not ordered. The physician said that the clinical situation was very compromised even before the vaccination: for 10 years he was no longer fed by mouth and had passed from SNG to percutaneous endoscopic gastrostomy then to jejunectomy and then to NPT, already attempted in the first months but then promptly replaced due to frequent sepsis of the CVC. This last time he had gone better: since September he had CVC without major problems except the appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy (all negative, it looked like sternochondritis of NDD) which eventually turned into a trophic ulcer that it was added to that of the button of the dismissed jejunostomy. Numerous repeatedly negative sore swabs were performed except the last positive for Candida Albicans (06May2021). The analyzes of that day (patients for the rest stationary and ''''asymptomatic '''' except hyperchromic urine) showed pancytopenia and initial renal insufficiency. On 13May2021, physician requested new hematochemicals that had shown worsening of pancytopenia (GB 3.32, GR 2.46, Hb /, 36, PLT 66,000) and the appearance of impaired coagulation PTT 1.58. It was reported by family members that the patient had woken up the previous morning with blood on his mouth. He was hospitalized and I know from internist colleague that the blood culture confirmed a Candida plus a bacterium, during the hospitalization he developed a low-grade fever with an episode at 38 degrees C. They immediately replaced him with the CVC, positioned CV. The situation was complex but it had gone through far worse situations. During the daily visit of the family he spoke, gesticulated normally, however on Sunday 30May2021 the doctor informed the relatives who had noticed that he did not move a little arm and right leg (until the late evening of 29May2021 no motor problems). From that moment on he presented right hemiplegia, dysarthria with the absence of the swallowing reflex and emission of indistinct sounds only. After that he presented labored breathing, he was aspirated and in the afternoon of 06Jun2021 he passed away. On a very fragile ground it seems that vaccination has triggered a chain reaction that involved blood crasis, coagulation and kidney function. Each time, before replacing the PEG or jejunostomy, the patient always performed blood chemistry including PT and PTT but never had changes in coagulation, much less thromboembolic episodes. Septic episodes, on the other hand, were usual but not in the last 7 years, in which he had enjoyed stable clinical conditions even if in very precarious balance. The reporter added the stroke was documented by cranial CT on 30May2021; the health file was emptied therefore it is impossible to provide documentation of the haematiochemicals and imaging. Sender''s comments: 08Jul2021 RLFV: request to the reporter (who declares that the vaccine may have contributed) clinical report on the case. The reporter specifies that he is not currently in possession of the hospital clinical documentation. 08Jul2021 RLFV feedback from the reporter who is reported in the description of the case. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWI


VAERS ID: 1517185 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
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 CARDIAC ARREST and PYREXIA in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003655) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 01-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 05-Jul-2021. The reported cause of death was Arrest cardiac and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. In addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received included no new information; Sender''s Comments: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. in addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Reported Cause(s) of Death: Arrest cardiac; Fever.


VAERS ID: 1517199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arterial rupture, Computerised tomogram, Echocardiogram, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TALOFEN; DEURSIL; METFORMIN HYDROCHLORIDE; DOBETIN; LEDERFOLIN; LASIX; TIXTELLER; NORMIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Cirrhosis liver
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:had no problems; Test Name: echo; Result Unstructured Data: Test Result:unknown results; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10
CDC Split Type: ITPFIZER INC202100939466

Write-up: ruptured aorta; This is a spontaneous report from a contactable consumer from the Regulatory Authority [IT-MINISAL02-756578]. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via intramuscular in the left arm on 24Jun2021 (Lot number: FC1526) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included exotoxic cirrhosis and aortic aneurysm treated with prosthesis years ago (in place by echo and CT scan made a month and a half ago). Concomitant medications included TALOFEN, DEURSIL, metformin hydrochloride, DOBETIN, LEDERFOLIN, LASIX, TIXTELLER, NORMIX. The patient after taking the first dose of Pfizer on 24Jun2021, had a ruptured aorta that had no problems a month before from CT. Compensation of previous cirrhosis. It was reported that the patient who died on 04Jul2021. Lab data included CT scan and echo that both with unknown results on unspecified date; CT scan had no problems a month ago; impact on quality of life was 10/10 on unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed. Reporters comment: Exotoxic cirrhosis Aortic aneurysm treated with prosthesis years ago (in place by echo and CT scan made a month and a half ago). Senders comment: attached file of the er for all the details and to examination diagnostic and instrumental. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ruptured aorta


VAERS ID: 1517217 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       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: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular). On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (ECG); (seriousness criteria death and medically significant). The patient died on 16-Jul-2021. The reported cause of death was cardio-respiratory (ecg). 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 and treatment information provided. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional information was received from regulatory authority and contains no new information; Sender''s Comments: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested.


VAERS ID: 1517218 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002543 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coombs positive haemolytic anaemia, Dyspnoea, Thrombocytopenia
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 THROMBOCYTOPENIA, COOMBS POSITIVE HAEMOLYTIC ANAEMIA and DYSPNOEA in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002543) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (seriousness criteria death and medically significant), COOMBS POSITIVE HAEMOLYTIC ANAEMIA (seriousness criteria death and medically significant) and DYSPNOEA (seriousness criterion death). The patient died on 10-Jun-2021. The reported cause of death was Thrombocytopenia, Hemolytic autoimmune anemia DCP and Dyspnea. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported No treatment information was provided. The patient developed Haemolytic autoimmune anaemia ICP and Haemolytic autoimmune anaemia DCP. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Thrombocytopenia; Hemolytic autoimmune anemia DCP; Dyspnea


VAERS ID: 1517236 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
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 INC202100916579

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 second 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. Medical history and concomitant medications were not reported. It was reported by the physician that in the last two weeks (the last case yesterday at the time of report), on an unknown date, 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. Autopsies was performed and they are waiting for the results of autopsies. The patient died on an unspecified date after vaccination. The clinical outcome of the event was fatal.; Sender''s Comments: Limited information of dose -event relationship post vaccination and other alternate explanation preclude a comprehensive causality assessment, however the causal role of BNT162B2 cannot be excluded for the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: death


VAERS ID: 1517246 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hepatic function abnormal, Respiratory disorder, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: blood examination; Result Unstructured Data: Test Result:abnormal hepatic function
CDC Split Type: JPPFIZER INC202100908630

Write-up: Respiratory condition aggravated; Vomiting; Abnormal hepatic function; This is a spontaneous report from a contactable physician received through the COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 75-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination, but not specified. 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 bedridden condition due to late effects of cerebral infarction. On 08Jul2021 at 14:00 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY Solution for injection, Lot number and expiration date were not reported) in the arm left as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. On 10Jul2021 (one day after the vaccination), the patient experienced vomiting. On 11Jul2021, the respiratory condition was aggravated. On 11Jul2021 (2 days after the vaccination), the patient experienced death. The events resulted in death. The outcome of the event was fatal. It was unknown whether the treatment was provided. The reporting physician assessed the event as serious (death). It was unknown if the autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 08Jul2021 at 14:00, the patient received a dose of BNT162b2 vaccination. On 10Jul2021, the patient experienced vomiting. On 11Jul2021, the respiratory condition was aggravated. On the same day, at 19:35 (3 days after vaccination), the patient was confirmed to die at the hospital where he was transferred to. The causality between the event and BNT162b2 vaccination was unknown. The blood examination at the hospital, where the patient was transferred to, showed abnormal hepatic function in Jul2021.; Reported Cause(s) of Death: vomiting; respiratory condition aggravated; Abnormal hepatic function


VAERS ID: 1517250 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Cardio-respiratory arrest, Hypercapnia, Respiratory arrest, SARS-CoV-2 test
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), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Bacteraemia (Hospitalized from 26Jul2021); Carbon dioxide narcosis; Cellulitis (Hospitalized from 26Jul2021); Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210222; Test Name: SARS-CoV-2 test; Test Result: Positive.
CDC Split Type: JPPFIZER INC202100909733

Write-up: carbon dioxide narcosis; cardio-respiratory arrest; respiratory arrest; Apnoea; This is a spontaneous report initial from a contactable physician and follow-up report from a contactable pharmacist received from the Regulatory Authority. The Regulatory authority report number is v21120038. An 82-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5249, Expiration date 30Sep2021) at the age of 82-year-old via an unspecified route of administration on 14Jul2021 at 13:48 (the day of vaccination), as dose 2, single for COVID-19 immunization. Medical history included urinary tract infection. Body temperature before vaccination was 36.8 degrees centigrade. The patient had no particular family history. Concomitant medication included ELIQUIS orally for atrial fibrillation in order to prevent cerebral infarction. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 15Jul2021 at 04:30 (14 hours/42 minutes after the vaccination), the patient experienced respiratory arrest. On 28Jun2021 (before the vaccination), the patient was admitted to the hospital. On 15Jul2021 (one day after the vaccination), the outcome of the events was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 22Feb2021, the patient originally had a history of hospitalization for COVID-19 positive at another hospital. The patient was being admitted to the institution for advanced age or some kind of neurological disease, and her level of care needed was 4. On 28Jun2021, the patient was admitted to the hospital for cellulitis and bacteraemia. From 28Jun2021 to 12Jul2021, during hospitalization, ceftriaxone (CTR) 2g/day was administered for 14 days. The responsible bacteria was group G Streptococcus. 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 carbon dioxide narcosis. On 14Jul2021 at 13:48, the patient was vaccinated, and no adverse reaction was noted after that. On 15Jul2021, at night, presumably 3 or 4 o''clock, the patient was found in cardiac arrest by a nurse on patrol. It was informed that the patient was in respiratory arrest. A monitor had not been placed. The patient was found under condition of cardio-respiratory arrest. The patient''s death was confirmed at 5:33 by the physician. The reporting physician commented as follows: The patient suddenly had respiratory arrest just before the discharge and after the vaccination, and thus, the involvement of BNT162b2 vaccination was suspected.; Reported Cause(s) of Death: Apnoea; carbon dioxide narcosis; respiratory arrest; Respiratory arrest.


VAERS ID: 1517251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Foaming at mouth, Loss of consciousness, Malaise, Pyrexia, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EFIENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valvulopathy (underwent surgery 3 times for cardiac valvulopathy at hospital A); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade
CDC Split Type: JPPFIZER INC202100909738

Write-up: cardio-respiratory arrest; unconscious/lost consciousness; did not respond to verbal stimulation; foamed at the mouth; Cardiac failure acute; feverish; malaise; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21120106. An 86-year and 11-month female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included cardiac valvulopathy: The patient underwent surgery 3 times for cardiac valvulopathy at hospital A. She was still regularly visiting the hospital. The patient regularly visited hospital for the treatment of cardiac disease. Concomitant medication included prasugrel hydrochloride (EFIENT) tablet 5 mg. The patient received the first dose of Comirnaty on 19Jun2021. Body temperature before second vaccination was 36.5 degrees centigrade. On 10Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Lot# FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jul2021, in the evening, (2 days after the vaccination), the patient experienced acute cardiac failure. On 12Jul2021 at 19:23, (2 days after the vaccination), the outcome of the events (Cardiac failure acute and cardio-respiratory arrest) was fatal. The course of the event was as follows: On 19Jun2021, the patient received the first dose of BNT162b2. On 10Jul2021, early in the morning, the patient had edema in her limbs and visited the emergency unit of hospital A. On 10Jul2021, in the afternoon, the patient received the second dose of BNT162b2. No changes were noted in the patient''s conditions while she was in the vaccination site and also after she went back home. On 11Jul2021, the patient was feverish and had malaise, but she was able to eat meals and drink water. On 12Jul2021, at 18:00, the patient''s family member found her unconscious in her room.. She foamed at the mouth. lost consciousness, and did not respond to verbal stimulation. Her family member asked for ambulance, and she was transferred to hospital B (The patient''s physician was in hospital A, but since they considered that the patient''s conditions required to be urgently treated, she was transferred to hospital B).At 18:56, when the ambulance arrived at the hospital, the patient had cardio-respiratory arrest. Resuscitative maneuver was performed, but no response was noted. At 19:23, the patient was confirmed dead at hospital B. The cause of death was acute cardiac failure. The reporting physician classified the events (Cardiac failure acute and cardio-respiratory arrest) as serious (death) and considered the causality of the event to BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was also unassessable. The outcome of feverish, malaise, lost consciousness, foamed at the mouth and did not respond to verbal stimulation was unknown.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1517252 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Disuse syndrome (the patient has been hospitalized since 02Feb2019); Hospitalisation
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result :at the maximum of 37.9 Centigrade; Comments: on the following day of the second vaccination
CDC Split Type: JPPFIZER INC202100909741

Write-up: Apnoea; respiratory arrest; oral intake became impossible; transient pyrexia at the maximum of 37.9 degrees centigrade; This is a spontaneous report from a contactable physician received from the regulatory authority, regulatory authority report number is v21120085. A 94-year and 3-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021), via an unspecified route of administration on 13Jul2021 10:32 as dose 2, single (at the age of 94 years old) for COVID-19 immunisation. Medical history included dementia Alzheimer''s type and disuse syndrome; from an unknown date, for which the patient has been hospitalized since 02Feb2019. The patient''s concomitant medications were not reported. On 16Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) for COVID-19 immunisation and experienced transient pyrexia at the maximum of 37.3 degrees centigrade. Family history was not reported. Body temperature before vaccination was 37.1 degrees centigrade. On 16Jul2021 at 08:45 (2 days 22 hours 13 minutes after the vaccination), the patient experienced apnoea. The course of the event was as follows: The patient has been hospitalized in the reporting hospital since 02Feb2019 due to disuse syndrome caused by dementia Alzheimer''s type. On 16Jun2021, the patient received the first dose of COMIRNATY. On the following day, the patient experienced transient pyrexia at the maximum of 37.3 degrees centigrade only and had no other appreciable event. On 13Jul2021, the patient received the second dose of COMIRNATY. On the following day (14Jul2021), the patient experienced transient pyrexia at the maximum of 37.9 degrees centigrade. From the same time, oral intake became impossible and the patient was managed with infusion; however, respiration and hemodynamics were stable. On the following day in the morning (15Jul2021), the patient was able to eat breakfast. However, subsequently at bedtime, the patient was found to have respiratory arrest and death was confirmed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was dementia Alzheimer''s type. The patient underwent lab tests and procedures which included body temperature: 37.1 centigrade on 13Jul2021 before vaccination, body temperature: at the maximum of 37.9 centigrade on 14Jul2021 on the following day of the second vaccination. Therapeutic measures were taken as a result of oral intake became impossible. On 16Jul2021 (3 days after the vaccination), the outcome of the event Apnoea and respiratory arrest was fatal. The outcome of the other events was unknown. The patient died on 16Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The patient had advanced dementia with independence in activities of daily living for the elderly with dementia rank IV. Considering the patient''s age, risk of sudden turn for the worse and death was generally high; thus, causality between the vaccination and the event was unknown.; Reporter''s Comments: The patient had advanced dementia with independence in activities of daily living for the elderly with dementia rank IV. Considering the patient''s age, risk of sudden turn for the worse and death was generally high; thus, causality between the vaccination and the event was unknown.; Reported Cause(s) of Death: Apnoea; respiratory arrest


VAERS ID: 1517253 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Body temperature, Computerised tomogram, Imaging procedure, Interstitial lung disease, Oxygen saturation, SARS-CoV-2 test
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Antibody qualitative test; Test Result: Negative ; Test Date: 20210617; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 2021; Test Name: CT; Result Unstructured Data: Test Result:Bilateral diffuse crazy paving appearance; Comments: Bilateral pulmonary diffuse crazy paving appearance was observed; Test Date: 2021; Test Name: Imaging procedure; Result Unstructured Data: Test Result:aggravation; Comments: aggravation of bilateral interstitial pneumonia image were observed; Test Date: 20210630; Test Name: Imaging procedure; Result Unstructured Data: Test Result:bilateral pneumonia image were found; Test Date: 20210630; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100909745

Write-up: Interstitial pneumonia; This is a spontaneous report from a contactable primary physician received from the Regulatory Agency (RA). Regulatory authority report number is v21120141. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 14:00 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) (at the age of 92 years old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# was not provided). The patient experienced interstitial pneumonia on 30Jun2021. The patient was hospitalized for interstitial pneumonia from 30Jun2021 to an unknown date. On 30Jun2021 at unknown time (thirteen days after the vaccination), the patient experienced Interstitial pneumonia. On 30Jun2021 (thirteen days after the vaccination), the patient was admitted to the hospital. On 08Jul2021 (twenty-two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021, SpO2 decreased and bilateral pneumonia image were found and the patient was admitted to a hospital. The administration of antibacterial drugs was begun for Pneumonia bacterial, but there was no effect. Respiratory status of the patient worsened, and steroids were added. After that, Respiratory failure and aggravation of bilateral interstitial pneumonia image were observed. On 08Jul2021, the patient died. Search for the cause with such as bronchoscopy was not performed because it was not mentioned in the informed consent with the family. Bilateral pulmonary diffuse crazy paving appearance was observed on the Computerised tomogram image. Findings of the images were not typical Pneumonia bacterial or Pneumonia aspiration, and they matched with COVID-19 pneumonia. SARS-CoV-2 PCR was performed twice, and the results were negative. The result of antibody qualitative test was also negative. The patient''s body temperature was 36.4 C on 17Jun2021 before vaccination. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was the complication of Pneumonia bacterial. The reporting physician commented as follows: "I cannot diagnose as COVID-19 pneumonia, but I reported because the pneumonia images after the vaccination of Comirnaty matched with COVID-19 pneumonia." The patient died on 08Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1517256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pleural effusion, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909756

Write-up: Sudden cardiac death; bilateral pleural effusion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120037. A 93-year-old female patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 08Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included cardiac failure. Body temperature before vaccination and family history were not reported. Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN for COVID-19 immunisation. On 08Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN. On 13Jul2021 at 10:01 (5 days after the vaccination), the patient experienced sudden cardiac death. On 13Jul2021 at 10:01 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 08Jul2021, the patient received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN. Afterwards, the patient had no fever. However, the patient did not take meals and was almost bedridden. On 13Jul2021 at 08:00, the patient''s breathing was hard when her eldest son went to observe her. He removed her sputum with a tissue. At 08:30, the patient was not breathing; therefore, the son called a care manager. The care manager requested an ambulance. At 09:00, the son performed cardiopulmonary resuscitation (CPR) on the patient. At 09:12, an emergency medical team arrived and performed CPR on the patient. At 09:20, a doctor car contacted them. An intubation was performed, and adrenaline was administered. At 09:38, the patient arrived at a hospital. Asystole persisted. The resuscitation was finished. At 10:01, the patient''s death was confirmed. A computerised tomogram (CT) showed bilateral pleural effusion and no pericardial fluid. The reporting physician classified the event as serious (death) and assessed the causality between the event and COVID-19 VACCINE - MANUFACTURER UNKNOWN as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: No particular abnormalities were observed before the vaccination.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1517297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, Oxygen saturation
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder; Autism spectrum disorder; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210707; Test Name: SpO2; Test Result: 77 %
CDC Split Type: JPPFIZER INC202100910825

Write-up: Cardiac tamponade; Acute aortic dissection; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120190. A 56-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Jul2021 at 12:00 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no notable family history. Medical history included underlying conditions (autism spectrum disorder, attention deficit/hyperactivity disorder (AD/HD), epilepsy). The patient''s concomitant medications were not reported. The patient was on inpatient treatment at the reporting hospital since 21May2020 for drug adjustment for significant behaviour disorder and emotional disturbance and for epilepsy that were due to autism spectrum disorder and AD/HD. On 07Jul2021 at 17:20 (1 day after the vaccination), the patient experienced cardiac tamponade and acute aortic dissection. On 07Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 06Jul2021 (the day of vaccination), no specific serious problem was noted before the vaccination, and no side effects had been noted after the vaccination. On 07Jul2021 at 17:00 (1 day after the vaccination), the patient was screaming and moving actively at her room. At 17:20, there was a room visit as she stopped screaming and became silent, and she was found lying on the floor with complexion ill, loss of spontaneous respiration, cyanosis, and SpO2 77%. Cardiac massage, intravenous route securing, endotracheal intubation, automated external defibrillator (AED), and BOSMIN intramuscular injection were performed. While continuing resuscitation, an ambulance was called at 17:37, and the patient was urgently transported from the reporting hospital to Medical Center at 17:55. Thereafter, the patient underwent resuscitation at Medical Center but was unresponsive, and after waiting for her family to arrive, she was confirmed dead at 20:01. The cause of death was diagnosed as cardiac tamponade and acute aortic dissection. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Assessment of the diagnosis of the symptoms and causal relationship were not possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Assessment of the diagnosis of the symptoms and causal relationship were not possible.; Reported Cause(s) of Death: Cardiac tamponade; Acute aortic dissection


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