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From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1578846 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9758 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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: Medical History/Concurrent Conditions: Hypertension; Stress
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987778

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100145048. An adult male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: FD9758) as dose number unknown, 0.3ml single for covid-19 immunisation. Medical history included hypertension and stress. The patient''s concomitant medications were not reported. The patient experienced acute myocardial infarction on 16Jul2021. The patient died on 16Jul2021 due to acute myocardial infarction. It was unknown if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1578847 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-15
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Decreased appetite, Fatigue, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; COPD; Emphysema pulmonary; Hypertension; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987727

Write-up: Hypoxia; Circulatory instability; Appetite lost; Tiredness; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100145066. A 68-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FF0900) (at the age of 68-yrs-old) as dose 2, 0.3ml single for COVID-19 immunisation. The patient''s weight and height were not reported. Medical history and concurrent conditions included emphysema pulmonary, chronic respiratory failure, chronic obstructive pulmonary disease (COPD GOLD), sleep apnoea syndrome, hypertension. No concomitant medications were reported. Historical Vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 03Jun2021 (Batch/Lot Number was not reported) (at the age of 68-yrs-old) as dose 1, 0.3ml single for COVID-19 immunisation. On 15Jul2021, the patient experienced circulatory instability, appetite lost, and tiredness. On 18Jul2021, the patient experienced again tiredness. This report is serious - death. The outcome of the events was fatal. The patient died on 18Jul2021. Reported cause of death was hypoxia. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypoxia


VAERS ID: 1578848 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
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: 2021-07-14
   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: Medical History/Concurrent Conditions: LDL increased; Lipid metabolism disorder NOS; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Smoker, Lipid metabolism disorder NOS and LDL increased. Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA. On 11-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 14-Jul-2021 The patient died on 14-Jul-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Treatment information was not provided. Company Comment: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death of an unknown cause in a 72-year-old female subject with hx of smoking and lipid metabolism disorder who died 3 days after receiving mRNA-1273. An autopsy was not performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578851 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100987552

Write-up: Acute myocardial infarction; This is a spontaneous report downloaded from the Regulatory Authority. Report number DE-PEI-202100146478. A non-contactable physician reported that a 74-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Jun2021 (at the age of 74-year-old) (Batch/Lot Number: FD7958) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27Jun2021, the patient experienced acute myocardial infarction. The patient died on an unspecified date. It was not reported if an autopsy was performed. Source of assessment Result of Assessment C. Inconsistent causal association to immunization No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1578853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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: DEPFIZER INC202100987630

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100146521. A 58-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 vaccination. The patient experienced unknown cause of death on 16Jul2021. The patient died on 16Jul2021. An autopsy was performed and results were not provided. Causal relationship between the event and the administration of CORMINATY was assessed as "Unclassifiable" by the RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578855 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-10
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D015A / 2 - / -

Administered by: Other       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: DEPFIZER INC202100987718

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100146645. A 52-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: 1D015A), via an unspecified route of administration on 01Jun2021 (at the age of 52-years-old) as dose 2, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 10Jul2021. This report is serious - death. The patient died on 10Jul2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Computerised tomogram, Resuscitation
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Post-traumatic stress disorder; Substance dependence
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: computerised tomography; Result Unstructured Data: Test Result:Pulmonary artery embolism; Comments: Pulmonary artery embolism ruled out by thorax computerized tomography on 11Jul2021; Test Date: 20210711; Test Name: computerised tomography; Result Unstructured Data: Test Result:Coronary heart disease; Comments: no pericardial effusion, no pathological tox-screening, no further specific causes recognisable so far; Test Name: reanimation procedure; Result Unstructured Data: Test Result:connection vaccination is assumed.; Comments: A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed.
CDC Split Type: DEPFIZER INC202100987605

Write-up: Hypoxic brain damage; This is a spontaneous report from a non-contactable pharmacist downloaded through the Regulatory Authority. Report number DE-PEI-202100148158. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 05Jul2021 (Lot Number: FC1440) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included substance dependence, and post-traumatic stress disorder, all were unknown if ongoing. The patient received the first dose of bnt162b2 (COMIRNATY) on 25May2021 as dose 1, 0.3 mL single for prophylactic vaccination. The patient''s concomitant medications were not reported. On 11Jul2021, the patient experienced hypoxic brain damage which was considered as serious fatal with hospitalization. On 16Jul2021, the patient experienced death. It was reported that computerized tomography on 11Jul2021 included pulmonary artery embolism ruled out by thorax computerised tomography on 11Jul2021, and computerised tomography on 11Jul 2021 showed coronary heart disease ruled out by PRIVACY on 11Jul2021, no pericardial effusion, no pathological tox-screening, no further specific causes recognizable so far, implantation on 11Jul2021. A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed. An examination into an alleged irreversible brain function collapse following reanimation remains to be done. The outcome of the event was fatal. The patient died on 16Jul2021. It was not reported if an autopsy was performed. Sender comment: Computerised tomography on 11Jul2021, Pulmonary artery embolism ruled out by thorax computerised tomography on 11Jul2021, computerised tomography on 11Jul 2021, Coronary heart disease ruled out by PRIVACY on 11Jul2021, no pericardial effusion, no pathological tox-screening, no further specific causes recognizable so far, implantation on 11Jul2021. A genesis of the reanimation procedure in the tests s-far provides no indication, but a formal temporal connection with the vaccination is assumed. An examination into an alleged irreversible brain function collapse following reanimation remains to be done. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Hypoxic brain damage


VAERS ID: 1578861 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-23
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: skull CT; Result Unstructured Data: Test Result:complete medial and anterior infarction on the rig; Comments: complete medial and anterior infarction on the right, sec. Hemorrhage
CDC Split Type: DEPFIZER INC202100987776

Write-up: Right media infarction; This is a spontaneous report from a non-contactable healthcare professional downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100148269. A 65-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (at the age of 65-year-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 23Apr2021, the patient experienced right media infarction (middle cerebral artery infarct). The patient was hospitalized due to the event on an unspecified date and event was considered as life threatening. The patient underwent lab test and procedure on 06Apr2021 which included skull computerised tomogram (CT) which showed complete medial and anterior infarction on the right, sec. hemorrhage. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Skull CT 6Apr2021: complete medial and anterior infarction on the right, sec. Hemorrhage Comirnaty/ Middle cerebral artery infarct / unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Right media infarction


VAERS ID: 1578864 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatic carcinoma, Sudden death, Weight, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow)

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:
Allergies:
Diagnostic Lab Data: Test Name: weight loss; Result Unstructured Data: Test Result: over 30 kg.
CDC Split Type: DEPFIZER INC202100987794

Write-up: suspected pancreatic cancer; Continuous weight loss over 30 kg; Death sudden; This is a spontaneous report received from a non-contactable healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100149322. A 69-year-old male patient received BNT162B2 (COMIRNATY; strength 0.3ml), via an unspecified route of administration on 15Jul2021 (Lot Number: FE7011, unknown expiration; at the age of 69 years old) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 10Jun2021 (at the age of 69 years old) for prophylactic vaccination. The patient experienced continuous weight loss over 30 kg, suspected pancreatic cancer on unspecified dates. The patient experienced death sudden on 17Jul2021. The patient died on 17Jul2021. Outcome of the remaining events was unknown. It was unknown if an autopsy was performed. Sender''s comment: Continuous weight loss over 30 kg, suspected pancreatic cancer. Relatedness of the events were assessed by RA as "D. Unclassifiable". No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1578870 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E029A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987575

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician, downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100149661. An 84-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 mL), via an unspecified route of administration on 22Jul2021 at the age of 84 years old (Batch/Lot Number: 1E029A, Expiration date: unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death sudden on 27Jul2021. This report was considered serious due to death. The patient died on 27Jul2021. It was not reported if an autopsy was performed. The result of the assessment of relatedness of drug to the reaction/event, "death sudden," by the source of assessment, RA, was reported as "D. Unclassifiable." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1578874 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-08
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis, Intervertebral discitis, Multiple organ dysfunction syndrome, Staphylococcal sepsis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic sclerosis; Atrial fibrillation; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987753

Write-up: Thrombocytopenia; Staphylococcus aureus-Sepsis; the suspicion of spondylodiscitis; Mitral valve-endocarditis; Multi-organ failure with Lethal outcome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100150829. An 85-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12May2021 (Lot Number: EX8680) as dose 2, single (at the age of 85 years old) for COVID-19 immunisation. Medical history included atrial fibrillation, chronic obstructive pulmonary disease (COPD), aortic sclerosis; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took pneumovax on 20Apr2020 and experienced erythema on the abdominal wall, healed; COMIRNATY on 07Apr2021 as dose 1, 0.3 mL single for COVID-19 immunisation. The patient''s weight was not reported, and height was not reported. On 08Jun2021, the patient experienced multiorgan failure with lethal outcome, staphylococcus aureus sepsis (septicemia), mitral valve endocarditis, the suspicion of spondylodiscitis. The patient also experienced thrombocytopenia on an unspecified date. This report was serious due to death, hospitalization, life threatening. The outcome of all the events was fatal. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Sender''s comments: After Pneumovax vaccination on 20Apr2020 as a reaction an erythema on the abdominal wall, healed. Info: Patient had previously seen cardiologist, was in very good General Condition, cared for a relative at home. Hospital document available. Relatedness of drug to reactions/events per was unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multi-organ failure with lethal outcome; Thrombocytopenia; Staphylococcus aureus-Sepsis; the suspicion of spondylodiscitis; Mitral valve endocarditis


VAERS ID: 1578875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987759

Write-up: Death (another history of myocardial infarction); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100151658. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jul2021 (Lot Number: FE9174), dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death (another history of myocardial infarction) on 28Jul2021. The patient was hospitalized on an unknown date in Jul2021. The event was reported as life threatening. The patient died on 28Jul2021 due to the event. It was not reported if an autopsy was performed. Event assessment for Comirnaty with the event (source of assessment: Regulatory Authority) was unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death (another history of myocardial infarction)


VAERS ID: 1578876 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addicted to amphetamine; Alcohol addiction; Coronary heart disease; Hyperlipidemia; Hypertension; Hyperuricaemia; Obesity; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987619

Write-up: from Myocardial ischemia, Exitus letalis; first dose of Comirnaty on 29May2021/ on 10Jul2021 as dose 2, single; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100151748. A 35-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FC1440) (at the age of 35 years old) as dose 2, single for COVID-19 immunisation. Medical history included hyperlipidemia from 06Mar2020, hyperuricemia from 06Mar2020, smoker from 06Mar2020, addicted to amphetamine from 06Mar2020, obesity from 06Mar2020, hypertension from 06Mar2020, coronary artery disease from 06Mar2020 and alcohol addiction from 06Mar2020, all were unknown if ongoing. The patient''s concomitant medications were not reported. The patient took the first dose of Comirnaty on 29May2021 for COVID-19 immunisation. The patient experienced ''Myocardial ischemia, exitus letalis'' on 12Jul2021. This report is serious - death, hospitalization, life threatening. The patient died on 12Jul2021. It was not reported if an autopsy was performed. Event assessment: RA / D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial ischemia, Exitus letalis


VAERS ID: 1578885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-23
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016065

Write-up: Myocarditis; Sudden cardiac death with successful resuscitation; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB Worldwide unique case identification number DE-PEI-202100158148, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100158148. An 18-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot number was not reported) 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 myocarditis on 23Jul2021. The event was reported as life threatening and resulting hospitalization. Sudden cardiac death with successful resuscitation on unknown date. Therapeutic measures were taken as a result of events. The patient died on an unspecified date. It was unknown if an autopsy was performed. The patient was not recovered from myocarditis. Assessment: Comirnaty/ Myocarditis / RA: B. Indeterminate. Sender''s comments: Sudden cardiac death with successful resuscitation. No underlying disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death with successful resuscitation


VAERS ID: 1578887 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Muscle spasms, Myocardial infarction, Palpitations
SMQs:, Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (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: DEPFIZER INC202101016102

Write-up: Infarct myocardial; Accident cerebrovascular; Heart racing; Cramps; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority. Report number DE-PEI-202100158263. This consumer or other non hcp reported different doses and events for the same patient. This is the first of two reports-regarding the second dose. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran), at the age of 90 years old, on 10Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 90 years old, on 20Jan2021 at single dose for COVID-19 immunisation and experienced heart racing. On 11Feb2021, the patient experienced heart racing and cramps. On an unspecified date, the patient also experienced infarct myocardial and accident cerebrovascular. This report was serious - death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as D. Unclassifiable. The outcome of the events was fatal. 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) : DE-PFIZER INC-202101027573 same patient, different doses, different events; Reported Cause(s) of Death: Infarct myocardial; Heart racing; Accident cerebrovascular; Cramps


VAERS ID: 1578888 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Arterial hypertension; Chronic renal insufficiency; Hyperlipoproteinemia; Hyperuricaemia; Obesity; Proteinuria; Pulmonary granuloma; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026379

Write-up: Lethal death after attempted resuscitation by air rescue; This is a spontaneous report from non-contactable physician downloaded from the Regulatory Authority. Report number DE-PEI-202100159263. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: 1D020A, strength: 0.3 ml) (mRNA tozinameran), at the age of 69 years old, on 28Jul2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, chronic renal insufficiency, type 2 diabetes mellitus, hyperuricaemia, obesity, proteinuria, pulmonary granuloma and hyperlipidaemia (all were ongoing). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown, strength: 0.3 ml), at the age of 69 years old, on 07Jul2021 at single dose for COVID-19 immunisation. On 02Aug2021, the patient experienced lethal death after attempted resuscitation by air rescue (unknown cause of death). On 02Aug2021, air rescue informed about the lethal outcome after unsuccessful resuscitation. This report was serious - death. The patient died on 02Aug2021. An autopsy was not performed. Relatedness of drug to the event was assessed as D. Unclassifiable by Regulatory Authority . The outcome of the event was fatal.; Reported Cause(s) of Death: Lethal death after attempted resuscitation by air rescue


VAERS ID: 1579069 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body mass index, Glomerular filtration rate, Influenza, Low density lipoprotein, Platelet count, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Arrhythmia (cardiac arrhythmia, not further specified (I49.9G)); Cerebral infarction (results of a cerebral infarct (I69.3G)); Essential hypertension (essential hypertension, not further specified, without details of any hypertensive crisis (I10.90G)).
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (years ago); Atrioventricular block (atrioventricular Block 1. Degree (I44.0G)); Brain stem infarction; Cardiac insufficiency (upper congestion (I87.1G)); Chronic pain; Gastroesophageal reflux (gastro-esophageal reflux with oesophagitis (K21.0G)); Heart failure (heart failure, unspecified (I50.9G)); Hypercholesterolaemia (LDL: 1.51 gl (04May2021)); Obesity (adipositas, BMI 30-35 (E66.90G)); Oesophagitis; Renal insufficiency (last glomerular filtration rate: 51 ml/min (04May2021)); Rosacea ((L71.8G)); Thrombocytopenia (for years: 47 Gpt/l gl. (04May2021)).
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:30-35; Test Date: 20210504; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:51 ml/min; Test Date: 20210504; Test Name: LDL; Result Unstructured Data: Test Result:1.51 gl.; Test Date: 20210504; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:47 Gpt/l gl.
CDC Split Type: DEPFIZER INC202100987688

Write-up: Lung inflammation; Flu symptoms; pain in the back; This is a spontaneous report from a non-contactable consumer, downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-CADR2021114877. This is the first of two reports; the report for the second dose of Comirnaty. A 79-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 18May2021 at the age of 79 years old (Batch/Lot Number: EX8680, Expiration date: unknown) as dose 2, 0.3 mL single for COVID-19 immunization. Relevant medical history included obesity, further reported as adipositas with body mass index (BMI) of 30-35 on an unspecified date (E66.90G); ongoing hypertension, further described as essential hypertension, not further specified, without details of any hypertensive crisis (I10.90G); ongoing cerebral infarction, further described as results of a cerebral infarct (I69.3G); cardiac insufficiency, further described as upper congestion (I87.1G); brain stem infarction; gastro-esophageal reflux with oesophagitis (K21.0G); ongoing arrhythmia, further described as cardiac arrhythmia, not further specified (I49.9G); atrioventricular block, further reported as atrioventricular Block 1. Degree (I44.0G); heart failure, unspecified (I50.9G); apoplexy, years prior reporting; renal insufficiency with last glomerular filtration rate of 51 ml/min on 04May2021; hypercholesterolaemia with low-density lipoprotein (LDL) of 1.51 gl. on 04May2021; thrombocytopenia for years at 47 Gpt/l gl. on 04May2021; other rosacea and status after (L71.8G); and chronic (chr.) pain. The patient was on mobility without aids. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication at 5 mg high dose, start and stop date were not reported and an unspecified antihypertensive therapy, which was well adjusted for years. The patient previously took valsartan and experienced allergies. The patient previously received bnt162b2 (COMIRNATY) on 06Apr2021 as dose 1, single for COVID-19 immunization and experienced increased body pain and was on hydromorphine (as reported) therapy in the short term. On 18May2021, the patient experienced pain in the back. On 31May2021, the patient experienced lung inflammation and flu symptoms. The patient was without pain therapy on 18May2021, and was then admitted to the clinic as an emergency on 31May2021. This report was considered serious, since the event "lung inflammation" led to hospitalization and death. The patient was hospitalized for lung inflammation from 31May2021 to an unknown date. The outcome of lung inflammation was fatal; the patient was not recovered from flu symptoms; while the outcome of pain in the back was unknown. The patient died on an unspecified date. An autopsy was not performed. Sender Comment: Do you or the person concerned have any allergies? If so, which ones? Valsartan. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101005564 same patient and product; different dose and event; Reported Cause(s) of Death: Lung inflammation


VAERS ID: 1579080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Embolism, Myocardial infarction, Pulmonary embolism, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weight gain (according to family doctor approx. 50 kg within one year).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987601

Write-up: pulmonary embolism; thromboembolism; myocardial infarction; Respiratory failure; Arrest cardiac; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021124199, Safety Case Report Unique Identifier DE-PEI-202100120306. A 37-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included weight increased from an unknown date and unknown if ongoing (according to family doctor approx. 50 kg within one year). The patient''s concomitant medications were not reported. The patient experienced arrest cardiac (death) on 20May2021. On 24May2021, Respiratory failure, resuscitation, death. Suspected diagnoses of the emergency doctor: pulmonary embolism, thromboembolism, myocardial infarction. The patient died on 24May2021. An autopsy was not performed. Senders comment: Information on risk factors or previous illnesses No, only strong weight gain (according to family doctor approx. 50 kg within one year) / on May 24th. Respiratory failure, resuscitation, death. Suspected diagnoses of the emergency doctor: pulmonary embolism, thromboembolism, myocardial infarction. Batch/lot number: Unknown. Comirnaty/ Arrest cardiac/ RA/ Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac; Respiratory failure; pulmonary embolism; thromboembolism; myocardial infarction


VAERS ID: 1579082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Cardiac disorder, Dyspnoea, Extrasystoles, Lactic acidosis, Leukaemia, Multiple organ dysfunction syndrome, Pulmonary embolism, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Hypokalaemia (broad), Sepsis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: lactate; Result Unstructured Data: Test Result:29; Test Date: 20210703; Test Name: PH; Result Unstructured Data: Test Result:6.6; Test Date: 20210703; Test Name: Leukocytes; Result Unstructured Data: Test Result:314000; Comments: with Leukaemia.
CDC Split Type: DEPFIZER INC202100987670

Write-up: Lung embolism; Extrasystoles; Leukocytes of 314 thousand with Leukaemia; patient with dyspnie; right cardiac stress; Multiple organ failure; lactate acidosis; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, company number DE-PEI-CADR2021128714. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3ml, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced lung embolism, extrasystoles, leukocytes of 314 thousand with leukaemia, dyspnea and right cardiac stress. When taken to the clinic, the patient required reanimation with asystole. Reanimation cumulative 10 min. Death of patient with lactate acidosis ph 6.6 and lactate 29 and multiple organ failure. At the time of death, the outcome of the events lung embolism, extrasystoles, leukocytes of 314 thousand with leukaemia, dyspnea and right cardiac stress was not recovered. The patient died on 03Jul2021. An autopsy was not performed. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure; lactate acidosis


VAERS ID: 1579084 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic valve stenosis; Arterial hypertension; Coronary heart disease; Heart valve replacement
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100988205

Write-up: Unknown cause of death; Tiredness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021129130 and the safety report unique identifier is DE-CADRPEI-2021129130. A 79-year-old female patient received BNT162B2 (COMIRNATY, lot number: 1C007A), via an unspecified route of administration on 18May2021 (at the age of 79-years-old) at dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included coronary artery disease, heart valve replacement NOS/ heart valve prothesis, arterial hypertension, and aortic stenosis/ aortic valve stenosis, which were all ongoing. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunisation. It was reported that her first vaccination went well. On 19May2021, the patient experienced unknown cause of death which was reported as medically significant and tiredness. The outcome of the event tiredness was not recovered. The patient died on 19May2021. The cause of death was unknown. An autopsy was not performed. Sender''s Comment: Do you or the person concerned have any allergies? If so, which ones? Information on risk factors or previous diseases: Coronary heart disease, aortic valve stenosis, heart valve prothesis, arterial hypertension. Connection with vaccination?/Tired, exhausted on the first day after the second vaccination, died in the night. First vaccination went well. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579087 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987525

Write-up: Weakness; died with unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-CADR2021130428. A 90-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose 2, 0.3ml single for COVID-19 immunisation. The patient''s weight was 80 kg, and height was 170 cm. Medical history included heart disorder. No concomitant medications were reported. On Jun2021, the patient experienced weakness. On 05Jun2021, the patient died from unknown cause. The outcome of the event weakness was not recovered/not resolved. This report is serious - hospitalization. The patient died on 05Jun2021. An autopsy was not performed. Sender comment: Information on risk factors or previous diseases: Heart. After the second vaccination, my father was seen by a doctor in the community practice and felt weaker every day, therefore he was admitted to hospital for 4 days! Moreover, after his discharge from the community practice, no one bothered to see him. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579092 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Crush syndrome, Dyspnoea, Laboratory test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug addict
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Coronary heart disease.
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Laboratory test; Result Unstructured Data: Test Result: Crush Syndrome.
CDC Split Type: DEPFIZER INC202100987595

Write-up: Crush syndrome; Brain oedema; Dyspnoea; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134443. A 40-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Jun2021 (Batch/Lot Number: FD7958) as dose number unknown, 0.3ml single for COVID-19 immunization. Medical history included ongoing drug addict, Bronchial Asthma, and coronary heart disease from an unknown date. Concomitant medications were not reported. The patient experienced crush syndrome on 04Jul2021, dyspnoea and brain oedema on 02Jul2021. The patient was hospitalized due to the events. The patient a laboratory test which confirmed crush syndrome on 04Jul2021. The patient died from crush syndrome on 04Jul2021. An autopsy was not performed. The outcome of the events dyspnoea and brain oedema was not recovered. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No. Information on risk factors or previous diseases: Known bronchial asthma; drug use - for 20 years / initial shortness of breath, in the further course the patient required resuscitation; artificially ventilated; invasive exclusion of coronary heart disease; finding of massive cerebral oedema; laboratory constellation of Crush''s syndrome- on 04Jul2021- exitus letalis. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Crush syndrome


VAERS ID: 1579094 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Fatigue, International normalised ratio, Loss of consciousness, Mean cell haemoglobin, Mean cell haemoglobin concentration, Nausea, Pancytopenia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: Test Result: elevated; Test Name: mean corpuscular hemoglobin; Result Unstructured Data: Test Result: reduced; Test Name: mean cell hemoglobin concentration; Result Unstructured Data: Test Result: reduced.
CDC Split Type: DEPFIZER INC202100987711

Write-up: Sudden death; Pancytopenia; Anemia; Nausea; Unconsciousness; Tiredness; This is a spontaneous from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134914. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Jul2021 (Batch/Lot Number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unspecified dose and frequency as prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced pancytopenia, anemia, nausea, unconsciousness and tiredness on 08Jul2021 with outcome of not recovered prior to patient''s death. On 09Jul2021, the patient experienced sudden death. The patient underwent lab tests and procedures on an unspecified date which included international normalised ratio: elevated, mean cell haemoglobin: reduced, mean cell haemoglobin concentration: reduced. The patient died on 09Jul2021. It was unknown if an autopsy was performed. Sender''s comment: Do you or the person concerned have any allergies? If so, which ones? No Information on risk factors or previous diseases not available. None/ The patient has always been healthy according to the wife. He had received his first Corona vaccination with Astrazeneca four weeks ago and tolerated it well. Now, yesterday, there had been the possibility, regarding the newly recommended cross-immunisation to receive a Biontech vaccination, which was administered yesterday. Last night, her husband was tired and went to bed early. Slept until morning today, complained of nausea. Around noon, she said, he observed become unconscious, whereupon she began lay resuscitation. This was taken over by the emergency doctor and the admission of the patient took place under ongoing resuscitation with the mechanical resuscitation aid. Repeatedly No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-11
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

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

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Comprehensive check-up; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202100987786

Write-up: Unknown cause of death; Malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021137087. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jun2021 (Lot Number: FE6975) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing arterial hypertension and slight loss of appetite. Patient had no allergies. The patient''s concomitant medications were not reported. On 11Jul2021, the patient experienced malaise. On 12Jul2021, unknown cause of death was reported. The patient died on 12Jul2021. An autopsy was not performed. The outcome of malaise was not recovered. Sender comment: Do you or the person concerned have any allergies: None. Information on risk factors or previous diseases: arterial hypertension well under control and had slight loss of appetite with no vomiting, diarrhea, or fever. On 10Jul2021 went to bed normally, on the morning of 12Jul2021 (also reported as 11Jul2021, possibly discrepant) patient found lifeless in bed. Family doctor said that only the blood pressure was well established. Comprehensive check-up prior to vaccination with Comirnaty completely normal. Family doctor can state no other cause of death. Follow-up attempts are not possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Mitral valve replacement
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: levels of inflammation in the blood; Result Unstructured Data: Test Result: high levels of inflammation in the blood.
CDC Split Type: DEPFIZER INC202100987567

Write-up: High levels of inflammation in the blood, renal insufficiency. Cause for this was not found in the one week until death in the intensive care unit.; High levels of inflammation in the blood; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021138193; other case identifier numbers DE-PEI-202100136175 and DE-CADRPEI-2021138193. An 84-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW8904, expiry date not reported), via an unspecified route of administration on 14Apr2021 as dose number unknown, single for covid-19 immunisation. Medical history included ongoing mitral valve replacement. The patient had no known allergies. The patient''s concomitant medications were not reported. On 26Apr2021, the patient experienced high levels of inflammation in the blood and renal insufficiency. Cause for this was not found in the one week until death in the intensive care unit. Patient was admitted to intensive care unit from an unknown date in 2021 and person unresponsive but not comatose. Therapeutic measures were taken as a result of the event reported as agitated broad-spectrum antibiotic, morphine, and oxygen administration. Patient no change in the one week until death. Mitral valve replacement could not be determined as the cause of the inflammatory values. This report is serious - death. The patient died on an unspecified date in 2021. The causes of death were renal insufficiency and high levels of inflammation in the blood. It was unknown if an autopsy was performed. Sender''s Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous diseases: Mitral valve replacement, could not be determined as the cause of the inflammatory values. Intensive care unit: person unresponsive but not comatose, agitated broad-spectrum antibiotic, morphine, oxygen administration no change in the one week until death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: High levels of inflammation in the blood; renal insufficiency


VAERS ID: 1579107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiovascular disorder, Circulatory collapse, Death, Dizziness, Drug ineffective, Dyspnoea, Peripheral vascular disorder, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: DEPFIZER INC202100987540

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021139488, Safety Report Unique Identifier DE-PEI-202100138155. An elderly female patient received BNT162B2 (COMIRNATY, solution for injection, strength: 0.3 mL), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 1, single and then via an unspecified route of administration on 09Mar2021 (lot number and expiry date were not reported) as dose 2, single for COVID-19 immunization. Medical history included ongoing arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date, COVID-19 test pos. PCR, circulatory disorder peripheral, dizziness and circulatory problems, shortness of breath and collapse on 31Mar2021. The patient received unspecified intensive treatment. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 31Mar2021. The outcome of the event unknown cause of death was fatal while the outcome of all other events was not recovered. The patient died on an unspecified date. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses previously perfectly healthy mobile woman with arterial hypertension. Sudden symptoms after 2nd vaccination / intensive treatment with diagnosis of COVID-19 with positive PCR test. Causal relationship between the event(s) and the administration of CORMINATY was assessed as "Unclassifiable" by the PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1579111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C008A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Chest pain, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987750

Write-up: This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021144448, Safety Report Unique Identifier DE-PEI-202100144297. A 38-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 24May2021 (Batch/Lot Number: 1C008A) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 29May2021, the patient experienced cardiac death (death, medically significant). The patient died on 29May2021. Autopsy was not performed. On 27May2021, patient had pain in the chest and pain in the arm. Senders comment: Are you or the person concerned known of any allergies? If yes, which? Not known Information on risk factors or previous illnesses None. The outcome of cardiac death was fatal. The outcome of events pain in the chest and pain in the arm was not recovered. Event assessment: Comirnaty/ all events/PEI /Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial.


VAERS ID: 1579112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 48
Permanent Disability? 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: Artificial cardiac pacemaker wearer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987743

Write-up: Unknown cause of death; Malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021144865. A 67-year-old male patient received BNT162B2 (COMIRNATY, strength: 0.3 mL, solution for injection, lot number: 1D014A), via an unspecified route of administration on 27May2021 as dose 2, 0.3 mL single for COVID-19 immunization. Medical history included artificial cardiac pacemaker wearer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 19Jul2021 and malaise on 01Jun2021. The outcome of the event unknown cause of death was fatal while the outcome of the event malaise was not recovered. The patient died on 19Jul2021 due to an unknown cause of death. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses Cardiac defibrillator / permanent malaise. Causal relationship between the event(s) and the administration of CORMINATY was assessed as "Unclassifiable" by the Regulatory Authority. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579114 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-26
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYGEN
Current Illness: COPD (permanent oxygen for 4 years).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987653

Write-up: Unknown cause of death; severe pneumonia; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021145708, Safety report unique identifier DE-PEI-202100145867. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease and permanent oxygen for 4 years. Concomitant medication included oxygen. On 26May2021 the patient experienced Lung inflammation, Unknown cause of death. The outcome of the event Lung inflammation was recovered, other event was fatal. The two pneumonia were treated with antibiotics and morphine. He recovered from both of them. The patient''s weight was 80 kg, and height was 170 cm. This report is serious - death. Relatedness of drug to reactions/events. Source of assessment: RA. Result of Assessment: D. Unclassifiable.Patient had his first dose of Comirnaty on an unspecified date for covid-19 immunisation and experienced Lung inflammation. No autopsy done. Patient died on 26May2021. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anaphylactic shock
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016069

Write-up: Anaphylactic shock; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021149926, Safety Report Unique Identifier: DE-PEI-202100150260. A 55-year-old female patient (weight: 66 kg, height: 170 cm) received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2 via an unspecified route of administration on 22Jul2021 (Lot Number: EL1491) at 0.3 ml single dose for COVID-19 immunisation. Medical history included allergy and anaphylactic shock. The patient''s concomitant medications were not reported. The patient experienced anaphylactic shock on 23Jul2021. This report is serious for death. The patient died on 27Jul2021. An autopsy was not performed. The outcome of the event was fatal. Sender''s comments: Do you or the concerned person have any known allergies? If yes, which ones? Yes Information on risk factors or previous illnesses Anaphylactic shock The Regulatory Authority assessment on relatedness of drug to the event anaphylactic shock is D. Unclassifiable. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Anaphylactic shock


VAERS ID: 1579117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ferritin; Result Unstructured Data: Test Result:slight reduction of ferritin
CDC Split Type: DEPFIZER INC202101016095

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021153349. Safety Report Unique Identifier: DE-PEI-202100154208. A 79-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 11Jun2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included Hypertension from unknown date and ongoing. Concomitant medications were not reported. On 13Jun2021 (Time Interval between Beginning of Drug Administration and Start of Reaction / Event was also reported as 60 min) the patient experienced Death from heart failure. The patient died on 13Jun2021. It was not reported if an autopsy was performed. The event assessment between the events to the suspect drug was reported as Unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? : No. Information on risk factors or previous illnesses hypertension, controlled by medication slight reduction of ferritin / 60 hours after receiving the 2nd biotech vaccination death due to heart failure. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death from heart failure.


VAERS ID: 1579118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 77
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016094

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021153552, Safety Report Unique Identifier DE-PEI-202100154781. A 79-year-old male patient received bnt162b2 (COMIRNATY) strength: 0.3 ml, dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021 the patient experienced lung failure 12 days after the 1st vaccination with biontech/lung embolism and shortness of breath. Clinical course was as below: 12 days after the 1st vaccination, the person was admitted to the hospital due to shortness of breath. There he was given oxygen for about 5 weeks, at the beginning about 40 l / min with 90 percent oxygen. The medical team could not determine the cause, but ultimately suspected a shunt without being able to locate it. The condition improved 3 to 4 weeks after admission to the hospital, so that oxygen administration with mobile devices was possible. Patient was then discharged into short-term care for 3 weeks after 5 weeks of hospitalization. After the short-term care, he came back home for 4 weeks at his own request, where he unfortunately died in mid-June2021. An autopsy was not performed. The patient''s outcome was: fatal for Lung embolism and unknown for shortness of breath. This report is serious - death and hospitalization. Causality of events assessment with Comirnaty was D. Unclassifiable per PEI. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Not known. / 12 days after the 1st vaccination, the person was admitted to the hospital due to shortness of breath. There he was given oxygen for about 5 weeks, at the beginning about 40 l / min with 90 percent oxygen. The medical team could not determine the cause, but ultimately suspected a shunt without being able to locate it. The condition improved 3 to 4 weeks after admission to the hospital, so that oxygen administration with mobile devices was possible. Patient was then discharged into short-term care for 3 weeks after 5 weeks of hospitalization. After the short-term care, he came back home for 4 weeks at his own request, where he unfortunately died in mid-June. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: lung failure 12 days after the 1st vaccination with biontech/lung embolism


VAERS ID: 1579120 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026319

Write-up: Guillain Barre syndrome; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021155945], Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100157926. A 78-year-old male patient received the first dose of BNT162B2 (COMIRNATY, strength 0.3 ml) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had no allergies, no previous illnesses. The patient experienced Guillain Barre syndrome that resulting hospitalization, unknown cause of death. It was unknown if an autopsy was performed or not. The patient was not recovered from Guillain Barre syndrome, fatal for unknown cause of death. Relatedness of drug to reaction(s)/event(s) Source of assessment RA Result of Assessment D. Unclassifiable No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579121 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210827072

Write-up: HEART ATTACK RESULTING IN DEATH AFTER 6 WEEKS OF VACCINATION WITH JOHNSON&JOHNSON; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-CADR2021156450] concerned a 65 year old male of unknown race and ethnicity. The patient''s weight was 84 kilograms, and height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 22-JUL-2021, the patient had heart attack (infarct myocardial) resulting in death after 6 weeks of vaccination. 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: 20210827072-COVID-19 VACCINE AD26.COV2.S.-Heart attack resulting in death after 6 weeks of vaccination with Johnson & johnson. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: INFARCT MYOCARDIAL


VAERS ID: 1579123 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100994641

Write-up: Death; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report from the Regulatory Authority-WEB DE-PEI-202100143727. A elderly male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Batch/Lot Number: ER7812) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event assessment : Comirnaty/ all events/RA/Result of Assessment : B. Indeterminate. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202100987532 same reporter/suspect drug/ event, different patient; Reported Cause(s) of Death: Death


VAERS ID: 1579136 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Computerised tomogram head, Inappropriate schedule of product administration, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: Aneurysm cerebral
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Angiography; Result Unstructured Data: Test Result:no results reported; Test Date: 20210726; Test Name: Head CT; Result Unstructured Data: Test Result:no results reported
CDC Split Type: DKPFIZER INC202101016258

Write-up: This is a spontaneous report downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0081896] received from a contactable Physician with Safety Report Unique Identifier DK-DKMA-ADR 25736830. A 54-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Lot Number: FE9174) at 54 years old as single dose for covid-19 immunisation. Medical history included ongoing Aneurysm cerebral. The patient''s concomitant medications were not reported. The patient was vaccinated with first dose of COMIRNATY (Batch number: FC2336) on 09Jun2021 for COVID-19 immunisation. On 26Jul2021, 5 days after the second vaccination, the patient developed bleeding from aneurysm (arteria basilaris) and subarachnoid haemorrhage from the basilar artery with following incarceration. The patient was treated with an attempt of endovascular treatment of the aneurysm (not specified). The ADRs(adverse drug reactions) were by the reporter reported as being fatal. The patient underwent lab tests and procedures which included on 26Jul2021 Head CT (computed tomogram) and angiography, both with no results reported. The patient died on 27Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Bleeding from aneurysm (arteria basilaris); Subarachnoid haemorrhage from the basilar artery with following incarceration.


VAERS ID: 1579228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Irritability, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN; SIMVASTATIN; HYDREX [HYDROCHLOROTHIAZIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in residential institution.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100996870

Write-up: Sudden death; Irritability; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213739. A 64-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 08Jul2021 (Batch/Lot Number: FE3065) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included living in enhanced service housing. Concomitant medications included losartan; simvastatin; and hydrochlorothiazide (HYDREX [HYDROCHLOROTHIAZIDE]). On 10Jul2021, the patient experienced sudden death and irritability, both resulted to fatal outcome. It was further reported that a man living in enhanced service housing received a booster vaccine on Thursday 08Jul. Did not verbally tell about the changes in his well-being, but the staff found that the resident was more aggressive than normal. Resident was met on Saturday 10Jul at 11:00 and was found dead in the apartment at 16:00. There was no information on the contribution of the vaccination to death. The deceased was delivered for medical autopsy. The patient died on 10Jul2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death; Irritability


VAERS ID: 1579233 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / 1 - / OT

Administered by: Unknown       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: COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; CARDENSIEL; LASILIX [FUROSEMIDE]; PROCORALAN
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Death of brother cardiac arrest; Left ventricular ejection fraction (40%); Overweight; smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: AM20212231) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CARDIAC ARREST in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. The patient''s past medical history included Smoking, Overweight, Left ventricular ejection fraction (40%) and Chronic respiratory failure. Family history included Death of brother; cardiac arrest. Concurrent medical conditions included Hypertension arterial. Concomitant products included PERINDOPRIL ARGININE (COVERSYL [PERINDOPRIL ARGININE]), ACETYLSALICYLATE LYSINE (KARDEGIC), BISOPROLOL FUMARATE (CARDENSIEL), FUROSEMIDE (LASILIX [FUROSEMIDE]) and IVABRADINE HYDROCHLORIDE (PROCORALAN) for an unknown indication. On 14-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment to the event was not reported. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list; Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 1579269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Infarction, Nausea, Neurosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Pollen allergy; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026443

Write-up: Dyspnea/difficulty in breathing; Arrest cardiac; nausea; neurosis; infarction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number [FR-AFSSAPS-PB20215002]. A 54-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 13May2021 (Lot Number: FA5829) as dose 1, single for COVID-19 immunization. Medical history included smoker, alcohol user and pollen allergy. The patient''s concomitant medications were not reported. On 19May2021, the patient presented several effects: nausea, difficulty in breathing and cardiac arrest potentially due to either a neurosis or an infarction leading to the death of the patient despite the intervention of the firefighters. Therapeutic measures were taken as a result of the events. The patient died on 19May2021. Cause of death were cardiac arrest, dyspnea, nausea, neurosis and infarction. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Dyspnea; nausea; neurosis; infarction


VAERS ID: 1579276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-20
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Computerised tomogram thorax, Fraction of inspired oxygen, Haemodynamic test, Multiple organ dysfunction syndrome, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISONE; ESOMEPRAZOLE; GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; LERCANIDIPINE; PERINDOPRIL; NEOMERCAZOLE; IVABRADINE; SIMVASTATIN; SYMBICORT; LEDERFOLINE; DAFALGAN; UVEDOSE
Current Illness: Arthritis rheumatoid; Dialysis (awaiting transplantation); Dyslipidaemia; End stage renal failure; Goiter; Hypertension arterial; Hyperthyroidism; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes zoster; Interstitial pneumonitis (interstitial lung disease with a favourable evolution in 2001 with probable sequelae); Phlebitis; Pneumocystosis; Thrombophlebitis
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: thoracic CT scan; Result Unstructured Data: Test Result:severe damage greater than 50%; Test Date: 20210622; Test Name: FiO2; Test Result: 100 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210623; Test Name: FiO2; Test Result: 100 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210607; Test Name: oxygen saturation; Test Result: 83 %; Test Date: 20210622; Test Name: oxygen saturation; Test Result: 80 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210623; Test Name: oxygen saturation; Test Result: 80 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210604; Test Name: sars-cov-2 PCR test; Test Result: Positive ; Test Date: 202106; Test Name: Hemodynamics; Result Unstructured Data: Test Result:deteriorated; Test Date: 20210520; Test Name: body temperature; Result Unstructured Data: Test Result:hyperthermia
CDC Split Type: FRPFIZER INC202101016176

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212356. A 61-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Apr2021 (Batch/Lot Number: Unknown) as dose 2, single, dose 1 intramuscular on 20Mar2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunization. Medical history included thrombophlebitis from 2012, ongoing end-stage chronic renal failure, ongoing dialysis awaiting transplantation, ongoing arterial hypertension, ongoing type 2 diabetes mellitus, ongoing dyslipidaemia, ongoing Arthritis rheumatoid, pneumocystis in 2010, femoropopliteal phlebitis in 2012, goitre with ongoing hyperthyroidism, herpes zoster and Interstitial pneumonitis (interstitial lung disease with a favourable evolution in 2001 with probable sequelae). No known history of allergy. Covid-19 history was No. Concomitant medications included prednisone; esomeprazole; algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON); lercanidipine; perindopril; carbimazole (NEOMERCAZOLE); ivabradine; simvastatin; budesonide, formoterol fumarate (SYMBICORT); calcium folinate (LEDERFOLINE); paracetamol (DAFALGAN); colecalciferol (UVEDOSE). On 20May2021 she presented with hyperthermia, myalgia and general deterioration. Positive PCR on 04Jun2021. Put on Augmentin for 7 days. On 07Jun2021, she was hospitalized in a specialized department due to increased dyspnea and desaturation at 83% after her usual dialysis session. The thoracic CT scan showed severe damage greater than 50%. No pleural effusion. During the night of 22Jun2021 to 23Jun2021, the patient''s respiratory status deteriorated with hypercapnic acidosis with major oxygen deprivation leading to desaturation of 80% despite a FiO2 of 100%. Hemodynamics deteriorated secondarily with increased doses of Noradrenaline up to 2 ug/kg/minute. Tazocillin and Amiklin were started on suspicion of septic shock with a pulmonary origin. The evolution towards a refractory multivisceral failure syndrome led to the death of the patient on 23Jun2021. In total, 61-year-old patient hospitalized for Covid-19 infection with severe respiratory failure leading to death, after vaccination with 2 doses of COMIRNATY. The patient died on 23Jun2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Covid-19 infection with severe respiratory failure; multivisceral failure syndrome; Covid-19 infection with severe respiratory failure.


VAERS ID: 1579296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-06
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

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: BISOPROLOL; CANDESARTAN; DIAZEPAM; FOLIC ACID; METOJECT; OMEPRAZOLE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthralgia (arising from rotator cuff injury); Colitis ulcerative; Hypertension; Rotator cuff syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992332

Write-up: This is a spontaneous report from a contactable physician received from Regulatory Authority. The regulatory authority report number is GB-MHRA-TPP30313820C968716YC1626777544107. A 5-years-old male patient received second dose of bnt162b2 (bnt162b2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 15Jun2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included colitis ulcerative, hypertension, arthralgia, ongoing arising from rotator cuff injury and rotator cuff syndrome from an unknown date and unknown if ongoing. Concomitant medications included bisoprolol taken for an unspecified indication from 15Nov2018 to 07Jul2021; candesartan taken for hypertension from 21Oct2019 to 07Jul2021; diazepam taken for an unspecified indication from 12Nov2015 to 07Jul2021; folic acid taken for an unspecified indication from 03Jan2014 to 07Jul2021; methotrexate sodium (Metoject) taken for an unspecified indication from 23Sep2019 to 07Jul2021; omeprazole taken for an unspecified indication from 02Oct2018 to 07Jul2021; tramadol taken for an unspecified indication from 11Dec2018 to 07Jul2021. On 06Jul2021, patient experienced pulmonary embolus (pulmonary embolism) (death, medically significant) and on an unspecified date patient experienced deep vein thrombosis. On 06Jul2021, patient died due to pulmonary embolus. Cause of death from post-mortem determined as pulmonary embolus secondary to right calf deep vein thrombosis. The outcome of deep vein thrombosis was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.; Reported Cause(s) of Death: Pulmonary embolism.


VAERS ID: 1579326 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-23
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound foetal
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? Yes
Died? Yes
   Date died: 2021-07-28
   Days after onset: 35
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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy; Comments: Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210705; Test Name: ultrasound fetal; Result Unstructured Data: 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks; Test Date: 20210719; Test Name: ultrasound fetal; Result Unstructured Data: 2nd scan confirmed no growth and no heartbeat.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 25742447) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage), ABORTION SPONTANEOUS (surgical miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding. The patient''s past medical history included Miscarriage and Pregnancy. Concurrent medical conditions included Lactation decreased. Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (surgical miscarriage) (seriousness criteria hospitalization, medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) (seriousness criteria hospitalization and congenital anomaly). The delivery occurred on 28-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABORTION SPONTANEOUS (surgical miscarriage) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Ultrasound foetal: 5 wks 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks. On 19-Jul-2021, Ultrasound foetal: abnormal (abnormal) 2nd scan confirmed no growth and no heartbeat.. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was stated that patient was exposed to the medicine before pregnancy. Details of scans or investigations: Scan at 7 weeks gestation showed 5 week measurements. Further scan at 9 weeks confirmed no growth and no heartbeat. Treatment medication was not provided by the reporter. Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. 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. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. 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. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1579553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: GBPFIZER INC202100998300

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108040856409310-DSWWG. Safety Report Unique Identifier is GB-MHRA-ADR 25750434. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not known, expiry date not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. The patient experienced death on 04Feb2021. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained.; Reported Cause(s) of Death: Death.


VAERS ID: 1579624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: No adverse Event, no medical history per source document.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No adverse Event, no medical history per source document. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria death and medically significant). The reported cause of death was Pneumonia. It is unknown if an autopsy was performed. No concomitant medications were provided. No treatment information was provided. This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Sender''s Comments: This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1579676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, SARS-CoV-2 test
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None.
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101028687

Write-up: Brain swelling; This is a spontaneous report from a contactable healthcare professional received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108091935046780-ZA83N, Safety Report Unique Identifier GB-MHRA-ADR 25776597 A 34-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 08Aug2021 as single dose for COVID-19 immunisation. No relevant medical history. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced brain swelling (fatal per HA assessment) on 09Aug2021. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 09Aug2021. This report is not related to possible blood clots or low platelet counts. The patient died on 09Aug2021. 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: Brain swelling


VAERS ID: 1579689 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:showed the baby died just days after receiving the; Comments: vaccine just after 8 weeks.
CDC Split Type: GBPFIZER INC202101019814

Write-up: Baby died; Patient was exposed to the medicine first-trimester (1-12 weeks).; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a fetus report. The mother report is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051925090980-SOJDR. Safety Report Unique Identifier GB-MHRA-ADR 25761509. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 transplacental on 17Jul2021 (Lot Number: FE1510) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid taken for vitamin supplementation. Baby died days after 2nd vaccine dose just over 8 weeks gestation (baby had not been conceived before first dose). Patient was exposed to the medicine first-trimester (1-12 weeks). Scan just before 12 weeks showed the baby died just days after receiving the vaccine just after 8 weeks. The baby died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101012902 case for mother; Reported Cause(s) of Death: Patient was exposed to the medicine first-trimester (1-12 weeks); baby died


VAERS ID: 1579698 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATACAND
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19 (The patient presented covid-19 disease months before and recovered at home under medication); Hyperplasia of prostate (Benign hyperplasia of prostate).
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:40 Centigrade; Comments: fever up to 40 degree Celsius; Test Date: 20210723; Test Name: Fever; Result Unstructured Data: Test Result:$g39 Centigrade; Comments: over 39 degree Celsius.
CDC Split Type: GRPFIZER INC202101026136

Write-up: FEVER OVER 39 DEGREE CELSIUS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is GR-GREOF-20216444. This physician reported different events for both doses of COMIRNATY for the same patient. This is the first of two reports for events under the second dose. A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 (at the age of 90-year-old) (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included arterial hypertension, Hyperplasia of prostate (Benign hyperplasia of prostate). The patient also presented covid-19 months before and recovered at home under medication on unknown date. Concomitant medication included candesartan cilexetil (ATACAND) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation on unknown date (Batch/Lot Number: Unknown) and the patient after the first dose of COMIRNATY presented fever up to 40 degree celsius and received medication with antifebrile for 3 days. The patient experienced fever over 39 degree Celsius on 23Jul2021 and reported as serious due to death and medically significant. It was reported that on 23Jul2021 he received the second dose of COMIRNATY. At night he presented fever over 39 degree celsius. On 24Jul2021 he was found on floor at home unconscious. He was dead. Despite his age he was totally functional and self service. His wife died from covid-19 months before. The patient died on 24Jul2021 due to fever. 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.; Sender''s Comments: Linked Report(s) : GR-PFIZER INC-202101037434 the same patient, different doses and outcome; Reported Cause(s) of Death: Fever


VAERS ID: 1579782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Hypertension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypertension (narrow), 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: Medical History/Concurrent Conditions: Hypertension (treatment with antihypertensive drugs).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101016246

Write-up: hypertension; Sudden cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-765753. A 62-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 14:29 (Batch/Lot Number: FE2625; Expiration Date: 31Oct2021) at single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing (treatment with antihypertensive drugs). Concomitant medication included antihypertensive drugs. The patient experienced sudden cardiac arrest (death) on 15Jul2021 18:00. It was reported the actions taken (Cardiopulmonary resuscitation and unsuccessful adrenaline administration, family refuses diagnostic finding). It was reported from the resuscitation protocol to which the patient was subjected without success it is indicated that: the husband reported that after hearing a noise he saw patient unconscious on the ground. After a few minutes, help arrived and cadiopulmonary resuscitation with adrenaline sum was performed, but unfortunately the asystole was permanent, and the lady died. The general practitioner reported that the patient was hypertensive on treatment with antihypertensive drugs, but had strong doubts about the patient''s adherence to the therapy. Therapeutic measures were taken as a result of sudden cardiac arrest. The patient died on 15Jul2021. The cause of death was hypertension and sudden cardiac arrest. It was unknown if an autopsy was performed. The outcome of event was fatal. Reporters comment: Difficult to identify an etiology in the absence of diagnostic evidence, presumably the underlying hypertension represents the primary cause of sudden asystole - Reaction time: 18:00 - Posted by RA. Senders comment: 03Aug2021 Regulatory Authority: requests for follow-up information from the reporter regarding the clinical report of the case and any concomitant drugs. 05Aug2021 Regulatory Authority: the form is updated with the additional information provided by the reporter; Reporter''s Comments: Difficult to identify an etiology in the absence of diagnostic evidence, presumably the underlying hypertension represents the primary cause of sudden asystole - Reaction time: 18:00 - Posted by RA; Reported Cause(s) of Death: sudden cardiac arrest; hypertension


VAERS ID: 1579791 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERPLEX FOL; CARDIOASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Pulse; Result Unstructured Data: Test Result: There was no longer a pulse.
CDC Split Type: ITPFIZER INC202101025916

Write-up: Maternal exposure during pregnancy, second trimester (14 weeks); There was no longer a pulse; Dimensions of the fetus were stopped at 14 weeks; This is a spontaneous report from a contactable consumer (patient''s mother). This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB (Regulatory Authority Report Number: IT-MINISAL02-762143). This consumer reported events for both mother and fetus. This is the fetus report. A 37-year-old mother received BNT162B2 (COMIRNATY; Lot Number: FC5089, Expiration Date: 31Oct2021), via an unspecified route of administration in left arm, on 20Jun2021 at 16:33 (at the age of 37 years), as dose 1, single, for COVID-19 immunization. The mother''s medical history included pregnancy. The mother''s concomitant medications included calcium folinate/ iron succinyl-protein complex (FERPLEX FOL) for pregnancy and acetylsalicylic acid (CARDIOASPIRIN). On 20Jun2021, the fetal patient of an unspecified gender experienced maternal exposure during pregnancy, second trimester via transplacental route of administration. The patient experienced congenital anomaly. On 14Jul2021, the mother made the visit (physician office visit) because she was in the eighteenth week of pregnancy, but she discovered that there was no longer a pulse, the dimensions (dimens) of the fetus were stopped at 14 weeks, that of the first dose vaccine (20Jun2021). The events were considered serious as medically significant. The outcome of the events was fatal. The patient died on 20Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202100988280 Maternal case; Reported Cause(s) of Death: Maternal exposure during pregnancy, second trimester; There was no longer a pulse; Dimensions of the fetus were stopped at 14 weeks


VAERS ID: 1579806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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 INC202100987289

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122909. The patient was an 87-year-old male. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 16Jul2021 (17 days after the vaccination), the patient experienced unknown cause of death. The outcome of the event was fatal. The outcome date was reported as 27Jul2021 (as reported).The course of the event was as follows: On 25Jul2021 (26 days after vaccination), in the evening, when the patient''s oldest son visited the patient''s home, he noticed that the package which was delivered on 18Jul2021 (19 days after vaccination) when he visited the previous time was left undisturbed. When the son searched around the neighborhood, the patient was dead on the bank under the patient''s field. The dead body was almost skeletonized. The last time when the patient was found alive was on 16Jul2021, at around 07:30 (17 days after vaccination) when the neighbor found the patient doing farm work. The last time when the oldest son, who was visiting the patient''s home every week, met the patient was on 11Jul2021, at around 18:00 (12 days after vaccination). The last hospital visit to the orthopedic surgery clinic, where the patient was periodically visiting for lumbago, was 13Jul2021 (14 days after vaccination). On both days, the patient seemed not to complain of physical deconditioning. Although the patient was an elderly, he was not periodically visiting the hospital for a medical disease. The involvement of severe injury associated with fracture was ruled out on the autopsy. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The possibility of heat illness or the onset of an acute disease was considerable. However, when the patient was found, the dead body was almost skeletonized. Thus, although the involvement of severe injury associated with fracture was ruled out, the cause of death was not identified. The reporting physician commented as follows: Although it was reported that the patient received the second dose of BNT162b2 vaccination on 29Jun2021 (the day of vaccination), the symptoms from the vaccination to the death were unknown. At least, the patient did not complain of physical deconditioning on 11Jul2021 (12 days after vaccination) when the son met the patient and on 13Jul2021 (14 days after vaccination) when the patient visited the hospital where he was periodically visiting. The dead body which was found on 25Jul2021 (26 days after vaccination) was almost skeletonized, and the cause of death could not be identified. Of note, it was judged that the patient died on around 16Jul2021 (17 days after vaccination, until 18Jul2021 [19 days after vaccination] at the latest) according to the last eyewitness information. However, it was the end of the rainy season in the district where the patient lived at that time, and the highest temperature was above 30 degrees Celsius. Thus, the possibility of heat illness other than the onset of an acute disease was fully considerable. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579808 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-31
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: TAKEPRON; PREDNISOLONE; ALFAROL; FOLIAMIN [FOLIC ACID]; LIPITOR; ASPARA-CA; ALINAMIN [FURSULTIAMINE HYDROCHLORIDE]; DAIPHEN; IMURAN [AZATHIOPRINE]; SENNOSIDE [SENNOSIDE A+B]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Folate deficiency; Interstitial pneumonia; Microscopic polyangiitis; Vitamin B1 deficiency.
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result: 36.3 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100987359

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122145. A 87-year and 4-month-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EY0572; Expiration Date: 31Oct2021), via an unspecified route of administration on 16Jul2021 (at the age of 87-years-old) as dose 2, single for COVID-19 immunisation. On 25Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). Body temperature before vaccination was 36.3 degrees centigrade. The family history was not provided. The patient had medical histories of microscopic polyangiitis, interstitial pneumonia, dementia, folate deficiency, and vitamin B1 deficiency. The concomitant medications included lansoprazole (TAKEPRON OD tablet 15 mg) at 15 mg x 1 tablet, prednisolone (PREDNISOLONE oral powder 1% ) at 0.3 g, alfacalcidol(ALFAROL oral powder 1 ug/g) at 1 g, folic acid (FOLIAMIN 5mg) at 5 mg x 1 tablet, atorvastatin calcium hydrate (LIPITOR 5 mg) at 5 mg x 1 tablet, aspartate calcium (ASPARA-CA 200) at 200 x 2 tablets, fursulfianine hydrochloride (ALINAMIN 25 mg) at 25 mg x 2 tablets, sulfamethoxazole, trimethoprim (DAIPHEN granules) at 1 g, azathioprine (IMURAN 50 mg) at 50 mg x 1 tablet, and sennoside A,B calcium (SENNOSIDE) at 0.3 g. The patient experienced cardio-respiratory on 31Jul2021. The clinical course was reported as follows: On 31Jul2021 at 07:00 (15 days after the vaccination), the patient experienced cardio-respiratory arrest. The patient was receiving periodical doctor''s visit from the reporting hospital for the above described underlying diseases. The patient was orally taking above described drugs for interstitial pneumonia and others. In addition, the patient was undergoing home oxygen therapy. The patient received the first dose of BNT162b2 vaccination on 25Jun2021, and the second dose on 16Jul2021 (the day of vaccination). Until then, the course was observed with stable condition. No particular findings were observed at doctor''s visit on 26Jul2021 (10 days after vaccination). However, on 31Jul2021, at around 07:00 (15 days after vaccination), the patient had been already in a state of cardio-respiratory arrest. On the same day, at 04:00 (15 days after vaccination), no abnormal changes were observed. On 31Jul2021 (15 days after the vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were respiratory failure due to interstitial pneumonia and others. The reporting physician commented as follows: In this case, the patient who had a stable course until then suddenly died on Day 15 after the second dose of the vaccination. Thus, the causality between the event and BNT162b2 vaccination could not be ruled out, and thus, this case was reported. However, since the patient had an underlying disease of interstitial pneumonia which required home oxygen therapy and she was an elderly, these factors themselves were considered as the risks of a sudden change.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1579810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987495

Write-up: aortic rupture; cardiac arrest; This is a spontaneous report from a contactable physician received via a Pfizer employee. A 93-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), intramuscularly on 04Jun2021 as dose number unknown, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced aortic rupture and cardiac arrest on 20Jun2021. The clinical course was as follows: On 04Jun2021, the patient received Comirnaty. It had passed without any problems. On 20Jun2021, the patient died from cardiac arrest due to aortic rupture at the facility that the patient went for a short stay. The cause of death was aortic rupture. The patient died on 20Jun2021. It was not reported if an autopsy was performed and the reported causes of death were aortic rupture and cardiac arrest. The reporting physician commented as follows: It had passed more than two weeks after the vaccination, and the causality was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: aortic rupture; cardiac arrest


VAERS ID: 1579822 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Migraine (Pre-existing disease)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993482

Write-up: Death due to aortic dissection; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 73-year-old female. Medical history included migraine. The patient''s concomitant medications were not reported. On 05Jun2021 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose (at the age of 73-years-old) for COVID-19 immunization. On an unknown date (one week or more after the vaccination), the patient experienced aortic dissection. On an unknown date (one week or more after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had migraine as a pre-existing disease. On 05Jun2021, the patient received the first dose of Comirnaty. On unknown date (one week or more after the vaccination), the patient experienced aortic dissection and died (when Information was received from the patient''s family member about cancellation of the second vaccination, the occurrence of the event was revealed). Outcome of the events was fatal. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the event was unlikely related to BNT162b2 because the patient died one week or more after the vaccination. The reporting physician commented: Due to the characteristics of the event, it was impossible to collect detailed information from the patient''s family member about the hospital to which the patient was urgently transferred. There was thus no further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Due to the characteristics of the event, it was impossible to collect detailed information from the patient''s family member about the hospital to which the patient was urgently transferred. There was thus no further information.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event aortic dissection and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Aortic dissection


VAERS ID: 1579823 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Disseminated intravascular coagulation, Hepatorenal syndrome, Hyperglycaemic hyperosmolar nonketotic syndrome, Respiratory failure, Somnolence, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood glucose; Test Result: 794 mg/dl; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result: decreased; Comments: Blood pressure decreased; Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: Test Result:37s to 38s Centigrade.
CDC Split Type: JPPFIZER INC202100993491

Write-up: Respiratory failure; groggy after vomiting; groggy after vomiting; Hyperosmolar hyperglycaemic syndrome; disseminated intravascular coagulation; hepatorenal disorders; This is a spontaneous report from a contactable physician received from the Regulatory Authority; the Regulatory Authority report number is v21122205. An 85-year-old male patient (reported as 85-year and 5-month-old) received the second dose of BNT162B2 (COMIRNATY) Solution for injection (batch/lot number: EY0573 and expiration date: 30Sep2021) via an unspecified route of administration, on 26Jul2021 at 13:54 (the day of vaccination) at the age of 85 years old, as DOSE 2, SINGLE for COVID-19 immunization. Patient''s body temperature before vaccination was 36.7 degrees centigrade. Medical history included diabetes mellitus and dementia Alzheimer''s type, both from an unknown date. The patient''s family history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY) via an unspecified route of administration, on an unspecified date (batch/lot number and expiration date were unknown) as DOSE 1, SINGLE for COVID-19 immunization. On 02Aug2021 at 12:00 (7 days after the vaccination, as reported), the patient experienced hyperosmolar hyperglycaemic syndrome. On 02Aug2021 (7 days after the vaccination, as reported), the patient was admitted to the hospital. On 02Aug2021 at 17:23 (7 days after the vaccination, as reported), the outcome of the event was fatal. The course of the events was as follows: On 26Jul2021, the patient received the second dose of Comirnaty. From 27Jul2021, the patient had pyrexia of 37s to 38s degrees C (Centigrade). On 02Aug2021 at around 12:00, the patient became groggy after vomiting, and at around 12:45, he was urgently transferred to the reporting hospital. On arrival at hospital, the patient presented with consciousness disturbed, blood pressure decreased, and respiratory failure. Blood test showed blood glucose of 794 mg/dL, disseminated intravascular coagulation, and hepatorenal disorders. The patient was considered to have hyperosmolar hyperglycaemic syndrome, for which treatment was started but showed poor response. At 17:23, he was confirmed dead. Outcome of the event hyperosmolar hyperglycaemic syndrome was fatal. Outcome of the other events was unknown. The reporting physician classified the event hyperosmolar hyperglycaemic syndrome as serious (death and hospitalization) and assessed that the causality between the event and BNT162B2 was unassessable. Date of hospitalization was 02Aug2021, Date of discharge(death) was 02Aug2021. Other possible cause of the events such as any other diseases was diabetes mellitus. Outcome of the event hyperosmolar hyperglycaemic syndrome was fatal. It was not reported if an autopsy was performed. The reporting physician commented as follows: The event was considered likely to be related to the underlying disease of diabetes mellitus, however, the causality was unknown. Since the event occurred after the vaccination, this case was accordingly reported.; Reported Cause(s) of Death: Hyperosmolar hyperglycaemic syndrome


VAERS ID: 1579825 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: CONIEL; URINORM [BENZBROMARONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Lung cancer; Varicose veins of lower extremities.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993556

Write-up: aortic dissection; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 13Jul2021 15:15 (Batch/Lot Number: EY0572; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. Medical history included lung cancer, hypertension and varicose veins of lower extremities. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included benidipine hydrochloride (CONIEL) and benzbromarone (URINORM) both taken for an unspecified indication, start and stop date were not reported. On 26Jul2021 (13 days after the vaccination), the patient experienced death due to aortic dissection. The event resulted in emergency room/department or urgent care. The outcome of the event was fatal, and it was unknown if treatment was performed. The reporting physician assessed the event as serious (fatal). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 26Jul2021 due to aortic dissociation. It was unknown if an autopsy was performed.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the event aortic dissection cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1579836 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lung neoplasm malignant, Neoplasm progression
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   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: BEPOTASTINE BESILATE; TRANEXAMIC ACID; CARBAZOCHROME SODIUM SULFONATE; CODEINE PHOSPHATE; RINDERON [BETAMETHASONE DIPROPIONATE]
Current Illness: Lung cancer (for the treatment, the patient received on palliative therapy at home).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023257

Write-up: died due to the underlying disease (lung cancer); died due to the underlying disease (lung cancer); This is a spontaneous report from a contactable consumer via a sales representative. A 74-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose number unknown, single (at age of 74-years-old) for covid-19 immunisation. Medical history included ongoing lung cancer, for the treatment, the patient received on palliative therapy at home. Concomitant medications included bepotastine besilate; tranexamic acid tablet; carbazochrome sodium sulfonate tablet; codeine phosphate; betamethasone dipropionate (RINDERON). On 09Aug2021 (3 days after the vaccination), the patient died due to the underlying disease (lung cancer). The patient died on 09Aug2021. It was not reported if an autopsy was performed. Outcome of the events 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: died due to the underlying disease (lung cancer); died due to the underlying disease (lung cancer)


VAERS ID: 1579838 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Septic shock, Urinary tract infection
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), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   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: Test Date: 20210809; Test Name: blood pressure; Result Unstructured Data: Test Result:60s
CDC Split Type: JPPFIZER INC202101023997

Write-up: septic shock due to urinary tract infection was suspected; Cardio-respiratory arrest; septic shock due to urinary tract infection was suspected; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21122832. A 73-year and 5-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot # unknown) at the age of 73 years, via an unspecified route of administration on 17Jul2021 (the day of vaccination) as dose 2, single for COVID-19 immunization. The family history was not provided. The medical history and concomitant medications were unknown. On 26Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# unknown) as a single dose for COVID-19 immunization. Body temperature before vaccination was unknown. On 09Aug2021 at 08:00 (23 days after the vaccination), the patient experienced the events. The course of the events was as follows: On 09Aug2021, at 08:00 (23 days after the vaccination), after the patient took a meal, the blood pressure was measured, which showed 60s. The patient did not respond to a call, and an ambulance was called. When the patient was transferred, she had shock vital. The results of the detailed examination showed that septic shock due to urinary tract infection was suspected. However, it was difficult to assess the definite cause. The patient had pulseless electrical activity (PEA), and then she had cardiopulmonary arrest (CPA), and she died. The outcome of the events was fatal. 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. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest; septic shock due to urinary tract infection was suspected; septic shock due to urinary tract infection was suspected


VAERS ID: 1579851 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acidosis, Cardiac death, Circulatory collapse, Computerised tomogram, Discoloured vomit, Hypersensitivity, SARS-CoV-2 test, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Fruit allergy (kiwi); Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: whole-body CT scan after death; Result Unstructured Data: Whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs.; Test Date: 20210802; Test Name: SARS CoV-2 antigen test; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210802; Test Name: scan; Result Unstructured Data: image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right-sided enlargement.
CDC Split Type: JPTAKEDA2021TJP069671

Write-up: cardiac death; Acute circulatory failure; Allergy; Acidosis; Discoloured vomit; This case was received via Regulatory Authority (Reference number: 2021TJP069671) on 05-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician via a medical representative, and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21122425). A patient had allergy to kiwi fruits and obesity. On an unknown date, body temperature before the vaccination: unknown. On 02-Aug-2021, around 18:00, the patient received the 1st dose of the vaccine. Around 19:30, the patient did not complain of any symptom. Around 20:00, a gurgling sound was heard from the bed, and a small amount of yellow colored vomit was noted. The patient did not respond to calls and had ill complexion. An emergency call was made, and cardiopulmonary resuscitation was started as instructed by the operations center. At 20:17, on arrival of the ambulance team, the patient was asystole and was transported with intubation and adrenaline administration by a physician. At 20:42, the patient arrived at the hospital. On arrival, JCS was 300, and the patient was asystole, had no spontaneous breathing, both dilated pupils of 6 mm in diameter, and coldness with poor skin tone of the whole body including the face. The patient was obese. Marked acidosis was found on the blood gas measurement. Resuscitation was continued thereafter , but there was no response. At 22:06, the patient was confirmed dead. The result of the SARS CoV-2 antigen test was negative. A whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs. However, there was a possibility that changes associated with cardiac massage, pulmonary congestion, or aspiration occurred. In addition, image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right sided enlargement. On 03-Aug-2021, the body was moved through the police to the university, and a legal autopsy was performed. The following were the details: 1) there were findings of acute circulatory failure such as congestion of the face, petechiae of the palpebral conjunctiva, cerebral edema, and pulmonary congestion. 2) reportedly, there were findings of suspected allergy such as edema of the epiglottis and submucosal petechiae of the larynx. The exact cause of death was unclear, but acute circulatory failure/acute cardiac death was suspected from the findings in the legal autopsy. The outcome of acute circulatory failure, acute cardiac death, allergy, acidosis, and yellow-colored vomit was reported as fatal. Follow-up investigation will be made.; 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. However, the patient''s underlying obesity is a confounder.; Reported Cause(s) of Death: Cardiac death; Acute circulatory failure; Allergy; Acidosis; Vomiting


VAERS ID: 1579910 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E40585 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Cough, Dysphagia, Dyspnoea, Headache, Nausea, Respiratory distress, Seizure, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101023160

Write-up: headache; Chills; Nausea; Vomit; Abdominal pain epigastric; Tachycardia; Cough; Dyspnea/ Respiratory distress; Dyspnea/ Respiratory distress; afebrile seizures; intolerance oral/Dysphagia; hospitalized due to deterioration; This is a spontaneous report from a non-contactable other hcp. This is a report received. The Regulatory authority report number 16987-8. A 40-year-old female non-pregnant patient received bnt162b2 (Pfizer vaccine), dose 1 intramuscular, administered in arm left on 07Jul2021 at her 40-year-old (Lot Number: E40585) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, chills, nausea, vomit, abdominal pain epigastric, tachycardia, cough, dyspnea, respiratory distress, afebrile seizures, dysphagia, hospitalized due to deterioration, all on an unspecified date with fatal outcome. Therapeutic measures were taken as a result of all events. The patient died on an unspecified date. It was not reported if an autopsy was performed. All events were assessed as serious with death, hospitalization. The clinical course was reported as follows: Female patient who presents hours past receiving Pfizer vaccine epigastric abdominal pain, nausea, and vomit, as well as oral intolerance, treatment, 48 hours past was hospitalized due to deterioration. Treatment administered: Yes; norepinephrine 98 mg in 100 mL at 0.5 MCG KG minute dose. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: hospitalized due to deterioration; Headache; Chills; Nausea; Vomit; abdominal pain epigastric; tachycardia; cough; dyspnea; respiratory distress; dyspnea; respiratory distress; Afebrile seizure; intolerance oral; dysphagia.


VAERS ID: 1579913 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Haemoptysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC202101018490

Write-up: Reason of death was written as "old age"; coughed bloody sputum thereafter (time between vaccination and 1st incident of bloody sputum is unknown); This is a spontaneous report from a contactable consumer via Pfizer colleague. An 80-year-old female patient received 2nd dose of bnt162b2 (COMIRNATY, lot number was not provided) at 80-year-old, via an unknown route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. It was reported that the batch number and expiry date with vaccine details will be provided after funeral arrangements are sorted out. Patient''s medical history and concomitant medications were not reported. The patient passed away this morning on 09Aug2021. Patient had her 2nd dose of Comirnaty on 06Aug2021 and was coughing bloody sputum a few days after (It was also reported that She coughed bloody sputum thereafter, time between vaccination and 1st incident of bloody sputum is unknown). She passed away at home and her body was found haemorrhaging. She had other health issues as well. Police did not require post-mortem and reported the death as "old Age". Attached is the death certificate. Based on the information from the death certificate, it was noted that the patient''s age was 80 years 5 months and 14 days old and date of death was on 09Aug2021 at 10:20am. Reason of death was written as "old age". Therapeutic measure taken in response to the event was not provided. patient died on 09Aug2021. The autopsy was not performed. The lot number for bnt162b2, was not provided and will be requested during follow up. Reported Cause(s) of Death: Reason of death was written as old age.


VAERS ID: 1579945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Infarction, Myocarditis, Pericarditis, Pneumonia
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
Permanent Disability? 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: NLMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: 00648744) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA, MYOCARDITIS, PERICARDITIS and INFARCTION in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 3001946) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PNEUMONIA (seriousness criteria death and medically significant), MYOCARDITIS (seriousness criteria death and medically significant), PERICARDITIS (seriousness criteria death and medically significant), INFARCTION (seriousness criteria death and medically significant) and ABDOMINAL PAIN. The patient died on 02-Jul-2021. The reported cause of death was infarcts organs. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN outcome was unknown. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: infarcts organs


VAERS ID: 1579983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Hallucination
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100990208

Write-up: hallucinations; cardiac arrest; died as a result of cardiac arrest; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 35-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. In a patient with a massive physique, a few days after receiving 2 doses of Comirnaty, hallucinations appeared. The patient was taken to the hospital, where he died as a result of cardiac arrest. The reporting person claims that the patient was healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome cardiac arrest was fatal while for hallucinatons was unknown. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1580049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram, Dyspnoea, Fatigue, Insomnia, Multiple organ dysfunction syndrome, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Hypertension; Marfan''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography; Result Unstructured Data: Test Result:confirms widespread pulmonary embolism in both rig; Comments: confirms widespread pulmonary embolism in both right and left pulmonary lobes
CDC Split Type: SEPFIZER INC202101026632

Write-up: Pulmonary embolism; Breathlessness; Insomnia; decreased energy; Fatigue; multi-organ failure (heart, liver, kidneys); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number SE-MPA-2021-069638. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Jun2021 (Lot Number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient took the first dose of vaccine with unknown batch number on an unknown date in Apr2021 for COVID-19 immunization. Medical history included ongoing marfan''s syndrome, ongoing cardiac failure, ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism (death, hospitalization, life threatening) in Jul2021, multi-organ failure (heart, liver, kidneys) (death, hospitalization, life threatening) in 2021, breathlessness (death, hospitalization, life threatening) in Jun2021, insomnia (death, hospitalization, life threatening) in Jun2021, decreased energy (death, hospitalization, life threatening) in Jun2021, fatigue (death, hospitalization, life threatening) in Jun2021. The patient presented to the emergency department after a 4-week history of new onset symptoms of decreased energy, dyspnea (shortness of breath), insomnia which started 1 week after the 2nd dose of vaccine. The patient has never had problems with thrombosis before, and has not had any symptoms during the spring. No suspicion of malignancy. Dyspnea has progressed during July. Computed tomography approximately 1 month after onset of symptoms in 2021 confirms widespread pulmonary embolism in both right and left pulmonary lobes, which is considered likely to be caused by the vaccination. Significantly deteriorates during the course of care and develops multi-organ failure (heart, liver, kidneys). Dies in the aftermath after about two weeks in hospital. Cause of death was given as pulmonary embolism causing multi-organ failure. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: multi-organ failure (heart, liver, kidneys); Pulmonary embolism


VAERS ID: 1581971 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-07-07
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypoaesthesia, Pulmonary embolism
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma bronchial (well-tolerated); Diabetes mellitus; Hypertension; Lupus erythematosus (well-tolerated).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CYMODERNATX, INC.MOD20212

Write-up: Pulmonary embolism; Numbness in hand; Fatigue extreme; This case was received via the Regulatory Authority (Reference number: 220721KK6) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus, Hypertension, Asthma bronchial (well-tolerated) and Lupus erythematosus (well-tolerated). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jul-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme). The patient died on 07-Jul-2021. The reported cause of death was Acute massive pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was Acute massive pulmonary embolism. At the time of death, HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported y the reporter. This is a case of sudden death in a 62-year-old female subject with HX of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Sender''s Comments: This is a case of sudden death in a 62-year-old female subject with hx of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Reported Cause(s) of Death: Acute massive pulmonary embolism; Autopsy-determined Cause(s) of Death: Acute massive pulmonary embolism


VAERS ID: 1581975 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Death, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORECAN; DRETACEN
Current Illness: Epilepsy (seizure maximum one per year, last time in 03/2021).
Preexisting Conditions: Medical History/Concurrent Conditions: Backache (14 days before vaccination, he got injection).
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Backache (14 days before vaccination, he got injection) on 07-Jun-2021. Concurrent medical conditions included Epilepsy (seizure maximum one per year, last time in 03/2021). Concomitant products included THIETHYLPERAZINE MALEATE (TORECAN) for Seizure, LEVETIRACETAM (DRETACEN) for an unknown indication. On 21-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced DEATH (seriousness criteria death and medically significant), BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA. The patient died on 30-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA outcome was unknown. Treatment information was not provided.; 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: Found dead (cause undetermined)


VAERS ID: 1581976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fall, Head injury, Loss of consciousness, Neurological examination, Pulmonary embolism, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy
Allergies:
Diagnostic Lab Data: Test Name: X-ray CT of the head; Result Unstructured Data: Test Result:normal; Test Name: neurological examination; Result Unstructured Data: Test Result:normal
CDC Split Type: CZPFIZER INC202101016129

Write-up: Convulsions; Collapse/ Lost consciousness; Lung embolism; Fall; head injury; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21009285. A 58-years-old male patient received first dose of BNT162B2 (COMIRNATY) intramuscular single dose for COVID-19 immunisation on 17Jul2021. Medical history included: nephrectomy from 2017. No concomitant medication. The patient experienced convulsions, collapse/ lost consciousness and lung embolism all on 25Jul2021 (death, life threatening), fall (medically significant) on 22Jul2021 with outcome of recovered. The patient fell and had head injury on the 5th day after vaccination (22Jul2021). Day 8 after vaccination (25Jul2021) collapse, convulsions, after transport to the hospital died. Extensive pulmonary embolism. Lab test included X-ray CT of the head, neurological examinations showed normal. The patient died on 25Jul2021. An autopsy was performed and results were not provided. Outcome of the other event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Lung embolism; Convulsions; Collapse/ Lost consciousness


VAERS ID: 1581995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Interchange of vaccine products, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
Permanent Disability? 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 INC202100987544

Write-up: Pulmonary embolus; Deep vein thrombosis; VAXZEVRIA DOSE 1, SINGLE/COMIRNATY DOSE 2, SINGLE; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-202100139560. A 53-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received first dose of COVID-19 vaccine NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) on Apr2021, as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced pulmonary embolus and deep vein thrombosis. Outcome was fatal. The patient died on 02Jul2021. An autopsy was performed and results were not provided. This report is serious - death. Comirnaty/ PEI / all events/ unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep vein thrombosis; Pulmonary embolism


VAERS ID: 1582198 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033742

Write-up: Adverse event following immunization; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598302. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 12Jul2021 which is fatal. It was unknown if autopsy was done. 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: Adverse event following immunization


VAERS ID: 1582199 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaise, Pyrexia, Tachypnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033743

Write-up: Diarrhoea; Malaise; Pyrexia; Tachypnoea; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598769. A 60-years-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), 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 and concomitant medications were not reported. The patient experienced diarrhoea; malaise; pyrexia; tachypnoea; and vomiting. The outcome of events was fatal. The patient died on an unspecified date. The cause of death was diarrhoea; malaise; pyrexia; tachypnoea; and vomiting. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Diarrhoea; Malaise; Pyrexia; Tachypnoea; Vomiting


VAERS ID: 1582268 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chills, Death, Decreased appetite, Fatigue, Feeling cold, Gastrointestinal haemorrhage, Headache, Malaise, Nausea, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Skin discolouration, X-ray
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 97
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: Ex-tobacco user (quit 30 years ago).
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: CRP; Result Unstructured Data: Test Result: increased; Test Date: 20210412; Test Name: oxygen saturation; Test Result: 45 %; Comments: When he entered the hospital, he was 45% saturated.; Test Date: 20210412; Test Name: oxygen saturation; Test Result: 75 %; Comments: 75% desaturation despite 4 liters of oxygen / minute; Test Date: 20210412; Test Name: X-ray; Result Unstructured Data: Test Result: pneumonia.
CDC Split Type: BEPFIZER INC202101026645

Write-up: He had 45% saturation/oxygen saturation low; Nausea; Feeling cold; Malaise; Fatigue; CRP increased; Discolouration skin/black face; Decreased appetite; Headache; Fever; Shivering; pneumonia; digestive bleeding/hemorrhage of digestive tract; Death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-103977. A 66-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12Apr2021 (at the age of 66-year-old) as single dose for covid-19 immunisation. Medical history included former smoker (quit 30 years ago). The patient''s concomitant medications were not reported. On 12Apr2021, patient experienced fever, malaise, shivering, fatigue, nausea, headache, feeling cold, discolouration skin, decreased appetite, oxygen saturation low, hemorrhage of digestive tract, CRP (C-reactive protein) increased. On 18Jul2021, patient experienced death. The clinical course was as follows: the very day of the vaccine, patient had a fever, a feeling of cold, black face, decreased appetite, fatigue, nausea, headache (X-ray: pneumonia). Then he went to the hospital. When he entered the hospital, he was 45% saturated. It was incubated and had 75% desaturation despite 4 liters of oxygen/minute. He had digestive bleeding after a gastroscopy (probably medical related). The outcome of the events was fatal. The patient died on 18Jul2021. 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: Nausea; Feeling cold; Malaise; Fatigue; CRP increased; Discolouration skin/black face; Decreased appetite; Headache; Fever; digestive bleeding/hemorrhage of digestive tract; Shivering; pneumonia; He had 45% saturation/oxygen saturation low; Death


VAERS ID: 1582288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LOSARTAN; NORVASC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101033956

Write-up: Death; This is a Spontaneous report from a contactable Physician. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report number 000947581. This information was initially reported to Regulatory Authority on 26Apr2021 from the community. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular 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. Concomitant medications included losartan taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. 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.; Reported Cause(s) of Death: Death


VAERS ID: 1582327 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death
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: 2021-04-14
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202100997770

Write-up: Stroke; She past away on the 14th of April/died; This is a spontaneous report received from a contactable consumer (son) or other non HCP via the Regulatory Authority. Regulatory authority report number CH-SM-2021-17194. A 89-year-old female, patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: EP9605, Expiration date: was not reported) via intramuscular on 25Mar2021 (Age at vaccination: 89-year-old) as DOSE 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: EM0477, Expiration date: was not reported) via intramuscular on 25Feb2021 (Age at vaccination: 89-year-old) as DOSE 1, single for COVID-19 immunization. On 26Mar2021, she was found in bed (one day after vaccination), at around 13.00 hr. with a stroke (she could no longer speak and was partially paralyzed) and was immediately transported in the ambulance to hospital. She died on 14Apr2021. Reporter also stated her condition did not improve. A causal relationship between Comirnaty and Death and Stroke was assessed by Regulatory Authority as unlikely. RA assessed this case as serious with seriousness criterion results in death. The outcome of events was Fatal. Health Authority Comment: Unfortunately, we do not know whether an autopsy was performed that could have given important indications. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Death and Cerebrovascular accident and suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown


VAERS ID: 1583252 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Pyrexia, Staphylococcal sepsis, Staphylococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Essential hypertension.
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Staphylococcus aureus; Result Unstructured Data: Test Result: Positive.
CDC Split Type: DEPFIZER INC202100987737

Write-up: Fever; General physical condition decreased; Staphylococcus aureus septicemia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-DCGMA-21190509. A 94-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single (at the age of 94 years old) for COVID-19 immunisation. Medical history included cardiac failure, essential hypertension, atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 on 13Jan2021 for COVID-19 immunisation. The patient experienced fever, general physical condition decreased and staphylococcus aureus septicemia (Staphylococcus aureus test positive) on 05Feb2021. The events led to hospitalization. The patient died on 17Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Fever; General physical condition decreased; Staphylococcus aureus septicemia


VAERS ID: 1583272 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100133881

Write-up: Flu-like illness; Myalgia; Pyrexia; This case was received via the Regulatory Authority (Reference number: 202100133881) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like illness), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like illness) (seriousness criterion death), MYALGIA (Myalgia) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). 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 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Sender''s Comments: This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1583317 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pemphigoid
SMQs:, Severe cutaneous adverse reactions (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: DEPFIZER INC202100987782

Write-up: Bullous pemphigoid; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100144669. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 03Feb2021 (at the age of 87-years-old) at dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY; strength: 0.3 ml) received on 08Jan2021 (at the age of 87-years-old) at dose 1, 0.3 ml single for COVID-19 immunisation. On Feb2021, the patient experienced bullous pemphigoid. The patient died on an unspecified date in 2021 due to the event. It was reported that autopsy was not done. Outcome of the event was fatal. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Bullous pemphigoid


VAERS ID: 1583473 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
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: AUPFIZER INC202101033737

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 596980. An 80-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event outcome 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: Adverse event following immunisation


VAERS ID: 1583474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-23
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiomegaly, Myocardial fibrosis
SMQs:, Cardiac failure (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033741

Write-up: Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598170. An 89-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis, all on 23APR2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis


VAERS ID: 1583475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Dyspnoea, Groin pain, Malaise, Myocardial infarction, Myocarditis
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (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: AUPFIZER INC202101033744

Write-up: Chest pain; Cough; Dyspnoea; Groin pain; Malaise; Myocardial infarction; Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598851. A 52-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jul2021, the patient experienced chest pain, cough, dyspnoea, groin pain, malaise, myocardial infarction, myocarditis. 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: Chest pain; Cough; Dyspnoea; Groin pain; Malaise; Myocardial infarction; Myocarditis


VAERS ID: 1583476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, General physical health deterioration, Lethargy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033745

Write-up: Fall; General physical health deterioration; Lethargy; Syncope; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598893. A 98-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall (death) on 04Apr2021, general physical health deterioration (death) on 04Apr2021 , lethargy (death) on 04Apr2021 , syncope (death) on 04Apr2021. The patient died in 2021. 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. No further information is expected.; Reported Cause(s) of Death: Fall; General physical health deterioration; Lethargy; Syncope


VAERS ID: 1583477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-02
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033746

Write-up: Adverse event following immunization; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598895. An 87-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 02May2021 which was fatal. It was unknown if autopsy was done. 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: Adverse event following immunization


VAERS ID: 1583478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Lower respiratory tract infection, Oxygen saturation, Oxygen saturation decreased, Sepsis, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: decreased.
CDC Split Type: AUPFIZER INC202101033747

Write-up: Fall; Lower respiratory tract infection; Oxygen saturation decreased; Sepsis; Syncope; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598896. A 90-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall (death) on 12Apr2021, lower respiratory tract infection (death) on 12Apr2021, oxygen saturation decreased (death) on 12Apr2021 , sepsis (death) on 12Apr2021 , syncope (death) on 12Apr2021 , vomiting (death) on 12Apr2021. The patient underwent lab tests and procedures which included oxygen saturation: decreased on 12Apr2021. The patient died in 2021. 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. No further information is expected; Reported Cause(s) of Death: Fall; Lower respiratory tract infection; Oxygen saturation decreased; Sepsis; Syncope; Vomiting


VAERS ID: 1583555 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: Atrial fibrillation (Since years, exact date of diagnosis unknown); Coronary artery disease (Date of diagnosis unknown).
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior myocardial infarction (anterior wall infarction).
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101032788

Write-up: fatal heart attack; This is a spontaneous report received from a contactable physician via the Regulatory Authority. Regulatory authority report number CH-SM-2021-19975. A 89-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Jan2021 (Batch/Lot number was not reported) at the age of 89-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing atrial fibrillation Since years, exact date of diagnosis unknown, a history of anterior wall infarction in 2004 (not ongoing), ongoing coronary artery disease, date of diagnosis unknown, otherwise cardiacally well-compensated until fatal episode. No allergies reported by doctor. The patient''s concomitant medications were not reported. The patient experienced fatal heart attack on 12Jan2021. It is not known whether medical intervention was possible. The patient died on 12Jan2021. An autopsy was not performed. The outcome of the event heart attack was fatal. A causal relationship between Comirnaty and Myocardial infarction was assessed as unlikely. Regulatory authority assessed this case as serious with fatal outcome. Reporter Comment: Fatal heart attack in 89-year-old male patient with cardiac history with a history of heart disease, 7 days after administration of Comirnaty. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The event of myocardial infarction is assessed as not related to BNT162B2 and more likely due to the underlying medical condition of coronary artery disease in this elderly patient with a medical history of anterior wall infarction and atrial fibrillation.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1583661 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE0174 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987666

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100150596. A 66-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: FE0174), via an unspecified route of administration on 23Jul2021 (at the age of 66-years-old) at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY) received on an unspecified date for COVID-19 immunisation. On an unspecified date on 2021, the patient experienced infarct myocardial. The reporter assessed the event as serious since life-threatening and fatal outcome. The patient died on an unspecified date in 2021 due to the event. Autopsy was done; however, autopsy results are not available. Outcome of the event was fatal. Sender''s comments: Inquest; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1583780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-26
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Herpes zoster, Immune system disorder, Pneumonia, Pyrexia, Sleep disorder, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 128
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996489

Write-up: fever; apathy; struggling in sleep; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition/ severely weakened immune system; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021034283. Safety Report Unique Identifier DE-PEI-202100022184. This consumer reporter events after both doses. This is report for dose 1. A 95-year-old male patient received BNT162b2 (COMIRNATY, mRNA Tozinameran, Solution for injection), dose 1 intramuscular on 08Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced throat tightness, immune system disorder (nos), shingles, pneumonia; all on 26Jan2021. As reported, this report was serious of hospitalization. The patient''s weight was 90 kg, and height was 174 cm. It was reported that on 08Jan2021 first dose of Corona vaccination with Biontech/Pfizer was vaccinated, on 26Jan2021 shingles occurred. On 27Jan2021 the patient visit to the doctor with fever, apathy, struggling in sleep, severely weakened immune system (after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition). On 12Feb2021, the patient was transferred back to the retirement home. Since then, he was bedridden with care level 5. Patient was died on 04Jun2021. The outcome of the event throat tightness, immune system disorder (nos), shingles, pneumonia was recovered with sequelae while of other events was unknown. Senders comment: the person concerned had no known of any allergies. Information on risk factors or previous illnesses: before: good general condition without serious pre-existing illnesses. 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) : DE-PFIZER INC-202101028277 same patient, first/second dose; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1584580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Cardiac arrest, Coma, Dyspnoea, Encephalopathy, General physical health deterioration, Hypoxia, Inflammation, Myocardial infarction, Pain in extremity, Pyrexia, Respiratory arrest, Skin ulcer
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arteriosclerosis; Bypass surgery; Coronary artery disease; Hypercholesterolaemia; Hypertension; Insulin-dependent diabetes mellitus; Metabolic syndrome; Polyneuropathy; Retinopathy; Sleep apnea.
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Dust allergy; Penicillin allergy (amoxicillin well tolerated).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987763

Write-up: Encephalopathy; arrest cardiac; respiratory arrest; hypoxia; deep coma; Heart attack/Infarct myocardial; shortness of breath/Dyspnoea; anuria; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; slight pain in the arm- easier than with the first vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021146961, Safety Report Unique Identifier DE-PEI-202100146895. This report described events for the second dose. A 65-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Jul2021 (Lot Number: FE6975) as dose 2, single for COVID-19 immunisation. Medical history included ongoing insulin-dependent diabetes mellitus, hypertension, hypercholesterolaemia, retinopathy, polyneuropathy, metabolic syndrome, coronary artery disease, arteriosclerosis, bypass surgery, sleep apnea; allergy to grain and grasses, dust mites, probably to penicillin (amoxicillin well tolerated). The patient''s concomitant medications were not reported. The patient''s weight was 215 kg, and height was 186 cm. On 08Jul2021 (day 1/2), patient experienced slight pain in the arm - easier than with the first vaccination. On 10Jul2021, the patient experienced infarct myocardial, dyspnoea, anuria, very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear. On 13Jul2021, the patient experienced arrest cardiac. As reported, patient had heart attack, shortness of breath, anuria on the 3rd day after the 2nd injection. Biontech, stent placement on the 5th after the injection, despite the good condition of the heart on the 6th after the injection, respiratory arrest followed by cardiac arrest on 13Jul2021. It was reported that on Day 6 (13Jul2021), at noon at the ICU, respiratory arrest followed by a hypoxia-related myocardial infarction, despite immediate resuscitation, high-grade hypoxia and renewed resuscitation, duration of hypoxia about 30 minutes, deep coma due to hypoxia. Encephalopathy followed by death on 20Jul2021. This report is serious due to hospitalization, life threatening. The patient''s outcome was not recovered/not resolved for dyspnoea, anuria, recovered on 13Jul2021 for hypoxia, fatal for arrest cardiac, infarct myocardial and encephalopathy while unknown for the other events. The patient died on 20Jul2021. An autopsy was not performed. Events heart attack, dyspnea, anuria, cardiac arrest per RA was unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Grains and grasses, dust mites, probably on penicillin (amoxicillin well tolerated) Information on risk factors or previous illnesses hypertension, hypercholesterolemia, insulin-dependent diabetes mellitus type 2 with retinopathy and polyneuropathy, metabolic syndrome, coronary artery Heart disease, coronary artery sclerosis Bypass OP, sleep apnea / day 1/2 - slight pain in the arm - easier than with the first vaccination Day 3) 10Jul20/21 shortness of breath, anuria, very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear Day 4 no better, but you don''t want to go to the hospital on Sunday Day 05-12Jul2021.-Ambulance, Clinic, Heart attack diagnosis, two attempts at stenting unsuccessful due to excess weight, in the evening transfer to Hospital, successful stenting and planned monitoring for 1-2 days in the intensive care unit, in the evening the circumstances correspondingly good, stable condition Day 6-13Jul2021-at noon at the ICU Respiratory arrest followed by a hypoxia-related myocardial infarction, despite immediate resuscitation, high-grade hypoxia and renewed resuscitation, duration of hypoxia about 30 minutes, deep coma due to hypoxia Encephalopathy followed by death on 20Jul2021; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101004075 same patient, different dose; Reported Cause(s) of Death: Infarct myocardial; Encephalopathy; Arrest cardiac


VAERS ID: 1584638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: Medical History/Concurrent Conditions: Blood pressure increased; Overweight; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101039216

Write-up: death; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 79525], license party for Comirnaty. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 for COVID-19 immunisation. Medical history included high blood pressure, overweight, strong smoker. The patient''s concomitant medications were not reported. It was reported case of death 5 days after administration of the second vaccination. The patient died on 10Aug2021. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1584690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain injury, Cardiac arrest, Fatigue, Intracardiac thrombus, Physical examination, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 21
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: ATORVASTATIN TEVA; ELTROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypothyroidism.
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown; Test Date: 202106; Test Name: Physical examination; Result Unstructured Data: Test Result: Unknown; Test Date: 202106; Test Name: Scan; Result Unstructured Data: Test Result: Unknown scan: unknown.
CDC Split Type: DKPFIZER INC202101026754

Write-up: Intracardiac thrombus; cardiac arrest; severe brain damage; tiredness; This is a spontaneous report from a contactable consumer (relative to the patient) downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0076168. A 61-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EW6126; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 24May2021 as single dose for covid-19 immunisation. Medical history included hypothyroidism and hypercholesterolaemia. Concomitant medications included atorvastatin calcium (ATORVASTATIN TEVA) taken for hypercholesterolaemia from 2019 to 01Jun2021; levothyroxine sodium (ELTROXIN) taken for hypothyroidism from 2019 to 01Jun2021. There was no information regarding past medication. The patient experienced severe brain damage on an unspecified date of Jun2021, tiredness on 30May2021, intracardiac thrombus and cardiac arrest on 02Jun2021. Clinical course: On 30May2021, 6 days after the vaccination, the patient developed tiredness. On 02Jun2021, 9 days after the vaccination, the patient experienced Intracardiac thrombus and cardiac arrest. On an unknown date thereafter in Jun2021 the patient developed severe brain damage. The ADRs were by the reporter reported as resulting in hospitalisation in the beginning of Jun2021 and fatal. The patient was resuscitated after the cardiac arrest. The physicians fought for the patient''s life for 15 days, however in vain due to the severe brain damage. The patient underwent lab tests and procedures which included blood test, physical examination and unknown scan, all with unknown result on an unspecified date of Jun2021. The outcome of events intracardiac thrombus, brain damage and cardiac arrest was fatal, tiredness was recovered on 01Jun2021. The patient died on 20Jun2021. Cause of death was reported as intracardiac thrombus, brain damage and cardiac arrest. 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: Intracardiac thrombus; Brain damage; Cardiac arrest


VAERS ID: 1584691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT brain scan; Result Unstructured Data: Test Result: Shows large intracerebral haemorrhage; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:191; Comments: Unit not specified.
CDC Split Type: DKPFIZER INC202101026542

Write-up: Intracerebral haemorrhage; This is a spontaneous report from three contactable physicians downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0079650. A 57-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FD0932), dose 2 intramuscular on 14Jul2021 as single dose for covid-19 immunisation. Medical history included alcohol abuse from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Lot Number: FC2336) intramuscular on 09Jun2021 for covid-19 immunisation. The day after the second vaccination, the patient experienced intracerebral haemorrhage on 15Jul2021. The patient underwent lab tests and procedures which included CT brain scan: shows large intracerebral haemorrhage on an unspecified date of Jul2021, thrombocyte count: 191 (Unit not specified) on unknown date. Tests for Pf4, D-dimer or fibrinogen were not performed. No treatment due to the ADR was reported and no medical procedure was performed. The patient died on 17Jul2021. Reported causes of death: Intracerebral haemorrhage. An autopsy was performed and results were not provided. Causality: Another physician does by no means thinks that the patients death / Intracerebral haemorrhage is related to the vaccination with COMIRNATY. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Due to implausible temporal association, the event of intracerebral haemorrhage with fatal outcome is assessed as unrelated to the product BNT162B2.Case will be re-assessed upon the additional information provided.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Intracerebral haemorrhage


VAERS ID: 1584702 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-17
Onset:2021-06-26
   Days after vaccination:526
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood pressure measurement, Chest pain, Electrocardiogram, Low density lipoprotein, Sudden cardiac death, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLATRAMYL; PREGABALIN SANDOZ; MALFIN; CIPRAMIL [CITALOPRAM HYDROBROMIDE]; FUCICORT; IMOVANE; SUMATRIPTAN MYLAN
Current Illness: Chronic back pain
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Infected eczema; Neuropathic pain; Pain; Sleeplessness.
Allergies:
Diagnostic Lab Data: Test Date: 202001; Test Name: Cholesterol total; Result Unstructured Data: Test Result:5.7; Comments: unit not specified; Test Date: 202001; Test Name: Blood pressure; Result Unstructured Data: Test Result: normal; Test Date: 20210802; Test Name: EKG; Result Unstructured Data: Test Result: continuingly measured, unknown; Test Date: 20210802; Test Name: EKG; Result Unstructured Data: Test Result: ventricle fibrillation found, then asystole; Test Date: 202001; Test Name: LDL; Result Unstructured Data: Test Result: 3.7; Comments: unit not specified; Test Date: 20210802; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: stagnant cordis.
CDC Split Type: DKPFIZER INC202101045522

Write-up: sudden cardiac death, found lifeless after doing hedge trimming; Retrosternal chest pain on/off since 2nd vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0082510. A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ,Lot Number: FE2083; Expiration Date: 31Oct2021) via an unspecified route of administration on 25Jun2021 as a dose 2 ,single for covid-19 immunisation, sumatriptan succinate (SUMATRIPTAN MYLAN), oral from 17Jan2020 (Batch/Lot Number: Unknown), at 100 mg as needed for migraine. Medical history included ongoing back pain, depression, pain, eczema infected, insomnia, neuralgia from an unknown date and unknown if ongoing. Concomitant medication(s) included tramadol hydrochloride taken for pain from 25Nov2015 to an unspecified stop date; pregabalin (PREGABALIN SANDOZ) taken for neuralgia from 18Feb2021 to an unspecified stop date; morphine sulphate taken for pain from 04May2017 to an unspecified stop date; citalopram hydrobromide taken for depression from 02Sep2019 to an unspecified stop date; betamethasone valerate, fusidic acid taken for eczema infected from 07Mar2016 to an unspecified stop date; zopiclone taken for insomnia from 24Jan2020 to an unspecified stop date. On 02Aug2021 the patient experienced sudden cardiac death, found lifeless after doing hedge trimming, on 26Jun2021 retrosternal chest pain on/off since 2nd vaccination. The patient was attempted treated with cardiopulmonary resuscitation when found lifeless. Upon arrival on the address. A detectable heart rhythm was found. The patient was given 5 direct current conversions, adrenaline and amiodaron i.o., without effect. The rhythm is primarily from ventricle fibrillation. The patient is transported with acute helicopter to a hospital and ventricle fibrillation is found using ultrasound. The patient was treated twice with direct current conversion and magnesium without effect, and the patient goes into asystole. The patient underwent lab tests and procedures which included blood cholesterol: 5.7 on Jan2020 unit not specified, blood pressure measurement: normal on Jan2020, low density lipoprotein: 3.7 on Jan2020 unit not specified. On 26Jun2021, the day after 2nd dose vaccination with Comirnaty, the patient developed Retrosternal chest pain (Retrosternal chest pain on/off since 2nd vaccination). Patient apparent to be a physical well and healthy and was not known to have any cardiovascular diseases or previous history with chest pain. The patient was attempted treated with cardiopulmonary resuscitation when found lifeless. Upon arrival on the address. A detectable heart rhythm was found. The patient was given 5 direct current conversions, adrenaline and amiodaron i.o., without effect. The rhythm was primarily from ventricle fibrillation. The patient was transported with acute helicopter to a hospital and ventricle fibrillation is found using ultrasound on 02Aug2021 which showed stagnant cordis. The patient was treated twice with direct current conversion and magnesium without effect. EKG continuingly measured, Ventricle fibrillation found and then patient gone to asystole. On 02Aug2021 the patient developed sudden cardiac death sudden cardiac death, found lifeless after doing hedge trimming). Physician had reported the death to the police and did not know if an autopsy will be performed. Respond from the Safety Authority awaits. Causality: The reporter states, that he is a summer substitute and has not seen the patient. All information in the report is from the patient''s electronic medical records. The reporter received information about the death of the patient and upon reading the patient''s medical records, the reporter started suspecting a possible relation between Comirnaty and the ADRs. The reporter also suspects Sumatriptan to be a possible suspected drug after reading the product resume However, nothing in the patient''s medical records suspects that the patient has reacted negatively to Sumatriptan before. There is no information weather the patient has experienced ADRs after the first dose vaccination with Comirnaty. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1584829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Computerised tomogram, Electroencephalogram, Ischaemic stroke, Platelet count, Scan brain
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral vertigo, unspecified; Vocal cord cyst.
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result: Study carried out after a second injection; Comments: Study carried out after a second injection of intravenous contrast, in arterial phase, of the TSA and polygon of Willis. Occlusion of right M1 prior to bifurcation and of the right anterior cerebral artery segment A2. Vertebral and basilar arteries and the rest of the normal circle of Willis; Test Date: 20210728; Test Name: CT scan; Result Unstructured Data: Test Result: Study carried out after the; Comments: Study carried out after the administration of intravenous contrast, the findings suggest an established infarction, however it is necessary to take into account the short time elapsed and the tension of the patient that can alter the maps.; Test Date: 20210730; Test Name: EEG; Result Unstructured Data: Test Result: a flare-suppression tracing, compatible with very; Comments: 2021 Electroencephalogram: shows a flare-suppression tracing, compatible with very severe diffuse brain involvement; Test Date: 20210728; Test Name: Platelet count; Result Unstructured Data: Test Result:260; Comments: Units:10*3/uL; Test Date: 20210729; Test Name: Scan brain; Result Unstructured Data: Test Result: Radiographic findings compatible with established; Comments: Brain CT (without contrast). Radiographic findings compatible with established ischemic stroke, without signs of hemorrhagic transformation that can be assessed using this technique. It exerts a certain mass effect on the ipsilateral ventricular system and the midline, shifted to the left by about 5 mm, with no obvious signs of parenchymal herniation at the present time.
CDC Split Type: ESPFIZER INC202101031963

Write-up: Ischaemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [ES-AEMPS-962054]. A 43 years old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number: FC1435) intramuscular at 0.3 ml single dose for COVID-19 immuniation on 16Jul2021. Relevant history included peripheral vertigo, unspecified and submucous cyst of right vocal string. Relevant concomitant drug was not reported. Past drug included sulpiride 50mg. The patient experienced ischaemic stroke on 28Jul2021. The clinical course was reported as: on 28Jul2021, at 12pm the patient was well, at 12:15 pm, the patient was found in the room with a decrease in the level of consciousness and relaxation of the sphinters. it is transferred to the hospital as a stroke code. Arrived at 1:12 pm, went to the lightning room at 1:20 pm, and was informed of stop in the initial segment of the right cerebral artery (m1) at 1:29 pm. in the perfusion infarction data established, but favorable aspects and it was in the first hours why interventionist radiology was advised. in front of left frontal craneoenephalic injury, fibrinolysis was discarded. arrived in the angiography room at 1:40 pm. being in the room, angiography presented an episode of rigidity of the 4 extremities and eye deviation to the left. before the possibility of acute symptomatic crisis, treatment with levetiracetam 1000 / 12h is started. tests performed: biochemical (28Jul2021): normal plate count, 260 103 / ul. no data on dimer d. 1.tc simple basal: no signs of intracranial hemorrhage. aspects 9-10; 2.tc perfusion: study carried out after the administration of endovenous contrast, the findings suggested an established infarction, however it was necessary to take into account the lack of time elapsed and the patient''s tension (supporting map. tsa) and willis polygon: study carried out after a second injection of endovenous contrast, in arterial phase, of the tsa and willis polygon. occlusion of right m1 prior to bifurcation and of the right anterior cerebral artery segment a2. vertebral arteries, basilar and the rest of the normal willis polygon. diagnostic impression: territory stroke of the right mca (m1) of undetermined etiology. territory stroke of the right aca of undetermined territory others: possible acute symptomatic crisis. Evolution: mechanical brain thrombectomy was performed. on 29Jul2021 brain TAC (without contrast): radiological findings compatible with established ischemic lca, without signs of hemorrhagic transformation valuable by this technique. it exercised a certain mass effect on the homolateral ventricular system and the middle line, offseted toward the left by about 5 mm, with no evident signs of parenchymate herniation at the current moment. on 30Jul2021 electroencephalogram: showed an outbreak-suppression trace, compatible with very severe degree diffuse brain involvement. on 01Aug2021 it presented refractory intracranial hypertension with very poor short-term evolution. on 02Aug2021, the patient presented encephal death at 12:15 am and subsequently exitus at 9:30 am. Causation assessment: compatible time sequence, 13 days after vaccination. thrombotic events were not described on the Pfizer vaccine data sheet. The data available did not allow to confirm or dismiss the existence of an alternative causal explanation other than the vaccine.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1584857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       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: ESPFIZER INC202101032160

Write-up: Acute myocarditis; This is a spontaneous report from a contactable consumer (A family member) downloaded from the Regulatory Authority-WEB [ES-AEMPS-969891]. An adult male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 21Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY) for COVID-19 immunisation. The patient experienced acute myocarditis (death) on 22Jun2021. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of 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: Acute myocarditis


VAERS ID: 1584882 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Back pain, Dysgeusia, Feeling cold, Interchange of vaccine products, Investigation, Off label use, Pyrexia, Thrombosis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 35
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: Arterial operation NOS (on both sides of the neck); Arterial operation NOS; Arteriosclerosis obliterans; Bypass surgery; Coronary artery bypass (at the age of 26 in 1987); Coronary heart disease; Familial hypercholesterolemia.
Allergies:
Diagnostic Lab Data: Test Name: images; Result Unstructured Data: Test Result: there was not anything that could have caused pain; Comments: there was not anything that could have caused pain in the right side.
CDC Split Type: FIPFIZER INC202100996837

Write-up: Back pain/pain coming in pulses to the right side of his back; Feeling cold; fever; bad taste in the mouth; suspicion of a thrombosis on the vascular side; arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation; Ventricular fibrillation; Interchange of vaccine products; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20213714. A 60-year-old male patient received 2nd dose (initial Pfizer dose) of BNT162B2 (COMIRNATY, Batch/Lot Number unknown) via an unspecified route of administration on 25May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Concomitant medications were not reported. The patient previously received 1st single dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for COVID-19 immunisation. Patient had a terrible pain coming in pulses to the right side of his back within a few days (in May2021). they fetched a painkiller injection against the back pain from the health center on 01Jun2021, but it only helped for a while. patient had to the hospital in ambulance in the morning on 02Jun2021 where his heart stopped. He was resuscitated for 40 min. and finally the heart was set in motion. To intensive care unit - but on 05Jun2021 upon waking up he died. The doctor said the vaccination certainly had an effect on what happened, but it could not be proven. Patient was 60-year-old and belonged to the risk group due to his illnesses. On 27Jul2021 follow up from reporter, it was reported that the back pain was weird. It came to the so-called healthy side (right) and was alternating and was really intense. The pain was such that patient already said sometimes he could not stand it. A day or two after the vaccination, patient said he was just feeling like he had a fever. A bad taste in the mouth and was feeling cold all the time. Patient did not get fever easily so the thermometer did not show it. The health station doctor who wrote the referral to the ambulance said that at no point did patient have any signs of heart problems, nor were they experienced at home. Reporter did not know exactly what happened there when not everything was told and he had made a reminder about this, and reporter was still waiting for an answer. There, in the emergency room, patient''s heart stopped anyway and he was resuscitated according to the death certificate for 40 min. Reporter only got information from the doctor about what happened in the afternoon at about one 1 pm. On the phone reporter was told that the resuscitation lasted 30 mins. Patient was kept anesthetized connected to the machine and when they started to wake him up and took the equipment off he died. Although it was known that he might not survive, reporter was not informed of it. The doctor called when patient was already dead. When reporter visited there earlier and talked to the doctor and asked about the effect of the Covid vaccination in this case, the answer was that it certainly did contribute, but it could not be proven. The back apparently was not examined at all, although that was the reason why he was taken there. The back physician thought that in the images which were taken there was not anything that could have caused pain in the right side. He said that new images should be taken upon recovery and also raised a suspicion of a thrombosis on the vascular side. Death certificate: A 60-year-old man with severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Now came to the hospital due to severe back pain, at the emergency department went unresponsive and immediately resuscitation was started. Resuscitated for a total of about 40 minutes, receiving ample adrenaline and amiodarone during resuscitation. Defibrillation for ventricular fibrillation many times. The Return of spontaneous circulation was achieved and the patient was then treated under temperature control in the intensive care unit. At the intensive care unit hemodynamics have been moderately stable as long as the patient was asleep. Discussed with cardiology, due to severe arteriosclerosis obliterans disease, patient was not suitable for arterial dilation treatments, although there was a possible narrowing in the coronary arteries. After further discussion with a thoracic surgeon, the patient was also not suitable for bypass surgery because all the veins had already been used. Decided not to resuscitate anymore. On 05Jun2021 waking up was started, upon waking began to have signs of arrhythmia. After extubation, the rhythm changed from sinus rhythm to ventricular fibrillation, through which the asystole. Not resuscitated. Official time of death was on 05Jun2021 15:51. The outcome of the event Atherosclerotic cardiovascular disease was fatal, of other events was unknown. The patient died on 05Jun2021 15:51. 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.; Sender''s Comments: Linked Report(s) : FI-NAM-19900040; Reported Cause(s) of Death: arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation


VAERS ID: 1585033 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-19
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Auscultation, Bacterial test, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Electrocardiogram, Legionella test, Oxygen saturation, PO2, Physical examination, Pneumococcal infection, Respiratory rate, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 10
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: GLUCOPHAGE; ALLOPURINOL; DIAMICRON; RAMIPRIL; SPIRIVA
Current Illness: Chronic obstructive airways disease; Hypertension arterial; Obstructive sleep apnea syndrome; Type 2 diabetes mellitus.
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cholecystectomy; Ganglionic tuberculosis; Prostatectomy.
Allergies:
Diagnostic Lab Data: Test Name: auscultation; Result Unstructured Data: Test Result: clear; Test Name: Pneumococcal; Test Result: Positive ; Test Name: blood pressure; Result Unstructured Data: Test Result:161/73 (121) mmHg; Test Date: 20210725; Test Name: fever; Result Unstructured Data: Test Result:39.5 Centigrade; Test Name: Chest CT; Result Unstructured Data: Test Result:50% parenchymal involvement, left basal; Comments: condensation; Test Name: CRP; Result Unstructured Data: Test Result:230; Test Name: ECG; Result Unstructured Data: Test Result: transthoracic echocardiography: integral; Comments: time-velocity under Aortic 18, E / A 0.6, no dilation right cavities, no pericardial effusion, visual left ventricular ejection fraction 50%; Test Name: Legionella; Test Result: Negative ; Test Name: oxygen saturation; Test Result: 90 %; Test Name: oxygen saturation; Test Result: 92 %; Test Name: oxygen saturation; Test Result: 92 %; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210725; Test Name: oxygen saturation; Test Result: 79 %; Test Name: physical examination; Result Unstructured Data: Test Result: Neurologically: conscious and oriented, no; Comments: neurological deficit. Abdominal: supple depressible abdomen and painless, hydroaeric noises + No functional urinary signs. Preserved diuresis.; Test Name: PO2; Result Unstructured Data: Test Result:55; Test Name: respiratory rate; Result Unstructured Data: Test Result:22; Comments: /min; Test Name: respiratory rate; Result Unstructured Data: Test Result:26; Comments: /min; Test Date: 20210719; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101026513

Write-up: Acute respiratory failure; pneumococcal positive; COVID-19 pneumonitis; Vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216013. An 83 years old male patient received 1st dose of BNT162B2 (COMIRNATY) on unknown date and 2nd dose of BNT162B2 (COMIRNATY) in end of Apr2021, intramuscular for COVID-19 immunisation. Medical history included ongoing Chronic obstructive airways disease, Ganglionic tuberculosis, Appendectomy, ongoing Obstructive sleep apnea syndrome, Cholecystectomy, ongoing Type 2 diabetes mellitus, Prostatectomy, ongoing Hypertension arterial. Concomitant drugs included metformin hydrochloride (GLUCOPHAGE) for Type 2 diabetes mellitus, allopurinol, gliclazide (DIAMICRON) for Type 2 diabetes mellitus, ramipril for Hypertension arterial, tiotropium bromide monohydrate (SPIRIVA). The patient had COVID-19 pneumonitis and Vaccination failure on 19Jul2021 and Acute respiratory failure on unknown date. The patient was tested positive for COVID-19 on 19Jul2021 (variant not specified). Since 19Jul2021, the patient has presented with dyspnea with familial Covid contagion which motivates the realization of a PCR which returns positive on 19Jul2021. On 25Jul2021, he was sent to the emergency room for a 79% desaturation in ambient air and a fever of 39.5 centigrade. At emergency medical aid department, he was put under 9L with a high concentration mask to maintain a 92% SaO2, polypneic at 22 / min, no signs of respiratory distress. Chest CT not injected: 50% parenchymal involvement, left basal condensation. Faced with good clinical tolerance and the patient''s refusal, he was transferred to internal medicine. Biologically: C-reactive protein 230 without leukocytosis, no renal failure, hypoxemia at PO2 55 under 12L with a high concentration mask. Reminder from the doctor for an increase in oxygen dependence at 12L / min with SaO2 92% without sign of acute respiratory failure. Resuscitation care decision. Admission examination and initial development in the intensive care unit: On the respiratory level: SaO2 90% under 12L with a mask at high concentration respiratory rate 26 / min, no sign of struggle, some crackling on the left base, clear auscultation moreover. On the hemodynamic level: hypertensive side with arterial pressure, 161/73 (121) mmHg, no sign of right or left heart failure. Soft and painless calves. Neurologically: conscious and oriented, no neurological deficit. Abdominal: supple depressible abdomen and painless, hydroaeric noises + No functional urinary signs. Preserved diuresis. Initial management: High flow oxygen therapy then continuous positive airway pressure positive expiratory pressure 7 to maintain a 95% SaO2. Probabilistic antibiotic therapy with Augmentin. Legionella negative, pneumococcal positive. Corticosteroid therapy with dexamethasone. Preventive anticoagulation reinforced by Lovenox 0.4 mL x 2 / d. Blood pressure control by intravenous Loxen electric syringe. ECG: transthoracic echocardiography: integral time-velocity under Aortic 18, E / A 0.6, no dilation right cavities, no pericardial effusion, visual left ventricular ejection fraction 50%. In total: Acute respiratory failure in Covid pneumonia superinfected with Pneumococcus under non-invasive ventilation. Outcome of the events was fatal. The patient died on 29Jul2021. It was unknown whether 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: pneumococcal positive; COVID-19 pneumonitis; Vaccination failure; Acute respiratory failure


VAERS ID: 1585064 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Cured lymphoma progressive pulmonary fibrosis type 2 diabetes cognitive impairment.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210829148

Write-up: CARDIO-RESPIRATORY ARREST; SUDDEN DEATH; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-NC20213380] concerned a 90 year old female. The patient''s height, and weight were not reported. The patient was cured from lymphoma progressive pulmonary fibrosis type 2 diabetes cognitive impairment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms (total dose: 0.5 ml), 1 total administered (duration of drug administration: 1 day) on 27-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 29-JUL-2021, the patient had cardio-respiratory arrest and sudden death due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died with cardio-respiratory arrest on 29-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210829148- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cardio-respiratory arrest, Sudden 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: 1585097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-22
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diabetic ketoacidosis, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: Obesity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026453

Write-up: diabetic ketoacidosis; Acute pancreatitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PB20214934. A 27-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 23Apr2021 (Batch/Lot Number: EW4815) at single dose for COVID-19 immunisation. Medical history included obesity. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 30Mar2021 for COVID-19 immunisation. Patient presented on 22May2021 with abdominal pain, emergency room visit for abdominal pain. Returned home with simple analgesics then on 24May2021 brought to the emergency room in a diabetic ketoacidosis on pancreatitis Balthazar E alithiasic, leading to death. The patient died on 24May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: diabetic ketoacidosis; pancreatitis


VAERS ID: 1585154 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: ASMELOR; ADENURIC; DOLIPRANE; AMIODARONE; DIFFU K; CALCIDOSE VITAMINE D; XARELTO; NOVOPULMON; ZOPICLONE; PERINDOPRIL; ZYMAD; LASILIX SPECIAL [FUROSEMIDE]; ESOMEPRAZOLE
Current Illness: Atrial fibrillation; Cardiac failure; Chronic obstructive airways disease; Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210831971

Write-up: COVID-19 PNEUMONITIS; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-RE20212239] concerned an 87 year old male. Initial information was processed along with the additional information received on 17-AUG-2021: The patient''s weight was 98.1 kilograms, and height was 175 centimeters. The patient''s concurrent conditions included: atrial fibrillation, cardiac failure, hypertension arterial, and chronic obstructive airways disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 1 dosage forms, 1 total administered on JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included amiodarone, budesonide (Novopulmon), calcium carbonate/colecalciferol (Calcidose Vitamine D), colecalciferol (Zymad), esomeprazole, febuxostat (Adenuric), formoterol fumarate (Asmelor), furosemide (Lasilix special), paracetamol (Doliprane), perindopril, potassium chloride (Diffu K), rivaroxaban (Xarelto), and zopiclone. On 03-AUG-2021, the patient experienced covid-19 pneumonitis, and vaccination failure. On 10-AUG-2021, the patient died from covid-19 pneumonitis, and vaccination failure. It was unknown if an autopsy was performed. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210831971- Covid-19 vaccine ad26.cov2.s- Covid-19 pneumonitis. 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). 20210831971- Covid-19 vaccine ad26.cov2.s- Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 PNEUMONITIS; VACCINATION FAILURE


VAERS ID: 1585470 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Hypertension, Maternal exposure during pregnancy, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Hypertension; Pregnancy with advanced maternal age; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/101
CDC Split Type: GBPFIZER INC202100998230

Write-up: nausea; Maternal exposure during pregnancy; headaches; Hypertension worsened/ Hypertension; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108031756120450-Z4ZCI, Safety Report Unique Identifier is GB-MHRA-ADR 25748905. A 35-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 02Aug2021 (at the age of 35 years old) as single dose for COVID-19 immunisation. Medical history included hypertension, stroke, ongoing pregnancy, pregnancy with advanced maternal age, folic acid supplementation all from an unknown date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medications included enoxaparin sodium (CLEXANE) taken for pregnancy with advanced maternal age from 11Jun2021 to an unspecified stop date; folic acid (FOLIC ACID) taken for folic acid supplementation, start and stop date were not reported. Historical vaccine was taken for first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number was not reported) for COVID-19 immunisation. The patient experienced nausea, maternal exposure during pregnancy all on an unspecified date; hypertension/ hypertension worsened on 02Aug2021. The events were reported as serious (life threatening). Clinical course was reported as follows: increased blood pressure (166/101), headaches and nausea. Medication not bringing blood pressure down significantly as expected but to safer levels. My died of stroke/ hypertension despite having been on blood pressure tablets recently, she had both Pfizer vaccines shortly beforehand. Wondering if there is a connection? Blood pressure checked by midwife and followed up at local hospital. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was exposed to the medicine Third trimester (29-40 weeks). The outcome of nausea and headache was unknown. The patient died on an unspecified date. It was not reported if autopsy was performed. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypertension/ Hypertension worsened; Stroke


VAERS ID: 1585641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-17
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Arteriosclerosis, Asthenia, Cardiac failure, Cough, Death, Dyspnoea, Fall, Lung disorder, Multiple organ dysfunction syndrome, Myocardial infarction, Paralysis, Peripheral swelling, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 61
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: Breast cancer
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Result Unstructured Data: Test Result:left artery was 95% blocked and right was 75%
CDC Split Type: GBPFIZER INC202101022281

Write-up: Passed away on 17Jul2021; Swelling in feet; He is having cardiac failure; Angiogram showed left artery was 95% blocked and right was 75%; Vaccine is like a poison for lungs and made him weak; Hospital acquired pneumonia; Multi organ failure; Fall; Silent heart attack; Couldn''t breathe in shower; Husband got a cough; weak; paralysis; This is a spontaneous report from a contactable other HCP (patient''s wife) via a medical information team.. A 76-year-old male patient (husband) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunisation. Medical history included breast cancer. The patient''s concomitant medications were not reported. The patient experienced passed away on 17Jul2021 (death, hospitalization) on 17Jul2021, hospital acquired pneumonia (death, hospitalization) on an unspecified date in 2021, multi organ failure (hospitalization, life threatening) on an unspecified date in 2021 with outcome of unknown, fall (hospitalization) on an unspecified date in 2021 with outcome of unknown, silent heart attack (hospitalization) on an unspecified date in 2021 with outcome of unknown, swelling in feet (hospitalization) on 17Jun2021 with outcome of unknown, cardiac failure (hospitalization) on an unspecified date in 2021 with outcome of unknown, open heart surgery. heart repair and double bypass completed (hospitalization) on an unspecified date in 2021 with outcome of unknown, angiogram showed left artery was 95% blocked and right was 75% (hospitalization) on an unspecified date in 2021 with outcome of unknown, vaccine is like a poison for lungs and made him weak (hospitalization) on an unspecified date in 2021 with outcome of unknown, paralysis (medically significant) on an unspecified date in 2021 with outcome of unknown, couldn''t breathe in shower on 17May2021 with outcome of unknown, got a cough on an unspecified date in 2021 with outcome of unknown, weak on an unspecified date in 2021 with outcome of unknown. Clinical course reported as follow: 2 weeks later, husband got a cough. Took antibiotics. On 17May2021, patient couldn''t breathe in shower. Ambulance came and took husband to hospital. Perfectly ok pre vaccine. The reporter had heart operation in June and have previously had breast cancer. Husband had silent heart attack and was kept as an inpatient. He was sure this was caused by the vaccine. Husband only took vaccine so he could go to Country. Husband was unable to be transferred to same hospital as the reporter. Since 17Jun2021, he has had breathing difficulties and swelling in feet. The reporter was a doctor and knew the patient was having cardiac failure. Took husband to hospital. 29Jun2021 he had an open heart surgery. Heart repair and double bypass completed. Angiogram showed left artery was 95% blocked and right was 75%. The reporter knew everything happened due to the vaccine. A doctor has confirmed this was due to the vaccination. He had multi organ failure, suffered a fall whilst in hospital and passed away on 17Jul2021. Vaccine was like a poison for lungs and made him weak. Patient in Country had paralysis from the vaccine. Husband contracted hospital-acquired pneumonia prior to passing. The reporter was not happy with the way her husband was treated in the hospital prior to passing as he would have been better off in the same hospital as her or at home. The patient underwent lab tests and procedures which included angiogram: left artery was 95% blocked and right was 75%. The patient died on 17Jul2021. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information and noted underlying risk factors the reported events were more likely attributed to an underlying or an intercurrent medical condition and it is assessed as unrelated to the BNT162B2 in this 76 year old elderly subject. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away on 17Jul; Hospital acquired pneumonia


VAERS ID: 1585670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV2 antibody test; Result Unstructured Data: Test Result:85000; Test Date: 202108; Test Name: PCR test; Result Unstructured Data: Test Result:positive in SARS-CoV2 variant delta; Comments: positive for SARS-CoV2 variant delta
CDC Split Type: GRPFIZER INC202100962803

Write-up: severe pneumonia (COVID-19 pneumonia); severe pneumonia (COVID-19 pneumonia); The initial case was missing the following minimum criteria: identifiable reporter. Upon receipt of follow-up information on 17Aug2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 2, single, and received dose 1 via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient completed the full vaccination scheme, administered both doses of the Pfizer-Biontech vaccine on time, and 14 days had passed since the second dose. The patient did not have any relevant medical history, he was healthy, athletic type, and was paying attention to his diet and healthy nutrition, he was not smoking. The patient was not taking any concomitant medications. The patient experienced vaccination failure and COVID-19 pneumonia on an unknown date in 2021, requiring hospitalization in 2021. The patient had a positive test for SARS-CoV2, he underwent a PCR in Aug2021 and was positive for SARS-CoV2 variant delta. The patient experienced severe pneumonia. The patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. It was still unknown how he and his family got infected. The patient was hospitalized in the ICU for 15 days before he died. It was unknown if the patient displayed any clinical signs at rest indicative of severe systemic illness. The patient required supplemental oxygen and received mechanical ventilation. It was unknown if the patient had multiorgan failure, any cardiovascular, gastrointestinal/hepatic, vascular, renal, neurological, hematological, dermatological, or any other symptoms. The patient did not receive any additional therapies for COVID-19. He did not receive any new medication or initiate other treatment or procedure. Two days before he died (Aug2021), the patient underwent an antibody test, the result was 85,000 (unknown units). The patient had not had any disease other than Corona virus to date. Both doses of the Pfizer-Biontech vaccine on time, caught the Corona virus and was subsequently hospitalized for severe pneumonia, but passed away despite all efforts. The reporter stated "This is the first case our hospital has seen since the start of vaccinations. The patient had severe pneumonia. We do not have the profile of the strain. The vigil was closed yesterday with an increase in admissions. He had the Pfizer vaccine, 14 days have passed. He has no underlying diseases. He is the exception that confirms the rule. The effectiveness of the vaccines protects 9 out of 10." The patient died on an unknown date in Aug2021 due to Covid-19 pneumonia, an autopsy was not performed.; Sender''s Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1585931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101031665

Write-up: were vaccinated with the Corona vaccine and died a few days afterwards; This is a spontaneous report received from a physician via Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A 9-decade-old (over 80 years old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included few chronic disease from an unknown date. The patient''s concomitant medications were not reported. The patient died a few days afterwards on an unspecified date, event took place after use of product. The patient died on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Based on the information in the case report, a possible causal relationship between the event death and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-202101032022 Same reporter, same product, same event, different patient; Reported Cause(s) of Death: were vaccinated with the Corona vaccine and died a few days afterwards


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