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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: 1339154 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Cardiac arrest, Chest X-ray, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 15
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: CO IRABEL; LIPANOR; XETER; ACTRAPID HM [INSULIN HUMAN]; COVERCARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral vascular lesion; Diabetic vascular disorder; Dyslipidaemia; Hypertension; Type II diabetes mellitus; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Test Date: 20210401; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560093

Write-up: SARS-CoV-2 infection/COVID-19 pneumonia/COVID-19 rapid antigen test became positive; dyspnoea; coughing; fever; acute respiratory distress syndrome; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority also received from the agency, The regulatory authority report number is HU-OGYI-289721. A 70-year-old male patient received BNT162B2 (COMIRNATY, strength: 0.3 ml), dose 1 intramuscular, administered in Arm Left on 31Mar2021 (Batch/Lot Number: ET3620) as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included diabetic angiopathy, Type II diabetes mellitus, cerebral vascular lesion from 26Nov2013, vertebrobasilar insufficiency from Nov2013, dyslipidaemia and hypertension, all were not ongoing. Concomitant medications included hydrochlorothiazide, irbesartan hydrochloride (CO IRABEL, strength: 150 mg/12,5 mg); ciprofibrate (LIPANOR); rosuvastatin calcium (XETER); insulin human (ACTRAPID HM); amlodipine besilate, perindopril arginine (COVERCARD, strength: 5 mg/5 mg). Clinical course: On 01Apr2021, COVID-19 rapid antigen test became positive (SARS-CoV-2 infection). The patient was transferred to the emergency department due to fever, dyspnoea, and coughing. On 06Apr2021, chest X-ray confirmed COVID-19 pneumonia. Despite the applied therapy (clarithromycin 500 mg (KLACID); Dexamethasone 4 mg; vitamin D 3000 IU; Vitamin C 1000 mg; acetyl salicylic acid 100 mg; Pantoprazol 40 mg; Frontin (alprazolam) 0,25 mg; O2-supplementation, enoxaparin sodium 0,6 ml (CLEXANE), amoxicillin; clavulanic acid 1,2 g (AKTIL INJECTION); methylprednisolone 40 mg (SOLU MEDROL), acute respiratory distress syndrome developed, the patient died on 16Apr2021. Cause of death was cardiac arrest according to the death certificate. Autopsy was not done. All events reported as serious with seriousness criteria of fatal. All events reported requiring hospitalization except event ''cardiac arrest''. Please note that it was unknow whether the reporter was also the patient, thus VAERS Primary Reporter Addl Qualification could not be completed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; SARS-CoV-2 infection; Dyspnoea; coughing; fever; acute respiratory distress syndrome


VAERS ID: 1339155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Ischemic heart disease; Myocardial infarction; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560099

Write-up: circulatory failure; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-289821. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 1 intramuscular on 19Mar2021 (Batch/Lot Number: Unknown) as 0.3 ml, single dose for covid-19 immunisation. Medical history included myocardial infarction, arteriosclerosis, Parkinson''s disease, and myocardial ischaemia, all from an unknown date to an unknown date. The patient''s concomitant medications were not reported. The patient experienced circulatory failure on 11Apr2021. Additional information: On 11Apr2021 the patient collapsed, an ambulance was called. Reanimation was unsuccessful, the patient died due to circulatory failure. Autopsy was not done. In the reporter physician''s opinion, the event is related to the patient''s underlying diseases. The patient died on 11Apr2021. Sender''s comment: The 81-year-old patient died 23 days after Comirnaty vaccination. Cause of death was circulatory failure. Autopsy was not done. In the reporter physician''s opinion, the event is related to the patient''s underlying diseases. The case is serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1339156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fatigue, Haematemesis, Pain of skin, Pyrexia, SARS-CoV-2 test, Visual impairment
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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: OXYCORT [HYDROCORTISONE;OXYTETRACYCLINE HYDROCHLORIDE]; VITAMIN D3 FRESENIUS; DICLOFENAC; VEROSPIRON; QUAMATEL; FUROSEMIDE; ELENIUM [CHLORDIAZEPOXIDE]; KALDYUM; UREGYT; ALGOPYRIN [METAMIZOLE SODIUM]
Current Illness: Esophageal varices; Hepatic cirrhosis; IHD; Papular rash
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560090

Write-up: vomiting blood; vision deterioration; diarrhoea; fever; weakness; fatigability; pain of skin; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-290021. A 69-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW4815; Expiration Date: Jul2021), intramuscular, administered in Arm Left on 16Apr2021 09:10 (at unknown age) as 0.3 ml single for COVID-19 immunisation. Medical history included Ovarian cancer from 2006, ongoing Papular rash, ongoing IHD (Myocardial ischaemia), ongoing Hepatic cirrhosis, Esophageal varices from 2014 and ongoing. Concomitant medications included hydrocortisone, oxytetracycline hydrochloride (OXYCORT); colecalciferol (VITAMIN D3 FRESENIUS); diclofenac; spironolactone (VEROSPIRON); famotidine (QUAMATEL); furosemide; chlordiazepoxide (ELENIUM); potassium chloride (KALDYUM); etacrynic acid (UREGYT); metamizole sodium (ALGOPYRIN). A physician describes the occurrence of adverse events resulting in death after vaccination with COMIRNATY (tozinameran). On 21Apr2021, the patient experienced diarrhoea, fever, weakness, fatigability and pain of skin. From 24Apr2021, she experienced vision deterioration (low visual acuity). On 26Apr2021, the patient had vomiting blood and died after when submitted to hospital. The patient was hospitalized on unknown date. COVID-19 test was negative on 26Apr2021. Autopsy has been done, the results are not available. Based on the patient physician, the patient symptoms and death are not related with the vaccination. The patient died on 26Apr2021. Sender comments: Diarrhoea, fever, weakness, fatigability and skin pain are expected adverse events of COMIRNATY. Vision decreased and haematemesis are not expected adverse events. They might be resulted by the patient chronic diseases. TTO was 5 days for diarrhoea, fever, weakness, fatigability and skin pain; 8 days for low visual acuity and 10 days for haematemesis. Based on the above, relationship between the events and COMIRNATY is unlikely. The case is serious because the patient died. Comirnaty/Weakness, Fever, Pain of skin, Fatigability, Diarrhoea/Time Interval between Beginning of Drug Administration and Start of Reaction 5 days, Comirnaty/ Vision decreased/Time Interval between Beginning of Drug Administration and Start of Reaction 8 days, Comirnaty/Haematemesis/Time Interval between Beginning of Drug Administration and Start of Reaction 10 days. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information available the events are attributed to intercurrent medical conditions and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: diarrhoea; fever; weakness; fatigability; pain of skin; vision deterioration; vomiting blood


VAERS ID: 1339157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: ASTRIX; MERAMYL HCT; BISOBLOCK
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560189

Write-up: sudden death cause unknown; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority report. A 68-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administered in Arm Left on 07Apr2021 (Batch/Lot Number: EW2239) as 0.3ml, single for Covid-19 immunization. Medical history included ongoing hypertension. Concomitant medications included acetylsalicylic acid (ASTRIX); hydrochlorothiazide, ramipril (MERAMYL HCT); bisoprolol fumarate (BISOBLOCK), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death on 10Apr2021. On 07Apr2021, the 68-year-old female patient received BNT162b2. On 10Apr2021, her son found the patient dead at her home. Presumably, she could feel bad, so she took a chair to the open window and was found lying next to her. The patient died on 10Apr2021. The cause of death was unknown. The autopsy was initiated at the time of the report. Results are not available. According to the reporter physician, the relationship between the reported death and the vaccine is unlikely. Sender Comment: The 68-year-old patient died 3 days after Comirnaty vaccination. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the limited information available, until additional data surrounding the fatal event becomes available, the company, as a cautionary measure and for reporting purposes, cannot completely exclude that the patient''s sudden death, cause unknown, is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death


VAERS ID: 1339158 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lymphoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560188

Write-up: sudden death; weakness; inappetence; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number HU-OGYI-290921. An 89-year-old male patient received bnt162b2 (Pfizer vaccine), dose 2 intramuscular, administered in arm left on 14Apr2021 (Lot Number: EW4815) as 0.3 ml, single dose for covid-19 immunisation. Medical history included ongoing lymphoma. The patient previously received first dose of bnt162b2 (batch number: EP2163) intramuscularly, in the left arm at 0.3 ml on an unspecified date for covid-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced sudden death on 28Apr2021. The patient experienced weakness and inappetence in the period before death. The patient died on 28Apr2021. In the reporter physician opinion, the causal relationship between the reported death and the vaccine is unlikely. The outcome of weakness and inappetence was unknown. The autopsy was initiated at the time of the report. Results are not available. Sender comments: The 89- year-old patient died 14 days after Pfizer vaccination. The cause of death was unknown. Dechallenge and rechallenge were not applicable. The causal relationship between the reported death and the vaccine is not assessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: sudden death


VAERS ID: 1339159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KALIUM-R; ASA PROTECT PHARMAVIT; FURON [FUROSEMIDE]; NOLPAZA; RENITEC COMP; CONCOR; CORDARONE; SYNJARDY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis of arteries of the extremities; Cardiac insufficiency; Cardiomyopathy; COPD; Diabetes mellitus non-insulin-dependent; Hypertension; Measles; Myocardial infarct; Obesity; Respiratory insufficiency; Triple vessel disease; Ventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: COVID-19 antigen test positive; Test Result: Positive
CDC Split Type: HUPFIZER INC2021559890

Write-up: COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-291121 received via regulatory authority. This spontaneous, serious, medically confirmed case was reported on 28Apr2021 by a physician and concerns the occurrence of Covid-19 infection resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. A 70-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular in right arm on 17Mar2021 at 0.3 ml single for covid-19 immunisation. The patient was hospitalized on 27Mar2021 because of weakness which has been ongoing for 1 week and difficulty in breathing which occurred the day before. Previously a covid antigen was done on 23Mar2021 because the patient''s daughter got infected with covid, who she lives together with. The test result was positive. Bilateral pneumonia was confirmed in the hospital. The patient received antiviral, steroid, anticoagulant, anti-decompensation therapy and ulcus prophylaxis. Despite the therapy, the patients oxygenation continued to worsen and passed away on 30Mar2021 at 18:02. Medical history included atherosclerosis of arteries of the extremities, cardiac insufficiency, cardiomyophathy, COPD, non-insulin-dependent diabetes mellitus, hypertension, measles, myocardial infarct, obesity, respiratory insufficiency, triple vessel disease and ventricular tachycardia. Drug history included Xigduo (metformin; dapagliflozin), clopidogrel and canakinumab. Concomitant drugs were ASA Protect Pharmavit 100 mg (acetylsalicylic acid), Concor 2.5 mg (bisoprolol fumarate), Cordarone 100 mg (amiodarone), Furon 40 mg (furosemide), Kalim-R 1 g (potassium chloride), Nolpaza 40 mg (pantoprazole), Renitec 2.5 mg (enalapril) and Synjardy (empagliflozin; metformin). Further information is not expected. Sender Comment: According to the information of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with Covid-19 6 days after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event as the patient died due to Covid-19. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event "infected with Covid-19" is attributed to an intercurrent medical condition that was not related to BNT162B2 (COMIRNATY0 vaccine.; Reported Cause(s) of Death: covid-19


VAERS ID: 1339160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer; Haematuria; Hypertension; Metastatic colon cancer; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560088

Write-up: cardiovascular failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, number HU-OGYI-291221. This spontaneous, serious case was reported on 27Apr2021 by a physician and concerns the occurrence of cardiovascular failure resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. On 18Feb2021 the 77-year-old male patient received COMIRNATY concentrate for dispersion for injection (one dose 0.3 ml, contains tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EL0725, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly to prevent COVID-19. He received the first Comirnaty vaccine (one dose 0.3 ml, contains tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: EJ6134, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly on 28JAN2021. On 09Mar2021 the patient died from cardiovascular failure caused by the patient''s underlying hematuria, bladder cancer and metastatic colon cancer. Medical history included hematuria, metastatic colon cancer, bladder cancer, hypertension and psychiatric disorder not otherwise specified, all from an unspecified date and unknown if ongoing. Concomitant drugs are not reported. Further information is not expected. It was unknown if autopsy was performed. Sender''s comment: The patient died due to cardiovascular failure 19 days after the second dose of COMIRNATY caused by the patient''s underlying hematuria, bladder cancer and metastatic colon cancer. The events and the vaccination are not related. The case is considered serious due to fatal outcome. No follow up attempts are needed, no further information is expected.; Sender''s Comments: Based on the information currently available, the Company concurs with the reporter that there is not a reasonable possibility of an association between the suspect medication and the event cardiovascular failure, due most likely to underlying medical conditions.; Reported Cause(s) of Death: cardiovascular failure


VAERS ID: 1339161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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: Cerebral infarction; Hypertension; Ischemic heart disease; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560101

Write-up: died on 14Mar2021 due to cachexia and heart insufficiency; died on 14Mar2021 due to cachexia and heart insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB HU-OGYI-291421. This is a report received from the administrative authority (AA). A 83-year-old female patient received second dose BNT162B2 (COMIRNATY, lot/batch number EJ0725), intramuscular on 18-FEB-2021 at 0.3 ml single dose for COVID-19 immunization. Medical history included ischemic heart disease, Parkinson''s disease, hypertension and cerebral infarction. The concomitant medications were not reported.The Historical Vaccine was first dose COMIRNATY on 28JAN-021(batch number: EL6134 ,0.3 ml single) intramuscular for COVID-19 immunization. The patient died on 14Mar2021 due to cachexia and heart insufficiency. According to the reporter physician''s opinion the patient''s death was caused by her underlying diseases. The event and the vaccination were not related. The patient died on 14Mar2021. The autopsy was not performed. The cause of death was cachexia and heart insufficiency. The outcome of the events was fatal. Sender comments: The patient died due to cachexia and heart insufficiency 26 days after vaccination with COMIRNATY. The event and the vaccination are not related. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the clinical information currently provided, the company concurs with the causality assessment expressed by the reporter, considering there is not a reasonable possibility that the reported events are related to the suspect drug Comirnaty.; Reported Cause(s) of Death: cachexia; heart insufficiency


VAERS ID: 1339162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive encephalopathy, Respiratory failure, SARS-CoV-2 test, Vascular dementia
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), Dementia (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (narrow), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcoholism; Arteriosclerosis; Dementia; Enlarged prostate; Hypertension; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560190

Write-up: respiratory failure; hypertensive encephalopathy; vascular dementia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, Safety Report Unique Identifier HU-OGYI-291521. This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-291521. An 80-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscularly in the left arm on 28Jan2021 (lot number: EJ6134) at 0.3ml, single dose for COVID-19 immunisation. Medical history included ongoing Parkinson''s disease, ongoing enlarged prostate, ongoing hypertension, ongoing dementia, ongoing arteriosclerosis, and ongoing alcoholism. Concomitant medication was not reported. On 03Feb2021, the patient died. The autopsy was not performed. According to the patient''s death certificate, the direct cause of death was respiratory failure, indirect causes were hypertension, hypertensive encephalopathy, and vascular dementia. Other information: the patient lived in a nursing home at the time of the vaccinations. On 27Jan2021, the Covid-19 rapid POC test was negative. In the physician''s opinion, the patient''s death was related to his underlying diseases. Outcome of events was fatal. Senders comments: The 80- year-old patient died 6 days after BNT162B2 vaccination. The cause of death was respiratory failure. Dechallenge and rechallenge were not applicable. The relationship between the reported death and the vaccine was considered unlikely. The case was serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Respiratory failure; hypertension; hypertensive encephalopathy; vascular dementia


VAERS ID: 1339163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchial neoplasm, Death, Lung neoplasm, Neoplasm progression
SMQs:, Malignancy related conditions (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Bronchial neoplasm; COPD; Lung neoplasm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560197

Write-up: Bronchial neoplasm progresion; Bronchial neoplasm progresion; Lung neoplasm progression; Lung neoplasm progression; death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority. A 63-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EP2163) as 0.3 mL, single for covid-19 immunisation . Medical history included ongoing chronic obstructive pulmonary disease , ongoing lung neoplasm , ongoing bronchial neoplasm. The patient''s concomitant medications were not reported. On 30Jan2021, the patient received the first dose. Comirnaty The patient died on 22Feb2021. According to the patient death certificate, direct cause of death were respiratory and circulatory failure, indirect causes was lung and bronchial neoplasm. According to the physician, the patient death is related to his underlying diseases. The autopsy was not performed. Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, death is not expected. TTO (to take out) is 2 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered unlikely. The case is considered serious due to fatal outcome. No further information is expected.; Reported Cause(s) of Death: respiratory and circulatory failure - direct cause according to the patient death certificate; respiratory and circulatory failure - direct cause according to the patient death certificate; lung and bronchial neoplasm - indirect cause according to th


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