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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1339142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-25
   Days after vaccination:9
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: Laboratory test, Oesophageal varices haemorrhage, SARS-CoV-2 test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (treated); Cholelithiasis (treated); Gastrooesophageal varices (treated); Hepatic cirrhosis (treated)
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: Laboratory test; Result Unstructured Data: Test Result:Severe metabolic acidosis, high ammonia levels, si; Comments: Severe metabolic acidosis, high ammonia levels, significant anemia; Test Date: 20210425; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Covid-19 infection was not detected based on tests performed in the Emergency Department.
CDC Split Type: HUPFIZER INC2021560201

Write-up: Gastrooesophageal varices haemorrhage; This is a spontaneous report from a contactable physician received from a regulatory authority and downloaded from another regulatory authority-WEB (Regulatory Authority number HU-OGYI-286521). A 45-year-old female patient received the first dose of BNT162B2 (COMIRNATY; lot EW4815) intramuscular, in left arm, on 16Apr2021 at 12:00, at 0.3 ml single, for COVID-19 immunisation. Medical history included hepatic cirrhosis, alcohol abuse, gastrooesophageal varices and cholelithiasis, all from an unknown date to an unknown date and all were treated. Concomitant medications were not reported. No events occurred during the post-vaccination observation period. On 25Apr2021 the patient experienced gastrooesophageal varices haemorrhage. Clinical course included the following details. On 25Apr2021, an ambulance was called as the patient was vomiting fresh blood. Covid-19 infection was not detected based on tests performed in the Emergency Department. Laboratory tests performed on 25Apr2021 showed severe metabolic acidosis, high ammonia levels, significant anemia. The patient received blood transfusion in the intensive care unit; pantoprazole (CONTROLOC), NaHCO3, glucose, and amino acids (GLUTARSIN) were given intravenously. Despite this therapy, the patient died on 26Apr2021 at 6:30 A.M. An autopsy was requested. Results were not yet available. Sender''s comments: The 45-year-old patient died 10 days after Comirnaty vaccination due to gastrooesophageal varices haemorrhage. The causal relationship between the reported event and Comirnaty was considered not related. The case was serious due to fatal outcome. Stop date 26Apr2021 at 06:30 for event: gastrooesophageal varices haemorrhage, provided with outcome fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: The Company considered there was not a reasonable possibility that the reported event Gastrooesophageal varices haemorrhage (with fatal outcome) was related to the suspect product BNT162B2 (COMIRNATY). The event is more consistent with patient''s underlying condition of hepatic cirrhosis. 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: Gastrooesophageal varices haemorrhage


VAERS ID: 1339143 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-15
   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 ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cardiac arrest, Circulatory collapse, Drug ineffective, Dyspnoea, Loss of consciousness, Pulmonary embolism, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test, Scan, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: CO-RENITEC; THEOSPIREX [THEOPHYLLINE]; MERCKFORMIN; MILURIT; QUAMATEL; GLICLADA; ASA PROTECT PHARMAVIT; LYRICA; TRAJENTA; ELONTRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Asthma; Cerebrovascular disorder; Diabetes mellitus; Hypertension; Obesity; Psychiatric decompensation
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: COVID-19 with a rapid test; Test Result: Negative ; Test Date: 20210416; Test Name: PCR tests; Test Result: Positive ; Test Date: 20210423; Test Name: PCR tests; Test Result: Positive ; Test Date: 20210415; Test Name: scan; Result Unstructured Data: Test Result:COVID-19 pneumonia; Comments: confirmed COVID-19 pneumonia and pulmonary embolism
CDC Split Type: HUPFIZER INC2021559800

Write-up: COVID-19 pneumonia; COVID-19 pneumonia; collapse; loss of consciousness; dyspnea; cardiovascular failure; respiratory failure; asystole; pulmonary embolism; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority; regulatory authority number HU-OGYI-286621. A 63-years-old female patient received the first dose of BNT162B2(COMIRNATY, lot number/ batch number ET7205) Intramuscular on 27-MAR-2021 at 0.3 ml single to COVID-19 immunisation. Medical history includes psychiatric decompensation, Asthma, hypertension, obesity, diabetes mellitus, cerebrovascular disorder and arthrosis. Concomitant products are enalapril maleate, hydrochlorothiazide(CO-RENITEC), theophylline(THEOSPIREX, 300 mg), metformin hydrochloride(MERCKFORMIN, 1000 mg), allopurinol(MILURIT, 300 mg), famotidine(QUAMATEL, 40 mg), gliclazide(GLICLADA, 30 mg), acetylsalicylic acid(ASA PROTECT PHARMAVIT), pregabalin(LYRICA, 150 mg) , linagliptin(TRAJENTA, 5mg), bupropion hydrochloride (ELONTRIL, 30 mg). On 15Apr2021 the patient was taken to the hospital due to collapse, loss of consciousness and dyspnea. She was tested negative to COVID-19 with a rapid test but scans confirmed COVID-19 pneumonia and pulmonary embolism. PCR tests on 16Apr2021 and 23Apr2021 also confirmed COVID-19 infection. On 26Apr2021 the patients condition deteriorated, she experienced asystole, cardiovascular and respiratory failure, resuscitation was unsuccessful. The patient died due to asystole, pulmonary, Respiratory failure and cardiovascular failure caused by the infection 30 days after vaccination. The patient was hospitalized due to events COVID-19 pneumonia, collapse, loss of consciousness and dyspnea on 15Apr2021. The events asystole, pulmonary embolism, Respiratory failure and cardiovascular failure were assessed as hospitalization prolonged. The patient died on 26-APR-2021. It''s unknown if an autopsy was performed. The cause of death was asystole, pulmonary, Respiratory failure and cardiovascular failure. The patient underwent lab tests and procedures, which included COVID-19 with a rapid test on 15-APR-2021: Negative; scan on 15-APR-2021: confirmed COVID-19 pneumonia and pulmonary embolism; PCR tests on 16Apr2021 and 23Apr2021: Positive also confirmed COVID-19 infection. The outcome of the events asystole, pulmonary embolism, Respiratory failure , cardiovascular failure, COVID-19 pneumonia, Drug ineffective was Fatal, the others was unknown. Sender Comment: COVID-19 pneumonia was detected 19 days after vaccination with COMIRNATY. Immunity does not develop within 19 days after the first dose. The patient died due to asystole, pulmonary and cardiovascular failure caused by the infection 30 days after vaccination. The causal relationship between the vaccine and the event is unlikely. 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, there was not a reasonable possibility that the events "COVID-19 pneumonia, pulmonary embolism, cardiovascular failure, respiratory failure, asystole" were related to BNT162B2. The patient only received single dosage BNT162B2 and was not well protected for the occurrence of COVID-19 pneumonia. ; Reported Cause(s) of Death: asystole; Respiratory failure; cardiovascular failure; pulmonary; pulmonary; pulmonary embolism


VAERS ID: 1339144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-18
   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 10359267100013 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroesophageal reflux disease; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest CT; Result Unstructured Data: Test Result:Covid-19 pneumonia; Test Date: 20210218; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021560196

Write-up: Covid-19 infection; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority. This is a spontaneous report from a contactable physician. This is a report received from Regulatory Authority. A 77-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 12Feb2021 (Batch/Lot Number: 10359267100013) as 0.3mL single for covid-19 immunisation . Medical history included ongoing gastrooesophageal reflux disease , ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced covid-19 infection on 18Feb2021 leading to patient death on 12Mar2021. The patient underwent lab tests and procedures which included computerised tomogram thorax: covid-19 pneumonia, Sars-cov-2 test: positive on 18Feb2021. Course of the event. On 18Feb2021, the patient''s Covid-19 PCR test was positive. On 22Feb2021, the patient was admitted to the hospital because of coughing, fever, and loss of consciousness. According to CT, Covid-19 pneumonia was detected. Mechanical ventilation was necessary. On 12Mar2021, the patient died. Medical history included hypertension and gastroesophageal reflux disease. The patient''s concomitant medicinal products were not reported. According to the patient''s death certificate, the direct cause of death was respiratory insufficiency, the indirect cause was pneumonia and Covid-19 infection. The autopsy was not performed. Sender Comment: According to the Summary of Product Characteristics of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 12Feb2021 and got infected with the virus 6 days after, therefore immunity may not have developed yet without the second dose. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. No further information is expected.; Reported Cause(s) of Death: Covid-19 infection; respiratory insufficiency; pneumonia


VAERS ID: 1339145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cachexia, Dementia, SARS-CoV-2 test
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 13
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: Alzheimer''s disease; Bipolar affective disorder; Hypertension; Osteoporosis; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560195

Write-up: cachexia; Dementia NOS; General atherosclerosis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority WEB HU-OGYI-287021. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06Apr2021 (Batch/Lot Number: EW2239) as 2nd dose, 0.3ml single for covid-19 immunisation. Medical history included ongoing Alzheimer''s disease, ongoing osteoporosis, ongoing hypertension, ongoing Parkinson''s disease, ongoing Bipolar affective disorder. Historical vaccine included the first dose of 0.3 ml bnt162b2 (batch number: EJ6790, expiry date unknown, intramuscularly, in left arm) for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 14Apr2021, the patient died. According to the patient s death certificate, the direct cause of death was cachexia (on 14Apr2021), indirect causes were dementia NOS (in Apr2021) and general atherosclerosis (in Apr2021). The autopsy was not performed. Other information the patient was under in-patient care at the time of the vaccinations, the hospitalization started on 21Dec2020 (reported as 21Dec2021). The COVID-19 PCR test was negative. The outcome of events was fatal. In the reporter physician s opinion, the patient s death is related to her underlying diseases. Sender''s comments: The 70 year old patient died 8 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dementia NOS; General atherosclerosis; cachexia


VAERS ID: 1339146 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-26
   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 EJ6790 / 1 LA / OT

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

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? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia NOS; Hypertension; Pleural mesothelioma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210309; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560194

Write-up: cachexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-287221. This is a report received from the Regulatory Authority. Regulatory authority report number HU-OGYI-287221. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 02Mar2021 (Batch/Lot Number: EJ6790) as 0.3 mL, single at the age of 81-year-old for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing dementia, ongoing pleural mesothelioma. The patient''s concomitant medications were not reported. The patient was under in-patient care at the time of the vaccination. The hospitalization started on 14Dec2020. The patient experienced cachexia on 26Mar2021. The patient''s hospitalization was prolonged as a result of cachexia. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 22Feb2021 and on 09Mar2021. The patient died on 14Apr2021 (also reported as 24 days after Comirnaty vaccination). An autopsy was not performed. According to the patient''s death certificate, the direct cause of death was cachexia, indirect causes were pleural mesothelioma and dementia NOS. The outcome of events was fatal. In the reporter physician''s opinion, the patient''s death was related to his underlying diseases. Reporter Comment: The 81- year-old patient died 24 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The 81- year-old patient died 24 days after Comirnaty vaccination. The cause of death was cachexia. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome.; Reported Cause(s) of Death: cachexia


VAERS ID: 1339147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
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 EJ6790 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
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:
Current Illness:
Preexisting Conditions: Medical history/concurrent conditions: aseptic necrosis of head and neck of femur; coxarthrosis; decubitus; dementia; paranoid schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 with PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021560091

Write-up: cachexia associated with dementia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number HU-OGYI-287321. A 68-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via intramuscular on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml, single for covid-19 immunization. Medical history included dementia, aseptic necrosis of head and neck of femur, coxarthrosis, paranoid schizophrenia, decubitus. The patient was in the hospital since 22Jan2021 in need of inpatient care. She was tested several times to COVID-19 with PCR test with negative results each time. She experienced no side effects from vaccination. The patient had decubitus. Her condition was deteriorating in general and she died on 21Mar2021. According to the reporter physician the patient died due to cachexia associated with dementia. An autopsy was performed and results was unknown. The outcome of the event was fatal. Sender Comment: The patient died due to cachexia associated with dementia 19 days after 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: The 68-year-old female patient had medical history included dementia, aseptic necrosis of head and neck of femur, coxarthrosis, paranoid schizophrenia, and decubitus. The fatal event cachexia associated with dementia was not related to BNT162B2 (COMIRNATY), but was due to her pre-existing dementia and underlying diseases.; Reported Cause(s) of Death: cachexia associated with dementia; cachexia associated with dementia


VAERS ID: 1339148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Hyperventilation, Pneumonia, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (in the hospital since 25Sep2020 initially with COVID-19 infection); Dementia; Dystopic kidney; Gastroesophageal reflux disease; Hypertension; Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560092

Write-up: cachexia associated with pneumonia; cachexia associated with pneumonia; hyperventilation; somnolence; fever; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. Regulatory authority report number HU-OGYI-287421. An 85-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via intramuscular on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml, single for covid-19 immunization. Medical history included covid-19 (The patient was in the hospital since 25Sep2020 initially with COVID-19 infection. On 10Nov2020 she was transferred to the Nursing Department), dementia, hypertension, psoriasis, dystopic kidney and gastro-esophageal reflux disease. The patient''s concomitant medications were not reported. On 15Mar2021 the patient experienced hyperventilation, somnolence and fever due to pneumonia (hospitalization) not related to COVID-19. On 23Mar2021 the patient died due to cachexia associated with pneumonia. An autopsy was performed and results was unknow. The outcome of the event cachexia associated with pneumonia was fatal. Outcome for other events was unknown. Sender Comment: The patient died due to cachexia associated with pneumonia 21 days after 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 information provided, the events of hyperventilation, somnolence and fever due to pneumonia, cachexia associated with pneumonia more likely represent intercurrent illnesses which are unrelated to BNT162B2 (COMIRNATY). The case will be reassessed once more information become available.; Reported Cause(s) of Death: cachexia associated with pneumonia; cachexia associated with pneumonia


VAERS ID: 1339149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-25
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021560191

Write-up: death; This is a spontaneous report from a contactable physician via a regulatory authority, downloaded from another regulatory authority-WEB (Regulatory authority report number HU-OGYI-287821). A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular on 09Apr2021 (Batch/Lot number was not reported) at 0.3 ml single (30 micrograms of COVID-19 mRNA Vaccine) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 25Apr2021, 16 days after COMIRNATY vaccination, the patient died. There was no information about the cause of death. Autopsy was requested. The causal relationship between the reported death and COMIRNATY was unassessable. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1339150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Multiple organ dysfunction syndrome, Respiratory failure, SARS-CoV-2 test, Shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 17
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: ADEXOR; ELIQUIS
Current Illness: Fatty liver; Gastroesophageal reflux; NIDDM; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Choroid neoplasm; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Comments: diagnose of COVID-19 pneumonia; Test Date: 20210316; Test Name: SARS-CoV-2 test positive; Test Result: Positive ; Comments: diagnose of COVID-19; Test Name: Body temperature; Result Unstructured Data: Test Result:fever (unknown value)
CDC Split Type: HUPFIZER INC2021560200

Write-up: respiratory failure; shock; multiple organ failure; heart failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-288321. A 72-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 04Mar2021 (Batch/Lot Number: ET1831) as 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (NIDDM), pulmonary embolism in 2016, ongoing gastrooesophageal reflux disease, ongoing fatty liver, choroid neoplasm from an unknown date and unknown if ongoing and ongoing obesity. Concomitant medications included trimetazidine hydrochloride (ADEXOR, strength: 80 mg ) at 80 mg once a day and apixaban (ELIQUIS, strength: 2.5 mg) at 2.5 mg twice a day, both taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced fever and dyspnoea. On 11Mar2021, the patient was hospitalized. On 16Mar2021, the patient''s COVID-19 test was positive. On the same day, chest X-ray showed COVID-19 pneumonia. The patient''s condition worsened with time in the hospital. In the hospital, the patient received medicinal therapy as antibiotics, antiviral therapy, steroids, mucolytic medicines, mucus protective medicines, LMWH and oxygen therapy. The course of the disease was critical, the patient had respiratory failure, shock and multiple organ failure. On 02Apr2021, the patient died. According to the patient''s death certificate, the direct cause of death was heart failure. The primary disease that caused the patient''s death was COVID-19, which escalated to COVID-19 pneumonia and respiratory failure. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart failure; COVID-19 pneumonia; covid-19; respiratory failure; shock; multiple organ failure


VAERS ID: 1339151 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Medical History/Concurrent Conditions: Chest pain; Lung neoplasm malignant; Myocardial infarction; Vasoconstriction peripheral
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021559886

Write-up: suddenly died; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER concentrate for dispersion for injection, tozinameran; MAH: BioNTech Manufacturing GmbH, batch number: not reported, expiry date: unknown), administration route and site not reported, at 0.3 ml single dose on 20Apr2021 for COVID-19 immunisation. In the patient medical history, there was myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The patient''s concomitant medications were not reported. On 20Apr2021, the patient suddenly died. It was unknown if an autopsy was performed. According to the patient wife, he experienced stabbing chest pain in the morning, before the vaccination. According to the reporter, there was no causal relationship between sudden death and vaccination. Sender Comment: Sudden death is not expected after the use of Comirnaty concentrate for injection. TTO is less than a day. 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 are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatality and the use of the vaccine is unrelated, in agreement with the reporting physician. This is considering that the patient was reported to have had already experienced stabbing chest pain in the morning, before the vaccination which may indicate an ongoing event prior to vaccination. The possibility that the noted stabbing chest pain is a manifestation of an unknown fatal event is supported a history of myocardial infarction, severe lower limb vasoconstriction and lung neoplasm malignant. The case will be assessed further upon receipt of additional information.; Reported Cause(s) of Death: suddenly died


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