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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

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1344969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-28
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: Arteriosclerosis obliterans; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210211; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210223; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210308; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive
CDC Split Type: HUPFIZER INC2021560192

Write-up: respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is HU-OGYI-287121. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular, administered in left arm on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml single for covid-19 immunization. Medical history included ongoing arteriosclerosis obliterans, ongoing hypothyroidism. The patient''s concomitant medications were not reported. The patient was under in-patient care at the time of the vaccinations, the hospitalization started on 08Feb2021. The Covid-19 PCR test was negative. The occurrence of respiratory arrest after the administration of Comirnaty on 28Mar2021. On 28Mar2021, the patient died. Autopsy was not performed. According to the patient''s death certificate, the direct cause of death was respiratory arrest, indirect causes were general atherosclerosis. The patient''s hospitalization was prolonged as a result of respiratory arrest. In the reporter physician''s opinion, the patient''s death was related to his underlying diseases. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Feb2021, on 11Feb2021, on 23Feb2021 and on 08Mar2021. The outcome of the event was fatal. Sender Comment: The 90-year-old patient died 26 days after Comirnaty vaccination. The cause of death was respiratory arrest. 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 needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of respiratory arrest. The reported event likely appears associated with intercurrent medical conditions in this elderly 90 year old patent. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.; direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.


VAERS ID: 1344970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 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: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021572835

Write-up: sudden death (died suddenly, died 4 days after Comirnaty vaccination); This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-319321. A 79-years-old male patient received BNT162B2 (COMIRNATY), first dose intramuscularly administered in left arm on 29Apr2021 (Batch/Lot Number: EX6537) as 0.3 mL single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and was not ongoing. The patient''s concomitant medications were not reported. The patient experienced sudden death (died suddenly, died 4 days after Comirnaty vaccination) on 03May2021. There was no information about the cause of death and about the autopsy results. The patient died on 03May2021. It was not reported if an autopsy was performed. The causal relationship between the reported death and Comirnaty was unassessable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1344987 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiopathy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic kidney disease stage 3; Diverticular disease; IHD; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021553710

Write-up: ABDOMINAL PAIN; LIKELY VASCULAR EVENT; This is a spontaneous report from contactable Physician downloaded from a regulatory authority-WEB IE-HPRA-2021-072610. A 77-year-old male patient received second dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: EX2405) at 0.3 ml, single for COVID-19 immunisation. The patient''s medical history included chronic kidney disease (CKD3), prostate cancer, atrial fibrillation, ischemic heart disease (IHD), and diverticular disease. The patient''s concomitant medications were not reported. The patient previously received first dose bnt162b2 (COMIRNATY) via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: Unknown) at 0.3 mL, single for COVID-19 immunisation. On 23Apr2021, the patient experienced abdominal pain and died 12 hours post-vaccination. The reporter outlined that the cause of death was likely a vascular event, which they were awaiting post-mortem results to confirm. The patient died on an unspecified date in 23Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ABDOMINAL PAIN; LIKELY VASCULAR EVENT


VAERS ID: 1345166 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 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: 2021-05-12
   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: GLYCOPYRRONIUM BROMIDE; CLOPIDOGREL; TORVAST; PERINDOPRIL; LASIX [FUROSEMIDE]; OXYGEN; TAMSULOSIN; LUCEN [ESOMEPRAZOLE MAGNESIUM]; TENORMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579711

Write-up: Unexpected death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-729029. A 73-years-old male patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: FA5831), via an unspecified route of administration on 12May2021 (at the age of 73-years-old) as 2ND DOSE, SINGLE for covid-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications included GLYCOPYRRONIUM BROMIDE, CLOPIDOGREL, atorvastatin calcium (TORVAST), PERINDOPRIL, furosemide (LASIX ), OXYGEN, TAMSULOSIN, esomeprazole magnesium (LUCEN ), atenolol (TENORMIN). The patient previously took first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as 1ST DOSE, SINGLE for covid-19 immunization. On 12May2021, the patient experienced unexpected death. The patient died on 12May2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Case narrative: 2nd dose. On 13May2021 contacted reporter for information on reaction, clinical report and autopsy examination. On 13May2021 the reporter sent the attached report. No follow-up attempts possible. No further information expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1345167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: HEXOPRENALINE SULFATE; LEVOXACIN; CARDICOR; REVINTY ELLIPTA; FORTOVASE [SAQUINAVIR]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis); Non-Hodgkin''s lymphoma (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis); Pulmonary fibrosis (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579667

Write-up: cardiac arrest occurred; lack of appetite; weakness; Fever after first dose of Pfizer; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-729249. A 71-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EX7389, expiration date: 31Aug2021), via intramuscular route on 01May2021 at 15:48 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history of the patient included: Non-Hodgkin''s lymphoma, Chronic respiratory failure, pulmonary fibrosis [Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis]. Concomitant medications included: hexoprenaline sulfate, levoxacin (levofloxacin) at a dose of 500 ug/kg, Cardicor (bisoprolol fumarate) at a dose of 2.5mg, Revinty Ellipta (fluticasone furoate, vilanterol trifenatate) at a dose of 92 ug, Fortovase (saquinavir). On 02May2021, one day after first dose of vaccine, the patient experienced fever. On 06May2021, five days after vaccination, patient experienced lack of appetite and had weakness. Reportedly, impact on quality of life was 6/10. On 08May2021, seven days after receiving vaccination, patient died due to cardiac arrest. Cause of death was reported as cardiac arrest. It was unknown if the autopsy was performed or not. Corrective treatment included Tachipirin intake. Outcome for the event fever was resolved on 05May2021 (three days after onset), and for other events was fatal. Reporter''s comments: Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis Sender''s comments: a regulatory authority comment: The form has been modified according to the information requested from the reporter by email. The clinical report has been requested from the treating physician and will be attached to the clinical case as soon as he responds. FU of 17May2021: the clinical report received from the treating physician is attached.; Reporter''s Comments: Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1345168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery stenosis (Bilateral carotid stenosis since 2008, performed TEA left, right at last sten control); Multiple myeloma (Multiple myeloma since 2013, now in relapse phase with indication to restart chemo treatment); Parkinson''s disease (Parkinson''s disease since 2008)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579844

Write-up: DEATH BY SUDDEN DEATH; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-729634. A 69-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EX7389, Expiration Date: 05May2021), via intramuscular on 05May2021 at 10:39 as a 2nd dose, single for COVID-19 immunisation. The patient''s medical history included parkinson''s disease since 2008 and unknown if ongoing, bilateral carotid stenosis since 2008, performed TEA left, right at last sten control and unknown if ongoing, multiple myeloma since (plasma cell myeloma) 2013, now in relapse phase with indication to restart chemo treatment and unknown if ongoing. The patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246, Expiration Date: 31Jul2021), via intramuscular in left deltoid on 14Apr2021 at 13:13 as a 1st dose, single for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced death by sudden death on 12May2021. It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of death by sudden death. The outcome of the event was fatal. Description: Actions taken (INTERVENTION 112 WITH ACTIVATION OF REANIMATION PROCEDURES) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: DEATH BY SUDDEN DEATH


VAERS ID: 1345169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX 7389 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579760

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-730129. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX 7389, Expiration date not reported), via an unspecified route of administration on 04May2021 as a single dose for COVID-19 immunization. The patient past medical history and concomitant medication was not reported. It was reported that, the patient died on15May2021 but not due to the vaccine. Reporter assessed the causality of event as unrelated. The cause of death and autopsy was Unknown. Outcome of the event was was Fatal. Reporter''s comments: In my opinion this is an adverse event not related to the vaccine, with occasional concomitance only of a temporal and not causal type, i.e., not an adverse reaction but an adverse event not due to the vaccine. Sender''s comments: we asked the reporter for a clinical report. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In my opinion this is an adverse event not related to the vaccine, with occasional concomitance only of a temporal and not causal type, i.e. not an adverse reaction but an adverse event not due to the vaccine.; Reported Cause(s) of Death: death


VAERS ID: 1345171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-05-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage (with resentment of the left hemisoma but with discrete autonomy); Diabetes; Hypertension; Lymphoma (at the age of 80); Venous thrombosis (Previous venous or nail thrombosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579546

Write-up: Sudden death/instant death; Severe headache appeared, followed by almost instant death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-730302. A 93-year-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: ET7205, expiration date not reported) intramuscularly administered on right arm on 02Apr2021 as a 2nd dose, 0.3 ml single for COVID-19 immunisation. The patient medical history included diabetes, hypertension, previous venous or nail thrombosis, previous cerebral haemorrhage (2018) with resentment of the left hemisoma but with discrete autonomy, lymphoma at the age of 80. The patient concomitant medications were not reported. On an unknown date, the patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: not reported) via unspecified route of administration as 1st dose, single for COVID-19 immunisation. The patient had no adverse reaction during 1st dose of Comirnaty vaccine. On 02May2021(one month after the 2nd dose), the patient experienced severe headache, followed by almost instant death. After consulting the attending physician, he reported the symptoms as the cause of death given the symptoms: sudden death from cerebral haemorrhage, probable recurrence of cerebral haemorrhage which occurred in 2018 in an elderly patient with multiple pathologies-COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (right shoulder) Booster dose number (2). It was unknown if autopsy was performed or not. The outcome of the events was fatal. Reporter Comment: Diabetes, hypertension, previous venous or nail thrombosis, previous cerebral haemorrhage (2018) with resentment of the left hemisoma but with discrete autonomy, lymphoma at the age of 80. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1345215 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral ventricular rupture, Coma scale, Computerised tomogram head, Syncope, Thalamus haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 1
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: INSULIN
Current Illness: Diabetes mellitus (receiving insulin self-injection)
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pancreatitis acute
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210514; Test Name: GCS; Result Unstructured Data: Test Result:E1V1M2; Test Date: 20210514; Test Name: JCS; Result Unstructured Data: Test Result:III-200; Test Date: 20210514; Test Name: Head CT; Result Unstructured Data: Test Result:thalamus haemorrhage and cerebral ventricular; Comments: rupture
CDC Split Type: JPPFIZER INC2021572308

Write-up: Thalamus haemorrhage; Cerebral ventricular rupture; Swooning; This is a spontaneous report from two contactable physicians received from a regulatory authority. The regulatory authority report number is v21107553 and v21107462. A 63-year and 10-month-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration, on 11May2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (receiving insulin self-injection), hypertension, and pancreatitis acute. Concomitant medications included insulin (MANUFACTURER UNKNOWN) taken for diabetes mellitus from an unspecified date and ongoing. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 20Apr2021 for COVID-19 immunisation and experienced no adverse event. The patient experienced thalamus haemorrhage, cerebral ventricular rupture, and swooning on 14May2021 at 05:10, which required hospitalization from 14May2021 to 15May2021 and were reported as fatal. The clinical course was reported as follows: The patient received the first vaccination on 20Apr2021 and the second vaccination on 11May2021 at another hospital. The body temperature before vaccination was 36.2 degrees Centigrade on 11May2021. Subsequently, the patient had no adverse reaction post-vaccination. On 14May2021 (3 days after the vaccination) in the morning hours, the patient complained of dysphoria at home and at 05:10 (2 days 15 hours 10 minutes after the vaccination), when the patient was going to a toilet, the patient swooned, which was seen by the patient''s wife and the patient was taken to the reporting hospital by ambulance. At consultation, Coma Scale (JCS) was III-200 and Glasgow Coma Scale (GCS) was E1V1M2 on 14May2021. Head computerized tomogram (CT) revealed thalamus haemorrhage and cerebral ventricular rupture on 14May2021. There was no operability and the patient was admitted to intensive care unit (ICU). The patient was intubated and placed under mechanical ventilation; however, the condition did not improve. On 15May2021 at 11:45, the patient died and was discharged from the hospital. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 15May2021. The cause of death was reported as thalamus haemorrhage. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the events and BNT162B2 as unassessable. The reporting physician commented as follows: Hypertension may be a contributory factor in the onset of cerebral haemorrhage.; Reported Cause(s) of Death: Thalamus haemorrhage


VAERS ID: 1345216 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (historical condition); Dyslipidaemia (historical condition); Ischaemic heart disease (historical condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021576514

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician via a Company representative. An 85-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on 13May2021 (at the age of 85-year-old) at single dose for COVID-19 immunisation. Relevant medical history dementia, dyslipidaemia, and ischaemic heart disease. No relevant concomitant medications were provided. On 17May2021 at unknown time (4 days after the vaccination), the patient experienced myocardial infarction and died. It was unknown whether autopsy was done. Information about Batch/Lot number has been requested.; 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 event myocardial infarction cannot be excluded. The medical history of dyslipidaemia and ischaemic heart disease may provide plausible alternative explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


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