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

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



Case Details

This is page 127 out of 172

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VAERS ID: 1405123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram head, Dysphagia, Fall, Malaise, Pain, Transient ischaemic attack
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 30
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NATRIUMKLORID ABCUR; LOSARTAN ACTAVIS; AMLODIPIN SANDOZ [AMLODIPINE BESILATE]; FOLACIN [FOLIC ACID]
Current Illness: Arthrosis; Depression; Hypertension; Hyponatraemia; Neurogenic bladder
Preexisting Conditions: Medical History/Concurrent Conditions: Femur fracture; Hip fracture
Allergies:
Diagnostic Lab Data: Test Name: CT brain; Result Unstructured Data: Test Result:suspected TIA
CDC Split Type: SEPFIZER INC2021662744

Write-up: STROKE; TIA; She did not feel well; She fell; pain in her body; could no longer swallow; This is a spontaneous report from a contactable nurse downloaded from an agency regulatory authorities-WEB SE-MPA-2021-043958 with Safety Report Unique Identifier SE-VISMA-1622191930723. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EP 2166), via an unknown route, on 10Mar2021 at single dose for COVID-19 immunisation. Relevant medical history included neurogenic bladder ongoing from 2014, arthrosis ongoing from 2014, hip fracture in 2011, femur fracture in 2008, hyponatraemia ongoing from 2011, depression ongoing from 2013, and hypertension ongoing from 2006. Relevant concomitant medications included sodium chloride (NATRIUMKLORID ABCUR), losartan potassium (LOSARTAN ACTAVIS), amlodipine besilate (AMLODIPIN SANDOZ) and folic acid (FOLACIN). Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided) via an unknown route at single dose on unknown date for COVID-19 immunisation. She did not feel well after the vaccination. She fell and she had pain in her body. Two days after the vaccination she was admitted to the hospital. The reaction was treated as a stroke. Investigations were performed. According to the reporter difficulties with CT brain. Results were interpreted as suspected TIA. The patient was getting more alert but could no longer swallow. It was decided on palliative care. The patient could return home. The reported events are stroke and TIA serious because requiring hospitalization, for disability and resulted in death. The patient died one month after vaccination (Apr2021) due to stroke and TIA. The outcome of the remaining events at the time of death was unknown. It was unknown if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: tia; STROKE


VAERS ID: 1407390 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COIVD-19 virus test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021681918

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority Agency-WEB, regulatory authority number AT-BASGAGES-2021-30356. A 93-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiration date: unknown), dose 2 via intramuscular route on 18Mar2021 as single dose and received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiration date: unknown) dose 1 via an unknown route of administration on an unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021, the patient experienced vaccination failure, other and covid-19. On an unknown date, the patient had covid-19 virus test positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of events covid-19 was fatal and outcome of drug ineffective was unknown. Senders comments: The report is for a patient. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1407433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-17
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021677008

Write-up: passed away; This is a spontaneous report from a contactable pharmacist (patient''s family member). A 95-years-old male patient received bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown), dose 1 via unknown route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included didn''t have any comorbidities but had a pacemaker, a strong magnet had to be used to disactivate pacemaker by paramedic to reinitiate his rhythm. The patient''s concomitant medications were not reported. Patient passed away 3 weeks post vaccination (the day he was supposed to receive his 2nd dose). He only received 1st dose. The reporter didn''t know if patient received Pfizer or another vaccine. The patient died on an unspecified date. It was unknown if autopsy was performed. Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities. Information about lot/batch number was requested.; Sender''s Comments: Information provided is limited and does not allow a thorough medical assessment of this fatal case. Causality cannot be completely excluded for the ongoing treatment with suspect drug according to Company internal procedure for cases reporting death cause unknown. The impact of this report on the benefit/risk profile of the Pfizer drugs 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: passed away


VAERS ID: 1407470 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021662217

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100087449. A 73-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21May2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing arterial hypertension, ongoing diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced sudden death unexplained on 24May2021. The patient died on 24May2021. It was not reported if an autopsy was performed. The report is serious - death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1407471 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021662319

Write-up: Sudden death, cause unknown; This is as spontaneous report from a non contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100087450. A 54-year-old female patient received BNT162B2 (COMIRNATY, Strength 0.3ml), via an unspecified route of administration on 06May2021 (Lot Number: EX8679) (at age of 54-year-old) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden death, cause unknown (death) on 09May2021. The patient died on 09May2021. An autopsy was performed and results were not provided. Autopsy result is still pending. Event assessment: Comirnaty/event/Result of Assessment: D, Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1407472 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arterial occlusive disease; Coronary disease; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021662312

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100087451. A 98-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Batch/Lot Number: Unknown) at the age of 98-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing Arterial occlusive disease, ongoing Arterial hypertension, ongoing Coronary disease. The patient''s concomitant medications were not reported. On 24May2021 the patient experienced Sudden death unexplained 3 hours after vaccination. The patient died on 24May2021. It was unknown if an autopsy was performed. The patient''s outcome was fatal for Sudden death unexplained. Event assessment : Comirnaty/event/Result of Assessment : D. Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1407473 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021662324

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DCGMA number DE-PEI-202100087452. This report was forwarded via RA (Regulatory Authority), however no RA number was provided. A 74-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in Apr2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced unknown cause of death. The patient died on 21Apr2021 due to unknown cause of death. It was unknown if an autopsy performed. Event assessment: Comirnaty/event/Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1408058 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; EZETROL; DOXAZOSIN; VIPDOMET
Current Illness: Alcohol abuse; Arterial hypertension; Diabetes mellitus; Ischemic cardiomyopathy; Metabolic syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic bypass; Hydrocephalus; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Asthenia; Fever; This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA (Asthenia) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac). Concurrent medical conditions included Ischemic cardiomyopathy, Arterial hypertension, Diabetes mellitus, Alcohol abuse and Metabolic syndrome. Concomitant products included EDOXABAN TOSILATE (LIXIANA), EZETIMIBE (EZETROL), DOXAZOSIN and ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE (VIPDOMET) for an unknown indication. On 21-May-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ASTHENIA (Asthenia) (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 22-May-2021. The reported cause of death was Asthenia and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered ASTHENIA (Asthenia) and PYREXIA (Fever) to be possibly related. No treatment information was provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This is a case of sudden death in a 74-year-old male patient with a history of Ischemic cardiomyopathy, Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac), who died 1 day after receiving last dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 74-year-old male patient with a history of Ischemic cardiomyopathy, Hydrocephalus, Aortic bypass and Pacemaker insertion (cardiac), who died 1 day after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Asthenia; Fever


VAERS ID: 1408081 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021713939

Write-up: developed Covid after / despite 1st vaccination; developed Covid after / despite 1st vaccination; This is a spontaneous report from a contactable physician via information received by Pfizer from Biontech [manufacturer control number: 65140], license party for Comirnaty. A 90-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date, despite the first vaccination the patient developed covid (severe course (of the disease) and eventually died. On an unknown date, the patient died due to the event. It was not reported if an autopsy was performed. Lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Covid 19


VAERS ID: 1408089 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BALZAK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021674344

Write-up: Severe muscle pain, tenths of a fever, and a feeling of nausea; Churning of stomach; Received dose 1 on 21Apr2021, dose 2 on 05May2021; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-884616. An elderly male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 05May2021 as single dose as covid-19 vaccination. The patient medical history was not reported. Patient did not have COVID-19 passed. Concomitant medication(s) included amlodipine besilate, olmesartan medoxomil (BALZAK). Patient previously received of bnt162b2 (COMIRNATY), dose 1 administered in Arm Left on 21Apr2021 as single dose for covid-19 immunisation. The patient experienced febricula, severe muscle pain, tenths of a fever, and a feeling of nausea, churning of stomach, all on 06May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Severe muscle pain, tenths of a fever, and a feeling of nausea; Churning of stomach


VAERS ID: 1408119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-05-11
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021662412

Write-up: Fatigue; Death; This is a spontaneous report from a contactable consumer, downloaded from the Agency Regulatory Authority-WEB regulatory authority number FI-FIMEA-20212933. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included hypothyroidism, hypertension. The patient''s concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 (COMIRNATY), as single dose for covid-19 immunisation. The patient experienced fatigue (death, as reported) on 11May2021 and death on 11May2021. Reported as "Strong fatigue from which recovered. 11May2021 after lunch stayed seated in common area where suddenly collapsed in a chair, gray and pulseless. hyperthyrodism, hypertension, Fusic Acid Orifarm 20mg/g and Daktarin 2% as localised treatment". The patient died on 11May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1408126 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Herpes zoster, Loss of consciousness, Vaccination site dermatitis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021698506

Write-up: In the emergency room shingles was diagnosed; The general condition decreased; Consciousness was not restored.; Dermatitis on the arm soon after administration of the vaccine; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20213144. A 58-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route administered in Arm Right on an unspecified date as a unknown, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date in May2021, the reporter stated that the patient experienced a dermatitis on the arm soon after administration of the vaccine. In the emergency room shingles was diagnosed. The general condition decreased, the patient was transferred from the ward to the intensive care unit, consciousness was not restored. Patient died on 06Jun2021. The outcome of event was fatal. It was unknown if an autopsy was performed or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained ; Reported Cause(s) of Death: Death


VAERS ID: 1408177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Deep vein thrombosis, Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 15
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: Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021662227

Write-up: cerebral vascular accident; hemorrhagic stroke; Deep vein thrombosis behind the knee; This is a spontaneous report from a contactable consumer downloaded from theregulatory authority-WEB FR-AFSSAPS-2021062600. A 65-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 17Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included Kidney transplant. The patient''s concomitant medications were not reported. The patient experienced cerebral vascular accident (death, hospitalization, medically significant) on 01Apr2021, deep vein thrombosis behind the knee (medically significant) on 25Mar2021 with outcome of not recovered. Narrative: Thrombosis behind the knee, then cerebral vascular accident then death. Specifications: Summary produced by from additional information obtained from the declarant (patients son) and the nephrologist. 1 week later, on 25Mar2021, during a systematic check-up as part of the renal transplant follow-up, discovery in this asymptomatic patient with no history of thrombosis, of a deep vein thrombosis of a lower limb (popliteal? thrombosis at the back of the knee). Implementation of direct anticoagulant treatment (not specified). After a week of this treatment, on 01Apr2021, hospitalization for sudden onset of hemiplegia and facial paralysis. Diagnosis of hemorrhagic stroke. Despite ongoing medical care, progressively unfavourable evolution and death on 09Apr2021 following the cerebral vascular accident. In summary, deep vein thrombosis one week after a first injection of the Comirnaty vaccine in a patient with a kidney transplant with no history of thrombosis, treated with an anticoagulant. It is unknown if autopsy was done. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: CVA


VAERS ID: 1408254 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-23
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood glucose, Cerebrovascular accident, Coma scale, Magnetic resonance imaging
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: Glaucoma; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:stroke with occlusion of the proximal third of the; Comments: stroke with occlusion of the proximal third of the basilar trunk with recent left occipital infarction associated with several old disseminated parenchymal infarctions of embologenic origin; Test Name: blood sugar; Result Unstructured Data: Test Result:normal; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Test Name: MRI; Result Unstructured Data: Test Result:stroke with occlusion of the proximal third of the; Comments: stroke with occlusion of the proximal third of the basilar trunk with recent left occipital infarction associated with several old disseminated parenchymal infarctions of embologenic origin
CDC Split Type: FRPFIZER INC2021662194

Write-up: Cerebrovascular accident; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213039, Safety report unique identifier FR-AFSSAPS-2021037432. A 75-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, lot number: EP2166) intramuscular in the left arm on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included glaucoma and hypertension. Concomitant medications were unknown. The patient experienced cerebrovascular accident (AVC) and died on 23Mar2021. The patient had stroke on 23Mar2021without further details on D16 of a 1st dose of Comirnaty vaccine. The patient did not have COVID. Description of the effect: On D5 after vaccination, balance disorders with memory disorders, without medical consultation. On D16 at 4 am, malaise with disturbance of balance, then disturbance of consciousness, clonies of the upper limbs and jet vomiting. Home medical assistance, upon arrival, comatose patient, Glasgow at 3 with coiling, isocore but reactive pupils. No fever. Normal blood sugar. orotracheal intubation in rapid sequence in front of neurological failure. Switch to thrombolysis alert. CT angiography then MRI: stroke with occlusion of the proximal third of the basilar trunk with recent left occipital infarction associated with several old disseminated parenchymal infarctions of embologenic origin, fatal outcome. No autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: AVC


VAERS ID: 1408260 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Feeling cold, General physical health deterioration, Haemorrhage, Heart rate, International normalised ratio, International normalised ratio increased, Oxygen saturation, Oxygen saturation decreased, Rectal examination, Rectal haemorrhage
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL QUALIGEN; DIGOXINA; SEGURIL; CALCIO/VITAMINA D3 KERN PHARMA; EUTIROX; SINTROM; ABASAGLAR; CAPSICIN; ALDACTONE [SPIRONOLACTONE]
Current Illness: Atrial fibrillation with rapid ventricular response
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Blepharitis; Cataract bilateral NOS; Cataract operation (Cataract both eyes); Cognitive impairment (totally dependent/ Dependent for Activities of daily living.); Complete rupture of rotator cuff; Congestive heart failure; Diverticula of colon; Diverticulosis; Ear operation; Fibromyalgia syndrome; Helicobacter pylori gastritis (eradicated in 1996); Hemorrhoids; Hiatus hernia; Incontinence (surgery); Kidney operation NOS; Lower extremities ulcers of; Mitral regurgitation (intervened (2002)); Mitral valve replacement; Mitral valve stenosis and insufficiency; Mitral valvotomy; Osteoporosis (Osteoporosis with crush in D9); Prosthesis implantation; Rectorrhagia (episode in 2000); Rheumatic heart disease; Rotator cuff tear; Spondylolysis (Waist dystrophy); Type II diabetes mellitus; Urinary incontinence surgery; Varicose vein operation (varicose veins lower extremities); Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data: Test Name: HR; Result Unstructured Data: Test Result:74; Test Date: 20210301; Test Name: INR; Result Unstructured Data: Test Result:1.9; Test Date: 20210321; Test Name: INR; Result Unstructured Data: Test Result:7; Test Date: 20210322; Test Name: INR; Result Unstructured Data: Test Result:1.5; Test Name: SO2; Test Result: 80 %; Test Name: digital rectal examination; Result Unstructured Data: Test Result:presence of blood
CDC Split Type: ESPFIZER INC2021662573

Write-up: Rectorrhagia/rectal bleeding; Active bleeding; SO2: 80%; cyanosis; acrid coldness; vital decline/Bad general appearance; INR 7.0; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-891202. An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 18Mar2021 (Lot Number: ET1831) as unknown, 0.3 mL, single dose for COVID-19 vaccination. Medical history included Hiatus hernia; left ear operation; Atrial fibrillation with rapid ventricular response from 1997 and ongoing; Type II diabetes mellitus; Chronic gastritis Helycobacter pylori + eradicated in 1996; Diverticula of colon; Mitral valve replacement from an unknown date to 2002; Mitral valvotomy; Complete rupture of rotator cuff; Varicose vein operation (varicose veins lower extremities); Fibromyalgia syndrome; Ulcer in Right Lower Extremity; Osteoporosis with crush in D9; Incontinence (surgery); lumbar spondylolysis Waist dystrophy; Cataract operation (Cataract both eyes); Mitral valve stenosis and insufficiency; Chronic blepharitis; Cognitive impairment type Alzheimer''s disease; Rectorrhagia episode in 2000; Diverticulosis and major internal hemorrhoids; Rotator cuff tear in both shoulders, surgery left kidney descent; Congestive heart failure Rheumatic mitral valve disease: severe mitral stenosis and moderate mitral regurgitation, intervened (2002): wearer of a mechanical mitral prosthesis, Patient with severe cognitive impairment and totally dependent/ Dependent for Activities of daily living. She lived with her daughter, had a caregiver. Concomitant medications included paracetamol (PARACETAMOL QUALIGEN) from 08Nov2017 to 18Apr2021; Digoxina Teofarma from 15May2012 to 18Apr2021; furosemide (SEGURIL) from 08Apr2019 to 18Apr2021; calcium carbonate, colecalciferol (CALCIO/VITAMINA D3 KERN PHARMA) from 15May2012 to 09Apr2021; levothyroxine sodium (EUTIROX) from 21Jan2016 to 09Apr2021; acenocoumarol (SINTROM) from 15May2012 to 09Apr2021; insulin glargine (ABASAGLAR) from 11Oct2017 to 18Apr2021; capsaicin (CAPSICIN) from 21Jan2016 to 18Apr2021; spironolactone (ALDACTONE [SPIRONOLACTONE]) from 15May2012 to 09Apr2021, all reported as "drug withdrawn". The patient experienced rectorrhagia (death, hospitalization) on 21Mar2021. The patient died on 18Apr2021. An autopsy was not performed. It was reported that the patient Admitted to Hospital (Internal Medicine) (21Mar2021) due to rectal bleeding (presence of blood on digital rectal examination). Complementary tests: INR: 01Mar2021, (1.9); 21Mar2021 (7.0); 22Mar2021 (1.5). Diagnostic impression: rectal bleeding secondary to excess anthocoagulation with acenocoumarol, replacing it with enoxaparin 60 / 12h. Added on 23Mar2021. Evolution: Re-enter on 26Mar2021. Active bleeding not a candidate for diagnostic measures. Discharge (15Apr2021) to Palliative Care (Hospitalization at home) due to vital decline. (16Apr2021): Upon arrival at the home she was sedated, calm, with calm breathing and no noise of secretions. She did not hear wet rales. SO2: 80% HR: 74 bpm. Bad general appearance, cyanosis and acrid coldness, sharp nose. Exitus impresses in the very short term. ICSC / 24H was placed with 50mg morphic chloride + 50mg midazolam + 80mg Buscopan. (18Apr2021): During the nursing visit she passes away. The outcome of the event rectorrhagia/ rectal bleeding was fatal, of INR 7.0 was recovered on 22Mar2021, of the other events was unknown. Assessment of causality (SEFV algorithm): chronology compatible with the vaccine, rectal bleeding is not described in the technical data sheet. The excess anticoagulation (INR 7) associated with acenocoumarol could be a different alternative explanation of the vaccine for the triggering of rectal bleeding. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Rectorrhagia/rectal bleeding


VAERS ID: 1408294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood gases, Blood lactic acid, Blood pressure measurement, Blood urea, Body temperature, Brain natriuretic peptide, C-reactive protein, Coagulation factor V level, Coma scale, Computerised tomogram, Computerised tomogram head, Echocardiogram, Haemoglobin, Hepatic cytolysis, Ischaemic stroke, Laryngoscopy, Lymphocyte count, Magnetic resonance imaging head, Oxygen saturation, Platelet count, Prothrombin level, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin, Urine cytology, White blood cell count
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VALPROMIDE; LOXAPAC [LOXAPINE]; DEROXAT; PARKINANE LP; ELIQUIS; SOTALOL; TAHOR; EUPANTOL; LEVOTHYROX; HYDREA; PARACETAMOL; FORLAX; METEOSPASMYL [ALVERINE CITRATE;DL-METHIONINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (double angioplasty at the level of the circumflex and the right coronary with stent.); Atrial fibrillation (Discovery of atrial fibrillation in the etiological workup, treated with KARDEGIC); Confusional state; Coronary bypass; Deafness; Delirium; Depression (Severe depressive syndrome. Multiple hospitalizations for delirium.); Hemorrhage; Hospitalization; Hypertension arterial; Infarct myocardial; Ischaemic heart disease; Ischemic stroke (Left sylvian ischemic stroke thrombolysed in Aug2014); Myeloproliferative disorder NOS (Chronic myeloproliferative syndrome of the essential thrombocythemia type); Surgery; Thrombocythaemia; Weight loss (weight loss of around 5 kg in the space of 2 months)
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: ALT; Result Unstructured Data: Test Result:2411 IU/l; Test Date: 20210512; Test Name: ASAT; Result Unstructured Data: Test Result:6227 IU/l; Test Name: serum creatinine; Test Result: 157 umol; Test Date: 20210512; Test Name: serum creatinine; Test Result: 295 umol; Test Name: arterial gas analysis; Result Unstructured Data: Test Result:mixed acidosis, pH 7.26, pCO2 55.5, pO2 52.9, bica; Comments: mixed acidosis, pH 7.26, pCO2 55.5, pO2 52.9, bicar 23.2; Test Date: 20210514; Test Name: arterial gas analysis; Result Unstructured Data: Test Result:slight hypercapnia was noted; Test Date: 20210516; Test Name: arterial gas analysis; Result Unstructured Data: Test Result:PO2 75mmHg under FiO2 0.25 PEEP 5, normocapnia, no; Comments: PO2 75mmHg under FiO2 0.25 PEEP 5, normocapnia, normopH in VSAI AI + 8cmH2O; Test Name: lactatate; Result Unstructured Data: Test Result:hyperlactatemia at 7.5 mM; Test Date: 20210512; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension; Test Name: urea; Result Unstructured Data: Test Result:17; Test Date: 20210509; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210503; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:24000 ng/ml; Test Date: 20210512; Test Name: factor V; Test Result: 33 %; Test Name: Glasgow; Result Unstructured Data: Test Result:5; Comments: Glasgow aggravated to 3; Test Date: 20210515; Test Name: Computed tomography thorax-abdomen-pelvis; Result Unstructured Data: Test Result:), not showing any deep infectious focus; Comments: ), not showing any deep infectious focus, an abnormality of the bile ducts, of the digestive tract and no pneumopathy (passive condensations of the two bases).; Test Date: 20210514; Test Name: brain CT; Result Unstructured Data: Test Result:absence of intracranial hemorrhage. On the other h; Comments: absence of intracranial hemorrhage. On the other hand, the presence of multiple bilateral parieto-occipital hypodensities of unknown duration, suggesting embolic lesions. However, there is no lesion explaining the disorder of consciousness.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:216 mg/l; Test Date: 20210503; Test Name: C-reactive protein; Result Unstructured Data: Test Result:61 mg/l; Test Date: 20210510; Test Name: C-reactive protein; Result Unstructured Data: Test Result:221 mg/l; Test Date: 20210512; Test Name: C-reactive protein; Result Unstructured Data: Test Result:238 mg/l; Test Name: Transesophageal echocardigraphy; Result Unstructured Data: Test Result:no valve disease in favor of infective endocarditi; Comments: no valve disease in favor of infective endocarditis.; Test Date: 20210515; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:an alteration of the left ventricular ejection fra; Comments: an alteration of the left ventricular ejection fraction ( 30-35%) is noted, mainly related to an extension of the area of high hypokinesia to the entire septum (except the base) and the lateral wall. Furthermore, no obvious abnormality on the tricuspid, aortic and mitral valves. No evolution of known valve leaks. No obvious intracavitary thrombus.; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.7 g/dl; Test Name: hepatic cytolysis; Result Unstructured Data: Test Result:10; Comments: unit: N; Test Date: 20210514; Test Name: Laryngoscopy; Result Unstructured Data: Test Result:evidence of abundant very dry pharyngeal secretion; Comments: evidence of abundant very dry pharyngeal secretions almost completely obstructing the respiratory tract, removed.; Test Name: lymphocyte count; Result Unstructured Data: Test Result:750 /mm3; Comments: moderate lymphopenia; Test Date: 20210519; Test Name: Brain MRI; Result Unstructured Data: Test Result:bilateral sequelae suggestive of multiple semi-rec; Comments: bilateral sequelae suggestive of multiple semi-recent bilateral strokes.; Test Date: 20210510; Test Name: Oxygen saturation; Test Result: 98 %; Test Name: platelet count; Result Unstructured Data: Test Result:decrease; Comments: around 200-250,000 vs 500,000 / mm3; Test Date: 20210512; Test Name: prothrombin; Result Unstructured Data: Test Result:Concurrent drop; Test Name: SARS-CoV2 serology; Test Result: Positive ; Test Name: SARSCov2 PCR; Test Result: Negative ; Test Date: 20210503; Test Name: SARSCov2 PCR; Test Result: Negative ; Test Date: 20210516; Test Name: troponin; Result Unstructured Data: Test Result:35000 ng/L; Test Date: 20210503; Test Name: cytobacteriological urine test; Test Result: Negative ; Test Name: leucocyte count; Result Unstructured Data: Test Result:16 x10 9/l; Comments: leukocytosis
CDC Split Type: FRPFIZER INC2021662298

Write-up: Ischemic stroke; This is as spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-RS20211704, Safety report unique identifier FR-AFSSAPS-2021064511. A 79-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 21Apr2021 (Lot Number: EW2246) as single dose for COVID-19 immunisation. Medical history included Thrombocythaemia, Hemorrhage, Infarct myocardial from 1980, Atrial fibrillation (Discovery of atrial fibrillation in the etiological workup, treated with KARDEGIC), deafness, Ischaemic heart disease, Angioplasty (double angioplasty at the level of the circumflex and the right coronary with stent ), depression (Severe depressive syndrome. Multiple hospitalizations for delirium), ischaemic stroke from Aug2014 (Left sylvian ischemic stroke thrombolysed in Aug2014 and transformed into hemorrhage a few days later, without mass effect ), Myeloproliferative disorder NOS (Chronic myeloproliferative syndrome of the essential thrombocythemia type treated with HYDREA for a few weeks), Hypertension arterial, Coronary bypass from 1980, Confusional state, delirium, operations, hospitalizations, weight loss of around 5 kg in the space of 2 months. Concomitant medications included valpromide; loxapine (LOXAPAC); paroxetine hydrochloride (DEROXAT); trihexyphenidyl hydrochloride (PARKINANE LP); apixaban (ELIQUIS); sotalol; atorvastatin calcium (TAHOR); pantoprazole sodium sesquihydrate (EUPANTOL); levothyroxine sodium (LEVOTHYROX); hydroxycarbamide (HYDREA) taken for an unspecified indication from Feb2021 to an unspecified stop date; paracetamol; macrogol 4000 (FORLAX); alverine citrate, dl-methionine (METEOSPASMYL). The patient previously took first dose bnt162b2 (COMIRNATY, lot number ET3620) on 24Mar2021 for COVID-19 immunisation and experienced no adverse event, acetylsalicylate lysine (KARDEGIC) for atrial fibrillation, hydroxycarbamide (HYDREA) for myeloproliferative syndrome, hydroxycarbamide (HYDROXYUREA) from Feb2021. The patient experienced ischemic stroke (death, Medically Significant) in May2021. The clinical course was reported as follows: 03May2021, onset of fever, chills. Notion of a quiet cough. Lack of a straightforward clinical call point. Carrying out of tests in town finding a CRP at 61 mg / l, a Brain natriuretic peptide at 24000ng / ml, a negative SARSCov2 PCR, a negative cytobacteriological urine test. Implementation on 06May2021 of probabilistic antibiotic therapy with amoxicillin-clavulanate by the attending physician. Increase of furosemide to 80 mg / day.On 10May21, in front of the persistence of the picture (40 C on 09May2021, CRP at 221 mg / l on 10May2021), emergency room consultation. In the emergency room, the patient is moderately oxygen-dependent (98% SpO2 under O2 1l / min), does not present respiratory distress but diffuse wheezing. Biologically, leukocytosis at 16G / l, haemoglobin at 10.7 g / dl, moderate lymphopenia at 750 / mm3 old, urea 17, serum creatinine at 157uM, CRP 216 mg / l, hepatic cytolysis at 10N. On arterial gas analysis, mixed acidosis, pH 7.26, pCO2 55.5, pO2 52.9, bicar 23.2, hyperlactatemia at 7.5 mM. PCR SARSCoV2 negative. Transfer to the care service. Initial conclusion:1) Infectious syndrome without a call point; 2) Probable acute left heart failure of moderate severity in this context;3) Moderate uncomplicated acute renal failure and associated moderate hepatic cytolysis.Main initial hypothesis: acute global heart failure complicated by cardiac liver and cardio-renal syndrome, with an infectious syndrome as a triggering factor.Clinicians note that the isolated febrile syndrome appears several weeks after initiation of treatment with hydroxyurea, and two weeks after a booster vaccination. In the absence of proof of an infectious syndrome, toxic hypothesis raised.Conduct initially held:- Continuation of oxygen therapy, ventilation non invasive not indicated at this stage.- Diuretic treatment- Probabilistic antibiotic therapy with ceftriaxone- Suspension of treatment with hydroxyurea- Suspension of treatment with Direct oral anticoagulants and replacement by prophylactic heparin therapy with calciparin.- monitoring Evolution of the first hours: The first hours are marked by the onset of sudden respiratory distress, with diffuse crackles, which progresses very quickly favorably after a ventilation non invasive session and the administration of a second dose of furosemide. Decrease in transaminases and serum creatinine. Secondary evolution:The secondary course is surprisingly marked by the appearance of circulatory failure requiring catecholamines and the transient worsening of hepatic and renal damage. As these failures progress favorably, the appearance of an alteration in consciousness partially explained by respiratory distress requiring mechanical ventilation. Discovered images of multiple ischemic strokes and probable myocardial infarction. In detail, it is described as follows, in two phases:1) From 12May2021 to 14May2021: appearance of a picture of severe cytolytic hepatitis associated with a state of distributive shock with increased acute renal failure- On the hepatic level, after initial improvement, re-worsening of hepatic cytolysis from 12May2021, with gradual increase in ASAT / ALT to a maximum of 6227/2411 IU / l (on 12may2021 in the evening). Absence of associated cholestasis. The probable aggravating factor was the administration of paracetamol (specialty not known) on 10 and 11May2021. Concurrent drop in prothrombin and factor V up to 29% and 33% (12May2021), without evidence of hepatic encephalopathy, without hypoglycemia. Absence of associated cholestasis. Performing an etiological assessment including a hepatic Doppler (which excludes any hepatic or portal thrombosis), HAV, HBV, HEV, HIV serologies, EBV, CMV, HSV PCRs and an autoimmune assessment. The results are pending. Introduction of IV N-acetyl-cysteine and vitamin K.- In terms of infection, persistence of feverish peaks, increase in CRP up to 238 mg / l (12May2021) and procalcitonine up to 6 ug / l (12May2021). Decision to expand antibiotic therapy by replacing ceftriaxone with piperacillin-tazobactam. Addition of spiramycin quickly stopped. All samples (several blood cultures,) are negative. Lack of pneumonia image on x-ray. No infectious focus visible on Computed tomography thorax-abdomen-pelvis, without IV (13May2021). Entry SARS-CoV2 serology is positive for IgM.- On the renal level, re-rise in serum creatinine to 295 uM on 12May2021with a functional profile (locking of natriuresis).- Circulatory, on 12May2021, appearance of arterial hypotension requiring the introduction of norepinephrine, up to 1 mg / h. Under these conditions, introduction of hydrocortisone supplementation. The evolution of all of these elements is favorable as soon as the introduction of norepinephrine, which is weaned off within a few hours.2) From 14 to 16May2021: favorable evolution of renal and hepatic failures. Onset of hypercapnic respiratory distress requiring invasive mechanical ventilation. In the course of the correction of hypercapnia, delayed awakening; discovery of cerebral thromboembolic lesions. In addition, evidence of a major rise in troponin and an extension of the hypokinesis zone of the LV, suggesting a constituted IDM or a stress heart disease.The favorable course of renal and hepatic failure, as well as the infectious syndrome continues.On 14May2021 at night, on gas measurement a slight hypercapnia was noted. Establishment of a non-invasive ventilation. Progressive worsening and appearance of clinical signs of respiratory distress and coma during the night of 14/15May2021, with no obvious explanation at first glance. Decision for orotracheal intubation. Laryngoscopy, evidence of abundant very dry pharyngeal secretions almost completely obstructing the respiratory tract, removed. In the course of time, moderate arterial hypotension requiring low doses of noradrenaline very transiently. Normalization of gas exchange (16May2021 PO2 75mmHg under FiO2 0.25 PEEP 5, normocapnia, normopH in VSAI AI + 8cmH2O) without specific treatment, suggesting the responsibility of upper airway obstruction in the picture without any other cause found. In addition to the infectious assessment mentioned above, carrying out on 15May2021 of a Computed tomography thorax-abdomen-pelvis, with injection (in view of the renal improvement), not showing any deep infectious focus, an abnormality of the bile ducts, of the digestive tract and no pneumopathy (passive condensations of the two bases).Neurologically, no return to consciousness after correction of hypercapnia. Hypotonic coma without signs of localization. Carrying out on the night of 14May2021 to 15May2021 of a brain CT without IV; absence of intracranial hemorrhage. On the other hand, the presence of multiple bilateral parieto-occipital hypodensities of unknown duration, suggesting embolic lesions. However, there is no lesion explaining the disorder of consciousness. The hypothesis of hepatic encephalopathy is considered unlikely due to the improvement in liver function. Finally, faced with an absence of dose adjustment of piperacillin-tazobactam during an acute renal failure period, an overdose is suspected. Due to the lack of bacterial documentation, treatment was suspended on 14May2021. From 16May2021 in the morning, 24 hours after stopping all sedation (sufentanyl, propofol), very slow onset of awakening with reactivity to verbal and tactile stimulation and closing / opening of the eyes on demand.On the cardiac level, on an trans-thoracic echocardiography carried out during the night of 15May2021 to 16May2021 as part of research into arguments in favor of a possible endocarditis (in view of the signs of cerebral emboli), an alteration of the left ventricular ejection fraction ( 30-35%) is noted, mainly related to an extension of the area of high hypokinesia to the entire septum (except the base) and the lateral wall. Furthermore, no obvious abnormality on the tricuspid, aortic and mitral valves. No evolution of known valve leaks. No obvious intracavitary thrombus. An Transesophageal echocardigraphy would be desirable. A troponin I hs assay was carried out, finding on 16May2021 value of approx. 35,000 ng / l. The ECG is not changed. The two hypotheses mentioned are a coronary thrombotic event on the one hand, or a stress heart disease / "septic" heart disease on the other hand. Faced with the residual inflammatory syndrome and the uncertainty about the neurological outcome, coronary exploration at this stage does not seem possible. These elements are not associated with any circulatory distress or acute abortion at this stage. Introduction of anti-aggregating treatment with aspirin in principle. On the haematological level, faced with the suspicion of two potentially recent thrombotic events, the responsibility for the myeloproliferative syndrome of course, the infectious / inflammatory syndrome, but also the suspension of the curative anticoagulant treatment, and possibly the recent vaccination, is mentioned. Finally, faced with a decrease in the platelet count of more than 50% from D + 3 (around 200-250,000 vs 500,000 / mm3), the possibility of heparin-induced thrombocytopenia is raised in principle. Heparin is suspended, replaced by danaparoid (at a preventive dose, due to uncertainties about the blood-brain barrier). A rapid screening test for anti-PF4 is requested (collected on 16May2021 ).Given the foreseeable duration of ventilation$g 48h, the patient is transferred to intensive care on 16May2021.A family interview takes place with the wife on 15May2021, during which the elements of previous autonomy are confirmed on the one hand, and all recent events are explained on the other hand. The wife understands the gravity of the situation, and the concerns about the vital and functional prognosis. It is well clarified that in the event of transfer to intensive care, prolonged or heavy resuscitation would be unreasonable. Conclusion of clinicians:1) Undocumented febrile distributive shock with favorable outcome under empiric antibiotic therapy. The infectious origin is not proven. Toxic origin (hydroxyurea) not excluded (see case RS20211618).2) Severe acute cytolytic hepatitis of uncertain etiology under investigation, favorable outcome Possible worsening of hepatic cytolysis by treatment with paracetamol (see case RS20211619)3) Acute renal failure in this context, with favorable outcome4) Respiratory distress on obstruction of the upper airways by thick respiratory secretions, requiring invasive mechanical ventilation5) Potentially multifactorial disorder of consciousness (hypercapnia, beta-lactam toxicity, ischemic stroke) (cf. case RS20211620), requiring the continuation of mechanical ventilation. Favorable start of development.6) Possible thromboembolic events during exploration7) Alteration of LV systolic function, with anteroseptoapicolateral hypokinesia and major elevation of troponin, suggesting a prior MDI or stress heart disease. Evolution :Despite early cessation of sedation, and despite improvement in other organ failure, the patient does not recover to a state of alertness consistent with extubation. He was transferred to intensive care in another establishment. Hemodynamically, the patient is stable without amines. No sign of tissue hypoperfusion. No clinical sign of right or left HF. Neuro-wise, calm patient, Glasgow 5. No eye tracking or contact. No blink at the threat. Pupils in bilateral miosis, not very reactive. Undifferentiated plantar skin reflexes. No sign of pyramidal irritation. A chewing movement of the intubation probe is objectified.In terms of breathing, patient ventilated with spontaneous ventilation with pressure support, PEP 5, inspiratory support 8 cmH2O, FiO2 21%.On the digestive level, supple and depressible abdomen. Evolution :On the neuro level: no improvement. The patient did not show any signs of awakening even after prolonged stopping of sedations. Glasgow aggravated to 3. Partially preserved brainstem reflexes with symmetrical and responsive pupils. Brain MRI of 19May2021: bilateral sequelae suggestive of multiple semi-recent bilateral strokes.In terms of infection: cytobacteriological examination of sputum and cytobacteriological urine test remained negative. Demonstration of Staphylococcus epidermidis on BAL and on blood culture on peripheral vein.Transesophageal echocardigraphy: no valve disease in favor of infective endocarditis.Improvement in the initial multiorgan failure continues (normalization of renal function, liver function, hemodynamic stability and ventilation in VEC without the need for significant oxygen supply).After the neuro''s opinion, faced with the lack of awakening, the seriousness of the lesions on the imaging systems and the patient''s poor prognosis for functional recovery, it was decided, in consultation with the entire medical and paramedical team, to limit active therapies. for the patient and to set up comfort care. Patient died on 22May2021 following terminal extubation. In total, coma on multiple and bilateral ischemic strokes, without aetiology found in a 79-year-old male patient. Stopping acute care and setting up comfort care; death of the patient. Discovery of cerebral thromboembolic lesions approximately 23-25 days after second vaccination with COMIRNATY.Therapeutic measures were taken as a result of event. The patient died on 22May2021. An autopsy was not performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: multiple and bilateral ischemic strokes


VAERS ID: 1408296 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic lymphocytic leukaemia, Condition aggravated, Herpes zoster
SMQs:, Haematological malignant tumours (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic lymphocytic leukemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021662247

Write-up: chest shingles; Exacerbation of Chronic lymphocytic leukemia; Exacerbation of Chronic lymphocytic leukemia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20214152. Senders Safety Report Unique Identifier FR-AFSSAPS-2021063692 . A 87-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 18Feb2021 (Lot Number: EJ6788) as single dose for covid-19 immunisation. Medical history included ongoing chronic lymphocytic leukemia. The patient''s concomitant medications were not reported. Patient experienced chest shingles on 11Mar2021, 21 days (reported as 22 days) after the second injection, experienced exacerbation of chronic lymphocytic leukemia then death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exacerbation of Chronic lymphocytic leukemia; Herpes zoster; Exacerbation of Chronic lymphocytic leukemia


VAERS ID: 1408346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; BENZYLPENICILLIN; FOLIC ACID; COLECALCIFEROL; MIDAZOLAM; GLYCERYL TRINITRATE; DIAZEPAM; AMIODARONE; ASPIRINE; ONDANSETRON; DOXYCYCLINE; DIGOXIN; FUROSEMIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: troponin; Result Unstructured Data: Test Result:3804
CDC Split Type: GBPFIZER INC2021657559

Write-up: Myocardial infarct/ anterior ST elevation myocardial infarction; This is a spontaneous report from a contactable physician. This is a spontaneous report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103181739225310, Safety Report Unique Identifier GB-MHRA-ADR 25032260. An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test, was not enrolled in clinical trial, had not tested positive for COVID-19 since having the vaccine. Concomitant medications included escitalopram; benzylpenicillin; folic acid; colecalciferol; midazolam; glyceryl trinitrate; diazepam; amiodarone; acetylsalicylic acid (ASPIRINE); ondansetron; doxycycline; digoxin; furosemide. The patient historically received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced myocardial infarct (death) on 15Mar2021. The patient died on 16Mar2021. Clinical course detail provided as follows: the patient was admitted with anterior ST elevation myocardial infarction having become unwell 24 hours after second dose of COVID vaccine. She declined coronary intervention, deteriorated, and subsequently died, 24 hours after admission. She had no prior cardiac history but was 89. Patient''s family feel strongly there may be a connection with the vaccine and wished for it to be reported. No significant past medical history. The patient underwent lab tests and procedures which included troponin was 3804 on an unspecified date. An autopsy was not done. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Myocardial infarct/ anterior ST elevation myocardial infarction


VAERS ID: 1408844 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Prosthetic cardiac valve thrombosis, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021699276

Write-up: thrombotic thrombocytopenia; thrombosis of prosthetic aortic valve; acute myocardial infarction; cardiac arrest; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. It was reported that vaccine induced thrombotic thrombocytopenia has been identified as the start of patient''s cause of death, leading to thrombosis of prosthetic aortic valve, leading to an acute myocardial infarction resulting in a cardiac arrest and death. Outcome of the events was fatal. An autopsy was done.; Reported Cause(s) of Death: cardiac arrest; thrombotic thrombocytopenia; thrombosis of prosthetic aortic valve; acute myocardial infarction


VAERS ID: 1408892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal insufficiency; COVID-19; COVID-19 pneumonia; Hyperlipidaemia; Hypertension; Hyperthyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: Chest X-ray; Result Unstructured Data: Test Result:COVID-19 pneumonia; Test Date: 20210225; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021661672

Write-up: COVID-19/COVID-19 virus test positive; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB HU-OGYI-365821. An 80-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular in the right arm on 17Feb2021 (Batch/Lot Number: EL0725) as 0.3mL, single dose for COVID-19 immunisation. Medical history included COVID-19, COVID-19 pneumonia, chronic renal insufficiency, hypertension, atrial fibrillation, hyperlipidaemia, hyperthyroidism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced COVID-19 on 25Feb2021, COVID-19 virus test positive on 25Feb2021, COVID-19 pneumonia on 25Feb2021, reported as death, hospitalization. Clinical course reported as follow: The occurrence of COVID-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. The patient was hospitalized because of COVID-19 symptoms. On 25Feb2021 a COVID-19 virus test was done with a positive result. Chest X-ray confirmed COVID-19 pneumonia. The patient received therapy, but after a temporary improvement in her condition, the patient passed away on 09Mar2021 at 14:30. An autopsy was not performed. Case was assessed as serious, medically confirmed. Sender Comment: The patient got infected with COVID-19 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 events. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19/COVID-19 virus test positive


VAERS ID: 1408893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-14
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 6956 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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? No
Previous Vaccinations:
Other Medications: BUDENOFALK; SALOFALK [MESALAZINE]
Current Illness: Crohn''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: she was diagnosed to have COVID-19; Result Unstructured Data: Test Result:yes- positive
CDC Split Type: HUPFIZER INC2021689191

Write-up: the patient was diagnosed with COVID-19; the patient was diagnosed with COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB, regulatory authority number HU-OGYI-385521. This report is regarding the 1st dose and death due to vaccine. A 48-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET6956 and expiration dates were not reported), via intramuscular route of administration in the left upper arm administered on 21Apr2021 as 1ST dose, 0.3 ML single dose for COVID-19 immunisation. Medical history included ongoing crohn''s disease from an unknown date and she was a smoker. Concomitant medications included budesonide (BUDENOFALK) taken for an unspecified indication, start and stop date were not reported and mesalazine (SALOFALK) taken for an unspecified indication, start and stop date were not reported. On about 05May2021, the patient started to have unspecified symptoms and fever. On 14May2021, the patient was diagnosed with COVID-19. Her condition was worsening, she was submitted to hospital on 19May2021. She had severe symptoms requiring invasive ventilation. The patient died on 25May2021. It was not reported whether an autopsy was performed. Sender Comment: The patient started to have symptoms of COVID-19, 14 days after vaccination and was diagnosed to have COVID-19, 23 days after vaccination. Immunity may have not developed within 2 weeks after the first dose of COMIRNATY. The case is serious because the patient died. No further information was expected. Stop date for event Covid-19: 25May2021 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: the patient was diagnosed with COVID-19; the patient was diagnosed with COVID-19


VAERS ID: 1408894 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, COVID-19, COVID-19 pneumonia, Cardiopulmonary failure, Chest X-ray, Myocardial infarction, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLECTOR [DICLOFENAC EPOLAMINE]; KALIUM-R; TRIMBOW; FURON [FUROSEMIDE]; MATRIFEN; METFOGAMMA; VENTOLIN [SALBUTAMOL]; ASACTAL; DONALGIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: BPH; Chronic bronchitis; COPD; COVID-19; COVID-19 pneumonia; Diabetes mellitus; Gastric ulcer; Hypertension; Ischemic heart disease; Obesity; Prostatitis
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: Chest X-ray; Test Result: Positive ; Comments: covid pneumonia; Test Date: 20210425; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021698659

Write-up: bradycardia; cardiorespiratory failure; heart attack; COVID-19 pneumonia; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority HU-OGYI-394221. This spontaneous, serious, medically confirmed case was reported on 27May2021 by a physician and concerns the occurrence of Covid-19 infection and pneumonia resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. A 67-years-old male patient received bnt162b2 (COMIRNATY, concentrate for dispersion for injection tozinameran [COVID-19 mRNA Vaccine embedded in lipid nanoparticles]), dose 1 intramuscular on 12Apr2021 (at the age of 67-year-old) (Batch/Lot number and expiry date was reported as unknown) as 1st dose, 0.3ml single dose for covid-19 immunisation. Medical history of the patient included COVID-19, COVID-pneumonia, chronic bronchitis, COPD, diabetes mellitus, gastric ulcer, hypertension, obesity, prostatitis, BPH and ischemic heart disease. Concomitant drugs were acetylsalicylic acid (ASACTAL 100 mg), niflumic acid (DONALGIN 250 mg), diclofenac (FLECTOR), furosemide (FURON 40 mg), potassium chloride (KALIUM-R), fentanyl (MATRIFEN 25 microgram), metformin hydrochloride (METFOGAMMA 1000 mg), beclometasone; formoterol; glycopyrronium bromide (TRIMBOW) and salbutamol (VENTOLIN EVOHALER l) all taken for an unspecified indication, start and stop date were not reported. On 20Apr2021, patient started experiencing COVID symptoms. On 25Apr2021, patient underwent a lab test of COVID-19 antigen and resulted positive for COVID-19, and his wife also died because of COVID-19 on 25Apr2021. On 28Apr2021, the patient was hospitalized because of dyspnea which was ongoing for 3 days. On 28Apr2021, patient had a chest X-ray and was diagnosed with COVID-19 pneumonia. Patient received therapy, but on 29Apr2021 suddenly bradycardia and cardiorespiratory failure occurred. After an unsuccessful reanimation, the patient passed away at 05:25. Cause of death was reported as COVID-19. According to the autopsy report, the direct cause of death was a heart attack. Health authority comment: The patient got infected with Covid-19 after the first dose, therefore immunity may not have developed yet. 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. Further information is not expected. Case Comment: 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 serious events COVID-19, COVID19-Pneumonia,Myocardial infarction,cardiopulmonary failure and bradycardia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; Autopsy-determined Cause(s) of Death: heart attack


VAERS ID: 1408895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-18
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 pneumonia, Computerised tomogram, Diabetic ketoacidosis, Dyspnoea, Emergency care examination, Hypoxia, Loss of consciousness, Multiple organ dysfunction syndrome, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (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) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic bronchitis; COPD; Hypertension; Hypertensive cardiomyopathy; Hyperthyroidism; Ischemic stroke; Obesity; Smoker; Struma; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: cranial CT scan; Result Unstructured Data: Test Result:not detected; Comments: Intracranial haemorrhage or fresh large-scale ischemic lesions were not detected on a cranial CT scan; Test Name: chest examination; Result Unstructured Data: Test Result:plenty of B lines in the pleura; Comments: Ultrasound-guided jugular vein cannulation was performed, and plenty of B lines were detected in the pleura during chest examination; Test Date: 20210325; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021698664

Write-up: COVID-19 pneumonia; dyspnoea with fluctuating intensity; unconsciousness; diabetic ketoacidosis; acute respiratory distress syndrome; hypoxemia; multiorgan failure; COVID-19 rapid test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB, regulatory authority number HU-OGYI-401321. A 70-years-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: ET3620), via an intramuscular route on 17Mar2021 as 1st dose, 0.3 ml single dose in the left arm for covid-19 immunisation. The patient medical history included obesity, hypertension, hypertensive cardiomyopathy, type 2 diabetes, smoking, left hemisphere ischemic stroke in 2011, chronic bronchitis, hyperthyroidism, struma and COPD. The patient concomitant medications were not reported. On 25Mar2021, the patient was admitted to the hospital and experienced COVID-19 rapid test was positive, the patient said he had dyspnoea with fluctuating intensity, coughing, weakness and fever for 3 weeks. On 27Mar2021, Intensive Council was requested due to unconsciousness, diabetic ketoacidosis, and after preliminary consultation, the patient was admitted to the COVID-19 Intensive Care Unit after a cranial CT scan. Controlled mechanical respiration support was initiated. Abundant aspirate was removed from his tube. Due to ketoacid diabetes, fluid replacement was initiated with rapid acting insulin administered. The patients circulation required vasopressor support in increasing doses. Ultrasound guided jugular vein cannulation was performed, and plenty of B lines were detected in the pleura during chest examination. Previously initiated antiviral, steroid, ulcer, elevated-dose thrombosis prophylaxis was continued. Intracranial haemorrhage or fresh large-scale ischemic lesions were not detected on a cranial CT scan. Despite the complex intensive therapy used, his condition progressed further. The patient died of coronavirus-induced symptoms of acute respiratory distress syndrome, hypoxemia, and then multiorgan failure on 01Apr 2021 at 7.45 a.m. Autopsy was not done. It was reported that on 28May2021, concerning positive COVID 19 rapid test and acute respiratory distress syndrome. The events was assessed as serious due to hospitalization. The outcome of the events was fatal. Sender Comment: COVID 19 rapid test became positive 8 days after, and the patient died 15 days after Comirnaty vaccination due to COVID 19 pneumonia. The patient s symptoms started before vaccination. Autopsy was not done. The events and Comirnaty vaccination is not related. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available,suspect product BNT162B2 or comirnaty was unrelated to the events,covid-19 ,covid019 pneumonia,acute respiratory distress,multiorgan failure,hypoxia,dyspnoea,lossof consciousness,diabetic ketoacidosis.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: COVID-19 rapid test positive; COVID-19 pneumonia


VAERS ID: 1408913 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, COVID-19, Death, Drug ineffective, Ejection fraction decreased
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia (Days in hospital- 1 )
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021680836

Write-up: DIED; Severe Covid 14 days following vaccination/ Active severe covid 19; Active severe covid 19; global arrhythmia; EF 15%; This is a spontaneous report from a contactable consumer received via the Regulatory Authority, Regulatory Authority report number is unspecified. The health department reported similar events for two patients. This is the fifth of eight reports. A 72-year-old patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: not provided) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included dyslipidemia,Days in hospital- 1 from an unknown date. The patient''s concomitant medications were not reported. The patient died due to unknown cause of death. The patient developed active severe covid 19, global arrhythmia, and EF 15%. The patient experienced severe Covid 14 days following vaccination/ Active severe covid 19. The outcome of the event died was fatal. The outcome of the events active severe covid 19, global arrhythmia, and EF 15%, and severe Covid 14 days following vaccination/ Active severe covid 19 was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1408916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210632598

Write-up: HEART ATTACK; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnicity The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died due to heart attack. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of heart attack on an unspecified date. This report was serious (Death).; Sender''s Comments: V0-20210632598-covid-19 vaccine ad26.cov2.s -Heart Attack-This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: HEART ATTACK


VAERS ID: 1409223 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Body temperature, Cardio-respiratory arrest, Computerised tomogram thorax, Heart rate, Loss of consciousness, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOTRIGA; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; FOLIAMIN; NEUROVITAN [CYANOCOBALAMIN;OCTOTIAMINE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN]; GASMOTIN; MYTEAR ARTIFICIAL TEAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210608; Test Name: Chest CT; Result Unstructured Data: Test Result:showed aortic dissection rupture in the chest; Test Date: 20210608; Test Name: heartbeat; Result Unstructured Data: Test Result:resumed
CDC Split Type: JPPFIZER INC2021666844

Write-up: Loss of consciousness; Wheezing; dissecting aneurysm ruptured; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via agency. This is a report received from the Regulatory Authority. Regulatory authority report number is v21112408. An 89-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: FA2453; Expiration Date: 31Aug2021), intramuscularly in the left arm on 01Jun2021 at 13:00 at a single dose for covid-19 immunisation. The vaccination was performed by the reporting physician. Medical history included cerebral infarction and cardiac failure chronic. The patient had no allergies to medications, food, or other products. Concomitant medications included omega-3-acid ethyl ester (LOTRIGA); esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]); folic acid (FOLIAMIN); cyanocobalamin/octotiamine/ pyridoxine hydrochloride/riboflavin (NEUROVITAN [CYANOCOBALAMIN;OCTOTIAMINE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN]); mosapride citrate (GASMOTIN); boric acid/potassium chloride/sodium carbonate anhydrous/sodium chloride/sodium phosphate dibasic (MYTEAR ARTIFICIAL TEAR) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Jun2021 at 08:15, the patient experienced dissecting aneurysm ruptured. On 08Jun2021, the patient experienced cardio-respiratory arrest. On 08Jun2021 at 08:25, the patient experienced wheezing and loss of consciousness. The clinical course was as follows: on 01Jun2021 at 13:00 (the day of vaccination), the patient received?the first single dose of bnt162b2. On 08Jun2021 at 08:15 (7 days after the vaccination), the patient experienced dissecting aneurysm ruptured. The event resulted in emergency room/department or urgent care. The events were further described as: on 08Jun2021 at 8:25 am, wheezing was noted while eating. Subsequently, the patient lost her consciousness and was rushed to a hospital at 8:46. Upon arriving, the patient was in a state of cardio-respiratory arrest. ALS was performed and heartbeat resumed on 08Jun2021. Chest CT showed aortic dissection rupture in the chest on 08Jun2021. The body temperature before vaccination was 36.8 degrees Centigrade on 01Jun2021. Therapeutic measures were taken as a result of dissecting aneurysm ruptured and cardio-respiratory arrest. The clinical outcome of the event, cardio-respiratory arrest, was recovered on an unknown date. The clinical outcome of the events, loss of consciousness and wheezing, was unknown. The clinical outcome of the event, dissecting aneurysm ruptured, was fatal. The patient died on 08Jun2021 at 9:22 due to dissecting aortic aneurysm, ruptured. Autopsy was not performed. The reporting physician assessed the event as serious (death). The reporting physician assessed causality as unassessable. REPORTER COMMENT: The patient was currently treated for cerebral infarction at our clinic. The causality of the event to vaccine was unknown, however, it was considered reportable. There were similar reported cases.; Reported Cause(s) of Death: Dissecting aortic aneurysm, ruptured


VAERS ID: 1409224 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Cardiac arrest, Chills, Coma scale, Depressed level of consciousness, Dyspnoea, Heart rate, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder cancer; Cancer surgery; Gastric cancer; Incisional hernia; Type 2 diabetes mellitus; Vertebral artery stenosis; Weakness
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: blood pressure; Result Unstructured Data: Test Result:50 to 60; Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210608; Test Name: Coma Scale (CS); Result Unstructured Data: Test Result:3; Test Date: 20210608; Test Name: pulse rate; Result Unstructured Data: Test Result:107; Comments: beats/minute
CDC Split Type: JPPFIZER INC2021672096

Write-up: Cardiac arrest; Depressed level of consciousness; Weakness; Vomiting; Chills; breathing in short gasps; churning of stomach; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. Regulatory authority report number is v21112374. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 07Jun2021 at 15:05 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) at 79-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included gastric cancer, incisional hernia, type 2 diabetes mellitus, postoperative bladder cancer, vertebral artery stenosis, and weakness; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunisation on an unknown date in 2021 (1st dose; Lot number unknown, Expiration date unknown). On 07Jun2021 at 19:00, 3 hours 55 minutes after the second dose, the patient experienced churning of stomach (medically significant). On 08Jun2021 00:00, 8 hours 55 minutes after the second dose, the patient experienced: breathing in short gasps (medically significant). On 08Jun2021 at 02:00, 10 hours 55 minutes after the second dose, the patient experienced: vomiting (medically significant) and chills (medically significant). On 08Jun2021 at 04:00, 12 hours 55 minutes after the second dose, the patient experienced: weakness (medically significant) and depressed level of consciousness (medically significant). On 08Jun2021 at 04:22, 13 hours 17 minutes after the second dose, the patient experienced: cardiac arrest (death, medically significant). The clinical course was reported as follows: The patient was a 79-year and 2-month-old male. Body temperature before vaccination was 36.4 degrees Centigrade. The family history was not provided. The patient had medical histories of gastric cancer, incisional hernia, type 2 diabetes mellitus, postoperative bladder cancer, vertebral artery stenosis, and weakness. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 07Jun2021 at 15:05 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 08Jun2021 at 02:00 (10 hours and 55 minutes after the vaccination), the patient experienced cardiac arrest. On 08Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 08Jun2021, at around 2:00 (10 hours and 55 minutes after vaccination), the patient was aware of vomiting and chills. At around 04:00 (12 hours and 55 minutes after vaccination), the patient experienced weakness and depressed level of consciousness. At 04:08 (13 hours and 3 minutes after vaccination), an ambulance was called. At 04:17 (13 hours and 12 minutes after vaccination), the emergency medical assistance arrived on the site. At that time, Coma Scale (CS) was 3, the pulse rate was 107 beats/minute, and the blood pressure was 50 to 60. The patient was breathing in short gasps. At 04:22 (13 hours and 17 minutes after vaccination), the patient had cardiac arrest, and he was transferred to the reporting hospital at 04:45 (13 hours and 40 minutes after vaccination). The patient did not respond to the resuscitation. At 05:43 (14 hours and 38 minutes after vaccination), the patient was confirmed to die. On 07Jun2021, at around 19:00 (3 hours and 55 minutes after vaccination), the patient complained of churning of stomach and others. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: The causality between the death and BNT162b2 vaccination was unknown. The patient underwent lab tests and procedures which included blood pressure: 50 to 60 on 08Jun2021, body temperature: 36.4 Centigrade on 07Jun2021 (Before vaccination), pulse rate: 107 beats/minute on 08Jun2021, Coma Scale (CS): 3 on 08Jun2021. Therapeutic measures were taken as a result of cardiac arrest. The clinical outcome of the events: churning of stomach, breathing in short gasps, vomiting, chills, weakness, depressed level of consciousness, was unknown. The clinical outcome of the event, cardiac arrest, was fatal. The patient died on 08Jun2021 due to cardiac arrest. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1409225 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021672107

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death the following day (1 day after the vaccination), on an unspecified date. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Death


VAERS ID: 1409230 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-13
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension; Old cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021694821

Write-up: The reporting physician himself considered sudden death/myocardial infarction; The reporting physician himself considered sudden death/myocardial infarction; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 78-year-old male. Medical history included hypertension, hyperlipidaemia, and old cerebral infarction. Concomitant medications were not reported. On 27May2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) intramuscularly at the age of 78-year-old as a single dose for COVID-19 immunisation. On 13Jun2021 at unknown time (17 days after the vaccination), the patient experienced death, and the reporting physician himself considered sudden death/myocardial infarction. On an unknown date, the outcome of the events was fatal. Autopsy was performed. The course of the events was as follows: On 27May2021 at unknown time (the day of vaccination), the patient received the first vaccination at a different clinic (not a primary care clinic). The reporting physician had went to an autopsy of a dead person and had heard from the family about the vaccination given. The reporting physician himself considered sudden death/myocardial infarction and made the call after wondering whether to report this case or not. The reporting physician classified the events as serious (death). The causality was not reported.; Sender''s Comments: There is not a reasonable possibility that reported sudden death and myocardial infarction are related to BNT162B2. Events are most likely intercurrent medical conditions for this elderly patient with underlying hypertension, hyperlipidemia and cerebral infarction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: The reporting physician himself considered sudden death/myocardial infarction; The reporting physician himself considered sudden death/myocardial infarction


VAERS ID: 1409238 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-21
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / 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: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO PERINEVA; ATORVASTATIN TEVA; SERMION [NICERGOLINE]
Current Illness: Arterial hypertension; Cerebrovascular insufficiency; Dyslipidaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC2021662253

Write-up: Sudden death; This is a spontaneous report from a contactable physician. A 61-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07May2021 (Batch/Lot Number: EW6126) as 1st dose, 0.3ml single for covid-19 immunisation. Medical history included arterial hypertension, dyslipidaemia, chronic cerebrovascular insufficiency, all ongoing. Concomitant medications include indapamide, perindopril erbumine (CO PERINEVA) since 24May2019 for arterial hypertension, atorvastatin calcium (ATORVASTATIN TEVA) since 23Oct2019 for dyslipidaemia, nicergoline (SERMION) since 09Jun2020 for chronic cerebrovascular insufficiency. On 21May2021 the patient was found dead in their bed. Diagnosis - sudden death. It was noted that since 14May2021 the patient was using alcohol without taking a break. On the evening of 20May2021 the patient went to bed, without any complaints. The patient did not experience any symptoms after vaccination. The patient remains are scheduled for an autopsy, results are thus far not available. The patient GP (General Practitioner) was not able to tell if the patient was an alcoholic. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1409249 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, Cardiomegaly, Cough, Disorientation, Drug ineffective, Dyspnoea, Hypoventilation, Malaise, Nodule, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Rales, Respiratory distress, SARS-CoV-2 antibody test, Somnolence, Suspected COVID-19, Tachycardia, Tachypnoea, Vomiting, Wheezing, X-ray
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: Auscultation; Result Unstructured Data: Test Result:rales, wheezing, bibasal; Test Date: 20210505; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: greater than or equal to 38 celsius degrees; Test Date: 20210505; Test Name: oxygen saturation; Test Result: 82 %; Test Date: 20210505; Test Name: PAR is taken for SARS COV-2; Test Result: Negative ; Test Date: 20210505; Test Name: X rays; Result Unstructured Data: Test Result:pattern and cardiomegaly
CDC Split Type: MXPFIZER INC2021681304

Write-up: brown vomiting; poor general conditions; polypnea; tachycardia; O2 saturation 82%; desaturation where COVID-19 is classified as a suspected case; desaturation where COVID-19 is classified as a suspected case; Fever greater than or equal to 38 Celsius degrees /Temperature 39 C; Pulmonary fields with rales, wheezing; Pulmonary fields with rales, wheezing; bibasal hypoventilation; peripheral nodular; cardiomegaly; cough; Dyspnea/Respiratory Distress; Dyspnea/Respiratory Distress; drowsiness; disorientation; This is a Spontaneous report from a non-contactable Other Health Professional received from the Regulatory Authority. Regulatory authority report number is 14564-6. A 72-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 05May2021 15:00 (Batch/Lot Number: EW2245; Expiration Date: 01Jul2021) at 72 years old as single dose for covid-19 immunisation. Medical history included expectorant cough from 04May2021. The patient was not healthy before vaccination. The patient was not pregnant. The patient''s concomitant medications were not reported. The patient experienced fever greater than or equal to 38 celsius degrees /temperature 39c (pyrexia) (death, hospitalization) on 05May2021 16:00, cough (cough) (death) on 05May2021 16:00, dyspnea/respiratory distress (dyspnoea) (death) on 05May2021 16:00 , dyspnea/respiratory distress (respiratory distress) (death) on 05May2021 16:00, drowsiness (somnolence) (death) on 05May2021 16:00, disorientation (disorientation) (death) on 05May2021 16:00, o2 saturation 82% (oxygen saturation decreased) (death, hospitalization) on 05May2021 16:00, desaturation where covid-19 is classified as a suspected case (suspected covid-19) (death, hospitalization) on 05May2021 16:00, pulmonary fields with rales, wheezing (rales) (death, hospitalization) (wheezing) (death, hospitalization) on 05May2021, bibasal hypoventilation (hypoventilation) (death, hospitalization) on 05May2021, peripheral nodular (nodule) (death, hospitalization) on 05May2021, cardiomegaly (cardiomegaly) (death, hospitalization) on 05May2021, brown vomiting (vomiting) (death, hospitalization) on 07May2021, poor general conditions (malaise) (death, hospitalization) on 07May2021, polypnea (tachypnoea) (death, hospitalization) on 07May2021, tachycardia (tachycardia) (death, hospitalization) on 07May2021. The patient underwent lab tests and procedures on 05May2021 which included PAR is taken for SARS COV-2: negative, auscultation: rales, wheezing, bibasal, body temperature: 39 C (fever greater than or equal to 38 degrees centigrade), oxygen saturation: 82 %, x-ray: pattern and cardiomegaly. Therapeutic measures were taken as a result of poor general conditions (malaise), polypnea (tachypnoea), tachycardia (tachycardia) and included Ceftriaxone 1 gr iv (intravenous) every 12 hours, low molecular weight heparin. The patient died on 07May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever greater than or equal to 38 Celsius degrees /Temperature 39 C; Cough; Dyspnea/Respiratory Distress; Dyspnea/Respiratory Distress; drowsiness; disorientation; O2 saturation 82%; desaturation where COVID-19 is classified as a suspected case; Pul


VAERS ID: 1409250 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6924 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal sphincter atony, Dizziness, Headache, Loss of consciousness, Musculoskeletal stiffness, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021681337

Write-up: Headache; Dizziness; Vertigo; Generalized stiffness; Loss of consciousness; sphincter relaxation; This is a Spontaneous report from a non-contactable Other Health Professional received from the Regulatory Authority. Regulatory authority report number is 14785-6. A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 12May2021 (Batch/Lot Number: ET6924) at 60 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was healthy before vaccination. The patient experienced headache (headache), dizziness (dizziness), vertigo (vertigo), generalized stiffness (musculoskeletal stiffness), loss of consciousness (loss of consciousness), sphincter relaxation (anal sphincter atony) all on 13May2021, 20 hours after vaccination. All the events were serious as per hospitalization and due to fatal outcome. Therapeutic measures were taken as result of the events. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course was reported as follows. Started 13May2021 with headache, dizziness, vertigo, generalized rigidity and loss of consciousness and relaxation of the sphincters. Treatment received: Physiological solution 1000 + 40 mEq potassium chloride + 2 grams of magnesium sulphate, propofol 1mg IV every 8 hours, fentanyl 1 mg graduated, norepinephrine 8 mg graduated, omeprazole every 24 hours, methoclopramide each 8 hours, lactulose each 24 hours, paracetamol 1 g every 6 hours as needed, mannitol 20% 200 mL every 6 hours. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dizziness; Generalized stiffness; Loss of consciousness; sphincter relaxation; vertigo; Headache


VAERS ID: 1409251 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0195 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021681350

Write-up: when leaving the place of the vaccination dies when arriving at his car; This is a Spontaneous report from a non-contactable Other Health Professional. Regulatory authority report number is 14939-6. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 19May2021 (Batch/Lot Number: EW0195; Expiration Date: 01Sep2021) at 54 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 19May2021. It was not reported if an autopsy was performed. Clinical course was reported as follows. The patient does not present symptoms after vaccination, the 30 minutes of observation pass without anything out of the ordinary, it refers that when leaving the place of the vaccination dies when arriving at his car. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: when leaving the place of the vaccination dies when arriving at his car


VAERS ID: 1409307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-23
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 - / 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: 2021-04-23
   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: FURIX [FUROSEMIDE]; NOVORAPID; TRESIBA; LEVAXIN; LIPITOR [ATORVASTATIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia; Hypothyreosis; Living alone; Smoker; Type I diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021662739

Write-up: Found dead in a chair (sudden death); This is a spontaneous report from a contactable other hcp downloaded from the Agency Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-00293-Uee19n, Safety Report Unique Identifier NO-NOMAADVRE-FHI-2021-00293. A 72-years-old female patient received bnt162b2 (COMIRNATY), first dose intramuscularly on 14Apr2021 (Lot Number: EX2405) as 0.3 mL single dose for covid-19 immunisation. Medical history included hypercholesterolaemia, hypothyroidism, smoked for many years, type 1 diabetes mellitus, lived alone. Concomitant medications included furosemide (FURIX); insulin aspart (NOVORAPID) taken for type 1 diabetes mellitus; insulin degludec (TRESIBA) taken for type 1 diabetes mellitus; levothyroxine sodium (LEVAXIN) taken for hypothyroidism; atorvastatin (LIPITOR) taken for hypercholesterolaemia. The patient was found dead in a chair (sudden death) on 23Apr2021. The patient died on 23Apr2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Found dead in a chair (sudden death)


VAERS ID: 1409312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Autopsy, Blood gases, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIVOTRIL; IMIGRANE [SUMATRIPTAN]; COAPROVEL; SOMAC; CALCIGRAN FORTE; ALENDRONAT SANDOZ; CIPRALEX [ESCITALOPRAM]
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Depressive episode; Dyspnea (Heavy breath since Easter.); Dystonic tremor (DYSTONIC TREMOR in head. Botulinum treatments, last in March 2021); Enlargement heart ("Known to have large heart shadow"); Factor V Leiden heterozygote; Irritable bowel syndrome; Lung embolism (several episodes with unilateral LUNG EMBOLISM); Migraine; Osteoporosis; Pressure chest (CT-cor with normal findings); Swollen ankles (unilateral swollen ankle several times after flights, not considered as DVT and pain has subsided.)
Allergies:
Diagnostic Lab Data: Test Date: 201903; Test Name: CT angiography; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Autopsy; Result Unstructured Data: Test Result:Central, occlusive pulmonary emboli; Comments: Findings during autopsy: Central, occlusive pulmonary emboli in the first branch of the right and left pulmonary arteries. Open to the left overlap. Leg veins were cut up without findings of thrombi.; Test Date: 202104; Test Name: blood gas; Result Unstructured Data: Test Result:intubated without significant improvement
CDC Split Type: NOPFIZER INC2021662359

Write-up: lung embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NO-NOMAADVRE-FHI-2021-U5ymar. A 71-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 15Apr2021 (Batch/Lot Number: EW8904) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, osteoporosis, Enlargement heart ("Known to have large heart shadow"), Factor V Leiden heterozygote (A referral from the emergency department 22Jun2018 mentioned that the patient has a Leiden mutation, presumed heterozygous. Possible GP knows more about this, as it is not mentioned anywhere else in our medical record system), Dyspnea from Mar2021 (Heavy breath since Easter), Depressive episode, Swollen ankles (not ongoing) (the patient has in the past had unilateral swollen ankle several times after flights, then not considered as DVT and pain has subsided), irritable bowel syndrome, dystonic tremor in head (Botulinum treatments, last in March 2021), pressure chest from Mar2019 to an unknown date (CT-cor with normal findings), lung embolism (several episodes with unilateral lung embolism) and migraine. Concomitant medications included clonazepam (RIVOTRIL) taken for dystonic tremor, start and stop date were not reported; sumatriptan (IMIGRANE) taken for migraine, start and stop date were not reported; hydrochlorothiazide, irbesartan (COAPROVEL) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (SOMAC) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIGRAN FORTE) taken for an unspecified indication, start and stop date were not reported; alendronate sodium (ALENDRONAT SANDOZ) taken for an unspecified indication, start and stop date were not reported; escitalopram (CIPRALEX) taken for depression, start and stop date were not reported. On 26Apr2021, the patient developed lung embolism. The patient has had heavy breath since Easter acute deterioration 26Apr2021, hypoxia and respiratory arrest in ambulance. In the emergency department, several resp. stops with PEA (Pulseless Electrical Activity), compressed with fast ROSC (Return of spontaneous circulation). Gets metalysis due to suspected pulmonary embolism. Still circulatory unstable, in and out of PEA (Pulseless Electrical Activity), intubated without significant improvement in blood gas. No treatment-requiring arrhythmias. Increasingly hypotensive. Rated as not a candidate for thromectomy or ECMO (Extra Corporeal Membrane Oxygenation). Stops resuscitation after 1 hour, (death) at 13.55 on 26Apr2021. Relevant laboratory findings and investigations included in the report (AUTOPSY, 2021, Findings during autopsy: Central, occlusive pulmonary emboli in the first branch of the right and left pulmonary arteries. Open to the left overlap. Leg veins were cut up without findings of thrombi.) (CT ANGIOGRAPHY, Mar/2019, Normal). The patient''s outcome was Fatal. The case was considered to be Serious. Relatedness of drug to reaction(s)/event(s) Lung embolism: Source of assessment-Regional Pharmacovigilance Center. Result of Assessment-Possible Sender''s comment: Since the vaccine is new, it is subject to special surveillance to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that were not discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after corona vaccination in the Adverse Reaction Register are processed by Public Health in collaboration with the Information Centers. Agency publishes weekly summaries of reports of suspected side effects after vaccination. If you have further information about the course of events such as information about the outcome, a copy of the medical record / epicrisis / laboratory answer and / or other reports, this can be sent in response to this message. The information is processed securely, and this dialog is automatically deleted after 4 months. Processing and storage of personal data takes place. Causality is assessed in accordance with international criteria (1). We do not currently have the capacity to send individual adverse reaction reports. For updated information and advice on the use of the vaccines and precautions, refer to the Vaccination Guide (2): Advice for further vaccination of people who have received the first dose of Astra Zeneca vaccine: Questions about corona vaccine that cannot be answered by local experts can be directed to PRIVACY. We request that no special categories of personal information (health information) be sent by e-mail. If it is impossible to ask a question without including such information, we recommend calling the vaccine phone (open every weekday from 13-14.30).; Reported Cause(s) of Death: LUNG EMBOLISM; Autopsy-determined Cause(s) of Death: LUNG EMBOLISM


VAERS ID: 1409367 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021699213

Write-up: Death; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number: and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on the day following vaccination, the patient died on an unspecified date for an unspecified reason. An autopsy was performed, and results were not provided. Information on batch number has been requested.; Reported Cause(s) of Death: Death


VAERS ID: 1409400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-17
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Biopsy kidney, Blood albumin, Blood creatinine, Computerised tomogram abdomen, Epistaxis, Haemoglobin, Haemoglobin decreased, Hypoalbuminaemia, Platelet count, Renal failure, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALVEDON; KALCIPOS-D; FURIX; FOLACIN [FOLIC ACID]; AMLODIPIN ACCORD; METOPROLOL ORION; ALENDRONAT MYLAN; ELIQUIS
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure (woman had severe renal failure stage 4); Sedimentation rate increased (woman has had several years with high blood sedimentation rate); Uterine cancer (operated on about a year ago)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: auscultation; Result Unstructured Data: Test Result:without any remark; Comments: the lungs and heart were auscultated without any remark; Test Date: 2021; Test Name: kidney punch test; Result Unstructured Data: Test Result:no obvious soreness over the kidney lodges; Comments: no obvious soreness over the kidney lodges when doing the kidney punch test; Test Date: 2021; Test Name: albumin; Result Unstructured Data: Test Result:18 g/l; Comments: dropped to 18; Test Date: 2021; Test Name: Creatinine; Result Unstructured Data: Test Result:around 180 umol/l; Comments: elevated to around 180; Test Date: 202103; Test Name: CT scan abdomen; Result Unstructured Data: Test Result:no hydronephrosis nor any spread of malignancy was; Comments: CT scan was performed on the abdomen in March, but no hydronephrosis nor any spread of malignancy was found.; Test Date: 2021; Test Name: Hemoglobin; Result Unstructured Data: Test Result:Low; Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: Test Result:have decreased; Test Date: 2021; Test Name: TPK; Result Unstructured Data: Test Result:60 10*6/mL; Test Date: 20210511; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021662460

Write-up: Hypoalbuminemia; Thrombocytopenia; Renal failure; nosebleeds; low Hb; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-2021-043549. A 87-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EJ6790) as 2nd dose, single dose for covid-19 immunisation. Patient took the first dose of vaccine on 26Jan2021 (Batch/lot number: EJ6134) for covid-19 immunization. Medical history included ongoing atrial fibrillation, uterine cancer from an unknown date and not ongoing, renal failure. The patient also had a tumor in the uterus that was operated on about a year ago by the Clinic, and according to the physician, there is a risk of malignancy spreading. However it is stated that a CT scan was performed on the abdomen in March, but no hydronephrosis nor any spread of malignancy was found. The woman has had several years with high blood sedimentation rate, abnormal IgA and IgG, and several years with platelets around 150 and creatinine around 100-120. Concomitant medications included paracetamol (ALVEDON); calcium carbonate, colecalciferol (KALCIPOS-D); furosemide (FURIX); folacin folic acid (FOLACIN); amlodipine besilate (AMLODIPIN ACCORD); metoprolol succinate (METOPROLOL ORION); alendronate sodium (ALENDRONAT MYLAN); apixaban (ELIQUIS), all taken for an unspecified indication, start and stop date were not reported. The patient experienced renal failure (death) on 17Mar2021, hypoalbuminemia (death) on 10May2021, thrombocytopenia (death) on 17Mar2021. The physician describes that the woman in relation to treatment with Ciprofloxacin in Mar2021 due to pyelonephritis-like symptoms, had reduced urine production and had the last 3-4 weeks after that intense interval pain, VAS 10 right flank which made it difficult for her to sit still. According to the medical records this use to happen about 3 times a day. At that time, the lungs and heart were auscultated without any remark. During the examination, no obvious soreness over the kidney lodges when doing the kidney punch test. For pain, she has been prescribed Citodon respective Oxycontin on various occasions. The physician stated that it was recently discovered that the woman had severe renal failure stage 4. On the basis of this, Alendronate and Eliquis were discontinued. The physician stated in the medical record that the woman has gained around 20 kg against her normal weight. It was also stated that she recently weighed 120 kg and that it mostly consists of water. The dose of Furix was temporarily increased to 80 mg daily dose to reduce bone swelling but was later reduced to 20 mg daily dose due to the woman''s low pressure. The woman has had a lot of problems with intense periods of nosebleeds and in connection to that low Hb was also noted. At the same time, it was also observed that the woman''s platelets in her blood have decreased and that the woman has severe hypoalbuminemia. The physician states that there is no known cause for this, but an observation is that the woman has been vaccinated against covid-19. After the vaccination, rapid declining kidney function was observed, TPK was at 60 (ref B-TPK 10x9/L 165-390), the albumin dropped to 18 (refP-Albumin g/L 34-45) and creatinine elevated to around 180 (refP-Kreatinin umol/L 45-90), and a distinct decrease of her general condition since March was also observed. After a confirmed terminal kidney failure in March, the woman died a few months later. It appears in the Medical record that the last days before she died, they had switched to palliative care. It was also noted that the woman on the 11May2021 was tested negative for COVID-19. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Hypoalbuminemia; Thrombocytopenia; Renal failure


VAERS ID: 1409404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-09
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021662711

Write-up: Dizziness; This is a spontaneous report from a contactable nurse from the Agency, regulatory authority number SE-MPA-2021-044186, Case identifiers SE-VISMA-1622210436573. An 84-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes. The patient''s concomitant medications were not reported. The patient experienced dizziness (death) on 09Mar2021. Reported suspect adverse events were severe dizziness starting on 09Mar2021 after the first dose. It is unknown if autopsy has been performed. Outcome: Fatal. Report assessed as serious, death. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dizziness


VAERS ID: 1409405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-04-29
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH REQUESTED / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; SIMVASTATIN
Current Illness: Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021662455

Write-up: cardiac arrest; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-044786. A 47-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unknown date in Feb2021 (Batch/Lot Number: REQUESTED) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020, ongoing type 2 diabetes mellitus, ongoing obesity. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unknown date in Jan2021 for covid-19 immunisation. The patient experienced pulmonary embolism on 29Apr2021. The physician described that the woman came to the emergency room in cardiac arrest, and died after two hours of CPR (Cardiopulmonary resuscitation) despite being given thrombolysis. Pulmonary embolism was stated as the cause of death. The physician stated that the woman had a symptom-free covid infection in Dec2020 and was vaccinated by the nurse where she worked with the Pfizer vaccine. It appeared in the report that she received dose 1 in January and dose 2 in February. According to the physician, it''s been at least 10 weeks from the second vaccine dose to the massive pulmonary embolism the physician reported that the connection seems quite unlikely, but the woman had no risk factors for embolism other than severe obesity and according to her relatives she has not felt well since the vaccination. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event pulmonary embolism and cardiac arrest was fatal. Report assessed as serious, death. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest; Pulmonary embolism


VAERS ID: 1409407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive lung disease; Essential hypertension; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (consumed harmful amounts of alcohol); Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021662446

Write-up: ACUTE HEART ATTACK; This is a spontaneous report from a contactable physician downloaded from the Agency. The regulatory authority report number is SE-MPA-2021-044976. This 76-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number not provided), via an unspecified route of administration, in Apr2021 at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number not provided) administered on 23Mar2021. Relevant medical history included ongoing type 2 diabetes mellitus, ongoing essential hypertension, and ongoing chronic obstructive lung disease. The patient was a smoker and an alcohol user (consumed harmful amounts of alcohol). No relevant concomitant medications were provided. The physician stated that the man got ill one week after dose two of the vaccine with chest pain that occurred at rest. It appears in the report that the man did not seek emergency care despite his relative''s proposal, and died, unfortunately, the same night. The patient died due to acute heart attack. According to the physician, the clinical autopsy showed moderate to severe atherosclerosis of the coronary arteries of the heart and severe atherosclerosis of the aorta, as well as recent myocardial infarction involving the posterior wall of the left ventricle and transition to the septum. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: moderate to severe atherosclerosis of the coronary arteries of the heart; atherosclerosis of the aorta; Acute myocardial infarction


VAERS ID: 1409408 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021675470

Write-up: passed away 3 days after vaccination; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, on 02Jun2021 (at the age of 70-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. No relevant medical history and concomitant medications were provided. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient passed away 3 days after vaccination on 05Jun2021 14:00. Cause of death was unknown. An autopsy was not performed. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: passed away 3 days after vaccination


VAERS ID: 1409820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210548786

Write-up: MYSTERIOUS BRAIN BLEEDING; This spontaneous report received from a consumer concerned a 61 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, every 1 total, therapy dates were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed mysterious brain bleeding several days, and was hospitalized (date unspecified). On 14-MAY-2021, the patient died from mysterious brain bleeding. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender''s Comments: V0 - 20210548786-covid-19 vaccine ad26.cov2.s-Mysterious brain bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MYSTERIOUS BRAIN BLEEDING SEVERAL DAYS


VAERS ID: 1410555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-31
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Death, Headache, Nervous system disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness: Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm cerebral
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210626342

Write-up: PASSED AWAY; MASSIVE CEREBRAL HEMORRHAGE; NEUROLOGICAL PROBLEM; HEADACHE; This spontaneous report received from a physician via a Regulatory Authority concerned a 62 year old female race and ethnicity not reported. The patient''s weight was 64 kilograms, and height was 165 centimeters. The patient''s past medical history included cerebral aneurysm, and concurrent conditions included smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C11 expiry: unknown) dose was not reported, 1 total dose administered on 25-MAY-2021 for covid-19 immunisation. Concomitant medications included bisoprolol. On 31-MAY-2021, the patient experienced massive cerebral hemorrhage, neurological problem and headache. On 01-JUN-2021, the patient experienced passed away. On 01-JUN-2021, the subject died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away, massive cerebral hemorrhage, neurological problem and headache on 01-JUN-2021. This report was serious (Death).; Reporter''s Comments: Treatment - Examinations -Sender''s Comments: V0:20210626342-COVID-19 VACCINE AD26.COV2.S-Passed away, massive cerebral hemorrhage, neurological problem and headache. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1410630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-31
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Enteritis
SMQs:, Cardiac failure (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Autopsy result still pending
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210626423

Write-up: ENTERITIS; DECOMPENSATION CARDIAC; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-202100092408] concerned an 89 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included autopsy result still pending. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-MAY-2021, the patient experienced enteritis and decompensation cardiac. On 31-MAY-2021, the patient died from decompensation cardiac. An autopsy was performed on an unspecified date and results were pending. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of enteritis on 31-MAY-2021. This report was serious (Death).; Sender''s Comments: V0:20210626423-COVID-19 VACCINE AD26.COV2.S-ENTERITIS,DECOMPENSATION CARDIAC.This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: DECOMPENSATION CARDIAC; Autopsy-determined Cause(s) of Death: DECOMPENSATION CARDIAC


VAERS ID: 1411117 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood sodium, C-reactive protein, Echocardiogram, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; DOLOPROCT [FLUOCORTOLONE PIVALATE;LIDOCAINE HYDROCHLORIDE]; CALCIUM OG D-VITAMIN; FURIX [FUROSEMIDE]; PANODIL; LANSOPRAZOL; GLYCEROL "OBA"; LACTULOSE "ORIFARM"; SPIRIX; HUSK PSYLLIUM FLOHSAMENSCHALEN; BRENTAN [MICONAZOLE NITRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (Aortic stenosis was diagnosed during hospitalization due to fainting on 27-28 May 2020); Dizziness; Falling (Tendencey to fall); Hyponatremia; Reduced general condition (Unexplained)
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Sodium; Result Unstructured Data: Hyponatraemia; Test Date: 20210416; Test Name: C-reactive protein; Result Unstructured Data: Severe increased CRP; Test Date: 202005; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: Mild aortic valve stenosis and normal EF; Test Date: 20210416; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: EF 55%, Normal right ventricle, mild valve pathology and hemodynamic mild pericardial effusion (fluid leakage).
CDC Split Type: DKMODERNATX, INC.MOD20212

Write-up: Acute pericarditis; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Acute pericarditis) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. Concurrent medical conditions included Hyponatremia on 01-Jan-2019, Reduced general condition (Unexplained), Aortic stenosis (Aortic stenosis was diagnosed during hospitalization due to fainting on 27-28 May 2020), Falling (Tendencey to fall) and Dizziness. Concomitant products included GLYCEROL (GLYCEROL "OBA") from 23-Feb-2021 to an unknown date and LACTULOSE (LACTULOSE "ORIFARM") from 14-Dec-2020 to an unknown date for Constipation, PLANTAGO OVATA HUSK (HUSK PSYLLIUM FLOHSAMENSCHALEN) from 14-Dec-2020 to an unknown date for Constipation chronic, FUROSEMIDE (FURIX [FUROSEMIDE]) from 19-Apr-2021 to an unknown date and SPIRONOLACTONE (SPIRIX) from 23-Apr-2021 to an unknown date for Diuretic therapy, LANSOPRAZOL from 02-Jul-2019 to 23-Apr-2021 for Esophageal acid reflux, MICONAZOLE NITRATE (BRENTAN [MICONAZOLE NITRATE]) from 12-Nov-2020 to 16-Apr-2021 for Fungal infection, FLUOCORTOLONE PIVALATE, LIDOCAINE HYDROCHLORIDE (DOLOPROCT [FLUOCORTOLONE PIVALATE;LIDOCAINE HYDROCHLORIDE]) from 26-Mar-2021 to an unknown date for Haemorrhoids, PARACETAMOL (PANODIL) from 10-Jan-2020 to an unknown date for Pain, ATORVASTATIN from 20-Apr-2021 to an unknown date for Thrombosis prophylaxis, CALCIUM, VITAMIN D SUBSTANCES (CALCIUM OG D-VITAMIN) for Vitamin D supplementation. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PERICARDITIS (Acute pericarditis) (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 15-May-2021. The reported cause of death was Acute pericarditis. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2020, Echocardiogram: unknown (Inconclusive) Mild aortic valve stenosis and normal EF. On 16-Apr-2021, Blood sodium: low (Low) Hyponatraemia. On 16-Apr-2021, C-reactive protein: high (High) Severe increased CRP. On 16-Apr-2021, Echocardiogram: unknown (Inconclusive) EF 55%, Normal right ventricle, mild valve pathology and hemodynamic mild pericardial effusion (fluid leakage).. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was given. This is a case of death in a 78-year-old male subject with a medical history of Aortic stenosis, who died 36 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No significant information for this follow up changing the previous causality assessment was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Translation received On 15-Jun-2021: laboratory data updated.; Sender''s Comments: This is a case of death in a 78-year-old male subject with a medical history of Aortic stenosis, who died 36 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No significant information for this follow up changing the previous causality assessment was reported.; Reported Cause(s) of Death: Acute pericarditis


VAERS ID: 1411394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-29
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Rash, SARS-CoV-2 test, Wrong product administered
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 16
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EPILIM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Intracardiac thrombus; Mitral regurgitation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021671328

Write-up: Rash; Confusion; Wrong vaccine administered; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106022021324620-I4LNY, Safety Report Unique Identifier GB-MHRA-ADR 25408287. A 78-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization and second dose of covid-19 vaccine (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA; Batch/Lot number was not reported) on 29Apr2021 via an unspecified route of administration as a single dose for covid-19 immunization. Medical history included intracardiac thrombus and was treated in hospital for mitral valve regurgitation from an unknown date and unknown if ongoing. Heart and blood pressure medications taken but not known to the family. Patient had not tested positive for COVID-19 since having the vaccine. Patient did not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included valproate sodium (EPILIM) taken for epilepsy from 2002 to an unspecified stop date. The patient received first dose of Pfizer vaccine and second dose of AstraZeneca vaccine (coded to wrong vaccine administered). The patient was admitted in hospital and experienced rash and confusion on an unspecified date, later he was discharged from hospital. He was readmitted three days later and passed away after six days on 15May2021. It was not reported if an autopsy was performed. He was not expected to die. The events of rash and confusion were assessed as fatal, hospitalization, disability, medically significant and life threatening, event of wrong vaccine administered was assessed as non-serious by health authority. End date of reactions was reported as 15May2021. It was unknown if the reaction recured on re-administration of Comirnaty and COVID-19 VACCINE ASTRAZENECA. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on an unspecified date. Outcome of the event at the time of last observation for confusion was reported as not recovered/not resolved. Outcome for rash was fatal and for wrong vaccine administered was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Confusional state; Rash


VAERS ID: 1411635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Placental histology; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671682

Write-up: Stillbirth; Maternal exposure during pregnancy; This is a spontaneous report received from a contactable Other Health Professional from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106072030392800-ZLHTG, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25433570. This other health care professional reported information for both mother and fetus. This is a maternal report. A 41-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) dose 1, via an unspecified route of administration on 03Jun2021 as 1st dose single dose for covid-19 immunization. Medical history included suppressed lactation. Patient was pregnant at the time of vaccination. The patient has not had symptoms associated with COVID-19 and had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient report was not related to possible blood clots or low platelet counts. Concomitant medication(s) included folic acid (FOLIC ACID) taken for vitamin supplementation. On an unknown date the patient underwent lab tests and procedures which included Placental histology which result was unknown and COVID-19 virus test which result was negative. It was reported that on 03Jun2021 patient received the first dose of vaccine while she was pregnant and was exposed to the vaccine in her third trimester (29-40 weeks) and on 04Jun2021 the pregnancy resulted in stillbirth. The seriousness criteria were reported as death and medically significant. Death date was reported on 04Jun2021 and it was unknown if an autopsy was performed. The outcome of the event maternal exposure during pregnancy was unknown and outcome was fatal for the event of stillbirth. No follow-up attempts are possible, information on batch number and expiry date cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : GB-PFIZER INC-2021676820 mother/foetus case; Reported Cause(s) of Death: Stillbirth


VAERS ID: 1411645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Fatigue, Limb injury, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-06-07
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021693010

Write-up: Miscarriage; Exhaustion; Arm injury; Swollen arm; This is a spontaneous report received from a contactable consumer or other non HCP from the Regulatory Agency (RA). The regulatory authority report number is (GB-MHRA-WEBCOVID-202106121548503420-OGSAK), Safety Report Unique Identifier GB-MHRA-ADR 25466169 A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29May2021, as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 30May2021, the patient had exhaustion, arm injury, and swollen arm. On 03Jun2021, the patient had miscarriage. The patient underwent lab tests and procedures which included COVID-19 virus test: negative COVID-19 test on an unspecified date. On 07Jun2021, the patient died, and the cause of death was unknown. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1411723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-20
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021707922

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-395221. A 66-years-old male patient received bnt162b2 (COMIRNATY, COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran), intramuscular, administered in left arm on 28Apr2021 (Lot Number: ET6956, strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine) as unknown dose number, 0.3ml single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died in his home on 20May2021. Autopsy was performed and results were not provided. The cause of death was unknown. The outcome of event was fatal. Sender Comment: The patient died 22 days after Comirnaty vaccination. Autopsy was done, further information is expected.. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1411728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes simplex encephalitis
SMQs:, Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Nil
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021674395

Write-up: HSV Encephalitis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-075128. A 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. The patient previously took first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration on 09Mar2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have any concurrent conditions or risk factors. On 13Apr2021 (7-days after second dose), patient experienced herpes simplex virus (HSV) encephalitis. The time interval between the first dose and the event is 35-days and second dose and the event is 7-days. Therapeutic measures were taken as a result of herpes simplex virus (HSV) encephalitis included intravenous Aciclovir. The patient died on 13Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Herpes simplex encephalitis


VAERS ID: 1411815 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893-01-117 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Pulmonary thrombosis, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: GIANT; BISOPROLOL FUMARATE; DIURESIX [TORASEMIDE SODIUM]; OLMESARTAN MEDOXOMIL
Current Illness: Chronic renal failure; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: AFib
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Test Date: 20210524; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Test Date: 20210521; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021668392

Write-up: Respiratory failure in subject with positive antigenic swab; COVID-type interstitial pneumonia with $g75% involvement; pulmonary embolic thrombosis in CPAP (Continuous Positive Airway Pressure); pulmonary embolic thrombosis; respiratory failure; vaccination failure; sars-cov-2 test: positive on 21May2021; This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-739120. An 85-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EW2246-37-030, expiration date: 31Jul2021) via an unspecified route of administration on 10Apr2021 as single dose for COVID-19 immunisation. The patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EX0893-01-117, expiration date: 31Jul2021) via an intramuscular route of administration on 01May2021 at a dose of 0.3 ml as single dose for COVID-19 immunisation. The patient''s medical history included ongoing chronic kidney disease, ongoing hypertension and atrial fibrillation. Concomitant medications included amlodipine besilate, olmesartan medoxomil (GIANT) taken for hypertension, bisoprolol fumarate taken for hypertension, torasemide sodium (DIURESIX [TORASEMIDE SODIUM]) taken for chronic kidney disease and olmesartan medoxomil taken for hypertension. On 21May2021, the patient experienced respiratory failure in subject with positive antigenic swab, COVID-type interstitial pneumonia with $g75% involvement, pulmonary embolic thrombosis in CPAP (continuous positive airway pressure) and vaccination failure. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on 24May2021, SARS-COV-2 antibody test: positive on 24May2021, SARS-COV-2 test: positive on 21May2021. Therapeutic measures were taken as a result of adverse event. The patient died on 03Jun2021. The death was due to respiratory failure in subject with positive antigenic swab; COVID-type interstitial pneumonia with $g75% involvement; pulmonary embolic thrombosis in CPAP (Continuous Positive Airway Pressure), pulmonary embolic thrombosis, respiratory failure, vaccination failure and SARS-COV-2 test: positive on 21May2021. It was not reported if an autopsy was performed. The outcome of events was fatal.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021668395 patient spouse case; Reported Cause(s) of Death: Respiratory failure in subject with positive antigenic swab; COVID-type interstitial pneumonia with $g75% involvement; pulmonary embolic thrombosis in CPAP (Continuous Positive Airway Pressure); Pulmonary embolic thrombosis; Respiratory failure; Covid


VAERS ID: 1412020 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Schizophrenia
Preexisting Conditions: Medical History/Concurrent Conditions: Extrapyramidal symptoms (due to antipsychotic drug; discontinued since Dec2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021672283

Write-up: Geromarasmus; cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly, on 27May2021 (at the age of 80-years-old) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included ongoing schizophrenia and extrapyramidal symptom (due to antipsychotic drug; discontinued since Dec2020). The patient''s concomitant medications were not reported. The patient previously took macrogol 4000;potassium chloride;sodium bicarbonate;sodium chloride (MOVICOL) for an unspecified indication and experienced diarrhoea. The patient experienced geromarasmus on 29May2021 at 06:00 (2 days after the vaccination), which was reported as fatal. The patient also experienced cardio-respiratory arrest on 29May2021 at 06:00. The clinical course was reported as follows: The patient was being admitted to the hospital for schizophrenia. On 27May2021 (the day of vaccination), the patient received the first dose of BNT162B2 vaccination. On 28May2021, since the patient was unable to take meals, fluid replacement was performed. On 29May2021, at 06:00 (2 days after vaccination), the patient was confirmed to die in cardio-respiratory arrest. Therapeutic measures were taken as a result of geromarasmus as aforementioned. The cause of death was considered as geromarasmus. Although myocarditis was suspected by the physician, it was not confirmed. The patient died on 29May2021. The cause of death was reported as geromarasmus and also assessed as cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed that the event, geromarasmus, was probably related to BNT162B2.; Sender''s Comments: Based on the current available information, the events Geromarasmus and Cardio-respiratory arrest are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. 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: Geromarasmus; cardio-respiratory arrest


VAERS ID: 1412022 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Oesophageal carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021684425

Write-up: sudden deterioration; This is a spontaneous report from a contactable physician received via regulatory authority. A 74-year-old male patient received BNT162B2 (COMIRNATY; lot EY0779, expiry date 31Aug2021) intramuscular, in left arm, on 07Jun2021 at 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included oesophageal carcinoma and allergy to premedication used before gastroendoscopy (details were unknown). The patient received unspecified anti-cancer drug within 2 weeks of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 07Jun2021 at 10:30 (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. The course of the event was provided as follows: On 10Jun2021, the reporter received information from the patient''s family that sudden deterioration occurred in the patient and he passed away. Details were unknown. Causality was unknown. It was unknown if an autopsy was performed.Event outcome was fatal.; Sender''s Comments: Event sudden deterioration represents an intercurrent medical condition and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden deterioration


VAERS ID: 1412029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021693444

Write-up: Death; This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. An elderly male patient of unspecified age (physician of the reporter''s hospital) received BNT162B2 (COMIRNATY) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was only stated that the patient had no underlying diseases, but accurate information has not been obtained. On an unspecified date the patient died. It was uncertain if the patient received BNT162b2 (COMIRNATY) because he died, but in general, most physicians had already received BNT162b2, therefore, this case was reported. Event outcome was fatal. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the reported death for case unknown cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1412034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-19
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amyotrophic lateral sclerosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021710887

Write-up: Death; This is a spontaneous report from a contactable physician via a company representative. The patient was an 87-year-old male. Medical history included amyotrophic lateral sclerosis. Concomitant medications were not reported. On an unknown date at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot number unknown, expiration date unknown) intramuscularly at 1st dose, 0.3 ml single dose for COVID-19 immunisation. On an unknown date at unknown time (8 days after the vaccination), the patient experienced death. The course of the event was reported as follows: the patient died 8 days after the first BNT162b2 vaccination. On an unknown date, the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death). The causality of the event was not reported. Information about lot/batch number has been requested.; Sender''s Comments: The information on clinical course, recent lab data, status of lateral sclerosis and concurrent medical condition for this elderly patient is missing. Until sufficient information becomes available to exclude a reasonable possibility of relatedness between "death" and BNT162b2 , the reported event is assessed as possibly related to BNT162b2, as a cautionary measure and for reporting purposes. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1413624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-05-16
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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: 2021-06-07
   Days after onset: 22
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: PROLOPA; SYNTHROID; MANTIDAN; VITAXON [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE]; OMEGA-3 [OMEGA-3 NOS]; MAGNESIUM; PROPOLIS; OSCAL D [CALCIUM CARBONATE;VITAMIN D NOS]; ASPIRIN [ACETYLSALICYLIC ACID]; DASTENE; CENTRUM
Current Illness: Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (more than 10 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: BRSA2021SA203122

Write-up: COVID-19 PCR test positive; Covid-19; This initial Information regarding this unsolicited valid serious death case was received on 14-Jun-2021 from a non-healthcare professional (unknown relationship with patient) through Business Partner, which was forwarded to Regulatory Authority on 15-Jun-2021. On 14Jun2021, Regulatory Authority received a report of a serious adverse event after the use of influenza vaccine through the customer service. The reporter, profession not informed, reports that the patient, (comorbidity, continuous medication use, and unknown demographics), received the first dose of the adsorbed covid-19 (inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. On 16/May/2021 the patient had the first symptom of Covid-19 [Covid-19] (patient had unspecified treatment for 7 days), and on 24/May/2021 the patient underwent PCR (Polymerase chain reaction) test: positive. On an unspecified date the patient had to be admitted to the ICU (intensive care unit) and died on 07/Jun/2021 as a result of complications in the disease-related condition. On 14/Jun/2021 after receiving the initial e-mail, we received more information about the case, in which data from the reporter, the patient, medical history, concomitant and treatment medications, and the evolution of the patient''s condition were reported. On the same date, we received information about the patient''s vaccination status, in which he reports receiving the influenza vaccine in 2021, batch not informed. Here is additional information: reporter, biochemical engineer. Patient: 174 cm, weight 89 kg, It was reported that the patient was medicated with influenza vaccine in 2021, after administration of covid-19 (inactivated) adsorbed vaccine, within the recommended interval between vaccine administration (more than 15 days). For treatment of the serious adverse event, the patient was medicated from 17/Mai/2021, with Zinnat (Cefuroxime), 1g/day; Atrovent (ipratropium bromide), 1 drop/mL, 5 mL, inhalation with saline. Beginning on 21/May/2021, with a positive result for COVID, he was medicated with moxifloxacin hydrochloride 400 mg/day; Atrovent (ipratropium bromide), 5 drops/mL, 5 mL serum; and beginning on 24/May/2021 the patient was hospitalized at Hospital, in which the patient underwent submitted to unspecified tests. The reporter reported that on 21/May/2021 the patient had a pharmacy test for COVID (corona virus disease) with a positive result. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Concomitant medications: Prolopa BD (levodopa and benserazide hydrochloride), Syntroid (levothyroxine sodium), Mantidam (amantadine hydrochloride), Vitaxon(multivitamin), Omega 3, Magnesium, propolis, Oscal (calcium and vitamin D), Aspirin Prevent (acetylsalicylic acid), Dastene (Dutasteride), Centrum tabs man (multivitamin), Magnen B6(magnesium glycinate), Glifage (metformin), and simvastatin, without further information about the therapies. The patient received the first dose of the adsorbed covid-19 (inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. Patient medical history, concomitant disease, risk factor: Medical history of surgery for placing a saphenous vein graft more than 10 years ago, but with cardiologist follow-up, led a healthy and normal life and atypical Parksonism, since date not informed. It is unknown if the patient had any additional medical history, concomitant disease or risk factor. Lab data/results: Exam: SARS-COV-2 (Severe acute respiratory syndrome coronavirus 2) TEST Date: 24 May 2021 Result: positive. It is unknown if there were additional lab data/results available.; Sender''s Comments: This case concerns 86-year-old male patient who had Covid-19 (corona virus disease), COVID-19 PCR (Polymerase chain reaction) test positive and died after vaccination with INFLUENZA VACCINE (TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE INACT (not produced by sanofi pasture). The time to onset is unknown. Medical condition at the time of vaccination was Parkinson''s disease. The patient''s past vaccinations and tolerance, autopsy result and other laboratory test ruling out alternate etiologies were needed to fully assess the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: COVID-19; COVID-19 PCR test positive


VAERS ID: 1413629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-04
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast cancer female NOS; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210636762

Write-up: DEATH SUDDEN; This spontaneous report received from a physician via a Regulatory Authority concerned a 59 year old female. The patient''s weight was 38 kilograms, and height was 155 centimeters. The patient''s concurrent conditions included breast cancer female nos, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985 expiry: UNKNOWN) dose was not reported at a frequency of 1 total, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced death sudden. It was unknown if the autopsy was done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0; 20210636762-COVID-19 VACCINE AD26.COV2.S-DEATH SUDDEN. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEATH SUDDEN


VAERS ID: 1414796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: PRADAXA
Current Illness: Arterial hypertension; Atrial fibrillation (Atrial fibrillation arrhythmia with ongoing Pradaxa therapy)
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplectic fit (condition after Insult 2000)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021687989

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number AT-BASGAGES-2021-30362. A 88-year-old male patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: FC0681) intramuscularly on 20May2021 as single dose for COVID-19 immunization. Patient''s medical history included Apoplectic fit (cerebrovascular accident) from 2000 to an unknown date condition after Insult 2000. He also had ongoing atrial fibrillation (Atrial fibrillation arrhythmia with ongoing Pradaxa therapy) and ongoing Arterial hypertension both from an unspecified date. Concomitant medication included Dabigatran Etexilate Mesilate (PRADAXA) taken for an unspecified indication, start and stop date were not reported. On 23May2021 the patient experienced Death not otherwise specified (NOS) death. It was not reported if an autopsy was performed. Outcome of the event was fatal. Sender Comment: The report is for a patient No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1414799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-02
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide, Depressed mood, Incontinence, Panic reaction, Tension
SMQs:, Suicide/self-injury (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic Lyme disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021698985

Write-up: my father was suddenly incontinent. He never had problems in this regard, was very fit for his age. From one day to another he needed pads and mobile briefs.; He committed suicide 2 weeks after the incontinence occurred and exactly 4 weeks after the second vaccination.; Nervous, panicked, helpless, depressed he seemed the same during this time!; Nervous, panicked, helpless, depressed he seemed the same during this time!; Nervous, panicked, helpless, depressed he seemed the same during this time!; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-31103. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Mar2021 (Lot Number: ET3620) as single dose for covid-19 immunisation. Medical history included ongoing chronic Lyme disease. The patient''s concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 (COMIRNATY), on 27Feb2021 as single dose for covid-19 immunisation. On 02Apr2021 the patient experienced Incontinence, hospitalization. On 02Apr2021 the patient experienced Depressed mood death, other, Panic reaction, Feeling tense. On 17Apr2021 the patient experienced Completed suicide death. 2x he was brought to the hospital by the ambulance, checked there and sent back home. Several times he went to the urologist and to his family doctor. He was prescribed medications, others were prescribed, nothing helped. He was given painkillers, sedatives and medications for the incontinence. 2 weeks after the onset of incontinence and exactly 4th week after the second vaccination he committed suicide. Nervous, panicked, helpless, depressed he seemed the same during this time. The patient''s outcome was fatal for Completed suicide, not recovered for other events. The patient was died in 2021. It was not reported if an autopsy was performed. Sender''s comments: The report is for a relative. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Completed suicide


VAERS ID: 1414800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Presyncope, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAXI KALZ; RISPERIDON; MIRTEL [TELMISARTAN]; LASIX [FUROSEMIDE]; FORTECORTIN [DEXAMETHASONE]; DOMINAL [ACETYLSALICYLIC ACID]; OLEOVIT D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Arterial hypertension; Bronchial carcinoma; Cerebral ischaemia; Korsakoff''s syndrome; Paranoid schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021699014

Write-up: Circulatory failure; Presyncope; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-31270. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as unknown, single dose for covid-19 immunisation. Medical history included alcohol use, Arterial hypertension, Paranoid schizophrenia, Bronchial carcinoma, Korsakoff''s syndrome, Cerebral ischaemia. Concomitant medications included calcium (MAXI KALZ); risperidone; telmisartan (MIRTEL [TELMISARTAN]); furosemide (LASIX [FUROSEMIDE]); dexamethasone (FORTECORTIN [DEXAMETHASONE]); acetylsalicylic acid (DOMINAL [ACETYLSALICYLIC ACID]); colecalciferol (OLEOVIT D3). The patient''s weight was 45 kg, and height was 160 cm. The patient received Comirnaty on 20Apr2021.On 21Apr2021, the patient experienced Pyrexia, Presyncope. On 22Apr2021, the patient experienced Circulatory failure death, Found dead. The patient died on 22Apr2021 from Circulatory failure. No autopsy was performed. The outcome Pyrexia and Presyncope was unknown, of Circulatory failure was fatal. No follow-up attempts are possible. Information on lot/batch numbers cannot be obtained.; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1414839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, COVID-19, Computerised tomogram, Dyspnoea, Influenza like illness, Myocardial infarction, Oxygen saturation, Respiratory disorder, Rhinitis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 3
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: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: blood exams; Result Unstructured Data: Test Result:lots of indicators were altered; Test Date: 20210531; Test Name: tomography; Result Unstructured Data: Test Result:presented 75% of compromise; Test Date: 20210531; Test Name: saturation; Result Unstructured Data: Test Result:83-84 %; Test Date: 20210531; Test Name: saturation; Result Unstructured Data: Test Result:went up to 90-94 %; Test Date: 20210606; Test Name: saturation; Result Unstructured Data: Test Result:dropped to 90 %; Comments: afternoon; Test Date: 20210531; Test Name: test; Test Result: Positive
CDC Split Type: BRPFIZER INC2021701597

Write-up: to do the test, and the patient''s and the patient''s wife results were positive; heart attack; in the tomography the patient presented 75% of compromise; shortness of breath; light flu symptoms; coryza; This is a spontaneous report from a contactable consumer (patient''s brother). A 42-years-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing obese and did not have other pre-existing condition. The patient''s concomitant medications were not reported. On the day of 28May2021, the patient took the first dose of the Pfizer vaccine. Until the present moment he did not have any flu symptoms or anything of the like. On the following of 29May2021 and 30May2021, the patient had light flu symptoms, with a bit of coryza. The patient thought that it could be a reaction to the vaccine. On the day of 31May2021, the patient woke up with a lot of shortness of breath. Before going to the hospital the patient went to the drugstore to do the test, and the patient''s and the patient''s wife results were positive. Immediately the patient went to a certain hospital from a certain neighborhood in a certain city. When the patient got there, his saturation was between 83-84%. Immediately they introduced the oxygen, the patient''s oxygenation went up to 90-94%, they collected blood exams, and lots of indicators were altered and in the tomography the patient presented 75% of compromise. And 13 hours after the first symptoms the patient was already doing treatment with the medications of the COVID protocol. The clinical condition during the following days of 31May to 06Jun2021 was rapidly evolving. On the day of 06Jun2021 in the afternoon, the patient''s saturation dropped to 90% and on the day of 07Jun2021 the patient was sent to the ICU (Intensive Care Unit) and his clinical condition evolves rapidly. In approximately 24 hours of ICU, they did the intubation process. And after this, in approximately 4 hours the patient suffered a heart attack (Jun2021). The reporter was reporting a family experience to help in the process of enhancement of the vaccine use. Probably, the patient was with a COVID in the asymptomatic and when the patient took the vaccine, all the process was intensified. The outcome of heart attack was fatal, of other events was unknown. The patient died in Jun2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: heart attack


VAERS ID: 1414863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Bacterial test, Blood chloride, Blood creatinine, Blood glucose, Blood pressure measurement, Blood sodium, Blood urea, Body height, C-reactive protein, Cardiolipin antibody, Chest X-ray, Circulatory collapse, Computerised tomogram, Computerised tomogram thorax, Cough, Decreased appetite, Drug ineffective, Dyspnoea, Electrocardiogram, Fibrin D dimer, Haemoglobin, Headache, Heart rate, Influenza A virus test, Influenza B virus test, International normalised ratio, Legionella test, Oxygen saturation, Platelet count, Pneumonia, Prothrombin time, Prothrombin time ratio, Pseudomonas infection, Pseudomonas test, Red blood cell count, Respiratory failure, Respiratory syncytial virus test, SARS-CoV-2 test, Stress cardiomyopathy, Suspected COVID-19, Troponin, Weight, White blood cell count, X-ray
SMQs:, Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Non-tobacco user
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Cholecystectomy; Obesity; Radical hysterectomy; Rheumatoid arthritis (long-term stable, with minimum manifestations)
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: APTT; Test Result: 35.4 s; Test Date: 20210511; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.11; Test Date: 20210518; Test Name: Bacteria sputum no organisms observed; Result Unstructured Data: Test Result:negative for Streptococcus pneumoniae, Legionella; Comments: negative for Streptococcus pneumoniae, Legionella pneumophila, Haemophilus influenzae Bordetella parapertussis: Mycoplasma pneumoniae, Bordetella pertussis, Chlamydia pneumoniae:; Test Date: 20210511; Test Name: Blood chloride; Result Unstructured Data: Test Result:101 mmol/L; Test Date: 20210511; Test Name: Blood creatinine; Result Unstructured Data: Test Result:74 umol/l; Test Date: 20210511; Test Name: Blood glucose; Result Unstructured Data: Test Result:8.6 mmol/L; Test Date: 20210512; Test Name: Blood glucose; Result Unstructured Data: Test Result:13.6 mmol/L; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/62 mmHg; Test Date: 20210511; Test Name: Blood sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210511; Test Name: Urea; Result Unstructured Data: Test Result:5.9 mmol/L; Test Date: 20210511; Test Name: Body height; Result Unstructured Data: Test Result:149cm; Test Date: 20210511; Test Name: Antibodies anticardiolipin; Result Unstructured Data: Test Result:IgE 108 kU/L; Test Date: 20210511; Test Name: Anticardiolipin antibodies; Result Unstructured Data: Test Result:IgM 1.30 U/mL; Test Date: 20210511; Test Name: Anticardiolipin antibodies; Result Unstructured Data: Test Result:IgM 3.40 U/ML; Test Date: 202105; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:typical for COVID-19; Test Date: 202105; Test Name: Computerised tomography; Result Unstructured Data: Test Result:typical for COVID-19; Test Date: 20210512; Test Name: Chest CT; Result Unstructured Data: Test Result:without clear signs of pulmonary embolsim. In peri; Comments: without clear signs of pulmonary embolsim. In peripheral parts of lung post inflammatory changes typical for Covid-19. CT done with angiography of truncus pulmonaris; Test Date: 20210511; Test Name: C-reactive protein; Result Unstructured Data: Test Result:40.9 mg/l; Test Date: 20210512; Test Name: C-reactive protein; Result Unstructured Data: Test Result:35.6 mg/l; Test Date: 20210511; Test Name: EKG; Result Unstructured Data: Test Result:sinus rhythm, left axis, PQ = 0.12s, QRS = 0.08s,; Comments: sinus rhythm, left axis, PQ = 0.12s, QRS = 0.08s, ST isoelectric, without acute ischemic changes; Test Date: 20210519; Test Name: EKG; Result Unstructured Data: Test Result:ST elevation in the leads V2-V6, hypokinesia of th; Comments: ST elevation in the leads V2-V6, hypokinesia of the myocardium seen laterally. The condition was concluded as stress cardiomyopathy.; Test Date: 20210511; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1.21 - positive mg/l; Test Date: 20210512; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:more than 4 mg/l; Test Date: 20210511; Test Name: Hemoglobin; Result Unstructured Data: Test Result:143 mg/l; Test Date: 20210511; Test Name: Pulse rate; Result Unstructured Data: Test Result:96 Units:/min; Test Date: 20210513; Test Name: Influenza A virus test; Test Result: Negative ; Test Date: 20210513; Test Name: Influenza B virus test; Test Result: Negative ; Test Date: 20210511; Test Name: International normalised ratio; Result Unstructured Data: Test Result:0.97; Test Date: 20210518; Test Name: Legionella test; Test Result: Negative ; Test Date: 20210511; Test Name: O2 saturation; Result Unstructured Data: Test Result:92-93 with oxygen support 3.5 l / min %; Test Date: 202105; Test Name: Oximetry; Result Unstructured Data: Test Result:hypoxia; Test Date: 20210511; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:357 x10 9/l; Test Date: 20210511; Test Name: Pro-thrombin time; Test Result: 13 s; Test Date: 20210511; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:0.97; Test Date: 20210518; Test Name: Pseudomonas aeruginosa test; Test Result: Positive ; Test Date: 20210511; Test Name: Red blood cell count; Result Unstructured Data: Test Result:4.98 x10 12/l; Test Date: 20210513; Test Name: Respiratory syncytial virus test; Test Result: Negative ; Test Date: 20210511; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Comments: 5 times negative done from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab; Test Date: 20210512; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Comments: 5 times negative done from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab; Test Date: 20210513; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Comments: 5 times negative done from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab; Test Date: 202105; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Comments: 5 times negative done from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab; Test Date: 20210518; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Comments: from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab; Test Date: 20210519; Test Name: troponin; Result Unstructured Data: Test Result:elevation to unmeasurable values; Test Date: 20210511; Test Name: Weight; Test Result: 76 kg; Test Date: 20210511; Test Name: White blood cells; Result Unstructured Data: Test Result:8.7 x10 9/l; Test Date: 20210512; Test Name: White blood cells; Result Unstructured Data: Test Result:13.4 x10 9/l; Test Date: 20210511; Test Name: X-ray thorax skiagramm; Result Unstructured Data: Test Result:progression of inhomogeneous obscuration of the na; Comments: progression of inhomogeneous obscuration of the nature of infiltrative changes bilaterally, with a maximum basally, coarse lung pattern, without fluidothorax.
CDC Split Type: CZPFIZER INC2021699188

Write-up: Circulatory failure; Stress cardiomyopathy; respiratory insufficiency; breathlessness; bilateral pneumonia; infection Pseudomonas aeruginosa; Drug ineffective; Suspected COVID-19; loss of appetite; headache; irritant cough; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21006474. A 74-year-old female patient received bnt162b2 (COMIRNATY), first dose intramuscular on 16Mar2021 (Batch/Lot number was not reported) as single dose, second dose intramuscular on 13Apr2021 (Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included cholecystectomy (not ongoing), obesity, rheumatoid arthritis (long-term stable, with minimum manifestations (not ongoing)); ongoing non-tobacco user, appendicectomy (not ongoing), radical hysterectomy (not ongoing). The patient did not have COVID-19 or tuberculosis, no allergies. No concomitant medication. The patient experienced circulatory failure (death, hospitalization, medically significant, life threatening) on 19May2021, stress cardiomyopathy (death, hospitalization, medically significant, life threatening) on 19May2021, breathlessness (hospitalization, medically significant, life threatening) in May2021, respiratory insufficiency (hospitalization, medically significant, life threatening) on 11May2021, infection pseudomonas aeruginosa (life threatening) on 18May2021, bilateral pneumonia (hospitalization, medically significant) on May2021, irritant cough (medically significant) on May2021, loss of appetite (non-serious) on May2021, headache (non-serious) on May2021. The patient died on 19May2021. An autopsy was not performed. The clinical course reported as below: the patient had following adverse drug reaction after being vaccinated with COMIRNATY vaccine (13Apr2021, 2nd dose): respiratory insufficiency. On11May2021 respiratory insufficiency and hospitalization in a faculty hospital. On X-rays and computed tomography, there were signs characteristic of Covid-19. During hospitalization, a polymerase chain reaction test was performed 5 times, but was always Covid-negative. Nevertheless, despite treatment with corticoids, low molecular weight heparin and other drugs, the condition got worse. The X-ray findings, the general condition and especially the respiratory insufficiency were worse. Oxygen therapy was constantly increased, then the patient was given high flow nasal oxygen, then non-invasive artificial lung ventilation, then invasive artificial lung ventilation. The course was very similar to rapidly progressing Covid-19 pneumonia. From 18May2021 patient was move to the anesthesiology and resuscitation department. Antibiotic therapy was changed to Tazocin / Klacid because of the finding of pseudomonas aeruginosa in urine. 19May2021 troponin elevation to unmeasurable values, on the ECG ST elevation in the leads V2-V6, on echocardiography hypokinesia of the myocardium was seen laterally. The condition was concluded as stress cardiomyopathy. The patient had heart failure, did not respond to levosimendan. 19May2021 the patient died of circulatory failure and circulatory arrest. Treatment of the ADRs included: SoluMedrol, oxygen, high-flow oxygen therapy, non-invasive ventilation, Clexane, invasive artificial lung ventilation, amoxicillin, piperacillin + tazobactam, clarithromycin, Propofol, sufentanil, noradrenaline, levosimendan, amiodarone, methylprednisolone, nintedanib. Therapeutic measures were taken as a result of circulatory failure, stress cardiomyopathy, breathlessness, respiratory insufficiency, infection pseudomonas aeruginosa, bilateral pneumonia. Tests from 11May2021 included: Antibodies anticardiolipin: IgE 108 ku/l, Antibodies anticardiolipin: IgM 1.30 U/mL, Antibodies anticardiolipin: IgM 3.40 U/ML, C-reactive protein 40.9 mg/l, COVID-19 PCR test was negative (5 times negative done from 11 may 2021 to 18 May 2021 (the last test) - done from nasopharyngeal swab), weight: 76 kg, height: 149 cm, Blood pressure: 120/62 mmHg, Puls: 96 / min, oxygen saturation: 92-93% with oxygen support 3.5 l / min, Electrocardiogram: sinus rhythm, left axis, PQ = 0.12s, QRS = 0.08s, ST isoelectric, without acute ischemic changes, glycemia: 8.6 mmol / l, In blood: 134 mmol / l, K: hemolytic sample, Cl in blood: 101 mmol / l, Urea in blood: 5.9 mmol / l, Creatinin in the blood: 74 umol / l, Bilirubin, ALT, ALP: physiological, AST, GGT: hemolytic sample, leukocytes in the blood: 8.7x10 * 9 / l, red blood cells in the blood: 4.98x10 * 9 / l, Plateletts in blood: 357x10 * 9 / l, Hemoglobin in the blood: 143g / l, Prothrombin time: 13 s, Protrombin test ratio: 0.97, INR: 0.97, APTT-p: 35.4 s, APTT ratio: 1.11, D-dimers of fibrin: 1.21 mg / L-positive, skiagram of the chest: progression of inhomogeneous obscuration of the nature of infiltrative changes bilaterally, with a maximum basally, coarse lung pattern, without fluidothorax. Tests of 12May2021 included: Glycemia: 13.6 mmol/l (also reported as "13.9 mmol/l"), Chest CT without clear signs of pulmonary embolsim. In peripheral parts of lung post inflammatory changes typical for Covid-19. CT done with angiography of truncus pulmonaris, leukocytes in the blood: 13.4x10 * 9 / l, C-reactive protein: 35.6 mg / l, D-dimers: above 4mg / l-strongly positive, PCR examination COVID-19: negative. Tests from 13May2021 included: PCR examination COVID-19: negative. Tests from 18May2021 included: PCR examination COVID-19: negative. PCR examination COVID-19: negative in May2021. Event outcome for circulatory failure, stress cardiomyopathy was fatal. Event outcome for breathlessness, respiratory insufficiency, bilateral pneumonia was not recovered; for the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: after circulation failure and stress cardiomyopathy


VAERS ID: 1414868 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699236

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-202100093883. An 81-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Apr2021 at single dose (0.3 mL single) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 16Apr2021. This report was serious - death. It was not reported if an autopsy was performed. Event assessment: Comirnaty/event/Regulatory Authority/Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414869 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-06
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Emphysema pulmonary; End stage COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea at rest
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210636773

Write-up: DEATH SUDDEN; This spontaneous report received from a physician via a Regulatory Authority concerned a 69 year old male with unknown race and ethnicity. The patient''s weight was 90 kilograms, and height was not reported. The patient''s past medical history included shortness of breath at rest with significantly reduced bodily, and concurrent conditions included emphysema pulmonary, and end stage COPD (chronic obstructive pulmonary disease). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: X0975 expiry: UNKNOWN) dose was not reported,1 total administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the patient died suddenly and cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210636773-COVID-19 VACCINE AD26.COV2.S-death. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1414870 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699252

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100093898. A 77 years age old Female patient received 2nd dose of BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, Batch/ lot number: unknown) at the age of 77 years old, on 02Jun2021 at single dose for covid-19 immunization. No relevant medical history and concurrent conditions reported. Concomitant drug was not reported. Historical Vaccine was 1st dose of COMIRNATY in Apr2021 for covid-19 immunization. The patient experienced unknown cause of death. Whether Autopsy Done or not unknown. The patient''s outcome was fatal. This report is serious - death. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414876 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-27
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Coronary disease
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction (2 heart attacks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699185

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable Physician which downloaded from the WEB DCGMA number DE-PEI-202100095314 . A 72-year-old Male patient received BNT162B2 (COMIRNAT, Lot Number unknown) at 0.3 ml single dose for COVID-19 immunisation on 06Apr2021. Relevant history included Myocardial infarction (2 heart attacks), ongoing Cardiac failure and ongoing Coronary disease. No concomitant medication was reported. On 27Apr2021 the patient experienced Unknown cause of death. Event assessment : Comirnaty/event/PEI /Result of Assessment : D. Unclassifiable No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414877 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699234

Write-up: Sudden death, cause unknown; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority WEB number DE-PEI-202100095320. A 32-year-old male patient received BNT162B2 (COMIRNATY) at 0.3 ml single dose via an unknown route on 28May2021 at 32-year-old for COVID-19 immunisation. Medical history and concomitant drug were not provided. This report was serious with seriousness criteria of death. On 07Jun2021 the patient experienced sudden death, cause unknown. Outcome of the event was fatal. Event assessment : Comirnaty/event/PEI /Result of Assessment was: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1414885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypoxia, Investigation, Pyrexia, Respiratory failure, SARS-CoV-2 test, Somnolence
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood cultures; Test Result: Negative ; Test Name: Covid-19 PCR; Test Result: Negative
CDC Split Type: DEPFIZER INC2021699289

Write-up: Unknown cause of death; Respiratory insufficiency; hypoxia; High fever infection with somnolence GCS 3; High fever infection with somnolence GCS 3; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021087286, Safety Report Unique Identifier DE-PEI-202100080193. A 94-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Apr2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 10Apr2021, respiratory insufficiency on 10Apr2021, hypoxia on 10Apr2021, high fever infection with somnolence gcs 3 on 08Apr2021. The patient underwent lab tests and procedures which included blood cultures: Negative on an unspecified date, and Covid-19 PCR: Negative on an unspecified date. The patient died on 10Apr2021. The patient''s outcome was not recovered for pyrexia and somnolence. An autopsy was not performed. Senders comments: Urosepsis excluded. Blood cultures negative, Covid-19 PCR negative, influenza negative. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Respiratory insufficiency; hypoxia


VAERS ID: 1414886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Dyspnoea, Influenza, Organ failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 29
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: COPD
Preexisting Conditions: Medical History/Concurrent Conditions: House dust allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699167

Write-up: organ failure; Dyspnoea; Arrhythmia; Arrest cardiac; Flu symptoms; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021087411, Safety Report Unique Identifier DE-PEI-202100080259. A 75-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 31Mar2021 (Lot Number: ER7812) as 1st dose, 0.3mL, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, Allergy to Pollen, house dust. The patient''s concomitant medications were not reported. The patient experienced arrest cardiac (Hospitalized) on 06Apr2021 with outcome as fatal, Dyspnoea, Arrhythmia (both Hospitalized) on 06Apr2021 with outcome of not recovered, flu symptoms on 04Apr2021 with outcome of not recovered. organ failure on unknown date with fatal outcome. Therapeutic measures were taken as a result of arrest cardiac, dyspnoea, arrhythmia and flu symptoms. The patient died on 03May2021. Cause of death was Pre-existing disease, Organ failure and Arrest cardiac. An autopsy was not performed. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? Pollen, house dust. Information on risk factors or previous illnesses COPD / Moderate cold-like symptoms. On 6Apr2021 an attack of severe shortness of breath ending in unconsciousness and cardiac arrest. Resuscitation, treatment in hospital. On 29Apr2021 reorientation of treatment to purely palliative measures due to onset of organ failure (kidney, intestine). Death on 3May2021. The main reason for this course is very probably the severe previous illness (COPD, see below). Due to the proximity in time, a side effect of the vaccination should at least be considered as an aggravating factor. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pre-existing disease; Organ failure; Arrest cardiac


VAERS ID: 1414888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung function abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699331

Write-up: The victim died of a blood clot.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021092103, Safety Report Unique Identifier DE-PEI-202100085614. A 62-year-old male patient received second dose of BNT162B2 (COMIRNATY, lot number: EP9598) on 02Mar2021 at single dose for COVID-19 immunisation. Medical history included ongoing Lung function abnormal. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY) on 09Feb2021 for Covid-19 immunisation. The patient experienced blood clot on unspecified date. The patient died of blood clot on 09Apr2021. No autopsy was done. Senders comments: Information on risk factors or previous illnesses. The person concerned was mentally ill and lived in an institution. He had pulmonary dysfunction. I do not understand why an unproven vaccine is given to people with such pre-existing conditions. The GP who recommended the vaccine has no comment on the case / The person collapsed in the street and was resuscitated and died of a blood clot in the lung or heart in hospital. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Clot blood


VAERS ID: 1414889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699273

Write-up: Died 14 days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. Regulatory Authority-WEB DE-PEI-CADR2021094200, Safety Report Unique Identifier DE-PEI-202100088346. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died 14 days after vaccination on 19May2021. An autopsy was not performed. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? no. Information on risk factors or previous illnesses none known / after 1 day feeling unwell, after 4 days admission to hospital, after 7 days in intensive care unit with artificial respiration, dead after 14 days. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulseless electrical activity, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699308

Write-up: The patient died unexpectedly suddenly on 23May2021 with electromechanical decoupling.; The patient died unexpectedly suddenly on 23May2021 with electromechanical decoupling.; This is a spontaneous report downloaded from the Regulatory Authority-WEB DCGMA number DE-PEI-CADR2021094229, Safety Report Unique Identifier DE-PEI-202100087916. A non-contactable consumer reported that a 77-year-old female patient received second dose of bnt162b2 (COMIRNATY, Lot Number: 1C007), via an unspecified route of administration on 21May2021 at 0.3ml single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient died unexpectedly suddenly on 23may2021 with electromechanical decoupling. A connection to the vaccination cannot be ruled out with certainty on 23May2021. The outcome of events was fatal. The patient died on 23May2021. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? not clear Information on risk factors or previous illnesses unclear / unclear Event assessment: Comirnaty/event/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: The patient died unexpectedly suddenly on 23May2021 with electromechanical decoupling.; The patient died unexpectedly suddenly on 23May2021 with electromechanical decoupling.


VAERS ID: 1414891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aneurysm of aorta (infrarenal aortic aneurysm)
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary sclerosis; Renal artery stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699271

Write-up: Cause of death: Bleeding to death due to ruptured aortic aneurysm; This is a spontaneous report from a non-contactable consumer downloaded from the WEB [DE-PEI-CADR2021096725], Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100089413. A 70-year-old female patient received BNT162B2 (COMIRNATY, strength: 0.3 ml) at single dose on 01Apr2021 for COVID-19 immunisation. Medical history included ongoing aneurysm of aorta; exit stenosis of the renal arteries; coronary sclerosis. Concomitant medication was not reported. The patient experienced aortic aneurysm rupture, described as cause of death: bleeding to death due to ruptured aortic aneurysm. This report was serious - death, died on 17Apr2021. The outcome of event was fatal. Sender Comment: Information on risk factors or previous illnesses previously known: infrarenal aortic aneurysm Exit stenosis of the renal arteries Coronary sclerosis/vaccination with Comirnaty on 01Apr2021. On 14Apr2021, uncomplicated surgery for colon carcinoma inconspicuous postoperative course. Occurrence of loss of appetite and slight nausea, slight increase in infection values, otherwise symptom-free. Found dead in bed in the hospital room on 17Apr2021. Relatedness of drug to reaction(s)/event(s) Source of assessment Regulatory Authority Result of Assessment C. Inconsistent causal association to immunization No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Bleeding to death due to ruptured aortic aneurysm


VAERS ID: 1414892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699301

Write-up: Cause of death: unclear, compatible with apoplexy;smallest calf vein thrombosis;death in temporal connection with vaccination; Cause of death: unclear, compatible with apoplexy;smallest calf vein thrombosis;death in temporal connection with vaccination; This is a spontaneous report from a non-contactable consumer, received from regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021096744, Safety Report Unique Identifier is DE-PEI-202100089430. An 83-year-old female patient (weight was 71 kg, height was 155 cm) received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown, strength: 0.3mL), via an unspecified route of administration on 06Apr2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced "cause of death: unclear, compatible with apoplexy; smallest calf vein thrombosis; death in temporal connection with vaccination" on an unspecified date. This report is serious - death. The patient was found dead in the flat on 16Apr2021; no complaints reported before; Findings compatible with apoplexy; in addition, smallest calf vein thrombosis of the left leg. The outcome was fatal for unknown cause of death, not recovered for thrombosis. The patient died on 16Apr2021. An autopsy was not performed. Relatedness of drug events for all events was unclassifiable. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery thrombosis, Decreased appetite, Malaise, Myocardial infarction, Thrombophlebitis superficial
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699304

Write-up: coronary thrombosis (Intraluminal coronary thrombosis); additional small lower leg vein thrombosis on the left (Superficial venous thrombosis of leg); ruptured myocardial infarction/Infarct myocardial; loss of appetite; malaise; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-CADR2021096761, Safety Report Unique Identifier DE-PEI-202100089435. A non-contactable consumer reported that a 76-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 18Apr2021 at 0.3ml single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient complained about malaise from on 25Apr2021, loss of appetite on unspecified date. The patient experienced also Infarct myocardial, Intraluminal coronary thrombosis, Superficial venous thrombosis of leg on unspecified date. Cause of death was reported as ruptured myocardial infarction due to coronary thrombosis; additional small lower leg vein thrombosis on the left. The patient was hospitalized for events coronary thrombosis (Intraluminal coronary thrombosis) and additional small lower leg vein thrombosis on the left (Superficial venous thrombosis of leg). The outcome of events malaise and loss of appetite was unknown and other events was fatal. The patient died on 28Apr2021. An autopsy was not performed. Death temporally related to a Covid-19 vaccination Sender Comment: Are you or the person concerned known of any allergies? If yes, which? unknown Information on risk factors or previous illnesses none known / on 18Apr2021 vaccination with Comirnaty Complained about malaise from around 25Apr2021, loss of appetite found dead in the apartment on 28Apr2021. Event assessment: Comirnaty/ all events/Regulatory Authority /Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: coronary thrombosis (Intraluminal coronary thrombosis); additional small lower leg vein thrombosis on the left (Superficial venous thrombosis of leg); ruptured myocardial infarction/Infarct myocardial


VAERS ID: 1414894 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Off label use, Product use issue, Vaccination site pain
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699346

Write-up: vaccination site pain; Death in temporal connection with vaccinationCause of death macroscopically unclear; Received VAXZEVRIA on 21Mar2021/ Received COMIRNATY on 05May2021; Received VAXZEVRIA on 21Mar2021/ Received COMIRNATY on 05May2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021097277, Safety Report Unique Identifier DE-PEI-202100089873. A 58-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3ml) at 58-year-old, dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported), at 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death in temporal connection with vaccination/cause of death macroscopically unclear on an unspecified date, vaccination site pain on an unspecified date. The patient was treated with Comirnaty (mRNA TOZINAMERAN), unknown dosage. The patient experienced also unknown cause of death. This report is serious - death. The patient died on 10May2021 with unknown cause. Outcome of vaccination site pain was recovered. Outcome of Received VAXZEVRIA on 21Mar2021/ Received COMIRNATY on 05May2021 was unknown. It was unknown if an autopsy was performed. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? unknown. Information on risk factors or previous illnesses no relevant previous illnesses known / no known previous illnesses had only pain at the vaccination site after vaccination, this had subsided quickly. Found dead on the toilet on 10May2021, no previous symptoms. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. batch/ lot number: unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dyspnoea, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; Open wound
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699340

Write-up: Unknown cause of death; Chest pain; Sweating attack; Dyspnoea/shortness of breath; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB number DE-PEI-CADR2021098041, Safety Report Unique Identifier DE-PEI-202100090990. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 11May2021 (Batch/Lot Number: EX8680) as 1st dose, 0.3 ml single for covid-19 immunisation. The patient medical history included open wound on the knee and cough. Concomitant medications were not reported. On 23May2021, the patient experienced dyspnoea/shortness of breath, sweating attack, chest pain. The patient experienced also unknown cause of death on an unspecified date. Information on risk factors or previous illnesses: open wound on the knee, cough / sudden shortness of breath with sweating, chest pain. Died after a short time. The patient was not recovered for dyspnoea/shortness of breath, sweating attack, and chest pain. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report is serious due to death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses open wound on the knee, cough / sudden shortness of breath with sweating, chest pain. died after a short time. Event assessment : Comirnaty/ all events/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Headache, Pelvic venous thrombosis, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699283

Write-up: Death in temporal connection with vaccination (time interval 14 days between vaccination and death); cause of death unclear; in autopsy calf vein thrombosis and pelvic vein thrombosis; Death in temporal connection with vaccination (time interval 14 days between vaccination and death); cause of death unclear; in autopsy calf vein thrombosis and pelvic vein thrombosis; Death in temporal connection with vaccination (time interval 14 days between vaccination and death); cause of death unclear; in autopsy calf vein thrombosis and pelvic vein thrombosis; small pulmonary artery thromboembolism in the periphery of the left upper lobe of the upper lobe of the lung; headaches; increased fatigue in the last weeks before death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB -CADR2021099489, Safety Report Unique Identifier -202100092630. A 73-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Medical history included chronic alcohol consumption. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death, pelvic venous thrombosis, thrombosis leg. Senders comments: Do you or the person concerned have any known allergies? If yes, which ones? unknown. Information on risk factors or previous illnesses Possible chronic alcohol consumption / complained of headaches two to three days after vaccination; increased fatigue in the last weeks before death; Cause of death could not be determined macroscopically by autopsy; striking findings: numerous calf vein thromboses; left pelvic vein thrombosis, small pulmonary artery thromboembolism in the periphery of the left upper lobe of the upper lobe of the lung. The patient''s outcome was fatal for unknown cause of death, not recovered/not resolved for pelvic venous thrombosis, not recovered/not resolved for thrombosis leg. Outcome of Pulmonary thromboembolism was not resolved. Outcome of headache and fatigue was unknown. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Autopsy-determined Cause(s) of Death: numerous calf vein thromboses; left pelvic vein thrombosis; small pulmonary artery thromboembolism in the periphery of the left upper lobe of the upper lobe of the lung


VAERS ID: 1414897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Myocardial infarction, Pneumothorax, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699333

Write-up: Lung embolism; Heart attack; coughed up blood; Severe shortness of breath; lung collapsed; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, Regulatory Authority-WEB number DE-PEI-CADR2021100086, Safety Report Unique Identifier DE-PEI-202100093408. A 59-year-old male patient received bnt162b2 (COMIRNATY) (strength: 0.3 ml), dose 2 via an unspecified route of administration on 26May2021 (Batch/Lot Number: 1D012A) as 2nd dose, 0.3 ml single for covid-19 immunisation. The patient was received the first does of bnt162b2 dose 1 (batch unknown, 0.3 ml) on an unknown date. Medical history included lung cancer. No known allergies. The patient''s concomitant medications were not reported. On 02Jun2021, the patient experienced lung embolism, heart attack and coughed up blood. Severe shortness of breath after the 2nd vaccination (2021), then to the doctor with a referral hospital, suspected embolism. This confirmed a heart attack is the ''''healthy'''' half of the lung collapsed (2021). Died 2 days later. This report is serious due to hospitalization. The patient died on 06Jun2021 due to lung embolism. The patient was not recovered for other events. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses: Lung cancer / severe shortness of breath after the 2nd vaccination, then to the doctor with a referral Hospital, suspected embolism. This confirmed a heart attack is the '''' healthy '''' half of the lung collapsed. Died 2 days later. Event assessment : Comirnaty/ all events /Result of Assessment : D. Unclassifiable Batch/lot number 1D012A No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1414898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-05-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699153

Write-up: Death; Shortly after vaccination bright spots in right eye and headache.; Shortly after vaccination bright spots in right eye and headache; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021100704. An 80-year-old male patient received the second dose of bnt162b2 (COMIRNATY: strength: 0.3 ml) via an unspecified route of administration on 25Apr2021 (Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included the first dose of bnt162b2 (COMIRNATY) on an unknown date as single dose for covid-19 immunisation. The patient experienced shortly after vaccination bright spots in right eye and headache on 02May2021, death with unknown cause, 1 week after 2nd injection. The outcome of events Visual disturbance and headache was not recovered. The patient died on 02May2021. It was not reported if an autopsy was performed. Senders comments: No any known allergies; No details of risk factors or previous illnesses; Check-up with the doctor before the first vaccination: Everything perfect. Relatedness of drug to reaction(s)/event(s) for all events D. Unclassifiable. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1414899 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699293

Write-up: Suspected pulmonary embolism , Cardiovascular arrest; Suspected pulmonary embolism; This is a spontaneous report received from a non-contactable consumer, received from regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021101280, Safety report unique identifier DE-PEI-202100094988. A 79-year-old male patient (weight was 72 kg, height was 172 cm) received the second dose of BNT162B2 (COMIRNATY, Lot Number: EX7823), via an unspecified route of administration on 24May2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No known allergies information on risk factors or previous illnesses. The patient previously received the first dose of BNT162B2 (COMIRNATY, strength: 0.3 mL) on 14Apr2021 at single dose for COVID-19 immunisation. The patient experienced suspected pulmonary embolism, cardiovascular arrest (arrest cardiac) on 05Jun2021. The outcome of the event arrest cardiac was fatal; outcome of other event was unknown. The patient died on 05Jun2021. It was unknown if an autopsy was performed. The cause of death was arrest cardiac. This report is serious with criteria of death. Relatedness of drug to event arrest cardiac was unclassifiable and inconsistent causal association to immunization per (Source of assessment). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1414900 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-15
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 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: Dementia; Primary hyperthyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Underweight (BMI 18.4)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021699297

Write-up: death; This is a spontaneous report from a non-contactable physician, received from regulatory authority, downloaded from the Regulatory Authority -WEB. The regulatory authority report number is DE-PEI-CADR2021101558, DE-PEI-202100094828. A 84-year-old female patient (weight was 50 kg, height was 165 cm) received the first dose of BNT162B2 (COMIRNATY, Lot Number: EX3599), via an unspecified route of administration on 27Apr2021 (unknown age at time of vaccination) at 0.3ml single dose for COVID-19 immunization. Medical history included ongoing dementia, ongoing primary hyperthyroidism, underweight (BMI 18.4). There were no known allergies. The patient''s concomitant medications were not reported. This report is serious - death. On 15May2021 the patient experienced Unknown cause of death. The patient died on 15May2021. It was unknown if an autopsy was performed. Relatedness of drug to event for all events was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood pressure measurement, Body temperature, Chest X-ray, Concomitant disease aggravated, Heart rate, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Urinary sediment
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 12
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: SYMBICORT; ALENDRONIC ACID; NATECAL D; PREDNISONE; EUTIROX; TOUJEO; APIDRA; SEGURIL; HIDROFEROL; SEVREDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pneumonitis; Dyspnea; Hypothyroidism; Insulin-requiring type II diabetes mellitus; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:144/73; Test Name: temp; Result Unstructured Data: Test Result:38.7; Test Name: chest X-ray; Result Unstructured Data: Test Result:progression of chronic infiltrates, without...; Comments: condensation; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Comments: bpm; Test Name: O2 Saturation; Test Result: 92 %; Comments: (ventilation mask 24%); Test Name: Breathing frequency; Result Unstructured Data: Test Result:24; Comments: rpm; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Name: urinary sediment; Test Result: Negative
CDC Split Type: ESPFIZER INC2021699278

Write-up: Acute respiratory failure; Concomitant disease aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-901418. A 71-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in deltoid left on 06May2021 (Batch/Lot Number: EX8679) as 0.3 ml single for COVID-19 immunisation. Medical history included with no known allergies, diabetes mellitus type 2 on insulin treatment, chronic hypersensitivity pneumonitis in pulmonary fibrosis phase. Pulmonary hypertension. In treatment with systemic corticosteroid it was adjusted on Feb2021. In the last few months, dyspnea worsened, especially after eating. It fits morphic. Oxygen therapy. ECHO cardio Feb2020: preserved ejection fraction, no valvular disease. Hypothyroidism in replacement therapy. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT), ongoing morphine, morphine sulfate (SEVREDOL), alendronic acid, calcium carbonate/colecalciferol (NATECAL D), prednisone, levothyroxine sodium (EUTIROX), insulin glargine (TOUJEO), insulin glulisine (APIDRA), furosemide (SEGURIL), calcifediol (HIDROFEROL), all taken for an unspecified indication, from unknown date. The patient experienced acute respiratory failure and concomitant disease aggravated on 08May2021. The patient died on 20May2021 from above events. It was not reported if an autopsy was performed. Clinical course was reported as 8-day progressive clinical consultation (from about two days after the administration of the 1st dose of BNT162B2 vaccine). Increased dyspnea at rest, orthopnea, and increased edema in systemic lupus erythematosus. Not oliguria. No increased cough (usually morning cough) or changes in expectoration. No treatment changes. No dysthermic sensation. Blood pressure 144/73 Heart Rate: 120bpm Breathing frequency: 24rpm Temp: 38.7 C O2 Saturation: 92% (ventilation mask 24%). TCR, mesocardial systolic murmur. Fine bilateral crackles. Normal abdomen and neurological. Upon arrival at the emergency room and the patient was admitted, she was tachycardic and tachypeunic, with respiratory work, feverish and maintained tensions. Ejection fraction with bilateral crackles and EEII edema. Analytical with acute phase reactants and exacerbated global chronic respiratory failure. The chest X-ray shows the progression of chronic infiltrates, without condensation. TAR negative. Blood culture in progress. Negative urinary sediment. Antibiotic therapy was started with iv ceftriaxone and levofloxacin, iv methylprednisolone, and diuretic treatment (iv furosemide). Oral morphine treatment (continuous Morphine pain reliever) is maintained. IV cotrimoxazole is added to cover P. jiroveci. The patient is in an acceptable general condition and has supplemental d''O2 with an FiO2 of 45%. The SARS-CoV-2 PCR is negative. At 24 hours, the O2 supply with reservoir and the total dose of oral morphine are increased. The next day this is replaced by an intravenous infusion. 24 hours later, the patient presented a very poor general condition, with tachypnea of more than 40 rpm and tachycardia of 125 bpm. Faced with no response to the established treatment and clinical deterioration, reporter spoke with the husband and by mutual agreement all the treatment was withdrawn and a palliative sedation pump was put on. The death of the patient occurs on 20May2021 at 5.30 p.m. Diagnoses: Respiratory infection vs reaction to the COVID-19 vaccine. Acute global chronic respiratory failure. Hypersensitivity pneumonitis in the fibrosis phase. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Concomitant disease aggravated; Acute respiratory failure.


VAERS ID: 1415561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 128
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANTUS; METFORMIN; DEPAKINE [VALPROIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Covid-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021698719

Write-up: Death NOS/Death which occurred suddenly; COVID test positive/COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021069085. A 78-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular in left arm on 20Jan2021 (Lot Number: EJ6788) as single dose for COVID-19 immunisation. Medical history included diabetes, dementia and epilepsy. Concomitant medications included insulin glargine (LANTUS); metformin; valproic acid (DEPAKINE). The patient experienced death nos on 30May2021. Death which occurred suddenly on 30May2021: resident found dead on the ground in the morning. The patient underwent lab tests and procedures which included Covid-19 virus test: positive on 21Jan2021. The patient died on 30May2021. It was unknown if an autopsy was performed with unknown cause of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1415563 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, SARS-CoV-2 test, Sudden death, Ultrasound Doppler, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL; TAHOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Epilepsy; Phlebitis
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 2020; Test Name: doppler; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021698802

Write-up: sudden death unexplained; asthenia; vomiting; poor appetite; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. Regulatory authority number FR-AFSSAPS-2021070853. A 75-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscularly on 26May2021 (Batch/Lot Number: FC3558) as single dose for covid-19 immunisation. Medical history included epilepsy, phlebitis from Apr2013 (currently untreated (doppler in 2020 normal)), dyslipidaemia. Patient was living with her daughter. Patient had no history of COVID. Concomitant medications included lamotrigine (LAMICTAL) and atorvastatin calcium (TAHOR). On 28May2021, 48 hours after the vaccine, patient had asthenia and vomiting 2 episodes, poor appetite, the next day 2 had new episodes of vomiting. Improvement during the day of 30May2021. The patient experienced sudden death unexplained on 31May2021. During the night of 30May2021 to 31May2021, the patient got up to go to the toilet. Her daughter heard a noise and found her dead mother on the ground. No autopsy at the daughter''s request. Outcome of events asthenia, vomiting and poor appetite was not reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death unexplained


VAERS ID: 1415572 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-18
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acquired haemophilia, Activated partial thromboplastin time, Acute kidney injury, Arthralgia, Blood creatinine, Blood fibrinogen, Blood lactic acid, Cardio-respiratory arrest, Coagulation factor V level, Coagulation test, Coma, Computerised tomogram, Fall, General physical health deterioration, Haematoma, Haemoglobin, Haemophilia A with anti factor VIII, Platelet count, Prothrombin time, Rheumatoid arthritis, Shock haemorrhagic, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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 (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DUROGESIC; PREDNISONE; SPIRIVA; INDACATEROL; PENTASA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Crohn''s disease; Hip fracture (a left hip fracture requiring placement of a gamma nail); Legionellal pneumonia (Pulmonary legionellosis in 2011); Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: TCA; Result Unstructured Data: Test Result:an increased TCA ratio at 4 sec; Test Date: 20210523; Test Name: TCA; Result Unstructured Data: Test Result:220; Comments: (control at 31); Test Date: 20210521; Test Name: creatinine; Result Unstructured Data: Test Result:31 mg/l; Test Date: 20210523; Test Name: fibrynogen; Result Unstructured Data: Test Result:0.4; Test Date: 20210521; Test Name: lactic acid; Result Unstructured Data: Test Result:10 mmol/L; Test Date: 20210521; Test Name: factor V; Test Result: 73 %; Test Date: 20210521; Test Name: coagulation assessment; Result Unstructured Data: Test Result:found a factor VIII deficiency (undetectable); Comments: suggesting acquired hemophilia.; Test Date: 20210521; Test Name: rest of the CT scan; Result Unstructured Data: Test Result:especially on the abdominopelvic floor, found; Comments: no visceral lesions; Test Date: 20210521; Test Name: The thoraco-abdomino-pelvic scanner; Result Unstructured Data: Test Result:diffuse muscle hematomas; Comments: diffuse muscle hematomas, predominant in particular in the muscles of the right axillary region. There is no active contrast product visualized with injection, no thrombus, no bone injury, no traumatic bone injury. No visceral lesions. The coagulation assessment found a factor VIII deficiency (undetectable), suggesting acquired hemophilia; Test Date: 20210523; Test Name: The thoraco-abdomino-pelvic scanner; Result Unstructured Data: Test Result:an increase in the extension of the haematic infil; Comments: developed at the level of the right lateral and posterolateral wall; Test Date: 202105; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.3 g/dl; Comments: the previous figure; Test Date: 20210521; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.2 g/dl; Test Date: 20210522; Test Name: hemoglobin; Result Unstructured Data: Test Result:7 g/dl; Test Date: 20210522; Test Name: antifactor VIII; Test Result: 15 [iU]; Test Date: 20210521; Test Name: platelet count; Result Unstructured Data: Test Result:273000 /mm3; Test Date: 20210521; Test Name: PT; Test Result: 63 %; Test Date: 20210523; Test Name: PT; Test Result: 24 %
CDC Split Type: FRPFIZER INC2021698806

Write-up: onset of a coma without any sign of focusing; cardio-respiratory arrest; hemorrhagic shock; acute renal failure; Acquired haemophilia with anti FVIII, XI, or XIII; Vomiting; deterioration of the general condition; mechanical fall at home; diffuse hematomas/ diffuse muscle hematomas; suspecting an outbreak of rheumatoid arthritis; the increase in joint pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LL20213827. Safety Report Unique Identifier FR-AFSSAPS-2021070548. A 67-year-old male patient received bnt162b2 (COMIRNATY) as an intramuscular single dose on an unspecified date for COVID-19 immunisation. The patient''s medical history included rheumatoid arthritis, Crohn''s disease, a left hip fracture requiring placement of a gamma nail, pulmonary legionellosis in 2011 and obesity. Concomitant medications (home treatment) included fentanyl (DUROGESIC), prednisone, tiotropium BROMIDE (SPIRIVA), indacaterol and mesalazine (PENTASA). During the night of 18May2021 to 19May2021, the patient presented a mechanical fall at home. In the following, he noted the appearance of diffuse hematomas. There was no point of cranial impact, no malaise, no loss of consciousness. Afterwards he consulted his attending physician faced with the increase in joint pain, treatment with DUROGESIC was increased and corticosteroid therapy with PREDNISONE was initiated, suspecting an outbreak of rheumatoid arthritis. During the night of 21May2021 to 22May2021, he contacted the emergency medical service in front of a deterioration of the general condition and vomiting. He was brought to the Emergency Reception Service. A state of shock was diagnosed with a hemoglobin at 6.2 g/dl, hyperlactatemia at 10 mmol/l on gas measurement, and acute renal failure without threat, with creatinine at 31 mg/l. He was hospitalized from 22May2021 to 24May2021 for the management of hemorrhagic shock. The thoraco-abdomino-pelvic scanner found diffuse muscle hematomas, predominant in particular in the muscles of the right axillary region. There is no active bleeding visualized after injecting contrast product, no thrombus, no bone injury, no traumatic bone injury. The rest of the CT scan, especially on the abdominopelvic floor, found no visceral lesions. The coagulation assessment found a factor VIII deficiency (undetectable), suggesting acquired hemophilia. On the locomotor level, multiple hematomas were observed, particularly in the chest wall, without the right axillary region extending to the right thoracic. There was no sign of limb ischemia. The coagulation balance showed an increased TCA ratio at 4 sec, a PT at 63%, and a factor V at 73%, platelets at 273,000 / mm3. Overall at entry: hemorrhagic shock associated with acute renal failure, in the context of the discovery of acquired hemophilia type A, antifactor VIII at 15U on 22May2021. The patient received a transfusion of 2 packed red blood cells with a hemoglobin of 7 g/dl. During the night of 23May2021 to 24May2021, there was a sudden deterioration with the onset of a coma without any sign of focusing. The control hemoglobin regained a loss of 2 points compared to the previous figure of 6.3 g/dl after stopping. TCA at 220 (control at 31) TP at 24, fibrinogen at 0.4 Transfusion of packed red blood cells in vital emergency and NORADRENALINE. A thoraco-abdomino-pelvic scan found an increase in the extension of the haematic infiltration developed at the level of the right lateral and posterolateral wall. A maximalist management was performed with a new dose of FEIBA Transfusion of red blood cells and fresh frozen plasma The patient presented a new cardio-respiratory arrest, which was not recovered, provoking the death at 08:14 on 24May2021. In total: 67-year-old patient admitted for hemorrhagic shock in the context of the discovery of acquired anti-factor VIII hemophilia. Secondary degradation with multi-visceral failure syndrome linked to a probable re-bleeding, with no sign of active embolism reported or eligible for a surgical cost price. This patient had been vaccinated with Pfizer (dose and date unknown; recovering). NB: imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. The outcome of events Acquired haemophilia with anti FVIII, XI, or XIII, coma, Cardio-respiratory arrest was fatal, and outcome of other events was unknown. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: coma; cardio-respiratory arrest; Acquired haemophilia with anti FVIII, XI, or XIII


VAERS ID: 1415577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anosognosia, Blood creatinine, Blood pressure systolic, Cerebral haematoma, Dysarthria, Eye movement disorder, Haemostasis, Hemianaesthesia, Hemianopia, Hemiapraxia, Hypertension, Laboratory test, Lower respiratory tract congestion, Malaise, Mini mental status examination, Oxygen saturation, Oxygen saturation decreased, Platelet count, Scan brain
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Optic nerve disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: PANTOPRAZOLE; MACROGOL; THYROZOL; PLAVIX; BISOCE; PERINDOPRIL; HYDROCHLOROTHIAZIDE; PARACETAMOL; SERESTA; NEOMERCAZOLE; TAMSULOZIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal (non-anticoagulated); Cognitive disturbance (MMS (mini mental state) at 17/30 recently reassessed); Hypertension arterial; Hyperthyroidism (under NEOMERCAZOL); Normal pressure hydrocephalus
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: creatinine; Result Unstructured Data: Test Result:105 umol/l; Test Date: 20210519; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:240; Test Date: 202105; Test Name: haemostasis; Result Unstructured Data: Test Result:no haemostasis disorder; Test Date: 202105; Test Name: general biological assessment; Result Unstructured Data: Test Result:did not show any thrombocytopenia; Comments: no haemostasis disorder, serum creatinine 105umol / l, no biological inflammatory syndrome; Test Name: mini mental state (MMS); Result Unstructured Data: Test Result:17/30; Test Date: 20210519; Test Name: oxygen saturation; Result Unstructured Data: Test Result:89-90 %; Test Date: 202105; Test Name: thromocyte count; Result Unstructured Data: Test Result:does not show any thrombocytopenia; Test Date: 202105; Test Name: cerebral tomodensitometric examination; Result Unstructured Data: Test Result:revealed a right temporo-parietal lobar; Comments: intraparenchymal hematoma with ventricular flooding, temporal and falcorial engagement.
CDC Split Type: FRPFIZER INC2021697571

Write-up: left hemiplegia; a rise in systolic blood pressure of 240, proportional/intracerebral hematoma of hypertension; anosognosia; heminegligence; hemianopia; deviation of the eyes to the right; left anesthesia; dysarthria; bronchial congestion with 89-90% saturation; bronchial congestion with 89-90% saturation; malaise; Hematoma cerebral/intracerebral hematoma/large right hemispherical hematoma, essentially deep with ventricular flooding on pressure surge; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-TO20214472. Safety Report Unique Identifier FR-AFSSAPS-2021069831. A 90-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13May2021 (Batch/Lot Number: FA5831) as 2nd dose, single for covid-19 immunisation; Medical history included hyperthyroidism (under neomercazol), normal pressure hydrocephalus, cognitive disturbance (MMS (mini mental state) at 17/30 recently reassessed), hypertension arterial, atrial fibrillation paroxysmal (non-anticoagulated). Concomitant medications included pantoprazole (strength: 20 mg); macrogol; thiamazole (THYROZOL, strength: 5 mg); clopidogrel bisulfate (PLAVIX, strength: 75 mg); bisoprolol fumarate (BISOCE, strength: 1.25 mg); perindopril; hydrochlorothiazide (strength: 1.25mg); paracetamol (strength: 1g); oxazepam (SERESTA, strength: 10 mg); carbimazole (NEOMERCAZOLE), tamsulosin hydrochloride (TAMSULOZIN, strength: 0.5 mg). Clinical course: on 19May2021 at 6:45 am, the patient presented with malaise. At 7.15 am, a sudden left hemiplegia was noted with a rise in systolic blood pressure of 240, proportional, anosognosia, heminegligence, hemianopia, deviation of the eyes to the right, left anesthesia and dysarthria, it was a total right sylvian syndrome. bronchial congestion with 89-90% saturation. the cerebral tomodensitometric examination revealed a right temporo-parietal lobar intraparenchymal hematoma with ventricular flooding, temporal and falcorial engagement. The general biological assessment did not show any thrombocytopenia, no haemostasis disorder, serum creatinine 105umol / l, no biological inflammatory syndrome. PCR covid showed negative control of hypertension by loxen pse, furosemide, use of analgesics. worsening of the repercussions of this hematoma, taking into account the age and the evolution, implementation of palliative care, allowing the death of the patient on 25May2021 at 14:00. In total: large right hemispherical hematoma, essentially deep with ventricular flooding on pressure surge, in an elderly patient with cognitive impairment. It is above all an intracerebral hematoma of hypertension. Evolution: death. An autopsy was not performed. The outcome of events was fatal. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: intracerebral hematoma/large right hemispherical hematoma, essentially deep with ventricular flooding on pressure surge


VAERS ID: 1416139 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: undergone several tests; Result Unstructured Data: Test Result:did not know if there was a condition diagnosed
CDC Split Type: GRPFIZER INC2021735757

Write-up: anaphylactic shock; This is a spontaneous report from a non-contactable consumer (website) and contactable physician directly and through a Pfizer sales representative. This is the 1st report out of 2 for the same patient, reporting different events with the same vaccine. This is about the second vaccine dose. A 56-year-old female patient received BNT162B2 (COMIRNATY, Lot unknown, second dose) solution for injection intramuscular on 18Jun2021 (at the age of 56-years-old) as a single dose for COVID-19 vaccination. Medical history included unknown underlying condition (it was not clear). She had lost a child in a car accident and since than she had undergone several tests, but the physician did not know if there was a condition diagnosed. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, first dose) for COVID-19 vaccination in May2021 and experienced felt something like a burning and recovered. When the patient received the second dose of the vaccine, she had a port ready as a precaution. She most probably experienced an anaphylactic shock on 18Jun2021, deteriorated very quickly, despite the efforts of the physicians to revive her, she was intubated by a certified physician, but she did not respond at all and died on 18Jun2021. She was given adrenaline and all support that was possible and even more, in a hospital (admitted). The reporting physician has not received the official autopsy results yet. As far as the physician knew, it was not a pulmonary embolism and anaphylaxis was not verified yet. She was transferred to the hospital for autopsy. The outcome of the event anaphylactic shock was fatal. Information on lot number/batch number has been requested.; Sender''s Comments: Linked Report(s) : GR-PFIZER INC-2021743128 same patient/drug, different dose/event; Reported Cause(s) of Death: anaphylactic shock


VAERS ID: 1416158 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-13
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastric ulcer haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLATOR; VEROSPIRON; ASPIRIN PROTECT; CONCOR; DIAPREL; PERINDOPRIL ARGININE; METFOGAMMA
Current Illness: Diabetes mellitus; Dyspnoea on effort; Ischaemic cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Gastric ulcer haemorrhage; This regulatory authority case was reported by a physician and describes the occurrence of GASTRIC ULCER HAEMORRHAGE in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001940 and 3001650) for COVID-19 vaccination. Concurrent medical conditions included Dyspnoea on effort, Ischaemic cardiomyopathy and Diabetes mellitus. Concomitant products included AMLODIPINE BESILATE, ATORVASTATIN L-LYSINE (AMLATOR), SPIRONOLACTONE (VEROSPIRON), ACETYLSALICYLIC ACID (ASPIRIN PROTECT), BISOPROLOL FUMARATE (CONCOR), GLICLAZIDE (DIAPREL), PERINDOPRIL ARGININE and METFORMIN HYDROCHLORIDE (METFOGAMMA) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 04-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 13-May-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (seriousness criteria death and medically significant). The patient died on 24-May-2021. The reported cause of death was Gastric ulcer haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not provided. Gastric ulcer haemorrhage is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 9 days. Taking into account the presence of a gastric ulcer before the vaccination, and the runoff of the disease, causality between gastric ulcer haemorrhage and vaccination is unlikely. The case is serious because the patient died. No further information is expected.; Sender''s Comments: Gastric ulcer haemorrhage is not expected adverse event of COVID-19 VACCINE MODERNA. Time to onset was 9 days. Taking into account the presence of a gastric ulcer before the vaccination, and the runoff of the disease, causality between gastric ulcer haemorrhage and vaccination is unlikely. The case is serious because the patient died. No further information is expected.; Reported Cause(s) of Death: Gastric ulcer haemorrhage


VAERS ID: 1416159 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram abdomen, Decreased appetite, Metastases to liver, Neoplasm malignant, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cachexia; Malignant breast neoplasm; Mastectomy; Metastases to bone
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: Abdomen CT; Result Unstructured Data: Test Result:extensive lesions; Comments: extensive space-occupying lesions in the head of pancreas and in the liver; Test Date: 20210514; Test Name: weight; Result Unstructured Data: Test Result:loss (16 kgs)
CDC Split Type: HUPFIZER INC2021698655

Write-up: death/extensive cancer; weakness; loss of appetite; weight loss (16 kgs); suspicion of liver metastasis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number HU-OGYI-385321. A 68-year-old female patient received bnt162b2 (COMIRNATY, 30 micrograms of COVID-19 mRNA Vaccine, COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran), via intramuscular, administered in left arm on 02May2021 (Batch/Lot Number: ET3620) as 2nd dose, 0.3 mL, single for covid-19 immunisation. Medical history included malignant neoplasm of breast, cachexia, mastectomy in 2001, metastasis to bone since Feb2020 and atrial fibrillation. The patient received tamoxifen therapy for 5 years. Concomitant medication was not reported. The patient previous took the first dose of Comirnaty on 28Mar2021 (batch number: unknown) for COVID-19 immunisation. On 14May2021, the patient was admitted to the hospital due to weakness, loss of appetite, weight loss (16 kgs) and suspicion of liver metastasis. On 18May2021, abdominal CT was performed, extensive space-occupying lesions were seen in the head of the pancreas and in the liver. Further examinations could not be performed due to the patient''s deteriorating condition. The patient died on 26May2021 due to extensive cancer. There is no information whether autopsy was done. No further information is expected. The outcome of event death/extensive cancer was fatal and of other events was unknown. Sender Comment: The patient died 24 days after Comirnaty vaccination due to metastatic breast cancer. There is no information whether autopsy was done. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: extensive cancer


VAERS ID: 1416160 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOCARD; ASACTAL; IRBESARTAN; MILURIT; MEZITAN; LECALPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Cardiac insufficiency; Dementia; Emphysema; Hypertension; Ischemic heart disease; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Patient was Covid 19 Negative.
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: DEATH; This regulatory authority case was reported by a physician and describes the occurrence of DEATH in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis, Cardiac insufficiency, Dementia, Hypertension, Emphysema, Ischemic heart disease and Pulmonary embolism. Concomitant products included BISOPROLOL FUMARATE (BISOCARD), ACETYLSALICYLIC ACID (ASACTAL), IRBESARTAN, ALLOPURINOL (MILURIT), TRIMETAZIDINE HYDROCHLORIDE (MEZITAN) and LERCANIDIPINE HYDROCHLORIDE (LECALPIN) for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 16-May-2021 The patient died on 16-May-2021. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, SARS-CoV-2 test: unknown (Negative) Patient was Covid 19 Negative.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be unlikely related. Treatment information was not provided. This case concerns an 89-year-old female reported as hospitalization with a serious unexpected event of death associated with the patient''s primary diseases. Event latency 26 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender''s Comments: This case concerns an 89-year-old female reported as hospitalization with a serious unexpected event of death associated with the patient''s primary diseases. Event latency 26 days after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information is not expected.


VAERS ID: 1416161 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Alzheimer''s disease; Anxiety; Asthma bronchial; Atherosclerosis; Bedridden; Congestive heart failure; Dementia; GERD; Hypertension; Sleep disorder; Suicide attempt; Vascular encephalopathy (EXAMINATION); Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021698657

Write-up: cause of death, heart failure; appetite worsened; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-394421. This spontaneous, serious case was reported on 27May2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. A 79-years-old (also reported as 80 years) female patient received BNT162B2 (COMIRNATY, Solution for injection, concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles)), dose 1 intramuscular on 19Apr2021 (also reported as 19Feb2021) (Batch/Lot Number: Unknown) as 1st dose, 0.3 ml single for covid-19 immunisation. Medical history included Alzheimer''s disease, bronchial asthma, atherosclerosis, congestive heart failure, GERD and hypertension, Dementia, all from an unknown date and unknown if ongoing. The patient was already under ongoing hospital care since 18Aug2020 (reported as 18Aug2021) after a suicide attempt on 04Aug2020. The patient was mostly bedridden, weak, required complete care, and suffered from sleeping problems and anxiety. Examinations showed vascular encephalopathy. The patient received therapy and her condition started to get better. Concomitant drugs were not reported. In Apr2021, patient appetite worsened and required parenteral feeding. On 04May2021 the patient passed away. According to the autopsy report, the patient''s primary diseases contributed to the direct cause of death, heart failure (death, hospitalization). The outcome of heart failure was fatal, of appetite worsened was unknown. Further information is not expected. Sender Comment: As the reporter physician assessed the adverse event as related to the patient''s primary diseases, the causal relationship is unlikely between the suspected drug and the event of death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: heart failure; Autopsy-determined Cause(s) of Death: heart failure


VAERS ID: 1416162 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-29
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain contusion, Brain oedema, COVID-19, Computerised tomogram head, Confusional state, Craniocerebral injury, Drug ineffective, Epistaxis, Fall, SARS-CoV-2 test, Subarachnoid haemorrhage
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; COPD (Chronic Obstructive Pulmonary Disease); COVID-19; Haemorrhage subarachnoid; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: Head CT; Result Unstructured Data: Test Result:subarachnoid hemorrhage and cerebral contusion; Comments: subarachnoid hemorrhage and cerebral contusion; Test Date: 20210429; Test Name: Head CT; Result Unstructured Data: Test Result:progressing perifocal edema,; Comments: progressing perifocal edema; Test Date: 20210429; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021698662

Write-up: fall; intracranial injuries; Covid-19 PCR (Polymerase chain reaction) test was also positive/COVID-19; Covid-19 PCR (Polymerase chain reaction) test was also positive/COVID-19; The patient was hospitalized on 29/04/2021 because of nose bleeding and mild confusion.; The patient was hospitalized on 29/04/2021 because of nose bleeding and mild confusion.; subarachnoid hemorrhage and cerebral contusion; subarachnoid hemorrhage and cerebral contusion; progressing perifocal edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-394621. This serious case was reported on 27May2021 by a physician concerned the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. A 76-years-old female patient received BNT162B2 (COMIRNATY, concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles)), dose 1 intramuscular on 14Apr2021 (Batch/Lot Number: Unknown) as 1st dose, 0.3ml single for covid-19 immunisation. Medical history included hypertension, osteoporosis, COPD (chronic obstructive pulmonary disease), Haemorrhage subarachnoid and allergy to antibiotics, COVID-19, all from an unknown date and unknown if ongoing. Concomitant drugs were not reported. The patient was hospitalized on 29Apr2021 because of nose bleeding and mild confusion. Her daughter found the patient in her home after a possible fall. Head CT (Computerised tomogram) showed subarachnoid hemorrhage and cerebral contusion. Covid-19 PCR (Polymerase chain reaction) test was also positive/ COVID-19. Control head CT (comupterised tomogram) showed progressing perifocal edema, but surgery was not performed because improvement was not expectable. The patient''s condition continuously deteriorated but based on the patient''s age, primary diseases and intracranial injuries, intensive therapy was not started. The patient passed away on 06May2021 at 7:43. Further information is not expected. The patient died on 06May2021. The outcome of fall and intracranial injuries, COVID-19 was fatal (as reported), of other events was unknown. It was not reported if an autopsy was performed. Sender Comment: Although the patient''s Covid-19 PCR (polymerase chain reaction) test was positive, her death is associated with the intracranial injuries she suffered after a possible fall. Based on above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: intracranial injuries; fall; Covid-19 PCR (Polymerase chain reaction) test was also positive/COVID-19; Covid-19 PCR (Polymerase chain reaction) test was also positive/COVID-19


VAERS ID: 1416163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-25
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Acute myocardial infarction, Anaemia, Chest X-ray, Circulatory collapse, Echocardiogram, Electrocardiogram, Laboratory test, Pneumonia, Renal failure, Respiratory arrest
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; COPD; Diabetes mellitus; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:increased bronchovascular pattern; Test Name: Echocardiography; Result Unstructured Data: Test Result:Dilated left ventricule, akinesis of inferior wall; Comments: Dilated left ventricule, akinesis of inferior wall and hypokinesis of inferolateral segment were seen; Test Date: 20210522; Test Name: ECG; Result Unstructured Data: Test Result:subacute inferior STEMI; Test Name: Laboratory test; Result Unstructured Data: Test Result:Inflammatory parameters, impaired renal function,; Comments: Inflammatory parameters, impaired renal function, anaemia and acidosis were seen
CDC Split Type: HUPFIZER INC2021698661

Write-up: Inferior STEMI/increasing dyspnoea and recurrent chest pain; renal failure/impaired renal function; anaemia and acidosis; anaemia and acidosis; bronchopneumonia; circulatory arrest; respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB Regulatory Authority with Regulatory Authority number: HU-OGYI-395021. On 14May2021, the 64-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FA5829), intramuscular at left arm as 0.3 ml single dose for COVID-19 immunisation. Medical history included severe obesity, diabetes mellitus, chronic renal insufficiency, COPD (Chronic obstructive pulmonary disease) and hypertension. Concomitant medication was not reported. On 22May2021, the patient was admitted to the hospital due to increasing dyspnoea and recurrent chest pain started one week before. ECG and biomarkers showed subacute inferior STEMI on 22May2021. Inflammatory parameters, impaired renal function, anaemia and acidosis were seen in laboratory results on unknown date. Chest X-ray showed increased bronchovascular pattern on unknown date. Dilated left ventricule, akinesis of inferior wall and hypokinesis of inferolateral segment were seen during echocardiography on unknown date. Mixed murmur and spasticity was heard with a hypotonic tendency above the lung. A bladder catheter was placed to follow the diuresis, circulatory support was started with dobutamine, diuretics, antibiotics, and bronchodilators were given. Hemodialysis was initiated due to progressive renal failure. On 25May2021, circulatory and then respiratory arrest developed, complete resuscitation was unsuccessful, and the patient died at 21:30. There is no information whether autopsy was done. Sender Comment: The patient died after vaccination with Comirnaty. Inferior STEMI, renal failure, and bronchopneumonia on unknown date may both have played a role in the patient''s death. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Inferior STEMI/increasing dyspnoea and recurrent chest pain; renal failure/impaired renal function; bronchopneumonia; circulatory arrest; respiratory arrest; anaemia and acidosis; anaemia and acidosis


VAERS ID: 1416164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Blood glucose, Blood glucose fluctuation, Blood iron, Blood test, Cardiac failure, Confusional state, Eye movement disorder, General physical health deterioration, Malaise, Pericardial effusion, Pleural effusion, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVEMIR; FUROSEMIDE; WARFARIN; MARIXINO; DESUNIN; ATORVASTATIN; PANTOPRAZOLE; NOVORAPID; FRUMIL; CARDURA; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder NOS; Dementia; Diabetic (on insulin since 1982); Fluid retention; Renal disease
Allergies:
Diagnostic Lab Data: Test Name: GLUCOSE; Result Unstructured Data: Test Result:glucose levels were fluctuating; Comments: glucose levels were fluctuating and difficult to control; Test Date: 20210406; Test Name: iron; Result Unstructured Data: Test Result:low; Test Name: blood test; Result Unstructured Data: Test Result:The patient''s GP was contacted and his blood test; Comments: The patient''s GP was contacted and his blood test results from 06Apr2021 were reviewed again. It was noted that the patient''s kidney function had declined since his previous blood tests (date unspecified).; Test Date: 20210406; Test Name: blood test; Result Unstructured Data: Test Result:No issues identified other than being low in iron
CDC Split Type: IEPFIZER INC2021698861

Write-up: SPEECH GONE; EYES ROLLING; heart and kidneys were failing; heart and kidneys were failing; FLUID AROUND HEART AND LUNGS; FLUID AROUND HEART AND LUNGS; VERY UNWELL; physical health had declined; CONFUSED AND HE DID NOT RECOGNISE WHERE THEY WERE; weak; GLUCOSE LEVELS WERE FLUCTUATING AND DIFFICULT TO CONTROL; This is a spontaneous report from a contactable consumer (patient''s relative) downloaded from the Regulatory Authority. This is first of two reports. An 83-year-old male patient received second dose of BNT162B2 (COMIRNATY) Lot number EW2243, on 07Apr2021 at single dose for COVID-19 immunisation. Medical history included Diabetic (on insulin since 1982), Renal disease, cardiac disorder, fluid retention, blood pressure abnormal and dementia. The patient''s concomitant medication included insulin detemir (LEVEMIR) for diabetes, furosemide for Fluid retention, warfarin, memantine hydrochloride (MARIXINO) for Dementia, colecalciferol (DESUNIN), atorvastatin, pantoprazole to protect stomach, insulin aspart (NOVORAPID) for diabetes, amiloride hydrochloride, furosemide (FRUMIL) for Fluid retention, doxazosin mesylate (CARDURA) for blood pressure, and insulin from 1982 for diabetes. The patient previously received first dose of BNT162B2 (COMIRNATY) Batch/lot number: EP9605 on 10Mar2021 and experienced Iron low, General physical health deterioration, Function kidney decreased, Discomfort, INR increased, Weakness, Breathing difficult, Tiredness, Pulmonary effusion, Activities of daily living impaired. On 07Apr2021, the patient was vaccinated with his second dose of Comirnaty (batch number: EW2243). It was noted that the patient''s blood test results were reviewed prior to the second dose administration (06Apr2021) and they could not identify any issues other than low iron. Following administration of the second dose, the patient was very weak and went to bed. It was reported that the patient''s glucose levels were fluctuating and difficult to control. On 08Apr2021, the patient was very confused and he did not recognize where he was. Although at home, the patient thought he was in a nursing home. The patient''s physical health had declined and the patient could no longer get out of bed to use the bathroom. The patient''s GP was contacted and his blood test results from 06Apr2021 were reviewed again. It was noted that the patient''s kidney function had declined since his previous blood tests (date unspecified). The patient''s GP advised to transfer the patient to hospital. On 09Apr2021, the patient was unwell. The patient''s health nurse was contacted, who advised to transfer the patient to hospital. Following his admittance, it was noted that the patient had fluid around his heart and lungs. On 11Apr2021, the patient eyes were rolling and his speech was gone. The hospital Doctors advised that the patient''s heart and kidneys were failing. On 13Apr2021, the patient passed away. The reporter stated that until Mar2021 before he had received the vaccine, although the patient was frail and would spend a few hours in bed, he would be able to move about independently, attending his doctor''s appointments and visit family. The patient''s health issues were under control with his medication. Prior to vaccination, the patient had also never experienced any issues with his breathing. The reporter indicated that the patient''s health declined faster following vaccination than it should have. The reporter felt that the first dose caused some additional fluid retention and breathing problems and the second dose exacerbated his kidney and heart failure. The outcome of all events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: FLUID AROUND HEART AND LUNGS; FLUID AROUND HEART AND LUNGS; VERY UNWELL; weak; GLUCOSE LEVELS WERE FLUCTUATING AND DIFFICULT TO CONTROL; physical health had declined; CONFUSED AND HE DID NOT RECOGNISE WHERE THEY WERE; SPEECH GONE; heart and kidneys w


VAERS ID: 1416166 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood iron, Blood iron decreased, Blood test, Discomfort, Dyspnoea, Fatigue, General physical health deterioration, International normalised ratio, International normalised ratio increased, Loss of personal independence in daily activities, Pleural effusion, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEMIR; FUROSEMIDE; WARFARIN; MARIXINO; DESUNIN; ATORVASTATIN; PANTOPRAZOLE; NOVORAPID; FRUMIL; CARDURA; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Cardiac disorder NOS; Dementia; Diabetic (on insulin since 1982); Fluid retention; Prophylaxis against gastrointestinal ulcer; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: iron; Result Unstructured Data: Test Result:low; Test Date: 20210406; Test Name: Blood test; Result Unstructured Data: Test Result:No issues identified other than being low in iron; Comments: No issues identified other than being low in iron; Test Date: 20210406; Test Name: Blood test; Result Unstructured Data: Test Result:the patient''s kidney function had declined since h; Comments: the patient''s kidney function had declined since his previous blood tests (date unspecified).; Test Date: 2021; Test Name: INR; Result Unstructured Data: Test Result:noted to be higher than normal
CDC Split Type: IEPFIZER INC2021708337

Write-up: low iron; health had declined; kidney function had declined; INR levels /noted to be higher than normal; Very weak; Breathing problems/difficulty breathing; Tired; May have extra fluid around lungs; Difficulty coming down stairs; uncomfortable lying down; This is a spontaneous report from a contactable consumer (patient''s relative). This is the second of two reports. The first report is a report downloaded from the Regulatory Authority. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EP9605) as 1st dose, single at the age of 83-year-old for covid-19 immunisation. The patient''s medical history included Diabetic (on insulin since 1982), renal disease, cardiac disorder NOS, fluid retention, and dementia. Concomitant medications included insulin detemir (LEVEMIR) taken for diabetes; furosemide taken for fluid retention; warfarin; memantine hydrochloride (MARIXINO) taken for dementia, start and stop date were not reported; colecalciferol (DESUNIN); atorvastatin; pantoprazole taken to protect stomach; insulin aspart (NOVORAPID) taken for diabetes; amiloride hydrochloride, furosemide (FRUMIL) taken for fluid retention; doxazosin mesilate (CARDURA) taken for blood pressure; insulin taken for diabetes from 1982 to an unspecified stop date. On 10Mar2021, the patient was vaccinated with his first dose of bnt162b2. On 10Mar2021, following his first dose, the patient experienced tiredness. 17Mar2021, one week after his first dose, the patient experienced breathing difficulties. The reporter outlined that despite the patient''s medical history, he had never experienced any breathing issues before. An out-of-hours doctor was called to attend the patient and the doctor advised that he could not see anything seriously wrong. In the following days (Mar2021), the patient''s breathing difficulties continued to progress and the patient had difficulty coming down the stairs and was uncomfortable lying down. The patient attended his GP who advised that the patient may had extra fluid around his lungs and prescribed spironolactone (ALDACTONE). The week prior to the second dose (2021), the patient''s INR levels were checked and were noted to be higher than normal. The reporter outlined that the patient''s INR levels had always been steady and under control with his warfarin. On 06Apr2021, the patient''s blood tests were performed. The second dose administration on 07Apr2021 was also queried. The patient was very weak and his health had declined, which he was using a wheelchair to attend his appointment. On 07Apr2021, the patient was vaccinated with his second dose of bnt162b2 (batch number: EW2243). It was noted that the patient''s blood test results were reviewed prior to the second dose administration and they could not identify any issues other than low iron. The patient''s GP was contacted and his blood test results from 06Apr2021 were reviewed again. It was noted that the patient''s kidney function had declined since his previous blood tests (date unspecified). On 13Apr2021, the patient passed away. The reporter stated that until Mar2021 before he had received the vaccine, although the patient was frail and would spend a few hours in bed, he would be able to move about independently, attending his doctor''s appointments and visit family. The patient''s health issues were under control with his medication. Prior to vaccination, the patient had also never experienced any issues with his breathing. The reporter indicated that the patient''s health declined faster following vaccination than it should have. The reporter felt that the first dose caused some additional fluid retention and breathing problems. Therapeutic measures were taken as a result of may have extra fluid around lungs. The seriousness reported as death. The patient died on 13Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: uncomfortable lying down; INR levels /noted to be higher than normal; very weak; breathing problems/difficulty breathing; tired; may have extra fluid around lungs; difficulty coming down stairs; low iron; health had declined; kidney function had decl


VAERS ID: 1416210 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021699037

Write-up: headache; cardiac arrest; Additional information on drug Comirnaty : Overdose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number IT-MINISAL02-740826. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30May2021 (Lot Number: FC1131) at 53-year-old as 1st dose 0.3 mL, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Additional information on drug Comirnaty: Overdose. The patient also experienced post-vaccine headache and took Moment. The patient experienced cardiac arrest on 06Jun2021. The patient died on 06Jun2021. Reporter comment: Sudden death in a patient without history. Sender Comment: The outcome of the autopsy is awaited. It should be noted that the GP (general practitioner) knew from the patient''s father that for the post-vaccine headache, he took Moment.; Reporter''s Comments: Sudden death in a patient without history; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1416213 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, Bronchoalveolar lavage, C-reactive protein, Cardiac arrest, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Tachycardia, Transaminases, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Blood fibrinogen; Result Unstructured Data: Test Result:decreased; Test Name: Bronchoalveolar Lavage; Result Unstructured Data: Test Result:negative for Covid; Test Name: abdomen CT; Result Unstructured Data: Test Result:unknown results; Test Name: brain CT; Result Unstructured Data: Test Result:diffuse edema, thin, subtly hyperdense striae at t; Comments: diffuse edema, thin, subtly hyperdense striae at the level of the fissures and subarachnoid spaces; Test Name: CT chest; Result Unstructured Data: Test Result:apico-basal pleural effusion - thickening-atelecta; Comments: apico-basal pleural effusion - thickening-atelectasis of the contiguous parenchyma in apico-basal declivity; Test Name: CRP; Result Unstructured Data: Test Result:0; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Name: d-dimer; Result Unstructured Data: Test Result:Non-detectable; Test Name: transaminase; Result Unstructured Data: Test Result:severely increased; Test Name: troponin; Result Unstructured Data: Test Result:severely increased
CDC Split Type: ITPFIZER INC2021699045

Write-up: 13May2021 1st dose Pfizer anti-Covid - 31May2021 tachycardia resolved in Emergency Room - 08Jun2021 cardiac arrest; 13May2021 1st dose Pfizer anti-Covid - 31May2021 tachycardia resolved in Emergency Room - 08Jun2021 cardiac arrest; This is a spontaneous report received from a contactable physician downloaded from the Regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-741737. A 23-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 13May2021 (Lot Number: FA5831) at 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported as 31May2021 tachycardia resolved in Emergency Room - 08Jun2021 cardiac arrest. The patient underwent lab tests and procedures which included blood fibrinogen: decreased on 08Jun2021; Non-detectable d-dimer, severely increased transaminase and troponin, C-reactive protein 0, Bronchoalveolar Lavage negative for Covid, CT Chest: apico-basal pleural effusion - thickening-atelectasis of the contiguous parenchyma in apico-basal declivity, CT brain: diffuse edema, thin, subtly hyperdense striae at the level of the fissures and subarachnoid spaces, computerized tomography of the brain-thorax-abdomen-echocardiogram. Measures taken included Orotracheal intubation. The outcome of events was fatal. The patient died on 08Jun2021. It was not reported if an autopsy was performed. Reporter''s comments: this report is sent in consideration of the onset of symptoms 13 days after the administration of the vaccine (apparently resolved) with death after another 8 days for cardiac arrest (to our knowledge, in full well-being) no associated pathologies or familiarity were reported for potentially fatal pathological conditions.; Reporter''s Comments: this report is sent in consideration of the onset of symptoms 13 days after the administration of the vaccine (apparently resolved) with death after another 8 days for cardiac arrest (to our knowledge, in full well-being) no associated pathologies or familiarity were reported for potentially fatal pathological conditions.; Reported Cause(s) of Death: Standstill cardiac; Tachycardia


VAERS ID: 1416217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021705805

Write-up: thrombosis FOLLOWED BY DEATH; pain in the upper part of the legs; This is a spontaneous report from a contactable consumer for her grandmother received through Pfizer. An 88-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had thrombosis, after complaining of pain in the upper part of the legs, followed by death, 20 days after having received the second dose of the Comirnaty vaccine. The death occurred in the hospital It was not reported if an autopsy was performed. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Thrombosis


VAERS ID: 1416261 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adjusted calcium, Alanine aminotransferase, Albumin globulin ratio, Anaphylactic shock, Anti-islet cell antibody, Aspartate aminotransferase, Aspartate aminotransferase increased, Base excess, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood cholesterol, Blood copper, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood erythropoietin, Blood folate, Blood glucose, Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood phosphorus, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood triglycerides, Blood urea, Blood uric acid, Blood zinc, Body temperature, Breath sounds, C-reactive protein, Cardiothoracic ratio, Coronary artery occlusion, Electrocardiogram, Eosinophil count, Eyelid oedema, Fibrin D dimer, Fibrin degradation products, Gamma-glutamyltransferase, Glomerular filtration rate, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Haemoglobin decreased, Heart rate, High density lipoprotein, Infection, Investigation, Iron binding capacity total, Iron binding capacity unsaturated, Low density lipoprotein, Lymphocyte count, Lymphocyte morphology abnormal, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Myocarditis, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Obstructive airways disorder, Oxygen saturation, PCO2, PO2, Platelet count, Pleural effusion, Pneumonia, Protein total, Red blood cell count, Respiratory failure, Reticulocyte count, Serum ferritin, Thrombin-antithrombin III complex, Thrombosis, Thyroxine free, Tri-iodothyronine, Troponin T, Ultrasound scan, Upper respiratory tract infection bacterial, Vitamin B12, Weight, White blood cell count, pH body fluid
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Malignant lymphomas (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; SENNOSIDES; PAROXETINE; RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina unstable; Cardiomegaly (CTR 58% on 20Dec2018); Constipation; Delirium nocturnal; Depression; Diabetes mellitus; Diabetic nephropathy; Femoral neck fracture; Hyperlipidaemia (No medications were given in accordance with guidelines for the elderly.); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Albumin adjustment; Result Unstructured Data: Test Result:8.7; Test Date: 20210512; Test Name: Albumin adjustment; Result Unstructured Data: Test Result:8.7; Test Date: 20210513; Test Name: Albumin adjustment; Result Unstructured Data: Test Result:8.8; Test Date: 20210514; Test Name: Albumin adjustment; Result Unstructured Data: Test Result:8.9; Test Date: 20210517; Test Name: Albumin adjustment; Result Unstructured Data: Test Result:8.8; Test Date: 20210421; Test Name: ALT; Result Unstructured Data: Test Result:8; Test Date: 20210512; Test Name: ALT; Result Unstructured Data: Test Result:33; Test Date: 20210513; Test Name: ALT; Result Unstructured Data: Test Result:29; Test Date: 20210514; Test Name: ALT; Result Unstructured Data: Test Result:27; Test Date: 20210517; Test Name: ALT; Result Unstructured Data: Test Result:18; Test Date: 20210421; Test Name: A/G; Result Unstructured Data: Test Result:1.1; Test Date: 20210517; Test Name: iCa; Result Unstructured Data: Test Result:1.12; Test Date: 20210421; Test Name: AST; Result Unstructured Data: Test Result:17; Test Date: 20210512; Test Name: AST; Result Unstructured Data: Test Result:184; Test Date: 20210513; Test Name: AST; Result Unstructured Data: Test Result:113; Test Date: 20210514; Test Name: AST; Result Unstructured Data: Test Result:83; Test Date: 20210517; Test Name: AST; Result Unstructured Data: Test Result:30; Test Date: 20210517; Test Name: BEecf; Result Unstructured Data: Test Result:-2; Comments: Norm: -2 to +3; Test Date: 20210421; Test Name: BAS; Result Unstructured Data: Test Result:0.4; Test Date: 20210512; Test Name: BAS; Result Unstructured Data: Test Result:0.0; Test Date: 20210513; Test Name: BAS; Result Unstructured Data: Test Result:0.0; Test Date: 20210514; Test Name: BAS; Result Unstructured Data: Test Result:1.0; Test Date: 20210517; Test Name: BAS; Result Unstructured Data: Test Result:0.3; Test Date: 20210421; Test Name: Alb; Result Unstructured Data: Test Result:3.4; Test Date: 20210512; Test Name: Alb; Result Unstructured Data: Test Result:3.1; Test Date: 20210513; Test Name: Alb; Result Unstructured Data: Test Result:3.1; Test Date: 20210514; Test Name: Alb; Result Unstructured Data: Test Result:3.2; Test Date: 20210517; Test Name: Alb; Result Unstructured Data: Test Result:2.7; Test Date: 20210421; Test Name: ALP (IFCC); Result Unstructured Data: Test Result:53; Test Date: 20210517; Test Name: HCO3; Result Unstructured Data: Test Result:21.9; Test Date: 20210421; Test Name: T-Bil; Result Unstructured Data: Test Result:0.3; Test Date: 20210421; Test Name: Ca; Result Unstructured Data: Test Result:8.1; Test Date: 20210512; Test Name: Ca; Result Unstructured Data: Test Result:7.8; Test Date: 20210513; Test Name: Ca; Result Unstructured Data: Test Result:7.9; Test Date: 20210514; Test Name: Ca; Result Unstructured Data: Test Result:8.1; Test Date: 20210517; Test Name: Ca; Result Unstructured Data: Test Result:7.5; Test Date: 20210421; Test Name: Cl; Result Unstructured Data: Test Result:109; Test Date: 20210512; Test Name: Cl; Result Unstructured Data: Test Result:101; Test Date: 20210513; Test Name: Cl; Result Unstructured Data: Test Result:104; Test Date: 20210514; Test Name: Cl; Result Unstructured Data: Test Result:105; Test Date: 20210517; Test Name: Cl; Result Unstructured Data: Test Result:110; Test Date: 20210421; Test Name: TC; Result Unstructured Data: Test Result:222; Test Date: 20210421; Test Name: Cu; Result Unstructured Data: Test Result:91; Test Date: 20210421; Test Name: CK; Result Unstructured Data: Test Result:102; Test Date: 20210514; Test Name: CK; Result Unstructured Data: Test Result:853; Test Date: 20210517; Test Name: CK; Result Unstructured Data: Test Result:206; Test Date: 20210514; Test Name: CK-MB; Result Unstructured Data: Test Result:52.4; Comments: Norm: 7.5 or less; Test Date: 20210517; Test Name: CK-MB; Result Unstructured Data: Test Result:9.9; Comments: Norm: 7.5 or less; Test Date: 20210421; Test Name: Cr; Result Unstructured Data: Test Result:1.48; Test Date: 20210512; Test Name: Cr; Result Unstructured Data: Test Result:1.89; Test Date: 20210513; Test Name: Cr; Result Unstructured Data: Test Result:2.09; Test Date: 20210514; Test Name: Cr; Result Unstructured Data: Test Result:1.91; Test Date: 20210517; Test Name: Cr; Result Unstructured Data: Test Result:1.66; Test Date: 20210421; Test Name: EPO; Result Unstructured Data: Test Result:8.7; Test Date: 20210421; Test Name: Folate; Result Unstructured Data: Test Result:3.2; Test Date: 20210421; Test Name: FPG; Result Unstructured Data: Test Result:128; Test Date: 20210517; Test Name: Glu; Result Unstructured Data: Test Result:125; Test Date: 20210421; Test Name: Fe; Result Unstructured Data: Test Result:57; Test Date: 20210421; Test Name: LD; Result Unstructured Data: Test Result:188; Test Date: 20210512; Test Name: LD; Result Unstructured Data: Test Result:957; Test Date: 20210513; Test Name: LD; Result Unstructured Data: Test Result:954; Test Date: 20210514; Test Name: LD; Result Unstructured Data: Test Result:904; Test Date: 20210517; Test Name: LD; Result Unstructured Data: Test Result:583; Test Date: 20210421; Test Name: Mg; Result Unstructured Data: Test Result:1.9; Test Date: 20210421; Test Name: IP; Result Unstructured Data: Test Result:3.0; Test Date: 20210512; Test Name: IP; Result Unstructured Data: Test Result:3.2; Test Date: 20210513; Test Name: IP; Result Unstructured Data: Test Result:3.3; Test Date: 20210514; Test Name: IP; Result Unstructured Data: Test Result:1.9; Test Date: 20210517; Test Name: IP; Result Unstructured Data: Test Result:2.8; Test Date: 20210517; Test Name: K; Result Unstructured Data: Test Result:3.9; Comments: i-STAT; Test Date: 20210421; Test Name: K; Result Unstructured Data: Test Result:3.9; Test Date: 20210512; Test Name: K; Result Unstructured Data: Test Result:3.3; Test Date: 20210513; Test Name: K; Result Unstructured Data: Test Result:3.8; Test Date: 20210514; Test Name: K; Result Unstructured Data: Test Result:3.3; Test Date: 20210517; Test Name: K; Result Unstructured Data: Test Result:4.0; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:186/83 to 183/98 mmHg; Test Date: 20210421; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:133-158/69-88 with no change mmHg; Test Date: 20210512; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:157/90 mmHg; Comments: at 11:25; Test Date: 20210512; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/77 mmHg; Comments: at 12:25; Test Date: 20210512; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:104/54 mmHg; Comments: at 16:00; Test Date: 20210513; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:134/82 mmHg; Test Date: 20210514; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:128/42 mmHg; Test Date: 20210517; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:118/66 mmHg; Comments: at 20:00; Test Date: 20210518; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:109/58 mmHg; Comments: at 06:00; Test Date: 20210421; Test Name: Na; Result Unstructured Data: Test Result:142; Test Date: 20210512; Test Name: Na; Result Unstructured Data: Test Result:134; Test Date: 20210513; Test Name: Na; Result Unstructured Data: Test Result:137; Test Date: 20210514; Test Name: Na; Result Unstructured Data: Test Result:139; Test Date: 20210517; Test Name: Na; Result Unstructured Data: Test Result:142; Test Date: 20210517; Test Name: Na; Result Unstructured Data: Test Result:142; Comments: i-STAT; Test Date: 20210421; Test Name: TSH; Result Unstructured Data: Test Result:1.205; Test Date: 20210421; Test Name: TG; Result Unstructured Data: Test Result:79; Test Date: 20210421; Test Name: BUN; Result Unstructured Data: Test Result:27.4; Test Date: 20210512; Test Name: BUN; Result Unstructured Data: Test Result:31.7; Test Date: 20210513; Test Name: BUN; Result Unstructured Data: Test Result:42.9; Test Date: 20210514; Test Name: BUN; Result Unstructured Data: Test Result:44.0; Test Date: 20210517; Test Name: BUN; Result Unstructured Data: Test Result:38.4; Test Date: 20210421; Test Name: UA; Result Unstructured Data: Test Result:7.8; Test Date: 20210421; Test Name: Zn; Result Unstructured Data: Test Result:64; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: at 11:25; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: at 12:25; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: around noon; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: at 16:00; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: at 20:00; Test Date: 20210518; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: at 06:00; Test Date: 20210512; Test Name: Breath sounds; Result Unstructured Data: Test Result:bilateral wheezing during expiration; Comments: at 11:25; Test Date: 20210513; Test Name: Breath sounds; Result Unstructured Data: Test Result:bilateral wheezing disappeared; Test Date: 20210514; Test Name: Breath sounds; Result Unstructured Data: Test Result:stridor disappeared; Test Date: 20210517; Test Name: Breath sounds; Result Unstructured Data: Test Result:clear in the left, crepitus in right; Comments: clear in the left lung field but crepitus is heard in the entire right lung filed; Test Name: CTR; Test Result: 58 %; Test Date: 20210421; Test Name: CRP (quantitative); Result Unstructured Data: Test Result:0.17; Comments: Norm: 0.30 or less; Test Date: 20210512; Test Name: CRP (quantitative); Result Unstructured Data: Test Result:8.02; Comments: Norm: 0.30 or less; Test Date: 20210513; Test Name: CRP (quantitative); Result Unstructured Data: Test Result:9.83; Comments: Norm: 0.30 or less; Test Date: 20210514; Test Name: CRP (quantitative); Result Unstructured Data: Test Result:4.85; Comments: Norm: 0.30 or less; Test Date: 20210517; Test Name: CRP (quantitative); Result Unstructured Data: Test Result:2.97; Comments: Norm: 0.30 or less; Test Date: 20210514; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST depressed; Test Date: 20210421; Test Name: EOS; Result Unstructured Data: Test Result:3.5; Test Date: 20210512; Test Name: EOS; Result Unstructured Data: Test Result:0.0; Test Date: 20210513; Test Name: EOS; Result Unstructured Data: Test Result:0.0; Test Date: 20210514; Test Name: EOS; Result Unstructured Data: Test Result:1.0; Test Date: 20210517; Test Name: EOS; Result Unstructured Data: Test Result:3.5; Test Date: 20210514; Test Name: D-dimer; Result Unstructured Data: Test Result:4.6; Comments: Norm: 1.0 or less; Test Date: 20210517; Test Name: D-dimer; Result Unstructured Data: Test Result:2.1; Comments: Norm: 1.0 or less; Test Date: 20210514; Test Name: FDP quantitative; Result Unstructured Data: Test Result:8.6; Comments: Norm: 5.0 or less; Test Date: 20210517; Test Name: FDP quantitative; Result Unstructured Data: Test Result:4.1; Comments: Norm: 5.0 or less; Test Date: 20210421; Test Name: Gamma GT; Result Unstructured Data: Test Result:12; Test Date: 20210421; Test Name: eGFR; Result Unstructured Data: Test Result:25.1; Comments: Norm: 60.0 or more; Test Date: 20210512; Test Name: eGFR; Result Unstructured Data: Test Result:19.2; Comments: Norm: 60.0 or more; Test Date: 20210513; Test Name: eGFR; Result Unstructured Data: Test Result:17.2; Comments: Norm: 60.0 or more; Test Date: 20210514; Test Name: eGFR; Result Unstructured Data: Test Result:19.0; Comments: Norm: 60.0 or more; Test Date: 20210517; Test Name: eGFR; Result Unstructured Data: Test Result:22.2; Comments: Norm: 60.0 or more; Test Date: 20210421; Test Name: A1C (NGSP); Result Unstructured Data: Test Result:6.5; Test Date: 20210517; Test Name: Hct; Result Unstructured Data: Test Result:23; Test Date: 20210421; Test Name: Ht; Result Unstructured Data: Test Result:27.5; Test Date: 20210512; Test Name: Ht; Result Unstructured Data: Test Result:25.3; Test Date: 20210513; Test Name: Ht; Result Unstructured Data: Test Result:27.5; Test Date: 20210514; Test Name: Ht; Result Unstructured Data: Test Result:29.7; Test Date: 20210517; Test Name: Ht; Result Unstructured Data: Test Result:23.5; Test Date: 20210421; Test Name: Hb; Result Unstructured Data: Test Result:8.9; Test Date: 20210512; Test Name: Hb; Result Unstructured Data: Test Result:8.1; Test Date: 20210513; Test Name: Hb; Result Unstructured Data: Test Result:8.8; Test Date: 20210514; Test Name: Hb; Result Unstructured Data: Test Result:9.8; Test Date: 20210517; Test Name: Hb; Result Unstructured Data: Test Result:7.8; Test Date: 20210517; Test Name: Hb; Result Unstructured Data: Test Result:7.8; Comments: i-STAT; Test Name: Pulse rate; Result Unstructured Data: Test Result:76 to 79 bpm; Test Date: 20210512; Test Name: Pulse rate; Result Unstructured Data: Test Result:96; Comments: at 11:25; Test Date: 20210512; Test Name: Pulse rate; Result Unstructured Data: Test Result:92; Comments: at 12:25; Test Date: 20210512; Test Name: Pulse rate; Result Unstructured Data: Test Result:91 bpm; Comments: at 16:00; Test Date: 20210513; Test Name: Pulse rate; Result Unstructured Data: Test Result:86; Test Date: 20210514; Test Name: Pulse rate; Result Unstructured Data: Test Result:90; Test Date: 20210514; Test Name: Pulse rate; Result Unstructured Data: Test Result:110 bpm; Test Date: 20210517; Test Name: Pulse rate; Result Unstructured Data: Test Result:64; Comments: at 20:00; Test Date: 20210518; Test Name: Pulse rate; Result Unstructured Data: Test Result:60; Comments: at 06:00; Test Date: 20210421; Test Name: HDL-C; Result Unstructured Data: Test Result:61; Test Date: 20210421; Test Name: CHr; Result Unstructured Data: Test Result:28.3; Comments: ?Content of reticulocyte hemoglobin; Test Date: 20210517; Test Name: H-FABP; Result Unstructured Data: Test Result:23.3; Comments: Heart-type fatty acid-binding protein; Test Date: 20210421; Test Name: TIBC; Result Unstructured Data: Test Result:230; Test Date: 20210421; Test Name: UIBC; Result Unstructured Data: Test Result:173; Test Date: 20210421; Test Name: LDL-C; Result Unstructured Data: Test Result:142; Test Date: 20210421; Test Name: LYM; Result Unstructured Data: Test Result:17.8; Test Date: 20210512; Test Name: LYM; Result Unstructured Data: Test Result:0.0; Test Date: 20210513; Test Name: LYM; Result Unstructured Data: Test Result:2.0; Test Date: 20210514; Test Name: LYM; Result Unstructured Data: Test Result:5.0; Test Date: 20210517; Test Name: LYM; Result Unstructured Data: Test Result:10.1; Test Date: 20210512; Test Name: Atypical LY; Result Unstructured Data: Test Result:0.0; Test Date: 20210513; Test Name: Atypical LY; Result Unstructured Data: Test Result:0.0; Test Date: 20210514; Test Name: Atypical LY; Result Unstructured Data: Test Result:0.0; Test Date: 20210421; Test Name: MCH; Result Unstructured Data: Test Result:28.3; Test Date: 20210512; Test Name: MCH; Result Unstructured Data: Test Result:27.2; Test Date: 20210513; Test Name: MCH; Result Unstructured Data: Test Result:26.9; Test Date: 20210514; Test Name: MCH; Result Unstructured Data: Test Result:28.1; Test Date: 20210517; Test Name: MCH; Result Unstructured Data: Test Result:28.5; Test Date: 20210421; Test Name: MCHC; Result Unstructured Data: Test Result:32.4; Test Date: 20210512; Test Name: MCHC; Result Unstructured Data: Test Result:32.0; Test Date: 20210513; Test Name: MCHC; Result Unstructured Data: Test Result:32.0; Test Date: 20210514; Test Name: MCHC; Result Unstructured Data: Test Result:33.0; Test Date: 20210517; Test Name: MCHC; Result Unstructured Data: Test Result:33.2; Test Date: 20210421; Test Name: MCV; Result Unstructured Data: Test Result:87.3; Test Date: 20210512; Test Name: MCV; Result Unstructured Data: Test Result:84.9; Test Date: 20210513; Test Name: MCV; Result Unstructured Data: Test Result:84.1; Test Date: 20210514; Test Name: MCV; Result Unstructured Data: Test Result:85.1; Test Date: 20210517; Test Name: MCV; Result Unstructured Data: Test Result:85.8; Test Date: 20210421; Test Name: MON; Result Unstructured Data: Test Result:5.4; Test Date: 20210512; Test Name: MON; Result Unstructured Data: Test Result:1.0; Test Date: 20210513; Test Name: MON; Result Unstructured Data: Test Result:3.0; Test Date: 20210514; Test Name: MON; Result Unstructured Data: Test Result:5.0; Test Date: 20210517; Test Name: MON; Result Unstructured Data: Test Result:5.4; Test Date: 202104; Test Name: NEUT; Test Result: 73 %; Test Date: 20210421; Test Name: NEUT; Test Result: 72.9 %; Test Date: 20210512; Test Name: NEUT; Test Result: 99.0 %; Test Date: 20210513; Test Name: NEUT; Test Result: 95.0 %; Test Date: 20210514; Test Name: NEUT; Test Result: 88.0 %; Test Date: 20210517; Test Name: NEUT; Test Result: 80.7 %; Test Date: 20210421; Test Name: NT-pro BNP; Result Unstructured Data: Test Result:424; Comments: Norm: Less than 125/500; Test Date: 20210512; Test Name: NT-pro BNP; Result Unstructured Data: Test Result:10238; Comments: Norm: Less than 125/500; Test Date: 20210517; Test Name: sO2; Result Unstructured Data: Test Result:93; Test Name: SpO2; Test Result: 99 %; Test Date: 20210512; Test Name: SpO2; Result Unstructured Data: Test Result:89-93 %; Comments: at 11:25; remained at 89% thereafter, 96% after the third dose of adrenaline; Test Date: 20210512; Test Name: SpO2; Result Unstructured Data: Test Result:83-99 %; Comments: at 16:00; Test Date: 20210512; Test Name: SpO2; Result Unstructured Data: Test Result:declined to 82 %; Test Date: 20210513; Test Name: SpO2; Result Unstructured Data: Test Result:90-93 %; Test Date: 20210514; Test Name: SpO2; Result Unstructured Data: Test Result:87 to 95-96 %; Test Date: 20210514; Test Name: SpO2; Result Unstructured Data: Test Result:below 90 %; Test Date: 20210517; Test Name: SpO2; Test Result: 92 %; Test Date: 20210517; Test Name: PaCO2; Result Unstructured Data: Test Result:31.0; Test Date: 20210517; Test Name: TCO2; Result Unstructured Data: Test Result:23; Test Date: 20210517; Test Name: pH; Result Unstructured Data: Test Result:7.457; Test Date: 20210421; Test Name: PLT; Result Unstructured Data: Test Result:20.6; Test Date: 20210512; Test Name: PLT; Result Unstructured Data: Test Result:19.2; Test Date: 20210513; Test Name: PLT; Result Unstructured Data: Test Result:21.7; Test Date: 20210514; Test Name: PLT; Result Unstructured Data: Test Result:26.5; Test Date: 20210517; Test Name: PLT; Result Unstructured Data: Test Result:26.2; Test Date: 20210517; Test Name: PaO2; Result Unstructured Data: Test Result:62; Test Date: 20210421; Test Name: TP; Result Unstructured Data: Test Result:6.6; Test Date: 20210421; Test Name: RBC; Result Unstructured Data: Test Result:315; Test Date: 20210512; Test Name: RBC; Result Unstructured Data: Test Result:298; Test Date: 20210513; Test Name: RBC; Result Unstructured Data: Test Result:327; Test Date: 20210514; Test Name: RBC; Result Unstructured Data: Test Result:349; Test Date: 20210517; Test Name: RBC; Result Unstructured Data: Test Result:274; Test Date: 20210421; Test Name: Ret; Result Unstructured Data: Test Result:13; Test Date: 20210421; Test Name: Ferritin; Result Unstructured Data: Test Result:22.5; Test Date: 20210517; Test Name: TAT; Result Unstructured Data: Test Result:6.6; Comments: Norm: less than 4.0; Test Date: 20210421; Test Name: FT4; Result Unstructured Data: Test Result:1.12; Test Date: 20210421; Test Name: FT3; Result Unstructured Data: Test Result:2.37; Test Date: 20210514; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:4.620; Comments: Norm: 0.014 or less; Test Date: 20210517; Test Name: Cardiac troponin T; Result Unstructured Data: Test Result:7.550; Comments: Norm: 0.014 or less; Test Date: 20210517; Test Name: Chest/abdominal ultrasound; Result Unstructured Data: Test Result:pleural effusion bilaterally; Comments: approx. 1-2 cm; Test Date: 20210421; Test Name: V.B 12; Result Unstructured Data: Test Result:477; Test Date: 202103; Test Name: weight; Result Unstructured Data: Test Result:42.1 kg + 1.45 kg; Test Date: 20210421; Test Name: WBC; Result Unstructured Data: Test Result:6800; Test Date: 20210512; Test Name: WBC; Result Unstructured Data: Test Result:17500; Test Date: 20210513; Test Name: WBC; Result Unstructured Data: Test Result:18000; Test Date: 20210514; Test Name: WBC; Result Unstructured Data: Test Result:16400; Test Date: 20210517; Test Name: WBC; Result Unstructured Data: Test Result:10900
CDC Split Type: JPPFIZER INC2021672110

Write-up: Myocarditis; Thrombus formation; Coronary artery blockage; Bilateral pleural effusion; Mild oedema of both eyelids; Decreased hemoglobin; airway stenosis; Anaphylactic shock; Infection; Increased AST; Respiratory failure; Pneumonia; Suspected bacterial infection of the airway; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority report. A 97-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 12May2021 at 09:45 at a single dose for covid-19 immunisation. Medical history included left femoral neck fracture, diabetes mellitus, diabetic nephropathy, hypertension, unstable angina, hyperlipidaemia (no medications were given in accordance with guidelines for the elderly), cardiomegaly (CTR 58% on 20Dec2018), constipation, suspected depression, and suspected delirium nocturnal (all not ongoing). The patient had no family history. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) taken for hypertension; sennoside a+b (SENNOSIDES) taken for constipation; paroxetine (MANUFACTURER UNKNOWN) taken for suspected depression; risperidone (MANUFACTURER UNKNOWN) taken for suspected delirium nocturnal. On 12May2021, the patient experienced suspected bacterial infection of the airway. On 12May2021 at 11:25, the patient experienced anaphylactic shock, which was medically significant. On 14May2021, the patient experienced myocarditis, which was serious for death and hospitalization from 14May2021 to 17May2021. On 17May2021, the patient experienced bilateral pleural effusion and mild oedema of both eyelids. On an unknown date the patient experienced thrombus formation and coronary artery blockage. On 12May2021 at 11:30, the patient experienced airway stenosis. On 12May2021, the patient experienced respiratory failure, pneumonia, infection, and increased AST. On 17May2021, the patient experienced decreased hemoglobin. The clinical course was as follows: Blood pressure was 133-158/69-88 with no change. Weight in March: 42.1 kg + 1.45 kg. Blood pressure: 186/83 mmHg to 183/98 mmHg; Pulse: 76 bpm to 79 bpm; SpO2: 99%; Body temperature: 36.4 degrees C; Oedema: Mild oedema over the surface of tibia was noted. Blood test: Hb 8.9 Fe 57 TIBC 230 FERITIN 22.5 CKD was noted. Data of iron-deficiency anemia Folate 3.2 Data of folate deficiency. Check on an unknown date: Medications had been given for lifestyle diseases, but they were stopped over time. Reason was asked. Medications were stopped and health was regained. No delirium at night, either. Treatment for anaemia was discussed. Following the previous attempt to reduce medications, we decided not to give any new iron preparation or folic acid. On 12May2021, home visit was made due to the adverse reaction that developed after receiving a corona vaccine. SpO2 was originally 99% according to the medical records. At 9:45, corona vaccine was administered. At 11:25, BP was 157/90, P 96, and BT 36.4. SpO2: 89%-93%. Breath sounds: bilateral wheezing during expiration with panting, pale face. The patient uttered that she is ready to die anytime. At 11:32, first dose of adrenaline was given at 0.3 mg intramuscularly. SpO2 remained at 89% thereafter. At 11:42, second dose of adrenaline was given at 0.3 mg intramuscularly. At 11:50, intravenous drip infusion of LACTEC was initiated. At 12:01, third dose of adrenaline was given at 0.3 mg intramuscularly. SpO2 was 96% thereafter. At 12:08, POLARAMINE 5 mg and saline 20 mL was given intravenously. At 12:15, HYDROCORTONE 1000 mg and 5 % glucose solution 100 mL were given. At 12:25, BP was 140/77, P 92, and BT 36.9 In the end, the patient smiled and said thank you with face color returning to normal. As prophylaxis for delayed allergy reaction, intravenous POLARAMINE and drip infusion of HYDROCORTONE were initiated. Condition was reassessed in the evening. Pyrexia of 37.7 degrees C developed around noon. Pyrexia of 38s degrees C developed in the evening (16:00). Blood pressure: 104/54 mmHg; Pulse: 91 bpm; SpO2: 83-99%; Body temperature: 38.0 degrees C. SpO2 declined to 82%. Wheezing (breath sounds) persisted. Considering a possibility of pneumonia, in-hospital 2 + NT-proBNP, blood test was performed. Drip infusion of Acelio was initiated for pyrexia. Since the patient had diabetic nephropathy, the amount of drip infusion was adjusted to 1000 mL per eGFR. Cardiomegaly was noted. Chronic heart failure may be present as well. Laboratory data on 12May2021: Neutrophil: 99%; CRP: 8.02; White blood cell: 17500; AST: 184; ALT: 33; eGFR: 19.2 BUN:31 Cr: 1.89. Steroid may have caused elevation of white blood cells, but CRP is also elevated; some kind of infection cannot be ruled out. Ceftriaxone was initiated starting from 13May2021. On 13May2021, there was no response when the patient was called out, and thus doctor''s visit was requested. Home visit was made. Four days earlier, car ride made the patient sick and the patient vomited. Since then, the patient seemed unwell. Blood pressure: 134/82 mmHg Pulse: 86 bpm SpO2: 90-93 % Body temperature: 36.8 degrees C; Breath sounds: bilateral wheezing disappeared. SOLU-CORTEF was effective. Abdominal findings: flat and soft with regular peristaltic sounds. Laboratory data on 12May: Neutrophil: 99% (data in Apr2021: 73%); CRP: 8.02; White blood cell: 17500; AST: 184; ALT: 33; eGFR: 19.2 BUN:31 Cr: 1.89. Data on 14May2021: neutrophil: 95%; CRP: 9.83; White blood cell: 18000; LD: 954; AST: 113; ALT: 29. High inflammatory values: possibility of pneumonia aspiration was considered based on the episode of vomiting. No apparent increase in the amount of expectoration and no cough were observed. White blood cells may be elevated, but CRP is also elevated; some kind of infection cannot be ruled out. Repeat blood test was performed. Ceftriaxone was initiated for one week. If dietary intake is not possible, SOLDEM #3 solution should be started at twice daily. Neutrophil: 99% Data in April was 72% and can be considered as acute symptom. There must be some kind of infection. High AST with normal ATL. Elevation of AST alone may indicate myocardial involvement. This is a level requiring a visit to emergency department. LD 900s Anaphylactic shock on 12May2021; Bilateral wheezing during expiration was heard. Considering anaphylactic shock due to vaccine, adrenaline + SOLU-CORTEF 1000 mg were given. Today''s auscultation did not pick up apparent wheezing. Electrocardiogram is scheduled on the following day. CK CKMB troponin T measurement 14May2021, along with deterioration in laboratory values, doctor''s home visit was requested and performed. Blood pressure: 128/42 mmHg; Pulse: 90 bpm; SpO2: 87% to 95-96%; Body temperature: 36.6 degrees C; Breath sounds: stridor disappeared; abdominal findings: flat and soft. Laboratory data on 13May showed AST-dominant elevation as well as inflammatory findings. AST is a myocardium-derived or skeletal muscle-derived value. Myocardium-derived elevation was more likely based on the presence of hypoxemia. Furthermore, myocarditis was suspected most based on the hypoxemia and high inflammatory findings. Electrocardiogram showed ST depressed (no abnormalities were detected by the cardiogram in 2019) with pulse at 110 beats per minute. Considering oxygen falling below 90%, myocarditis was considered plausible. Pulse irregular with atrial fibrillation, for which no drugs were given. The patient was referred to another hospital due to suspected myocarditis. On 17May2021, the patient was discharged from the hospital on this day. Home visit was made for post-discharge examination and prescription. SpO2: 92%; Breath sounds: clear in the left lung field but crepitus is heard in the entire right lung filed; chest/abdominal ultrasound showed pleural effusion bilaterally (approx. 1-2 cm on ultrasound). Sticky sputum in the throat and stridor are also heard. Abdominal findings: flat and soft. No oedema was observed. During the visit, the patient reported no chest pain, breathing difficulty or stuffy feeling. However, at the end of expiration, we noticed that the patient exhaled by abdominal breathing and seemed to have difficulty breathing to some extent. Mild oedema is noted on both eyelids. For pleural effusion and oedema, addition of diuretic(s) is considered necessary as well as co-administration of bronchodilator and theophylline. Due to marked decrease in hemoglobin (7.8 g/day), DUVROQ was additionally prescribed. Laboratory data showed rapid improvement of cardiac enzymes with normalization of EDP. D-dimer was down by half as well. Reviewing the course of this heart-associated attack, the association with COVID-19 vaccination cannot be ruled out. Vaccination; one hour and 40 minutes (100 minutes) later, symptoms of airway stenosis appeared and it was alleviated with emergency treatment approx. 60 minutes after the attack. The attack temporarily improved but worsened again with symptoms of respiratory failure in the evening. At this stage, concurrent bacterial infection of the airway was suspected and antibiotic chemical treatment was initiated. In the afternoon of the following day (13th), depressed level of consciousness was observed and emergency visit was made. By then, airway symptoms were gone. However, there was apparent decrease in SpO2 as compared with the SpO2 of 99% at the initial visit on 21Apr2021; it was considered to be respiratory failure. Sample examination showed aggravation of inflammatory values except for neutrophils. It was also assumed that COVID-19 vaccination enhanced the activation of the immune system that had started by the inflammation inside the body, leading to the thrombus formation and causing transient blockage in the coronary artery. That is, this may be a reportable case of COVID-19 vaccine adverse reaction. First, need to stabilize the current condition and then establish a measure to prevent recurrent thrombus formation (prevention of recurrent myocardial infarction). Prescription by the hospital where the patient was hospitalized/prescription by our hospital: Amlodin 2.5 mg; Risperidone 0.5 mg; Sennoside 12 mg; In addition to the above: Plavix 75 mg; Crestor 2.5 mg; Maintate 0.625 mg; Renivace 2.5 mg; Pariet 10 mg and oral medications for preventing heart failure and the recurrence of myocardial infarction were prescribed. Continued use of oral medications is considered necessary. Also, coadministration of diuretic(s) for pleural effusion (possibly associated with heart failure) and bronchodilator/ theophylline preparation for symptoms of airway stenosis and decreased SpO2 was considered desirable and thus these drugs were additionally prescribed. If respiratory insufficiency persists with these medications, temporary introduction of home oxygen therapy (HOT) should be considered. On the other hand, there was a concern over discontinuation (sudden interruption) of Paxil, however, as the dosage was small (5 mg), it can be addressed while observing the course. Laboratory results did not show the resolution of elevated inflammatory values, and because the patient refuses to receive drip infusion, oral antibiotic chemical treatment must be continued. We will use FRPM (Farom) and observe the course. On 17May2021: The patient finished up dinner in a wheelchair. At 20:00, body temperature was 36.4 degrees C, blood pressure 118/66 and pulse 64. 18May: At 6:00, body temperature was 36.0 degrees C, blood pressure 109/58 and pulse 60. At 8:00, the patient washed face, not vibrant but uttered some words. At 8:30, the patient was found to have respiratory arrest when visited. At 9:25, the situation was explained to the family. At 9:52, death was confirmed. No pupillary reflex, respiratory arrest, cardiac arrest and no pulse were felt. Time of death was confirmed as 9:52 on 18May2021. More accurate time of death on which the facility staff confirmed respiratory arrest was 8:30. To correct the time of death to 8:30 on the death certificate, the physician went to the municipal office and made a double-lined correction on the previously submitted document and put a personal seal on it. Change of time of death was notified to the family via telephone and they accepted it. In addition, the municipal office said that they would contact the cremation place regarding the submitted death certificate. Results of sample examination was as follows: On 21Apr2021, TP was 6.6, Alb was 3.4, A/G was 1.1, T-Bil was 0.3, AST was 17, ALT was 8, LD was 188, ALP (IFCC) was 53, gamma GT was12, CK was 102, TC was 222, HDL-C was 61, LDL-C was 142, TG was 79, BUN was 27.4, Cr was 1.48, eGFR was 25.1, UA was 7.8, Na was 142, K was 3.9, Cl was 109, Ca was 8.1, albumin adjustment was 8.7, IP was 3.0, Mg was 1.9, Cu was 91, Zn was 64, TSH was 1.205, FT3 was 2.37, FT4 was 1.12, FPG was 128, A1C (NGSP) was 6.5, CRP (quantitative) was 0.17, RBC was 315, Hb was 8.9, Ht was 27.5, MCV was 87.3, MCH was 28.3, MCHC was 32.4, Fe was 57, UIBC was 173, TIBC was 230, Ferritin was 22.5, Ret was 13, CHr was 28.3, WBC was 6800, PLT was 20.6, NEUT was 72.9, LYM was 17.8, MON was 5.4, EOS was 3.5, BAS was 0.4, V.B 12 was 477, folate was 3.2, EPO was 8.7, and NT-pro BNP was 424. On 12May2021, Alb was 3.1, AST was 184, ALT was 33, LD was 957, BUN was 31.7, Cr was 1.89, eGFR was 19.2, Na was 134, K was 3.3, Cl was 101, Ca was 7.8, albumin adjustment was 8.7, IP was 3.2, CRP (quantitative) was 8.02, RBC was 298, Hb was 8.1, Ht was 25.3, MCV was 84.9, MCH was 27.2, MCHC was 32.0, WBC was 17500, PLT was 19.2, NEUT was 99.0, LYM was 0.0, MON was 1.0, EOS was 0.0, BAS was 0.0, atypical LY was0.0, and NT-pro BNP was 10238. On 13May2021, Alb was 3.1, AST was 113, ALT was 29, LD was 954, BUN was 42.9, Cr was 2.09, eGFR was 17.2, Na was 137, K was 3.8, Cl was 104, Ca was 7.9, albumin adjustment was 8.8, IP was 3.3, CRP (quantitative) was 9.83, RBC was 327, Hb was 8.8, Ht was 27.5, MCV was 84.1, MCH was 26.9, MCHC was 32.0, WBC was 18000, PLT was 21.7, NEUT was 95.0, LYM was 2.0, MON was 3.0, EOS was 0.0, BAS was 0.0, and atypical LY was 0.0. On 14May2021, Alb was 3.2, AST was 83, ALT was 27, LD was 904, CK was 653, BUN was 44.0, Cr was 1.91, eGFR was 19.0, Na was 139, K was 3.3, Cl was 105, Ca was 8.1, albumin adjustment was 8.9, IP was 1.9, CRP (quantitative) was 4.85, RBC was 349, Hb was 9.8, Ht was 29.7, MCV was 85.1, MCH was 28.1, MCHC was 33.0, WBC was 16400, PLT was 26.5, NEUT was 88.0, LYM was 5.0, MON was 5.0, EOS was 1.0, BAS was 1.0, atypical LY was 0.0, D-dimer was 4.6, FDP quantitative was 8.6, cardiac troponin T was 4.620, and CK-MB was 52.4. On 17May2021, Alb was 2.7, AST was 30, ALT was 18, LD was 563, CK was 206, BUN was 38.4, Cr was 1.66, eGFR was 22.2, Na was 142, K was 4.0, Cl was 110, Ca was 7.5, albumin adjustment was 8.8, IP was 2.8, CRP (quantitative) was 2.97, RBC was 274, Hb was 7.8, Ht was 23.5, MCV was 85.8, MCH was 28.5, MCHC was 33.2, WBC was 10900, PLT was 26.2, NEUT was 80.7, LYM was 10.1, MON was 5.4, EOS was 3.5, BAS was 0.3, D-dimer was 2.1, FDP quantitative was 4.1, cardiac troponin T was 7.550, CK-MB was 9.9, TAT was 6.6, and H-FABP was 23.3. Results of i-STAT was as follows: On 17May2021, pH was 7.457, PaCO2 was 31.0, PaO2 was 62, BEecf was -2, HCO3 was 21.9, TCO2 was 23, sO2 was 93, Na was 142, K was 3.9, iCa was 1.12, Glu was 125, Hct was 23, and Hb was 7.8. Normal range was reported as follows: TP (6.7-8.3), Alb (4.0-5.0), A/G (1.0-1.8), T-Bil (0.3-1.2), D-Bil (0.1-0.4), AST (13-33), ALT (6-27), LD (119-229), ALP (IFOC) (38-113), gamma GT(10-47), CK (45-163), TC (128-219), HDL-C (40-96), LDL-C (70-139), TG (30-149), BUN (8.0-22.0), Cr (0.40-0.70), eGFR ($g60.0), UA (2.3-7.0), Na (138-146), K (3.6-4.9), Cl (99-108), Ca (8.7-10.3), Ca albumin adjustment (8.7-10.3), IP (2.5-4.), Mg (1.9-2.5), Cu (66-130), Zn (80-130), TSH (0.541-4.261), FT3 (2.30-4.06), FT4 (0.76-1.65), FPG (70-109), A1C(NGSP) (4.6-6.2), CRP (quantitative) (<0.30), RBC (370-490), Hb (11.5-15.0), MCV (83.0-100.0), MCH (28.0-34.0), MCHC (32.0-36.0), Fe (43-172), UIBC (137-325), TIBC (251-398), Feritin (12.0-60.0), Ret (3-17), CHr (29.9-35.9), WBC (3500-8500), PLT (15.0-35.0), NEUT (45.0-65.0), LYM (25.0-45.0), MON (4.0-7.0), EOS (2.0-5.0), BAS (0.0-1.0), D-dimer (<1.0), FDP quantitive (<5.0), cardiac troponin T (<0.014), CK-MB (<7.5), TAT (<4.0), H-FABP (<6.2), V.B12 (233-914), folate (4.6-12.9), EPO (4.2-23.7), NT-pro BNP (<125/500). Normal range for I-STAT tests were as follows, pH (7.31-7.41), PaCO2 (35-45), PaO2 (80-105), BEecf (-2-+3), HCO3 (22-26), TCO2 (23-27), sO2 (95-98), Na (138-146), K (3.5-4.9), iCa (1.12-1.32), Glu (70-105), Hct (38-51) Prescription by the reporting hospital: 1) Amlodipine oral disintegration tablet 5 mg 1 tablet and NOBELZIN tablet 25 mg 1 tablet, once daily after breakfast for 35 days. 2) Sennoside tablet 12 mg 1 tablet, once daily after supper for 35 days. 3) Paroxetine tablet 5 mg 1 tablet, once daily after supper for 35 days. 4) Risperidone oral disintegration tablet 0.5 mg 1 tablet, once daily after supper for 35 days. Body temperature before vaccination was 36.2 degrees Centigrade on 12May2021. Therapeutic measures were taken as a result of myocarditis, anaphylactic shock, suspected bacterial infection of the airway, bilateral pleural effusion, mild oedema of both eyelids, airway stenosis, respiratory failure, pneumonia, infection, and decreased hemoglobin. The clinical outcome of the event, anaphylactic shock, suspected bacterial infection of the airway, bilateral pleural effusion, and mild oedema of both eyelids, was unknown. The clinical outcome of the events, thrombus formation, coronary artery blockage, respiratory failure, pneumonia, infection, increased AST, and decreased hemoglobin, was unknown. The clinical outcome of the event, airway stenosis, was recovered on 12May2021. The clinical outcome of the event, myocarditis, was fatal. The patient died on 18May2021 due to myocarditis. It was not reported if an autopsy was performed. The reporting other health professional classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was not reported. REPORTER COMMENT: it was considered that after the vaccination, thrombus was formed which blocked coronary artery temporarily, resulting in myocardial disorder. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Myocarditis


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