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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 92 out of 172

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VAERS ID: 1072578 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222210

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-PEI-PEI2021002936. A 74-years-old male patient received bnt162b2 (COMIRNATY) (lot# EJ6797), on 06Jan2021 at single dose for Covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced exitus letalis on 11Jan2021. The patient died on 11Jan2021. It was not reported if an autopsy was performed. Inconsistent causal association was assessed by Attending Physician. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1072579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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 INC2021222205

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority WEB DE-PEI-PEI2021002937. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (lot/batch number EJ6797), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed death on 16Jan2021 after vaccination. The patient died on 16Jan2021. 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: 1072580 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
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: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222215

Write-up: Death; This is a spontaneous report from a non-contactable physician from the Regulatory Authority-WEB DE-PEI-PEI2021002941. An 80-year-old female patient received first dose of BNT162B2 (COMIRNATY) at the age of 80-years, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 12Jan2021, the same day after vaccination the patient developed death. It was unknown if an autopsy was done or not. COMIRNATY/death/PEI: Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1072581 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222226

Write-up: Exitus letalis; This is a spontaneous report from physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002945. This is a spontaneous report from a non-contactable physician. A 74-years-old male patient received bnt162b2 (COMIRNATY; Lot/Batch No.: EL8723) first dose, intramuscular on 22Feb2021 at SINGLE DOSE for covid-19 immunization (age at vaccination was 74 years old). The patient''s medical history and concomitant medications were not reported. The patient experienced exitus letalis (death) on an unspecified date. 46 hours after vaccination the patient developed Death, lasting for unknown. The patient was dead. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1072584 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-04
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: DEPFIZER INC2021228915

Write-up: died; This is a spontaneous report from a Non-contactable consumer. This consumer reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. This consumer reported that "I went to the Vaccine Impact website at (web address) yesterday and saw these articles regarding the COVID-19 vaccines. There were other articles posted as well. Whistleblower Video Footage of Forced COVID Vaccines Goes Public: "We''re Dealing with Homicide, Maybe Even Murder". 28-Year-Old PhD Physical Therapist DEAD 2 Days After Being Injected with COVID Experimental mRNA Vaccine. Second Pfizer COVID Shot Halted After 46 Deaths in One Nursing Home Following the First Shot 28-Year-old Healthcare Worker has Aneurysm - Brain Dead Five Days After Second Experimental Pfizer mRNA COVID Injection? Local Talk Radio Reports "Many Dying" in (country name) Following Pfizer Experimental mRNA Injections." No follow-up attempts are possible; Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1072585 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-01-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: ANCOZAN; DONEPEZIL SANDOZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Fall; Fracture of pelvis (Small fracture of the pelvis after fall the 09Jun2020); Hematoma (Hematoma after fall the 09Jun2020); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021220493

Write-up: An elderly man with dementia died one week after receiving the 2nd COVID 19 vaccine. The death was unexpected.; After vaccination the patient experience tiredness; decreased appetite occured after vaccination.; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB DK-DKMA-WBS-0033921. A 91-years-old male patient received second dose of bnt162b2 (COMIRNATY, lot number: EK9788, expiration date: 31May2021), intramuscular on 31Jan2021 at single dose for covid-19 immunisation. Medical history included fall on 09Jun2020, fracture of pelvis on 09Jun2020 (a small fracture of the pelvis after fall on 09Jun2020), hematoma on 09Jun2020 (hematoma after fall the 09Jun2020), hypertension and Dementia Alzheimer type. Concomitant medication included losartan potassium (ANCOZAN) from 13Jan2015 for Hypertension, donepezil hydrochloride (DONEPEZIL SANDOZ) from 20Sep2016 for Dementia Alzheimer''s type. The patient previously took pneumovax on 05May2020 for pneumococcal immunisation, ditebooster on 09Jun2020 for tetanus immunisation, fluzone on 19Oct2020 for influenza immunisation, bnt162b2 (COMIRNATY, lot: EM0477, expiration date: 30Apr2021) first dose on 07Jan2021 for covid-19 immunisation. The patient had not previously experienced a drugs/vaccine reaction and was not familiar with any CAVE/allergies. On 31Jan2021, immediately after receiving the 2nd dose of COMIRNATY, the patient developed decreased appetite and tiredness. One week later, on 07Feb2021, the patient died. The patient did not experience pain/was not suffering. The ADRs were by the physician reported as fatal. The outcome for the ADRs, decreased appetite and tiredness was also reported as unknown. No treatment was reported. The patient died on 07Feb2021. An autopsy was not performed. The physician had made following comment: Dementia had been progressive since lock-down due to isolation, but had remain stable lately. The physician thought that the course of events was consistent with the patient dementia and sees nothing remarkably about it. However, as the patient experienced the ADRs, Decreased appetite and tiredness immediately after the 2nd vaccine and as the patient died the week after the 2nd vaccination, the physician stated that there might be a small relation between the suspect drug and the fatal outcome. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: After vaccination the patient experience tiredness; decreased appetite occured after vaccination.; Death


VAERS ID: 1072588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-08
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6678 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: Arrhythmia; Bladder neoplasm; Mitral valve insufficiency; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232765

Write-up: Death unexplained; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-NC20210576. An 80-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6678), via intramuscular, on 22Jan2021, at single dose, for COVID-19 immunization, as part of an anti-COVID vaccination. Medical history included mitral valve leak, bladder neoplasia, TIA (transient ischemic attack) and arrhythmia. The concomitant medication was not reported. The patient did not present any symptoms immediately following his vaccination. On 08Feb2021, the patient experienced death unexplained, patient was found dead on the ground. Other treatment included anticoagulant (not specified). The outcome of the event was fatal. The cause of death was not reported. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures Official Bulletin of the Minister in charge of Health no. 84/50, January 24, 1985. Published in Therapy 1985; 40: 111-8 No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death unexplained


VAERS ID: 1072592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Aortic arteriosclerosis, Arteriosclerosis coronary artery, Chest discomfort, Constipation, Cough, Decreased appetite, Emphysema, Myocardial ischaemia, Nausea, Overflow diarrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Noninfectious diarrhoea (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: AMITRIPTYLINE; ALENDRONIC ACID; GEMFIBROZIL; AMOXICILLIN; PREGABALIN; RIVAROXABAN; VERAPAMIL; LETROZOLE; DOXYCYCLINE; VITAMIN D NOS; LANSOPRAZOLE; THYROXINE; TRAZODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Barrett''s esophagus; Breast cancer (treated by mastectomy, chemotherapy and possible radiotherapy); Chronic kidney disease stage 3; Chronic obstructive pulmonary disease; Diverticular disease; Gallstones; Hyperlipidemia; Hypertension; Hypothyroidism; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: GBPFIZER INC2021217441

Write-up: Aortic calcification; ischaemic heart disease; Coronary artery atheroma; Emphysema pulmonary; constipation with overflow diarrhoea; Nausea; Abdominal pain upper; Constipation; Decreased appetite; Chest discomfort; Cough; This is a spontaneous report from a contactable other healthcare professional received from the RA. Regulatory authority report number GB-RA-ADR 24835021. An 83-year-old female patient received First dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Unknown) , via an unspecified route of administration at single dose on 12Jan2021 for COVID-19 immunisation. Medical history included aortic stenosis, osteoporosis from 2015, diverticular disease, atrial fibrillation from 2012, hypothyroidism from 2005, chronic obstructive pulmonary disease from 2009, breast cancer (treated by mastectomy, chemotherapy and possible radiotherapy), hyperlipidaemia from 1998, chronic kidney disease stage 3 from 2011, Barrett''s esophagus from 2012, hypertension from 2012 and gallstones from 2015. Concomitant medication included amitriptyline, alendronic acid, gemfibrozil, amoxicillin, pregabalin, rivaroxaban, verapamil, letrozole, doxycycline, vitamin D, lansoprazole, levothyroxine sodium (Thyroxine) and trazodone. The patient previously took chemotherapy NOS and lisinopril and experienced hypersensitivity. The patient experienced cough on 13Jan2021, aortic calcification (death) on an unspecified date, ischaemic heart disease (medically significant) on an unspecified date, coronary artery atheroma on an unspecified date, emphysema pulmonary on an unspecified date, chest tightness on 13Jan2021, nausea on 19Jan2021, stomach cramps on 19Jan2021, constipation on 19Jan2021, decreased appetite on 19Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test (date unspecified): negative. Therapeutic measures were taken as a result of cough and chest discomfort and included treatment with amoxicillin. The patient died on 20Jan2021. An autopsy was performed on an unspecified date and the cause of death was: Aortic calcification, Ischaemic heart disease, Coronary artery atheroma and Emphysema pulmonary. The outcome of event cough was reported to be fatal. The patient had not recovered from events chest tightness, nausea, stomach cramps, constipation and appetite lost at the time of death. The clinical course was reported as follows: General practice notes entry 12Jan2021: first dose of COVID vaccine administered. General Practice notes entry 13Jan2021: tightness in chest; slight cough with white sputum. No chest pain. Symptoms similar to those about a month ago which resolved with antibiotics. Presumed infective exacerbation COPD, treated with amoxicillin. GP notes entry 19Jan2021: stomach cramps, feeling sick and not eating. Constipated for a few days, and "all came away" yesterday with watery unformed stool. No fever. Diagnosed likely ongoing constipation with overflow diarrhoea. GP notes from Jan2012: drug allergy to lisinopril (an ACE inhibitor): "likely moderate allergy causing hereditary angioedema". Patient was an 83-year-old woman with a history of previous breast cancer (treated by mastectomy, chemotherapy and possible radiotherapy), aortic stenosis, diverticular disease, atrial fibrillation and chronic obstructive pulmonary disease, who was found dead at home address with no suspicious circumstances. Autopsy has shown significant coronary artery disease, sufficient to cause sudden death, together with calcific aortic stenosis. Pulmonary emphysema was confirmed but there were no lung changes to suggest COVID 19 infection. There was no evidence of recurrence or spread of the previous breast cancer. A COVID swab taken at autopsy was negative. Patient had received the first dose of the COVID 19 vaccine about eight days before death. There is an entry in her General practitioner notes from 2012 indicating a likely allergic response to lisinopril (an angiotensin-converting-enzyme inhibitor used to treat high blood pressure), with a diagnosis of hereditary angioedema (a severe form of allergy causing swelling of the airways which can be fatal). I have spoken to patients General Practitioner, who tells me that the diagnosis of hereditary angioedema was probably due to limitations of the Read codes used by General Practioner practices to classify diseases, and probably merely indicated soft tissue swelling of the face and mouth which is not an uncommon side effect of angiotensin-converting-enzyme inhibitors. I have also spoken to Dr consultant immunologist at the hospital, who told me that this side-effect of angiotensin-converting-enzyme (ACE) inhibitors is not an allergy or hypersensitivity but rather a true mechanistic side effect due to blockade of bradykinin degradation. He also confirmed that COVID 19 vaccination eight days before death could not feasibly have caused or contributed to patients death by way of an anaphylactic allergic reaction, as this would have occurred within minutes to an hour after the vaccination. There was no other indication at autopsy of any other type of allergic reaction (such as Stevens-Johnson syndrome) and I am therefore confident that patients recent COVID vaccination was merely coincidental with no other significance and that it made no contribution to her death. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Aortic calcification; Ischaemic heart disease; Coronary artery atheroma; Emphysema pulmonary


VAERS ID: 1073315 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-02-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Congestive cardiomyopathy, SARS-CoV-2 test, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021228690

Write-up: dilated cardiomyopathy; VR arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103010951329320, Safety Report Unique Identifier GB-MHRA-ADR 24854884. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:ER1741), via an unspecified route of administration on 27Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included atenolol for Palpitation. The patient experienced dilated cardiomyopathy (medically significant) on an unspecified date and VR (Ventricular rhythm) arrest (death, medically significant) on 28Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test (date unspecified): no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of dilated cardiomyopathy was unknown. The clinical course was reported as follows: It was not thought this was caused by the vaccine. But reported as occurred within 24 hours. Suspect underlying heart condition, dilated cardiomyopathy/ previous non-sustained VT. Patient within 24 hours of vaccine had VF arrest and died. The patient died on 28Feb2021. It was not reported if autopsy was not performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: VR arrest


VAERS ID: 1073398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021221987

Write-up: Death; This is a spontaneous report a contactable consumer downloaded from the Regulatory Authority-WEB [regulatory authority GR-GREOF-20211324]. An 80-year-old male patient received BNT162B2 (COMIRNATY) via intramuscular on 02Feb2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient was dead on 17Feb2021. Time interval between beginning of drug administration and start of reaction/event (number) was 15 days. Autopsy was performed, results not available. Outcome of the event was fatal. Seriousness criteria was reported as death and medically significant. Reporter Comment: necrotomy, autopsy conducted. cause of death according to the death certificate: unspecified, waiting for the laboratory examination results.no medical history.no drugs. winter swimmer. the patient did total check up during last summer without findings. on 17Feb2021(date of death, morning) he went for a walk with his wife and fell down. He was admitted to hospital (without pulse) where diagnosed his death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reporter''s Comments: necrotomy,autopsy conducted.cause of death according to the death certificate:unspecified,waiting for the laboratory examination results.no medical history.no drugs.winter swimmer.the patient did total check up during last summer without findings.on 17/2/2021(date of death,morning) he went for a walk with his wife and fell down.he was admitted to hospital (without pulse) where diagnosed his death; Reported Cause(s) of Death: Unknown cause of death,waiting for the laboratory examination results.


VAERS ID: 1073451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-04
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: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BURINEX; ELTROXIN; LEXAPRO; ATORVASTATIN; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass graft; hypothyroidism; ischaemic heart disease; NIDDM
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021226301

Write-up: UNEXPECTED DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB (IE-HPRA-2021-067397). A 93-year-old female patient received her first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Feb2021 at single dose for covid-19 immunisation. Medical history included myocardial ischaemia, hypothyroidism, Type 2 diabetes mellitus and coronary artery bypass (2002). Concomitant medication included bumetanide (BURINEX), levothyroxine sodium (ELTROXIN), escitalopram oxalate (LEXAPRO), atorvastatin, acetylsalicylic acid. The patient experienced unexpected death on 25Feb2021. The reporter outlined that the patient was elderly and frail but was living independently and generally very well. Her relative checked in on her daily and the patient had no illness of note recently. The patient was sent for post mortem. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: unexpected death


VAERS ID: 1073452 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease (on Parkinson medications)
Allergies:
Diagnostic Lab Data: Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: ILPFIZER INC2021218097

Write-up: death; Since the vaccination, the patient has been tested for COVID-19/ nasal swab: positive; This is a spontaneous report from a contactable Consumer received via COVAES portal IL-COVAES-8443f81e-417d-4bfb-8ab8-e8884c15af83. A 68-year-old male patient received first dose of bnt162b2 (Batch/lot number: Unknown), via an unspecified route of administration, at arm left, on 03Feb2021 at single dose for covid-19 immunisation. Medical history included parkinson''s disease from an unknown date and was on Parkinson medications. The patient''s concomitant medications included Parkinson medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced death on 03Feb2021. The patient was hospitalized for death for 2 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: positive on unknown date. The outcome of nasal swab positive was unknown.The patient died on an unspecified date. An autopsy was not performed.; 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: Pfizer vaccine


VAERS ID: 1073456 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, Fall, Fatigue
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   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: PANTOPRAZOL [PANTOPRAZOLE]; ACETYLSALICYLIC ACID; TAMSULOSINE [TAMSULOSIN]; ALISKIREN
Current Illness: Atrial fibrillation; hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric disorder (angle stomach protruding twice)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021222064

Write-up: fell; tiredness; passed away; 2 instances of dizziness after vaccine; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority -WEB [regulatory authority NL-LRB-00446981], Safety Report Unique Identifier [NL-LRB-00451638]. This serious spontaneous report from a physician concerns a male aged 87 Years, with death (death), dizziness, fatigue following administration of covid-19 vaccin pfizer injvlst (action taken: not applicable) for Covid 19 immunisation. The health of the patient was excellent before and at the time of vaccination. The patient experienced dizziness twice due to which he fell and he experienced fatigue following vaccination. the patient deceased 1 week after vacciantion (following the second fall). He never had experienced dizziness before. No SARS COV2 test was performed. No autopsy was performed. The outcome of death is fatal, the outcome of dizziness is unknown and the outcome of fatigue is unknown. Drugs and latency: 1. covid-19 vaccin pfizer injvlst death: 1 day after start dizziness: 1 day after start fatigue: latency unknown. Concomitant medication: pantoprazol tablet msr 40 mg aliskiren tablet 300 mg acetylsalicylic acid tablet 80 mg tamsulosine capsule mga 0.4 mg. Medical history: hypertension, atrial fibrillation. BioNTech/Pfizer vaccin (Comirnaty): no-passed away -Additional information ADR: 2 instances of dizziness after vaccine-BSN available: yes- COVID19-Previous COVID-19 infection: No-Other diagnostic procedures: No Follow-up 22Feb2021 Follow - up received: died at 17Feb2021 hypertension and atrial fibrillation, angle stomach protruding twice became dizzy and fell, fatigue after vaccination no, never not seen in the past 10 years attack dizziness no no test taken vaccine with great difficulty cause death no autopsy done unfortunately. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1073457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXOCOBALAMINE; ACENOCOUMAROL; ATIMOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021222071

Write-up: Nausea; Headache; Fatigue; not feeling well; This is a spontaneous report from a contactable CONSUMER OR OTHER NON PROFESSIONAL downloaded from the Regulatory Authority-WEB NL-LRB-00448644. A 98-years-old female patient received bnt162b2 (COMIRNATY) , via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation . Medical history included heart failure. Concomitant medication included hydroxocobalamine (HYDROXOCOBALAMINE), acenocoumarol (ACENOCOUMAROL), formoterol fumarate (ATIMOS). The patient experienced nausea, headache, fatigue, not feeling well on 06Feb2021. The patient was not admitted to the hospital & no treatment received because of her age which was policy. Confounding factors: heart failure; Previous COVID-19 infection: No. The patient deceased within 16 days after vaccination. The patient died on 19Feb2021. 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: nausea; not feeling well; fatigue; headache


VAERS ID: 1073458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Physical examination
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: Test Name: physical examination; Result Unstructured Data: Test Result:No obvious abnormalities were found
CDC Split Type: NLPFIZER INC2021222067

Write-up: Malaise, not feeling well After receiving the vaccine; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA). Regulatory Authority report number is NL-LRB-00449078. A 94-year-old female patient received bnt162b2 (COMIRNATY, lot number: unknown), via an unspecified route of administration on 11Feb2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced malaise, not feeling well after receiving the vaccine, the patient became bedridden and eventually died on an unspecified date. No obvious abnormalities were found physical examination. The outcome of the event malaise was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Malaise, not feeling well After receiving the vaccine


VAERS ID: 1073459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
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: 2021-02-18
   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: SPIRONOLACTON; BUMETANIDE; PREDNISON; ACENOCOUMAROL; COMBIVENT; BISOPROLOL; METFORMIN; BICALUTAMIDE; PANTOPRAZOLE; CYANOCOBALAMIN; AZITROMYCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226263

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB [NL-LRB-00453223]. An 86-year-old male patient received BNT162B2 (COMIRNATY, lot number unknown) via an unspecified route of administration on 17Feb2021 at single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTON), bumetanide, prednisone (PREDNISON), acenocoumarol, ipratropium bromide, salbutamol sulfate (COMBIVENT), bisoprolol, metformin, bicalutamide, pantoprazole, cyanocobalamin, and azithromycin (AZITROMYCINE), all taken from an unspecified date for an unspecified indication. It reported the patient was death following administration of covid-19 vaccine Pfizer injectable solution. It further reported that one day after vaccination (18Feb2021), the patient was resuscitated and deceased. It was unknown if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Death. Additional information ADR: Vaccinated on Wednesday 17Feb2021 via X, on Thursday morning 18Feb2021 ended up in a resuscitation setting and died. COVID19. Previous COVID-19 infection: No. Other diagnostic procedures: No. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Death. Additional information ADR: Vaccinated on Wednesday 17Feb2021 via X, on Thursday morning 18Feb2021 ended up in a resuscitation setting and died. COVID19. Previous COVID-19 infection: No. Other diagnostic procedures: No.; Reported Cause(s) of Death: death


VAERS ID: 1073466 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: ACETYLCYSTEINE; BETOLVIDON; ENALAPRIL; ACETYLSALICYLIC ACID; ATROVENT; TRIMBOW; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (alcoholism); CABG (past, previous CABG surgery); Cardiac failure (heart failure); Chronic obstructive lung disease (stage D); Hypertension; Ischemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021222173

Write-up: Death unattended; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number SE-MPA-2021-005462. Other case identifier number SE-MPA-1613660691877. Report from a physician regarding a 77-year-old male with chronic obstructive pulmonary disease GOLD stage D, ischemic heart disease, previous CABG surgery, hypertension, heart failure and alcoholism. Reported suspect vaccine is Comirnaty (Covid-19 vaccine). The reported adverse reaction is death not witnessed. The man was found dead one day after the vaccination with Comirnaty had been given. According to the reporter, no autopsy will be performed. Outcome: Fatal. Report assessed as serious, death. Concomitant medications were Atrovent, Betolvidon, Trimbow, acetylcysteine, acetylsalicylic acid, bisoprolol, enalapril. Batch/lot number: EL0725. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unattended


VAERS ID: 1074131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Death, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atheromatosis; Coronary heart disease; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Colonic polyp; Right inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20210

Write-up: Death; Probl?me cardiovasculaire; Uniquement une douleur au point d''injection le 05/02/21, aucune autre plainte/sympt?me; A regulatory authority report was received from a physician concerning a 55 years old, male patient who received Moderna''s Covid-19 Vaccine (mRNA-1273) and experienced cardiovascular disorder, injection site pain and death. The patient''s medical history, as provided by the reporter, included aortic aneurysm, hypertension, colonic polyp, atheromatosis, coronary heart disease, and right inguinal hernia. On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly (Lot number: 300042721) for prophylaxis of Covid-19 infection. On 05 Feb 2021, the patient experienced cardiovascular disorder and injection site pain. On 09 Feb 2021, the patient died. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, cardiovascular disorder, was fatal. The outcome of the event, injection site pain, was unknown. The cause of death was reported as cardiac disorder. It was unknown whether an autopsy was performed. Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of injection site pain, a causal relationship cannot be excluded. Based on reporter''s causality of unlikely the event of cardio vascular disorder is assessed as unlikely related to mRNA-1273. Of note, patient''s underlying HTA, coronary artery disease and aortic aneurysm may have been contributory to the occurrence of fatal cardio vascular disorder.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1074132 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Chills, Death, Dysstasia, Insomnia, Muscular weakness, Respiration abnormal, Restlessness, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass graft; Hypophysectomy; Neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20210

Write-up: Death; Cardiac arrest; Couldn''t wake him up; Breathing different; Shivering; No muscle strength; Unable to raise himself; Restless; Couldn''t sleep; A spontaneous report (United States) was received from a consumer concerning a 79-year-old, male patient was participated in the mRNA-1273 emergency use program and experienced cardiac arrest, could not sleep/insomnia, no muscle strength/muscular weakness, unable to raise/dysstasia, restlessness, could not wake up/somnolence, breathing different/respirations abnormal, shivering/chills, and died. The patient''s medical history included diabetes, triple bypass years ago, pituitary gland removal and neuropathy. Concomitant medications were not provided. On unknown date in Jan 2021, prior to the onset of the events,the patient received their first of two planned doses of mRNA-1273 (Batch number is not provided as well as the details of first dose of vaccination) for COVID-19 infection. On 11 FEB 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273(Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 FEB 2021,same day of second dose of vaccination the patient could not sleep, had no muscle strength and was unable to raise. On 12 FEB 2021,the patient become restless. On 13 FEB 2021,the patient could not wake up, was breathing different ,shivering, eyes were rolled up to the head. On 13 FEB 2021,the patient was taken to the hospital where he had cardiac arrest. The patient was resuscitated and was intubated, and was removed from the ventilator on 19 FEB 2021. On 21 FEB 2021,the patient died. An autopsy was done or not is unknown. The outcome of the event cardiac arrest is fatal. The outcome of the events insomnia, muscular weakness, unable to raise/dysstasia, restlessness, could not wake up/somnolence, breathing different/respirations abnormal, shivering/chills are not applicable.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1074140 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Hypophagia, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: No intake, From February 8th no appetite and don''t want to drink; Not feeling well; Fatigue; Pain in the joints; Headache; Myalgia; A regulatory report was received from a consumer concerning a 88-years-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myalgia, no intake, from February 8th no appetite and don''t want to drink, headache, pain in joints, fatigue and not feeling well. The patient''s medical history as provided by the consumer included dementia. No relevant concomitant medications were reported. On 03 Feb 2021, one day prior to the onset of events myalgia and headache, the patient received their dose of mRNA-1273 (Lot/batch: unknown) for prophylaxis of COVID-19 infection. On 03 Feb 2021, the patient experienced medically significant events of myalgia and headache. On 04 Feb 2021, the patient had medically significant event of pain in joints. On 08 Feb 2021, the patient had medically significant events of no intake, from February 8th no appetite and don''t want to drink, fatigue and not feeling well. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date, the patient died. The cause of death was myalgia, no intake, from February 8th no appetite and don''t want to drink, headache, pain in joints, fatigue and not feeling well. Plans for an autopsy were unknown.; Reporter''s Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of vaccine cannot be excluded however, the fatal outcome is assessed as unlikely as the patient refused intake. Causality is confounded by the patient''s advanced age and dementia.; Reported Cause(s) of Death: Myalgia; No intake, From February 8th no appetite and don''t want to drink; Headache; Pain in the joints; Fatigue; Not feeling well


VAERS ID: 1074911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death of unknown causes; A regulatory authority report was received from a health care professional concerning a 58 years old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced sudden death. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Batch number: 300042698) for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced sudden death with an unknown cause. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal. It was unknown whether an autopsy was performed.; Reporter''s Comments: This is a case of sudden death in a 58-year-old female patient with unknown medical history died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1075434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervix carcinoma (status after Cervix-Ca)
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Sars-CoV2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221782

Write-up: Death/ Sars-CoV-2 infection positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-04879]. A 89-years-old female patient received bnt162b2 (COMIRNATY, batch/lot number: EL1491), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. Medical history included status after Cervix-Ca (not ongoing Cervix carcinoma). The patient''s concomitant medications were not reported. The patient experienced SARS-COV-2 test positive on 22Jan2021. The patient died on 27Jan2021 from COVID-19 respiratory infection (also reported the patient experienced death on 22Jan2021). The cause of death was SARS-COV-2 infection according to death certificate. It was not reported if an autopsy was performed. The patient''s outcome was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1075435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ATPFIZER INC2021221791

Write-up: COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB AT-BASGAGES-2021-04881. A 91 years old male patient received first dose of bnt162b2 (COMIRNATY, Lot Number EL1491 and Expiration Date unknown) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history COVID-19 from unknown date (continuing). The concomitant medications were not reported. In Jan2021 the patient experienced COVID-19 and died on 30Jan2021 from COVID-19 respiratory infection. Lab test included positive COVID-19 PCR test on 25Jan2021. There is no autopsy was done. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1075436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 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: 2021-02-05
   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: COVID-19 (COVID infection in patient''s retirement home since Jan2021)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221795

Write-up: COVID-19 pos infection/COVID-19 respiratory infection; COVID-19 pos infection/COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-04885. An 85-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot EL1491), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included exposure to COVID-19 (ongoing COVID infection in patient''s retirement home since Jan2021). The patient''s concomitant medications were not reported. The patient experienced covid-19 pos infection on 28Jan2021. The patient died on 05Feb2021 from COVID-19 respiratory infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 28Jan2021. The patient died on 05Feb2021. An autopsy was not performed. BASGAGES comment: no further info available.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1075437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Cardio-respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 36
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 insufficiency; Chronic pain; Chronic renal insufficiency; Polyneuropathy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (COVID post Infection)
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221817

Write-up: Cardio-respiratory arrest; Cardiac insufficiency; COVID post Infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB AT-BASGAGES-2021-04887. A 91-year-old female patient received 1st vaccination of bnt162b2 (COMIRNATY, lot number: EL1491) via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. Ongoing underlying diseases include polyneuropathy, chronic pain syndrome, chronic renal insufficiency, cardiac insufficiency. Patient had COVID-19 (COVID post Infection) in Jan2021. The patient''s concomitant medications were not reported. A possible connection between deaths and COVID vaccinations carried out shortly before is suspected. The people were all vaccinated against COVID-19 on 15Jan2021 (1st vaccination with Comirnaty, batch EL1491), tested positive 4 to 13 days later (one patient 32nd Days later) and died 10 to 20 days after the vaccination (said patient 37 days later). A comparable number of deaths has not occurred in the retirement home in recent years. Since 01Jan COVID infection is circulating in the home. All 12/14 deceased were tested positive for Sars-CoV2 by means of PCR. The patient of this report is also positive, tested for Sars-CoV2 by means of PCR (20Jan2021), then on 06Feb2021 patient died in the home. Patient died on 06Feb2021 from COVID-19 respiratory infection, Cardio-respiratory arrest, Cardiac insufficiency. Causes of death according to death certificate from 07Feb2021: Cardiovascular arrest, known cardiac insufficiency, status post COVID positive infection. No autopsy performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac insufficiency; Cardio-respiratory arrest; COVID post Infection


VAERS ID: 1075450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY6789 / 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: 2021-02-11
   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: COPD; Ischemic cardiomyopathy; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021221880

Write-up: sudden death occurring 48 hours after the 2nd dose of vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority BE-FAMHP-DHH-N2021-77736. A 95-years-old male patient received the second dose of bnt162b2 (COMIRNATY) (Lot# EY6789), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunisation. The patient medical history included ischemic cardiomyopathy, chronic obstructive pulmonary disease (COPD), pacemaker. The patient''s concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. The patient experienced sudden death on 11Feb2021. Autopsy was not performed. Relatedness of drug to reaction/event for COMIRNATY to event reported by FAMHP as unclassifiable. Reporters comments: Treatment - No. CFS (cognitive function scale) : 6 but advanced dementia; nothing to report within hours after vaccination; the patient presented no acute symptoms prior to vaccination and had been examined a few days before with excellent clinical parameters. That said, the patient would turn 96 in the coming weeks with a history of ischemic heart disease, pacemaker and COPD (completely stable pathologies). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death occurring 48 hours after the 2nd dose of vaccine


VAERS ID: 1075452 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-30
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Carcinoma; Drug intolerance; Hip prosthesis insertion; Knee arthrodesis; Knee prosthesis insertion; Nephrectomy; Parkinson''s disease; Patella fracture (temporary arthrodesis of the left knee); Prostatectomy; Quadriceps tendon rupture (hospitalized in the trauma department for rupture of the left quadriceps tendon)
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:140/70; Comments: 140/70 before vaccination; Test Name: BP; Result Unstructured Data: Test Result:110/60; Comments: after vaccination; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: 35.7? before vaccination; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: after vaccination; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: evening; Test Name: Heart rate; Result Unstructured Data: Test Result:84; Comments: 84 beats; Test Name: Heart rate; Result Unstructured Data: Test Result:76; Comments: in the afternoon
CDC Split Type: BEPFIZER INC2021221936

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority BE-FAMHP-DHH-N2021-78000. An 82-year-old male patient received his first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on unknown date (reported as 29Jan2020) at single dose for COVID-19 immunisation. Medical history included hospitalized in the trauma department for rupture of the left quadriceps tendon, fracture of the left patella and temporary arthrodesis of the left knee, arterial hypertension, parkinsons disease, right PTG (total knee prosthesis), prostatectomy, right PTH (total hip prosthesis), right nephrectomy for carcinoma, no known allergy, but intolerance to morphine and derivatives. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 30Jan2021. Evolution of the ADR: Death. Frailty of the patient (autonomy, need for help): At the AVJ level: full support for hygiene care; full assistance for dressing and undressing; help 2 people for mobilizations. Urine and stool incontinence; space/time disorientation. Status within hours of vaccination: temperature of the day: 35.7 deg before vaccination, 36.7 deg after vaccination, 36.7deg evening; Blood pressure: 140/70 before vaccination and 110/60 after vaccination; Heart rate: 84 beats and 76 in the afternoon. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1075470 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-03-05
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: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas per magna; Bypass surgery; Carotid artery occlusion; Middle cerebral artery infarct; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222137

Write-up: Unclear cause of death; This is a spontaneous report received from a physician downloaded from the Regulatory Authority-WEB DCGMA number DE-DCGMA-21188150. A 79-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history included Myocardial infarction, Bypass surgery, Adipositas per magna, Middle cerebral artery infarct, Carotid artery occlusion. The patient''s concomitant medications were not reported. 16 days after vaccination the patient died on 28Jan2021, lasting for unknown. No autopsy performed. The event assessment per PEI as "Unclassifiable". Reporters comments: Unclear cause of death (was found lying lifeless in front of the bed). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: unclear cause of death (was found lying lifeless in front of the bed).; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death. 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: Unclear cause of death


VAERS ID: 1075471 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-02
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; dementia; depressive disorder (organic depressive disorder); exsiccosis; hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222174

Write-up: Death; This is a spontaneous report from physician downloaded from the Regulatory Authority -WEB DCGMA number DE-DCGMA-21188155. This report was forwarded via RA, however no RA number was provided. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration in Jan2021 at single dose for Covid-19 immunisation. Medical history included exsiccosis, acute on chronic renal failure, organic depressive disorder, dementia, hypertension. The patient''s concomitant medications were not reported. 11 days after vaccination the patient developed death on 02Feb2021. It was not reported if an autopsy was performed. Death certificate was not available. No follow-up attempts possible, information about lot/batch# cannot be obtain.; Reported Cause(s) of Death: death


VAERS ID: 1075480 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CL1441 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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 INC2021222115

Write-up: The lethal outcome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority - DE-PEI-PEI2021002875. A 97-year-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number CL1441), via an unspecified route of administration on 27Jan2021 (at age of 97 years old) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced the lethal outcome on 08Feb2021. On 08Feb2021 after vaccination the patient developed death. The patient died on 08Feb2021. It was unknown if an autopsy was performed. Event assessment: Attending Physician. Inconsistent causal association. No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1075481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coma, Dyskinesia, Pain, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; heart disease, unspecified; hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222117

Write-up: suspected Stroke; Fever; pain; comatose; jerking; This is a spontaneous report from a non-contactable consumer (granddaughter of the patient) received from the Regulatory Authority -WEB. Regulatory authority or other manufacturer number DE-PEI-PEI2021002878. An 88-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Feb2021 at single dose (reported 1 DF) for Covid-19 immunisation. Medical history included ongoing hypertension, ongoing heart disease, ongoing diabetes mellitus. Historical vaccine included first dose of Comirnaty on 25Jan2021 for covid-19 immunization. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced suspected stroke, fever, pain and comatose, the events were serious due to resulted in death. The patient died on 19Feb2021. It was not reported if an autopsy was performed. Details were as follows: Fever occurred about 1 to 2 days after vaccination. After 4 to 5 days, jerking appeared that had to be treated with morphine, and the patient became comatose. A stroke was suspected. Relatedness of drug to all reported reactions/events assesed as D. Unclassifiable. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain.; Reported Cause(s) of Death: fever; pain; comatose; suspected stroke


VAERS ID: 1075482 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
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: anemia; aphasia; basalioma; dysphagia; hemiparesis; incontinence; middle cerebral artery infarct
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222127

Write-up: Exitus letalis/decompensated heart failure; This is a spontaneous report from a non-contactable physician from the Regulatory Authority -WEB DE-PEI-PEI2021002881. A 92-years-old female patient received the first dose of BNT162B2 (COMIRNATY) (lot no.: EM0477) via an unspecified route of administration on 01Jan2021 at single dose for COVID-19 immunisation. Medical history included Middle cerebral artery infarct, Incontinence, Hemiparesis, Aphasia, Dysphagia, Anaemia, Basalioma; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jan2021 after vaccination the patient developed Death, lasting for unknown. Death cause was reported as decompensated heart failure. The patient died on 13Jan2021. An autopsy was not performed. Causality assessment was reported as Comirnaty/death/ PEI: C. Inconsistent causal association.; Reported Cause(s) of Death: Decompensated heart failure


VAERS ID: 1075483 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-18
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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 INC2021222147

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-PEI-PEI2021002903 This is a report received from the Regulatory Authority. A 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot#: EK9788), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had previously received the 1st dose of Comirnaty on 08Jan2021 for COVID-19 immunization and had been tolerated. On 18Feb2021 after vaccination the patient developed death. Death cause was reported as unknown cause of death. It was not reported if an autopsy was performed or not. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1075484 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222208

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician from the Regulatory Authority -WEB DE-PEI-PEI2021002935. A 85-year-old male patient received bnt162b2 (COMIRNATY, batch number: EJ6789), via an unspecified route of administration on 20Feb2021 at the age of 85-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced exitus letalis on 22Feb2021. 2 day after vaccination the patient developed death, lasting for unknown. The time interval between beginning of drug administration and start of reaction was also reported as 3 days. The patient was dead on 22Feb2021. It was not reported if an autopsy was performed. The assessment of bnt162b2 and death was D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1075485 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: cardiac insufficiency; COPD; dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: Body temperature; Result Unstructured Data: Test Result: 39.7 Centigrade.
CDC Split Type: DEPFIZER INC2021222216

Write-up: Exitus letalis; Febrile reaction/Hyperpyrexia; This is a spontaneous report from a non-contactable physician from the Regulatory Authority -WEB DE-PEI-PEI2021002940. A 89-years-old male patient received second dose of bnt162b2 (COMIRNATY, batch/lot number EJ6788), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunisation. Medical history included cardiac insufficiency, chronic obstructive pulmonary disease (COPD), dementia. The patient''s concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 22Jan2021 for covid-19 immunisation and patient had been tolerated. The patient experienced exitus letalis on 15Feb2021, febrile reaction/hyperpyrexia on 14Feb2021. Event seriousness criteria was death. The lab data included body temperature: 39.7 centigrade on 14Feb2021. The patient died on 15Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event ''hyperpyrexia'' was confirmed with temperature value below 41.5?C (or 106.7?F, choose the appropriate value), a value which, from a medical point of view is not consistent with ''hyperpyrexia''. The Company therefore coded this event as ''pyrexia''.; Reported Cause(s) of Death: Febrile reaction/Hyperpyrexia; Exitus letalis


VAERS ID: 1075486 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / 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: 2021-02-23
   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: atrial fibrillation; cardiac insufficiency; coronary heart disease; heart valve insufficiency; herpes zoster; osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: positive/positive NA; Test Date: 20210222; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result: positive/positive NA.
CDC Split Type: DEPFIZER INC2021222219

Write-up: Exitus letalis/dead; COVID-19 rapid POC test positiv/positive,COVID-19 PCR test positiv/positive; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-PEI-PEI2021002943. This is a report received from the Regulatory Authority. A 85-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6789), intramuscular on 13Feb2021 at single dose for Covid-19 immunisation. Medical history included coronary heart disease, cardiac insufficiency, heart valve insufficiency, atrial fibrillation, osteoporosis and herpes zoster all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 23Feb2021 after vaccination the patient developed exitus letalis/death, lasting for unknown. The patient was dead. The patient underwent lab tests and procedures which included COVID-19 rapid POC test (result: positive/positive, unit: NA), COVID-19 PCR test (result: positive/positive, unit: NA) both on 22Feb2021. An autopsy was not performed. Relatedness of drug to reaction/event assessed as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Exitus letalis/dead


VAERS ID: 1075487 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Circulatory collapse, General physical health deterioration, Influenza, Jaundice, Myocarditis septic, Pain in extremity, Pyrexia
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), 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), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: Chronic lymphatic leukemia
Preexisting Conditions: Medical History/Concurrent Conditions: aortic bypass; cardiac insufficiency; chronic renal insufficiency; coronary heart disease; heart valve insufficiency; hyperlipidemia; hypertension arterial; myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: body temperature; Result Unstructured Data: Test Result: 40 Centigrade; Comments: fever up to 40 ? C.
CDC Split Type: DEPFIZER INC2021226115

Write-up: Jaundice; Fever up to 40 ? C; Suspected septic myocarditis; Tendency to collapse; Deterioration in general condition; Feeling flu; Limbs ache; weakness; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-PEI-PEI2021002976. This is a report received from the Regulatory Authority. An 89-year-old male patient received his first dose of bnt162b2 (COMIRNATY, lot number EL8723), via an unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunisation. Medical history included chronic lymphatic leukaemia from Mar2015 and ongoing, coronary heart disease, aortic bypass, cardiac insufficiency, myocardial infarction from 2016, heart valve insufficiency, hypertension arterial, hyperlipidaemia and chronic renal insufficiency. The patient''s concomitant medications were not reported. The patient experienced feeling flu, weakness, limbs ache, tendency to collapse and deterioration in general condition on 11Feb2021, jaundice, fever up to 40 ? c and suspected septic myocarditis on 19Feb2021. Events seriousness was reported as death. The patient died on 19Feb2021. It was unknown if an autopsy was performed. Death cause was reported as Myocarditis septic. Relatedness of drug to Myocarditis septic + Jaundice: Unclassifiable. Relatedness of drug to the rest events: Consistent causal association to. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Sender''s Comments: The reported event ''hyperpyrexia'' was confirmed with temperature value below 41.5?C (or 106.7?F, choose the appropriate value), a value which, from a medical point of view is not consistent with ''hyperpyrexia''. The Company therefore coded this event as ''pyrexia''.; Reported Cause(s) of Death: Feeling flu; Jaundice; weakness; Fever up to 40 ? C; Limbs ache; Tendency to collapse; Deterioration in general condition; Myocarditis septic


VAERS ID: 1075488 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: coronary heart disease (with EF 20%)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021226131

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number DE-PEI-PEI2021002992. A 85-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number unknown), via an unspecified route of administration on 23Feb2021 at single dose for Covid-19 immunisation. Medical history included coronary artery disease from 2017 to an unknown date with EF 20%. The patient''s concomitant medications were not reported. The patient experienced 1 hour(s) after vaccination the patient developed sudden cardiac death on 23Feb2021. The patient was dead. It was not reported if an autopsy was performed. Event Assessment: sudden cardiac death. Unclassifiable. Reporters comment: One hour after the vaccination, the patient had to be resuscitated. Died despite resuscitation. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1075489 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021226813

Write-up: death; subcutaneously on 11Feb2021; This is a spontaneous report from a contactable healthcare professional and physician. An 86-year-old male patient received the second dose of BNT162B2 (COMIRNATY) (lot number unknown), Subcutaneously on 11Feb2021 (at the age of 86-year-old) at single dose for COVID-19 vaccination. The patient medical history was not provided. Patient had taken medication (unspecified) before reported event. No other vaccinations (including SARS-CoV 2) performed shortly before reported event. The patient previously vaccinated the first dose of BNT162B2 (COMIRNATY) (lot number unknown) for COVID-19 vaccination on 14Jan2021 at single dose, intramuscularly in upper arm and developed Urticaria (in extremities, face, body stem). It was reported: "Patient died on 20Feb2021 (2. dose administered). An anaphylactic reaction is not known to me. The confirmation of death has not been performed by me". The patient died on 20Feb2021.It was unknown if an autopsy was performed or not. information on the lot/batch number has been requested.; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1075530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal exploration, Cachexia, Constipation, Dyspnoea, General physical health deterioration, Pain, Restlessness, SARS-CoV-2 antibody test, SARS-CoV-2 test, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LACTULOSA; TRAZODONA [TRAZODONE]; PARACETAMOL; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Aphasia motor; Atrial fibrillation; Constipation; Crural hernia; Hemorrhage intracerebral; Hyporexia; Intestinal obstruction (FOR INCARCERATED LEFT CRURAL HERNIA); Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: exploration Abdomen; Result Unstructured Data: Test Result:without relevant findings; Test Date: 20210104; Test Name: SARS-CoV-2 antibody test; Test Result: Positive ; Test Date: 20210201; Test Name: PCR SARS-CoV-2; Test Result: Positive
CDC Split Type: ESPFIZER INC2021226094

Write-up: Tendency to sleep; Constipation; Cachectic; restlessness; dyspnea; impression of pain; General physical health deterioration; This is a spontaneous report received from a contactable physician, downloaded from the Medicines Agency (MA) ES-AEMPS-767074. An 83-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: el8723), intramuscular on 12Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included intestinal obstruction from 24Apr2011 for incarcerated left crural hernia, anaemia from an unknown date, irritable bowel syndrome from an unknown date, Hyporexia from an unknown date, atrial fibrillation from an unknown date, constipation from an unknown date, Hemorrhage intracerebral from an unknown date, motor aphasia (comprehension is maintained) from an unknown date. Concomitant medication included lactulosa, trazodona [Trazodone], paracetamol, bisoprolol. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 22Jan2021 for COVID-19 immunisation. The patient was Institutionalized patient. Hospital admission (internal medicine) was from 25Jan2021 to 06Feb2021. LABORATORY included PCR SARS CoV 2 (01Feb2021, positive). She was discharged with a diagnosis of acute renal failure and hypernatremia due to dehydration. Atrial fibrillation with rapid RV. Bisoprolol dose was adjusted and digoxin was added. Upon follow-up on 12Feb2021, she was vaccinated with bnt162b2 on 12Feb2021 for the 2nd dose. The patient experienced general physical health deterioration on 13Feb2021. On 15Feb2021 MAP: Progressive deterioration. It did not accept solid or water intake. The patient experienced tendency to sleep, constipation, bedridden, cachectic, complaining to exploration, abdomen and PCA without relevant findings. End of life impression. Physician recommend taking a sc (Subcutaneous) route and in case of restlessness, dyspnea or impression of pain, use 1cc of dilution of 1 amp of midazolam 15mg + 1 amp of morphine 1% and 7cc SF. On 16Feb2021, MAP: Agonia. Patient was in terminal stage, with rescue morphine chloride, the last hours more deteriorated. On 17Feb2021, Exitus at dawn. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive on 04Jan2021, PCR SARS-CoV-2: positive on 01Feb2021, exploration Abdomen without relevant findings on 15Feb2021. The patient died on 17Feb2021. The outcome of event general physical health deterioration was fatal. The outcome of the other events was unknown. It was not reported if an autopsy was performed. Reporter''s Causality assessment: Despite the chronology, the patient''s history and her evolution after discharge suggest an alternative causal explanation, not related to the vaccine, for her deterioration and death. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available the reported events deterioration and death are considered not related to the vaccine.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1075596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Investigation, Livedo reticularis, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: KARDEGIC; LANTUS; LASILIX [FUROSEMIDE]; ALDACTONE [SPIRONOLACTONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Cardiac failure; Diabetes mellitus insulin-dependent; Hypertension arterial; Living in nursing home (for about 7 or 8 years); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 202102; Test Name: Temperature; Result Unstructured Data: Test Result:monitored without any particular anomaly; Test Date: 202102; Test Name: constants; Result Unstructured Data: Test Result:monitored without any particular anomaly; Test Date: 20210126; Test Name: COVID-19 PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232830

Write-up: Death unexplained; patient was a little mottled at the level of the thorax; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-DJ20210314. A 92-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscularly on 18Feb2021 around 3 p.m as a single dose (1 DF) for covid-19 immunisation, lot number: EK9788. Medical history included arterial hypertension, cardiac failure, diabetes mellitus insulin-dependent, vascular dementia and asymptomatic Covid19 in Oct2020. She had no history of stroke or transient ischemic attack; no history of arrhythmia. Patient had been living in a nursing home for about 7 or 8 years. Concomitant medications included acetylsalicylate lysine (KARDEGIC), insulin glargine (LANTUS), furosemide (LASILIX) and spironolactone (ALDACTONE). No psychotropic treatment. First vaccine dose of BNT162B2 (COMIRNATY) was administered on 26Jan2021 for COVID-19 immunisation, lot number: unknown. The first dose of vaccine had gone very well. It was reported that patient died suddenly and unexplained the day after second (2 nd) injection of COMIRNATY (Lot EK9788). A polymerase chain reaction (PCR) was carried out at the time of the first vaccine dose of COMIRNATY, on 26Jan2021, and came back negative. No current context of Covid19 disease in the facility for dependent elderly people (as reported). The blood pressure checked recently and more particularly at the time of the vaccination against Covid19 were normal. The patient received a second (2 nd) dose of COMIRNATY on 18Feb2021 around 3 p.m. No particular event was noted in the afternoon, evening or during the nurse''s night shift. Temperature and constants were monitored without any particular anomaly. The next morning, on 19Feb2021, the nurse found the deceased patient in her bed. She was still warm, evoking a very recent death. The nurse found that the patient was a little mottled at the level of the thorax, not frank according to the doctor. There was no obvious particular context: no sign of vomiting, no sign of restlessness. The patient was found as if she were sleeping. No autopsy was performed. Declaration made taking into account the chronology with regard to the vaccination against Covid19. Outcome of the other event was unknown. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1076452 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-04
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 9
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: Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Oxygen saturation; Test Result: 60 %; Test Date: 20210204; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021228856

Write-up: SARS-CoV-2 infection; unwell; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102282003076740, Safety Report Unique Identifier GB-MHRA-ADR 24852738. A 68 year old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:EL0739) via an unspecified route of administration, on 29Jan2021 at single dose for COVID-19 immunisation. The patient medical history included: reporter was unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 04Feb2021 the patient experienced SARS-CoV-2 infection (death, hospitalization and medically significant) and unwell (hospitalization and medically significant). The patient underwent lab tests and procedures which included oxygen saturation (04Feb2021): 60 % and COVID-19 virus test (04Feb2021): yes - positive COVID-19 test. The patient died on 13Feb2021. The patient had not recovered from the event unwell at the time of death. It was not reported if an autopsy was performed. The reported cause of death was SARS-CoV-2 infection. The clinical course was reported as follows: Patient became unwell on the evening of the day of his covid jab. Gradually deteriorated and was tested positive for covid on the 04Feb2021. The reporter saw him at the covid hub on the 4th where his saturations were 60%. He was sent to hospital where he passed away on the 13Feb2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1076453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Constipation, Pyrexia, Rhabdomyolysis, SARS-CoV-2 test, Seizure
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: BACLOFEN; BUDESONIDE; COLOMYCIN [COLISTIMETHATE SODIUM]; GABAPENTIN; LAMOTRIGINE; MELATONIN; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haematoma; Cerebral palsy (Patient had complex PMH with severe cerebral palsy, 1 functioning kidney and epilepsy); Chronic pain; Constipation; Epilepsy (Patient had complex PMH with severe cerebral palsy, 1 functioning kidney and epilepsy); Kidney absent (Patient had complex PMH with severe cerebral palsy, 1 functioning kidney and epilepsy); Nephrectomy; Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021228309

Write-up: acute kidney injury; rhabdomyolysis; seizures; Fever; constipation; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103011429430490, Safety Report Unique Identifier GB-MHRA-ADR 24857405. A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Not known), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunisation. Medical history included: patient had complex past medical history with severe cerebral palsy, constipation, epilepsy, cerebral haematoma, 1 functioning kidney, previous nephrectomy, chronic pain and tracheostomy. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included baclofen and colistimethate sodium (COLOMYCIN, reported as colistimethate sodium, colistin sulphate) for Cerebral palsy, budesonide, gabapentin for pain, lamotrigine for Epilepsy, melatonin and omeprazole. The patient experienced fever on 14Feb2021, serious due to death and medically significant; seizures, acute kidney injury, rhabdomyolysis, all in Feb2021 and were considered as serious due to death, hospitalization, medically significant; constipation (non-serious) in Feb2021. Non-specifically unwell with constipation in Feb2021 and fevers. Exact timescale unclear. Likely developed fevers approximately 1 week after vaccine. Advised to give regular paracetamol. Developed seizures in Feb2021 and on hospital admission on 20Feb2021, had evidence of rhabdomyolysis and acute kidney injury. Not appropriate for dialysis. Treated with IVF, ambroxol hydrochloride (reported as Abx) and N-AC but died on 23Feb2021. Cause of death AKI secondary to rhabdomyolysis secondary to seizures. No definite association to vaccine but reported as poorly controlled seizures in context of recent vaccination when had been stable at home for years. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 20Feb2021. Therapeutic measures were taken as a result of acute kidney injury, rhabdomyolysis, seizures and fever. The patient died on 23Feb2021. It was not reported if an autopsy was performed. The outcome of event constipation was unknown, outcome of the other events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: AKI secondary to rhabdomyolysis secondary to seizures; AKI secondary to rhabdomyolysis secondary to seizures; fever; AKI secondary to rhabdomyolysis secondary to seizures


VAERS ID: 1076454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Disease recurrence, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; FOSTAIR; VENTOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (Admission to hospital 14May2020-15May2020); Alcoholic liver disease; COPD; Hypertension; Hyponatraemia (chronic hyponatraemia. Admission to hospital 10Feb2020-13Feb2020); Comments: History of alcoholic liver disease, COPD and chronic hyponatraemia. Admission to Hospital 10-13/2/20 with hyponatraemia secondary to excess alcohol. Admission to NGH 14-15/5/20 with upper abdominal pain no specific diagnosis. Tested positive for covid during that admission although not clear whether symptomatic. During that admission was noted to be hypertensive and was invited to follow up high BP with GP. Came for hypertension assessment in January following his routine COPD check, home BP diary confirmed hypertension, started amlodipine 5mg. Unsure if patient has had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20200514; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive
CDC Split Type: GBPFIZER INC2021235059

Write-up: Death; abdominal pain; abdominal pain; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103020916328620, Safety Report Unique Identifier GB-MHRA-ADR 24861031. A 58-years-old male patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) (lot number:ER1741), via an unspecified route of administration on 24Feb2021 at single dose for COVID-19 immunisation. Medical history included abdominal pain, alcoholic liver disease, hyponatraemia, hypertension/ hypertension, chronic obstructive pulmonary disease (COPD). History of alcoholic liver disease, COPD and chronic hyponatraemia. Admission to hospital 10Feb2020-13Feb2020 with hyponatraemia secondary to excess alcohol. Admission to hospital 14May2020-15May2020 with upper abdominal pain no specific diagnosis. Tested positive for COVID during that admission although not clear whether symptomatic. During that admission was noted to be hypertensive and was invited to follow up high BP with GP. Came for hypertension assessment in January following his routine COPD check, home BP diary confirmed hypertension, started amlodipine 5 mg. Unsure if patient had had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medication included amlodipine from 19Feb2021 for hypertension, beclometasone dipropionate, formoterol fumarate (FOSTAIR) from 31Jan2019 for COPD, pneumococcal vaccine polysacch (PNEUMOCOCCAL POLYSACCHARIDE VACCINE) on 26Jan2021 for COPD, salbutamol sulfate (VENTOLIN) from 31Jan2019 for COPD. The patient experienced abdominal pain and death on 26Feb2021. Event details included presented with severe abdominal pain on 26Feb2021, died the same day in A&E, cause unknown, awaiting post mortem examination. The reporter had spoken to his wife and explained that we need to report his death as just a couple of days after the vaccination, although it''s likely to be a coincidence. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive on 14May2020. The patient died on 26Feb2021. The outcome of the event abdominal pain was unknown. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1076460 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Diarrhoea, Malaise, Oesophageal varices haemorrhage, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Liver cirrhosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021184938

Write-up: Vomiting; Diarrhoea; She started to be sick; Bleeding esophageal varices; coma; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 14:30 at single dose for covid-19 immunization. The patient''s medical history included diabetic type 2 and cirrhosis of the liver. The patient''s concomitant medications were not reported. They gave the leaflet to the patient after the injection is given and this is not good. As of 22Feb2021, patient started to be sick as soon as she got home on the evening of 22Jan2021. She then thought she was getting better, but then it came back. On 22Jan2021 15:30 the patient experienced consisted of vomiting and diarrhoea which continued until the patients death on 26Jan2021 at 9.00 am. The daughter made two phone call to the doctor''s surgery for the doctor to phone her mother ASAP as 111 were not helpful. An ambulance took the patient to Emergency but the patient did not regain consciousness. The patient was found in a coma. The patients daughter was called within 10 minutes, she did cardiopulmonary resuscitation (CPR) for 20 mins and called an ambulance, they tried all they could, adrenaline etc, taken to Emergency but later passed away at 9 am. The patient died on 26Jan2021 9:00. Cause of death as reported on the death certificate include: I (a) Bleeding esophageal varices, (b) cirrhosis, (c) non-alcoholic liver disease, II diabetes mellitus, chronic kidney disease. It was not reported if an autopsy was performed. The outcome of the other events was not recovered. Information on the lot/batch number has been requested. Follow-up (22Feb2021): New information received from the same consumer included: patient details, medical history, product information (vaccination date specified as 22Jan2021) and reaction data (new events ''to be sick and coma''). Information on the lot/batch number has been requested. Follow-up (01Mar2021): New information from the same consumer (the patients daughter) includes: new event (Bleeding esophageal varices), cause of death, event details. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cirrhosis; non-alcoholic liver disease; diabetes mellitus; chronic kidney disease; Bleeding esophageal varices


VAERS ID: 1076462 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic kidney disease; Community acquired pneumonia; Fall; Hypertension; Mobility decreased; Pain in arm; Weakness of arms; Comments: Pacemaker fitted Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021201419

Write-up: condition only deteriorated further; This is a spontaneous report from a contactable consumer for his mother. This consumer reported events for two separate vaccine doses. This is the second of two reports for the second vaccine dose. The first report is a report received from the Regulatory authority; report number GB-MHRA-WEBCOVID-202102201443489280. A 94-year-old elderly female patient received the second dose of bnt162b2 via an unspecified route of administration on an unspecified date, lot number unknown, at single dose for COVID-19 immunization. Medical history included community acquired pneumonia, chronic kidney disease, atrial fibrillation, hypertension, fall, pain and weakness in her right arm, mobility difficulties. Prior to her vaccination, the patient suffered mobility difficulties but was able to move around her bungalow with the aid of a trolley, and with some effort and assistance was able to get outside to travel as a car passenger or for short excursions being pushed in her wheelchair. After a previous fall, she had also experienced pain and weakness in her right arm, though by the beginning of Dec2020, she said that it was improving. The patient''s concomitant medications were not reported. The patient received first vaccination of bnt162b2, lot number EJ0553, in her left arm on 08Dec2020 and experienced chronic kidney disease on an unspecified date, mobility decreased on 09Dec2020, loss of energy on 09Dec2020, appetite lost on 09Dec2020. Immediately following her first vaccination, the patient lost all use of her right arm. She no longer had sufficient strength in this arm to even lift her plastic beaker of water and had to have all of her food cut up for her. It was pitiful to see her chasing her food around her plate with a fork in her left hand and from this point on understandably she no longer seemed interested in food whereas previously she had a very healthy appetite. She would sit constantly holding her right arm. She also suffered a catastrophic decline in mobility - on the few occasions she got up from her lounge chair, she walked with a significant lean and stoop to her right. The difficulty and effort in getting up and moving around meant that during the day and the night she no longer even made the effort to go to the toilet. She accordingly reduced her already meagre intake of fluids, which the reporter contributed significantly to the cause of chronic kidney disease. When the time arrived for her second vaccination, it was an almost impossible task for even reporter''s wife and reporter to manoeuvre her into and out of the car to attend the appointment. At the hospital, reporter expressed his concerns about patient''s apparent reaction to the first vaccination. The colleague suggested going ahead with the vaccination and the patient received the second dose. The patient''s condition only deteriorated further from that day onwards. She required help to get up out of bed and to get washed. She needed food and drinks prepared for her and she also needed help in dressing and undressing. The reporter commented that a previously independent lady needed a lot more care from around the time that the vaccinations were administered. The patient was admitted to hospital on 09Jan2021 and she later died in hospital on 11Jan2021. The reporter stated the he accepted the deterioration in patient''s condition and the timing of her vaccinations may be purely coincidental but he thought it worthwhile to bring concerns in case they are of any medical significance. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on an unspecified date. The patient died on 11Jan2021. The death certificate cited "Community acquired pneumonia" as the primary cause, with contributory factors of hypertension, chronic kidney disease and atrial fibrillation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021186665 same patient, drug, different AE under separate dose; Reported Cause(s) of Death: condition only deteriorated further; Community acquired pneumonia; hypertension; chronic kidney disease; atrial fibrillation


VAERS ID: 1076464 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-16
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, 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: 2021-03-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CLL
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: SATS; Result Unstructured Data: Test Result:low; Test Date: 20210216; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021203766

Write-up: tested positive on 16th February/ died directly as a result of COVID; tested positive on 16th February/ died directly as a result of COVID; This is a spontaneous report from a contactable consumer reporting on behalf of her father (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL). The patient''s concomitant medications were not reported. The patient received his first Pfizer COVID vaccine in early January. The reporter returned and both she and her father (patient who received the vaccine) displayed symptoms of COVID last week (Feb2021). They tested positive on 16Feb2021. The patient tested positive following receipt of the Pfizer vaccine. He was a retired general practitioner and currently shielding. The patient has died directly as a result of COVID, the elderly gentleman was 77 with underlying, treated CLL and received immunoglobulins on a 3 monthly basis. He was admitted to hospital on Saturday 27Feb2021 as his SATS were incredibly low and then placed on CPAP on Sunday 28Feb2021. He passed away on the evening of Monday 1Mar2021. He had received his first dose of the Pfizer vaccine some weeks ago but not received the 2nd dose. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died directly as a result of COVID; died directly as a result of COVID


VAERS ID: 1076562 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Subarachnoid 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: 2021-03-01
   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:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: cerebrospinal fluid test; Result Unstructured Data: Test Result:bloody fluid
CDC Split Type: JPPFIZER INC2021226430

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received via COVAES, Pfizer-BioNTech COVID-19 Vaccine Adverse Event Reporting System. The regulatory authority number is v20100863. A 61-year-old non-pregnant female received the first dose of BNT162B2 (COMIRNATY, Lot number: EP2163, Expiration date: 31May2021, Solution for injection) intramuscularly in arm left on 26Feb2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation in a hospital. The patient had no underlying illness. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Mar2021 (3 day after the vaccination), the patient experienced subarachnoid haemorrhage and the patient died due to the event. On 01Mar2021, the patient was scheduled to go to work but did not come to the workplace. The reporter was unable to contact the patient, so her family was contacted. The patient''s family member who returned home found her lying in the bathroom at home and requested an ambulance. The patient was in cardio-respiratory arrest upon the arrival of the ambulance crews, and she was taken to a medical facility, and the death was confirmed. A cerebrospinal fluid test was performed at the medical facility where the patient was transported, and as a result, bloody fluid was confirmed. The reporting physician classified the event as serious (resulting in death). Therapeutic measures were reported as unknown as a result of the event. Therefore, subarachnoid hemorrhage was considered to be the cause of death, but the final diagnosis would be based on the autopsy results. An autopsy was performed with the result unknown. Causality assessment between the event and BNT162B2 was not provided.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1076577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Dyspnoea, Hypotension, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (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: Cervical vertebral fracture (neck fracture for which surgery and then delirium.); Delirium; Femur fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: fever: 38 to 40.5 celsius degrees
CDC Split Type: NLPFIZER INC2021221946

Write-up: dyspnoea: severity increased progressively; hypotension: severity increased at a progressive rate; Fever: 38 to 40.5 Celsius degrees; Cold shivers; Myalgia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority NL-LRB-00445703. An elderly male patient (also reported as "a male aged 90 years") received BNT162B2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 05Feb2021 at single dose (reported as "1 DF") for covid-19 immunisation. Medical history included femur fracture, delirium, neck fracture for which surgery and then delirium. No previous COVID-19 infection. No past drug therapy BioNTech/Pfizer vaccine. The patient''s concomitant medications were not reported. The patient experienced fever: 38 to 40.5 celsius degrees on 10Feb2021, myalgia on 06Feb2021, cold shivers on 10Feb2021, dyspnoea: severity increased progressively on 11Feb2021, hypotension: severity increased at a progressive rate on 10Feb2021. The case was reported as serious due to death outcome of all reported events. It was reported that the patient with dyspnoea (death), chills (death), myalgia (death), pyrexia (death), hypotension (death) following administration of covid-19 Pfizer vaccine. Chills was treated with paracetamol, dyspnoea is treated with oxygen and palliative care, hypotension is treated with oxygen and palliative care and pyrexia is treated with paracetamol. The outcome of chills is fatal, the outcome of dyspnoea is fatal, the outcome of hypotension is fatal, the outcome of myalgia is fatal and the outcome of pyrexia is fatal. The severity of dyspnoea and hypotension increased at a progressive rate. Drugs and latency: dyspnoea: 6 days after start, chills: 5 days after start, myalgia: 1 days after start, pyrexia: 5 days after start, hypotension: 6 days after start. Treatment received for all reported events. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: fever: 38 to 40.5 celsius degrees; myalgia; cold shivers; dyspnoea: severity increased progressively; hypotension: severity increased at a progressive rate


VAERS ID: 1076579 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: INSULINE ASPARTE; PERINDOPRIL; ATORVASTATINE [ATORVASTATIN]; SPIRONOLACTON; FENPROCOUMON; METOPROLOL; FUROSEMIDE; INSULINE DETEMIR; TRAMADOL/PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; COVID-19 (hospitalization); Decompensation cardiac; Peripheral arterial disease (Fontaine intravenously)
Allergies:
Diagnostic Lab Data: Test Date: 20201222; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021222049

Write-up: no cause of death was found; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA). Regulatory Authority Report Number: NL-LRB-00450839. This is a spontaneous report received from a contactable physician. A 79 years old male patient received bnt162b2 (COMIRNATY, Lot Number and Expiration Date unknown) via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 (22Dec2020), decompensation cardiac, cerebrovascular accident, peripheral arterial disease (Fontaine intravenously). Concomitant medication included atorvastatine tablet 40mg, phenprocoumon (FENPROCOUMON) tablet 3mg, furosemide tablet 40mg, insuline detemir injection 100 units/ml, metoprolol modified-release tablet 200mg, (tartrate) insuline aspart injection 100 units/ml, perindopril tablet 4mg (erbumine), spironolacton tablet 25mg, paracetamol, tramadol hydrochloride (TRAMADOL/PARACETAMOL) film-coated tablet 37.5mg/325mg. 2 days after administration, patient was death on 08Feb2021. The reporter described that autopsy (obduction) was done. At time of reporting, only the macroscopic result was known: no cause of death was found. Lab test included corona, confirmed with positive test on 22Dec2020. Sender Comment: Based on the reporter''s narrative the outcome of the reaction (death) was adjusted from not recovered to fatal by the assessor. Case Summary and Reporter''s Comments Text : Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: patient was found dead on 08Feb2021 in the morning by healthcare workers. BSN available: Yes. Confounding factors: Cardiac decompensation, CVA (cerebrovascular accident), PAV fontaine IV (which stands for tissue loss, necrosis). Previous COVID-19 infection: disease symptoms: hospitalization. Other - diagnostic procedures: Obduction, only macroscopic result known so far. No cause of death was found. The results of the microscopy, pathology and possibly brain obduction will follow. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: no cause of death was found


VAERS ID: 1076580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021221957

Write-up: resulted in death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00451820. A 79-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Oct2020 to an unknown date (disease symptoms: quite). The patient''s concomitant medications were not reported. Past drug therapy BioNTech/Pfizer vaccin (Comirnaty) reported as no. The patient experienced death on 17Feb2021. The cause of death was unknown. The patient underwent lab tests and procedures which included corona, confirmed with test: positive on 28Oct2020. The patient died on 17Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1076581 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Confusional state, Depressed level of consciousness, Epilepsy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: PARACETAMOL; PASSIFLORA ALATA EXTRACT; OMEPRAZOL; EUTHYROX; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with no symptoms)
Allergies:
Diagnostic Lab Data: Test Date: 20201216; Test Name: corona, bevestigd met test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021221962

Write-up: CVA; sudden confusion / gibberish; Consciousness decreased; Fever; with vomiting; epileptic seizure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB manufacturer report number NL-LRB-00452103. A 95-years-old male patient received bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 with no symptoms from 16Dec2020. Concomitant medications included paracetamol, passiflora alata extract, omeprazole (OMEPRAZOL), levothyroxine sodium (EUTHYROX), macrogol. No past drug therapy. The patient was died 3 days after vaccination due to sudden confusion / gibberish, consciousness decreased, fever, with vomiting, epileptic seizure, the events onset date was on 05Feb2021. It started with a confusional state and fever, followed by a decreased level of consciousness and seizure with vomiting. After this the patient did not regain consciousness again. Confounding factors: CVA (cerebrovascular accident) / epileptic seizure. No diagnostic procedures. The patient underwent lab tests and procedures which included corona confirmed by test: positive on 16Dec2020. The patient died on 07Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CVA; sudden confusion / gibberish; Consciousness decreased; Fever; with vomiting; epileptic seizure


VAERS ID: 1076582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: QUETIAPINE; OXAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius
CDC Split Type: NLPFIZER INC2021226258

Write-up: Fatigue; Pyrexia; Decreased appetite; Malaise; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA), regulatory Authority Report Number NL-LRB-00452721. A 77-years-old female patient received second dose of bnt162b2 (COMIRNATY) (lot number: EJ6795), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunisation. Medical history included dementia. Concomitant medication included quetiapine and oxazepam. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 19Jan2021 at single dose for prophylactic vaccination, first covid-19 vaccine pfizer vaccination with no adverse event. The patient experienced fatigue, pyrexia, decreased appetite and malaise on 11Feb2021 following the second administration of covid-19 vaccine Pfizer injection. The report was reported as serious with the criteria of death. The outcome of the events was fatal. The patient died on 2021. Cause of death was reported as not feeling well, fever: 38 to 40.5 degrees Celsius, Loss of appetite and fatigue. It was not reported if an autopsy was performed. Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes. Adverse drug reactions: None. Date: 19Jan2021. Loss of appetite. Additional information adverse drug reaction: No need more food and drink. Confounding factors: Dementia. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: not feeling well; Fever: 38 to 40.5 degrees Celsius; Loss of appetite; fatigue


VAERS ID: 1076583 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Pneumonia aspiration
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple system atrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226273

Write-up: Aspiration pneumonia; Swallowing impaired; Dyspnoea; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Medicines Agency (MA) WEB manufacturer report number NL-LRB-00452923. A 92-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 01Feb2021 at single dosefor covid-19 immunisation. Medical history included multiple system atrophy (MSA). The patient''s concomitant medications were not reported. The patient experienced aspiration pneumonia, swallowing impaired, dyspnoea on 01Feb2021, which occurred 5 hours after started. Events were treated with antibiotics. The patient died on an unspecified date. Cause of death was reported as aspiration pneumonia, swallowing impaired, dyspnoea. It was not reported if an autopsy was performed. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no pneumonia Additional information ADR: severe tightness of the chest and inability to swallow BSN available: yes confounding factors confounding factors: MSA COVID19 Previous COVID-19 infection: No Other diagnostic procedures: was no longer welcome in hospital, blood pressure measurement, oxygen measurement Comments on report form: It is possible that this case has already been reported. I am the daughter and am only now getting around to it. The doctor mentioned choking pneumonia. This is because of the MSA.; Reporter''s Comments: Additional information ADR: severe tightness of the chest and inability to swallow BSN available: yes confounding factors: MSA Previous COVID-19 infection: No Other diagnostic procedures: was no longer welcome in hospital, blood pressure measurement, oxygen measurement Comments on report form: It is possible that this case has already been reported. I am the daughter and am only now getting around to it. The doctor mentioned choking pneumonia. This is because of the MSA.; Reported Cause(s) of Death: Swallowing impaired; Dyspnoea; choking pneumonia


VAERS ID: 1076584 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood test, Dyspnoea, Nausea, Ultrasound abdomen, Vomiting, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 10
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: Diaphragmatic hernia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:unknown results; Test Name: X-ray abdomen; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021226256

Write-up: shortness of breath; upset stomach: Nausea; upset stomach: Nausea; stomach complaints: Vomiting; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB NL-LRB-00453181. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number EJ6134), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing diaphragmatic hernia. The patient''s concomitant medications were not reported. The patient experienced shortness of breath on an unspecified date, upset stomach: nausea, stomach complaints: vomiting on 29Jan2021, 2 hours after vaccination. The patient was hospitalised due to shortness of breath. The patient underwent lab tests and procedures which included blood test, ultrasound abdomen, x-ray: unknown results. Therapeutic measures were taken as a result of events included tube feeding and antibiotics. The patient died on 08Feb2021. It was not reported if an autopsy was performed. The outcome of events was fatal.; Reported Cause(s) of Death: shortness of breath; vomiting; Nausea; upset stomach


VAERS ID: 1076585 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: MORFINE; MIDAZOLAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood tests; Result Unstructured Data: Test Result:increased infection parameters
CDC Split Type: NLPFIZER INC2021226280

Write-up: Death; infection (probably a complicated urinary tract infection) / increased infection parameters; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) WEB NL-LRB-00453421. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EM0477), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included morfine, midazolam. Following the first administration of bnt162b2, 8 days after, the patient experienced death on 10Feb2021. It was unknown if an autopsy was performed. According to the reporter, the patient deceased due to an infection (probably a complicated urinary tract infection) (Feb2021). Blood test showed increased infection parameters (Feb2021). In the reporter''s opinion, death as a result of infection, but report due to not long after COVID vaccination. Confounding factors: infection (probably complicated urinary tract infection). The patient didn''t have previous COVID-19 infection. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death; infection (probably a complicated urinary tract infection) / increased infection parameters


VAERS ID: 1076586 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: TRIAMCINOLONACETONIDE; PRAVASTATIN; ACENOCOUMAROL; OMEPRAZOL; CARBOMER; COLECALCIFEROL; LISINOPRIL; FUROSEMIDE; HYLAN; TEMAZEPAM; NITROGLYCERINE; DOXYCYCLINE; METOPROLOL; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021226300

Write-up: SARS COV2 test was appeared to be positive; COVID-19; fever; cough; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority NL-LRB-00455159. A 92-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure. Concomitant medication included triamcinolone acetonide (TRIAMCINOLONACETONIDE, strength: 1 mg), pravastatin (strength: 40 mg), acenocoumarol (strength: 1 mg), omeprazole (OMEPRAZOL, strength: 20 mg), carbomer, colecalciferol (strength: 5600 IU), lisinopril, furosemide, carbomer, hyaluronate sodium (HYLAN), temazepam (strength: 10 mg), glyceryl trinitrate (NITROGLYCERINE), doxycycline (strength: 100 mg), metoprolol (strength: 100 mg), allopurinol (strength: 100 mg). The patient experienced fever (death) on 04Feb2021, cough (death) on 04Feb2021 and covid 19 (death) on 05Feb2021, then deceased. Clinical course: The patient experienced fever and cough one day after vaccination on 04Feb2021. The patient was seen by the general practitioner 2 days after vaccination and a SARS-COV-2 test was performed and appeared to be positive on 05Feb2021. The patient was treated with antibiotics. The outcome of events was fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Senders note: Comedication Vaseline cetomacrogol cream and liquid food with vitamin K was delicited as comedicaiton because this started after the day of vaccination Reporters comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Death Additional information ADR: Patient was vaccinated on 03Feb2021; I saw him on 05Feb2021 because of fever, which can be stressful for someone with severe heart failure. Because he also had a cough, he took a Covid test which turned out positive on 05Feb2021. Confounding factors confounding factors: COVID19. Previous COVID-19 infection: disease symptoms: quite. No other diagnostic procedures.; Reported Cause(s) of Death: COVID-19; Cough; Fever; positive corona test


VAERS ID: 1076587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (Advanced disease.); Multimorbidity (several diseases)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021226264

Write-up: Death; fatigue; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB NO-NOMAADVRE-FHI-2021-U9jqz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016057. A 94 years old female patient received her second dose of bnt162b2 (COMIRNATY, Batch/lot no: EK9788), intramuscularly on 04Feb2021 at single dose, left arm, for vaccination(The reporter thought the vaccine was given 10Feb2021, but data confirmed it was given 04Feb2021). No information given on concomitant medication. The medical history included ongoing living in nursing home, dementia (advanced disease), ongoing heart failure, multimorbidity. In Feb2021, the patient experienced fatigue. Around 12Feb2021, the patient developed reduced general condition. She died peacefully on 17Feb2021. It was not known what caused the deterioration in the patient''s general condition, but she died within weeks after her second dose of bnt162b2 and therefore this death was reported. In the death report, multimorbidity (dementia, heart failure ++ (not specified further diseases) was set as the cause of death. The patient''s outcome was fatal, at the time of the report. No autopsy was done. The case was considered to be serious. Relatedness of drug to the events Reduced general condition, Death: Possible, Source of assessment: Pharmacovigilance Center. Sender Comments: The report concerns a nursing home patient in her 90s, who a week after the second dose of the Covid-19 vaccine Comirnaty became more fatigued and had a drop in her general condition. The patient died peacefully approximately two weeks after vaccination. It is not known what caused the drop in the general condition. The patient had advanced dementia, heart failure and several diseases (not stated which), and this is set as the cause of death on the death report. It is reported due to the close time relationship between vaccination and death (Reporter was somewhat uncertain about the vaccination date and stated 10Feb, but a search confirmed the vaccination date to be 04Feb, in other words, almost a week earlier). In pre-marketing studies with Comirnaty, the most common side effects were injection site pain, fatigue, headache, myalgia and chills, arthralgia, fever and injection site swelling. The reactions occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and resolved after a few days. However, we cannot rule out that relatively mild side effects may become more pronounced and / or lead to a more serious course in severely debilitated patients. Data from use in frail patients with comorbidity is limited, and such lack of information will be obtained in post-marketing studies. In a study of patients on long-term stays in nursing homes, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and show, among other things, that the risk of death is increased in the first four months after nursing-home admission, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In the individual case, however, it is difficult to know whether the symptoms prior to the death are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Based on the information in the report, the causal connection with vaccination is considered as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: multimorbidity (dementia, heart failure ++ (not specified further diseases); multimorbidity (dementia, heart failure ++ (not specified further diseases); REDUCED GENERAL CONDITION; fatigue


VAERS ID: 1076591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; METFORMIN; RAMIPRIL ACTAVIS; FURIX [FUROSEMIDE]; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; KALEORID; ALBYL-E
Current Illness: Aortic stenosis (Severe); Heart failure (Severe)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Ischemic heart disease; Living alone; Syncope (had syncopated several times in connection to her serious aortic stenosis.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021221990

Write-up: A cardiac event that was unrelated to the vaccination is strongly suspected; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB NO-NOMAADVRE-FHI-2021-Uwweg, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015837. An 84-year-old female patient received her first single dose of BNT162B2 (COMIRNATY, lot number EJ6789) intramuscularly in her right arm on 11Feb2021 for COVID-19 immunisation. Patient had a history of living alone, ongoing severe heart failure, ongoing severe aortic stenosis, diabetes, ischemic heart disease and had syncopated several times. Concomitant medications included apixaban (ELIQUIS) for heart failure, metformin for diabetes, ramipril (RAMIPRIL ACTAVIS) for heart failure, furosemide (FURIX) for heart failure, metoprolol succinate (METOPROLOL SANDOZ), potassium chloride (KALEORID), and acetylsalicylic acid, magnesium oxide (ALBYL-E) for ischemic heart disease. The patient died on 12Feb2021. No autopsy performed. Woman in her 80s with severe aortic stenosis and severe heart failure got her medicines delivered by the community nurse system, but she organized the rest herself. She had been considered too frail for TIVA in 2017. She was in her normal condition when she came for vaccination of the first dose against Covid-19 accompanied by relatives. After vaccination she was observed for 20 minutes and the relatives escorted her home, a journey of at least 45 minutes. No symptoms occurred. After the relatives tried to call her and she did not answer the phone, they found her dead in her bed. This was two days after vaccination, but she had probably died the day before. Lots of medicines could be found in her kitchen cupboard, so the woman had obviously not taken the drugs as prescribed. According to the reporter, no symptoms like fever, feeling unwell or suspicion of an allergic reaction had been reported. On previous occasions the patient had syncopated several times in connection to her serious aortic stenosis. A cardiac event that was unrelated to the vaccination is strongly suspected, especially since important medicines had not been taken as they should. The death is reported since it is happened closely to the vaccination. No autopsy performed. Sender''s Comment: When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including deaths, may occur shortly after vaccination without any connection to vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another, random, concurrent cause that has nothing to do with the vaccination in question. Here, there is no observation of the patient in the time around the death. Based on the information in the report, we have assessed the causal relationship with vaccination as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. The reporter has stated that there is no suspicion of a connection with vaccination, and therefore the reporter''s assessment of the causal connection with the vaccination is set as unlikely. An unlikely causal relationship is defined as a reaction, including pathological laboratory tests, that occurs in such a temporal relationship to the use of a drug that a causal relationship is unlikely (but not impossible), and where underlying disease, other drugs or chemicals may explain the reaction. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: This 84-year-old female had medical history of severe heart failure, severe aortic stenosis, diabetes, ischemic heart disease and syncopated several times, and was on multiple concomitant medications. The reported fatal event cardiac disorder was most likely due to underlying cardiac disorder, and unlikely causally related to the first single dose of BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: unknown cause of death; A cardiac event that was unrelated to the vaccination is strongly suspected


VAERS ID: 1076647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH HAS BEEN REQUES / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myocardial infarction, Pneumonia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021222110

Write-up: pneumonia; Vomiting; Dyspnoea; heart attack; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number SE-MPA-2021-004762. An 87-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date at 0.3 mL, single for covid-19 immunisation. Medical history included Alzheimer''s disease. The patient''s concomitant medications were not reported. The patient experienced vomiting on Jan2021, dyspnoea on Jan2021. Events were report assessed as serious, death. Event description: the woman suffered from vomiting, shortness of breath, unknown time after vaccination. Hospitalized due to pneumonia. Discharged home, hospitalized again eleven days after vomiting and shortness of breath started. Died of a heart attack after three days. It was not reported if an autopsy was performed. information on the lot/batch number has been requested.; Reported Cause(s) of Death: vomiting; dyspnoea; Myocardial infarct


VAERS ID: 1076648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-05
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, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021222111

Write-up: Felt sick; Cardiac arrest; acute heart attack; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-005185. Other case identifier number SE-MPA-1613570887217. A 61-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included overweight, smoker. The patient''s concomitant medications were not reported. The patient suffered from prehospital cardiac arrest, about a week after vaccination, arrived at hospital and died when CPR was interrupted in the emergency room on Jan2021 with outcome of fatal. The reporter writes presumed to be an acute heart attack as findings do not suggest other genesis. The patient felt sick with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Report assessed as serious, Death. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest; Acute myocardial infarction


VAERS ID: 1076649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Respiratory rate increased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cardiac failure; Osteoporosis; Seropositive rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 202102; Test Name: CRP; Result Unstructured Data: Test Result:246 mg/ml; Test Date: 202102; Test Name: oxygen saturation; Result Unstructured Data: Test Result:75-80 %; Test Date: 202102; Test Name: ESR; Result Unstructured Data: Test Result:63; Comments: ref.<30 mm
CDC Split Type: SEPFIZER INC2021222116

Write-up: SR 63 (ref.<30 mm); Fever 38.4 degrees; saturation 75-80 %; CRP 246 (ref.<5 mg/ml); Wheezing; breathless, frequency 34; reduced AT-included; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number SE-MPA-2021-005206. Other case identifier number SE-MPA-1613570038064. An 83-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EJ6136), intramuscular at left arm in Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included cardiac failure, Seropositive rheumatoid arthritis, anaemia, osteoporosis. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EJ6136) in Jan2021 for COVID-19 immunization. The patient experienced SR 63, fever 38.4 degrees, saturation 75-80 %, CRP 246, wheezing, breathless, frequency 34, reduced at-included in Feb2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course reported as: The patient developed fever 38.4 degrees, breathlessness, frequency 34, reduced general condition, CRP increased, 246 (ref.<5 mg/ml), ESR increased, 63 (ref.<30 mm), oxygen saturation decreased, 75-80%, wheezing. On suspicion of pneumonia, phenoxymethylpenicillin 1 g x 3, first 2 doses 2 g, was prescribed four days after the vaccination. The woman improved in her breathing, became free from fever but her general condition deteriorated and the woman died one week after the vaccination. Case was reported as serious fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SR 63 (ref.<30 mm); Fever 38.4 degrees; saturation 75-80 %; CRP 246 (ref.<5 mg/ml); Wheezing; breathless, frequency 34; reduced AT-included


VAERS ID: 1080086 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-02-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2021-02-28
   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: Cognitive disturbance; Hypertension; Knee replacement; Myocardial infarction; Parkinson''s disease; Peripheral vascular disease
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: temperature; Result Unstructured Data: Test Result:36.6
CDC Split Type: AUPFIZER INC2021226235

Write-up: unresponsive; potential cardiac arrest; He was not noted to have been unwell at the time of the injection; This is a spontaneous report from a contactable other hcp via VOC. A 76-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Feb2021 16:34 at single dose for covid-19 immunisation. Medical history included Parkinson''s disease, hypertension, Peripheral vascular disease (PVD) and cognitive decline. He had undergone a knee replacement in Nov2020. He had had a previous Myocardial Infarction in 2015. The patient was a long term rehab patient at a local hospital, as he could no longer be cared for in his home, and had been in the past 2 weeks transferred to the facility on respite to be closer to family. The patient''s concomitant medications were not reported. The patient experienced potential cardiac arrest on 28Feb2021, unresponsive on 28Feb2021 17:14. Reported as "After vaccination no redness or swelling was noted and his temperature was 36.6degC. He was not noted to have been unwell at the time of the injection. No other adverse events have been noted to have been observed post injection. He was reviewed for regular observations at 16.00 pm on Sunday 28Feb2021 and then was found unresponsive at 17.14pm on Sunday 28Feb2021. A preliminary cause of death is potential cardiac arrest. Consent for the vaccination was obtained prior to the vaccination. The family were present during the resuscitation and are saddened but not aggrieved and are accepting and a comment was made by the nursing home that the family may think there is a link to the vaccine. This matter has already been referred to the coroner."The patient underwent lab tests and procedures which included body temperature: 36.6 on 27Feb2021. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained; Reported Cause(s) of Death: potential cardiac arrest


VAERS ID: 1081776 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
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: 2021-02-20
   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: TORASEMID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021236716

Write-up: death; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB, Regulatory authority report number is DE-PEI-PEI2021003039. A non-contactable physician reporting information for the same patient. This is first of two reports. A 96 years old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 at single dose for covid-19 immunisation. The patient''s medical history was not reported, no major previous illnesses. Concomitant medication included torasemide (TORASEMID). The patient received the first dose of bnt162b2 (COMIRNATY) on 27Jan2021 for covid-19 immunisation and experienced General physical health, muscle tremors, refusal to eat, tiredness and immobility and 08Feb2021: abnormal urine status, suspected urinary tract infection. The patient experienced 3 days after vaccination the patient developed Death. The patient died on 20Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021242330 same patient and same product, different event for different dose.; Reported Cause(s) of Death: Death


VAERS ID: 1081797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Dyspnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: Alzheimer''s disease (advanced)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021236722

Write-up: Death; Vomiting; Abdominal pain; Dyspnoea; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (FI-FIMEA-20210955). An 86-year-old male patient received BNT162B2 (COMIRNATY; Lot number EL1491) intramuscular on 28Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included advanced Alzheimer''s disease. Concomitant medications were not reported. On 29Jan2021, the patient experienced vomiting, abdominal pain and dyspnoea and on 30Jan2021 he died. The cause of death was unknown. It was not reported if an autopsy was performed. The events of vomiting, abdominal pain and dyspnoea were reported with a fatal outcome. The patient was a patient of respite care and the death was expected, however there was a clear time connection to the vaccine. Treatment according to the symptoms with painkillers on the respite care. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1081802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENANTONE [LEUPRORELIN]; KARDEGIC; CASODEX; INEXIUM [ESOMEPRAZOLE MAGNESIUM]; PRAVASTATIN; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate; Cognitive disturbance; Dyslipidaemia; Hypertension arterial; Myocardial infarction; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232802

Write-up: progressive deterioration of the general state; Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (FR-AFSSAPS-AN20210572). A 100-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 11Feb2021 at a single dose for COVID-19 immunisation. Medical history included renal insufficiency, dyslipidaemia, hypertension arterial, myocardial infarction, cognitive disturbance, and cancer of prostate. Concomitant medication included leuprorelin (ENANTONE), acetylsalicylate lysine (KARDEGIC), bicalutamide (CASODEX), esomeprazole magnesium (INEXIUM), pravastatin (MANUFACTURER UNKNOWN), and mirtazapine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (COMIRNATY) on 21Jan2021 for COVID-19 immunisation. The patient experienced progressive deterioration of the general state on an unspecified date. The patient experienced death NOS on 17Feb2021, which was reported as fatal. The clinical course was reported as: The patient was at risk of developing a severe form of COVID-19 disease. The patient presented with a progressive deterioration of the general state for several weeks, with slip syndrome. The clinical outcome of progressive deterioration of the general state was unknown. The patient died on 17Feb2021. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The reporter assessed the causality the event as unrelated to the suspect vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1081806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: General physical condition abnormal; Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Deglutition disorder; Dementia NOS aggravated; Disease Parkinson''s; Hypothermia; Tonic-clonic seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232796

Write-up: Died in sleep; This is a spontaneous report downloaded from the Regulatory Authority [Regulatory Authority Report Number: FR-AFSSAPS-BR20210383]. A contactable physician reported an 89-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY batch EP9598), intramuscular on the right arm on 23Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Parkinson''s disease, deglutition disorder, and dementia NOS aggravated. Concomitant medications were not reported.The patient received the first dose of COMIRNATY (Lot/batch number not provided) on an unknown date as COVID-19 immunization. It was reported that the patient was hospitalized in palliative care. Her general condition was very altered and prompted the recent initiation of antiepileptic treatment due to tonic clonic seizures. She also has episodes of fluctuating hypothermia. On 23Feb2021, the patient received a 2nd injection of the COMIRNATY vaccine. On the night of 24Feb2021, she died. For the clinician, the death was not related to the vaccination but was related to a significant deterioration in the general condition. It was not reported (unknown) if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the close temporal relationship, the association between the event death with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1081810 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Antidepressant drug level, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatinine, Blood gases, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Brain natriuretic peptide, C-reactive protein increased, Coma, Coma scale, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, Heart rate, Hypoxia, Lipase, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Protein total, Prothrombin time, Quadriplegia, Troponin, White blood cell count
SMQs:, Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VERATRAN; LERCAN; NEURONTIN; FUMAFER; LEVOTHYROX; XARELTO; UVEDOSE; TAREG; CALCIDOSE [CALCIUM CARBONATE]; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Activities of daily living impaired; Atrial fibrillation; Cognitive disorders (advanced); Embolism pulmonary; General physical health deterioration; Hypertension arterial; Meningoencephalitis (with hippocampal involvement); Osteoporosis; Uterine cancer NOS
Allergies:
Diagnostic Lab Data: Test Name: alat; Result Unstructured Data: Test Result:30; Test Name: TCA; Result Unstructured Data: Test Result:40; Test Name: ASAT; Result Unstructured Data: Test Result:25; Test Name: albumin; Test Result: 37 g; Test Name: PAL; Result Unstructured Data: Test Result:103; Test Name: Ca; Result Unstructured Data: Test Result:2.37; Test Name: Cl; Result Unstructured Data: Test Result:99 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:45 umol/l; Test Name: blood gasses; Result Unstructured Data: Test Result:7,11 pH units; Test Name: blood glucose; Result Unstructured Data: Test Result:10 mmol/L; Test Name: blood sugar; Result Unstructured Data: Test Result:1.56 g/l; Comments: fasting; Test Name: K; Result Unstructured Data: Test Result:5 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:170/70 mmHg; Test Name: Na; Result Unstructured Data: Test Result:141 mmol/L; Test Name: Urea; Result Unstructured Data: Test Result:9.9 mmol/L; Test Name: BNP; Result Unstructured Data: Test Result:56; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Test Name: CRP; Result Unstructured Data: Test Result:0,8; Test Name: GammaGT; Result Unstructured Data: Test Result:13; Test Name: GFR; Result Unstructured Data: Test Result:95 ml/min; Test Name: Hb; Test Result: 16.4 g; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Name: Lipase; Test Result: 37 g; Test Name: PNN; Result Unstructured Data: Test Result:8.4 x10 9/l; Test Name: Saturation; Result Unstructured Data: Test Result:63%; Test Name: Saturation; Result Unstructured Data: Test Result:93%; Comments: under 9l of O2; Test Name: PCO2; Result Unstructured Data: Test Result:131; Test Name: platelets; Result Unstructured Data: Test Result:331 x10 9/l; Test Name: po2; Result Unstructured Data: Test Result:232; Test Name: protein; Result Unstructured Data: Test Result:69 g/l; Test Name: prothrombin time; Result Unstructured Data: Test Result:52%; Test Name: troponin; Result Unstructured Data: Test Result:10.9; Comments: without further details; Test Name: Leukocyte count; Result Unstructured Data: Test Result:10.4 x10 9/l
CDC Split Type: FRPFIZER INC2021232797

Write-up: Coma; Hypoxia/Severe hypoxia (O2 Sat 63%); flaccid quadriplegia; This is a spontaneous report downloaded from the Regulatory Authority, regulatory authority report number: FR-AFSSAPS-BX20211195. A contactable physician reported that an 88-year-old female patient received bnt162b2 (COMIRNATY solution for injection; lot number: EJ6795; expiry date: unknown) intramuscular on 02Feb2021 at 14:30, at a single dose, for COVID-19 immunisation. Medical history included hypertension arterial, embolism pulmonary, uterine cancer NOS, atrial fibrillation, and osteoporosis. Patient with an extensive history including meningoencephalitis in 2002 with hippocampal involvement, advanced cognitive disorders, assistance requried in all daily activities, patient communicating with slate, with a deterioration of the general condition for several days. Concomitant medication included clotiazepam (VERATRAN), lercanidipine hydrochloride (LERCAN), gabapentin (NEURONTIN), ferrous fumarate (FUMAFER), levothyroxine sodium (LEVOTHYROX), rivaroxaban (XARELTO), colecalciferol (UVEDOSE), valsartan (TAREG), calcium carbonate (CALCIDOSE), and pantoprazole. The morning of the vaccination, apathetic patient, found slumped on the right side with a doubt of a facial paralysis, but with responses to simple orders, without sensory-motor deficit or frank facial paralysis demonstrated by the nurse. No notion of choking in the last few days. Vaccination at 2:30 p.m., mention of the lack of immediate effect on the report. The patient experienced severe hypoxia (O2 Sat 63%) and unfavorable coma after vaccination, cause of death not found. According to the declarant, 20 minutes after vaccination, sudden desaturation (Sat O2 63%) with hypovigilance increasing to coma, flaccid quadriplegia observed during transport. Arrival at emergency at 3:54 p.m., GCS 3, TA 170/70 mmHg, HR 80 bpm, blood glucose 10 mmol / l, 98% saturation under 9L of oxygen, auscultation with symmetrically reduced mV, breathing through the mouth, absence of polypnea, abdomen supple without guarding. Neurological examination with flaccid quadriplegia, no ROT, reactive symmetrical pupils, (suspicion of anisocoria), suspicion of right facial paralysis. Biological Examination were as follows: Blood gas: pH 7,11 - PO2 232 - PCO2 131. NF with leucoytes 10.4 G / L, PNN 8.4 G / L, Hb 16.4 g / l, platelets 331 G / L, PT 52%, TCA 40, CRP 0,8, Na + 141 mmol / l, K + 5 mmol / l, Ca 2.37, Cl 99 mmol / l, creatinine 45 micromol / l, DFG 95 ml / min, Urea 9.9 mmol / l, protein 69 g / L, albumin 37 g, ASAT 25, ALAT 30, GammaGT 13, PAL 103, Lipase 35, fasting blood sugar, 1.56 g / l, troponin 10.9 (without further details), BNP 56, Other explorations: RSR ECG, no polarization disorder, brain MRI: no stroke, sequelae of old stroke, no bleeding. Development: With regard to the general condition and risk of death, decision on comfort care after collegial discussion. In the hypothesis of an aa status epilepticus, treatment with levetiracetam 3.5 g slow IV, no improvement. Treatment with morphine and midazolam in the face of pain and polypnea facies (40 rpm). Death noted at 10:30 am the next day (03Feb2021). Autopsy information was unknown. Details of treatment, pre-vaccination context, exploratory workup and death, cause of death and date. N.B.: Accountability "without prejudice to elements of investigations that might be performed for legal or indemnity purposes." No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death; Hypoxia/Severe hypoxia (O2 Sat 63%); flaccid quadriplegia


VAERS ID: 1081820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / 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: 2021-02-05
   Days after onset: 10
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: Cancer of prostate; CVA; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: no variant search
CDC Split Type: FRPFIZER INC2021232869

Write-up: COVID-19 aggravated; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority [FR-AFSSAPS-MP20210273]. A 96-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Lot no.: EJ6788), intramuscular in the right arm on 21Jan2021 at single dose for covid-19 immunization. Medical history included ischaemic heart disease, cancer of prostate, and CVA (cerebrovascular accident). The patient''s concomitant medications were not reported. The patient experienced covid-19 aggravated on 02Feb2021. The patient was vaccinated as part of the COVID-19 vaccination campaign. The patient considered to be at risk of developing a severe form of COVID-19 disease. It was not specified if the patient had a history of COVID-19. On 26Jan2021: performance of a positive PCR test (no variant search) and on 02Feb2021: Onset of symptoms of COVID-19. The patient was treated in the nursing home. The patient died on 05Feb2021. The cause of death was COVID-19 aggravated and COVID-19 PCR test positive. The outcome of the events was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19 PCR test positive


VAERS ID: 1081821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ9788 / 1 RA / 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: 2021-02-06
   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:
Current Illness: Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Dwarfism
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232877

Write-up: COVID-19 AGGRAVATED; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210274. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ9788), via intramuscular on 21Jan2021 at single dose in right arm for COVID-19 immunisation. Medical history included dwarfism from an unknown date and unknown if ongoing, ongoing renal insufficiency, dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was considered to be at risk of developing a severe form of COVID-19 disease (age). Patient vaccinated as part of the COVID-19 vaccination campaign. It was reported on 26Jan2021: performance of a positive COVID-19 PCR test (no variant search). On 02Feb2021, onset of symptoms of COVID-19, COVID-19 aggravated. Patient treated in the nursing home. Duration was reported as 5 days. Evolution: On 06Feb2021, death of the patient. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19 AGGRAVATED


VAERS ID: 1081822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / 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: 2021-02-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arteritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: no variant research
CDC Split Type: FRPFIZER INC2021232864

Write-up: COVID-19 aggravated; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-MP20210275. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 21Jan2021 at single dose in right arm for covid-19 immunisation. Medical history included ongoing arteritis. The patient''s concomitant medications were not reported. On 28Jan2021, the patient Symptoms of COVID-19 appear Covid-19 aggravated was reported, performance of a positive PCR test (no variant search). Patient treated in the nursing home. EVOLUTION: On 03Feb2021: Death of the patient. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19 PCR test positive


VAERS ID: 1081823 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-08
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, 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: 2021-01-28
   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: AFib; CVA; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR; Test Result: Positive ; Comments: no research for a variant
CDC Split Type: FRPFIZER INC2021232860

Write-up: COVID-19 PCR test positive; COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210277. A 78-year-old male patient received he first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on the left arm, on 21Jan2021 at a single dose for covid-19 immunisation. Ongoing medical history included Afib, heart failure, and CVA (cerebrovascular accident). The patient''s concomitant medications were not reported. On 23Jan202, symptoms of COVID-19 appear/ COVID-19 aggravated. On 25Jan2021: performed a positive PCR test (no variant search)/ COVID-19 PCR test positive. The patient died on 28Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19


VAERS ID: 1081824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; LOXEN [NICARDIPINE HYDROCHLORIDE]; PANTOPRAZOLE; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal insufficiency; Cholelithiasis; Chondrocalcinosis; Diarrhoea (1-day); Hip prosthesis user; Hypertension arterial; Obstruction bronchial; Renal insufficiency; Rhizomelic pseudopolyarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: SARS CoV2 test; Test Result: Negative ; Test Date: 20210204; Test Name: SARS CoV2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232886

Write-up: Sudden death; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB with the regulatory authority report number is FR-AFSSAPS-NC20210527. A contactable physician reported that a 95-year-old female patient received her first dose of bnt162b2 (COMIRNATY; lot number: EJ6789; expiration date: unknown) at unknown vaccination age intramuscular in the left deltoid on 11Feb2021 12:00 at a single dose for covid-19 immunisation. Medical history included adrenal insufficiency, hypertension arterial, chondrocalcinosis, mild renal insufficiency, cholelithiasis, right hip prosthesis, rhizomelic pseudopolyarthritis, diarrhoea on 24Jan2021 and bronchial obstruction (bronchial episode) from 28Jan2021 to 02Feb2021. Concomitant medication included hydrocortisone (HYDROCORTISONE), nicardipine hydrochloride (LOXEN), pantoprazole and oxazepam (SERESTA). The patient previously took racecadotril (TIORFAN) on 24Jan2021 for diarrhea, amoxicillin, clavulanate potassium (AUGMENTIN) from 28Jan2021 to 02Feb2021 for bronchial episode and salbutamol (VENTOLINE) from 28Jan2021 to 02Feb2021 for bronchial episode. She presented a 1-day diarrheal episode on 24Jan2021 which resolved under Tiorfan * and a bronchial episode on 28Jan treated with Augmentin * + Ventolin * for 6 days. The physician reported that the vaccination was carried out on 11Feb2021 (D1) at 12 noon in the facility for dependent elderly people in the left deltoid. On 12Feb2021, the patient was found dead in her bed in the morning. This is a patient residing in facility for dependent elderly people, usually tending to communicate the slightest unusual problem. On the day of vaccination, the patient was in good shape, ate well at lunchtime and in the evening and reported no complaints (no pain at the vaccination site, no flu-like condition after vaccination). She was found dead in the morning when she usually woke up. It was concluded that the patient had sudden death the day after vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 24Jan2021 and on 04Feb2021. The patient died on 12Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1081826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Lung disorder, Myocardial infarction, Pneumonitis, SARS-CoV-2 test, Troponin
SMQs:, Interstitial lung disease (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kyphoscoliosis; Restrictive respiratory insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: ECG; Result Unstructured Data: Test Result:indicated myocardial infarction; Test Name: COVID-19 test; Result Unstructured Data: Test Result:did not develop covid-19; Test Date: 20210212; Test Name: troponins; Result Unstructured Data: Test Result:elevated
CDC Split Type: FRPFIZER INC2021232882

Write-up: Infarct myocardial/experienced chest pain, the troponins came back elevated and the ECG indicated myocardial infarction; Pneumopathy; bilateral pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority with regulatory authority report number FR-AFSSAPS-NT20210360. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), intramuscularly on the left arm, on 27Jan2021, at single dose, for covid-19 immunization. Medical history included kyphoscoliosis with restrictive respiratory failure GIR1. Covid-19 history: The patient did not develop covid-19 (test performed but no date). The patient''s concomitant medications were not reported. The patient experienced pneumopathy on 10Feb2021, and infarct myocardial on 12Feb2021. Description of the adverse effect: Vaccination on 27Jan2021 with a first injection of COMIRNATY. Onset of bilateral pneumonitis on 10Feb2021. Two days later, on 12Feb2021, the patient experienced chest pain, the troponins came back elevated and the ECG indicated myocardial infarction. Evolution: Death of the patient. The outcome of the adverse events was fatal. The patient died on an unknown date in 2021. It was unknown if an autopsy was performed. Notabene: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible, information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: bilateral pneumonitis; Infarct myocardial; Pneumopathy


VAERS ID: 1081827 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021232969

Write-up: Status epilepticus; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. Regulatory authority report number FR-AFSSAPS-NT20210430. A 93-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number EK9788), intramuscular on the left arm on 04Feb2021 at a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first dose of the bnt162b2 vaccine against COVID-19 on 04Feb2021. The patient was diagnosed with status epilepticus on 15Feb2021, with no known history of epilepsy in this patient. The patient had COVID-19 test with negative result on an unspecified date. The patient died on 15Feb2021. Cause of death was status epilepticus. It was not reported if autopsy was performed. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1081829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Death
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: KARDEGIC; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder; Disorder gait; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:good
CDC Split Type: FRPFIZER INC2021232768

Write-up: Abdominal pain; stomach aches; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-PC20210394. An 85-year-old male patient received second dose of bnt162b2 (COMIRNATY; lot: EM6950) intramuscular, at the age of 85-year-old, on 18Feb2021, at single dose for covid-19 immunisation. Medical history included gait disturbance from an unknown date and unknown if ongoing, cognitive disorder from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylate lysine (KARDEGIC) and lercanidipine. The patient previously received first dose of bnt162b2 (COMIRNATY; lot number and expiry date not reported) on 28Jan2021, single dose for covid-19 immunisation and had no adverse effect. He was an elderly patient who has been treated for his hypertension for several years, with good blood tests. He introduced significant cognitive disorders also affecting his walking (in a relieving chair), a pathology of walking for several years as well. On 18Feb2021, the patient was in normal state during the day and then in the evening, he complained of stomach aches. Spasfon + laxative were given in response to the event. The patient was in bed but died around 9 p.m. No other clinical signs to the reporters knowledge and no identified cause of death. The patient was expected a decline in cognitive faculties, but not such a sudden departure. He received the 2nd injection of the vaccine the same morning and seems to have spent the day in a normal state then only complained of stomach aches a few hours before death. Outcome of the event stomach aches was unknown. The patient had sudden and unexpected death on 18Feb2021. It was unknown if an autopsy was performed. Reporter Comments: Patient in nursing home since 22Jan2021. Had the 1st injection of the vaccine against Covid-19 on January 28, no adverse effect reported. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden and unexpected death


VAERS ID: 1081832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Aplasia, Blood bicarbonate, Blood bicarbonate decreased, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood creatinine, Blood glucose, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood sodium increased, Blood urea, Body temperature, Glomerular filtration rate, Haemoglobin, Haemoglobin decreased, Heart rate, Investigation, Laboratory test abnormal, Lactic acidosis, Myelofibrosis, Neutrophil count, Neutrophil count decreased, Oxygen saturation, Platelet count, Platelet count decreased, Protein total, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sepsis, Shock, White blood cell count, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (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 (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Blood premalignant disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
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: CACIT VITAMIN D3; DIAZEPAM; METFORMIN; OXAZEPAM; XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Alzheimer dementia); Bedridden; Diabetes; Loss of personal independence in daily activities; Malnutrition; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: CPK; Result Unstructured Data: Test Result:198 IU/l; Comments: 198 UI/l; Test Date: 20210127; Test Name: creatinine; Result Unstructured Data: Test Result:352 umol/l; Test Date: 20210127; Test Name: glycemia; Result Unstructured Data: Test Result:27.5 mmol/L; Test Date: 20210127; Test Name: glycemia; Result Unstructured Data: Test Result:4.95 g/l; Test Date: 20210127; Test Name: Calculated plasma osmolarity; Result Unstructured Data: Test Result:357 mmol/L; Test Date: 20210127; Test Name: K; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/7; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/6; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:12/6; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Test Date: 20210119; Test Name: blood pressure; Result Unstructured Data: Test Result:10/7; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:9/5; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:10/6; Test Date: 20210120; Test Name: blood pressure; Result Unstructured Data: Test Result:10/8; Test Date: 20210127; Test Name: Na; Result Unstructured Data: Test Result:145 mmol/L; Test Date: 20210127; Test Name: Na corrected/glycemia; Result Unstructured Data: Test Result:152 mmol/L; Test Date: 20210127; Test Name: Urea; Result Unstructured Data: Test Result:31.2 mmol/L; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210119; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210127; Test Name: GFR per MDRD; Result Unstructured Data: Test Result:14.2 ml/min/1.73; Comments: 14.2 ml/min/1.73 (Caucasian subject) or 17.2 ml/min/1.73 (African subject); Test Date: 20210127; Test Name: Hb; Result Unstructured Data: Test Result:10.5 g/dl; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:89; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:79; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:84; Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: Test Result:83; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:82; Test Date: 20210120; Test Name: heart rate; Result Unstructured Data: Test Result:80; Test Date: 20210127; Test Name: anionic Hole; Result Unstructured Data: Test Result:22 mmol/L; Test Date: 20210127; Test Name: neutrophil; Result Unstructured Data: Test Result:0.33 g/l; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:95; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:97; Test Date: 20210119; Test Name: oxygen saturation; Result Unstructured Data: Test Result:95; Test Date: 20210120; Test Name: oxygen saturation; Result Unstructured Data: Test Result:98; Test Date: 20210127; Test Name: Platelet; Result Unstructured Data: Test Result:92 g/l; Test Date: 20210127; Test Name: Protides; Result Unstructured Data: Test Result:56 g/l; Test Date: 20210127; Test Name: anti-SARS-CoV-2 serology; Test Result: Negative ; Test Date: 20210127; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210127; Test Name: Leukocytes; Result Unstructured Data: Test Result:0.45 g/l; Test Date: 20210127; Test Name: Bicarbonates; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 20210127; Test Name: Calcium; Result Unstructured Data: Test Result:2.06 mmol/L; Test Date: 20210127; Test Name: Cl; Result Unstructured Data: Test Result:107 mmol/L
CDC Split Type: FRPFIZER INC2021232899

Write-up: Shock; Aplasia; septic; lactic acidosis; complicated acute renal insufficiency; myelofibrosis; Na corrected/glycemia 152 mmol/l (N=136-145 mmol/l); bicarbonates 16 mmol/l (N=22-29 mmol/l); anionic hole 22 mmol/l (N=8-16 mmol/l); CPK 198 UI/l (N=25-190); leukocytes 0.45 g/l (N=4-10g/l); neutrophils 0.33 g/l (N=1.5-7.0g/l); Hb 10.5 g/dl (N=13-17g/dl); platelets 92 g/l (N=150-400); This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-PS20210336. This is a report received from the Regulatory Authority. A 91-year-old male patient received the first dose of bnt162b2 (COMIRNATY; lot: EJ6795, expiry: unknown), intramuscular on 19Jan2021 at a single dose for covid-19 immunisation. Medical history included diabetes, starvation and Alzheimer''s disease. The patient was suffering from Alzheimer dementia, diabetic, bedridden with extreme malnutrition, no autonomy, and was unable to be treated. Concomitant medications included calcium carbonate, colecalciferol (CACIT VITAMIN D3), diazepam if agitation or oxazepam is not taken, metformin, oxazepam, alfuzosin hydrochloride (XATRAL). On 19Jan2021, in the morning before vaccination, patient''s temperature (T): 36.2 C, heart rate (HR): 89, saturation (sat): 95, and blood pressure (BP): 12/7. 15 min after vaccination, T: 36.6 C, HR: 80, Sat: 97, BP: 12/6. 2 hours (H) after vaccination, T: 36.4 C, HR: 79, Sat: 97, BP: 12/6. At 18:00 on 19Jan2021, T: 36.6 C, HR: 84, Sat: 95, BP: 13/7. At 22:00 on 19Jan2021, T: 36.9 C, HR: 83, BP: 10/7. At 07:00 on 20Jan2021, T: 36.2 C, HR: 80, Sat: 98, BP: 9/5. At 11:00 on 20Jan2021, T: 36.2 C, HR: 82, BP: 10/6. At 18:00 on 20Jan2021, T: 36.2 C, HR: 80, BP: 10/8. On 27Jan2021, the patient arrived at Emergency in a state of shock, probably septic, but also possibility of lactic acidosis due to metformin (but metformin was not given for some time a "priori"), complicated acute renal insufficiency on an unknown renal function baseline. The patient of 91 years old in hitherto unknown aplasia (myelofibrosis??). The patient was very malnourished (weight 35kg) and significant change to his general state on his arrival at Emergency. Lab test on 27Jan2021 includes: Na 145mmol/l, Na corrected/glycemia 152 mmol/l (N=136-145 mmol/l), K 4.3 mmol/l, Cl 107 mmol/l, bicarbonates 16 mmol/l (N=22-29 mmol/l), anionic hole 22 mmol/l (N=8-16 mmol/l), protides 56 g/l (N=65-80 g/l), urea 31.2 mmol/l (N=3.0-7.0 mmol/l), creatinine 352 Umol/l (N=62-106 umol/l), GFR per MDRD 14.2 ml/min/1.73 (Caucasian subject) or 17.2 ml/min/1.73 (African subject), glycemia 27.5 mmol/l (N=3.9-6.1 mmol/l) or 4.95 g/l (N=0.7-1.1), calcium 2.06 mmol/l (N=2.25-2.6 mmol/L), calculated plasma osmolarity 357mmol/l, CPK 198 UI/l (N=25-190), leukocytes 0.45 g/l (N=4-10g/l), neutrophils 0.33 g/l (N=1.5-7.0g/l), Hb 10.5 g/dl (N=13-17g/dl), platelets 92 g/l (N=150-400). Negative rapid SARS-CoV-2 test and Ac anti-SARS-CoV-2 serology done on the same day and negative. The patient had massive filling, empirical antibiotic treatment with C3G + flash of gentamicin, and hospitalisation. The patient died in a state of shock on 27Jan2021. Overall, the patient was hospitalised for less than 12 hours. The patient was suffering from Alzheimer dementia, diabetic, bedridden with extreme malnutrition, no autonomy, and unable to be treated. The patient has no known haematological history. No reference blood test. The patient died on 27Jan2021 due to shock and aplasia. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: shock; Aplasia


VAERS ID: 1081833 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Brain stem haemorrhage, Coma, Coma scale, Haemorrhagic stroke, International normalised ratio, International normalised ratio increased, Investigation, Mydriasis, Oxygen saturation, Pupils unequal, Scan brain
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: AMLODIPINE; LASILIX [FUROSEMIDE]; RENITEC [ENALAPRIL MALEATE]; TEMERIT; XELEVIA; ZYLORIC
Current Illness: AFib; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Artificial cardiac pacemaker user; Basal cell carcinoma (of the forehead with complete resection in Jun2018); Squamous cell carcinoma of skin (in the left cheek with complete resection in Jun2018); Surgery; Transient ischaemic attack (without sequelae)
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: BP; Result Unstructured Data: Test Result:83/62; Test Date: 20210126; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Comments: a reactive bilateral mydriasis, no reflex; Test Date: 20191115; Test Name: INR; Result Unstructured Data: Test Result:between 2 and 3; Test Date: 20201231; Test Name: INR; Result Unstructured Data: Test Result:between 2 and 3; Test Date: 20201231; Test Name: INR; Result Unstructured Data: Test Result:1.69; Test Date: 20210123; Test Name: INR; Result Unstructured Data: Test Result:4.93; Comments: two days before vaccination.; Test Date: 20210126; Test Name: investigation; Result Unstructured Data: Test Result: anisocoria, reactive right mydriasis, probab; Comments: anisocoria, reactive right mydriasis, probable inhalation.; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 94 %; Comments: Patient put under 15 L of O2, 94% saturation;; Test Date: 20210126; Test Name: oxygen saturation; Test Result: 57 %; Comments: At 9PM 57% saturation under 15 L of O2.; Test Date: 20210126; Test Name: brain scan; Result Unstructured Data: Test Result:reveals a hematoma of the brainstem
CDC Split Type: FRPFIZER INC2021232785

Write-up: International normalised ratio increased; Brain stem haemorrhage; TOTAL, haemorrhagic stroke of the trunk with fatal progression; in a coma; anisocoria; reactive right mydriasis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-PV20210357. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number:EJ6788, expiry date was not reported) (at 89 years of age), intramuscular in the right arm on 25Jan2021 at 0.3 mL, single for COVID-19 immunisation; acetylsalicylate lysine (KARDEGIC, strength: 75 mg), oral from an unspecified date at 75 mg, 1x/day for atrial fibrillation; and warfarin sodium (COUMADINE, strength: 2 mg), oral from an unspecified date at 1.25 DF, 1x/day for atrial fibrillation. Medical history included ongoing hypertension arterial, squamous cell carcinoma of skin in the left cheek with complete resection in Jun2018, basal cell carcinoma of the forehead with complete resection in Jun2018, transient ischaemic attack in 2011 without sequelae, ongoing atrial fibrillation, complete arrhythmia and patient was with a pacemaker. Concomitant medication included amlodipine, furosemide (LASILIX [FUROSEMIDE]), enalapril maleate (RENITEC [ENALAPRIL MALEATE]), nebivolol hydrochloride (TEMERIT), sitagliptin phosphate (XELEVIA), and allopurinol (ZYLORIC). The patient experienced international normalised ratio increased on an unspecified date and brain stem haemorrhage on 26Jan2021, both events with fatal outcome. It was reported that the patient was an autonomous patient, no cognitive impairment, living alone. On 25Jan2021, she received 1st injection of COMIRNATY. On 26Jan2021 at 2 p.m., call from her daughter, everything was fine. At 7:40 p.m., his daughters called back, no answer, goes home and found him in a coma in the toilet at 8:05 p.m. When the fire brigade arrived, the patient responded to simple orders on the hands at 8.15 p.m. Anisocoria, reactive right mydriasis, probable inhalation. Patient put under 15 L of O2, 94% saturation and administration of 250 mL of MANNITOL. At 9:20 p.m .: a brain scan in the emergency room, which revealed a hematoma of the brainstem. The clinical examination found a Glasgow at 3, a reactive bilateral mydriasis, no reflex. 57% saturation under 15 L of O2. Very likely inhalation. TA at 83/62. After collegial specialist opinion, no therapeutic resource, patient not antagonized. EVOLUTION: Death of the patient in the evening. DIFFERENTIAL DIAGNOSIS: Balanced arterial hypertension for several years according to the attending physician. INR between 15Nov2019 and 31Dec2020: between 2 and 3. 31Dec2020: INR = 1.69. 23Jan2021, i.e. two days before vaccination: INR = 4.93. Most probable hypothesis of a cerebral hemorrhage linked to an overdose of AVK (anti-vitamin K) with imbalance of the INR(international normalized ratio). TOTAL, haemorrhagic stroke of the trunk with fatal progression occurring the day after a 1st vaccination with COMIRNATY in an 89-year-old patient in a context of overdose of COUMADINE (INR 4.93 two days before vaccination) and a treatment with KARDEGIC. The action taken in response to the event for acetylsalicylate lysine and warfarin sodium was not applicable. The outcome of coma, anisocoria and reactive right mydriasis was unknown. The patient died on 26Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Brain stem haemorrhage; International normalised ratio increased; TOTAL, haemorrhagic stroke of the trunk with fatal progression


VAERS ID: 1081836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Dyspnoea, Electrocardiogram, Fatigue, Loss of consciousness, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DETENSIEL [BISOPROLOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: bradycardia; Result Unstructured Data: Test Result:37/min; Test Date: 20210213; Test Name: ECG; Result Unstructured Data: Test Result:AVB (atrioventricular block) 2 or even 3
CDC Split Type: FRPFIZER INC2021232918

Write-up: Sudden death; suddenly loses consciousness; Atrioventricular block, complete; bradycardia at 37/min; Fatigue; Nausea; Respiration labored; This is a spontaneous report from a contactable physician from the regulatory authority-WEB FR-AFSSAPS-RS20210251. An 88-year-old male patient received the first dose of bnt162b2 (COMIRNATY) lot number: EJ6789, intramuscular on 09Feb2021 at a single dose for covid-19 immunisation. Medical history included hypertension arterial and Alzheimer''s disease. Concomitant medication included bisoprolol (DETENSIEL [BISOPROLOL]) for hypertension. Since 12Feb2021, the patient experienced unusual fatigue (need to stop twice on a 1 km walk outdoors), nausea, episode of labored respiration, without syncope, without discomfort. The patient had a medical consultation on 13Feb2021. Poor clinical examination apart from bradycardia at 37 / min, AVB (atrioventricular block) 2 or even 3 on ECG. No cardiac decompensation. Immediate hospitalization was done. The patient had to be fitted (with a device) on 15Feb2021 for this AVB and on 14Feb2021, the patient has his wife on the phone and shows no complaints or disturbances but fifteen minutes later, he suddenly loses consciousness and dies. The patient died on 14Feb2021. It was not reported if an autopsy was performed. The outcome of other events was unknown at the time of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1081837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Pneumonia aspiration, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Drug allergy; Feeling sick; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232903

Write-up: Emesis/episode of vomiting; Pneumonia aspiration; recovery of the state of consciousness; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number is FR-AFSSAPS-RS20210260. A 96-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6789), intramuscularly on 11Feb2021 at a single dose for COVID-19 immunization. Medical history included starvation, drug allergy, dementia and feeling sick, all from an unknown date and unknown if ongoing. It was also reported that she was a very dependent patient, GIR 1 (as reported). The patient''s concomitant medications were not reported. The patient previously took paracetamol and experienced allergy. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported) for COVID-19 immunization and was well tolerated by the patient. The patient experienced emesis/episode of vomiting and pneumonia aspiration on 11Feb2021. It was reported that the patient received second injection of BNT162B2 on 11Feb2021, and good immediate tolerance was reported. Two hours later, during the meal, onset of emesis/episode of vomiting (no cough, no dyspnea, no fever). Wrong route with significant inhalation. Patient was put in recovery position, aspiration, oxygen therapy; saturation recovered after putting on O2, but the recovery of the state of consciousness was moderate. The patient was put on Augmentin. Family was informed and the decision was to not hospitalize the patient. The evolution was unfavorable the following days; the patient died on an unspecified date in Feb2021 (reported as during the night of February 13 to 14). The physician mentioned a death linked to aspiration pneumonia in this patient whose state of health was very precarious. The reporter assessed the events emesis/episode of vomiting and aspiration pneumonia as serious (death). The patient died on an unspecified date of Feb2021. It was not reported if an autopsy was performed. No follow-up attempts were possible. No further information is expected. Information on lot and batch numbers were already obtained.; Reported Cause(s) of Death: Pneumonia aspiration; Emesis/episode of vomiting


VAERS ID: 1081847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood creatinine, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiovascular disorder, Coma scale, Cyanosis, Dehydration, Dyspnoea, Electrocardiogram, Heart rate, Hyperkalaemia, Hypernatraemia, Investigation, Oxygen saturation, Oxygen saturation decreased, Renal failure, Respiratory rate
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Knee arthroplasty (PAO); Pulmonary embolism (left PE); Unspecified disorder of thyroid
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: Creatinine; Result Unstructured Data: Test Result:423; Comments: renal failure with creatinine 423; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:hypotension; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/67 mmHg; Test Date: 20210215; Test Name: Body Temperature; Result Unstructured Data: Test Result:Afebrile; Test Date: 20210215; Test Name: Body Temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210215; Test Name: BNP; Result Unstructured Data: Test Result:1000; Comments: BNP (ventricular natriuretic protein) 1000; Test Date: 20210215; Test Name: GCS; Result Unstructured Data: Test Result:E3V2M6; Comments: obeying commands, incomprehensible speech, eye opening in response to speech; there was no localization sign; Test Date: 20210215; Test Name: C-reactive protein; Result Unstructured Data: Test Result:170; Test Date: 20210215; Test Name: ECG; Result Unstructured Data: Test Result:130 bpm; Comments: rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; Test Date: 20210215; Test Name: Heart rate; Result Unstructured Data: Test Result:decreased; Test Date: 20210215; Test Name: Pulse; Result Unstructured Data: Test Result:60; Test Date: 20210215; Test Name: Tachycardia; Result Unstructured Data: Test Result:130; Test Date: 20210215; Test Name: Hyperkalaemia; Result Unstructured Data: Test Result:6.1; Test Date: 20210215; Test Name: Hypernatremia; Result Unstructured Data: Test Result:158; Test Date: 20210215; Test Name: Clinical examination; Result Unstructured Data: Test Result:borderline blood pressure, tachycardia 130; Comments: borderline blood pressure, tachycardia 130, afebrile, rapid BDC (rapid heart sound disturbances), no OMI (legs oedema), superficial polypnea, and bilateral crackles; Test Date: 20210215; Test Name: Clinical examination; Result Unstructured Data: Test Result:clinically dehydrated; Test Date: 20210216; Test Name: Clinical examination; Result Unstructured Data: Test Result:progressive degradation of hemodynamics; Comments: progressive degradation of hemodynamics, and with cyanosis; Test Date: 20210215; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:100/2 L/min oxygen; Test Date: 20210215; Test Name: Respiratory rate; Result Unstructured Data: Test Result:20
CDC Split Type: FRPFIZER INC2021232772

Write-up: progressive degradation of hemodynamics; Cyanosis; AFib / rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; Major dehydration/ clinically dehydrated; Oxygen saturation decreased/ desaturation; Dyspnoea; renal failure with creatinine 423, BNP (ventricular natriuretic protein) 1000, and CRP (C-reactive protein) 170; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB; the Regulatory Authority Report Number is: FR-AFSSAPS-TS20210392. A 95-year-old female patient received the first dose of the BNT162B2 (COMIRNATY; lot/batch number and expiry date were unknown), intramuscular on 11Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient''s medical history included ongoing hypertension arterial and heart failure; Patient had periacetabular osteotomy (PAO), left pulmonary embolism (PE), atrial fibrillation, and dysthyroidism, all from an unknown date and unknown if ongoing. Patient was in a nursery home. Concomitant medications were not reported. On 15Feb2021, day 4 after the first dose of Comirnaty, the patient experienced a rapid outbreak of ACFA that was poorly tolerated with desaturation and major dehydration. It was reported that the patient was admitted in the emergency room for dyspnea on 15Feb2021. The patient underwent lab tests and procedures on 15Feb2021 which included: Pulse: 60, Blood pressure left arm (Max/Min): 96/67 mmHg, Oxygen saturation: 100/2 L/min oxygen, Respiratory rate: 20, and Temperature: 37.3 degrees Centigrade. Per clinical examination, patient had borderline blood pressure, tachycardia 130, afebrile, rapid BDC (rapid heart sound disturbances), no OMI (legs oedema), superficial polypnea, and bilateral crackles. GCS (Glasgow coma scale) E3V2M6 (obeying commands, incomprehensible speech, eye opening in response to speech; there was no localization sign). On ECG, the following was noted: rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances. Faced with poorly tolerated ACFA, patient was administered with 300mg cordarone over 30 min plus 80mg of lasilix. Upon reassessment, the following were observed: decrease in heart rate, hypotension, and patient was clinically dehydrated. Other laboratory assessments performed in 15Feb2021 showed hypernatremia at 158, hyperkalaemia at 6.1, renal failure with creatinine 423, BNP (ventricular natriuretic protein) 1000, and CRP (C-reactive protein) 170. The following were conducted: probabilistic antibiotic therapy by C3G (third generation cephalosporins), rehydration by NaCl 1000/24h, and anxiolysis by midazolam 0.5 mg/h. On 16Feb2021 patient had progressive degradation of hemodynamics, and with cyanosis. Comfort treatment with 0.5 mg/h of morphine was initiated and patient died on 16Feb2021 at 7:10 am. No autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation decreased/ desaturation; Major dehydration/ clinically dehydrated; Renal failure; AFib / rapid atrial fibrillation (rapid ACFA) 130 bpm with diffuse repolarization disturbances; progressive degradation of hemodynamics; Cyanosis


VAERS ID: 1082415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4244/PF/IM / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Cough, Death, Pulmonary function test, Respiratory acidosis, Respiratory failure, SARS-CoV-2 test
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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Respiratory failure
Allergies:
Diagnostic Lab Data: Test Name: Respiratory test; Result Unstructured Data: Test Result:non infective exacerbation of COPD and respiratory; Comments: revealed non infective exacerbation of COPD and respiratory acidosis; Test Date: 20210226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:no - negative covid-19 test
CDC Split Type: GBPFIZER INC2021239390

Write-up: type 2 respiratory failure; respiratory acidosis; cough; non infective exacerbation of COPD; Death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202103021834112350, and Safety Report Unique Identifier is GB-MHRA-ADR 24864762. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK4244/PF/IM, via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunisation. Medical history included respiratory failure and COPD (chronic obstructive pulmonary disease). Patient has not had symptoms associated with COVID-19 and patient was not enrolled in clinical trial. The patients concomitant medications were not reported. The patient experienced type 2 respiratory failure on an unspecified date, respiratory acidosis on an unspecified date, cough on an unspecified date, death on 01Mar2021 also reported as 24Feb2021 and non-infective exacerbation of COPD on an unspecified date. It was reported that patient had moderate COPD but had good quality of life. She was well through shielding time from Mar2020 until Feb2021.She had vaccine and 12 days later developed chesty cough. Collapsed two days later and was admitted to ITU with type 2 respiratory failure and died 3 days later. Patient never previously had a COPD related hospital admission. Patient has not tested positive for COVID-19 since having the vaccine. ITU tests (respiratory test) revealed non infective exacerbation of COPD and respiratory acidosis. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 26Feb2021, and respiratory test: revealed non infective exacerbation of COPD and respiratory acidosis on an unspecified date. The outcome of the events was fatal. The patient died on 01Mar2021 also reported as 24Feb2021. 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: type 2 respiratory failure; respiratory acidosis; cough; death; non-infective exacerbation of COPD


VAERS ID: 1082464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, Oral discharge, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 13
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: COVID-19; Subarachnoid haemorrhage (7 + years ago required full care however had been medically well for several years.); Comments: Patient had a SAH 7 + years ago required full care however had been medically well for several years. Patient had COVID in Jan 2020 caught in a care home. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021238920

Write-up: Death NOS; Symptoms included an increase in Oral secretions and a reduction in alertness.; Symptoms included an increase in Oral secretions and a reduction in alertness.; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Agency RA)(. Regulatory authority report number GB-MHRA-WEBCOVID-202103031027278470, Safety Report Unique Identifier GB-MHRA-ADR 24867272. A 71-year-old female patient received the first dose of BNT162B2 (P FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included subarachnoid haemorrhage (7 + years ago required full care however had been medically well for several years) and COVID in Jan2020 (the patient had COVID in Jan2020 caught in a care home.) The patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient was vaccinated on Monday 08Feb2021 and she had a slow deterioration over the week. The patient had complex care needs however she was medically well and being looked after at home. Symptoms included an increase in oral secretions and a reduction in alertness. The outcome of oral secretions and a reduction in alertness was unknown. The patient died on 14Feb2021. The cause of death was not reported; it was unknown if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1082667 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Arresto cardio-circolatorio; A regulatory authority report (Italy) was received from a physician concerning a female patient of 87-year-old, who was received Moderna''s COVID-19 vaccine(mRNA-1273) and experienced arrest cardiac. The patients'' medical history was not provided. No relevant Concomitant medications were reported. On 08 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273(Lot number: 300042721) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced cardiac arrest and passed away. The event was also considered medically significant. Treatment information was not provided. Action taken with the mRNA-1273 was not applicable. The outcome of event was fatal as patient died on 11 Feb 2021 due to arresto cardio-circolatorio. The autopsy details were not provided.; Reporter''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The autopsy details were not provided. However, the patient''s age may be a confounding factor for causality assessment.; Reported Cause(s) of Death: Arresto cardio-circolatorio


VAERS ID: 1082764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (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: PLPFIZER INC2021237485

Write-up: Pulmonary edema; This is a spontaneous report from a contactable consumer through the Medical Information Team. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient had pulmonary edema. The patient had died on an unspecified due to pulmonary edema. It was unknown if an autopsy was performed. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Pulmonary edema


VAERS ID: 1083580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: GANFORT; SIMBRINZA; KARDEGIC; fluoxetine hcl; BROMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Falling down; Glaucoma; Lyme disease; Rhizomelic pseudopolyarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232825

Write-up: Falling down; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-AN20210501. A 93-year-old male patient received their second dose of bnt162b2 (COMIRNATY; lot number and expiry date were not reported), intramuscular on 10Feb2021 at single dose for covid-19 immunisation, acetylsalicylate lysine (KARDEGIC), oral from an unspecified date to 18Feb2021 at 1 DF, 1x/day for cardiovascular event prophylaxis, fluoxetine hcl, oral from an unspecified date to 18Feb2021 at 10 mg, 1x/day for anxiodepressive syndrome, bromazepam (BROMAZEPAM), oral from an unspecified date to 18Feb2021 at 2 DF, 1x/day for anxiodepressive syndrome. Medical history included glaucoma, anxiodepressive syndrome, Lyme disease, falling down and Rhizomelic pseudopolyarthritis; all from an unknown date and unknown if ongoing. The patient received their first dose of bnt162b2 (COMIRNATY; lot number and expiry date not reported) on 20Jan2021 for covid-19 immunisation. Concomitant medication included bimatoprost, timolol maleate (GANFORT) and brimonidine tartrate, brinzolamide (SIMBRINZA). It was reported that the patient died following a fall/falling down 9 days after a second injection of COMIRNATY and during treatment with FLUOXETINE, BROMAZEPAM and KARDEGIC on 19Feb2021. The action taken in response to the event for acetylsalicylate lysine, fluoxetine hcl and bromazepam was not applicable. The patient died on 19Feb2021. An autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. Information about the batch/lot number cannot be obtained.; Reported Cause(s) of Death: Falling down


VAERS ID: 1083701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest X-ray, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FINASTERIDE; SIMVASTATIN; MONOKET; ZOLOFT; ACETYLSALICYLIC ACID; CERCHIO; SELOKEN [METOPROLOL SUCCINATE]
Current Illness: Chronic ischaemic heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Thorax X-ray; Result Unstructured Data: Test Result:increase in cardiac damage markers
CDC Split Type: ITPFIZER INC2021226253

Write-up: cardiocirculatory arrest; dyspnea; fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-686372. An 88-year-old male patient received second dose of BNT162B2 (COMIRNATY, lot number EJ6136, Expiration Date 30Apr2021), intramuscularly on 30Jan2021 11:30 on left shoulder at 0.3 mL, single dose for COVID-19 immunization. Medical history included ongoing chronic ischaemic heart disease, unspecified. Concomitant medications included finasteride, simvastatin, isosorbide mononitrate (MONOKET), sertraline hydrochloride (ZOLOFT), acetylsalicylic acid, cetirizine hydrochloride (CERCHIO), metoprolol succinate (SELOKEN). Historical Vaccine included first dose of COMIRNATY (lot number EL1484, Expiration date 30Apr2021) on 07Jan2021 18:40 on right shoulder for COVID-19 immunization and experienced signs of pulmonary congestion for which patient institutionalized. On 31Jan2021 at 23:00 the patient experienced dyspnea and fever. Emergency Services alerted at 01:25 and conducted to Emergency Room at 02:40. On 01Feb2021 04:30 am patient experienced cardiocirculatory arrest and death after ineffective resuscitation maneuvers. Lab data included thorax X-ray showed increase in cardiac damage markers on unspecified date. The patient died on 01Feb2021 due to dyspnea, fever and cardiocirculatory arrest. Autopsy was done and showed cardiac decompensation, myocardiosclerotic myocardial hypertrophy. The outcome of the events were fatal.; Reported Cause(s) of Death: dyspnea; fever; cardiocirculatory arrest


VAERS ID: 1083756 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy (Co-Amoxicillin and Codein)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COPD; Depression; Hypothyreosis; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report was received from a regulatory authority concerning a 96-years-old female patient, who was administered with Moderna''s Covid-19 vaccine and was died. Patient''s medical history included Renal failure, COPD, Hypertension arterial, Depression, and Hypothyroidism. Patient had allergy towards Co-amoxicillin and Codein. No relevant concomitant medications were mentioned. On 26-JAN-2021, prior to the onset of events patient received mRNA-1273 vaccine (Lot/Batch: unknown) for prophylaxis of Covid-19 infection. After vaccination, she had no local reaction, no fever, no discomfort. On 30-JAN-2021, she died acutely (patient found dead in bed, an hour before her condition was inconspicuous). Outcome for the event was considered fatal. Patient was dead on 30-JAN-2021 and the probable cause of death was heart attack or heart rhythm disorder.; Reporter''s Comments: Based on reporter''s causality of unlikely and patient''s advanced age along with multiple underlying conditions, the event of death is also assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1083758 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Respiratory distress, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Hypertension (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: Arteriopathic disease (1st grade arteriopathy of lower limbs); Extrasystoles ventricular; Hypertension arterial (benign); Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:170/100 mmHg; Test Date: 20210208; Test Name: heart rate; Result Unstructured Data: Test Result:130 bpm
CDC Split Type: FRPFIZER INC2021232821

Write-up: Hypertension arterial; Tachycardia; Distress respiratory; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-BR20210377. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 05Feb2021 at single dose in left arm for covid-19 immunisation. Medical history included 1st grade arteriopathy of lower limbs, Insulin-requiring type 2 diabetes mellitus, Extrasystoles ventricular, Hypertension arterial benign. The patient''s concomitant medications were not reported. On 08Feb2021, appearance of sudden onset respiratory distress. Tachycardia at 130 bpm, blood pressure at 170/100 mmHg. Impression of imminent death. Evolution towards death at 8:30 p.m., in 15 to 20 minutes. No physician on site. The patient underwent lab tests and procedures which included blood pressure measurement: 170/100 mmhg on 08Feb2021, heart rate: 130 bpm on 08Feb2021. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Hypertension arterial; tachycardia; Distress respiratory


VAERS ID: 1084861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 29
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 insufficiency; COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Viral hepatitis B
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221786

Write-up: COVID-19 respiratory infection; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority [regulatory authority AT-BASGAGES-2021-04880]. The reporter reported similar events for 2 patients, this is the 1st of 2 reports. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number EL1491) via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient''s medical history included Heart failure (continuing), Viral hepatitis B, COVID-19 (continuing). The patient''s concomitant medications were not reported. The patient was positive tested for Sars-CoV2 by means of PCR (25Jan), on 30Jan2021 21:05 and died in the home from COVID-19 respiratory infection. The patient was already palliative before COVID-19 and considered as a terminal patient. No autopsy was done. Causality between the event and vaccine was assessed as unlikely by the HA. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021242520 same reporter, same vaccine, similar events in different patient; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1084862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

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: 2021-02-11
   Days after onset: 10
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 carcinoma (Mammary gland right)
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct cerebral (ischemic infarction)
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221799

Write-up: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19; SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority AT-BASGAGES-2021-04886. A 94-year-old female patient received bnt162b2 (COMIRNATY, lot/batch number: EL1491) , via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation . Medical history included ongoing breast carcinoma (Mammary gland right) and Infarct cerebral (ischemic infarction) from an unspecified date and not ongoing. The patient''s concomitant medications were not reported. The patient experienced sars-cov2-positive infection/ covid-19 respiratory infection/ covid-19 (drug ineffective) (death) on Feb2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 05Feb2021. Narrative case summary and further information was reported as "possible association between deaths and COVID vaccinations given promptly before is suspected. The individuals were all vaccinated against COVID-19 on Jan152021 (1st partial vaccination with Comirnaty, batch EL1491), tested positive 4 to 13 days later (One patient 32 days later), and died 10 to 20 days after vaccination (said patient 37 days later). A similar cluster of deaths did not occur at the nursing home in recent years. COVID infection has been circulating in the home since 01Jan2021. All 12/14 decedents have tested positive for Sars-CoV2 by PCR. The patient in this NW report also tested pos. for Sars-CoV2 by PCR (05Feb2021), then died at the home on 11Feb2021. " The patient died on 11Feb2021 from COVID-19. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/ COVID-19


VAERS ID: 1084863 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 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: 2021-02-21
   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: Test Date: 20210216; Test Name: Covid-19; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC2021242520

Write-up: drug ineffective; COVID-19; This is a spontaneous report a contactable physician reporting on different patients, this is the second case. The first case report was downloaded from the Regulatory Authority [regulatory authority AT-BASGAGES-2021-04880]. A elderly patient of an unspecified gender received the first dose bnt162b2 (COMIRNATY; Lot # EL1491) vaccine , via an unspecified route of administration 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive to SARS-COV-2 on 16Feb2021 and died from it on 21Feb2021. It is unknown if an autopsy was carried out. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-2021221786 same reporter, same vaccine, similar events in different patient.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1084864 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021230129

Write-up: death; This is a spontaneous report from a contactable other healthcare professional via VOC. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, on unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected. ; Sender''s Comments: The event Death may be an intercurrent occurrence. However, based on the plausible temporal relation, the association between the event death and vaccination cannot be ruled out. 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: 1084866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Cardiac arrest, Cardiovascular disorder, Electrocardiogram, General physical health deterioration, Investigation, Loss of consciousness, Respiration abnormal, Rhythm idioventricular, Serum ferritin, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IRON; SALAZOPYRINE; ARANESP; ATENOLOL; LERCANIDIPINE; D-CURE; INDAPAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bechterew''s disease; Chronic renal failure; Hiatus hernia; Hyperuricaemia; Nephroangiosclerosis; Rheumatoid arthritis; Type II diabetes mellitus; Wrist fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: ECG; Result Unstructured Data: Test Result:3rd degree AV block; Comments: with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30.; Test Date: 20210208; Test Name: ECG; Result Unstructured Data: Test Result:relapse 3rd degree AV block; Comments: with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm); Test Name: Acute renal insufficiency; Result Unstructured Data: Test Result:Acute renal insufficiency KDIGO; Comments: presumably based on low flow with underlying CKD (chronic kidney disease) gr 4.; Test Date: 202011; Test Name: High ferritinemia; Result Unstructured Data: Test Result:505 ng/ml; Comments: Exceptionally High ferritinemia
CDC Split Type: BEPFIZER INC2021221941

Write-up: symptomatic bradycardia; However, rapid progression with deterioration to asystole; However, rapid progression with deterioration to asystole; Cardiovascular problem; Unresponsive; groaning breaths; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; very slow ventricular escape rhythm (<20bpm); This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA). Regulatory Authority Report Number : BE-FAMHP-DHH-N2021-77518. A 96-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number unknown), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunisation. Medical history included bechterew''s disease, nephroangiosclerosis, diabetes mellitus type II, arterial hypertension, chronic renal failure, rheumatoid arthritis, hyperuricaemia, wrist fracture, hiatus hernia, all from an unknown date. Concomitant medication included iron (IRON), sulfasalazine (SALAZOPYRINE), darbepoetin alfa (ARANESP), atenolol (ATENOLOL), lercanidipine (LERCANIDIPINE), colecalciferol (D-CURE), indapamide (INDAPAMIDE). The historical vaccination included first dose of bnt162b2 (COMIRNATY) on 15Jan2021 for COVID-19 Vaccination. Reported adverse drug reactions included Cardiovascular disorder, Unresponsive to stimuli, Abnormal breathing, Loss of consciousness, Atrioventricular block, Bradycardia, Ventricular escape rhythm, General physical health deterioration, Asystolia. On 05Feb2021, 2nd dose of Comirnaty vaccine. On 07Feb2021, unresponsive, moaning breathing for which Mobile Emergency and Resuscitation service call. Loss of consciousness based on 3rd degree AV (atrioventricular) block with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30. On 08Feb2021: Recovery, conversation possible. On 08Feb2021 in the evening: Relapse 3rd degree AV block with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm) suddenly areactive. Gasping breathing. Atropine 1x with short-term recovery rhythm. However, rapid progression with deterioration to asystole. No more resuscitation started given very old age and presumably sick heart. Treatment was reported as No. Evolution of the adverse drug reaction was Died. The serious critieria reported for the events were fatal, life-threatening and hospitalization. The patient underwent lab tests and procedures which included electrocardiogram: 3rd degree AV block with intermittent total AV block. In between acceptable sinsual rhythm and ventricular escape rhythm <30 on 07Feb2021, electrocardiogram: Relapse 3rd degree AV block with symptomatic bradycardia with very slow ventricular escape rhythm (<20bpm) on 08Feb2021, Serum ferritin: Exceptionally High ferritinemia, Last ferritin 505 ng/ml on Nov2020, Examinations included high ferritinemia; investigation: Acute renal insufficiency KDIGO (Clinical practice guideline) 1 presumably based on low flow with underlying CKD (chronic kidney disease) gr 4 on unspecified date. The patient died on 08Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiovascular problem; Unresponsive; groaning breaths; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; Loss of consciousness based on 3rd degree AV block with intermittent total AV block; symptomatic bradycardia;


VAERS ID: 1084875 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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 INC2021222140

Write-up: This is a spontaneous report from a non-contactable Physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002906. A 80 years old male patient received BNT162B2 (Comirnaty, lot number EK9788), via an unspecified route of administration on 18Feb2021 at the 80 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced lethal outcome on 18Feb2021. On the same day after vaccination the patient developed Death. The patient died on 18Feb2021. It''s unknown if an autopsy was performed. The cause of death was unknown. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: lethal outcome


VAERS ID: 1084886 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Choking, Decreased appetite, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Encephalopathy; Epilepsy; Infection; Rett''s disorder; Scoliosis (dorsolumbar scoliosis with left convexity)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232815

Write-up: Choked on food; Fever; asthenia; Anorexia; Fatigue; This is a spontaneous report from a consumer downloaded from the Agency Regulatory Authority FR-AFSSAPS-BR20210378. A 33-year-old female patient received the first dose of bnt162b2 (COMIRNATY; lot number EJ6790), intramuscular in the right arm on 18Feb2021 at a single dose for covid-19 immunisation. Medical history included rett''s syndrome, epilepsy, encephalopathy, dorsolumbar scoliosis with left convexity, severe constipation, and repeated infectious and comital episodes. The patient''s concomitant medications were not reported. After the vaccination, the person went home. Fatigue appeared on 18Feb2021; fever, asthenia, and anorexia on 19Feb2021, patient did not eat. On 21Feb2021, patient had less temperature. In the evening, she had dinner and took a wrong turn leading to death, patient choked on food. The patient died on 21Feb2021. It was not reported if an autopsy was performed. The events were reported as serious (fatal). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fatigue; fever; asthenia; anorexia; choked on food


VAERS ID: 1084887 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: Aortic stenosis; Aregenerative anemia; Atrioventricular block complete (Complete AVB with cardiac pacemaker installation in 2020); Cardiac pacemaker insertion; Chronic renal failure; Cirrhosis liver; Cognitive disturbance (neurocognitive disorders of mixed origin (degenerative and vascular)); Fracture of neck of femur; Hypertension arterial; Hypertensive heart disease NOS; Insulin-requiring type 2 diabetes mellitus; Kappa light chain analysis; Pertrochanteric fracture of femur, closed
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232806

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-BR20210400. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EK9788), intramuscular on 08Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included non-deficiency aregenerative anemia, atrioventricular block complete (Complete AVB with cardiac pacemaker installation in 2020), aortic stenosis, cirrhosis liver from 2020, hypertensive heart disease, hypertension arterial, cognitive disturbance (neurocognitive disorders of mixed origin (degenerative and vascular), cardiac pacemaker insertion in 2020, insulin-requiring type 2 diabetes mellitus, fracture of neck of femur from 2019, chronic renal failure, right pertrochanteric fracture from 2019, kappa light chains anomaly from May2020. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, lot number: EJ6795) on 18Jan2021 for COVID-19 Immunisation with no adverse effect. On 13Feb2021, the patient experienced infarct myocardial. Intervention by the doctor in the morning, then by the on-call resident in the afternoon, cardiological advice requested by telephone. The event resulted to fatal outcome. The patient died on 14Feb2021. 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: Infarct myocardial


VAERS ID: 1084889 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Myocardial infarction, Myocardial ischaemia, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pulmonary oedema, Troponin
SMQs:, Cardiac failure (narrow), Angioedema (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial flutter; Auricular fibrillation; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: Desaturation; Test Result: 85 %; Test Date: 20210202; Test Name: Troponins; Result Unstructured Data: Test Result:High
CDC Split Type: FRPFIZER INC2021232835

Write-up: cardiac decompensation; Atrial fibrillation; pulmonary edema; Arterial oxygen saturation decreased/85% desaturation; cardiac decompensation with suspicion of a massive infarction; myocardial ischemia (high troponins, no quantified value).; ankle edema; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-MA20210498. A 97-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number: EK9788, expiry date: unknown), intramuscular on 28Jan2021 (at the age of 97 years old) at a single dose in the right arm for covid-19 immunisation. Medical history included diabetes, auricular fibrillation, and atrial flutter. The patient''s concomitant medications were not reported. Covid-19 PCR test was not performed. The patient had no history of covid-19. History of allergy or hypersensitivity was unknown. On 30Jan2021, approximately 2 days after vaccination, the patient had appearance of ankle edema reported by the home nurse. On 02Feb2021, the patient presented with cardiac decompensation, atrial fibrillation, with pulmonary edema, 85% desaturation (also reported as arterial oxygen saturation decreased), change to poorly tolerated AF (atrial flutter) and myocardial ischemia (high troponins, no quantified value). The patient was hospitalized and treated with isosorbide dinitrate (RISORDAN) and diuretics. No coronary angiography performed. On 15Feb2021, the patient experienced new cardiac decompensation with suspicion of a massive infarction. Therapeutic measures were taken as a result of the events cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation. Outcome of the events cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation was fatal. Outcome of all the other events was unknown. The patient died on 16Feb2021 due to cardiac decompensation, atrial fibrillation, pulmonary edema and arterial oxygen saturation decreased/85% desaturation. It was not reported whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac decompensation; atrial fibrillation; pulmonary edema; arterial oxygen saturation decreased/85% desaturation


VAERS ID: 1084890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-09
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, 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: 2021-01-27
   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: AFib; Dementia; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: no variant search
CDC Split Type: FRPFIZER INC2021232874

Write-up: symptoms of COVID-19 appeared; symptoms of COVID-19 appeared and performance of a positive PCR test (no variant search); This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory Authority Report Number is FR-AFSSAPS-MP20210276. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY; lot number EJ6788), intramuscular in the left arm on 21Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing diabetes, ongoing dementia, and ongoing Afib. The patient''s concomitant medications were not reported. Declaration made through the national portal, made by a health professional. Patient considered to be at risk of developing a severe form of COVID-19 disease was yes (age). History of COVID-19 was not specified. Patient was vaccinated on 21Jan2021 as part of the COVID-19 vaccination campaign. On 26Jan2021, symptoms of COVID-19 appeared and performance of a positive PCR test (no variant search). Patient was treated in the nursing home. On 27Jan2021, the patient died. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. It was not reported if an autopsy was performed. The events are serious, fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: symptoms of COVID-19; positive PCR test


VAERS ID: 1084891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
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, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: CVA; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232855

Write-up: COVID-19 PCR test positive/ COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from Regulatory Authority, regulatory authority FR-AFSSAPS-MP20210278. A 77-year-old male patient received first dose of BNT162B2 (COMIRNATY; lot number: EJ6788) on left arm, intramuscular on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, cerebrovascular accident (CVA) from 2011 to 2013, and dementia. The patient''s concomitant medications were not reported. The patient experienced COVID-19 PCR test positive and COVID-19 aggravated on 25Jan2021. The patient was considered to be at risk of developing a severe form of COVID-19 disease. The patient was vaccinated as part of the COVID-19 vaccination campaign. It was also reported that on 25Jan2021, symptoms of COVID-19 appeared. Additionally on 25Jan2021, performance of a positive PCR test (no variant search). Patient was treated in the nursing home. On 28Jan2021, death of the patient. The patient died on 28Jan2021. 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: COVID-19 PCR test positive


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