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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1111252 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, General physical health deterioration, Myocardial infarction, SARS-CoV-2 test, Sepsis
SMQs:, Myocardial infarction (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Sepsis (narrow), Opportunistic infections (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALVEDON; LEVETIRACETAM; BLOXAZOC; FURIX [FUROSEMIDE]; ENALAPRIL; ATORVASTATIN; KETOGAN NOVUM; ACETYLSALICYLIC ACID; FELODIPINE; BETOLVIDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Ischemic heart disease; Type 2 diabetes mellitus; Watery diarrhea
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: SEPFIZER INC2021120364

Write-up: Watery Diarrhea; REDUCED general condition; MYOCARDIAL INFARCTION; SEPSIS; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority WEB and received via Regulatory Authority SE-MPA-2021-001789. A 90-years-old female patient received bnt162b2 (COMIRNATY) vaccine , via an unspecified route of administration on Jan2021 at single dose for Covid-19 immunisation . Medical history included type 2 diabetes mellitus , dementia , hypertension, diarrhoea , myocardial ischaemia . Concomitant medication included paracetamol (ALVEDON), levetiracetam (LEVETIRACETAM), metoprolol succinate (BLOXAZOC), furosemide (FURIX [FUROSEMIDE]), enalapril (ENALAPRIL) , atorvastatin (ATORVASTATIN), ketobemidone hydrochloride (KETOGAN NOVUM), acetylsalicylic acid (ACETYLSALICYLIC ACID), felodipine (FELODIPINE), cyanocobalamin (BETOLVIDON). The patient experienced reduced general condition on Jan2021 , myocardial infarction on Jan2021 , sepsis on Jan2021. The patient died from the reported events. No autopsy will be performed. The woman had earlier in the week been admitted to the Emergency room due to diffuse rashes, interpreted as age-related rashes/hemangiomas, normal lab tests were taken, thereafter she got vaccinated with Comirnaty. The woman arrived at the emergency room 2 days after the vaccination with a deteriorating general condition since the day before and recurring periods of watery diarrhoea (unclear how long they have lasted) and she was admitted. The woman received Ringer''s Acetate to raise her blood pressure and albumin but got insufficient effect from this and was started on piperacillin / tazobactam, all hypertensive drugs were paused. No new Covid test was taken, but the woman was kept isolated as a Covid patient, the diarrhoea could be a sign of Covid. Lab values: white 20.4, Pk/INR 1.2, albumin 25, creatinine which has gone up to 278 and therefore gives an eGFR of 12, ASAT 3.5, ALAT 0.95, CRP 192, Troponin$g 10000, lactate 2.3 Palliative care is initiated due to pain and anxiety, which the patient may feel. The patient was found dead the next morning, assessment sepsis with unclear focus with dehydration and pronounced secondary infarction, given age and previous illnesses. No follow-up attempts possible. No further information expected.Lot/batch number was not provided and unable to obtain; Reported Cause(s) of Death: Reduced general condition; Myocardial infarct; Sepsis


VAERS ID: 1112855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Haematemesis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: COVID pos in hospital
CDC Split Type: ATPFIZER INC2021250307

Write-up: SARS COVID 19; died within a week; Haematemesis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority number AT-BASGAGES-2021-09458]. A 76-year-old male patient received his first dose of BNT162b2 (COMIRNATY, lot number EP2163), intramuscular on 14Jan2021, at single dose for COVID-19 immunisation. The patient medical and concomitant medications were not reported. The patient experienced haematemesis and SARS COVID 19 on 17Jan2021. On 17Jan2021 the patient was hospitalized. On the same day, in hospital, the patient was found positive COVID-19 PCR test. The patient was vaccinated on Thursday and was positive on Sunday, so was probably vaccinated in the incubation period. Previously, he was never tested positive and tests were carried out very frequently in the affected nursing home. Patient was hospitalized on 17Jan2021 and died within a week due to SARS COVID 19 (on unspecified date in Jan2021). The outcome of event haematemesis was unknown. 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: SARS COVID 19; died within a week


VAERS ID: 1112860 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Contusion, Dysphagia, Myalgia, Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (mixed Alzheimer''s and vascular dementia.); Drowsiness; Swallowing difficult; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021265131

Write-up: weight loss; increased drowsiness; swallowing; Condition declined post vaccination - weight loss, increased drowsiness, swallowing; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; muscle/body aches; Bruising; This is a spontaneous report received from the Regulatory Authority (Regulatory authority number AU-TGA-0000521644). A contactable physician reported that a 78-year-old female patient received BNT162B2 (COMIRNATY) first dose on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included patient had end-stage dementia mixed Alzheimer''s and vascular dementia, patient was on palliative care pathway. Patient declining over some months - increased drowsiness over a few weeks prior to vaccination and weight loss, swallowing. Concomitant medications were not reported. Patient died on 04Mar2021 after COVID vaccine on 25Feb2021 Pain, redness, swelling on injection site, muscle/body aches Bruising. Condition declined post vaccination - weight loss, increased drowsiness, swallowing and end of life care commenced. Physician was not concerned that this was a vaccine reaction. Causality was reported as Causality possible. No follow-up attempts are possible. Information about batch cannot be obtained.; Reported Cause(s) of Death: Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; Pain, redness, swelling on injection site; muscle/body aches; Bruising; weight loss; increased drowsiness; swallowing; Condition declined post vaccination - weight


VAERS ID: 1112861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Confusional state, Hyperglycaemia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BGL; Result Unstructured Data: Test Result:27
CDC Split Type: AUPFIZER INC2021265262

Write-up: Vomited; confused; BGL 27; This is a spontaneous report received from the Therapeutic Goods Administration (TGA) (Regulatory authority number AU-TGA-0000522242). The reporter type to the TGA was reported as a Health Professional. A 95-year-old female patient received the first dose BNT162B2 (COMIRNATY; Lot number not provided), intramuscular on 07Mar2021 at 14:00, at single dose for covid-19 immunisation. Medical history was unknown. Relevant concomitant medications were unknown. The patient received the first dose of vaccine at 14:00, and did not experienced issues immediately following vaccination. On 07Mar2021 she was found confused at 02:00hrs with blood glucose 27. On 08Mar2021 at a 20:00hrs the patient experienced vomiting. The patient was transferred to hospital at 03.20hrs, 09Mar2021 (as reported). It was reported that the patient passed away in the evening of the 08Mar2021. Clinical outcome of the adverse events was fatal. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: Vomited; confused; BGL 27


VAERS ID: 1112868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-29
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, Nervous system disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: KEMADRIN; VITAMIN D NOS; HALDOL; LORMETAZEPAM; BEFACT [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; BISOPROLOL; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Mitral insufficiency (mild aortic and mitral insufficiency); Paranoid schizophrenia; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021250330

Write-up: Nervous system disorder; Hemorrhagic stroke; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The Regulatory Authority report number is BE-FAMHP-DHH-N2021-79017. This report originated from the Regulatory Authority. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. Medical history included paranoid schizophrenia, benign prostatic hyperplasia, and mild aortic and mitral insufficiency. Concomitant medications included procyclidine hydrochloride (KEMADRIN), vitamin D, haloperidol (HALDOL), lormetazepam, cyanocobalamin, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (BEFACT), bisoprolol, and tamsulosin; all taken from an unspecified date for an unspecified indication. Nutritional supplement included Easy-Transil. The patient experienced nervous system disorder and hemorrhagic stroke, both on 29Jan2021 with fatal outcome. There was no treatment received for the adverse events. The patient died on 01Feb2021. It was unknown if an autopsy was performed. Events were assessed by FAMHP as unclassifiable. Reporter comment: Patient was of a thin corpulence. He had a correct general condition before and after vaccination. On 29Jan2021, neurological problems appeared: agitation, mutism, swallowing disorders, falls,..linked with a cerebral haemorrhage. Follow-up attempts are not needed. No further information is expected.; Reported Cause(s) of Death: Nervous system disorder; Hemorrhagic stroke


VAERS ID: 1112870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-23
   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: L-THYROXINE [LEVOTHYROXINE SODIUM]; NEUROBION [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE DISULFIDE]; EMCORETIC; PRAREDUCT; ROCALTROL; CO-BISOPROLOL; SERTRALINE EG; TRAZODONE EG; LYSANXIA; OZEMPIC; L-THYROXINE [LEVOTHYROXINE SODIUM];
Current Illness: Cerebral atrophy; Hyperparathyroidism; Hypocalcemia; Malabsorption; Osteopenia; Supraventricular extrasystoles; Ventricular extrasystoles
Preexisting Conditions: Medical History/Concurrent Conditions: Algoneurodystrophy (complex regional pain syndrome); Bypass surgery; Cataract (left); Depression; Eventration repair; Gastric banding; Radius fracture; Skull fracture; Thyroidectomy total; Total knee replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021266825

Write-up: death in her sleep on day 5; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-79852. A 73-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number EK9788) via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included fronto-parietal atrophy from 18Sep2020 and ongoing; isolated supraventricular extrasystoles from 21Sep2020 and ongoing; rare ventricular extrasystoles from 21Sep2020 and ongoing; hyperparathyroidism due to hypocalcemia (malabsorption phenomenon) from 01Jan2010 and ongoing; mixed osteopenia from 19Mar2020 and ongoing; algoneurodystrophy on right total knee replacement (complex regional pain syndrome) from 01Jan2014 to 01Jan2017; depression on 01Jan2000 (as reported); head fracture right radius on 04Dec2016; gastric banding on 01Jan2000; bypass on 01Jan2009; left eye cataract on 02Mar2016; eventration cure from an unspecified date to 17Dec2020; right total knee replacement on 01Jan2014, and total thyroidectomy on 01Jan2000. Concomitant medications included levothyroxine sodium (L-THYROXINE) from 21Dec2020; cyanocobalamin, pyridoxine hydrochloride, thiamine disulfide (NEUROBION) from 09Mar2020; bisoprolol fumarate, hydrochlorothiazide (EMCORETIC) from 09Mar2020; pravastatin sodium (PRAREDUCT) from 09Mar2020; calcitriol (ROCALTROL) from 09Mar2020; bisoprolol fumarate, hydrochlorothiazide (CO-BISOPROLOL) from 20Oct2020; sertraline hydrochloride (SERTRALINE EG) from 17Dec2020; trazodone hydrochloride (TRAZODONE EG) from 17Dec2020; prazepam (LYSANXIA) from 11Sep2020; semaglutide (OZEMPIC) from an unspecified date; levothyroxine sodium (L-THYROXINE) from 20Oct2020; ferrous sulfate (FERO-GRADUMET) from 09Mar2020, all for unspecified indication. The patient experienced death in her sleep on day 5 on 23Feb2021. An autopsy was not performed. The Regulatory Authority considered the causality of the sudden death with Comirnaty as unclassifiable. Reporter Comment: No particular fragility: completely autonomous patient, no mobility problem, no cognitive disorders. She had little medical history that could explain such a sudden death. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No particular fragility: completely autonomous patient, no mobility problem, no cognitive disorders. She had little medical history that could explain such a sudden death.; Reported Cause(s) of Death: death in her sleep on day 5


VAERS ID: 1112871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

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: ALPRAZOLAM; PARACETAMOL; XARELTO; COVALSAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (pacemaker); Atrial fibrillation (consecrated atrial fibrillation); Mitral insufficiency; Weight normal (normal build)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021266831

Write-up: Cardiovascular disorder; This is a spontaneous report received from a physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-80414. This report originated from the Regulatory Authority. A 92 year old female patient received 2nd dose of bnt162b2 (COMIRNATY- lot number EJ6789), via an unspecified route of administration on 24Feb2021 12:00 for covid-19 immunisation. Medical history included consecrated atrial fibrillation, mitral valve incompetence. The patient had a pacemaker and was from normal build. Concomitant medication included alprazolam, paracetamol, rivaroxaban (XARELTO), hydrochlorothiazide, valsartan (COVALSAR). The patient experienced cardiovascular disorder on 25Feb2021. The patient died on 25Feb2021. It was not reported if an autopsy was performed. Regulatory Authority considered the event as unclassifiable. Reporter comment: vaccination process totally normal on 24Feb2021 at 12h, no post-vaccination reaction. Patient was found deceased in bed on 25Feb2021 at 8 am. The death certificate concludes a natural death, probably stroke or fatal arrhythmia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1112877 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: PANTOPRAZOL SPIRIG HC; CANSARTAN; CLOPIN ECO; CLOPIXOL [ZUCLOPENTHIXOL DECANOATE]; OXIS TURBOHALER; RIVOTRIL; SAYANA; AZICLAV
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Alcohol use (Occasional); Atheromatosis; Bronchitis chronic; Folliculitis (Cheek area on the right.); Hypertension; Nicotine abuse (Smoking:14 - 18 cig/day for years); Obesity; Schizophrenia; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021262161

Write-up: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.; Vaccination with Comirnaty on 11Feb2021, subcutaneously (not known why),; This is a spontaneous report received from a contactable physician, the regulatory authority. Regulatory authority report number CH-SM-2021-11636. A non-pregnant 35-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), subcutaneous on 11Feb2021 (at age of 35-year-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included eosophageal reflux, hypertension, Schizophrenia, chronic bonchitis, Nicotine abuse (Smoking: 14-18 cig/day for years), obesity, folliculitis in the cheek area on the right from 05Feb2021, Seizures from 07Sep2020, infected atheroma, Alcohol use (Occasional). Allergies was None. Kidney disease and Liver disease were Not known. Concomitant medications included: pantoprazole sodium sesquihydrate (PANTOPRAZOL SPIRIG HC) from May2018 for reflux, candesartan cilexetil (CANSARTAN) from 14Mar2017 for hypertension, clozapine (CLOPIN ECO) from 11Jan2011 for Schizophrenia, zuclopenthixol decanoate (CLOPIXOL) from 11Jan2011 for schizophrenia, formoterol fumarate (OXIS TURBOHALER), from 28May2018 for chronic bronchitis in nicotine abuse, clonazepam (RIVOTRIL) from 04Jul2017 for Seizures, medroxyprogesterone acetate (SAYANA) from 29Aug2017 for Contraception, amoxicillin, clavulanate potassium (AZICLAV) from 05Feb2021 to 12Feb2021 for infected atheroma/folliculitis in the cheek area on the right. Vaccination with COMIRNATY on 11Feb2021, subcutaneously (not known why), In the evening (13Feb2021), the patient was found dead in institution. Unexpected sudden death 30-36 hours after vaccination. Forensic medical examination at (privacy) ordered by prosecution. The outcome of the event was fatal. On 09Mar2021 the results of the autopsy were not yet available. As soon as we receive them we will evaluate the case and adjust the causality assessment. An autopsy was performed and results were not provided. A causal relationship between Comirnaty and Death is at the moment conditional/unclassified. This case was reported as serious (fatal outcome). Sender''s comment: Unexpected sudden death 30-36 hours after vaccine in a young patient known for several pathologies (schizophrenic, eosophageal reflux, hypertensive, chronic bonchitis, nictotin abuse, obese and recent folliculitis treated with antibiotic), and in chronic therapy with several drugs. From the first data of the autopsy a clear cause of death did not emerge but they are investigating further and will give us the details of the final report. At the moment (09Mar2021) we have therefore judged the causal correlation between the vaccine and the death of the patient as conditional/unclassified. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unexpected and sudden death 30-36 hours after vaccination with Pfizer-BioNTech 1st dose.


VAERS ID: 1112891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266918

Write-up: passed away; General physical health deterioration; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Regulatory Authority number DE-PEI-2021005791] from a non contactable consumer. An 81-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular, on 22Jan2021, at 0.3 ml single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took the 1st dose of Comirnaty on 05Jan2021 for COVID-19 immunisation and experienced pneumonia. The patient experienced general physical health deterioration (non-serious) on 22Jan2021 with outcome of unknown and passed away (death) on 24Jan2021. It was not reported if an autopsy was performed. Sender Comment: nothing known. The resident developed fever 8 hours after the first vaccination and problems to breathe. On the next day, he was hospitalized and a severe pneumonia was diagnosed so that the lungs had to be punctated additionally. Two weeks later the resident came back to the facility in a very bad general condition with oxygen device. On 22Jan2021, the resident received the second vaccination and one day later he stopped eating and was even weaker than before. A further day later he was found dead in his bed. Reported causality assessment (for both events): Source of assessment: Regulatory Authority. Result of Assessment: Inconsistent causal association to immunization.; Sender''s Comments: Linked Report(s) : DE-PEI-PEI2021005463; Reported Cause(s) of Death: passed away


VAERS ID: 1112892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Death, Decreased appetite, General physical health deterioration, Lethargy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia vascular
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266954

Write-up: The patient died; Loss of appetite; Physical deterioration; Lethargy; Weakness; Chills; This is a spontaneous report from a non-contactable consumer, downloaded from the Agency Regulatory Agency-WEB (regulatory authority number DE-PEI-CADR2021014865). An 86-year-old female patient received a single dose of BNT162b2 (COMIRNATY), intramuscular, on 28Dec2020, for COVID-19 immunisation. The patient''s medical history included ongoing vascular dementia. The patient''s concomitant medications were not reported. On 03Jan2021, the patient experienced weakness, chills, and lethargy, all reported as non-serious events. On an unspecified date the patient died. The date of death and cause of death were not provided. It was unknown if an autopsy was performed. The outcome of the events weakness, chills, and lethargy was unknown. The causality for the events increasing weakness and chills was assessed as "A. Consistent causal association to immunization" and for death and lethargy as "C. Inconsistent causal association to immunization" Sender''s comment: Known vascular dementia (early stage)/ increasing weakness, loss of appetite, physical deterioration. No follow-up attempts needed, follow-up automatically provided .; Sender''s Comments: Based on the information currently available a causal relationship between event death of unknown causa and BNT162b2 (COMIRNATY) vaccine can be excluded. This 86 year-old patient death is attributed to underlying medical conditions including ongoing vascular dementia. 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: 1112893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory failure
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266949

Write-up: Pulmonary failure; This is a spontaneous report downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB [regulatory authority number DE-PEI-CADR2021015336]. A 61-years-old male patient received bnt162b2 (COMIRNATY,Batch/Lot Number: EJ6797), intravenous on 06Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced pulmonary failure on 15Jan2021.The patient died on 02Feb2021. It was not reported if an autopsy was performed. Outcome of event was fatal. Sender Comment: mild hypertension / mild symptoms one day after vaccination, increasing deterioration within a week, hospitalization in the intensive care unit, lung failure. According to regulatory authority there is an Inconsistent causal association to immunization for the event Pulmonary failure. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1112894 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bechterew''s disease; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Shoulder operation NOS (2 shoulder surgeries in November 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266927

Write-up: Cardiac arrest; pulmonary embolism; This is a spontaneous report downloaded from the regulatory authority. The Regulatory authority report number is DE-PEI-CADR2021015340. A non-contactable consumer reported that an 82-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number and Expiry dates were not reported), via intramuscular route of administration, on 23Jan2021, as single dose for COVID-19 immunisation. Medical history included shoulder operation NOS in Nov2020 (2 shoulder surgeries in November 2020), ongoing parkinson''s disease, ongoing Bechterew''s disease and ankylosing spondylitis. The patient''s concomitant medications were not reported. On 23Jan2021 patient experienced cardiac arrest, pulmonary embolism. The outcome of the cardiac arrest was fatal and for pulmonary embolism outcome was unknown. The patient died on an unspecified date in 2021 due to cardiac arrest. It was not reported if an autopsy was performed. Causality: Inconsistent causal association to immunization for both events. Sender Comment: Parkinson''s disease, ankylosing spondylitis, 2 shoulder surgeries in November 2020/ cardiac arrest diagnosis pulmonary embolism Follow-up activities closed: downloaded from database.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1112895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Death, Incorrect route of product administration, Nausea, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 23
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: Aortic valve incompetence; Arterial hypertension; Cardiac failure; COPD; Mitral valve incompetence; Myelodysplastic syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Blood transfusion (approximately every 10 weeks); Dependence on oxygen therapy; Fatigue; Hearing loss (gradual); Listlessness; Mechanical ventilation; Mood disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267431

Write-up: vomit several times; Nausea; massive respiratory distress; COPD; My mother received the first Corona vaccination on 30Dec2020, on 20Jan2021 she received the second vaccination, four days later she was dead.; second dose of bnt162b2 (COMIRNATY) via intravenous; This is a spontaneous report downloaded from the Regulatory Authority-WEB. The regulatory authority numbers are DE-PEI-CADR2021015723 and DE-PEI-2021006148]. A non-contactable consumer reported that an 83-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) via Intravenous on 20Jan2021 as single dose for COVID-19 immunisation. The patient medical history included ongoing mitral valve incompetence, ongoing cardiac failure, ongoing myelodysplastic syndrome, ongoing aortic valve incompetence, ongoing chronic COPD (chronic obstructive pulmonary disease), ongoing arterial hypertension, oxygen concentrator permanently, NIV for night time (mechanical ventilation), blood transfusion (approximately every 10 weeks), Fatigue, listlessness, loss of hearing, mood disorders and back pain. The concomitant medication included 20 tablets and drops of various types per day (names was not specified). The patient previously took first dose of BNT162B2 (COMIRNATY) for prophylactic vaccination (Covid-19 immunisation) at a dose of 0.3 ml and experienced chills, very tired, slept all day. It was reported that patient was staying at senior centre. It was reported that after receiving second vaccination the patient was very nauseous and had to vomit several times on 24Jan2021. At the senior centre they gave her something for her stomach and reassured her by saying that the caregivers who had received the vaccination also had similar side effects. It was reported that nausea worsened, and doctor was called, the doctor arranged for her to be admitted to a hospital immediately. It was reported that on the on the day of admission, she was given a blood transfusion, but she developed massive respiratory distress and was transferred to the intensive care unit the next day. There she died after about 24 hours on 24Jan2021. The seriousness was reported as hospitalisation and fatal by the health authority. The cause of death according to the hospital was COPD. Neither the attending physician in the hospital nor the vaccinologist considered an autopsy necessary. The autopsy was not performed. The outcome of the events Nausea and vomit several times was not recovered; for the events My mother received the first Corona vaccination on 30Dec2020, on 20Jan2021 she received the second vaccination, four days later massive respiratory distress, COPD was fatal, second dose of bnt162b2 (COMIRNATY) via intravenous was unknown. The Causality of COMIRNATY and the events was reported as Inconsistent causal association to immunization by Regulatory Authority. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority, lot number cannot be received.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood pH, Body temperature, COVID-19, Incorrect route of product administration, Oxygen saturation, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug abuse and dependence (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Test Date: 202101; Test Name: saturation; Test Result: 90 %; Test Date: 202101; Test Name: pH value; Result Unstructured Data: Test Result:6.8
CDC Split Type: DEPFIZER INC2021267002

Write-up: Acute respiratory failure; COVID-19; Fever; Comirnaty was administered via subcutaneous route; This is a spontaneous report from a non-contactable consumer downloaded from Regulatory Authority-WEB DE-PEI-CADR2021015865. An 84-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Batch/Lot Number: Unknown) subcutaneous on 09Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Jan2021 the patient experienced fever, acute respiratory failure, COVID-19. The outcome for fever and COVID-19 was unknown, the outcome for acute respiratory failure was fatal. The patient underwent lab tests and procedures which included SARS-CoV2 test: positive on 21Jan2021. The patient died on 24Jan2021. An autopsy was not performed. Sender Comment: The current admission took place in COVID intensive care unit, accompanied by the emergency doctor. The emergency doctor reports that the patient developed a fever about a week ago with a known SARS-CoV2 infection. The patient had previously been vaccinated for the first time on 09Jan2021. A home resident had previously tested positive for SARS CoV2. When the emergency doctor arrived, the patient was already respiratory unstable with an SO2 of 50%. After NIV ventilation the saturation was 90%. Upon arrival at our hospital, we saw a cardiorespiratory unstable patient. The BGA showed global respiratory insufficiency with a pH value of 6.8. Within 5 minutes of her arrival, the patient was gasped and required resuscitation. The resuscitation remained frustrated. The patient died on 24Jan2021 at 7:19 a.m.". Causality from Regulatory Authority: Inconsistent causal association to immunization for all events. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1112897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
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: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267549

Write-up: died with unknown cause; This is a spontaneous report downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021015978]. A non-contactable consumer reported for 59-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection; Lot number: Not reported) intramuscularly on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing arterial hypertension. Concomitant medications were not reported. On 07Feb2021, the patient died with unknown cause while playing tennis. The event was assessed as serious (death). It was unknown if an autopsy was performed or not. The outcome of the event was reported as fatal. Health Authority Comment: Arter. Hypertension / sudden death while playing tennis. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died with unknown cause


VAERS ID: 1112898 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Dementia, General physical health deterioration, Mental disorder, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 27
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: Dementia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Covid-Test; Result Unstructured Data: Test Result:Negative; Comments: one day later is the same Test pos.; Test Date: 20210109; Test Name: Covid-Test; Result Unstructured Data: Test Result:Positive; Comments: one day ago is the same Test neg.
CDC Split Type: DEPFIZER INC2021267011

Write-up: COVID-19 disease; Dementia aggravated; high fever; unresponsiveness; demented state, her mental as well as physical condition increasingly deteriorated; demented state, her mental as well as physical condition increasingly deteriorated; Unknown cause of death; This is a spontaneous report from a non-contactable consumer (patient''s son/daughter) downloaded from the Agency Regulatory agency-WEB regulatory authority number DE-CADRPEI-2021016548, and DE-PEI-2021006881. A 72-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) intramuscular on 30Dec2020 as 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing dementia. The patient''s concomitant medications were not reported. On 08Jan2021 the patient experienced COVID-19 disease, dementia aggravated, high fever, unresponsiveness and was hospitalized. Her demented state, her mental as well as physical condition increasingly deteriorated in 2021. The patient died on 04Feb2021 with unknown cause of death. It was not reported if an autopsy was performed. Course of events: On 08Jan2021 she was taken to the hospital due to high fever and unresponsiveness, on that day her Corona test was still negative, then positive the next day 09Jan2021, whereupon she was isolated. Due to the 2 weeks of isolation in her demented state, her mental as well as physical condition increasingly deteriorated. No further symptoms developed, and the fever continued for about 1 week. Reporter queried if it was possible that patient''s PCR test for the mRNA of the vaccine had an effect and if it could have been a vaccine reaction. She passed away on 04Feb2021. The causality for all events was considered as Unclassifiable. Follow-up activities not applicable, Follow-up provided automatically.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Multiple organ dysfunction syndrome, Oxygen saturation, Pleural effusion, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (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), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer; Type I diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Acute cardiac insufficiency; Cough; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: investigation; Result Unstructured Data: Test Result:pulmonary effusion; Test Date: 20210113; Test Name: oxygen saturation; Result Unstructured Data: Test Result:below 70 despite oxygen
CDC Split Type: DEPFIZER INC2021266994

Write-up: reanimation with organ failure; Pulmonary effusion; Respiratory distress; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB with regulatory authority number DE-PEI-CADR2021016600. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY), via intramuscular on 13Jan2021 at single dose for COVID-19 immunisation. The relevant medical history included acute cardiac insufficiency from unspecified date and unknown if ongoing, artificial cardiac pacemaker wearer from unspecified date and ongoing, type I diabetes mellitus from unspecified date and ongoing, cough and very tired from 12Jan2021. Concomitant medications were not reported. On 13Jan2021 the patient experienced respiratory distress, pulmonary effusion, multi-organ-failure (reanimation with organ failure). The patient had hospitalization due to the events. The patient died on 13Jan2021. It was unknown if an autopsy was performed. The patient underwent lab test included oxygen saturation which showed below 70 despite oxygen on 13Jan2021; investigation showed pulmonary effusion on 13Jan2021. The outcome of the event reanimation with organ failure was fatal, while other events were not recovered. Sender Comment: Are allergies known in the affected person? No. Details regarding risk factors or pre-existing diseases: diabetes typ 1, cardiac insufficiency left. On the day before (12Jan2021), she complained about cough and was very tired. Was tired when she had to walk stairs. 13Jan call: dyspnea. Emergency physician called. Patient was responsive. According to emergency physician pulmonary effusion, oxygen saturation below 70 despite oxygen. After that reanimation. Patient had cardiac insufficiency left, diabetes type 1 and received a cardiac pacemaker one week ago since her heart skipped several beats again and again. Connection to corona vaccination or coincidence? Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: reanimation with organ failure


VAERS ID: 1112900 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), 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: 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266948

Write-up: Unknown cause of death; Respiratory distress; Patient received BNT162B2 (COMIRNATY) intravenous; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory authority number: DE-PEI-CADR2021017187 and DE-PEI-2021007890. A non-contactable consumer reported that a 95 years old female patient received BNT162B2 (COMIRNATY) intravenous, on 26Jan2021, at single dose, on COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 29Jan2021, the patient experienced respiratory distress. The patient died on 01Feb2021. It was unknown if autopsy was done. Unknown cause of death was reported. The patient did not recover from respiratory distress at time of patient''s death. Causality was provided by Regulatory Authority as Inconsistent causal association to immunization. No follow-up attempts are needed, information about lot number cannot be obtained. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112901 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-15
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Computerised tomogram, Hepatic failure, Multiple organ dysfunction syndrome
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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: Arterial hypertension; Celiac disease; Non-Hodgkin''s lymphoma (peripheral T-cell non-Hogkin lymphoma 2014); Transient ischaemic attack
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT abdomen; Result Unstructured Data: Test Result:suspected cholecystitis
CDC Split Type: DEPFIZER INC2021266922

Write-up: Acute myocardial infarction; Multiple organ failure; Hepatic failure; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [regulatory authority number DE-PEI-CADR2021017565]. A non-contactable Consumer reported that an 81-year-old male patient received BNT162B2 (comirnaty, Solution for injection, Lot number: unknown), via an unspecified route of administration from 25Jan2021 at single dose for covid-19 immunisation. Medical history included all ongoing Arterial hypertension, transient ischaemic attack, non-Hodgkin''s lymphoma from 2014, zoeliac disease from 25Jan2021. The patient''s concomitant medications were not reported. The patient experienced Acute myocardial infarction, multiorgan failure, liver failure on 15Feb2021. The patient underwent lab tests and procedures which included computerised tomogram suspected cholecystitis on an unknown date. The patient died on 15Feb2021 due to Acute myocardial infarction, multiorgan failure, liver failure. The outcome of the events was fatal. It was not reported if an autopsy was performed. There is an Inconsistent causal association to immunization for all three reported events. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses: arterial hypertension, state according to TIA, peripheral T-cell non-Hogkin lymphoma 2014, celiac disease / vaccination on 25Jan2021 with Biontech Covid vaccine. Presentation in domo on January 29th, 2021 in case of deteriorated general condition and electrolyte imbalance, in the course acute kidney failure and hypotension. permanent diagnosis adrenal cortical insufficiency with adrenalitis permanent diagnosis paraneoplastic in post-lymphoma condition. No improvement under cortisone. In the course of the disease, there was a septic constellation with compulsory catecholamines, admission to the intensive care unit. Here in the CT abdomen suspected cholecystitis, then cholecystectomy, fibrinous repositioning of the liver. Furthermore gastric ulcer with bleeding and progressive liver failure with coagulation disorder, anemia etc. Attempt to control the coagulation disorder, but acute PEA, no improvement under resuscitation measures and then death. No follow-up attempts needed. Follow-up provided automatically; Reported Cause(s) of Death: Acute myocardial infarction; liver failure; Multiple organ failure


VAERS ID: 1112902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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 INC2021266946

Write-up: Unknown cause of death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority [DE-PEI-CADR2021018344]. An elderly patient of an unspecified age and gender received the BNT162B2 (COMIRNATY, lot number unknown), via an unspecified route of administration, on 03Jan2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 08Jan2021. The autopsy was not performed. The outcome of the event was fatal. Sender Comment: Time of death between 08Jan and 06Feb2021, Cluster report 15 unknown deaths after 1st vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112903 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-Test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021267018

Write-up: Unknown cause of death; COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021018352. An elderly patient of an unspecified age and gender received the BNT162B2 (COMIRNATY, lot number unknown), via an unspecified route of administration, on 03Jan2021 at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced COVID-19, and unknown cause of death. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures, which included COVID test was positive on an unknown date. The outcome of the event "unknown cause of death" was fatal, of event "COVID-19" was not recovered. Sender Comment: 7x Covid infections after 1st dose, 1 of which is fatal; 10x Covid infections after the 2nd dose, 6 of them fatal up to 10 days after the 2nd dose. A variant PCR was commissioned in five cases, and two results are now available: In both cases, no mutation was detected. Cluster report. Causality: Inconsistent causal association to immunization No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112904 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EG6789 / 2 - / 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: Multimorbidity
Preexisting Conditions: Medical History/Concurrent Conditions: Cough; Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266989

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority DE-PEI-CADR2021019035. An 86-year-old female patient received the second dose of BNT162b2 (COMIRNATY; lot number: EG6789), intramuscularly on 17Feb2021 (at the age of 86-years-old) at single dose for COVID-19 immunisation. Medical history included ongoing multimorbidity, short-term headaches, mild cough. Concomitant medications were not reported. The patient previously took the first dose of COMIRNATY for COVID-19 immunization. On 17Feb2021, the patient experienced unknown cause of death. The patient''s outcome was fatal. It was unknown if an autopsy was performed. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: Pulmonary fibrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Shortness of breath; Thrombosis; Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267037

Write-up: Route of administration: Intravenous; Unknown cause of death; Flu-like symptoms; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority with regulatory authority number: DE-PEI-CADR2021023608. An 87-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number was not reported), intravenous on 15Feb2021 at single dose for Covid-19 immunisation. Medical history included pulmonary fibrosis from an unspecified date and ongoing, weakness due to shortness of breath and thrombosis. The patient''s concomitant medications were not reported. The patient experienced flu-like symptoms on 17Feb2021. The patient experienced unknown cause of death on 28Feb2021. It was not reported if an autopsy was performed. The outcome of event "flu-like symptoms" was not recovered. Causality provided by Regulatory Authority was "unclassifiable". Sender Comment: No known allergies. Risk factors: Pulmonary fibrosis/weakness due to shortness of breath and thrombosis has formed while the woman was still active. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1112915 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden death, Vaccination site pain
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: 2021-02-22
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma (In 2020 ulcerative lesion but malignancy was ruled out); Herpes labialis; Hypertension arterial; Ulceration (but malignancy was ruled out); Comments: HISTORY OF ARTERIAL HYPERTENSION, herpes labialis and basal cell carcinoma in 2015 (in 2020 ulcerative lesion but malignancy is ruled out)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021256310

Write-up: outcome: death, not vaccine-related; Vaccination site pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB (Regulatory Authority number ES-AEMPS-764232). A 96-year-old male patient received BNT162B2 (COMIRNATY; lot EM6950, expiry date 31May2021) on 18Feb2021 (at 96 years of age), at single dose, for COVID-19 immunisation. Medical history included basal cell carcinoma from 2015 to 2015 (in 2020 ulcerative lesion but malignancy was ruled out), herpes labialis from 2018 and hypertension arterial. The patient''s concomitant medications were not reported. The patient experienced vaccination site pain on 18Feb2021 with unknown outcome and death, not vaccine-related (sudden death) on 22Feb2021. The patient died at home on 22Feb2021. It was unknown if an autopsy was done. Event was reported given the time elapsed between administration and the episode, although it was not correlated apparently with the vaccination. The reporter did not consider the death of the patient related to the vaccine. He only had "a little pain in the vaccination area" and no other symptoms, he was fine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The Company concurs with the reporter that there is not a reasonable possibility of an association between BNT162B2 and sudden death in this 96 year old elderly patient. 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: outcome: death, not vaccine-related


VAERS ID: 1112923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-27
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19 (close contact of confirmed cases); Living in residential institution
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210122; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210209; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021261515

Write-up: Severe acute respiratory syndrome; Respiratory insufficiency; COVID-19/severe acute respiratory syndrome/ respiratory insufficiency; COVID-19; This is a spontaneous report downloaded from the Regulatory Authority-WEB (ES-AEMPS-775868). A contactable physician reported that a 86-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 (first dose, lot EJ6796) at single dose, and via an unspecified route of administration on 12Feb2021 (second dose, lot unknown) at single dose for covid-19 immunization. Medical history included being institutionalized, exposure to COVID-19 from Feb2021 (close contact of confirmed cases). The patient''s concomitant medications were not reported. The patient experienced covid-19 on 27Jan2021, and severe acute respiratory syndrome/ respiratory insufficiency on 16Feb2021. Ambulance was notified of severe acute respiratory syndrome associated with coronavirus. The patient underwent lab tests included COVID-19 PCR test: negative on 22Jan2021, COVID-19 PCR test: positive on 09Feb2021 with antibodies not performed, COVID-19 antigen test: positive on 27Jan2021. Outcome of events was fatal. The patient died on 18Feb2021. It was not reported if an autopsy was performed. The cause of death included drug ineffective, COVID-19, severe acute respiratory syndrome, respiratory insufficiency. This notification also informed that of the possibility of a post-vaccination reaction event to the second dose that was administered on 12Feb2021. The evaluation after reviewing and expanding the available information, considered that the verification of a previous positive Active Infection Diagnostic Test, a positive PCR prior to the events reported and the clinical judgment of severe acute respiratory disease associated with coronavirus, allowed establishing a relationship between the reported event with covid infection in a patient with incomplete immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Respiratory insufficiency; covid-19; Severe acute respiratory syndrome; COVID-19/severe acute respiratory syndrome/ respiratory insufficiency


VAERS ID: 1112927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Pneumonia
SMQs:, Cardiac failure (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: 2021-02-28
   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: MEMANTINE; FINASTERIDE; DARBEPOETIN ALFA; MELATONIN; FUROSEMIDE; CEFUROXIME; ISOSORBIDE MONONITRATE; ESOMEPRAZOLE; ALLOPURINOL; LOSARTAN; OXYCODONE; TINZAPARIN; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac valve prosthesis user; Coronary artery disease; Dementia; Gout; Hypercholesterolemia; Hypertension; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021256395

Write-up: Pneumonia; Cardiac insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FI-FIMEA-20211072 . An 88-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 at single dose for COVID-19 immunization. Medical history included blood pressure disease, coronary artery disease, atrial fibrillation (atrial appendage of the heart closed), artificial cardiac valve, hypercholesterolemia, gout, long-standing renal insufficiency, mixed type dementia. Concomitant medication included memantine, finasteride, darbepoetin alfa, melatonin, furosemide, cefuroxime, isosorbide mononitrate, esomeprazole, allopurinol, losartan, oxycodone, tinzaparin and bisoprolol. On 21Feb2021, the patient was admitted to hospital due to dyspnoea and confusion. The patient was found to have pneumonia and worsening of cardiac insufficiency. The patient''s condition deteriorated slowly, non-responsive to antibiotics and diuretic medication. Finally the patient passed away. No clear relationship with the vaccine and the course of events can be determined but due to the recommendation of the infectious disease specialist this report was made. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia; Cardiac insufficiency


VAERS ID: 1113080 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, 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: 2021-02-18
   Days after onset: 23
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; Hip prosthesis user
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210126; Test Name: oxygen desaturation; Result Unstructured Data: Test Result:oxygen desaturation; Test Date: 20210126; Test Name: COVID-19 Testing; Result Unstructured Data: Test Result:aggravated COVID-19
CDC Split Type: FRPFIZER INC2021272392

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-MP20210365. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6788), intramuscular, in Arm Left on 21Jan2021 at single dose (reported as 1 DF) for covid-19 immunisation. Medical history included Hip prosthesis user and COVID-19. The patient''s concomitant medications were not reported. The patient experienced covid-19 aggravated on 26Jan2021, serious due to resulted in death. Therapeutic measures were taken as a result of covid-19 aggravated (covid-19). The patient died on 18Feb2021. An autopsy was not performed. The clinical course was reported as follows: Reporting via national website from a healthcare professional. Patient considered to be at risk of developing severe COVID-19. The patient had history of COVID-19. Testing was done on 26Jan2021. Course of the events: The patient was vaccinated in the framework of anti-COVID-19 vaccination plan. The first injection was performed with COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY), lot #EJ6788 by intramuscular route in the left arm on 21Jan2021. On 26Jan2021, the patient was diagnosed with aggravated COVID-19 with fever and oxygen desaturation. On 03Feb2021, oxygen (unspecified trade name) therapy and IV fluids were given. From 09Feb2021, the patient presented with appetite loss, refusal of feeding and urinary retention. On 18Feb2021, the patient died. The conclusion was aggravated COVID-19 leading to death 28 days following vaccination. No other information was available. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1113257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Diarrhoea, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (narrow), 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: AMLODIPIN [AMLODIPINE BESILATE]; ATORVASTATIN; CLENIL MODULITE; MYCOPHENOLATE MOFETIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021259013

Write-up: Acute diarrhoea; COVID-19 pneumonitis; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number GB-MHRA-EYC 00242744, Safety Report Unique Identifier GB-MHRA-ADR 24881010. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 21Jan2021 at 30 ug single for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included amlodipine besilate (AMLODIPIN), atorvastatin, beclometasone dipropionate (CLENIL MODULITE) and mycophenolate mofetil for autoimmune eye disorder. On 24Jan2021, the patient experienced acute diarrhea, which was considered as non-serious and with an outcome of recovered on 04Feb2021. On an unspecified date in 2021, the patient experienced also COVID-19 pneumonitis. The patient got diarrhea 3 days after receiving COVID vaccination that stopped spontaneously after 10 days. She caught COVID-19 (within 3 weeks of vaccination) and died of COVID-19 pneumonitis on an unspecified date in 2021. There was a possibility that the diarrhea was a slow onset of COVID-19. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonitis; COVID-19 pneumonitis


VAERS ID: 1113785 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2021-01-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; Chronic kidney disease; Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021263133

Write-up: COVID-19; COVID-19; 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-202103071730497410, Safety Report Unique Identifier GB-MHRA-ADR 24895167. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: Not known), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 vaccination. Medical history included acute kidney injury, hypertension, chronic kidney disease and hypercholesterolaemia all unknown if ongoing, Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive covid-19 test on 03Jan2021. The patient died of covid-19 on 22Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1113786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Myelodysplastic syndrome
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Blood premalignant disorders (narrow), Myelodysplastic syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZACITIDINE; ERYTHROPOIETIN; OMEPRAZOLE; SOLIFENACIN; TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myelodysplasia; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Platelet transfusion
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021258425

Write-up: myelodysplasia; Death; 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-202103081208347660, Safety Report Unique Identifier GB-MHRA-ADR 24899259. A 74-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE; Lot number: ER1741), via an unspecified route of administration on 06Mar2021 for COVID-19 immunisation. Medical history included neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)) from an unknown date and unknown if ongoing, platelet transfusion from 20Feb2021 to an unknown date, High grade myelodysplasia from an unknown date and unknown if ongoing. It was reported that the patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial, and the patient did not have COVID-19 test. Concomitant medications included azacitidine, erythropoietin, omeprazole, solifenacin and tranexamic acid. The patient experienced myelodysplasia on an unspecified date and was found dead at home on 07Mar2021 of unknown cause. The patient was unresponsive and was referred to coroner. It was not reported if an autopsy was performed. The outcome of medically significant event of myelodysplasia was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1113788 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-03-02
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-03-02
   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: DEPAKINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (was a fit and healthy person, with controlled epilepsy who had been fit free for a number of years.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021262606

Write-up: Death; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202103091209028470, Safety Report Unique Identifier is GB-MHRA-ADR 24903452. A 41-year-old male patient received bnt162b2, first dose on 18Jan2021 and second dose on 06Feb2021 via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included epilepsy from an unknown date. The deceased was a fit and healthy person, with controlled epilepsy who had been fit free for a number of years. Patient has not had symptoms associated with COVID-19, patient was not enrolled in clinical trial. Concomitant medication included sodium valproate (DEPAKINE) for Epilepsy. The patient experienced death on 02Mar2021. The consumer reported that 3 weeks after receiving the second vaccination a healthy 41-year-old male passed away suddenly last week (on 02Mar2021). A post mortem was currently being carried out but this needed to be reported and logged as the consumer was not sure how a post mortem would see if the vaccine had any impact in his death. 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 unknown date. The patient died on 02Mar2021. An autopsy was performed and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1113790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertension, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: High temperature; Comments: Hypertension and high cholestorol 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 INC2021268506

Write-up: Hypertension/ caused her death at some stage; This is a spontaneous report downloaded from the Regulatory Agency. Regulatory authority numbers was GB-MHRA-WEBCOVID-202103101020100940, GB-MHRA-ADR 24910253. A contactable consumer reported a 70 years old female patient received 1st dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACINE) on 04Feb2021 at single dose for COVID-19 immunisation (Lot: EN3924). Relevant medical history included ongoing hypertension and high temperature. It was also noted that the patient had not had symptoms associated with COVID-19 and the patient was not enrolled in clinical trial. The relevant concomitant medications were unknown. The patient died on 17Feb2021. The reporter stated that the patient suffered all her life with hypertension and undoubtedly, it would have caused her death at some stage, but their feeling was that there could have been something around the COVID vaccine being administered that possibly tipped the balance. Results of test of the patient included negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. This case was reported with hypertension being the only fatal event. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: hypertension


VAERS ID: 1113804 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021261907

Write-up: heart attack; This is a spontaneous report received from a contactable consumer (daughter). A 76-year-old male patient received BNT162B2 on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller reported that her father had a heart attack and died after the vaccine. Patient deceased had a heart attack and died after the vaccination had no underlying health conditions was very fit and healthy for his age after the vaccine and before death, he was not responding to treatment two doctors that he knew commented that they never saw a person of his age in such a good shape. It was unknown if autopsy was done or not. Information about batch/lot has been requested.; Reported Cause(s) of Death: heart attack


VAERS ID: 1113816 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonitis, Pyrexia, Respiratory rate decreased
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), 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: 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: Cardiac failure; COVID-19; Unspecified disease of respiratory system
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021250326

Write-up: SEVERE PNEUMONITIS; VERY HIGH TEMPERATURE; LOW RESPIRATORY RATE; This is a spontaneous report from received from a contactable physician via regulatory authority (RA) downloaded from the Agency Regulatory Authority-WEB IE-HPRA-2021-066942. An 88-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number unknown), on 15Feb2021 (at the age of 88-year-old) at single dose for COVID-19 immunisation. The patient''s medical history included cardiac failure, unspecified disease of respiratory system and COVID-19 on Mar2020. The patient''s concomitant medications included various medicines (unspecified). The patient previously received the first dose of BNT162B2 (COMIRNATY, lot number unknown), on approximately 18Jan2021 at single dose for COVID-19 immunisation. In Feb2021, hours post vaccination, the patient experienced a very high temperature, low respiratory rate and severe pneumonitis. The patient was administered oxygen, midazolam and BUSCOPAN. The events were reported as serious with seriousness criteria death. In Feb2021, the patient died after experiencing pyrexia, respiratory rate decreased and pneumonitis following vaccination with COMIRNATY for COVID-19 immunisation. It was unknown if autopsy was performed. The outcome of the events was fatal. No follow up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SEVERE PNEUMONITIS; LOW RESPIRATORY RATE; VERY HIGH TEMPERATURE


VAERS ID: 1113817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

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: FOLIC ACID; FERROUS FUMARATE; ASPIRIN ZIPP; NEO-CYTAMEN; LEVOTHYROXINE; CALCICHEW-D3 FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Orthostatic hypertension; Prostate cancer; Comments: No known drug allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021261284

Write-up: DEATH; This is a spontaneous report downloaded from the Regulatory Authority, IE-HPRA-2021-066972. This is a report received from the other Regulatory Authority. A contactable other healthcare professional reported a 99 years old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, batch /lot number: EJ6134) via intramuscular (IM) in deltoid on 21Jan2021 at 0.3 ml single for COVID-19 immunisation. Medical history included orthostatic hypertension, prostate cancer. Concomitant medication included folic acid, ferrous fumarate, acetylsalicylic acid (ASPIRIN ZIPP), hydroxocobalamin (NEO-CYTAMEN), levothyroxine, calcium carbonate, colecalciferol (CALCICHEW-D3 FORTE). On 02Feb2021, the patient died. It was reported that the patient had no reaction to the vaccine and the reason for reporting was that the patient was not eligible for his second dose due to death. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: DEATH


VAERS ID: 1113820 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, 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: 2021-02-28
   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: COLECALCIFEROL; TRITTICO; PANTOPRAZOLE; RAMIPRIL
Current Illness: Alzheimer''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Febbre massimo 38?C; A regulatory authority report (ITALY) was received from a physician, concerning a 79-years-old female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced febbre massimo 38?C/pyrexia. The patient''s medical history included alzheimer''s disease since 01 Jan 2016. Concomitant medications included colecalciferol, trazodone hydrochloride, pantoprazole and ramipril. On 20 Feb 2021, approximately three days prior to the onset of the events, the patient received their unknown dose of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient experienced febbre massimo 38?C. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event was fatal, as patient died on 28 Feb 2021 due to febbre massimo 38?C. It was unknown if an autopsy was performed.; Reporter''s Comments: This is a report of fever resulting in death of 79-years-old female patient 3 days after administration of mRNA-1273 (Lot number: 300042721. Although fever is consistent with the known safety profile of the vaccine, it is unlikely that a temperate of 38?C cold have resulted in a fatal outcome. No additional information was provided such as other clinical presentation and diagnostic findings. Hence, the event is assessed as unlikely related to mRNA-1273 administration. No further information is expected.; Reported Cause(s) of Death: Febbre massimo 38?C


VAERS ID: 1113825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-17
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021256473

Write-up: diarrhea and vomiting resulting in dehydration; diarrhea and vomiting resulting in dehydration; diarrhea and vomiting resulting in dehydration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-690131. A 88-year-old female patient received her first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and the patient''s concomitant medications were not reported. The patient experienced dehydration, diarrhea and vomiting, all on 17Feb2021. The events were reported as serious per death and described as diarrhea and vomiting resulting in dehydration. The patient died on 18Feb2021. It was not reported if an autopsy was performed. Reporter comment: report induced by family members (a daughter in particular) for suspicion of the causes of death ; Reported Cause(s) of Death: diarrhea and vomiting resulting in dehydration; diarrhea and vomiting resulting in dehydration; diarrhea and vomiting resulting in dehydration


VAERS ID: 1113848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256593

Write-up: 2 weeks after vaccination dyspnoea; 2 weeks after vaccination fever; This is a spontaneous report from a contactable consumer received via the Regulatory Authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00456375. An 85-year-old female patient received BNT162B2 (COMIRNATY, batch: unknown) via an unspecified route of administration on 29Jan2021 (unknown age at vaccination) at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced 2 weeks after vaccination fever and 2 weeks after vaccination dyspnea, both on 17Feb2021. The patient died on 17Feb2021. The outcome of the events was fatal. It was unknown if an autopsy was performed. The reported cause of death was fever and dyspnea. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: fever; dyspnea


VAERS ID: 1113849 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test, Cardiogenic shock
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
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? No
Previous Vaccinations:
Other Medications: MOVICOLON; FOSINOPRIL; PREDNISOLON [PREDNISOLONE]; HYDROXOCOBALAMINE; TAMSULOSINE [TAMSULOSIN]; FUROSEMIDE; FLIXONASE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abrasions; Cachexia; Churg Strauss syndrome; Fractured ribs (fell down the stairs - fracture fracture transversal process Th8-10 + L1); Heart failure; Urosepsis (admitted to short-term hospital); Wound
Allergies:
Diagnostic Lab Data: Test Name: esbl in urine; Result Unstructured Data: Test Result:ESBL in urine
CDC Split Type: NLPFIZER INC2021256545

Write-up: died from shock, with known severe heart failure; This is a spontaneous report from a contactable physician from RA downloaded from the Agency Agency-WEB NL-LRB-00457419 An 89-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY. lot # unknown) at single on 03Feb2021 for COVID-19 immunization. Medical history included severe cardiac failure, Churg Strauss syndrome (eosinophilic granulomatosis with polyangiitis), cachexia, urosepsis from Nov2020 to an unknown date admitted to short-term hospital, urosepsis from Jan2020 to an unknown date admitted to short-term hospital, rib fracture, skin abrasion, wound. Patient was cachectic and weak, but in a stable condition prior to vaccination. Concomitant medication included macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON), fosinopril (manufacturer unknown), prednisolon [prednisolone] (PREDNISOLON), hydroxocobalamine (manufacturer unknown), tamsulosine [tamsulosin] (manufacturer unknown), furosemide (manufacturer unknown), fluticasone propionate (FLIXONASE). The patient died on 08Feb2021 from shock, with known severe heart failure, on 07Feb2021. The patient underwent lab tests and procedures which included antimicrobial susceptibility test: ESBL in urine. An autopsy was not performed. The reporting physician stated that he did not think that there is any relationship between the vaccination and the death. As indicated in the report, the patient had no complaints in the 4 days after vaccination. It was only in the afternoon on the fourth day that he suddenly became seriously ill with a shock. At time of the vaccination the patient was stabile. Additional information included: patient was very cachectic and had severe chronic heart failure. Furthermore, very susceptible to infections. In the months before death, the patient had been admitted to a short-term hospital ward and had undergone serious periods of illness there twice (Nov2020 and Jan2021) due to urosepsis. Before that he fell down the stairs at home resulting in - fracture rib 8 - fracture transversal process Th8-10 + L1, skin abrasions right upper arm and left lower arm and head wound. Lab test included ESBL in urine. No diagnostic procedures only symptomatic procedures, the patient died the next day. No follow-up attempts are possible; information about lot and or batch number cannot be obtained.; Reported Cause(s) of Death: Cardiogenic shock; shock image


VAERS ID: 1113851 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? No
Previous Vaccinations:
Other Medications: GLICLAZIDE; MACROGOL; TEMAZEPAM; CALCIUMCARBONAAT; ENALAPRIL; METFORMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021256535

Write-up: Pneumonia; Dyspnoea; This is a spontaneous report downloaded from the regulatory authority-WEB NL-LRB-00460560. A contactable physician reported that a 87-years-old female patient started to receive bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Feb2021 at 1 DF, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gliclazide (GLICLAZIDE), macrogol (MACROGOL), temazepam (TEMAZEPAM), calciumcarbonaat (CALCIUMCARBONAAT), enalapril (ENALAPRIL), metformin (METFORMIN). The patient experienced dyspnoea on 22Feb2021, pneumonia on an unspecified date on 25Feb2021. The patient died from the events on an unknown date. It was not reported if an autopsy was performed. Dyspnoea started 4 days after vaccination, 7 days after vaccination the dyspnoea worsened and the patient developed pneumonia. The decision was made to not treat the pneumonia and to start palliative sedation. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Dyspnea; pneumonie


VAERS ID: 1113852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Chills, Fatigue, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: pyrexia; Result Unstructured Data: Test Result:Fever: 38 to 40.5 degrees Celsius Centigrade; Test Date: 20210204; Test Name: SARS CoV 2 test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021256546

Write-up: Myalgia; Chills; Pain in the joints; Corona test / positive three days after first vaccination; Not feeling well; Fatigue; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB (NL-LRB-00461135). An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 01Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included pulmonary hypertension and heart failure. The patient was receiving unspecified concomitant medications. On 02Feb2021, the patient was not feeling well, she had fatigue and fever: 38 to 40.5 degrees Celsius. On 04Feb2021, the patient developed myalgia, chills and pain in the joints. These events led to patient''s death in 2021. On 04Feb2021, SARS-COV-2 test was done and resulted positive. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Fatigue; Fever: 38 to 40.5 degrees Celsius; Myalgia; Chills; Pain in the joints; Covid-19; Not feeling well


VAERS ID: 1113853 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: AMLODIPINE; LISINOPRIL; CLOPIDOGREL; COLECALCIFEROL; DESLORATADINE; PANTOPRAZOL [PANTOPRAZOLE]; FUROSEMIDE; MACROGOL; EDOXABAN; METOPROLOL SUCCINATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:a COVID-like picture was seen; Test Name: Covid antibody test; Test Result: Negative ; Test Name: Covid PCR test; Test Result: Negative ; Test Name: Covid PCR test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021256550

Write-up: Dyspnoea; This is a spontaneous report downloaded from the Regulatory Authority NL-LRB-00461274. A contactable physician reported that a 93-year-old female patient received BNT162B2 (COMIRNATY, Lot/batch number was unknown), via an unspecified route of administration at the age of 93-year-old on 12Feb2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included amlodipine tablet, lisinopril tablet, clopidogrel tablet, colecalciferol capsule, desloratadine tablet, pantoprazole tablet, furosemide tablet, macrogol powder for oral solution, edoxaban tablet, metoprolol succinate prolonged-release tablet. The patient experienced dyspnoea on 12Feb2021. The event was serious for being death. Onset latency of event dyspnoea was reported as 1 day after start. On unspecified dates the patient underwent lab tests included computerised tomogram (CT) scan was done on which a COVID-like picture was seen: Covid polymerase chain reaction (PCR) test was done twice and both times the result was negative. The result of the Covid antibody test also was negative. The patient was treated with dexamethason, antibiotics and oxygen for event dyspnoea. The outcome of event dyspnoea was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporters comments: This serious spontaneous report from a physician concerns a female aged 93 years, with dyspnoea (death) following administration of covid-19 vaccin pfizer (action taken: not applicable) for covid 19 immunisation. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dyspnoea


VAERS ID: 1113854 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fatigue, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021267109

Write-up: Pain in the joints; not feeling well; Fatigue; Nausea; Decreased appetite; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [NL-LRB-00463948]. An 82-year-old male patient received BNT162B2 (COMIRNATY) first dose on 29Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Previous COVID-19 infection was No. Patient died on 08Feb2021 due to Pain in the joints (30Jan2021), Decreased appetite (29Jan2021), not feeling well (30Jan2021), Fatigue (30Jan2021) and nausea (29Jan2021). Nausea and loss of appetite from the moment of vaccination. Treatment: Generalized joint pain is treated with Morphine. Unknown if autopsy was done.; Reported Cause(s) of Death: Decreased appetite; not feeling well; fatigue; nausea; Pain in the joints


VAERS ID: 1113855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Delirium, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Dehydration (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: CIPRAMIL [CITALOPRAM HYDROCHLORIDE]; COLECALCIFEROL; ZOPICLONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021267093

Write-up: Delirium; difficulty breathing; General malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [NL-LRB-00464229]. A 91-year-old male patient received BNT162B2 (COMIRNATY, lot number: EJ6790) second dose on 25Feb2021 for COVID-19 immunisation. Medical history was not reported. Previous COVID-19 infection was No. Concomitant medications included citalopram hydrochloride (CIPRAMIL) Coated tablet, colecalciferol tablet, zopiclone tablet. The patient previously took BNT162B2 (COMIRNATY) first dose on 28Jan2021 for covid-19 immunization. Patient died on unspecified date due to general malaise, dyspnea and delirium on 27Feb2021. Rapid deterioration of health condition. Unknown if autopsy was done. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-LRB-00464229 LRB; Reported Cause(s) of Death: general malaise; difficulty breathing; Delirium


VAERS ID: 1113856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Ischaemic cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

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: XARELTO; LOSARTAN; METOPROLOL; CELLUVISC [CARMELLOSE SODIUM]; SIMVASTATIN; GANFORT; LANOXIN; BRIMONIDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (familiar with atrial fibrillation, adequately anticoagulated with a direct acting oral anticoagulant)
Allergies:
Diagnostic Lab Data: Test Name: CT brain; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021267081

Write-up: Ischaemic cerebral infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB regulatory authority number NL-LRB-00464815. An 85-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, strength: 0.3 mL), via an unspecified route of administration at an unspecified age on 18Feb2021 (batch/lot number and expiration date unknown) at single dose for COVID-19 immunisation. Medical history included atrial fibrillation, patient was familiar with atrial fibrillation, for which she was adequately anticoagulated with a direct acting oral anticoagulant. The patient did not have previous COVID-19 infection. Concomitant medications included rivaroxaban (XARELTO), losartan, metoprolol, carmellose sodium (CELLUVISC), simvastatin, bimatoprost, timolol maleate (GANFORT), digoxin (LANOXIN), brimonidine. The patient experienced ischaemic cerebral infarction on 26Feb2021. During a walk, she suddenly collapsed, was successfully resuscitated due to an asystole. In the emergency department there was an ischemic cerebrovascular accident of the left hemisphere. Due to the size of the affected area, a palliative policy was instituted and the lady died the same day. In view of the occurrence of embolic processes in a corona infection and the fact that she was apparently treated adequately preventively. The patient underwent lab tests and procedures which included CT brain: unknown results on an unspecified date. The outcome of the event was fatal. The patient died on 26Feb2021. It was unknown if an autopsy was performed. The reporter stated that it''s impossible to say whether this cerebrovascular accident is related to the vaccination 8 days earlier. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Ischaemic cerebral infarction


VAERS ID: 1113859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Malaise, Pneumonia, Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 12
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 failure; Dementia; Living in nursing home; Multimorbidity; Pneumonia (Three pneumonias during the last six months.); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: C-reactive protein; Result Unstructured Data: Test Result:90 mg/l
CDC Split Type: NOPFIZER INC2021267102

Write-up: Febrile illness, probably infection; PNEUMONIA; unrest; malaise; This is a spontaneous report downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Ua4gp, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00018606. A contactable physician reported that an 88-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular route on 17Feb2021 at 14:20 (batch/lot number EP9598), at single dose (second dose, administered into left arm) for covid-19 immunisation. Medical history included multimorbidity, cardiac failure, pneumonia (three pneumonias during the last six months), living in residential institution, atrial fibrillation, dementia and renal failure. The patient''s concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation. The patient experienced febrile illness, probably infection on 28Feb2021, pneumonia on 28Feb2021, and unrest and malaise both on 19Feb2021 with outcome of recovered on an unspecified date in Feb2021. Dose 2 of the covid-19 vaccine Comirnaty was given 14 days after completion of treatment for the third penumonia. Some unrest and malaise two days after vaccination (19Feb2021) with c-reactive protein around 90, but recovered after this. Became abruptly worse 28Feb2021 and died 03Mar2021. Reporter perceives that the patient probable died of a new pneumonia. The patient underwent lab tests and procedures which included c-reactive protein: 90 mg/l on 19Feb2021. It was not reported if an autopsy was performed. Sender''s Comments: Background: Man in his 80s, lived in a nursing home. Known heart failure, atrial fibrillation, kidney failure, dementia. During the last six months had three pneumonias, and has generally worsened during this period with weight loss and increasing frailty. Dose 2 of the covid-19 vaccine Comirnaty was given 14 days after completion of treatment for the third pneumonia. Some unrest and malaise two days after vaccination (19.02.2021) with CRP rise to almost 90, but recovered after this. Became so abruptly worse 28.02.21 and died 03.03.21. Reporter perceives that it is overwhelmingly probable that he died of a new pneumonia. Comments: The vaccine is non-live and therefore cannot cause the disease one is being vaccinated against or any other infections. Symptoms such as general malaise and fever may still occur in the first few days after vaccination. Such systemic side effects are often more pronounced after the second dose than after the first dose of this vaccine. CRP elevation, that the patient initially experienced, is currently not listed under side effects in the approved Summary of Product Characteristics for Comirnaty, but theoretically it is conceivable that an acute inflammation in connection with vaccination may give a transient slight increase. However, it is not expected that such an immunological response alone will produce a CRP of 90. Symptoms as mentioned above are usually short-term and transient, but we cannot rule out that such relatively mild side effects may be more pronounced or lead to a more severe course in the elderly or debilitated patients. We consider a direct causal relationship between the vaccine and pneumonia 1 and a half week after vaccination to be unlikely. When vaccinating elderly patients with underlying diseases, some serious events, including death, may occur relatively shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine may have contributed to some of the symptoms at the beginning of the course of this disease, and possibly a worsening of the patient''s underlying disease / condition. 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.; Reported Cause(s) of Death: Febrile illness, probably infection; PNEUMONIA


VAERS ID: 1113862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / OT

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: 2021-02-24
   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: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021250343

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number is NO-NOMAADVRE-FHI-2021-Uw1p5, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00017156. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EP9598, expiry date not reported), intramuscular at the left arm on 19Feb2021 11:00 at single dose for COVID-19 immunization. Medical history included pneumonia from 2018 to 2018. Concomitant medication included lansoprazole for Gastrooesophageal reflux disease. The patient experienced sudden cardiac death on 24Feb2021. An autopsy was not performed. Case narrative as reported: An 84 years old man with gastro-esophageal reflux disease in periods was otherwise healthy, working and leading an active lifestyle. He has not seen his physician in the last 6 years except for pneumonia in 2018. The patient died suddenly and unexpectedly 5 days after first dose of COVID-19 vaccination (Comirnaty). There were no other known symptoms after vaccination, or known other causes, and the man died while jogging. Anesthesiologist tried heart and lung resuscitation (HLR) and later found no burst blood vessels. Cause of death was stated as sudden cardiac death. No autopsy is planned. Sender Comment: On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation 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 also classified as serious, even though a causal link between the vaccine and the death has not been established. Event assessment Sudden cardiac death for Comirnaty Source of assessment Facility Result of Assessment Possible Reporter''s comments : 03Mar2021 : additional information received. The following fields have been updated: Event, Event description. An 84 years old man with gastro-esophageal reflux disease in periods was otherwise healthy, working and leading an active lifestyle. He has not seen his physician in the last 6 years except for pneumonia in 2018. The patient died suddenly and unexpectedly 5 days after first dose of COVID-19 vaccination (Comirnaty). There were no other known symptoms after vaccination, or known other causes, and the man died while jogging. Anesthesiologist tried heart and lung resuscitation (HLR) and later found no burst blood vessels. Cause of death was stated as sudden cardiac death. No autopsy is planned. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 03Mar2021 : additional information received. The following fields have been updated: Event, Event description. An 84 years old man with gastro-esophageal reflux disease in periods was otherwise healthy, working and leading an active lifestyle. He has not seen his physician in the last 6 years except for pneumonia in 2018. The patient died suddenly and unexpectedly 5 days after first dose of COVID-19 vaccination (Comirnaty).; Reported Cause(s) of Death: sudden cardiac death


VAERS ID: 1113865 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac arrest, Fall, Loss of consciousness
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), Supraventricular tachyarrhythmias (narrow), 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anticoagulant therapy (Rivaroxaban); Atrial fibrillation with rapid ventricular response (Permanent atrial fibrillation with intermittent rapid ventricular activity); Cardiac failure chronic aggravated (Exacerbation of chronic heart failure with preserved left ventricular systolic function); Hypertension (Reduced hypertension); Hyperuricaemia; Subclinical hyperthyroidism (nodules in medical history); Tricuspid regurgitation (moderate tricuspid regurgitation)
Preexisting Conditions: Medical History/Concurrent Conditions: Claustrophobia; Hospitalization (Hospital Emergency Department); Hospitalization (Department of Cardiology); Thyroid nodule
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021256606

Write-up: Sudden circulatory arrest; atrial flutter; atrialfibrillation; Loss of consciousness; Fall; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority. Regulatory authority report number PL-URPL-3-197-2021. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EL8723, expiration date May2021) intramuscularly on 10Feb2021 (at the age of 89-years-old) at 16:25 at 0.3 ml single dose in left arm for COVID-19 immunisation. Medical history was reported as follows: the patient was treated in hospital from 28Jan2021 to 30Jan2021 at Hospital Emergency Department and from 30Jan2021 to 07Feb2021 at Department of Cardiology. Diagnosis was ongoing acute exacerbation of chronic heart failure with preserved left ventricular systolic function ongoing moderate tricuspid regurgitation, ongoing persistent atrial fibrillation with intermittent rapid ventricular activity, anticoagulant treatment with rivaroxaban (ongoing, as reported), reduced arterial hypertension (ongoing, as reported), hyperuricemia (ongoing), ongoing subclinical hyperthyroidism (history of nodules). Drugs taken at department of cardiology were Metizol, Hydroxyzinum, Diured, Potazek MAG, Digoxin Teva, Bisocard, Telmisartan Bluefish, Xarelto. It was reported that on 10Feb2021 at 17:00, a post-vaccination reaction occurred. Description of the reaction: Sudden cardiac arrest. Atrial fibrillation and flutter. Death at 17:53. The reporting person classified them as serious. Regulatory authority also classified the application as serious. On 18Feb2021 additional information was received: the patient was qualified for vaccination against the COVID-19 virus. Vaccination was done. After the vaccination, the patient stayed on the premises of the facility for 20 minutes, and after leaving the waiting room during the elevator called by the patient''s son, due to fear (the son claims she had claustrophobia), the patient fell on the hard ground and lost consciousness. The patient was transferred to the waiting room and placed on the couch with her legs raised above her head. Resuscitation measures were started immediately: compression massage of the chest and artificial respiration using the Ambu bag. Intravenous access was established, adrenaline was administered, NaCI transfusions 0.9% were started. An emergency medical team (EMS) was also called, which undertook all life-saving activities. Due to sudden cardiac arrest and heart failure, as well as atrial flutter and fibrillation, the patient did not regain consciousness and at 17:53 the patient''s death was registered by the EMS team. The events were listed as Loss of consciousness, Fall, Cardiac arrest all with onset date 10Feb2021 at 17:00 and with fatal outcome. Additional causes of death were reported as myocardial failure, atrial fibrillation, atrial flutter. It was not reported if an autopsy was performed. Reaction(s) / Event(s) Assessed: Loss of consciousness, Fall, Cardiac arrest Source of assessment: Agency Method of assessment: WHO scale Result of Assessment: Possible Sender''s comments: Comirnaty are an mRNA vaccine against COVID-19 (with modified nucleosides). It was not possible to determine whether all of the above-mentioned drugs taken in the cardiology department were used by the patient on a permanent basis and on the day of vaccination, therefore they were not included in the drugs used concurrently. Loss of consciousness and sudden cardiac arrest are not included in the Summary of Product Characteristics for Comirnata. From the information obtained, it is difficult to unequivocally determine the time of the fall (whether it occurred simultaneously with loss of consciousness and sudden cardiac arrest or earlier). The fall, loss of consciousness, and sudden cardiac arrest may have been the result of anaphylaxis, which is an expected adverse reaction. It is also a fact that the patient was chronically ill, and the doctor mentioned atrial fibrillation and flutter as well as heart failure, which had occurred in the patient, among the causes of death. The patient also had anxiety caused by the elevator ride (according to her son, the patient suffered from claustrophobia and, according to him, the fall was related to this fear) and there could be stress related to vaccination, which could also have contributed to the reaction. There is a close relationship over time between the administration of the vaccine and the appearance of symptoms. The reporting person classified them as severe. Regulatory authority also classified the application as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fall; Loss of consciousness; Myocardial failure; Atrial flutter; Sudden cardiac arrest; Atrial fibrillation


VAERS ID: 1113895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Infarction
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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: ROPFIZER INC2021273221

Write-up: infarction; This is a spontaneous report from a contactable pharmacist. This report was received via a sales representative. A male patient of an unspecified age, young, less than 50 years old, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date not reported, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced infarction on an unspecified date. The patient was vaccinated at local clinic and on the same day, in the evening, he suffered an infarction and died on unknown date. It is now being investigated whether it was related to the vaccine or not. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.; Sender''s Comments: Based on the limited information available particularly on patient''s past medical history, and plausible temporal association, the causal association between BNT162B2 and the event fatal infarction cannot be completely excluded at the time of review. This assessment will be updated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: infarction


VAERS ID: 1113896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021273255

Write-up: became infected with COVID-19, had a severe form of COVID-19 and then died; became infected with COVID-19, had a severe form of COVID-19 and then died; This is a spontaneous report from a contactable ICU physician. This report was received via a sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), first dose and second dose both via unspecified route of administration on unknown date (at unknown age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. A female patient who was vaccinated anti COVID-19 with both doses, became infected with COVID-19, had a severe form of COVID-19 and then died on unknown date. It is not known which COVID-19 vaccine was administered. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association in a context of LOE. The impact of this report on the benefit/risk profile of the Pfizer drug 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: became infected with COVID-19, had a severe form of COVID-19 and then died; became infected with COVID-19, had a severe form of COVID-19 and then died


VAERS ID: 1113903 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: TROMBYL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DONEPEZIL; NEUROBION [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholangiocarcinoma metastatic; Liver cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021250729

Write-up: Cerebral vascular lesion; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-006572. Other case identifier number SE-MPA-1613996903173. An 83-years-old female patient received her first dose of bnt162b2 (COMIRNATY, lot number: EP2163), intramuscular on Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Cholangiocarcinoma metastatic and Liver cirrhosis. Concomitant medication included acetylsalicylic acid (TROMBYL) from 19Aug2014 to Feb2021, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 29Jan2021 to Feb2021, donepezil from 07Sep2018 to Feb2021 and cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride (NEUROBION [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE]) from 18Feb2021. The patient experienced cerebral vascular lesion two days after vaccination on Feb2021, all lot numbers were unknown. The patient Died the same night without regaining consciousness. 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: Cerebral vascular lesion


VAERS ID: 1113904 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / -

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: DUROFERON; VISCOTEARS; SERTRALINE; MIRTAZAPINE; XALATAN; SALBUTAMOL SULFATE]; QUETIAPINE; PARACETAMOL; SYMBICORT TURBUHALER; ORIVAST; OESTRIOL; INNOVAIR
Current Illness: COVID-19 (declared healthy from COVID 19 10 days before the vaccine)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Glaucoma; Mixed dementia; Renal failure (stage 2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021256599

Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory authority-WEB, Regulatory authority number SE-MPA-2021-008343 and additional case identifier SE-MPA-1614245793874. A 95-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number EJ6790), via an unspecified route of administration, in Feb2021 at 0.3 mL single for COVID-19 immunisation. Relevant medical history included COVID-19 from Jan2021 to Feb2021 (declared healthy from COVID 19 10 days before the vaccine); mixed dementia, renal failure stage 2, asthma and glaucoma, from an unknown date and unknown if ongoing. Relevant concomitant medications included ferrous sulfate (DUROFERON) in Feb2021, carbomer (VISCOTEARS) from Oct2020 to Feb2021, sertraline from Oct2019 to Feb2021, mirtazapine from Dec2019 to Feb2021, latanoprost (XALATAN) from Mar2020 to Feb2021, salbutamol sulfate (VENTOLINE) from Nov2019 to Jan2021, quetiapine from Jan2020 to Feb2021, paracetamol from Dec2019 to Feb2021, budesonide, formoterol fumarate (SYMBICORT TURBUHALER) from Apr2019 to Jan2021, rivastigmine (ORIVAST) from May2020 to Feb2021, oestriol (OESTRIOL) from Nov2019 to Feb2021, and beclometasone dipropionate, formoterol fumarate (INNOVAIR), from Jan2021 to Feb2021. The patient was mobile and alert when she received the first dose of BNT162B2 (COMIRNATY). After this, the patient deteriorated and died two days after the vaccination. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1113974 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021267640

Write-up: patient had a cerebral hemorrhage and died; This is a spontaneous report from a contactable consumer received via a press release of the Agency. An adult female patient (a young caregiver) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient received the first dose of bnt162b2 in Jan2021. The patient medical history and concomitant medications were not reported. The patient experienced a cerebral hemorrhage and died on Mar2021. The patient died on Mar2021. Autopsy showed massive cerebral hemorrhage as cause of death. Clinical course: A young female caregiver unexpectedly died four weeks after vaccination after vaccination against the coronavirus. She received the bnt162b2 vaccination in January and February. The head of the county press service confirmed correspondent media reports. The woman still worked last week. She hardly had any reactions to the vaccination and felt well. She broke down, the emergency doctor tried to re-animate her. The woman was brought to the hospital where she died shortly after. The autopsy showed that she died due to a massive cerebral hemorrhage. A causal relationship to the vaccination has been excluded. The information on the batch/lot number has been requested.; Reported Cause(s) of Death: cerebral hemorrhage


VAERS ID: 1113975 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Depressed level of consciousness, Dysphagia, Hypophagia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nausea (in week prior to vaccination); Vomiting (in week prior to vaccination, increase in antiemetics prescribed by GP on 17Feb2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Metastatic neoplasm; Oral intake reduced
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021265102

Write-up: decreased consciousness; trouble swallowing; further vomiting; further deceased intake; further vomiting and deceased intake; This is a spontaneous report received from the Regulatory authority. Regulatory authority report number AU-TGA-0000521302. A contactable other healthcare professional (HCP) reported that an 81-year-old (also reported as 82-year-old) female patient received the first dose of BNT162B2 (COMIRNATY, lot/batch number not reported) via an unspecified route of administration on 23Feb2021 at 4:30 p.m. at single dose for COVID-19 immunisation. Medical history included carcinoma in right thigh which was thought to have metastasised and general decline-in weeks prior (onset date unknown)- reviewed by General Practitioner (GP) on 10Feb2021 and family had advised they did not wish for her to be transferred to hospital, other medical history included decrease in oral intake from Feb2021, ongoing nausea and vomiting issues in week prior to vaccination (Feb2021) and increase in antiemetics prescribed by GP on 17Feb2021. Decline continued post vaccination with medications being withdrawn a few days post vaccination. Treatment for vomiting: Ongoing GP assessments. The patient''s concomitant medications were not reported. As per clinical care coordinator, the patient received vaccine on 23Feb2021 at 4.30pm. Had some vomiting 2 days earlier with some decrease in oral intake. Reasonably well morning of vaccine. Had discussed with GP and family and happy to proceed with vaccine. Then following day on 24Feb2021, the patient experienced further vomiting and deceased intake. Reviewed by GP on 28Feb2021, diet changed from thin fluids to thickened fluids as trouble swallowing. On 01Mar2021, the patient experienced decreased consciousness, only eye opening to touch, medications ceased and palliated. The patient passed away on 03Mar2021. It was not reported if an autopsy was performed. The outcome of events all reported as fatal. The causality was provided as "Causality possible". No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: further vomiting and deceased intake; further vomiting and deceased intake; trouble swallowing; decreased consciousness; further vomiting and deceased intake


VAERS ID: 1113976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Hypoxia, Pneumonia aspiration, Sepsis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer; Nausea
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021265190

Write-up: Sepsis; Hypotension; Hypoxia; Vomiting; aspiration/secondary aspiration pneumonia; This is a spontaneous report received from a contactable physician (general practitioner) from the Agency Regulatory authority number AU-TGA-0000521683). An 81 (unit unspecified) female patient received BNT162B2 (COMIRNATY; dose form reported as injection) intramuscularly on 01Mar2021 at approximately 10-11.00 Monday in aged care facility at a single dose for COVID-19 immunisation. Afebrile at the time. Medical history included gastric cancer and baseline nausea. Concomitant medications were not reported. The patient experienced aspiration/secondary aspiration pneumonia and vomiting; both with onset date 01Mar2021 (onset date to be clarified) and with outcome of fatal; hypotension and hypoxia on 02Mar2021 and with outcome of fatal, and sepsis with onset date 03Mar2021 and with outcome of fatal. The patient was well on Monday pm and Tuesday am. Vomiting Tuesday pm - nursing assessment and transferred by ambulance at 17.49hrs. Hypotension and hypoxia in hospital Haematemesis leading to hospital admission. Treatment reported as nurse assessment and hospital admission details. Sepsis diagnosed likely secondary aspiration pneumonia. Commenced on IV antibiotics noradrenalin (no response) 2 Units of blood withdrew active treatment as per families wishes and commenced palliation. The patient was transferred back to nursing home this afternoon. Discussed case with coroner office on 05Mar2021. - Palliative, no eating - commenced on morphine/midazolam. The patient passed away on 04Mar2021 at 4:00 pm. It was unknown if an autopsy was performed. Causality reported as causality possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: aspiration/secondary aspiration pneumonia; Sepsis; Vomiting; Hypotension; Hypoxia


VAERS ID: 1113977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Rales, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure raised; Bowel cancer (previous (years before)); Congestive cardiac failure; Dementia; Diverticulitis; Joint replacement (related to osteoarthritis); Osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: O2; Test Result: 88 %
CDC Split Type: AUPFIZER INC2021265204

Write-up: short of breath; O2 was 88%; crepitations in the lungs; vomited; wheezing; This is a spontaneous report received from the regulatory authority (Regulatory authority number AU-TGA-0000521743). A contactable other Health Professional reported that a 90-year-old male patient (also reported "a man in his 90s") received BNT162B2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 02Mar2021 at 10:10 at single dose for covid-19 immunisation. Medical history included dementia, several conditions and joint replacements related to osteoarthritis, previous (years before) bowel cancer, diverticulitis, high blood pressure and congestive cardiac failure. The patient''s concomitant medications were not reported. The patient had his vaccine at 10:10 on 02Mar2021 and vomited at about 22:30 the same day. He was wheezing that night and was sat up in a chair. At 05:00 on 03Mar2021 he was short of breath, O2 was 88% and he had crepitations in the lungs. He was transferred to hospital on 03Mar2021 and died this morning (on 04Mar2021) about 09:15. The reporter was waiting for more details from the hospital. There were many possible reasons for his death, but he thought the cause should be investigated and vaccine-related causes ruled out. The patient died on 04Mar2021 due to these events. It was not reported if an autopsy was performed. No follow up attempts are needed, no further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: vomited; wheezing; short of breath; O2 was 88%; crepitations in the lungs


VAERS ID: 1113978 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Dyspnoea, General physical health deterioration, Heart rate increased, Hypotension, Oedema peripheral, Oxygen saturation decreased, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bowel cancer; Cardiac failure chronic; Dementia; Diverticulitis; Hypertension; Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021265245

Write-up: deteriorated; shortness of breath; Bronchopneumonia; acute pulmonary oedema; low blood pressure; increased heart rate; pitting peripheral oedema; low oxygen saturations; This is a spontaneous report from a contactable other HCP received from the Administration (Regulatory authority number AU-TGA-0000522108). A 92-year-old male patient received BNT162b2 (COMIRNATY), via Intramuscular route, on 02Mar2021 09:50 (at the age of 92-years-old) for COVID-19 immunization, at an aged care facility. Medical History included Osteo Arthritis, Bowel cancer (1980 diagnosis), Hypertension, diverticulitis disease, dementia, Alzheimer, Chronic Cardiac failure (CCF). On 02Mar2021 the patient experienced general physical health deterioration, shortness of breath, bronchopneumonia, acute pulmonary oedema, low blood pressure, increased heart rate, pitting peripheral oedema, low oxygen saturations. The patient died 03Mar2021. The events were reported with fatal outcome. The clinical course was reported as follows, the man deteriorated that afternoon and overnight and ambulance service was called taken to hospital Emergency Department on 03Mar2021 at 09:15 with shortness of breath. Acute conditions: bronchopneumonia and acute pulmonary oedema on top of other chronic medical conditions upon presentation to hospital ED. The man had advanced directives in place which resulted in a conservative management plan and he died at hospital ED on 03Mar2021. Symptoms of low blood pressure, increased heart rate and pitting peripheral oedema and low oxygen saturations in line with heart failure on arrival to the hospital ED. Treatment Received: Trial of non-invasive ventilation, IV antibiotics and steroids did not improve clinical outcome. The patient was hospitalized for the events. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information provided, this elderly patient with a medical history relevant for Osteo Arthritis, Bowel cancer , Hypertension, diverticulitis disease, dementia, Alzheimer, Chronic Cardiac failure (CCF), experienced general physical health deterioration, shortness of breath, bronchopneumonia, acute pulmonary oedema, low blood pressure, increased heart rate, pitting peripheral oedema, low oxygen saturations with fatal outcome. The reported events and fatal outcome is most likely related to underlying disease conditions and not related to suspect product. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: General physical health deterioration; Shortness of breath; Low blood pressure; Heart rate increased; Peripheral oedema; Oxygen saturation low; Bronchopneumonia; acute pulmonary oedema


VAERS ID: 1113979 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Investigation, 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: 2021-02-25
   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: ALDACTONE [SPIRONOLACTONE]; BURINEX; SERTRALINE; PANTOPRAZOLE; SPIRONOLACTONE; MEDROL [METHYLPREDNISOLONE ACETATE]; FLECAINIDE; LIXIANA; BISOPROLOL; ALLOPURINOL; ZURAMPIC; OEDIEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Chronic renal failure; Cognitive impairment ((MMSE 17/30)); Endometrial carcinoma; Falling; Food refusal (refused almost all food and drink); General physical health deterioration (deterioration in general condition, cognitive, mental and physical); Gout; Heart failure; Herpes zoster; Multimorbidity (for a long time); Pacemaker insertion (cardiac); Shoulder fracture (requiring osteosynthesis); Stomach haemorrhage; Thrombosis pulmonary
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: external examination; Result Unstructured Data: Test Result:could not find anything abnormal; Comments: no visible lesions, no ecchymoses, no swelling, no discoloration.
CDC Split Type: BEPFIZER INC2021283109

Write-up: Sudden death; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority BE-FAMHP-DHH-N2021-80111. This report received by the authorities on 25Feb2021. A 95-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 25Feb2021(at age of 95-year-old) (Lot Number: EP9598) at single dose for COVID-19 immunisation. Medical history included gout, cognitive impairment (MMSE 17/30), chronic renal failure, arterial hypertension, pacemaker in situ, stomach haemorrhage, shoulder fracture requiring osteosynthesis, heart failure, lung thrombosis, endometrial carcinoma, atrial fibrillation, multimorbidity for a long time. Since Apr2020, there was clear deterioration in general condition, cognitive, mental and physical. The patient admitted to a care center in Sep2020 after falling at home in unclear circumstances. This caused a significant decline. Initially mainly on a cognitive and mental level, including sleeping problems, wandering behavior and life fatigue. The patient also deteriorated strongly physically. For the last 2-3 weeks, the patient refused almost all food and drink. The patient was much emaciated and weakened because of this. The patient went through herpes zoster on 07Jan2021. Concomitant medications included spironolactone (ALDACTONE), bumetanide (BURINEX), sertraline, pantoprazole, spironolactone, methylprednisolone acetate (MEDROL), flecainide, edoxaban tosilate (LIXIANA), bisoprolol, allopurinol, lesinurad (ZURAMPIC) and dienogest, ethinylestradiol (OEDIEN). The patient experienced sudden death on 25Feb2021. It was reported just after vaccination, there was no signs of side effects, no fever, no signs of inflammation, no signs of allergic reaction, no breathing problems, no deterioration in general condition. The patient sat quietly in her chair when she was put to bed with a hoist shortly after noon. The nurses reported that the patient was as they always knew her. They put her to bed, then returned the hoist to neutral and when they turned to the patient, she was dead. Sudden death about three hours after vaccine administration. Shortly after death external examination by the deputy doctor. On this external examination, the deputy doctor could not find anything abnormal: no visible lesions, no ecchymoses, no swelling, no discoloration. According to the deputy doctor, there is no causal relationship with the vaccination. The patient died on 25Feb2021. No treatment was received for the event. It was not reported if an autopsy was performed. Reporter Comment: Treatment-No. Evolution of the ADR-Died. Examinations-None. Since April 2020: clear deterioration in general condition, cognitive, mental and physical. Admission to a care center in September 2020 after falling at home in unclear circumstances. This caused a significant decline. Initially mainly on a cognitive and mental level, including sleeping problems, wandering behavior and life fatigue. She also deteriorated strongly physically. For the last 2-3 weeks she refused almost all food and drink. She was much emaciated and weakened because of this. Go through herpes zoster on [07Jan2021], which means that vaccination is postponed by a few weeks. Just after vaccination: no signs of side effects, no fever, no signs of inflammation, no signs of allergic reaction, no breathing problems, no deterioration in general condition. The lady sat quietly in her chair when she was put to bed with a hoist shortly after noon. The nurses reported that the lady was as they always knew her. They put her to bed, then returned the hoist to neutral and when they turned to the lady, she was dead. Sudden death about three hours after vaccine administration. Shortly after death external examination by the deputy doctor. On this external examination, the deputy doctor could not find anything abnormal: no visible lesions, no ecchymoses, no swelling, no discoloration. According to the deputy doctor, there is no causal relationship with the vaccination. Relatedness of drug to event was ''unclassifiable'' as per source of assessment and with Method of assessment. No follow-up attempts possible. No information expected.; Reporter''s Comments: Summary of Reporter Comment: According to the deputy doctor, there is no causal relationship with the vaccination.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1113981 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Dyspnoea, Malaise, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; ASAFLOW; MIRTAZAPINE EG; TEMESTA EXPIDET; SYMBICORT TURBOHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma; Arthrosis; AV block second degree (left bundle branch block, 2nd grade AV type wenckebach); COVID-19; DVT; Prostatectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: saturation; Result Unstructured Data: Test Result:decrease in saturation
CDC Split Type: BEPFIZER INC2021266836

Write-up: Problem with heart or veins; Feeling unwell; Problem with breathing; 2x sudden desaturation; This is a spontaneous report from a contactable physician downloaded from the Agency WEB BE-FAMHP-DHH-N2021-80401. This is a report from the Health Authority. A 92-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EP9598), via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. Medical history included covid-19 from 25Nov2020, radical prostatectomy due to adenoca from an unknown date, deep vein thrombosis (DVT) from 2010, facetarthrosis from 2016, AV-Block grade 2 from 2019 (left bundle branch block, 2nd grade AV type Wneckebach). Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), acetylsalicylic acid (ASAFLOW), mirtazapine (MIRTAZAPINE EG), lorazepam (TEMESTA EXPIDET), budesonide, formoterol fumarate (SYMBICORT TURBOHALER). The patient previously took decapeptyl from 1998 to an unspecified date and from 2010 to an unspecified date and from 2013 to an unspecified date for adenoca (Adjuvant, restart due to increase psa (2010 and 2013)). The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation and had no pronounced effects. The patient experienced problem with heart or veins, feeling unwell, problem with breathing, 2x sudden desaturation; all on 23Feb2021. The events were reported as serious due to death. The patient died on 24Feb2021. It was not reported if an autopsy was performed. The patient underwent lab test included saturation which showed decrease in saturation on 23Feb2021. Therapeutic measures were taken as a result of the event 2x sudden desaturation, no treatment for other events. The outcome of the events was fatal. Reporter''s comments: Treatment - No. Evolution of the ADR - Death. ADR description - death, 2x sudden desaturation, unwell feeling between 2nd desaturation was fatal less than 36 hours after vaccination died. After the first vaccination there were no pronounced effects, the patient experienced covid on 25Nov2020 with also here mild presentation, no need for oxygen. For the 2nd vaccination the patient was in order, but after the covid infection there was a general deterioration of the general condition was known that was not yet fully recovered. A few hours after the vaccination the patient did not feel good with in the course of the night a sudden decrease in saturation leading to administration of oxygen. This improved the next day, then no more oxygen added. The patient did not feel optimal. No physician was asked seeing wat was supposedly an immunity reaction. The patient experience similar episodes the evening the day after the vaccination with sudden decrease in saturation, ratlle and soon after death. The physician did not expect a direct causal link but possible a too strong immune reaction? Cardial? No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment: No physician was asked seeing wat was supposedly an immunity reaction. The patient experience similar episodes the evening the day after the vaccination with sudden decrease in saturation, ratlle and soon after death. The physician did not expect a direct causal link but possible a too strong immune reaction? Cardial?; Reported Cause(s) of Death: Problem with heart or veins; Feeling unwell; Problem with breathing; 2x sudden desaturation


VAERS ID: 1113998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021267033

Write-up: died suddenly; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021-10862. A 78-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number not reported) via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. Medical history included polymorbid. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) in Jan2021 (reported as "first dose received 3 weeks earlier") for COVID-19 immunisation and experienced no adverse effect. The patient tolerated well the first vaccination three weeks before. It reported the patient died suddenly in the nursing home on 28Jan2021 afternoon. It was not reported if an autopsy was performed. A causal relationship between Comirnaty and Death is unassessable/unclassifiable. Regulatory Authority assessed this case as serious, results in death. Sender Comment (Regulatory Authority): Sudden death in an elderly polymorbid patient residing in an elderly home, of which we do not know any other details. There is a temporal correlation between the death and the second administration of the vaccine (1 day); we do not have clinical and anamnestic data that allow us to evaluate the case, which at the moment we have judged as unassessable (to say that however at the current moment of knowledge there are no data in the literature that speak in favor of a causal correlation between COVID-19 mRNA vaccine and sudden death). No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reporter''s Comments: Patient suddenly deceased.; Reported Cause(s) of Death: died suddenly


VAERS ID: 1114001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021281128

Write-up: Severe abdominal pain; Sudden death; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB CZ-CZSUKL-21002148. An 89-year-old female patient received first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Feb2021 (Lot Number: EK9788) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced severe abdominal pain (hospitalization) on 09Feb2021 and sudden death on 12Feb2021. The patient experienced severe abdominal pain after the vaccination with COMIRNATY (on the 08Feb2021, the 1st dose). It was necessary to call an emergency the next day at night (09Feb2021) - transport to the hospital. She was transferred to the anesthesiology and resuscitation department on the 11Feb2021. The patient died on 12Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114004 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Haemoglobin, Haemoglobin decreased
SMQs:, Cardiac failure (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad)

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: hemoglobin; Result Unstructured Data: Test Result:rapid decrease to 4.8
CDC Split Type: DEPFIZER INC2021266909

Write-up: Hemoglobin decreased; Atrial fibrillation/Tachyarrhythmia absoluta; rhythmogenic heart failure; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB regulatory authority number: DE-PEI-CADR2021014074. A non-contactable consumer reported that a 91-year-old female patient received BNT162B2 (COMIRNATY, lot number: EK9788) on 22Jan2021 intramuscularly at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had rapid decrease of hemoglobin to 4.8 on 26Jan2021, probably internal bleeding and consequently atrial fibrillation on 26Jan2021and later fatal course of rhythmogenic heart failure on 26Jan2021. Patient died on 27Jan2021. No autopsy was done. Sender''s comment: Hypertension, diast. relaxation disorder / patient felt unwell, vomited, came to the hospital where TAA was found together with hemoglobin drop 4.8, unsuccessful cardioversion, died in the course of arrhythmogenic heart failure. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hemoglobin decreased; Atrial fibrillation/Tachyarrhythmia absoluta; rhythmogenic heart failure


VAERS ID: 1114005 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Death, Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal pain, Hypotension, Incorrect route of product administration, Nausea, Oliguria, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Drug abuse and dependence (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Adipositas; Apoplexy; Arterial hypertension (Under treatment); Atrial fibrillation; Heart valve replacement NOS; Polyarthralgia
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20210116; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021266963

Write-up: Tested positive for COVID-19; Exsiccosis; Oliguria; Gut pain; Pyrexia; Nausea; Appetite lost; Diarrhoea; Hypotension; Unknown cause of death; BNT162b2 (COMIRNATY), intravenous; This is a spontaneous report from a non-contactable consumer, downloaded from the Regulatory Authority (regulatory authority number DE-PEI-CADR2021014173). A 75-year-old female patient received a single dose of BNT162b2 (COMIRNATY), intravenous, on 09Jan2021, for COVID-19 immunisation. The patient''s medical history included ongoing polyarthralgia, ongoing adipositas, ongoing cardiac valve replacement, ongoing apoplexy, ongoing atrial fibrillation, Hashimoto-Thyreoiditis, and ongoing hypertension. The patient''s concomitant medications included unspecified anti-hypertensive drug(s). The patient previously took Phenprocoumon (MARCUMAR) as anticoagulant therapy. On 10Jan2021 the patient experienced gut (abdominal) pain, fever, nausea, loss of appetite, and diarrhea (described as liquid stool). On 12Jan2021 the patient experienced deterioration with diarrhea, exsiccosis, and oliguria. On 15Jan2021, the patient was treated with infusions, and her hypertensive medication was reduced due to hypotension; the patient was hospitalized. On 16Jan2021, the patient tested positive for COVID-19. On 16Jan2021 the patient died, however the cause of death was not provided. No autopsy was performed. The patient had not recovered from diarrhea, exsiccosis, oliguria, while the outcome of the other events was unknown. Sender Comment: Arterial hypertension, adipositas, atrial fibrillation, anticoagulation with Marcumar, condition after cardiac valve replacement, polyarthrosis, Hashimoto-Thyreoiditis, condition after apoplexy. On 09Jan2021 vaccination COVID-19, on 10Jan2021 abdominal pain, fever, nausea, loss of appetite, liquid stool, 12Jan2021 deterioration with diarrhea, exsiccosis, oliguria; Therapy with infusions, reduction of hypertensive medication due to hypotension, on 15Jan2021 Hospitalization, positve test for Covid-19, on 16Jan2021 Exsitus letalis Causality has been assessed as "D. Unclassifiable " for all events by the Facility. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266938

Write-up: Bedridden; Unknown cause of death; This is a spontaneous report downloaded from a non-contactable reporter from the regulatory authority-WEB regulatory authority number DE-PEI-CADR2021014798. A 84-years-old female patient received bnt162b2 (COMIRNATY), intravenous on 27Dec2020 (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation. Medical history included ongoing dementia.The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 04Jan2021 , bedridden on an unspecified date. Outcome of unknown cause of death was fatal, of bedridden was unknown. The patient died on 04Jan2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114007 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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: 2021-01-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266968

Write-up: Unknown cause of death; Route of administration: Intravenous; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority with regulatory authority number DE-PEI-CADR2021014956. A 78-year-old female patient received BNT162B2 (COMIRNATY, lot number unknown), intravenous on 29Jan2021 at age of 78-year-old at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 31Jan2021. An autopsy was not performed. Sender Comment: my mother was in a nursing home and initially, she had refused her consent to the Corona vaccination. Since not all side effects were listed in the consent form, she was presented a new form for signature at a later date. How they wheedled consent from her, my mother can no longer tell us because she has died 48 hours after the vaccination. Friday she got the vaccination. Saturday she was brought with the emergency ambulance to the hospital and then died the following night. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114008 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebral infarction, Hemiparesis, Incorrect route of product administration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia; Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266957

Write-up: Masive middle cerebral artery infarct; Consciousness disturbed; severe left hemiparesis; COMIRNATY subcutaneous; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021015226. An 88-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), subcutaneously at an unspecified age on 14Jan2021 (lot number: EJ6797, expiration date unknown) at single dose for covid-19 immunisation. Medical history included atrial fibrillation and arrhythmia, both ongoing. The patient''s concomitant medications were not reported. The patient previously took rivaroxaban from 12Jan2001 to 14Jan2021 for anticoagulation drug level increased. On 24Jan2021 the patient experienced masive middle cerebral artery infarct, consciousness disturbed, severe left hemiparesis. The outcome of event masive middle cerebral artery infarct was fatal. The patient died on 04Feb2021. The outcome of the other events was unknown. It was not reported if an autopsy was performed. Sender Comment: Absolute arrhythmia in atrial fibrillation. Oral anticoagulation with rivaroxaban from 12Jan2021 to 14Jan2021 paused / acute media infarction on the right with impaired consciousness and severe hemiparesis on the left. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Masive middle cerebral artery infarct


VAERS ID: 1114009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: Asymptomatic COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: PCR smear; Result Unstructured Data: Test Result:unknown results; Comments: PCR result is not yet available; Test Date: 20210127; Test Name: rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021266931

Write-up: 27Jan2021 positive rapid test; Respiratory distress; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021015257. A 90-year-old female patient received bnt162b2 (COMIRNATY, lot number unknown), via intramuscular on 23Jan2021 at single dose for COVID-19 immunisation. The relevant medical history included asymptomatic COVID-19 from 27Dec2020. Concomitant medications were not reported. On 26Jan2021 the patient experienced breathing difficulties and respiratory distress. The patient had rapid test positive on 27Jan2021. The patient died on 31Jan2021. No autopsy was done. The patient underwent lab test included rapid test which showed positive on 27Jan2021; PCR smear with unknown results (PCR result is not yet available) on 29Jan2021. The outcome of the event respiratory distress was fatal, while other events were unknown. Sender Comment: Presumably the time of infection was 1-2 days before vaccination, 23Jan2021 first vaccination, 26Jan2021 first symptoms, 27Jan2021 positive rapid test, 29Jan2021 PCR smear, 31Jan2021 died, PCR result is not yet available. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1114010 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Death, Delusion, Disturbance in attention
SMQs:, Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency; Coronary disease; Hypertension; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Demyelinating disease (excl multiple sclerosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266953

Write-up: Arrhythmia; Delusion/attention disorders; Delusion/attention disorders; Exitus letalis/cause of death unknown; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority [regulatory authority number DE-PEI-CADR2021015311] and [DE-PEI-2021005723]. A 95-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY, lot number: EM0477) via intramuscular on 30Jan2021 at 0.3 ml single for prophylactic vaccination. Medical history included ongoing coronary disease, ongoing chronic renal insufficiency, ongoing hypertension, ongoing type II diabetes mellitus, demyelinating disease (excl multiple sclerosis) which was unknown if ongoing. Concomitant medications were unknown. The patient previously received the 1st dose of bnt162b2 (COMIRNATY) on 09Jan2021 for Prophylactic vaccination. On 31Jan2021 the patient experienced attention disorders. On 03Feb2021 the patient experienced arrhythmia and cause of death unknown (reported as Exitus letalis). Outcome of the event Exitus letalis/cause of death unknown was fatal, of the other events was unknown. This report was serious - hospitalization. Institution considered that there is an inconsistent causal association to immunization for all three events. Sender Comment: Diab. meel Typ 2 with multiple complications, chron. renal failure, hypertension, coronary heart disease / Exitus letalis. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Death, Dysphonia, Feeling cold, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute cardiac insufficiency; Chronic renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266952

Write-up: Chilliness/freezing; Vocal tone disorder; Arrhythmia; Tachycardia; Unknown cause of death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority [DE-PEI-CADR2021017275]. An elderly female patient of an unspecified age received the BNT162B2 (COMIRNATY, lot number unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing acute cardiac insufficiency and chronic renal insufficiency. The concomitant medications were not reported. On 05Feb2021 the patient experienced unknown cause of death. It was not reported if an autopsy was performed. The patient also experienced arrhythmia, tachycardia, chilliness/freezing, vocal tone disorder. This report was provided as serious (hospitalization). The outcome of event "unknown cause of death" was fatal; of other events was not recovered. Sender''s Comment: Information on risk factors or previous illnesses I stated: cardiac and renal insufficiency, marcumar patient. / The general health deteriorated rapidly. Health condition and vaccination response were too much. One should have recognized that. As the caring daughter, I stated on the form that I give consent to the vaccination if it was medically justifiable. I had doubts. But it was vaccinated in rows of three, according to my mother, a doctor consultation did not take place. I had to sign a form dated 22Dec2020 and a new one dated 18Jan2021. So far I have been vaccinated confidently, most recently the Schingrix vaccination. But my trust is destroyed. I will only get vaccinated by my family doctor after thorough consultation. Everything is still too early and has not been tested. Too many old people died soon after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114012 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Gait inability, Incorrect route of product administration, Quadriparesis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (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: Basalioma; Deep vein thrombosis leg; Glaucoma; Heart failure NYHA class II; Hypertensive heart disease; Hypoacusis; Incontinence of urine; Osteoporosis with fracture; Varicosity; Visual disturbances
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266933

Write-up: Unknown cause of death; Tetraparesis; inability to walk/gait inability; Chest ache; via intravenous; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021017373. A 98-year-old female patient received the BNT162B2 (COMIRNATY, lot number unknown), via intravenous, on 28Jan2021 (at the age of 98-year-old), at single dose, for COVID-19 immunization. Ongoing medical history included basalioma, heart failure NYHA class II, osteoporosis with fracture, hypoacusis, visual disturbances, incontinence of urine, glaucoma, varicosity, hypertensive heart disease, and deep vein thrombosis leg. The concomitant medications were not reported. The patient experienced unknown cause of death on 05Feb2021. It was not reported if an autopsy was performed. The patient also experienced tetraparesis, inability to walk/gait inability, and chest ache, on 29Jan2021. The outcome of the event "unknown cause of death" was fatal; of "via intravenous" was unknown; of other events was not recovered. Sender Comment: Information on risk factors or previous illnesses: Hypertensive heart disease with heart failure NYHA II; visual impairment; deep leg vein thrombosis left, sign after; osteoporosis with fracture; basalioma.condition after glaucoma; urinary incontinence; varicosis; hypacusis / vaccination 28Jan2021. The following day, 29Jan Thorax pain - after vaccination BIONTEC - and pain li body half + walking not possible for 2 hours. Death 15Feb: at 7:30 a.m. placed outside, washed, not doing so well, then back into the house, laid to bed, around 7:50 a.m. death or no sign of life. Unexpected death - assessment of death as a complication of vaccination Causality : Inconsistent causal association to immunization for all events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114013 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral haemorrhage, Cerebrovascular accident, Cranial nerve decompression, Hemiparesis, Loss of consciousness, Pyrexia, SARS-CoV-2 test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Atrial fibrillation (Permanent); Coagulation factor inhibitor assay; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hyperlipoproteinaemia
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: pos. Covid-PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC2021267067

Write-up: Fever; Aphasia; Cranial nerve decompression; Hemiparesis; Accident cerebrovascular; Cerebral haemorrhage; Loss of consciousness; This is a spontaneous report downloaded from the Regulatory Authority [Regulatory Authority Number DE-PEI-CADR2021018615]. A contactable consumer or other non-HCP reported that an 82-year-old female patient received the first dose of BTN162b2 (CORMINATY, Lot number unknown) intramuscularly on 05Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included ongoing permanent atrial fibrillation, ongoing hypertension, ongoing coagulation factor inhibition test and COVID-19 in Dec2020. It was also reportedthat the patient had HLP. The patient had COVID-19 infection with typical symptoms and a positive PCR test in Dec2020. No concomitant medications were reported, but it was mentioned that the patient was on anticoagulation with Eliquis. On 10Feb2021 the patient experienced loss of consciousness, stroke, hemiparesis, cerebral haemorrhage, decompression of the cranial nerve. It was reported that there was acute briefing on 10Feb2021 with malignant stroke ACM right with hemiplegia left and global aphasia as well as fever. Cause of death was reported as apoplectic fit. Outcome for loss of consciousness was reported as not resolved, while it was fatal for stroke, hemiparesis, cerebral haemorrhage and decompression of the cranial nerve. Outcome of the other event was unknown. It was unknown whether an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Apoplectic fit/Accident cerebrovascular; Cranial nerve decompression; Hemiparesis; Cerebral haemorrhage


VAERS ID: 1114019 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaemia, Cardiac failure, Hyponatraemia, Ileus, Subileus, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021287921

Write-up: decompensated heart insufficiency; bridenileus; abdominal pain and vomiting; abdominal pain and vomiting; Subileus; anemia; Hyponatremia; This is a spontaneous case from a consumer''s relative included the documentation of vaccinations and a physician letter. This case created for the second vaccination. A 90-year-old female patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on 01Feb2021 (lot number: EJ6788) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJ6796) on 11Jan2021 for COVID-19 immunization, the patient experienced lymph edema of the lower E. extremities stage II, arterial hypertension on 12Jan2021; pneumonia suspected, graded as severe bronchitis, severe nausea for a longer period of time and vomiting on 21Jan2021. The patient experienced purulent bronchitis on 26Jan2021. On 26Jan2021, the patient was treated with azithromycin probatory for suspected upper respiratory tract infection previously. The reporter did not consider any relationship to the bnt162b2 vaccination. On 04Feb2021, the patient experienced anemia and hyponatremia. On 09Feb2021, the patient experienced subileus. On 09Feb2021, the patient complained of abdominal pain and vomited. During the clinical examination Ileus was suspected. This finding was confirmed as bridenileus while hospitalization. After adhesion lysis, the patient came to the intensive care unit (ICU). In ICU biventricular decompensated heart insufficiency on 09Feb2021 with fatal outcome occurred in Feb2021. The patient died on Feb2021. It was not reported if an autopsy was performed. At the time of the inpatient admission, there was no evidence of a primary pulmonary event. The outcome of event decompensated heart insufficiency was fatal, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: decompensated heart insufficiency


VAERS ID: 1114025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bedridden; Fibrillation atrial; Parkinson''s disease; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021272270

Write-up: Choking; Cardio-respiratory arrest; Churning of stomach; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority ES-AEMPS-781793. A 93-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP2163), intramuscular on 03Mar2021 as single dose for Covid-19 immunisation. Medical history included: Bedridden since a month ago, Parkinson''s disease, atrial fibrillation, dementia Alzheimer''s type . The patient''s concomitant medications were not reported. On 03Mar2021 the patient died from choking , cardio-respiratory arrest , churning of stomach . It was not reported if an autopsy was performed. Course of the event On March 3, she gets the 1st dose of Pfizer vaccine. 2 hours later, while eating, the patient died suddenly. Additional info: they warn by syncope that does not respond. Bedridden life for a month. Alzheimer''s dementia. At 2:30 p.m. he has choked and had nausea without vomiting and has been left unresponsive. Very slow breathing. He has not responded for 10 minutes. Upon arrival at home, the patient was in cardiorespiratory arrest. The reporting physician did not start maneuvers for his baseline situation. They had vaccinated him this morning. The reporting physician thinks the cause was choking Follow up information has been requested.; Reported Cause(s) of Death: Choking; Cardio - respiratory arrest; Nausea


VAERS ID: 1114029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain
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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung lobectomy; Metastatic renal cell carcinoma; Nephrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; Chest pain; A regulatory authority report was received from a physician concerning a 76-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardio-respiratory arrest and chest pain. The patient''s medical history, as provided by the reporter, included metastatic renal cell carcinoma, and procedures of lung lobectomy and nephrectomy. Concomitant medications was not reported. On 11 Feb 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: 721 ) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced cardio-respiratory arrest and chest pain. No laboratory details was provided. Treatment information was not provided. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on 16 Feb 2021. The cause of death was reported as cardio-respiratory arrest. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 76 year old male with medical history of metastatic renal cell carcinoma, who experienced the unexpected events of cardio-respiratory arrest with fatal outcome and chest pain. The events occurred 6 days after the first dose of mRNA-1273. Very limited information regarding the events has been provided at this time. Additional information is not expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1114039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: End stage cardiac failure (for several months); Palliative care (for several months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272340

Write-up: Cardiac failure aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-DJ20210391 (Regulatory Authority reference) An 89-year-old male patient received the first dose of bnt162b2 (COMIRNATY), Lot PAA156571, intramuscular at single dose in the left arm, on 29Jan2021 for COVID-19 immunisation. Medical history included cardiac failure chronic for several months. Concomitant medications were not reported. On 30Jan2021, the patient experienced cardiac failure aggravated with fata outcome. The patient died on 30Jan2021. An autopsy was not performed. The death was expected for several weeks. This patient was considered to be at risk of developing a severe form of the COVID-19 disease. The patient had not had COVID-19 and had not been tested. After contact with her physician: patient in palliative care for several months. Did not present an immediate post-vaccination problem. Did not have a fever. Had not benefited from any particular monitoring of blood pressure or heart rate given his general condition, which was already very impaired. Reporting taking into account the chronology with a death the day after vaccination. The specific role of the vaccine not clearly retained. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: End stage cardiac failure


VAERS ID: 1114040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Malaise
SMQs:, Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (according to the clinic, prior to vaccination); Dyspnoea; Hypertension arterial; Tiredness
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272343

Write-up: Feeling sick; uneasy; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Agency Regulatory Authority FR-AFSSAPS-GR20210526 (Regulatory Authority reference). A 94-year-old female patient received 1st dose BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) intramuscularly on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension arterial, cardiac degradation, more out of breath from 15Jan2021 and more tired than usual from 15Jan2021. Differential diagnosis was reported as cardiac degradation, according to the clinic, prior to vaccination. There was no more precise cardiac assessment. Concomitant medications were not reported. From 15Jan2021, the patient was more out of breath and more tired than usual. On 17Feb2021, the patient became uneasy at her home. The patient experienced feeling sick on 17Feb2021 with seriousness criteria of death. There was intervention of the firefighters and the Emergencies (emergency room visit) but the patient could not be resuscitated. No hospitalization. The patient died on 17Feb2021. An autopsy was not performed. Outcome of event uneasy was unknown. Dose 2 was not completed (scheduled for 25Feb2021). No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Feeling sick


VAERS ID: 1114041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       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:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Aspiration; Behavioural disorder; Breast cancer female; Cataract; Choked on food; Deglutition disorder; Dementia; Difficulty in walking; Fracture of neck of femur; Hypertension arterial; Insomnia; Malnutrition; Starvation; Swallowing disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272425

Write-up: Death unexplained; This is a spontaneous report. Regulatory Authority FR-AFSSAPS-GR20210565. A contactable physician reported that a 93-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection and lot number EM0477) via Intramuscularly in left arm on 14Jan2021 at 30ug single for COVID-19 immunization. Medical history included dementia with behavioral problems, difficulty in walking, atrial fibrillation, hypertension arterial, cataract, starvation, fracture of neck of femur, Alzheimer''s disease, choked on food, deglutition disorder, insomnia, breast cancer, swallowing disorders with recurrent aspirations, malnutrition. Concomitant medications were not reported. The patient died/death unexplained on 30Jan2021. Long-standing treatment were unknown. There was no information available regarding possible symptoms between 14Jan2021 and 30Jan2021, or any biological work-up. Differential diagnosis included age and comorbidities. Outcome of event was fatal. It was unknown if autopsy was performed or not. No follow-up attempts are possible. No further information was provided.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1114042 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Oxygen saturation, Oxygen saturation decreased
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

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: Medical History/Concurrent Conditions: AFib; Cardiac failure; Choked on food; Deglutition disorder; Disease Parkinson''s; Prostatic adenoma; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: oxygen saturation; Result Unstructured Data: Test Result:arterial oxygen saturation decreased; Comments: sudden oxygen desaturation
CDC Split Type: FRPFIZER INC2021272309

Write-up: Arterial oxygen saturation decreased/ sudden oxygen desaturation; heart failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-GR20210566. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY) (Lot Number: EM0477) via intramuscular in arm left on 14Jan2021 at 30 ug, single for COVID-19 immunisation. Medical history included Prostatic adenoma from an unknown date and unknown if ongoing, disease Parkinson''s from an unknown date and unknown if ongoing, Atrial fibrillation from an unknown date and unknown if ongoing, starvation from an unknown date and unknown if ongoing, Deglutition disorder from an unknown date and unknown if ongoing, cardiac failure from an unknown date and unknown if ongoing, Choked on food from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced arterial oxygen saturation decreased and heart failure both on 16Jan2021. The outcome of the events was fatal. Course of the events: On 14Jan2021, the patient received the first vaccination with BNT162B2. On 16Jan2021, the patient experienced sudden oxygen desaturation and rapidly died. Differential diagnosis was heart failure. Oxygen saturation on 16Jan2021 showed arterial oxygen saturation decreased/ sudden oxygen desaturation. The patient died on 16Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart failure; Arterial oxygen saturation decreased/ sudden oxygen desaturation


VAERS ID: 1114043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-23
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: ARANESP; FUROSEMIDE; DIFFU-K; ELIQUIS; GANFORT; ZYMAD; DOLIPRANE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; EDUCTYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anaemia; Arrhythmia; COVID-19 (in autumn 2020); Deafness bilateral; Heart failure; Low back pain; Macular degeneration; Osteoporosis with fracture; Starvation; Thompson hip prosthesis (Left hip)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272423

Write-up: Decompensation cardiac; This is a spontaneous report received via the Agency and downloaded from the Agency Regulatory Authority-WEB [FR-AFSSAPS- GR20210567]. A contactable physician reported that a 95-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EM0477), intramuscular on arm left on 14Jan2021 at 30 ug, single for COVID-19 immunisation. Medical history included starvation, deafness bilateral, thompson hip prosthesis from Aug2020 (Left hip), anaemia, macular degeneration, osteoporosis with fracture, alzheimer''s disease, COVID-19 from 2020 (in autumn 2020), disabling low back pain, heart failure and rhythm disturbances. Concomitant medication included darbepoetin alfa (ARANESP), furosemide, potassium chloride (DIFFU-K), apixaban (ELIQUIS), bimatoprost, timolol maleate (GANFORT), colecalciferol (ZYMAD), paracetamol (DOLIPRANE), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) and potassium bitartrate/ sodium bicarbonate (EDUCTYL). No recent biological work-up (the last in Nov2020), no other information. The patient experienced decompensation cardiac on 23Jan2021. The patient died on 23Jan2021 from cardiac decompensation. It was not reported if an autopsy was performed. The outcome of the event was reported as fatal. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1114044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (NOS); CVA; Dementia; Depressive state; Disease coronary artery; Disorder behavior; Eschar; Hypertension arterial; Osteoporosis; Phlebitis NOS; Ulcer NOS; Vertebral injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272311

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the regulatory authority, downloaded from the regulatory authority-WEB FR-AFSSAPS-GR20210568. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EJ6796), via intramuscular, on the left arm, on 03Feb2021 (unknown age at time of vaccination) as 30 ug, single for covid-19 immunization. Medical history included osteoporosis, dementia, disorder behavior , arrhythmia (NOS), depressive state, hypertension arterial, disease coronary artery, CVA, phlebitis NOS, ulcers NOS, eschars, and disc pathology, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death unexplained on 10Feb2021. The outcome of the event 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: Death unexplained


VAERS ID: 1114045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac failure (~~~); Heart disease, unspecified; Pacemaker insertion (cardiac); Pulmonary embolism; Stroke
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Tachycardia at 130 / min
CDC Split Type: FRPFIZER INC2021272327

Write-up: Loss of consciousness; Tachycardia; This is a spontaneous report downloaded from the Regulatory Authority FR-AFSSAPS-LL20210995 (Regulatory Authority reference). A contactable physician reported that a 97-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot. EP9598) intramuscularly, in the left arm, at single dose, on 24Feb2021, for COVID-19 immunisation. Relevant medical history included cardiac failure, cardiac pacemaker insertion, arterial hypertension, hypertrophic cardiopathy, stroke in 2011, pulmonary embolism in 1996. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 25Feb2021, the patient experienced tachycardia and loss of consciousness. On 25Feb2021, the patient was found unconscious at around 12:15, stertoral breathing, no response to stimulation, tachycardia at 130 / min, impregnable arterial tension, emergency ambulance service at around 12:30: declaration of death. It was not reported if an autopsy was performed. The patient has not been tested for COVID-19. Clinical outcome of tachycardia and loss of consciousness was reported as fatal. No Follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: tachycardia; Loss of consciousness


VAERS ID: 1114047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 RA / OT

Administered by: Other       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: 2021-02-24
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic calcification; Carotid artery stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272381

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-LY20211241. An 87-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ER0641), intramuscular at right arm on 19Feb2021 (at unknown age) at single dose for COVID-19 immunisation. Medical history included calcified aortic stenosis, Carotid artery stenosis, both were from an unknown date and unknown if ongoing. No previous history of SARS-CoV-2 infection. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number not provided) for COVID-19 immunisation. No long-standing treatment was reported. On 24Feb2021, the patient developed cardiac arrest requiring emergency intervention. The patient died on 24Feb2021 as a result of the disease (Not otherwise specified). The patient had Emergency room visit. Seriousness criteria of the case was reported as adverse event leading to death. It was unknown if an autopsy was performed. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1114050 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
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, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Physical examination, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 20
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 macrocytic; COVID-19; Dementia; Starvation
Allergies:
Diagnostic Lab Data: Test Name: N-terminal prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:increase; Test Date: 20210130; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Name: crackles heard; Result Unstructured Data: Test Result:increased crackles heard over lower lung fields; Test Date: 20210130; Test Name: tested for COVID-19 on 30Jan2021; Result Unstructured Data: Test Result:COVID-19 aggravation
CDC Split Type: FRPFIZER INC2021272389

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable physician via Agency downloaded from the Regulatory Authority FR-AFSSAPS-MP20210366 A 97-years-old male patient received the first dose of bnt162b2 (COMIRNATY Batch/Lot Number: EJ6788), intramuscular, administered in Arm Right on 21Jan2021 as single dose for covid-19 immunisation. Medical history included starvation, dementia and anaemia macrocytic all unknown if ongoing. The patient had medical history of COVID-19 and was considered at risk of developing a severe form of COVID-19. The patient''s concomitant medications were not reported. The patient experienced covid-19 aggravated on 30Jan2021 with fatal outcome. The patient died on 19Feb2021. An autopsy was not performed. The clinical course of the events was reported as follows. On 30Jan2021, the patient presented dyspnea, fever and oxygen desaturation which required oxygen therapy was tested for COVID-19 on 30Jan2021 and was diagnosed with COVID-19 aggravation. The patient then presented worsening of confusion and agitation, increased crackles heard over lower lung fields and increase of N-terminal prohormone brain natriuretic peptide, asthenia and anorexia. Outcome: On 19Feb2021, 29 days after vaccination, the patient died due to COVID-19 aggravation. Complete file, no further information available.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1114053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Haemorrhagic stroke; Hematoma cerebral; Locked-in syndrome; Percutaneous endoscopic gastrostomy; Tracheostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272407

Write-up: Sudden death; This is a spontaneous report downloaded from the Regulatory Authority [FR-AFSSAPS- PA20210337] and received via the Agency. A contactable physician reported that a 62-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6795) via intramuscular in left arm on 13Jan2021 at 0.3 mL as a single dose for COVID-19 immunisation. The patient''s medical history included haemorrhagic stroke from an unknown date in Jul2019, spontaneous ventilation on tracheostomy, food exclusively on percutaneous endoscopic gastrostomy, hematoma of the posterior fossa with compression of the cerebral trunk on untreated arterial hypertension and severe neuro sequelae with equivalent of a partial locked-in syndrome. The patient had no history of COVID19 infection. Concomitant medications were not reported. On 31Jan2021, around 1:40 a.m. the patient had sudden death without any sign of previous deterioration detected by the medical team where she had been hospitalized for a year. The outcome of the event was fatal. The patient died on 31Jan2021. Cause of death was not reported. It was not reported if an autopsy was performed or not. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1114057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
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: 2021-02-12
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; Cold type hemolytic anemia; Deep vein thrombosis (bilateral); Diabetes mellitus insulin-dependent; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20210212; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:highly positive; Comments: PCR
CDC Split Type: FRPFIZER INC2021272321

Write-up: COVID-19 respiratory infection; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. This is a report received from the Agency, Regulatory authority report number FR-AFSSAPS-RE20210613. An 81-year-old male patient received his first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 05Feb2021 (Lot Number: EJ6788) as single dose for covid-19 immunisation. Medical history included acute on chronic renal failure from Nov2020 to an unknown date, Diabetes mellitus insulin-dependent from an unknown date and unknown if ongoing, Cold type auto-immune hemolytic anemia from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, bilateral deep vein thrombosis from Jan2021 to an unknown date. Long-standing treatment included anticoagulant (unspecified). The patient experienced covid-19 respiratory infection with fatal outcome on 12Feb2021. Course of the event: On 21Jan2021, a test was performed and turned out to be negative. On 05Feb2021, the patient received a first injection of bnt162b2. On 12Feb2021, it was reported "Highly positive PCR". The patient experienced an Apathetic confusional state, "respiratory distress could not be corrected". This was due to SARS-CoV-2 infection progression in context of multiple underlying pathologies, it was not an adverse event but a lack of efficacy a week after the injection of the vaccine. The patient was considered at risk of developing a severe form of the disease "because of his medical history". The patient died on 12Feb2021. It was not reported if an autopsy was performed. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1114058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac failure, Dyspnoea, Pulmonary embolism, Respiratory distress, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), 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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Heart failure; Ischaemic cardiomyopathy (under pacemaker); Mild neurocognitive disorder (moderate neurocognitive disorder)
Preexisting Conditions: Medical History/Concurrent Conditions: Dysrhythmias; Ischemic heart disease (under pacemaker)
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021272412

Write-up: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism; Cardiac decompensation with suspected pulmonary embolism; Respiratory distress; This is a spontaneous report downloaded from the Agency Regulatory Agency-WEB [FR-AFSSAPS- RN20210588] and received via the Agency . A contactable physician reported that an 89-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6789), intramuscularly in right arm on 05Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing mild neurocognitive disorder/ moderate neurocognitive disorder, ongoing heart failure, ongoing ischaemic cardiomyopathy under pacemaker, ischemic heart disease under pacemaker, dysrhythmic. The patient had no history of COVID-19. Concomitant medications were not reported. The patient experienced acute respiratory decompensation, dyspnea, cardiac decompensation with suspected pulmonary embolism, respiratory distress on 17Feb2021. On 18Feb2021, a COVID-19 test was performed, and it was negative. The patient condition required urgent medical intervention. The events acute respiratory decompensation, dyspnea, cardiac decompensation were considered as serious (death) by the physician. The outcome of the events pulmonary embolism, respiratory distress was unknown and fatal for the other events. The patient died on 22Feb2021. It was not reported if an autopsy was performed or not. Comment: Case from a report via the portal (# 20210222150517211), medically confirmed. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism


VAERS ID: 1114063 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Dyspepsia, Feeling hot, Heart rate, Malaise, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: XATRAL; PANTOPRAZOLE; FORLAX; LERCAN; LUMIGAN; CARTEOLOL HYDROCHLORIDE; DOLIPRANE; APIXABAN; LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cerebrovascular accident; Epilepsy; Glaucoma; Hypertension arterial; Mixed dementia; Senile macular degeneration; Surdity
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Comments: normal; Test Date: 20210220; Test Name: Body temperature; Result Unstructured Data: Test Result:37; Comments: normal; Test Date: 20210220; Test Name: beats per minute; Result Unstructured Data: Test Result:108; Comments: normal; Test Date: 20210220; Test Name: oxygen saturation; Test Result: 93 %; Comments: normal
CDC Split Type: FRPFIZER INC2021272356

Write-up: vomiting (low volume); feeling unwell; Found dead (cause undetermined); gastric burning; hot sensation without fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-TO20211123. A 91-year-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly, administered in Arm Left at single dose on 19Feb2021 (at age of 91-year-old) (Lot Number: EJ6788) for COVID-19 immunization. Medical history included cerebrovascular accident, surdity, epilepsy, mixed dementia, atrial fibrillation, Hypertension arterial, glaucoma, senile macular degeneration. Concomitant medications included alfuzosin hydrochloride (XATRAL LP, 10 mg prolong release tablet), pantoprazole, macrogol 4000 (FORLAX 10 g, powder for oral solution in sachet-dose), lercanidipine hydrochloride (LERCAN 20 mg film-coated tablet), bimatoprost (LUMIGAN); carteolol hydrochloride,paracetamol (DOLIPRANE), apixaban, and levetiracetam. On 19Feb2021, after vaccination, the patient developed a gastric burning and hot sensation without fever. On 20Feb2021 at 3.30 A.M., the patient experienced vomiting (low volume). Vital signs were normal (blood pressure 13/7, oxygen saturation 93%, beats per minute 108 and temperature 37 (units not provided)). On 20Feb2021, upon waking-up, the patient was feeling unwell, had breakfast in common room and then returned to bed. On 20Feb2021 at 10 A.M., the patient was found dead in his bed (unknown cause). The outcome of events ''gastric burning'' , ''hot sensation without fever'' and vomiting was not resolved, of the event ''feeling unwell'' was unknown. The patient died on 20Feb2021. An autopsy was not performed. No follow-up attempts are possible.No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Blood pressure measurement, Cerebrovascular accident, Hyperhidrosis, Hypertension, Malaise, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypertension (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: Hypertension arterial (without drug treatment); Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder (with agitation episodes for few weeks); COVID-19; Diabetes
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021272354

Write-up: Stroke; Sudation increased; Hypertension arterial; Tachycardia; Malaise; agitation; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number FR-AFSSAPS-TS20210524] from a contactable pharmacist. A 92-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular in right arm, on 17Feb2021 (Lot# ER0641), at single dose, for COVID-19 immunisation. Medical history included ongoing living in nursing home, COVID-19, diabetes, ongoing arterial hypertension (without drug treatment) and cognitive disorders with agitation episodes for few weeks. Concomitant medications were not reported. Previously the patient received the 1st dose of Comirnaty for COVID-19 immunisation. The patient experienced malaise (medically significant) on 18Feb2021 morning with outcome of unknown, agitation (medically significant) on 18Feb2021 morning with outcome of unknown, tachycardia (medically significant) on 18Feb2021 morning with outcome of recovered on 21Feb2021, stroke (death, medically significant) on 20Feb2021, sudation increased (medically significant) on 18Feb2021 morning with outcome of unknown, hypertension arterial (medically significant) on 18Feb2021 with outcome of recovered on 19Feb2021, tachycardia (medically significant) on 18Feb2021 with outcome of unknown. On 20Feb2021 the patient experienced hypotonia of one side and hypertonia of the other side, the physician diagnostic suggested a cerebrovascular accident (CVA). Later the patient was areactive and did not feed. The patient died on 23Feb2021. An autopsy was not performed. Follow-up attempts are completed. No further information in expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1114111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Head injury, SARS-CoV-2 test
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (only)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021274770

Write-up: Cardiac arrest; lack of oxygen brain damage; Head injury; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103092148547120, Safety Report Unique Identifier GB-MHRA-ADR 24908145. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection); via an unspecified route of administration on 19Feb2021 at a single dose for covid-19 immunisation. Medical history included asthma only. Patient had not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced death events of cardiac arrest on 20Feb2021 and lack of oxygen brain damage on Feb2021, non serious event of head injury on Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 19Feb2021. The patient died on 23Feb2021. It was not reported if an autopsy was performed. She was reported with cardiac arrest causing head injury and lack of oxygen brain damage. Patient had not tested positive for covid-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; lack of oxygen brain damage


VAERS ID: 1114115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Parkinson''s disease ((mild and stable) for which she was taking medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274681

Write-up: blood clots; Heart attack; sore arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103102255389050, Safety Report Unique Identifier GB-MHRA-ADR 24915706. This consumer reported similar events for three patients. This is the first of three reports. An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Jan2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunisation. The patient medical history included Parkinson''s (mild and stable) for which she was taking medication. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. It was reported that the patient had absolutely no side effects other than a sore arm for a day. She had no signs of any illness or anything of concern. The patient experienced blood clots on an unspecified date, and heart attack on 23Jan2021. The outcome of the events blood clots and heart attack was fatal. The patient died on 23Jan2021. It was not reported if an autopsy was performed and the reported cause of death was thrombosis and myocardial infarction. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021287274 Same reporter/drug, similar events in different patients;GB-PFIZER INC-2021287273 Same reporter/drug, similar events in different patients; Reported Cause(s) of Death: Clot blood; Heart attack


VAERS ID: 1114117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: DOPAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease (under control with medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274756

Write-up: Heart attack; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202103111105393570, Safety Report Unique Identifier GB-MHRA-ADR 24917743. A 78-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 as single dose for COVID-19 immunisation. Medical history included parkinson''s disease: (under control with medication. My mom had parkinsons but was all under control with medication). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication(s) included dopamine taken for parkinson''s disease. The patient experienced heart attack (myocardial infarction) on 23Jan2021 and the event was reported as death. "My mother suffered an accute heart attack and passed away 3 days after receiving the vaccine. she had no previous heart problems and there is no history of heart problems in the family. she was fine and well before she had the vaccine and to die 3 days after being given the vaccine was a massive shock to the family. I would like this investigated as this event has obviousely taken its toll on our family, we have lost a very dear mother, wife and nan and our lives have changed forever. No investigations were carried out and in my opinion they should have been!" The patient died on 23Jan2021. It was not reported if an autopsy was performed and the reported cause of death was heart attack. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1114128 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1185 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Diabetes mellitus, Myocardial ischaemia, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Embolic and thrombotic events, venous (narrow), Other ischaemic heart disease (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
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: Ischaemic heart disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274034

Write-up: pulmonary embolism; ischaemic heart disease; ischaemic heart disease; Diabetes mellitus; This is a spontaneous report from a contactable consumer via the portal. A 69-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN1185), via an unspecified route of administration in left arm on 31Jan2021 15:15 at single dose for COVID-19 immunization. The patient''s medical history included ischaemic heart disease and type 2 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The Facility where the most recent COVID-19 vaccine was administered was noted to be the Doctors office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter said Pfizer should ash the GP for a list of any other medications the patient received within 2 weeks of vaccination. A CPR was received a treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccine Facility information was also noted to be available. On an unspecified date, the patient experienced pulmonary embolism, ischaemic heart disease and diabetes mellitus. The events were considered as serious (death) by the consumer. The outcome of the events was fatal. The patient died on 08Mar2021 due to these events. An autopsy was performed that revealed pulmonary embolism, ischaemic heart disease and diabetes mellitus as the causes of death. The consumer said that the autopsy results were available at the time of this report.; Reported Cause(s) of Death: pulmonary embolism; ischaemic heart disease; diabetes mellitus; ischaemic heart disease


VAERS ID: 1114129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pulmonary oedema, Thrombosis
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021287274

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202103102255389050, Safety Report Unique Identifier GB-MHRA-ADR 24915706. This consumer reported similar events for three patients. This is the second of three reports. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the vaccine and then a couple days later had a blood clot that stopped the heart and caused fluid on the lungs and he died. The patient died on unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021274681 Same reporter/drug/events in different patients; GB-PFIZER INC-2021287273 Same reporter/drug/events in different patients; Reported Cause(s) of Death: fluid on the lungs; Clot blood; Heart arrest


VAERS ID: 1114135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood uric acid, Death, General physical health deterioration, Haemoglobin, Haemorrhage subcutaneous, Platelet count, Red blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: CONCOR; TRITACE; LORSILAN; FURSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Carotid artery stenosis (stenosis ACI bilat.); Cerebral infarction; Chronic renal insufficiency; Depression; Macrocytic anemia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Creatinine; Result Unstructured Data: Test Result:143 umol/l; Test Date: 202101; Test Name: Serum potassium; Result Unstructured Data: Test Result:2.8 mmol/L; Test Date: 202101; Test Name: Urate; Result Unstructured Data: Test Result:920 umol/l; Test Date: 202101; Test Name: Hemoglobin; Result Unstructured Data: Test Result:102 g/l; Test Date: 202101; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:96 x10 9/l; Test Date: 202101; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.4 x10 12/l
CDC Split Type: HRPFIZER INC2021267331

Write-up: death; deterioration of the general condition; Heavy subcutaneous bleeding; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HR-HALMED-300044751. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot number: EJ6796) via an unspecified route of administration on 09Jan2021 at 30 ug single for COVID-19 immunisation. Medical history included chronic renal insufficiency (chronic kidney. Insuf.,not ongoing), macrocytic anemia (not ongoing), carotid artery stenosis (not ongoing), arterial hypertension (not ongoing), depression (not ongoing), cerebral infarction (post CVI, I63) from 2007 (not ongoing). Concomitant medications included bisoprolol fumarate (CONCOR), ramipril (TRITACE), lorazepam (LORSILAN), furosemide (FURSEMIDE). The patient experienced heavy subcutaneous bleeding on 14Jan2021, deterioration of the general condition on 14Jan2021, death on 21Jan2021. Treatment of side effects was Oral compensation of K. The patient underwent lab tests and procedures in Jan2021 which included creatinine (ref. 63-107 umol/l): 143, Serum potassium (K, ref. 3.9-5.1 mmol/L): 2.8, urate (ref. 134-337 umol/l): 920, Hemoglobin (119-157 g/l): 102, Thrombocyte count (158- 424 x10 9/l): 96, Red blood cell count (ref. 3.86 - 5.08 x10 12/l): 2.4. It was unknown if autopsy was performed. Outcome of all events was fatal. Seriousness criteria was reported as death and life-threatening. Reporter comment: Reporter relatedness assessment: Possible. Sender Comment: 08Mar2021:Additional data was requested. Relatedness of drug to all events assessed by Regulatory Authority as Unassessable /Unclassifiable (Method of assessment: WHO-UMC Causality) Additional information on drug ADR is adequately labelled: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Reporter relatedness assessment: Possible.; Reported Cause(s) of Death: Heavy subcutaneous bleeding; deterioration of the general condition; Unknown cause of death


VAERS ID: 1114146 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, Electrocardiogram, Hyperventilation, Malaise, SARS-CoV-2 test, Ultrasound abdomen
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: OMEPRAZOLE; TEGRETOL; QUETIAPINE; TIMOPTOL; RIVOTRIL; ZESTORETIC 20; SPIRIVA RESPIMAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: blood gas; Result Unstructured Data: Test Result:results not provided; Test Date: 20210306; Test Name: blood test; Result Unstructured Data: Test Result:waiting for results; Test Date: 20210306; Test Name: ECG; Result Unstructured Data: Test Result:results not provided; Test Date: 20210306; Test Name: molecular swab; Test Result: Negative ; Test Date: 20210306; Test Name: abdomen ultrasound; Result Unstructured Data: Test Result:results not provided
CDC Split Type: ITPFIZER INC2021283394

Write-up: general malaise; hyperventilation; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-694840. A 93-year-old male patient received BNT162B2 (COMIRNATY, lot number: EP9598) second dose intramuscular on 06Mar2021 at 0.3 ml single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included omeprazole tablet, carbamazepine (TEGRETOL) modified-release tablet, quetiapine, timolol maleate (TIMOPTOL) for Glaucoma, clonazepam (RIVOTRIL) Oral solution, hydrochlorothiazide, lisinopril (ZESTORETIC 20) for Hypertension, tiotropium bromide (SPIRIVA RESPIMAT) Inhalation vapour, solution for COPD (Chronic obstructive pulmonary disease). The patient previously took BNT162B2 (COMIRNATY) first dose on 13Feb2021 intramuscular for COVID-19 vaccination and experienced no adverse reactions. The 2nd dose 06Mar2021: the patient showed general malaise and that is why he accessed the hospital emergency room on the same day. Blood tests were performed, waiting for results, the molecular swab was performed with negative results, and Urbason vial 40 mg, paracetamol, hemagel pantoprazole, bicarbonate, lasix intravenously were administered. Subsequently ECG, blood gas before and after hyperventilation, abdomen ultrasound. Patient death on 07Mar2021. On 10Mar2021 the reports of the examinations carried out and the death record were requested from the reporter. It was unknown if autopsy was done or not. No follow-up attempts possible. No information expected.; Reported Cause(s) of Death: General malaise; hyperventilation


VAERS ID: 1114167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (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: 2021-03-01
   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: ACETYLSALICYLIC ACID; PREDNISOLONE; OMEPRAZOLE; CALCI CHEW D3; QUETIAPINE; TRAMADOL; RIVASTIGMINE; PROLIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: body temperature; Result Unstructured Data: Test Result: Fever: 38 to 40.5 degrees Celsius Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius; Test Date: 20210303; Test Name: oxygen saturation; Test Result: 67 %; Comments: decreased.
CDC Split Type: NLPFIZER INC2021267083

Write-up: Fever: 38 to 40.5 degrees Celsius; Cold shivers; saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00463754. A 66-year-old male patient received the second dose of BNT162b2 (COMIRNATY; lot number: EP9598) on 02Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included acetylsalicylic acid tablet 80mg taken at 80 mg, prednisolone tablet 5mg taken at 5 mg, omeprazole gastro-resistant capsule 40mg taken at 40 mg, calcium carbonate, colecalciferol (CALCI CHEW D3) chewable tablet 2.5g / 800iU taken at 1000mg approximately, quetiapine tablet modified-release tablet 50mg taken at 50 mg, tramadol capsule modified-release 100mg taken at 100 mg, rivastigmine patch 9.5mg taken at 9.5 mg daily (24hrs), denosumab (PROLIA) solution for injection 60mg/ml taken at 60mg/ml. The patient previously took the first dose of BNT162b2 (COMIRNATY) on 01Feb2021 for COVID-19 immunisation with no adverse reaction. On 03Mar2021, the patient experienced saturation decreased, cold shivers and fever: 38 to 40.5 degrees Celsius following administration of BNT162b2. Saturation drop to 67% on 03Mar2021. The patient had not previous COVID-19 infection. No diagnostic procedures were performed. Chills was treated with amoxicilin/clavulanic acid, oxygen saturation decreased was treated with oxygen and pyrexia was treated with amoxicilin/clavulanic acid. The patient died in Mar2021. The outcome of the events was fatal. It was unknown if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty); past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes; ADRs: no; date: 01Feb2021; saturation additional information ADR: saturation drop to 67%; COVID-19: previous COVID-19 infection: no; other: diagnostic procedures: no. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: No Date: 01Feb2021 Saturation Additional information ADR: Saturation drop to 67% COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: No.; Reported Cause(s) of Death: saturation decreased; cold shivers; fever: 38 to 40.5 degrees Celsius


VAERS ID: 1114168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Rash, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankle fracture; Asthma; Diabetes mellitus; Living in residential institution; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: O2 saturation; Result Unstructured Data: Test Result:frequent falls
CDC Split Type: NOPFIZER INC2021136497

Write-up: suspected respiratory infection; EXANTHEMA; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (NO-NOMAADVRE-FHI-2021-U3ppz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014564). An 85-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6795) intramuscular on 06Jan2021 at single dose for COVID-19 immunisation and oral amoxicillin/clavulanic acid (AUGMENTIN) from an unspecified date to 04Jan2021 at 1 DF (amoxicillin 500mg/clavulanic acid 125mg) three times a day for respiratory tract infection. Relevant medical history included living in residential institution, ankle fracture, asthma, multimorbidity and diabetes mellitus. Concomitant medications were not reported. On 11Jan2021, the patient experienced exanthema with outcome of recovering and, on an unspecified date, she developed a suspect respiratory infection and she died from it on 22Jan2021. It was unknown if an autopsy as performed. The action taken in response to the events for amoxicillin/clavulanic acid was post-therapy. The Facility assessed the causal relationship between BNT162B2 (COMIRNATY) and amoxicillin/clavulanic acid and the reported event exanthema as possible. Sender''s comment: Background: Woman in her 80''s, lived in a care ward, multimorbid with diabetes, asthma and frequent respiratory infections. Vaccinated with the COVID-19 vaccine COMIRNATY. Prior to vaccination treated with AUGMENTIN (amoxicillin, clavulanic acid, penicillin) due to increasing CRP and decrease in O2 saturation. Good response, and CRP went down nicely. The antibiotic regimen was terminated two days before vaccination. Five days after vaccination, a rash appeared on the lower truncus and extremities. No itching or other ailments, felt in better shape. The rash was about to disappear 4-5 days after debut. The reporter states that the rash is a known side effect of amoxicillin, but is unsure whether the rash can also be due to the vaccine. It is further stated that the patient died two weeks after vaccination. She had been ill in the days before with frequent falls in O2 saturation. According reporter, this was a suspected respiratory infection and she died from it. Comment: The rash that was added is not described in more detail morphologically, only that it was non-itchy and went back spontaneously. The fact that it was non-itchy and came several days after the start of AUGMENTIN and vaccination, speaks against the fact that it was urticaria as part of a type 1 allergic reaction. However, it cannot be ruled out that the rash may have been an expression of a type V allergic reaction, which is cell-mediated and where the rash typically occurs after a few days. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug (here COMIRNATY and AUGMENTIN), but which can also be due to an underlying disease, other drugs or chemicals. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: suspected respiratory infection


VAERS ID: 1114169 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Ejection fraction
SMQs:

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure (Stable, moderate.); Gout; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 202006; Test Name: Ejection fraction; Result Unstructured Data: Test Result:40-50 %
CDC Split Type: NOPFIZER INC2021272700

Write-up: Sudden death, unnatural/found dead; This is a spontaneous report downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-Ujm73 and NO-NOMAADVRE-E2B_00017879. A contactable physician reported that a 72-year-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection and lot number: EP9598) via intramuscularly on 24Feb2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation, cardiac failure (stable, moderate), hypertension arterialis and gout. The patient''s concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunization. The patient underwent lab tests and procedures which included ejection fraction 40-50% on an unspecified date in Jun2020. It was reported that, the patient was seldom at check-ups at his GP (general physician), last laboratory tests were performed in Oct2019 (no values stated). The reporter stated that the patient was in good general condition. On 26Feb2021, the patient had sudden death, unnatural/ found dead, outside his home, by his brother. The patient was found next to his scooter, it appeared that he had tried to elevate the scooter with a jack. He was wearing a face mask, which was considered odd by the reporting physician, but the patient''s brother said that it was not unusual, and that the patient often wore a face mask when working outside, for protection. The reporter has stated that based on rigor mortis, the date of death is set to 26Feb2021. The patient''s brother had last seen the patient on the morning of 26Feb2021, when they had breakfast together. The patient had not complained about any symptoms following vaccination, according to his brother. At the time of reporting it was stated that an autopsy was not performed, but that it was planned for 09Mar2021. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. The Regional Pharmacovigilance Center assessed the causal relationship between BNT162B2 (COMIRNATY) and the reported event as Possible. Health Authority Comments: The report concerns a patient in his 70s, who was found dead outside his home a few days after the second dose of the Covid-19 vaccine COMIRNATY. The patient had not complained of any symptoms and was considered to be in his habitual condition before the death occurred. The patient had several underlying diseases. An autopsy was planned, but not carried out, when the report was submitted. When vaccinating patients with underlying diseases, some serious events may occur shortly after vaccination. In the individual 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. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. Data from use in patients with comorbidity is nevertheless limited, and such lack of information will be obtained in post-marketing studies, among other things. Since the report concerns death and autopsy is scheduled to be performed, we would like you to send us an update when the result of the autopsy report is available. This will provide useful additional information to the report and it''s assessment. Based on the information in the report so far and in accordance with international criteria, the causal link with vaccination is assessed 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 also 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.; Reported Cause(s) of Death: Sudden death, unnatural


VAERS ID: 1114173 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; COVID-19; HIV infection (medicated with antivirals and with stable viral counts); Ischaemic cardiomyopathy; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021272662

Write-up: Fever; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB PT-INFARMED-J202103-818. A contactable physician reported that a 64-year-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot/batch number: EP9598), Intramuscular on 19Feb2021 at 0.6 mL, single for COVID-19 immunisation. Medical history included HIV patient medicated with antivirals and with stable viral counts, suffered from chronic obstructive pulmonary disease, with severe ischemic cardiomyopathy, with COVID-19 in Jan2021, with a history of stroke. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) for COVID-19 immunization. No adverse reaction on the first dose. A history of ADR for any drug is unknown. Vaccination was scheduled 2 doses with an interval of at least 21 days between each dose. The patient had high fever associated with the use of BNT162B2 on 20Feb2021. The adverse reaction (ADR) started at home, less than 24 hours after taking the second dose of the suspected vaccine and led to the administration of Ben-U-Ron. The administration of the vaccine had taken place the day before, in the hemodialysis unit, without complaints immediately or in the first subsequent hours. The patient death was reported in evolution of ADR. The outcome of event was fatal. There was no autopsy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever


VAERS ID: 1114178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bundle branch block right, C-reactive protein, Chest pain, Computerised tomogram thorax, Culture, Dyspnoea, Electrocardiogram, Oxygen saturation, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Dementia; Hypertension; Obstipation; Parkinson''s disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: DT thorax; Result Unstructured Data: Test Result:bilateral pneumonia; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 202102; Test Name: C-reactive protein; Result Unstructured Data: Test Result:170; Test Date: 202102; Test Name: cultures; Result Unstructured Data: Test Result:unknown results; Test Date: 202102; Test Name: ECG; Result Unstructured Data: Test Result:new bundle branch block right; Test Date: 202102; Test Name: oxygen saturation; Result Unstructured Data: Test Result:70-80 %; Test Date: 202102; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021272667

Write-up: Acute dyspnea/suddenly developed respiratory distress; Chest pain; Oxygen saturation decreased/Saturation between 70-80%; bilateral pneumonia/Abnormal pulmonary status/Increasing CRP; a new bundle branch block right showed at ECG; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, Regulatory authority report number SE-MPA-2021-008936 and additional other number SE-MPA-1614348990521. A 76-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6134), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic renal failure, hypertension, constipation, dementia, type 2 diabetes mellitus, Parkinson''s disease, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse events were acute dyspnoea and chest pain with oxygen saturation decreased in Feb2021. The reporter describes that the man about three weeks after the vaccination in Feb2021 suddenly developed respiratory distress and had chest pain. Saturation between 70-80%, a new bundle branch block right showed at ECG. No fever. The man came to hospital. C-reactive protein 170. Abnormal pulmonary status (not further specified in the report). Covid negative. DT thorax shows bilateral pneumonia. Cultures was taken from several locations on the man''s body and he received intravenous antibiotics. Increasing CRP and the man deteriorates. He received infusions and inhalations according to the reporter. The man died after almost a week at the hospital on an unspecified date in 2021. Outcome: Fatal. Report assessed as serious, death. The outcome of the events "Acute dyspnea/suddenly developed respiratory distress", "Chest pain", "Oxygen saturation decreased/Saturation between 70-80%" and "bilateral pneumonia" was fatal. The outcome of other events was unknown. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute dyspnea/suddenly developed respiratory distress; Chest pain; Oxygen saturation decreased/Saturation between 70-80%; bilateral pneumonia


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