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

Found 14,925 cases where Vaccine is COVID19 and Patient Died



Case Details

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VAERS ID: 1065224 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Sudden death
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: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021197540

Write-up: Sudden death; cardiopulmonary arrest without prodrome; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-PC20210274. A 97-year-old female patient receive bnt162b2 (COMIRNATY, lot number EJ6789), intramuscular on 12Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension arterial unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced sudden death on 15Feb2021, cardiopulmonary arrest without prodrome occurred on 15Feb2021 (On D + 3 of vaccination). Unfavorable development. The patient died on 15Feb2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Sudden death; cardiopulmonary arrest without prodrome


VAERS ID: 1065229 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Oxygen saturation, Polymerase chain reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; TRIATEC [RAMIPRIL]; TERCIAN [CYAMEMAZINE]; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Confusion; Febrile reaction; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: BP; Result Unstructured Data: Test Result:13/8; Test Date: 20210209; Test Name: O2 Saturation; Test Result: 98 %; Test Date: 20201203; Test Name: PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021203720

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (regulatory authority number FR-AFSSAPS-RS20210237). An 84-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot EJ6789) intramuscular in the left arm on 09Feb2021 12:45 p.m. at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and schizophrenia from an unknown date and unknown if ongoing; febrile syndrome with confusional syndrome for no apparent reason on 03Dec2020. Concomitant medications included bisoprolol, ramipril (TRIATEC), cyamemazine (TERCIAN), vitamin D (VITAMIN D NOS). The patient had his first dose of BNT162B2 (COMIRNATY, batch unknown) on 18Jan2021- well tolerated, no adverse effect. On 09Feb2021: 12:45 p.m.- second injection of BNT162B2 in the left arm; no fever, 98% O2 saturation, BP 13/8. Meal without problem. At 2 p.m.- nothing to report. 4 p.m.- afternoon tea; no reported discomfort (patient able to express a complaint). 6 p.m.- patient found deceased (death unexplained). No medico-legal obstacle. Additional lab data included negative PCR test on 03Dec2020. It was unknown if an autopsy was performed. The outcome of ''BP 13/8'' was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1065230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: LEVOTHYROX; IMOVANE; PARACETAMOL; CERIS; XENAZINE; MIANSERINE [MIANSERIN HYDROCHLORIDE]; SERESTA; LOXAPAC [LOXAPINE SUCCINATE]; GABAPENTIN; CODEINE; ZYMAD; TRANSIPEG [MACROGOL]; PARACETAMOL CODEINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Huntington''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021203348

Write-up: Cardio-respiratory arrest; Feeling sick; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-TO20210697. A 69-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6788), intramuscular at deltoid left on 18Jan2021 at single dose for COVID-19 immunization. Medical history included Huntington''s disease from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROX, formulation: tablet, strength: 25 ug) oral at one dose form once a day, zopiclone (IMOVANE, formulation: film-coated tablet, strength: 3.75 mg) oral at 3.75 mg once a day, paracetamol oral, trospium chloride (CERIS, formulation: coated tablet, strength: 20 mg) oral at 20 mg once a day, tetrabenazine (XENAZINE, formulation: tablet, strength: 25mg) oral, mianserin hydrochloride (MIANSERINE) oral at 30 mg twice daily, oxazepam (SERESTA, formulation: tablet, strength: 50 mg) oral, loxapine succinate (LOXAPAC, formulation: oral solution) oral, gabapentin (strength: 100 mg) oral, codeine oral, colecalciferol (ZYMAD, formulation: oral solution, strength: 80000 iU) oral 1 ampoule every 2 months, macrogol (TRANSIPEG) oral once a day, codeine phosphate/paracetamol (PARACETAMOL CODEINE). The patient experienced cardio-respiratory arrest and feeling sick on 24Jan2021. The events were serious (fatal). The patient died on 24Jan2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1065232 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood pressure measurement, Cyanosis, Heart rate, Oxygen saturation, Somnolence, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (speaks but does not understand); Dyslipidemia; Girdle band sensation; Hypertension; Osteoarthritis; Venous thrombosis
Allergies:
Diagnostic Lab Data: Test Name: Arterial pressure; Result Unstructured Data: Test Result:10/6; Test Name: Pulse; Result Unstructured Data: Test Result:75 / min; Test Name: saturation; Test Result: 69 %; Test Name: polypnea; Result Unstructured Data: Test Result:30 / min
CDC Split Type: FRPFIZER INC2021199935

Write-up: drowsiness; Acute respiratory decompensation; polypnea and cyanosis; polypnea and cyanosis; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-TS20210291. An 89-year-old female patient received BNT162B2 (COMIRNATY, lot number: 9788) on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included advanced dementia (speaks but does not understand); GIR 2, hypertension, dyslipidemia, osteoarthritis and venous thrombosis. Eat little but no undernutrition BMI at 23.5. No history of COVID. Concomitant medications were not reported. No chronic treatment because refuses to take medication. On 11Feb2021, patient had polypnea and cyanosis; patient had drowsiness on unspecified date. No fever. Doctor''s visit: polypnea at 30 / min. Arterial pressure 10/6; Pulse at 75 / min; 69% saturation. Crackling bases. Put under O2, evacuation of a fecaloma. Scheduled blood test. But can''t stand his oxygen. Death during the night of 12Feb2021 to 13Feb2021. In total, death related to respiratory decompensation (etiology?) In an elderly patient with dementia at D4 of Comirnaty. Autopsy was not done. No follow-up attempts are required. No further information is expected.; Reported Cause(s) of Death: Acute respiratory decompensation


VAERS ID: 1065234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-05
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR Test; Test Result: Negative ; Test Name: COVID-19 PCR Test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021203201

Write-up: Unknown cause of death; This is a spontaneous report from a contactable consumer (patient''s son). An 80-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient did not have comorbidity signs, was in good health, was autonomous in her house with her husband. Concomitant medications were not reported. 3 days after vaccination the patient has been hospitalized, then transferred in resuscitation unit in another hospital where she died on 05Feb2021, 1 week after vaccination. The patient was tested twice negative to COVID-19 during her short hospitalization. The cause of death was unknown. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1065266 (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: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Ageusia, Eye pain, Headache, Illness, Muscle twitching, Neck pain, Pain in extremity, SARS-CoV-2 test, Somnolence, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GALCODINE
Current Illness:
Preexisting Conditions: Comments: Fit and healthy no other medical history Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021199061

Write-up: Sickness; faint; TWITCHING FINGERS; loss of taste; sore eyes; blurry vision; sore arm; headache; stomach ache; neck pain; sleepy; 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-202102220051147360, Safety Report Unique Identifier GB-MHRA-ADR 24811628. A female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 01Feb2021 at single dose for COVID-19 immunization. Concomitant medication included codeine phosphate (GALCODINE) on 01Feb2021. Relevant medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient last menstrual period date was 08Feb2021. Patient has not tested positive for COVID-19 since having the vaccine. On unknown date the patient experienced twitching fingers, loss of taste, sore eyes, blurry vision, sore arm, headache, stomachache, neck pain, sleepy, sickness and faint. The outcome of the events was not reported. The patient died of sickness on unknown date. An autopsy was not performed. Lab data included a COVID-19 virus test with a negative result on 08Feb2021. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: SICKNESS


VAERS ID: 1065267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Memory loss; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive
CDC Split Type: GBPFIZER INC2021205310

Write-up: positive COVID-19 test; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202102221318192820, Safety Report Unique Identifier GB-MHRA-ADR 24814558. An 84-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 19Jan2021 for covid-19 immunisation . Medical history included amnesia, dementia Alzheimer''s type. Concomitant medications were not reported. The patient experienced positive Covid-19 test on 25Jan2021. The patient died on 05Feb2021. It was not reported if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The reporter stated that: "My father was ok leading up to the vaccine he was quiet and tired due to boredom of being locked away in a care home unable to see relatives frequently or go outside and live a normal life". No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1065270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2021-01-20
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage intracranial, Immune thrombocytopenia, Pneumonia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
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: ALFACALCIDOL; APIXABAN; ATORVASTATIN; DIGOXIN; FUROSEMIDE; HUMULIN I; LETROZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic regurgitation; Aortic stenosis; Atrial fibrillation; Breast neoplasm malignant female; Chronic kidney disease stage 3; Chronic kidney disease stage 4; Degenerative disc disease; Frailty; Hip fracture; Hyperparathyroidism secondary; Hypertension; Malignant neoplasm of colon; Osteoarthritis; Pulmonary hypertension primary; Pulmonary oedema; Right ventricular failure; Spinal stenosis; Type 2 diabetes mellitus; Comments: HTN (1984), T2DM (1991), AF (2002), Osteoarthritis (2003), CKD3 (2007) / CKD4 (2015), Aortic stenosis (2007), secondary hyperparathyroidism (2011), primary pulmonary HTN & aortic regurgitation (2011), pulmonary oedema NOS (2016), spinal stenosis (2016), degenerative disc disease NOS (2016), fragility # (2016), Frailty (2017), right ventricular failure (2018), malignant neoplasm of breast (2018) 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 INC2021205264

Write-up: intracranial bleeds; Immune thrombocytopenia; contracted pneumonia and died (not Covid pneumonia); This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102221551218980, Safety Report Unique Identifier GB-MHRA-ADR 24815549. A 88-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunisation . Medical history included colon cancer from 2018 , right ventricular failure from 2018 , intervertebral disc degeneration from 2016, aortic valve incompetence from 2011 , hyperparathyroidism secondary from 2011, pulmonary oedema from 2016 , spinal stenosis from 2016 , aortic stenosis from 2007 , osteoarthritis from 2003 , hip fracture, asthenia from 2017, hypertension from 1984, type two diabetes mellitus from 1991, atrial fibrillation from 2002, Chronic kidney disease stage 3 from 2007, Chronic kidney disease stage 4 from 2015, Malignant neoplasm of breast from 2018 and primary pulmonary hypertension from 2011 . Concomitant medication included alfacalcidol (ALFACALCIDOL), apixaban (APIXABAN), atorvastatin (ATORVASTATIN), digoxin (DIGOXIN), furosemide (FUROSEMIDE) , insulin human injection, isophane (HUMULIN I), influenza vaccine (INFLUENZA VIRUS), letrozole (LETROZOLE). The patient contracted pneumonia and died (not covid pneumonia) on an unspecified date , intracranial bleeds on an unspecified date with outcome of unknown , immune thrombocytopenia on 20Jan2021 with outcome of not recovered. Intracranial bleeds and immune thrombocytopenia were considered Life Threatening event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative covid-19 test. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial; Reported Cause(s) of Death: contracted pneumonia and died (not Covid pneumonia)


VAERS ID: 1065274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2021-01-11
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALFUZOSIN; OMEPRAZOLE; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colon cancer; Interstitial lung disease; Whipple''s disease; Comments: Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021210283

Write-up: patient was admitted to the hospital; drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-ADR 24820376, Safety Report Unique Identifier GB-MHRA-WEBCOVID-202102231206328040. An 85 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 16Dec2020 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Interstitial lung disease, colon cancer on Mar2008, Whipple''s disease. Concomitant medications included alfuzosin, omeprazole and propranolol. On an unspecified date patient had acute diarrhea and was admitted to the hospital. On 11 Jan2021 SARS-CoV-2 infection occurred. Vaccine breakthrough infection (as reported). SARS-CoV-2 test was positive on an unspecified date. On 21Jan2021 the patient died due to Covid 19. Outcome of reported acute diarrhea at time of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1065318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Hepatitis C, Hepatitis C virus test, Jaundice, Pyrexia
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Liver infections (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXYCODON; METFORMIN; NORTRIPTYLINE
Current Illness: Hepatitis C; Liver cirrhosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 38 Centigrade; Comments: Fever: 37.5 to 38 degrees Celsius; Test Date: 20210126; Test Name: bloed test hepatitis c; Test Result: Positive
CDC Split Type: NLPFIZER INC2021198419

Write-up: Hepatitis C recurrent; Fatigue; Chills; body temperature on 24Jan2021: Fever: 37.5 to 38 degrees Celsius; Body temperature increased; Icterus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00436935. A 82 years old female patient received BNT162B2 (COMIRNATY, lot number EJ6795), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The medical history included hepatitis c, liver cirrhosis both from 2007 and ongoing. The concomitant medications were oxycodone hydrochloride(OXYCODON), metformin and nortriptyline. The patient experienced icterus on 23Jan2021, fatigue on 24Jan2021, chills on 24Jan2021, body temperature increased on 23Jan2021, hepatitis c recurrent on 26Jan2021. The patient underwent lab tests and procedures, which included body temperature on 24Jan2021: Fever: 37.5 to 38 degrees Celsius, blood test hepatitis c on 26Jan2021: positive. The outcome of the events Fatigue and Chills was recovered on 25Jan2021, the event Body temperature increased was recovering, the events hepatitis c recurrent and Icterus was fatal. The patient died on 16Feb2021. It''s unknown if an autopsy was performed. The cause of death was Hepatitis C recurrent and Icterus. Reporter comment Pfizer vaccine (Comirnaty) Past drug therapy Pfizer vaccine (Comirnaty): no jaundice; mw had hepatitis C in the past, pcr: hepatitis C again [blood test: 26Jan2021] Additional information ADR: today less icteric all this reported to RIVM COVID19 Previous COVID-19 infection: No Other diagnostic procedures: PCR on HCV, HBV, lab on icterus, liver function Follow-up information (from notification NL-LRB-00445487), processed as follow-up to this notification: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no previously reported: icterus, however Mrs. has deteriorated and died on 16Feb2021 Additional information ADR: likely to reactivate HCV confounding factors confounding factors: cirrhosis since first hepatitis C in 2007 COVID19 P. revious COVID-19 infection: No Other diagnostic procedures: viral load; Reporter''s Comments: Additional information ADR: today less icteric all this reported to RIVM COVID19 Previous COVID-19 infection: No Other diagnostic procedures: PCR on HCV, HBV, lab on icterus, liver function Follow-up information (from notification NL-LRB-00445487), processed as follow-up to this notification: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no previously reported: icterus, however Mrs. has deteriorated and died on 16Feb2021; Sender''s Comments: Linked Report(s) : NL-LRB-00445487 ;NL-LRB-00436935; Reported Cause(s) of Death: Hepatitis C recurrent; Icterus


VAERS ID: 1065321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 - / -

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

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: SPIRONOLACTON; PERINDOPRIL ERBUMINE; FUROSEMIDE; METOPROLOL SUCCINATE
Current Illness: Cardiac failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021199195

Write-up: Unexpected deaths are very likely to be acute cardiac death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00443588. Sender''s (Case) Safety Report Unique Identifier NL-LRB-00446543. An 84-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6136), via an unspecified route of administration on 09Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included ongoing cardiac failure. No Previous COVID-19 infection. Concomitant medication included spironolactone (SPIRONOLACTON), perindopril erbumine (PERINDOPRIL ERBUMINE), furosemide (FUROSEMIDE), metoprolol succinate (METOPROLOL SUCCINATE). The patient experienced unexpected death, most likely cardiac death on 12Feb2021 following administration of covid-19 vaccin pfizer injection fluid for covid 19 immunisation. The patient did not experience any adverse events following vaccination. The patient was known with cardiac failure, but this was well regulated. It concerned a vital patient conform his age. No symptoms of illnes or decompensation were seen before the patient deceased 3 days after vacciantion. It was reported: 1) Most likely acute cardiac death 2) No normal side effects: such as flu-like symptoms 3) No symptoms of illnes or decompensation were seen before the patient deceased 4) vital patient conform his age, known with cardiac failure 5) Yes Heart failure7) no. The patient died on 12Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute cardiac death


VAERS ID: 1065322 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Pneumonia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (covid 19 in Oct2020, disease symptoms: quite,)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius; Test Name: corona, bevestigd met test; Test Result: Negative ; Comments: Due to the complaints, the patient was tested for covid-19. The outcome was negative.; Test Date: 20201003; Test Name: corona, bevestigd met test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021199205

Write-up: Fever: 38 to 40.5 degrees Celsius; Not feeling well; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [NL-LRB-00445728]. A 96-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot/batch number unknown), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 from 03Oct2020 to an unknown date (covid 19 in Oct2020), disease symptoms: quite, ongoing pneumonia, ongoing heart failure. The patient''s concomitant medications included non specified antibiotica. No past drug therapy BioNTech/Pfizer vaccin (Comirnaty) received. The reporter described that the patient used a non specified antibiotic for the treatment of a pneumonia. The patient experienced 3 hours after vaccination (on 29Jan2021) start fever: 38 to 40.5 degrees Celsius and not feeling well. Due to the complaints, the patient was tested for covid-19. The outcome was negative. Corona test: it was negative. The patient underwent lab tests and procedures which included corona, bevestigd met test positive on 03Oct2020. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Fever: 38 to 40.5 degrees Celsius; Not feeling well


VAERS ID: 1065323 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: ATENOLOL; METFORMIN; LOSARTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021199198

Write-up: died; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00445785, received from Regulatory Authority. A 90-year-old male patient received the first dose of bnt162b2 (COMIRNATY, strength: 0.3 ml), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included atenolol (strength: 50 mg), metformin (strength: 500 mg) and losartan (strength: 50 mg). The patient died within 12 days after vaccination on 15Feb2021. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty): Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): nopatient died within 2 weeks Additional information ADR: found dead at home, by FAR considered, natural death; Citizen service number available: yes COVID19; Previous COVID-19 infection: No Other diagnostic procedures: no.Batch/lot number: UNKNOWN No follow up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty): Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): nopatient died within 2 weeks Additional information ADR: found dead at home, by FAR considered, natural death; Citizen service number available: yes COVID19; Previous COVID-19 infection: No Other diagnostic procedures: no; Reported Cause(s) of Death: died


VAERS ID: 1065324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: FOLIUMZUUR; CALCI CHEW D3; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021199232

Write-up: Chills; Nausea; Malaise; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB, Regulatory authority report number is NL-LRB-00446597. A 93-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Feb2021 at singe dose for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included folic acid (FOLIUMZUUR), calcium carbonate, colecalciferol (CALCI CHEW D3), acetylsalicylic acid. The patient experienced chills, nausea, malaise on 13Feb2021. The patient died due to these events on an unspecified date. It was unknown if an autopsy was performed. Therapeutic measures were taken as a result of chills included Paracetamol 1000mg supp. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: nausea; cold shivers; Malaise


VAERS ID: 1065325 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Haemorrhage, Head injury, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: EKG/Rhythm analyzes; Result Unstructured Data: Test Result:Asystole
CDC Split Type: NOPFIZER INC2021198349

Write-up: SUDDEN DEATH; bleeding head injury; bleeding head injury; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, NO-NOMAADVRE-FHI-2021-Uy1ew, Sender''s (Case) Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00015697. An 84-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6789), via an unspecified route of administration on 10Feb2021 17:04 at single dose in left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden death on 12Feb2021. It was reported that two days after vaccination, he was found unconscious and with abnormal/no respiration on the floor in the garage, and he had a bleeding head injury. Rhythm analyzes showed asystole. He had not shown signs of reaction from the vaccine in the time between vaccination and sudden death. No history of cardiovascular disease. Reporter indicates no clinical suspicion of a direct relationship between the vaccine and the fatal outcome. The side effect is reported with respect to the relatively short interval between the vaccine and the death. The patient underwent lab tests and procedures which included electrocardiogram (EKG)/ rhythm analyzes: asystole on 12Feb2021. The patient died on 12Feb2021. An autopsy was not performed. The outcome of the events bleeding head injury was unknown. Sender''s Comments: Background: A man in his 80s was vaccinated with the first dose of the covid-19 vaccine Comirnaty. Two days after vaccination, he was found unconscious and with abnormal / no respiration on the floor in the garage. At the end of his legs lay an overturned stool and he had a bleeding head injury on the left side along the parietal bone. No one had had contact with the deceased in the last 1.5 hours before he was found. All rhythm analyzes during the advanced cardiopulmonary resuscitation showed asystole, and the ambulance personnel were never able to secure free airways. According to the family, he had not shown signs of reaction from the vaccine in the period between the time of vaccination and death, but they can not answer whether the patient himself experienced symptoms. The deceased has no history of cardiovascular disease. Reporter indicates No clinical suspicion of a direct relationship between the vaccine and the outcome. The side effect is reported with respect to the relatively short interval between the vaccination and the death. A forensic autopsy was requested for the deceased, but this was rejected by the Police. Comment: The reporter has stated that there is no clinical suspicion of a connection with vaccination, and therefore a causal connection with vaccination is set as unlikely / but not impossible. At the same time, it can be said that there is a temporal connection between vaccination and the event, and on the basis of this we also add our assessment of causation as possible. According to international criteria, a possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1065348 (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: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (earlier); Bipolar disorder; Drug abuse (earlier); Pain in hip; Prosthesis related infection (discussed amputation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021199292

Write-up: Unexpected death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority number SE-MPA-2021-004684, other case identifier number SE-MPA-1613405866368). A 57-year-old male received the second dose of BNT162B2 (COMIRNATY; lot EJ6134) intramuscular, on an unspecified date in Jan2021, at 0.3 ml single, for COVID-19 immunisation. Medical history included pain in his right hip, flail joint right hip prosthesis related infection (discussed amputation), bipolar disorder, earlier alcohol and drug abuse. Concomitant medications were not reported. The patient received the first dose of Comirnaty on an unspecified date in Jan2021 (lot EJ6796, intramuscular, at 0.3 ml single) and developed dyspnoea, diarrhoea and fever (not known how long time after vaccination this happened). Three weeks later the second dose was received. The patient died 2,5 weeks later, on an unspecified date in Feb2021. A forensic autopsy was planned according to the reporter, anyway it was unknown if it was done or not. Reported suspect vaccine was Comirnaty. Reported suspect adverse reaction was unexpected death. The Swedish MPA will request more information. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021202436 same patient, first dose, different events.; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1065349 (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: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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; Chronic obstructive pulmonary disease; Diarrhea; Hypertension; Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021208059

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB (Regulatory authority number SE-MPA-2021-004999). An 89-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration in Feb2021, at single dose for COVID-19 immunisation. Medical history included cardiac failure, chronic obstructive pulmonary disease and hypertension, all unknown if ongoing, vomiting and diarrhea 2-4 days before vaccination. Concomitant medications were not provided. The patient was found dead the day after vaccination in Feb2021, it is unclear if it is dose 1 or dose 2. The cause of death was unknown. She had vomiting and diarrhea 2-4 days before vaccination. Clinical autopsy to be performed. The Medical Products Agency will sought for an autopsy protocol. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Found dead


VAERS ID: 1065561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Dysstasia, Fall, Fibrin D dimer, Fibrin D dimer increased, Liver function test abnormal, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Troponin, Troponin increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 6
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: NOBITEN [NEBIVOLOL]; LASIX [FUROSEMIDE]; LOORTAN; DONEPEZIL; PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Illness; Parkinson''s disease; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: CT; Result Unstructured Data: Test Result:Covid image; Test Date: 20210118; Test Name: D dimers; Result Unstructured Data: Test Result:High; Test Date: 20210118; Test Name: Liver function test abnormal; Result Unstructured Data: Test Result:Abnormal; Test Date: 20210118; Test Name: O2 saturation; Test Result: 46 %; Test Date: 20210118; Test Name: Covid-19 PCR; Result Unstructured Data: Test Result:Negative; Test Date: 20210118; Test Name: Troponin; Result Unstructured Data: Test Result:73
CDC Split Type: BEPFIZER INC2021173728

Write-up: severe dyspnoea with O2 saturation 46%; severe dyspnoea with O2 saturation 46%; Disturbed liver test; Increased troponins 73; very high D dimers; Fall; can still hardly stand on legs; This is a spontaneous report downloaded from the Medicines Agency (MA) regulatory authority-WEB, BE-FAMHP-DHH-N2021-76312. A contactable physician reported that an 84 years old male patient received the first dose of BNT162B2 (COMIRNATY) at single dose, on 18Jan2021, for COVID-19 immunisation. Relevant medical history included Parkinson''s disease, vascular dementia and illness (degenerative suffering, unspecified), all from an unspecified date. Concomitant medications included nebivolol (NOBITEN), furosemide (LASIX), losartan potassium (LOORTAN), donepezil, pantoprazole sodium sesquihydrate (PANTOMED) and lercanidipine, all from an unspecified date, at an unknown dose, for an unspecified indication. On 18Jan2021, the patient experienced severe dyspnoea with O2 saturation low, 46%, liver function test abnormal described as "disturbed liver test", increased troponins 73, fibrin D dimer high described as "very high D dimers", difficulty in standing described as "can still hardly stand on legs" and fall. The patient died on 24Jan2021. It was unknown if autopsy was done. Reporter''s comments: treatment received. Evolution of the ADR - Died. Situations - Other: administration in covid pneumonia without many symptoms. Examinations - lab, ct covid image, very high D dimers, increased troponins 73; disturbed liver set, negative PCR test (covid based on lung photo). 21Jan2021: admission to hospital because of increasing respiratory complaints: rapid deterioration already a weakened health condition, a chronic cough upon vaccination. Relatedness of drug to reactions/events for COMIRNATY for all AEs: Method of assessment: WHO Result of Assessment: unlikely No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: treatment received. Evolution of the ADR - Died. Situations - Other: administration in covid pneumonia without many symptoms. Examinations - lab, ct covid image, very high D dimers, increased troponins 73; disturbed liver set, negative PCR test (covid based on lung photo). 21Jan2021: admission to hospital because of increasing respiratory complaints: rapid deterioration already a weakened health condition, a chronic cough upon vaccination.; Reported Cause(s) of Death: Oxygen saturation low; Liver function test abnormal; Troponin increased; Fibrin D dimer high; Fall; Difficulty in standing; Dyspnea


VAERS ID: 1065562 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, General physical health deterioration, 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: 2021-01-30
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: Nasopharyngeal pcr test; Test Result: Positive
CDC Split Type: BEPFIZER INC2021181924

Write-up: Drug ineffective; Nasopharyngeal pcr test on the 21st, which came back positive; Degradation of general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-76426, received from Regulatory Authority. An elderly patient of unspecified gender received BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant mediations were unknown. The patient experienced COVID-19 virus test positive and degradation of general condition. The patient had nasopharyngeal pcr test on the 21st (unspecified date), which came back positive. The patient died on 30Jan2021. It was unknown if autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; Nasopharyngeal pcr test on the 21st, which came back positive; degradation of general condition


VAERS ID: 1065567 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cerebrovascular accident, Communication disorder, Fatigue, Hypersomnia, Illness, SARS-CoV-2 test
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Arthrosis multiple; Diabetic nephropathy; Diabetic polyneuropathy; Diabetic retinopathy (bilateral); Dyslipidemia (on therapy with statin); Glaucoma; Hepatic steatosis; Hypoxic-ischemic encephalopathy; Ischaemic heart disease (dysrhythmic form); Osteoporosis postmenopausal; Penicillin allergy (swelling of the face); Psoriatic arthropathy; Recurrent urinary tract infection; Smoker (3-5 cigarettes / day); Vertebrogenic pain syndrome; Vestibulocerebellar syndrome (instability with repeated falls)
Preexisting Conditions: Medical History/Concurrent Conditions: Abscess (trochanter abscess l.dx. sepses etiologically MRSA); Age-related macular degeneration (practical blindness on right); Appendectomy; Bedridden (Before the vaccination, the patient was a lying patient, but she raised her hands and communicated); Cataract operation (bilaterally); Cholecystolithiasis; Dysfunction thyroid; Endarterectomy (bilaterally); Euthyroid goiter; Hysterectomy; Hysterosalpingo-oophorectomy (for myomatosis); Psoriasis vulgaris; Recurrent stroke (recurrent stroke with mild residual left-sided finding, last stroke 5/2014); Small intestinal resection (for volvulus with peritonitis in 2005 and for volvulus in 2009); Type II diabetes mellitus (now without therapy); Ulcerative colitis (relapse May2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: Covid-19 test; Result Unstructured Data: Test Result:positive antigen
CDC Split Type: CZPFIZER INC2021180953

Write-up: COVID-19/positive antigen Covid-19 test; became ill; Sleep excessive/still asleep/she was sleepy; tired; Communication disorder/stopped communicating by phone; suspected of having another stroke/Suspicion of cerebrovascular accident; This is a spontaneous report received from a contactable consumer, downloaded from the Medicines Agency (MA) regulatory authority CZ-CZSUKL-21001005. A 72-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EL1491) via Intramuscular on 13Jan2021 at single dose for COVID-19 immunisation. Medical history included: ischemic heart disease, dysrhythmic form, recurrent stroke with mild residual left-sided finding, last stroke May2014, endarterectomy bilaterally 1999, ongoing vascular and hypoxic encephalopathy, ongoing arterial hypertension, type 2 diabetes mellitus since 2006, now without therapy, ongoing diabetic nephropathy, ongoing diabetic polyneuropathy, ongoing diabetic retinopathy bilateral and age-related macular degeneration (practical blindness on right), ongoing dyslipidemia on statin therapy, thyroidopathy, goitre, effector, dysfunction thyroid, ulcerative colitis, relapse in May2016, small bowel resection for volvulus with peritonitis in 2005, cholecystolithiasis, ongoing hepatic steatosis, psoriasis vulgaris, ongoing psoriatic arthropathy, ongoing vertebrogenic algic polytopic syndrome, ongoing cerebello-vestibular syndrome, instability with repeated falls, ongoing polyarthrosis, ongoing postmenopausal osteoporosis, recurrent urinary tract infections, intestinal resection for volvulus in 2009, trochanter abscess l.dx. sepses etiologically MRSA, appendectomy, hysterectomy + adnexectomy/ hysterosalpingo-oophorectomy for myomatosis, cataract surgery bilaterally, ongoing glaucoma, allergies to penicillin (swelling of the face), smoker (3-5 cigarettes /day). Family history was insignificant. Before the vaccination, the patient was a lying patient, but she raised her hands and communicated. Concomitant medications were not reported. Previous vaccination included: against tetanus in Jan2017. It was reported the next day she stopped communicating by phone/ communication disorder. The patient was in a nursing home, from where the reporter had information that the patient was sleep excessive/still asleep. She didn''t even say hello to the phone and stopped moving. Before the vaccination, the patient was a lying patient, but she raised her hands and communicated. The reporter was suspected of having another stroke/suspicion of cerebrovascular accident. According to the reporter, Covid-19 disease was also added. The patient died on 24Jan2021. On 15Feb2021, the attending physician was called: added medical history of the patient. 48 hours after vaccination, the patient was monitored and no deterioration was observed. On 17Jan2021 the patient became ill and was very sleepy. An ambulance was called and the patient was hospitalized. On 16Feb2021, charge nurse was called: patient was alright at the time of vaccination. No marks of stroke or infection. She was cooperating, consciousness. On 15Jan2021 she was sleepy and tired. On 17Jan2021 she had positive antigen Covid-19 test. Many patients had similar symptoms and many of them had antigen Covid-19 positive test. Rales, normal saturation, normal physiological function. She was transferred to neurological department after nurse urging. A hospitalisation report was requested. On 24Jan2021 patient died. Outcome of event COVID-19/positive antigen Covid-19 test was fatal, for other events were not recovered. Autopsy was not indicated. And the reported cause of death was COVID-19/positive antigen Covid-19 test.; Reported Cause(s) of Death: COVID-19/positive antigen Covid-19 test


VAERS ID: 1065568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Condition aggravated, Eating disorder, Hyperphagia, Oxygen saturation, Pulmonary embolism, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   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: Thyroid disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: O2 saturation; Test Result: 50 %; Test Date: 20210209; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC2021181088

Write-up: Pulmonary embolism; PCR Covid-19 positive; PCR Covid-19 positive; Vomiting; aggravated food intake; Eating disorder; Condition aggravated; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-CZSUKL-21001137. An 85-year-old female patient received bnt162b2 (COMIRNATY), 1st dose on 11Jan2021 and 2nd dose on 01Feb2021, both via intramuscular at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder and patient was on therapy (psychotropic medicinal products and food supplements) and varicose vein operation. The patient''s concomitant medications were not reported. After 7 days after the 2nd dose, there were some adverse reaction: aggravated condition, vomiting, aggravated food intake, eating disorder, all on 08Feb2021. She was transferred to the hospital, where she was diagnosed with massive pulmonary embolism with saturation 50% on 08Feb2021. PCR Covid-19 was positive on 09Feb2021. PCR Covid-19 positive 09Feb2021. Patient died on 09Feb2021. The cause of death was reported as embolism lung. Autopsy was done. Autopsy results was not available and will be informed about autopsy results. No follow-up attempts possible. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Embolism lung


VAERS ID: 1065573 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Perinatal brain damage (Early childhood brain damage)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT pituitary gland; Result Unstructured Data: Test Result:28; Test Date: 20210113; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021180651

Write-up: Covid-19; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB DE-PEI-PEI2021002654. A 54-year-old male patient received bnt162b2 (COMIRNATY) (lot number unknown), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included early childhood brain damage from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 (covid-19) (death, hospitalization) on 13Jan2021. Patient was vaccination with Comirnaty on 12Jan2021. After 1 day positive PCR test for SARS-CoV2. Symptoms of a Covid-19 infection after 2 days. Stationary admission on 16Jan2021 due to deterioration. With intake of massively increased Blood sugar ($g 900). Patient died on 21Jan2021. Preliminary autopsy findings included massive pneumonia with microabscesses, staph. aureus in the tracheal secretion, PCR positive for SARS-CoV2 in almost all organs, CT pituitary gland 28. Pathologist expresses suspicion of enhanced disease. Sequencing pending, Antibody determination pending. The patient died on 21Jan2021. An autopsy was performed. Comirnaty/ Covid-19/ PEI/ C. Inconsistent causal association. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1065575 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Atrial fibrillation, Cardiac failure congestive
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), 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: Medical History/Concurrent Conditions: Aortic valve stenosis; Hypertension arterial; Osteoporosis; Presbyacusia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021180652

Write-up: Tachyarrhythmia absoluta; Congestive cardiac failure; Acute coronary syndrome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002660 and received via Regulatory Authority. An 89-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included Aortic valve stenosis, Presbyacusia, Hypertension arterial, Osteoporosis. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 (COMIRNATY) on 29Dec2020 for covid-19 immunization had been tolerated. On 26Jan2021 after vaccination the patient developed Tachyarrhythmia absoluta and Congestive cardiac failure, death cause was reported as Acute coronary syndrome. The patient died on 27Jan2021. An autopsy was not performed. The outcome of the events was fatal. Relatedness of drug to events reported D. Unclassifiable by PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute coronary syndrome; Tachyarrhythmia absoluta; Congestive cardiac failure


VAERS ID: 1065576 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Death, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal hernia; Chronic renal failure; Degenerative arthritis spine; Epilepsy; Hypertension arterial; Macrocytic hyperchromic anaemia; Spinal meningioma
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021180657

Write-up: Decompensated COPD; Pleuropneumonia; Kidney failure; Exitus letalis(death); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority- WEB DCGMA number DE-PEI-PEI2021002661. A 91-year-old female patient received bnt162b2 (COMIRNATY, lot/batch no.: EM0477), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included chronic renal failure, macrocytic hyperchromic anaemia, spinal meningioma, hypertension arterial, epilepsy, degenerative arthritis spine, abdominal hernia, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. 8 days after vaccination on 27Jan2021 the patient developed end stage chronic obstructive pulmonary disease (COPD)/ decompensated COPD, pleuropneumonia, renal/kidney failure and death, lasting for unknown. The patient died on 27Jan2021. Outcome of the events was fatal. It was not reported if an autopsy was performed. Causality assessment provided by PEI was inconsistent causal association. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensated COPD; Pleuropneumonia; Kidney failure; Exitus letalis (death).


VAERS ID: 1065577 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory 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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Deep vein thrombosis leg; Dementia Alzheimer''s type; Gait instability; Hypertension arterial; Osteoporosis; Pulmonary haemorrhage (Lobar bleeding as a result of anticoagulation therapy); Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021180654

Write-up: Cardiovascular arrest; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority DE-PEI-PEI2021002665. An 86-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number: EK9788), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary haemorrhage (Lobar bleeding as a result of anticoagulation therapy), Hypertension arterial, osteoporosis from an unknown date and unknown if ongoing, Deep vein thrombosis leg from an unknown date and unknown if ongoing, Renal insufficiency from an unknown date and unknown if ongoing, Dementia Alzheimer''s type from an unknown date and unknown if ongoing, Gait instability from an unknown date and unknown if ongoing , Atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardiovascular arrest (death, medically significant) on 03Feb2021. On 03Feb2021 after vaccination the patient developed Cardio-respiratory arrest and Death, lasting for unknown. The patient is dead. Death cause was reported as Cardio-respiratory arrest. The patient died on 03Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Comirnaty/ all events/ PEI/ D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1065592 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood pressure measurement, Cardiogenic shock, Hypotension, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: Bullous pemphigoid; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: BP; Result Unstructured Data: Test Result:90/70; Comments: hypotension; Test Date: 20210201; Test Name: COVID-19 PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021180591

Write-up: Cardiogenic shock; extensive anterior and inferior acute ST + coronary syndrome; hypotension at 90/70; This is a spontaneous report from a contactable lawyer downloaded from the regulatory authority FR-AFSSAPS-BR20210214. A 97-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EK9788), intramuscular on 05Feb2021 at single dose (1 dose form) in left arm for COVID-19 immunisation/Administration of an antipyretic. Medical history included Hypertension arterial from an unknown date and unknown if ongoing, Bullous pemphigoid from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 05Feb2021, the second IM injection in the left arm of the COMIRNATY vaccine. On 06Feb2021, the patient experienced appearance of hypotension at 90/70, very unusual in this patient. On 08Feb2021, onset of extensive anterior and inferior acute ST + coronary syndrome, followed by cardiogenic shock resulting in death. The events resulted in hospitalization and death. The patient died on 08Feb2021. It was unknown if an autopsy was performed. Lab data on 01Feb2021 included negative COVID-19 PCR test. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: hypotension at 90/70; extensive anterior and inferior acute ST + coronary syndrome; Cardiogenic shock


VAERS ID: 1065595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood lactic acid, Blood pressure measurement, Blood sodium, Body temperature, Heart rate, Oxygen saturation, PCO2, PO2, Respiratory failure, Respiratory rate, SARS-CoV-2 test, Troponin, pH body fluid
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   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: DILTIAZEM HYDROCHLORIDE; ENTRESTO; LASILIX [FUROSEMIDE]; SERETIDE; XATRAL
Current Illness: Bronchitis; Dyspnea
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Chronic alcoholism; Chronic obstructive airways disease; Neuropathy; Renal insufficiency; Tabaquism; Ulcer gastric
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: HCO3; Result Unstructured Data: Test Result:24 mmHg; Test Date: 20210204; Test Name: creatinine; Result Unstructured Data: Test Result:292; Test Date: 20210204; Test Name: lactates; Result Unstructured Data: Test Result:0.29; Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:117/60 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210204; Test Name: sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210204; Test Name: temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210204; Test Name: Heart rate; Result Unstructured Data: Test Result:99 bpm; Test Date: 20210204; Test Name: Oxygen saturation; Test Result: 99 %; Comments: under 6L of oxygen; Test Date: 20210204; Test Name: PCO2; Result Unstructured Data: Test Result:44 mmHg; Test Date: 20210204; Test Name: Blood gas, pH; Result Unstructured Data: Test Result:7.34; Test Date: 20210204; Test Name: PO2; Result Unstructured Data: Test Result:49 mmHg; Test Date: 20210204; Test Name: respiratory rate; Result Unstructured Data: Test Result:37 rpm; Test Date: 20210204; Test Name: Antigen COVID; Test Result: Negative ; Test Date: 20210204; Test Name: PCR COVID; Test Result: Negative ; Test Date: 20210204; Test Name: troponin; Test Result: Negative
CDC Split Type: FRPFIZER INC2021169039

Write-up: Respiratory failure aggravated; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) regulatory authority-WEB FR-AFSSAPS-BX20210713. This is a report received from the Regulatory Authority. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6795) , intramuscular on 02Feb2021 at single dose on left arm for COVID-19 vaccination. Medical history included renal insufficiency, chronic alcoholism, neuropathy, cardiac failure, atrial fibrillation, tabaquism, chronic obstructive airways disease, ulcer gastric, all of which were from an unknown date and unknown if ongoing, ongoing bronchitis, and ongoing dyspnea. Concomitant medication included diltiazem hydrochloride, sacubitril valsartan sodium hydrate (ENTRESTO), furosemide (LASILIX), fluticasone propionate, salmeterol xinafoate (SERETIDE), alfuzosin hydrochloride (XATRAL). The patient experienced respiratory failure aggravated on 04Feb2021. It was reported that patient experienced respiratory failure with desaturation in a patient with a long history including chronic obstructive pulmonary disease and unweaned smoking at 100 blood pressure with death 3 days after the 1st dose of COMIRNATY. Hospital care from 04Feb2021 for respiratory failure with destruction. On admission, dyspnea for 4 days (therefore having started 2 days before vaccination), progressive worsening, notion of ongoing bronchitis without further details. Polypnea with pulling and swaying, major expiratory brake, bilateral wheezing, no crackles, no peripheral edema, painless abdomen. Diagnostic hypotheses: COVID or decompensation of chronic obstructive pulmonary disease. Evolution: aerosols and non-invasive ventilation, patient against resuscitation measures, privileged treatment limitation. Precarious response to the measures implemented with deterioration of the state of consciousness, sedation by morphine with death the next day at 9:30 p.m. The patient underwent lab tests and procedures 04Feb2021 which included HCO3: 24 mmhg, creatinine: 292, lactates: 0.29, blood pressure: 117/60 mmhg on 04Feb2021, 100 mmhg on an unspecified date, sodium: 134 mmol/l, temperature: 37.1 centigrade, heart rate: 99 bpm, oxygen saturation: 99 % under 6L of oxygen, pco2: 44 mmhg, Blood gas, pH: 7.34, po2: 49 mmhg, respiratory rate: 37 rpm, Antigen COVID: negative, PCR COVID: negative, troponin: negative. The patient died on 05Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Failure respiratory


VAERS ID: 1065597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Agitation, Confusional state, Discomfort, Dysphagia, General physical health deterioration, Inflammation, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), 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 (broad), Hostility/aggression (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Sigmoid polyp; Thompson hip prosthesis
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: COVID test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021181393

Write-up: discomfort; control of painful symptoms; swallowing disorders; biological inflammatory syndrome; confusional state; Acute renal failure; Reduced general condition; Agitation/restlessness; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-GR20210278. This is a report received from the Regulatory Authority. A 95-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot. EJ6795.), intramuscular left arm on 12Jan2021 at 30 ug, single for covid-19 immunisation. Medical history included Thompson hip prosthesis, Alzheimer''s disease, Sigmoid polyp in 1986. COVID test on 11Jan2021 negative. The patient''s concomitant medications were not reported. The patient experienced agitation, reduced general condition, acute renal failure on 15Jan2021. Clinical course reported as: From 15Jan2021: deterioration in general condition, restlessness and renal failure. Differential diagnosis Renal failure, Alzheimer''s disease. Evolution 20Jan2021, medical consultation: Patient with severe neurocognitive disorders; confusional state, discovery of a biological inflammatory syndrome and major acute renal failure in a context of dehydration. Correction of dehydration by hydration but progressive deterioration in general condition with swallowing disorders and state of agitation. On 29Jan21, decision to stay in care home with establishment of probabilistic antibiotic therapy with Rocephin and hydration. Faced with the state of agitation and discomfort, implementation of a Patient-controlled analgesia (PCA) of midazolam and control of painful symptoms by morphine with the project of end-of-life support. 02Feb2021, death. The patient died on 01Feb2021. An autopsy was not performed. Cause of death reported as Reduced general condition. Events agitation, reduced general condition, acute renal failure were reported as serious fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute renal failure; Agitation; Reduced general condition


VAERS ID: 1065598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Chest pain
SMQs:, Cardiac failure (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; PANTOPRAZOLE; GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM TRISILICATE;SODIUM ALGINATE;SODIUM B; SPASFON [PHLOROGLUCINOL]; PARACETAMOL; SPIRONOLACTONE; EUPHYTOSE [BALLOTA NIGRA EXTRACT;COLA NITIDA POWDER;CRAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Chest pain; COPD; Decompensation cardiac (hospitalizations on 15Dec2020); Heart block atrioventricular (Stage 3); Kidney absent (Single left kidney); Obesity; Stricture of artery (Aortic); Thresher''s lung
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021181391

Write-up: Decompensation cardiac; Chest pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-GR20210282 and received via regulatory authority. An 81-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscular left arm on 14Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included obesity, chronic obstructive pulmonary disease (COPD), Thresher''s lung, Heart block atrioventricular Stage 3, Kidney absent (Single left kidney), AFib, Aortic Stricture of artery, chest pain and cardiac decompensation. Concomitant medication included mirtazapine, pantoprazole, alginic acid, aluminium hydroxide gel, dried, magnesium trisilicate, sodium alginate, sodium bicarbonate (GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM TRISILICATE;SODIUM ALGINATE;SODIUM BICARBONATE]), phloroglucinol (SPASFON [PHLOROGLUCINOL]), paracetamol, spironolactone, ballota nigra extract, cola nitida powder, crataegus spp. extract, passiflora incarnata extract, paullinia cupana powder, valeriana officinalis extract (EUPHYTOSE [BALLOTA NIGRA EXTRACT;COLA NITIDA POWDER;CRATAEGUS SPP. EXTRACT;PASSIFLORA INCARNATA EXTRACT;PAULLINIA CUPANA POWDER;VALERIANA OFFICINALIS EXTRACT]), atorvastatin, allopurinol, silodosin, colecalciferol (UVEDOSE), fluticasone propionate; salmeterol, furosemide, potassium chloride (DIFFU K). The patient experienced decompensation cardiac and chest pain on 26Jan2021. Clinical course reported as: Patient presented with chest pain in the weeks preceding the vaccination leading to several hospitalizations (the last on 15Dec2020 for cardiac decompensation). Vaccination on 14Jan2021. On 26Jan2021, patient hospitalized again for a new episode of chest pain with cardiac decompensation. Differential diagnosis Poorly tolerated aortic stenosis, ACFA. Evolution Death on 26Jan2021. An autopsy was not performed. Cause of death reported as decompensation cardiac. Events decompensation cardiac and chest pain were reported as serious fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: chest pain; Decompensation cardiac


VAERS ID: 1065600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardiac failure, Myocardial infarction, Oxygen saturation, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 1
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: ALLOPURINOL; APIXABAN; BISOPROL; DIAMICRON; LANZOPRAZOL; LASILIX [FUROSEMIDE]; MIANSERINE [MIANSERIN]; RAMIPRIL; TAHOR; VILDAGLIPTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pulmonary oedema (left heart failure due to flutter and bronchitis); Bronchitis; Heart failure (left heart failure due to flutter and bronchitis); Heart fluttering; Hemiplegia; Hypercholesterolemia; Hypertension arterial; NIDDM; Stroke (with hemiplegia)
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:88-91 %; Test Name: PCR Covid; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021180629

Write-up: Acute oedema of lung, unspecified; Probable new outbreak of heart failure; myocardial infarction; This is a spontaneous report from a contactable Consumer downloaded from the regulatory authority FR-AFSSAPS-LM20210181. This is a report received from the Regulatory Authority. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 vaccination. Medical history included Stroke with hemiplegia in 2018, noninsulin-dependent diabetes mellitus (NIDDM), Hypertension arterial and Hypercholesterolemia, acute lung edema in Jan2020 (left heart failure due to flutter and bronchitis) and Aspirin allergy. No history of COVID infection. Concomitant medications included Apixaban 5mg, furosemide (LASILIX) 500, Ramipril 5, bisoprolol fumarate (BISOPROL) 2.5, gliclazide (DIAMICRON) 60, Vildagliptin 50, atorvastatin calcium (TAHOR) 40, Mianserine 30, Allopurinol 100, Lanzoprazole 15. The patient had Flu vaccine on 21Oct2020 and pneumococcal vaccine on 24Dec2020. The patient experienced acute oedema of lung, unspecified on 06Feb2021. Patient died on 07Feb2021 at 12h00. The description of the adverse reaction: Hospitalized in the emergency room on 06Feb2021 because of dyspnea with 88-91 percent desaturation, put under 6 L of O2, Crackling until mid-field with edema of the lower limbs. Probable new outbreak of heart failure, diuretic treatment initiated Evolution towards respiratory acidosis with hypercapnia, then onset of a coma (Y1, V1, M5), excessive sweating, persistence of crackles at the bases and edema of the lower limbs +++ over the entire height of the myocardial infarction, taking the cup, discrete myocardial infarction mottling, Generalized tonic clonic seizure followed by respiratory pause followed by extreme bradycardia. Patient died on 07Feb2021 at 12h00. An autopsy was not performed. The patient underwent lab tests and procedures which included Test polymerase chain reaction (PCR) Covid negative on an unknown date. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The patient medical history of stroke with hemiplegia, noninsulin-dependent diabetes mellitus, hypertension arterial, hypercholesterolemia and acute lung edema might have played a predisposing role in the clinical course leading to the reported events. 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: Probable new outbreak of heart failure; myocardial infarction; Acute oedema of lung, unspecified


VAERS ID: 1065858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / UNK - / -

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

Life Threatening? Yes
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: AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; DOXYCYCLINE; METFORMIN; PREDNISOLONE; RAMIPRIL; SALBUTAMOL; SILDENAFIL; UMECLIDINIUM; VILANTEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Amputation; Aortic aneurysm repair; Chronic obstructive lung disease; Cotton wool spots; Drug allergy (Aspirin allergy); Erectile dysfunction; Hypertension; IgA nephropathy (previous amputation below right knee in 1980); Paraproteinaemia; Perianal abscess; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021183176

Write-up: Sudden death; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102181011115160, Safety Report Unique Identifier GB-MHRA-ADR 24784906. Narrative via Generate Function: A 66-year-old male patient received bnt162b2 (lot number: EN3924), via an unspecified route of administration on 04Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included cotton wool spots, amputation, stroke, paraproteinaemia, aortic aneurysm repair, type 2 diabetes mellitus, chronic obstructive lung disease, hypertension, thromboangitis obliterans (berger''s disease) previous amputation below right knee in 1980, aspirin allergy, previous perianal abscess, erectile dysfunction, and alcohol excess all from an unspecified date. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial. Concomitant medication included amlodipine, atorvastatin, clopidogrel, doxycycline, metformin, prednisolone, ramipril, salbutamol, sildenafil, umeclidinium, vilanterol. The patient previously took doxycycline, prednisolone, in rescue pack weekend prior to death. The patient experienced sudden death (death, life threatening) on 17Feb2021. Unexplained death - found unresponsive at home. Risk factors for stroke, MI or AAA rupture. Pending post-mortem. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 17Feb2021. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1065866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-27
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021175223

Write-up: unexpected death two weeks after receiving first dose of the comirnaty vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, IE-HPRA-2021-064984. This is a report received from the Ireland''s Health Products Regulatory Authority (HPRA). An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (Lot no: EM0477), via an unspecified route of administration at 0.3 mL, single on 13Jan2021 for covid-19 immunisation. Medical history included cerebrovascular disorder and Parkinsonism. Concomitant medications were not reported. The patient experienced unexpected death two weeks after receiving first dose of the comirnaty vaccine on 27Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. The reporter outlined that the patient had been clinically stable when he received the first dose of Comirnaty. The patient''s outcome was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: unexpected death two weeks after receiving first dose of the comirnaty vaccine


VAERS ID: 1065868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   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: FOLSYRA EVOLAN; ELIQUIS; INCRUSE ELLIPTA; ALLONOL; BETMIGA; FURIX [CEFUROXIME]; BLOXAZOC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:Large parenchyma hemorrhage in the basal ganglia o; Comments: Large parenchyma hemorrhage in the basal ganglia on the left with breakthrough hemorrhage in the cerebral cortex - blood is present in all four cerebral chambers. High volume effect in the form of displacement of midline structures by 13 mm and a narrowed suprasellar cistern. Imminent uncal herniation and incipient hydrocephalus.
CDC Split Type: ISPFIZER INC2021182071

Write-up: Stroke; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency IS-IMA-1745. An 86-years-old male received bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid (FOLSYRA EVOLAN 5 mg), apixaban (ELIQUIS 5 mg), umeclidinium bromide (INCRUSE ELLIPTA 55 mcg for inhalation), allopurinol (ALLONOL 100 mg), mirabegron (BETMIGA 25 mg), cefuroxime (FURIX [CEFUROXIME] 20 mg), metoprolol succinate (BLOXAZOC 50 mg) and FINOL 5mg. The patient experienced stroke and was hospitalized on 24Jan2021. The patient died on 26Jan2021 because of the stroke. The event was serious due to hospitalization and death. The patient underwent lab tests and procedures which included CT scan on 24Jan2021: The conclusion from the scan was: Large parenchyma hemorrhage in the basal ganglia on the left with breakthrough hemorrhage in the cerebral cortex - blood is present in all four cerebral chambers. High volume effect in the form of displacement of midline structures by 13 mm and a narrowed suprasellar cistern. Imminent uncal herniation and incipient hydrocephalus. The event outcome was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1065892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT03 EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Chronic obstructive pulmonary disease, Heart rate, Pneumonia, Respiratory failure, Sepsis
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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal cortex insufficiency (Iatrogenic adrena cortex insufficiency.); Chronic obstructive lung disease (Serious chronic obstructive lung disease, with long-term oxygen therapy (LTOT).); Oxygen therapy (Serious chronic obstructive lung disease, with long-term oxygen therapy (LTOT).); Pneumonia (Repeated pneumonias, fewer the last year.); Respiratory failure type 2 (Tachypnoetic respiratory failure type 2)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/60 mmHg; Test Date: 20210129; Test Name: Body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 20210129; Test Name: C-reactive protein; Result Unstructured Data: Test Result:379 mg/l; Test Date: 20210129; Test Name: Heart rate; Result Unstructured Data: Test Result:140; Comments: beats/min
CDC Split Type: NOPFIZER INC2021181452

Write-up: PNEUMONIA; infectious acerbation of chronic obstructive lung disease leading to chronic respiratory failure; infectious acerbation of chronic obstructive lung disease leading to chronic respiratory failure; sepsis affecting the circulation; This is a spontaneous report from contactable physician downloaded from the regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-U7ynq, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015300. An 83-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot# BNT03 EM0477), intramuscular on 27Jan2021 19:45 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (Serious chronic obstructive lung disease, with long-term oxygen therapy (LTOT)), Iatrogenic adrena cortex insufficiency, Tachypnoetic respiratory failure type 2, pneumonia (Repeated pneumonias, fewer the last year. This last pneumonia was septic and affecting the circulation.). The patient''s concomitant medications were not reported. The patient experienced pneumonia on 29Jan2021. Clinical course reported as: patient was feeling well with no fever when receiving COVID-19 vaccine. Two days later he was admitted to hospital with symptoms of airway infection and exacerbation of chronic obstructive lung disease. The patient was diagnosed with pneumonia with serious sepsis affecting the circulation. The patient died after 8 days and the cause of death was given as infectious acerbation of chronic obstructive lung disease leading to chronic respiratory failure. Reporter was uncertain about any connection to vaccination. The patient underwent lab tests and procedures 29Jan2021which included blood pressure: 118/60 mmhg, body temperature: 39.1 centigrade, C-reactive protein: 379 mg/l, heart rate: 140 beats/min. The patient died on 06Feb2021. It was not reported if an autopsy was performed. Event pneumonia was reported as serious fatal. Sender Comment: An 83-year-old multimorbid man felt in good shape and was afebrile when he received the COVID-19 vaccine (Comirnaty). Two days later, he was hospitalized with symptoms of respiratory infection and worsening of chronic COPD. The patient was diagnosed with pneumonia with severe sepsis and circulatory effects. The patient died eight days after admission, and the cause of death was considered to be an infectious exacerbation of COPD which led to respiratory failure. There is currently little long-term data and there is limited data for the oldest age groups, or in people with underlying diseases on the vaccine in question. It is stated in the report that the patient has an underlying illness / diseases before vaccination. As the incident is described, it is more likely that these diseases are behind the incident. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. It is also conceivable that the incident had a completely different cause that only happened by chance after the vaccination. Causality is considered as possible. In general, the cause of death in elderly and nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (20%), respiratory and infectious diseases (including pneumonia and sepsis) (15%), and cancer (10%). Reporter''s comments: 16Feb2021 RELIS: additional information received. Updated Patient, date of death. This is a final report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: PNEUMONIA; infectious acerbation of chronic obstructive lung disease leading to chronic respiratory failure; infectious acerbation of chronic obstructive lung disease leading to chronic respiratory failure


VAERS ID: 1065894 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021181460

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority manufacturer report number PL-URPL-3-186-2021. A 90-yer-old patient of unspecified gender received the 1st dose of bnt162b2 (COMIRNATY, lot number: EK9788, expiration date: 31May2021) via intramuscular in the left arm on 04Feb2021 at 13:00 at 0.3ml single for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced death 2-3 hours after vaccination. Date of occurrence of the reaction 04Feb2021 at 15:00. It was unknown if autopsy was performed. Outcome of the event was fatal. Sender Comment: Death occurred hours after vaccination in an elderly person. The patient''s medical history is unknown. Regulatory authority requested additional information. There is a time relationship between vaccination and the occurrence of side effects. The person reporting ADR qualified it as severe. Regulatory authority assessed the ADR as heavy. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Death


VAERS ID: 1065902 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Somnolence, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: SORVASTA
Current Illness: Hypercholesterolemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021182627

Write-up: death with unexplained cause; unusual sleepiness; Pain in the arm where the patient was vaccinated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority SI-JAZMP-NCPHV-2021SI0135_0135 and JAZMP-300011147. A 82-year-old female patient received the second dose of bnt162b2 (COMIRNATY;lot/ batch EL0725) intramuscular on 04Feb2021 (at 82 years) at single dose for covid-19 immunisation . Medical history included ongoing hypercholesterolaemia, otherwise was healthy and in good psychophysical condition (every day she went for a long walk). Concomitant medication included rosuvastatin calcium (SORVASTA) for hypercholesterolemia. The patient previously, on 14Jan2021, took the first dose of the vaccine (batch/lot EJ6797) for covid-19 immunisation and no problems were detected. On 04Feb2021, after vaccination, the patient became unusually sleepy and felt pain in the arm where the vaccine was administered. On 10Feb2021 the patient''s daughter found her dead in her apartment. The daughter saw her for the last time on 09Feb2021 and at that time apart from sleepiness no other problems were identified. Death with unexplained cause occurred on 10Feb2021. Event unusual sleepiness was also reported as fatal. Outcome of pain in the arm where the patient was vaccinated was unknown. The patient was sent for autopsy for determining the cause of death (as reported). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unusual sleepiness; death with unexplaned cause


VAERS ID: 1067501 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; CONCOR COR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AV block (status post AV block IIb-III); Cardiac pacemaker insertion (Jul2020 two-chamber pacemaker was installed); Cardiac pacemaker insertion (cardiac pacemerker Implant); Dementia acquired (Demental development)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021208055

Write-up: acute right heart death/Cardiac death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-02956. An 89-year-old female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EK9788), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunisation. Medical history included dementia acquired from an unknown date and unknown if ongoing (Demental development), cardiac pacemaker insertion from Jul2020 and unknown if ongoing (Jul2020 two-chamber pacemaker was installed), AV block from an unknown date and unknown if ongoing (status post AV block IIb-III), Cardiac pacemaker insertion from an unknown date and unknown if ongoing (cardiac pacemerker Implant). Concomitant medications included amlodipine, bisoprolol fumarate (CONCOR COR). The patient previously took first dose bnt162b2 (COMIRNATY, batch/lot number: EJ6796) on 16Jan2021 for COVID-19 immunisation. The patient experienced acute right heart death/cardiac death (death, medically significant, life threatening) on 13Feb2021 07:00. The patient died on 13Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. The causal relationship between the product/substance Comirnaty / TOZINAMERAN and Cardiac death is assessd as unclassifiable by BASGAGES and as possible by reporter. Sender Comment: Confounding factors: advanced age of the patient and underlying AV block, Cardiac pacemaker insertion. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: acute right heart death/Cardiac death


VAERS ID: 1067518 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Auscultation, Blood count, Blood creatinine, Blood culture, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Culture urine, Electrocardiogram, Escherichia infection, Fibrin D dimer, Glomerular filtration rate, Heart rate, Klebsiella infection, Laboratory test, Lymphocyte count, Neutrophil count, Oxygen saturation, Pyrexia, Respiratory rate, SARS-CoV-2 test, Urine analysis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Benign prostatic hypertrophy
Preexisting Conditions: Medical History/Concurrent Conditions: Permanent urethral catheterisation (it was related to benign prostatic hypertrophy)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Auscultation; Result Unstructured Data: Test Result:listening breathing sharpened, basally with crepit; Test Date: 20210129; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210201; Test Name: Creatinine; Result Unstructured Data: Test Result:80 mmol/L; Test Date: 20210128; Test Name: Blood culture; Test Result: Negative ; Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/90 mmHg; Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/50 mmHg; Test Date: 20210201; Test Name: Urea; Result Unstructured Data: Test Result:12.1 mmol/L; Test Date: 20210120; Test Name: Body temperature; Result Unstructured Data: Test Result:elevated; Test Date: 20210121; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210127; Test Name: Body temperature; Result Unstructured Data: Test Result:above 39 Centigrade; Test Date: 20210128; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:bilateral interstitial pneumonia; Test Date: 20210129; Test Name: C-reactive protein; Result Unstructured Data: Test Result:144.8 mg/l; Test Date: 20210201; Test Name: C-reactive protein; Result Unstructured Data: Test Result:162.4 mg/l; Test Date: 20210126; Test Name: Urine culture; Test Result: Negative ; Test Date: 20210201; Test Name: ECG; Result Unstructured Data: Test Result:atrial flutter and tachycardia; Test Date: 20210201; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:more than 35.2 mg/l; Test Date: 20210201; Test Name: CKD-EPI; Result Unstructured Data: Test Result:1,3 ml/s/1,73m2; Test Date: 20210127; Test Name: Pulse rate; Result Unstructured Data: Test Result:74; Comments: 74/min; Test Date: 20210129; Test Name: Pulse rate; Result Unstructured Data: Test Result:110; Comments: 110/min; Test Date: 20210129; Test Name: biochemical examination; Result Unstructured Data: Test Result:normal; Test Date: 20210201; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.1 x10 9/l; Test Date: 20210201; Test Name: Neutrophils; Result Unstructured Data: Test Result:21 x10 9/l; Test Date: 20210127; Test Name: O2 saturation; Test Result: 89 %; Test Date: 20210129; Test Name: O2 saturation; Result Unstructured Data: Test Result:75-85 %; Test Date: 20210129; Test Name: Respiratory rate; Result Unstructured Data: Test Result:increased; Test Date: 20210127; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210122; Test Name: Urine analysis; Result Unstructured Data: Test Result:mild bacterial infection; Comments: proven mild bacterial infection of E. coli and Klebsiela pneumoniae; Test Date: 20210130; Test Name: Urine analysis; Test Result: Negative ; Test Date: 20210201; Test Name: White blood cells; Result Unstructured Data: Test Result:24.2 x10 9/l
CDC Split Type: CZPFIZER INC2021197617

Write-up: COVID-19 pneumonia; Feverish; mild bacterial infection of E. coli and Klebsiela pneumoniae; mild bacterial infection of E. coli and Klebsiela pneumoniae; felt discomfort in the lower abdomen; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority CZ-CZSUKL-21001042. An 84-year-old patient received first dose of BNT162B2 (COMIRNATY) intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing Benign prostatic hypertrophy; permanent urethral catheterization (it was related to benign prostatic hypertrophy). The patient was generally healthy and without major problems-apart from the prostate, he went for a catheter change in connection with it, he was vaccinated with the flu vaccine (not specified) in mid-Dec2020. The patient did not use any medication regularly before reporting the incident. Concomitant medications were not reported. The patient experienced COVID-19 pneumonia on 28Jan2021 which caused he died on 03Feb2021. The event COVID-19 pneumonia also reported as life-threatening. On Monday, 18Jan2021, he was vaccinated with the BNT162B2 vaccine at the hospital, he followed all the rules during the vaccination, he had an FFP3 respirator, he kept his distance. In the waiting room for an hour. No ADR immediately after vaccination. At home everyone (according to the reporter) follows the rules and was careful. On 20Jan2021, a planned catheter replacement was performed. From 20Jan2021 the patient felt discomfort in the lower abdomen. Then an elevated temperature appeared, from Thursday 21Jan2021 already fever 39?C, treated with PARALEN. On 22Jan2021, urine examination proven mild bacterial infection of E. coli and Klebsiela pneumoniae, prescribed amoxicillin trihydrate, clavulanate potassium (AMOXICLAV) every 12 hours. On 25Jan2021, the patient was treated on surgery. The fevers persisted. The urinary catheter was replaced. Culture reaffirmed bacteria. AMOXICLAV was increased every 8 hours. On 26Jan2021, urine cultivation was performed showed negative. On 27Jan2021, still fever above 39?C, in the morning transport to the hospital by ambulance, ethambutol dihydrochloride (ATB) given intravenously, O2 saturation 92 %, after antibiotherapy transport home again. In the evening, due to persistent fevers, he was taken to the hospital again, saturation 89 %, antigen test on COVID-19 was performed-positive. The patient was immediately hospitalised in the infection department. On 28Jan2021, X-ray confirmed bilateral interstitial pneumonia. On 29Jan2021 the patient was worsened, was somnolent, and there was a qualitative impairment of consciousness. An anesthesiology consultation was performed. The patient was switched to HFNO (high-flow oxygen therapy) and analgesia with morphine and NOVALGIN was initiated, O2 saturation of the patient was between 75-85 %. On 01Feb2021, atrial flutter and tachycardia are detected on the ECG. Cardilan + Betaloc was administered, already sinus rhythm on control. Nadroparin calcium (FRAXIPARIN) was administered for the elevation of D-dimers. Despite all the care, the patient got worse. The patient was hypo saturated, but did not perceive dyspnea. Bedspreads developed. Subjectively without problems. On 03Feb2021 morning gasping, confusion, hypotension and hyposaturation. In the evening the patient died. The patient had no pre-existing disease worsened during SARS-CoV2 infection. The patient had a positive SARS-CoV2 test. During COVID-19 disease, symptoms included: multiorgan failure: respiratory-tachypnoea, hypoxemia, COVID pneumonia, respiratory failure; cardiovascular-arrhythmia- tachycardia, atrial flutter 2:1; nervous-altered state of consciousness-somnolence, confusion; other-septic condition. Lab data included: on 29Jan2021 blood count in the normal; on 01Feb2021, leukocytes 24.2, lymphocytes 2.1 x10 9/l, neutrophils 21.0 x10 9/l, D-dimers over 35.2 mg/l; on 29Jan2021, biochemical examination (iontogram, renal and liver group) in the normal; on 01Feb2021-urea 12,1, Creatinine 80 mmol/L; on 29Jan2021 CRP 144.8 mg/l; on 01Feb2021 CRP 162.4 mg/l; Urine analysis-positive culture of E.coli and Klebsiel, then 26Jan2021 negative; Evidence of hypoxemia-saturation 75-85% on 29Jan2021; auscultation on 29Jan2021 showed listening breathing sharpened, basally with crepit; Blood culture on 28Jan2021 was negative; blood pressure on 27Jan2021 was 140/90 mmHg and on 29Jan2021 was 120/50 mmHg; CKD-EPI was 1,3 ml/s/1,73m2 on 01Feb2021; pulse rate was 74/min on 27Jan2021 and 110/min on 29Jan2021; respiratory rate increased on 29Jan2021. Outcome of the event COVID-19 pneumonia was fatal; of feverish was not recovered/not resolved while of remain was unknown. No autopsy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1067519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood osmolarity, Blood potassium, Blood urea, C-reactive protein, Cardio-respiratory arrest, Electrocardiogram, Gamma-glutamyltransferase, Glomerular filtration rate, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, SARS-CoV-2 test, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUPHYLLINE [THEOPHYLLINE]; STACYL; THYROZOL; OMEPRAZOL; PRESTANCE; EBRANTIL [URAPIDIL HYDROCHLORIDE]
Current Illness: Chronic kidney disease; Diabetes mellitus; Goitre nodular (polynodous); Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Bundle branch block left; Carotid angioplasty; Carotid artery stenosis (bilateral); Cataract operation (bilateral); Cholelithiasis; Colostomy; Diastolic dysfunction (2nd degree); Facial paresis (Post operation (carotid angioplasty)); Hepatopathy (diffuse); Hypertension arterial; Hypertension pulmonary; Hyperthyroidism; Intestinal carcinoma; Ischemic stroke; Peripheral arterial occlusive disease Fontaine stage I; Peripheral ischaemia; Wheezy bronchitis
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:0.64; Comments: Units:ukat/L; Test Date: 20210212; Test Name: Blood glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:0.53; Comments: Units:ukat/L; Test Date: 20210212; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:3.49; Test Date: 20210212; Test Name: Creatine kinase; Result Unstructured Data: Test Result:3.04; Test Date: 20210212; Test Name: CK-MB; Result Unstructured Data: Test Result:18.75; Comments: Units:ukat/L; Test Date: 20210212; Test Name: Creatinine; Result Unstructured Data: Test Result:243 umol/l; Test Date: 20210212; Test Name: Glucose; Result Unstructured Data: Test Result:19.01 mmol/L; Test Date: 20210212; Test Name: Serum osmolality; Result Unstructured Data: Test Result:308 mosm/L; Test Date: 20210212; Test Name: Potassium; Result Unstructured Data: Test Result:3.5 mmol/L; Test Date: 20210212; Test Name: Urea; Result Unstructured Data: Test Result:11.1 mmol/L; Test Date: 20210212; Test Name: C-reactive protein; Result Unstructured Data: Test Result:22.9 mg/l; Test Date: 20210212; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:supraventricular tachycardia, old left bundle bran; Comments: supraventricular tachycardia, old left bundle branch block, irregular myocardial activity; Test Date: 20210212; Test Name: Gamma GT; Result Unstructured Data: Test Result:0.82; Test Date: 20210212; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:0.25; Comments: Units:mL/s; Test Date: 20210212; Test Name: NT-proBNP; Result Unstructured Data: Test Result:17135 ng/L; Test Date: 202102; Test Name: O2 saturation; Result Unstructured Data: Test Result:severe hyposaturation; Test Date: 20210212; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210212; Test Name: White blood cells; Result Unstructured Data: Test Result:17.7 x10 9/l
CDC Split Type: CZPFIZER INC2021213319

Write-up: Acute respiratory failure; Respiratory and circulatory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority CZ-CZSUKL-21001204. An 87-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), Batch/lot number: EL0725, via intramuscular route on 11Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing ischemic heart disease, ischaemic stroke on an unknown date, ongoing goitre polynodous, diastolic dysfunction 2nd degree from an unknown date, spastic bronchitis from Dec2018, hyperthyroidism from an unknown date, arterial (carotid) bilateral stenosis from Oct2018, desobliteration of carotid arteries in Nov2017, paresis of facial nerve post operation, bilateral cataract operation on an unknown date, ongoing diabetes mellitus, ischemic lower limb disease, peripheral arterial occlusive disease from an unknown date, bundle branch block left from an unknown date, chronic kidney disease, surgery for intestinal carcinoma (colostomy) in Mar2015, arterial hypertension, hepatopathy, cholelithiasis and pulmonary hypertension. Concomitant medication included theophylline (EUPHYLLINE), acetylsalicylic acid (STACYL), thiamazole (THYROZOL), omeprazole, amlodipine besilate, perindopril arginine (PRESTANCE) and urapidil hydrochloride (EBRANTIL). On 12Feb2021, 1 day after the COVID-19 vaccination, the patient was admitted to hospital due to severe respiratory insufficiency with severe hyposaturation, worsening of the breathing was present in the 5 days before the admission. After admission to the hospital she was tested negatively for COVID-19. The patient?s condition progressed rapidly into cardiopulmonary arrest followed by death. Both the events acute respiratory failure and cardiopulmonary arrest were considered fatal. On 12Jan2021 the patient had undergone lab tests which included alanine aminotransferase: 0.64 ukat/L; on 12Feb2021 she underwent lab tests which included: aspartate aminotransferase: 0.53 ukat/L , blood alkaline phosphatase: 3.49, blood creatine phosphokinase: 3.04, blood creatine phosphokinase mb: 18.75 ukat/L, blood creatinine 243 umol/l, blood glucose 19.01 mmol/l, blood osmolarity 308 mosm/l, blood potassium 3.5 mmol/l, blood urea 11.1 mmol/l, c-reactive protein: 22.9 mg/l, electrocardiogram showed supraventricular tachycardia, old left bundle branch block, irregular myocardial activity, gamma-glutamyltransferase: 0.82, glomerular filtration rate 0.25 mL/s, n-terminal prohormone brain natriuretic peptide: 17135 ng/l and White blood cell count 17.7 x 10^9/L. The patient died on an unspecified date in Feb2021. An autopsy was performed, autopsy protocol was not available at the time of the report, however conclusion of the autopsy was without anything remarkable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: severe respiratory insufficiency; cardiopulmonary arrest


VAERS ID: 1067532 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021208060

Write-up: Lethal death in multimorbidity; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority [regulatory authority DE-PEI-PEI2021002827]. A 92-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 08Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (COMIRNATY) in Jan2021 for COVID-19 immunisation (had been tolerated). On 13Feb2021 after vaccination the patient developed lethal death in multimorbidity. The patient is dead. It was not reported if an autopsy was performed. Reaction(s) / Event(s) Assessed Unclassifiable by regulatory authority. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Lethal death in multimorbidity


VAERS ID: 1067533 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-10
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, SARS-CoV-2 test, Upper respiratory tract infection
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Test Date: 20210111; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021208067

Write-up: Rhinopharyngitis; Upper respiratory tract infection; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002828 and received via Regulatory Authority. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced rhinopharyngitis and upper respiratory tract infection on 10Jan2021. The patient underwent lab tests and procedures which included COVID-19 rapid POC test: negative on 11Jan2021. Patient died on16Jan2021. Death cause was reported as upper respiratory infection and rhinopharyngitis. It was unknown if an autopsy was performed. Event assessment: Regulatory authority/Comirnaty/to all events/C. Inconsistent causal association No follow-up attempts are possible, information about batch number cannot be obtained. ; Reported Cause(s) of Death: Rhinopharyngitis; Upper respiratory infection


VAERS ID: 1067534 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021208054

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002830. An 81 years old female patient received first dose BNT162B2 (COMIRNATY), via an unspecified route of administration on 15-FEB-2021 at single dose for COVID-19 immunisation. Medical history included Hypertension arterial and Hypothyroidism. The concomitant medications were not reported. At 5 days after vaccination, the patient died on 20Feb2021. The cause of death was unknown. It''s unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1067537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Electrolyte imbalance, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021212762

Write-up: Vomiting; Electrolyte imbalance; Congestive cardiac failure; This is a spontaneous report from a non-contactable physician via the regulatory authority DE-PEI-PEI2021002860. A 100-years-old patient female patient received the second dose of bnt162b2 (COMIRNATY, lot/batch no.: EK9788), via an unspecified route of administration on 01Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 04Jan2021 at single dose for covid-19 immunisation, had been tolerated. The patient experienced vomiting, electrolyte imbalance and congestive cardiac failure on 02Feb2021. The patient died due to the events on an unspecified date. It was not reported if an autopsy was performed. Event Assessment: Vomiting, Electrolyte disturbance / regulatory authority / A. Consistent causal association to. Congestive cardiac failure / regulatory authority / D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; Electrolyte disturbance; Congestive cardiac failure


VAERS ID: 1067538 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, 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: 2021-02-09
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021212995

Write-up: Pneumonia; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002861. A 101-year-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: EJ6796), intramuscular on 29Jan2021 (at the age of 101 years) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 08Jan2021 for COVID-19 immunization. The patient experienced pneumonia on 02Feb2021 with fatal outcome. The patient died on 09Feb2021; death cause was reported as pneumonia. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1067539 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021213046

Write-up: the fatal outcome; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002863. A 92-year-old male patient received BNT162B2 (COMIRNATY, batch/lot number EL1491) on 22Jan2021 (at the age of 92-year-old), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced "the fatal outcome" on 03Feb2021. On 03Feb2021 after vaccination the patient developed death. The patient was dead. The outcome of the event was fatal. It was unknown whether autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: the fatal outcome


VAERS ID: 1067540 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021212994

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority (Regulatory Authority number DE-PEI-PEI2021002864). This is a report received from the Regulatory Authority. A 68-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot no.: EM0477) via an unspecified route of administration on 31Jan2021 (at the age of 67-years-old) at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (COMIRNATY, lot no.: EK9788) via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 12Feb2021 after vaccination the patient died (reported as ''Exitus letalis''). The cause of death 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: Exitus letalis


VAERS ID: 1067541 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021212783

Write-up: Circulatory failure; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002865 and received via Regulatory Authority. An 89-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Feb2021 (at age of 89-year-old) as a single dose for covid-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. First vaccine dose of BNT162B2 (COMIRNATY) was administered on 05Jan2021 (at age of 89-year-old) for COVID-19 immunisation, Batch/lot number: unknown, had been tolerated. It was reported that seven (7) days after vaccination the patient developed circulatory failure (onset date 07Feb2021) lasting for unknown (as reported). Patient collapsed lifeless at the table at dinner. Emergency doctor: frustrating resuscitation. The patient was dead on 07Feb2021 due to the event. It was unknown if an autopsy was performed. Sender Comment: Collapsed lifeless at the table at dinner. Emergency doctor: frustrating resuscitation. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Circulatory failure


VAERS ID: 1067543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021214276

Write-up: The patient died 5 days after the first vaccination; This is a spontaneous report from a non-contactable physician. This is a report based on information received by Pfizer from BioNTech (manufacturer control number: 18811), license party for COMIRNATY. A 91-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient died 5 days after the first vaccination on 18Feb2021. The patient had an unknown cause of death, which was reported as fatal. An autopsy was not performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1067555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Computerised tomogram head, Confusional state, Dyskinesia, Electroencephalogram abnormal, Magnetic resonance imaging, Partial seizures, Psychomotor hyperactivity, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPIN [AMLODIPINE BESILATE]; TAPENTADOL; QUETIAPINA [QUETIAPINE]; PAROXETINA [PAROXETINE]; ATORVASTATINA [ATORVASTATIN]; LYRICA
Current Illness: COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment; Depression; Dyslipidaemia; Heart disease, unspecified; Hepatic steatosis; Hypertension arterial; Living in nursing home; Mobility decreased; Obesity; Stroke; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Name: head CT; Result Unstructured Data: Test Result:without relevant findings; Test Name: EEG; Result Unstructured Data: Test Result:diffuse slow EEG without seizure activity; Test Date: 20210119; Test Name: EEG; Result Unstructured Data: Test Result:epileptiform activity was appreciated (they do not; Comments: epileptiform activity was appreciated (they do not speak of Status Epilepticus).; Test Name: MRI; Result Unstructured Data: Test Result:no structural injury was seen; Test Date: 20210109; Test Name: COVID-19 antibody test; Test Result: Positive ; Test Date: 20210109; Test Name: SARS-CoV-2 IgG antibody test; Test Result: Positive ; Test Date: 20210109; Test Name: SARS-CoV-2 IgM antibody test; Test Result: Negative ; Test Date: 20210109; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC2021196427

Write-up: Severe sensory dysphasia; nonspecific involuntary movements; Psychomotor agitation; confusional syndrome; low-grade fever; urinary tract infection; Complex focal seizures of de novo repetition; This is a spontaneous report a contactable physician downloaded from the Regulatory Atuhority-WEB [regulatory authority ES-AEMPS-757640]. An 86-year-old female patient received bnt162b2 (COMIRNATY, lot #: EJ6796), intramuscular on 05Jan2021 at 0.3 mL, single for COVID-19 vaccination. Medical history included depression, dyslipidaemia, obesity, hypertension arterial, hepatic steatosis, covid-19 from Nov2020 and ongoing, vitamin d deficiency, heart disease with pacemaker and dependency situation with stay in nursing home due to motor limitations and possible concomitant cognitive impairment, and stroke. Concomitant medications included amlodipine besilate (AMLODIPIN), tapentadol, quetiapine (QUETIAPINA), paroxetine (PAROXETINA), atorvastatin (ATORVASTATINA), pregabalin (LYRICA). The patient experienced psychomotor agitation, focal seizures, confusion state all on 10Jan2021. Patient was admitted to the hospital to study a language disorder with confusion and psychomotor agitation, nonspecific involuntary movements (initially attributed to a possible urinary tract infection with low-grade fever). Simple head CT on admission without relevant findings and diffuse slow EEG without seizure activity. In addition, lumbar puncture was performed with normal CSF and MRI results in which no structural injury was seen. During the stay in the neurology ward, patient was with confusional syndrome. Attempts were made to control in a medicinal way without success. Due to a low level of consciousness, the patient requires NGS for correct feeding, but due to agitation, it was not possible to achieve positioning despite several attempts. The family was informed at all times of the poor prognosis and ultimately it was decided to favor comfort measures. On 19Jan2021, two other EEGs were performed in which epileptiform activity was appreciated (they do not speak of Status Epilepticus). Patient died on 24Jan2021 at 10:13. Diagnostic assessment: Complex focal seizures of de novo repetition. Severe sensory dysphasia and residual psychomotor agitation (complex focal status vs postcritical focality). Associated previous cognitive impairment and urinary tract infection. The patient underwent lab tests and procedures which also included SARS-CoV-2 IgG antibody test, COVID-19 antibody test and COVID-19 PCR test all with positive result, and SARS-CoV-2 IgM antibody test with negative result on 09Jan2021. Outcome of events psychomotor agitation, confusional syndrome and focal seizures was fatal, and outcome of other events was unknown. An autopsy was not performed. Causality assessment by the neurologist: Older patient with seizures and previous vaccination, although she had a brain injury (previous stroke) that can explain them. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Complex focal seizures of de novo repetition; confusional syndrome; psychomotor agitation


VAERS ID: 1067559 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia bacterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Pneumonia bacterial; A regulatory authority report was received from a health care professionl concerning a 87-years old, male patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and experienced Pneumonia bacterial. The patient''s medical history, was not provided by the reporter. Concomitant medications were not provided. On 29 JAN 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection. On 31 JAN 2021, the patient experienced pneumonia bacterial. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 11 FEB 2021. The cause of death was reported as pneumonia bacteria. Plans for an autopsy were unknown.; Reporter''s Comments: This case concerns an 87-year-old male who experienced a serious unexpected event of bacterial pneumonia with fatal outcome. The event occurred 1 day after the first dose of mRNA-1273. Treatment not reported. Event outcome fatal. Cause of death reported as bacterial pneumonia. Autopsy not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1067566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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: 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: AMLODIPINE; BISOPROLOL; IMOVANE; DIGOXIN; PANZOR; METFOREM; ELIQUIS; SIRDALUD RETARD; NORFLEX [ORPHENADRINE CITRATE]; PANADOL FORTE [PARACETAMOL]; RIVATRIL; DEPRAKINE [VALPROATE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia (predisposition to supraventricular tachycardia (SVT)); Hypertension; Pulmonary embolism (previously pulmonary embolism); Tetraparesis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021212906

Write-up: Sudden death; Pneumonia; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB FI-FIMEA-20210866. A 72-year-old male patient received his first dose of bnt162b2 (COMIRNATY) (Lot number: EL1491), intramuscularly on 14Jan2021 at single dose for covid-19 immunisation. Medical history included tetraparesis, cardiac arrhythmia (predisposition to supraventricular tachycardia (SVT)), type 2 diabetes, hypertension and previously pulmonary embolism. Concomitant medication included amlodipine, bisoprolol, zopiclone (IMOVANE), digoxin, pantoprazole sodium sesquihydrate (PANZOR), metformin hydrochloride (METFOREM), apixaban (ELIQUIS), tizanidine hydrochloride (SIRDALUD RETARD), orphenadrine citrate (NORFLEX), paracetamol (PANADOL FORTE), clonazepam (RIVATRIL), valproate sodium (DEPRAKINE). The patient experienced sudden death on 28Jan2021. Possible pneumonia on the day of death. The outcome of event "Pneumonia" was fatal. The patient died on 28Jan2021 "unexpectedly". Forensic autopsy will be performed on the patient. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Sudden death; Pneumonia


VAERS ID: 1067574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Discomfort, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021202960

Write-up: Death; brutal discomfort; Habit vomiting; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (Regulatory Authority number FR-AFSSAPS-BX20210946). An 82-year-old female patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6795) intramuscular, in left arm, on 29Jan2021, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient did not have Covid-19 before vaccination and had not been tested. Concomitant medications were not reported. On 31Jan2021 the patient experienced habit vomiting. The event was also described as repeated vomiting, no medical consultation. On 01Feb2021 the patient had brutal discomfort. Failure of the resuscitation maneuvers carried out by the emergency services. No medico-legal obstacle, no body examination, no autopsy. The patient died on 01Feb2021. Burial the same day. The events death and habit vomiting were reported with a fatal outcome. The outcome of brutal discomfort was unknown. NB: Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death; habit vomiting


VAERS ID: 1067587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-06
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Oxygen saturation decreased, Pallor, Pyrexia, Respiratory distress, Tension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: JANUVIA [SITAGLIPTIN PHOSPHATE]; BISOPROLOL HEMIFUMARATE; HYDROCHLOROTHIAZIDE; HYDROXYZINE HYDROCHLORIDE; INSULINE HUMAINE; PAROXETINE; LEVOTHYROX; FUROSEMIDE; PANTOPRAZOLE; CHOLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteritis; Bicytopenia; Cardiac failure; Gastrooesophageal reflux disease; Hypertension arterial; Monoclonal gammopathy; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: wears off upon taking paracetamol
CDC Split Type: FRPFIZER INC2021197525

Write-up: Distress respiratory; desaturation; feverish peak at 38.7 ?; tense; pale; Asthenia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-LM20210190. An 89-year-old female patient received second dose of bnt162b2 (COMIRNATY) , intramuscular on 28Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension arterial, gastrooesophageal reflux disease, arteritis, type 2 diabetes mellitus, bicytopenia, monoclonal gammopathy, cardiac failure, all of which were from an unknown date and unknown if ongoing. Concomitant medication included sitagliptin phosphate (JANUVIA), bisoprolol hemifumarate, hydrochlorothiazide, hydroxyzine hydrochloride, insuline humaine , paroxetine, levothyroxine sodium (LEVOTHYROX), furosemide, pantoprazole, cholecalciferol. The patient received first dose of COMIRNATY on 07Jan2021 for covid-19 immunisation. The patient experienced asthenia on 06Feb2021, distress respiratory on 07Feb2021. 06Feb2021: feverish peak at 38.7 ? C which wears off upon taking paracetamol, asthenic all day, pale and tense at night. 07Feb2021 morning: desaturation with intervention of firefighters who failed to reanimate her. The patient underwent lab tests and procedures which included body temperature: 38.7 centigrade on 06Feb2021 wears off upon taking paracetamol. The outcome of feverish peak at 38.7 ? was resolving, of tense and pale was unknown, of other events was fatal. The patient died on 07Feb2021. Cause of death was reported as respiratory distress. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1067592 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, C-reactive protein increased, Dehydration, Hyperleukocytosis, Neutrophil percentage abnormal, Tooth abscess
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Malignancy related conditions (narrow), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Dehydration (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension; Colorectal adenocarcinoma; Colostomy; Gingivitis; Hip prosthesis insertion; Tooth avulsion (Mucous thickening of the right maxillary sinus of appearance suggestive of a submucosal cyst)
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: CRP; Result Unstructured Data: Test Result:32 mg/l; Test Date: 20210128; Test Name: CRP; Result Unstructured Data: Test Result:37.4 mg/l; Test Date: 20210106; Test Name: Hyperleukocytosis; Result Unstructured Data: Test Result:11.6 g/l; Test Date: 20210128; Test Name: Hyperleukocytosis; Result Unstructured Data: Test Result:27.5 g/l; Test Date: 20210128; Test Name: Polynuclear neuthophiles; Test Result: 68 %
CDC Split Type: FRPFIZER INC2021203350

Write-up: Dehydration; Abscess dental; Asthenia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number : FR-AFSSAPS-PC20210116. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Lot number EJ6788), intramuscular at single dose in the left arm on 27Jan2021 for covid-19 immunisation. Medical history included arterial hypertension, Alzheimer''s disease, colorectal adenocarcinoma with colostomy, right hip prosthesis insertion in 2017. Concomitant medications were not reported. On 28Jan2021, the patient experienced dehydration, abscess dental, asthenia with fatal outcome. The patient died on 28Jan2021. It was not reported if an autopsy was performed. Clinical course was reported as follows: On 23Nov2020: Small gingivitis on the right side, with suspicion of pearlich. Introduction of antimycotic treatment. Firstly favorable evolution, then evolving towards CRP increased to 32 mg/l and hyperleukocytosis at 11.6 G/L on 06Jan2021. Faced with the suspicion of a dental abscess: introduction of treatment with Clamoxyl. On 18Jan2021: Dental avulsion confirmed. Mucous thickening of the right maxillary sinus of appearance suggestive of a submucosal cyst. On 27Jan2021 the patient vaccinated with Comirnaty. On 28Jan2021, asthenia and an inflammatory syndrome (CRP = 37.4 mg/L), Leukocytes = 27.5 G/L including 68% of PNN (polynuclear neutrophiles), considered as an infectious syndrome. Introduction of treatment with Bactrim. The patient subsequently presented with dehydration with diarrhea, which prompted her to be transferred to the emergency room. The same day (28Jan2021) death of the patient. Death possibly related to the effect. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dehydration; Abscess dental; Asthenia


VAERS ID: 1067599 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hyperthermia
SMQs:, Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adult failure to thrive; Arrhythmia; Arteriovenous malformation; Cognitive disturbance; Depression; Fall
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021199924

Write-up: Hyperthermia; This is a spontaneous report from contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-TO20210657. A 97-year-old male patient received 1st dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular in right arm on 09Feb2021 at single dose for COVID-19 immunisation. Medical history included adult failure to thrive, cognitive disturbance, depression, arrhythmia, arteriovenous lesions of the lower limbs and fall, all from an unknown date and unknown if ongoing. The patient''s concomitant medications included anticoagulant therapy. The patient experienced hyperthermia (death) on 13Feb2021. The outcome of event was fatal. The patient died on 14Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hyperthermia


VAERS ID: 1067742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Decreased appetite, Diarrhoea, Faeces discoloured, Hypophagia, Pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BRALTUS; LANSOPRAZOLE; LISINOPRIL; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diarrhea; Gastritis; High cholesterol; Hypertension; Type 2 diabetes mellitus; Comments: Type 2 diabetes mellitus Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021210141

Write-up: diarrhoea; reduced eating; diarrhoea dark brown and green watery stool; Diarrhoea; reduced appetite; generalised aches; leg pain; lower back pain; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102181535108410, Safety Report Unique Identifier GB-MHRA-ADR 24827783. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 at a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, diarrhea, chronic obstructive pulmonary disease (COPD), gastritis, hypertension, high cholesterol. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included tiotropium bromide (BRALTUS) from 01Jul2017 for COPD, lansoprazole from 04May2010 for gastritis, lisinopril from 20Dec2020 for hypertension, fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA) from 22May2017 for COPD, rosuvastatin from 25Nov2020 for blood cholesterol increased. Patient experienced diarrhea on an unspecified date with outcome fatal, diarrhoea on 30Jan2021 with outcome fatal. 1st Feb - NHS 111- started with diarrhoea on 30Jan2021, reduced appetite and generalised aches, leg pain, lower back pain. 4th Feb - GTD - diarrhoea since the day after covid injection. reduced eating, drinking ok. Slightly picked up on Tuesday, now diarrhoea dark brown and green watery stool. Notification from REDACTED Hospital - patient admitted on 05Feb2021 and died on 09Feb2021 due to diarrhoea. It was not reported if an autopsy was performed. The outcome of other events was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Diarrhoea; Diarrhoea


VAERS ID: 1067746 (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: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death, Dyspnoea, Hypotension, Pneumonia, Renal failure, Scan brain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (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: 2021-02-22
   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: Diabetes; Prostate cancer metastatic; Single functional kidney
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Pneumonia; Prostate cancer; Stroke; Suspected COVID-19; Comments: I do not know the list of his medication but he had high blood pressure and was on medication to lower it and also for prostate cancer. He had been on these medications for years. He no longer took medication for diabetes, which he had controlled through diet Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: brain scan; Result Unstructured Data: Test Result:showing recent stroke
CDC Split Type: GBPFIZER INC2021205321

Write-up: Death; failing kidneys; low blood pressure; breathing difficulty; pneumonia; stroke; This is a spontaneous report from a contactable consumer (reporting for his father) via the Medicines & Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202102222122092960, Safety Report Unique Identifier GB-MHRA-ADR 24818088. A 92-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. Medical history included prostate cancer, pneumonia, cerebrovascular accident, hypertension, ongoing diabetes mellitus, suspected covid-19 from 06Apr2020 to 12Apr2020 (as reported), neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)). The patient''s concomitant medications were not reported. Text for relevant medical history and concurrent conditions: The reporter did not know the list of his medications but he had high blood pressure and was on medication to lower it and also for prostate cancer. He had been on these medications for years. He no longer took medication for diabetes, which he had controlled through diet. The patient experienced death on 01Feb2021 (as reported) and stroke on unknown date in 2021 with outcome of unknown. The patient died on 22Feb2021. The cause of death was unknown (as reported). It was not reported if an autopsy was performed. It was reported that the patient (aged 92) was recommended to have the Pfizer vaccine in December by his GP, even though he had prostate cancer which had progressed to his bones, had one functioning kidney and he had been diabetic. He was not in a care home, saw very few people and he had COVID and survived it, back in March (as reported). He had the second jab 3-4 weeks before and 3 days after the jab that felt ill and fell. He then took to bed, with freezing hands, unable to eat and completely wasted away. On 16Feb2021, with failing kidneys and low blood pressure, he was rushed to hospital where they stabilised him enough to find that he had had a stroke three weeks before. Brain scan showing recent stroke. He developed breathing difficulties and died on 22Feb2021, not from COVID but pneumonia (they were informed, as reported). Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: pneumonia; death


VAERS ID: 1067747 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-02-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Electrocardiogram
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: 2021-02-23
   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: ADCAL D3; ALENDRONIC ACID; AMLODIPINE; CLOPIDOGREL; DOCUSATE; LAMOTRIGINE; NOVOMIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:ST elevation
CDC Split Type: GBPFIZER INC2021209836

Write-up: cardiac arrest; Death; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102240136245180, Safety Report Unique Identifier GB-MHRA-ADR 24824240. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Unsure if patient had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included calcium carbonate, colecalciferol (ADCAL D3), alendronic acid (ALENDRONIC ACID), amlodipine (AMLODIPINE), clopidogrel (CLOPIDOGREL), docusate (DOCUSATE), influenza vaccine (INFLUENZA VIRUS) on 18Jan2021, lamotrigine (LAMOTRIGINE), insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX). The patient experienced death on 23Feb2021, cardiac arrest on an unspecified date with outcome of unknown. It was reported Cardiac arrest 4 days following the vaccination (as reported). The patient underwent lab tests and procedures which included electrocardiogram: ECG showed ST elevation on unknown date. The patient died on 23Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1067753 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-27
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory disorder, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Heart failure; Type 2 diabetes mellitus; Comments: Background of heart failure, atrial fibrillation and type 2 diabetes Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021210107

Write-up: breathing problems; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102241337192530, Safety Report Unique Identifier GB-MHRA-ADR 24827145. An 88-years-old male patient received bnt162b2 (BNT162B2, Lot number: EK1768) dose 1, via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation, cardiac failure and type 2 diabetes, all from an unknown date and unknown if ongoing, ongoing suspected covid-19 Unsure when symptoms started. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced breathing problems (death, life threatening) on 27Jan2021 with fatal outcome. Patient died following development of breathing problems. The patient underwent lab test which included sars-cov-2 test: no - negative covid-19 test on 24Jan2021. The patient died on 27Jan2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: breathing problems


VAERS ID: 1067755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Choking
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Rett syndrome (so was receiving extensive medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021215130

Write-up: choked leading to heart failure; Choking; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202102251241165700, Safety Report Unique Identifier GB-MHRA-ADR 24834107. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not known), via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included heart failure, she suffered from Rett Syndrome and so was receiving extensive 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 included extensive medication for Rett Syndrome. The patient experienced heart failure on 21Feb2021, serious due to death and medically significant; choking on 21Feb2021, serious due to death. The patient suffered from a rare genetic neurological disorder called Rett Syndrome but she was in otherwise good health before being administered the Pfizer vaccine which caused her health to deteriorate immediately. She eventually choked leading to heart failure on 21Feb2021. No post-mortem had been deemed necessary. The outcome of the events was fatal. The patient died on 21Feb2021. An autopsy was not performed and the cause of death was heart failure and choking. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: choked leading to heart failure; Choking


VAERS ID: 1067765 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Muscular dystrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021213827

Write-up: died in his sleep through the night; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunisation. Medical history included muscular dystrophy. The patient''s concomitant medications were not reported. The patient received their covid vaccine on 08Feb2021 and who subsequently died in his sleep through the night of 08/09Feb2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1067766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021220561

Write-up: patient died; This is a spontaneous report from a contactable consumer who reported on behalf of his aunt. A female patient of an unknown age received (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications was not reported. On an unknown date, patient died 3 weeks after having the Pfizer vaccine at her care home. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1067790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (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: ILPFIZER INC2021208688

Write-up: A woman in week 20 or 24 was vaccinated and the next day the fetus died; This is a spontaneous report from a contactable physician who reported similar events for two patients. This is the first of two reports. A pregnant female patient (in week 20 or 24 of pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated and the next day the fetus died on an unspecified date. The reporter did not think there was a connection but due to the proximity to the vaccine she reported. Information about batch/lot number as been requested.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject product, BNT162B2 vaccine, contributed to the event of fetal death. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2021209291 same reporter/vaccine/event different patient; Reported Cause(s) of Death: fetal death


VAERS ID: 1067791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (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: ILPFIZER INC2021209291

Write-up: A woman in week 40 of pregnancy was vaccinated and the next day the fetus died; This is a spontaneous report from a contactable physician who reported similar events for two patients. This is the second of two reports. A pregnant female patient (in week 40 of pregnancy) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated and the next day the fetus died on an unspecified date. The reporter did not think there was a connection but due to the proximity to the vaccine she reported. Information about batch/lot number has been requested.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. Based on the current available information and in agreement with reporter''s assessment, the event is unlikely related to the suspected drug of BNT162B2. The case will be reassessed if additional information becomes available.,Linked Report(s) : IL-PFIZER INC-2021208688 same reporter/vaccine/event different patient; Reported Cause(s) of Death: Fetal death


VAERS ID: 1067859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6797 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholangitis, Jaundice, Jaundice cholestatic, Laboratory test, Pyrexia
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (narrow), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm of aorta; Cholelithiasis; Chronic atrial fibrillation; COVID-19; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: laboratory data; Result Unstructured Data: Test Result:unknown results; Test Date: 20210125; Test Name: Fever; Result Unstructured Data: Test Result:37.5 Centigrade
CDC Split Type: ITPFIZER INC2021203425

Write-up: obstructive jaundice; cholangitis; Fever 37.5 , jaundice.; Fever 37.5 , jaundice.; This is a spontaneous report from physician via Italian medicines Agency downloaded from the Regulatory Authority-WEB IT-MINISAL02-682087. An 83-years-old male patient received the second dose of bnt162b2 (COMIRNATY, lot EJ 6797, exp date 30Apr2021), intramuscular in the left arm on 19Jan2021 10:40 at 0.3 mL, single for covid-19 immunisation. Medical history included atrial fibrillation from 01Jan2017, aortic aneurysm from 01Jan2017, cholelithiasis from 01Jan2017, renal failure from 01Jan2017 all unknown if ongoing and covid-19 from Nov2020. The patient''s concomitant medications were not reported. The patient experienced fever 37.5 C, jaundice on 25Jan2021. The events had a fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s comments: Previous COVID-19 in November 2020. Sent to the emergency room 27Jan2021: diagnose of cholangitis, returns in the same day in the nursing home. On 02Feb due to clinical worsening and laboratory data returns to the hospital from where obstructive jaundice is being diagnosed in inoperable and terminal patient, he is sent back to the nursing home. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Previous COVID-19 in November 2020. Sent to the emergency room 27Jan: diagnose of cholangitis, returns in the same day in the nursing home. On 02Feb due to clinical worsening and laboratory data he returns to the hospital from where he diagnoses obstructive jaundice in inoperable and terminal patients, he is sent back to the nursing home.; Reported Cause(s) of Death: Fever 37.5 , jaundice; Fever 37.5 , jaundice


VAERS ID: 1067860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 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: 2021-02-10
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021212827

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-682577. A 42-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# EJ6136, Expiration Date: 30Apr2021) intramuscularly at arm left (reported as left shoulder) on 28Jan2021 at 0.3 mL, single for COVID-19 immunisation. Patient previously received 1st dose of BNT162B2 (COMIRNATY, Solution for injection, Lot# EL1484, Expiration Date: 30Apr2021) intramuscularly at deltoid left on 07Jan2021 15:48 at 0.3 mL, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. 13 days after the administration of the second dose of the comirnaty vaccine, the patient died suddenly on 10Feb2021. The causes were being ascertained (autopsy examination) at the time of reporting. Sender''s Comment: 22Feb2021: request for clinical report to reporter. The patient has returned to the first phase of vaccination as a Healthcare Operator. Reporter''s comments: 13 days after the administration of the second dose of the Comirnaty vaccine, the patient died suddenly. The causes are being ascertained (autopsy examination). No follow-up attempts are possible, no further information is expected.; Reporter''s Comments: 13 days after the administration of the second dose of the Comirnaty vaccine, the patient died suddenly. The causes are being ascertained (autopsy examination).; Reported Cause(s) of Death: the patient died suddenly


VAERS ID: 1067873 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Injection site erythema, Injection site inflammation, Injection site swelling, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal haemorrhage (narrow), Extravasation events (injections, infusions and implants) (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
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: ACETYLSALICYLZUUR CARDIO; ASCORBINEZUUR CF; OMEPRAZOL [OMEPRAZOLE]; FUROSEMIDE [FUROSEMIDE SODIUM]; METFORMINE [METFORMIN]; SIMVASTATINE; INSULINE INSULATARD HM NPH; VALSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Myocardial infarction; Gastrointestinal haemorrhage; Injection site erythema; Injection site swelling; Injection site inflammation; A Regulatory Authority report was received from a physician concerning a 90-year-old, female patient who experienced Injection site erythema, Injection site swelling, Injection site inflammation, Myocardial infarction, and Gastrointestinal hemorrhage. The patient''s medical history was not provided. Products known to have been used by the patient included [ACETYLSALICYLZUUR TABLET 80MG, ASCORBINEZUUR TABLET 500MG, OMEPRAZOL CAPSULE MSR 40MG, FUROSEMIDE TABLET 40MG, METFORMINE TABLET 500MG, SIMVASTATINE TABLET FO 40MG, INSULINE ISOFAAN INJSUSP 100IE/ML, VALSARTAN TABLET OMHULD] On 28 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: [300042698]) intramuscularly for prophylaxis of COVID-19 infection. The patient developed Injection site erythema on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient developed Injection site swelling on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient developed Injection site inflammation on 03 FEB 2021 and Course of the Event was 03 FEB 2021 to 08 FEB 2021. The patient experienced Myocardial infarction and Gastrointestinal hemorrhage on 10 FEB 2021. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was unknown. The event(s), Injection site erythema, Injection site swelling, Injection site inflammation, were considered recovered/resolved on 08 FEB 2021. The patient died on UNK-Feb-2021. The cause of death was reported as Myocardial infarction, and Gastrointestinal hemorrhage. Plans for an autopsy were unknown.; Reporter''s Comments: This case concerns a 90 Y/O F with serious unexpected Myocardial infarction and Gastrointestinal hemorrhage and NS expected injection site erythema, injection site swelling, injection site inflammation. Serious events occurred 14 days after first dose of mRNA-1273. Treatment not reported. Event outcome fatal. Autopsy plan unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: myocard infarct;


VAERS ID: 1067874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Oropharyngeal pain, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Oxygen saturation; Test Result: 79 %; Test Date: 20210208; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210210; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021199231

Write-up: death; COVID-19 positive; low oxygen saturation levels (79%); throat pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00446680 via Regulatory Authority. A 74-years-old female patient received first dose of BNT162B2 (COMIRNATY), via unknown route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on 12Feb2021. It was also reported that COVID-19 positive caused patient death. Three days after vaccination on 07Feb2021, the patient had throat pain. 08Feb2021, COVID-19 PCR test performed and patient tested positive. On 10Feb2021, COVID-19 PCR test was positive. The patient was treated with 5L oxygen, but low oxygen saturation levels (79%) remained on 11Feb2021. Start morphine with restrained policy. On 12Feb2021, the patient deceased. Outcome of the event other event was unknown. It was unknown if an autopsy was done or not. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Death Additional information ADR: 04Feb vaccination. 07Feb arise sore throat. 08Feb Covid-19 PCR test performed. 10Feb result: positive. 11Feb low saturation (79%) despite 5 liters of oxygen. Start morphine with restrained policy. 12Feb death BSN available: yes COVID19 Previous COVID-19 infection: disease symptoms: hospitalization; Reported Cause(s) of Death: Covid 19 positive; death


VAERS ID: 1067876 (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: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, C-reactive protein, C-reactive protein increased, Chronic obstructive pulmonary disease, Haemoglobin, Heart rate, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: ATROVENT; INUXAIR; VENTOLINE [SALBUTAMOL]; ZOPICLONE; PANTOPRAZOLE; LAXOBERAL; TOILAX; PREDNISOLON [PREDNISOLONE]; BURINEX; CIPRALEX [ESCITALOPRAM]; ELIQUIS; TARGINIQ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Anxiety; Atrial fibrillation; Bedridden (Much bedridden, mobilized up with active lift to wheelchair. Up at everey meal. In total need of care.); Chronic obstructive lung disease (Unknown grade.); Heart failure; Incontinence; Kidney failure; Living in residential institution (Long term from 2017. In total need of care.); Type 2 diabetes mellitus; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: Blood tests; Result Unstructured Data: Test Result:normal; Test Date: 20210123; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:45 mg/l; Test Date: 20210126; Test Name: C-reactive protein; Result Unstructured Data: Test Result:31 mg/l; Test Date: 20210115; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.3; Comments: Treatment started (iron and folic acid); Test Date: 20210123; Test Name: Pulse rate; Result Unstructured Data: Test Result:90-110; Comments: Known atrial fibrillation; Test Date: 20210124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: NOPFIZER INC2021213104

Write-up: COPD EXACERBATION; SOMNOLENCE; FEVER 38.4; CRP INCREASED; This is a spontaneous report from a contactable other HCP from the regulatory authority, number NO-NOMAADVRE-FHI-2021-00077. A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY) from lot# EM0477 on 20Jan2021 08:00 at single dose via intramuscular route at the left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications included ipratropium bromide (ATROVENT), beclometasone dipropionate, formoterol fumarate (INUXAIR), salbutamol (VENTOLINE), zopiclone, pantoprazole , sodium picosulfate (LAXOBERAL), bisacodyl (TOILAX), prednisolon, bumetanide (BURINEX), escitalopram (CIPRALEX) , apixaban (ELIQUIS), naloxone hydrochloride, oxycodone hydrochloride (TARGINIQ). Medical history included bedridden, mobilized up with active lift to wheelchair, anaemia, renal failure, anxiety, living in residential institution from 2017 to an unknown date, chronic obstructive pulmonary disease, atrial fibrillation, type 2 diabetes mellitus, cardiac failure, Incontinence all unknown if ongoing, On 23Jan2021 the patient experienced somnolence (slept all day), fever at 38.4 and increased CRP. These symptoms were improving after three days. Two days after the improvement she was again more somnolent. She got a COPD exacerbation seven days after the vaccination, and died 12 days after the vaccination, on 02Feb2021 due to the COPD exacerbation (according to the reporter). It was unknown if an autopsy was performed. The clinical course was as follows on 20Jan2021: tired and somnolent (might be due to anemia), gradually increasing the last three months. Respiratory stable lately, and is perceived as less short of breath. Physicaly weaker lately, eats well. Slightly clinically dehydrated. Abdominal pain that comes and goes. Emotional stable. Cognitively impaired. On 23Jan2021: perceived as more tired and exhausted than normal (three days after vaccination). Could not stay awake. Did not eat, only ingested drinks and medicines. On 24-25Jan2021: Slept during all visits. On 26Jan2021: No fever. Perceived as less somnolent and in improved general condition. Eats and drinks well. On 28Jan2021: Slept during all visits. Did not eat, only drank some milk. Initial pressure ulcers. Long term increased C-reactive protein (more than two years). Lab data included C-reactive protein: 45 on 23Jan2021 and 31 on 26Jan2021; Haemoglobin: 8.3 on 15Jan2021 and treatment started (iron and folic acid); Heart rate: 90/110 on 23Jan2021; COVID-19 virus test: negative on 24Jan2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 23Jan2021: additional information received from reporter (by phone). The following fields have been updated: Event, Event Description, Patient (Disease: date of death).; Reported Cause(s) of Death: COPD exacerbation


VAERS ID: 1067877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: METFORMIN; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PARALGIN FORTE [CODEINE PHOSPHATE;PARACETAMOL]; PARACET FRX; BACTRIM; MAREVAN; DIVISUN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Diabetes mellitus; Living in nursing home; Pain; Urinary tract infection; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021208064

Write-up: Vomiting; Nausea; Feeling unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority NO-NOMAADVRE-FHI-2021-Ugp2z], Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015729 A 10-decade-old (in his 90s) male patient received second dose of BNT162B2 (COMIRNATY, lot number: EJ6789), intramuscular in right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, living in nursing home, urinary tract infection, all from unknown date and unknown if ongoing; constipation; pain; vitamin D deficiency. Concomitant medications included metformin for diabetes mellitus; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation; codeine phosphate, paracetamol (PARALGIN FORTE) for pain; paracetamol (PARACET FRX) for pain; sulfamethoxazole, trimethoprim (BACTRIM) for urinary tract infection; warfarin sodium (MAREVAN); colecalciferol (DIVISUN) for vitamin D deficiency. On 12Feb2021 the patient experienced vomiting, nausea and feeling unwell, the events caused the patient died on 13Feb2021. It was reported that the second day after vaccination on 12Feb2021, he became unwell, nauseous and vomited. According to the physician, patient was ok, effortless respiration, no signs of infection. The next day on 13Feb2021, patient was found dead in his bed. No signs of external damage. It was unknown if an autopsy was performed. Sender''s Comments: General malaise/feeling unwell, nausea/vomiting have been reported in patients vaccinated with Comirnaty. There is a temporal relationship between vaccination and the onset of the symptoms, and we have considered it to be a possible causal relationship between the vaccination and the described symptoms. According to international criteria, 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. When vaccinating elderly patients with underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be completely ruled out that the vaccine may have contributed to the aggravation 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 possible. No further information expected.; Reported Cause(s) of Death: Vomiting; Nausea; Feeling unwell


VAERS ID: 1067878 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebrovascular accident, Heart rate, Loss of consciousness, Tachycardia, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), 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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Oral intake reduced (Reduced food and drink intake)
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bedridden; Cerebrovascular event; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Blood pressure; Result Unstructured Data: Test Result:Increased/high; Comments: Measured right after the patient fell unconscious.; Test Date: 20210129; Test Name: Heart rate; Result Unstructured Data: Test Result:150 beats/min
CDC Split Type: NOPFIZER INC2021212831

Write-up: LOSS OF CONSCIOUSNESS; TACHYPNOEA; TACHYCARDIA /Heart rate was 150 beats/min; CEREBROVASCULAR EVENT; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Ux1ep, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015688. A 88-year-old female patient received second dose of bnt162b2(COMIRNATY;lot EJ6136) on 29Jan2021 (at 88 years) intramuscular at single dose for COVID-19 immunization. No information about concomitant medication was given in the report. The medical history included Alzheimer''s disease, bedridden, living in nursing home, oral intake reduced (Reduced food and drink intake) from 22Jan2021 to 29Jan2021 and cerebrovascular event. On 29Jan2021, the patient developed tachycardia, loss of consciousness, tachypnoea, cerebrovascular event. Heart rate on 29Jan2021 was 150 beats/min and blood pressure on 29Jan2021 was Increased/high (measured right after the patient first fell unconscious). The reporter interpreted the incident as a cerebrovascular event, which also was considered to be cause of death. The patient''s outcome was Fatal, the patient died the following night on 30Jan2021 due to tachycardia, loss of consciousness, tachypnoea, cerebrovascular event.Autopsy was not done. Sender''s Comment: The report concerns a patient in his 80s, who less than 2 hours after the second dose of vaccine with Comirnaty had repeated episodes of loss of consciousness. The patient was not contactable, had tachycardia and tachypnoea, and died. Reporter stated that the episode was interpreted as a cerebral event.Normally, between 300 and 400 people die per week in nursing homes and similar institutions in Norway. In a Norwegian study of patients on long-term benefits, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death has increased in the first four months after hospitalization, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (~ 20%), respiratory and infectious diseases (including pneumonia and sepsis) (~15%), and cancer (~ 10%). When vaccinating vulnerable, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In the individual case, however, it is difficult to know whether the symptoms are due to a vaccine or another, random simultaneous cause that has nothing to do with the vaccine 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. 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. Reporter Comment: 19Feb2021 RELIS: additional information received. The following fields have been updated: Patient - date of death, autopsy performed, determined by autopsy; lab results - added blood pressure, event description was changed accordingly.No follow-up attempts possible. No further information expected.; Reporter''s Comments: 19Feb2021 RELIS: additional information received. The following fields have been updated: Patient - date of death, autopsy performed, determined by autopsy; lab results - added blood pressure, event description was changed accordingly.; Reported Cause(s) of Death: LOSS OF CONSCIOUSNESS; TACHYPNOEA; TACHYCARDIA; cerebrovascular event


VAERS ID: 1067884 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Bradyarrhythmia, Cardiac arrest, Cardiogenic shock, Hypotonic-hyporesponsive episode, Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Bradyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021208069

Write-up: Hypotonic-hyporesponsive episode with loss of consciousness; Hypotonic-hyporesponsive episode with loss of consciousness; Sudden cardiac arrest; Bradyarrhythmia; Inferior myocardial infarction with ST segment elevation; Inferior myocardial infarction with ST segment elevation; Cardiogenic shock; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (PL-URPL-3-132-2021). An 85-year-old patient of an unspecified gender received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6136; Expiration date (reported as): 29Jan2021), intramuscularly in the left arm, on 27Jan2021 at 12:30 (at the age of 85-years-old) at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hypotonic-hyporesponsive episode with loss of consciousness on 27Jan2021 13:40, which caused hospitalization and was reported as fatal. The patient also experienced sudden cardiac arrest, bradyarrhythmia, inferior myocardial infarction with ST segment elevation, and cardiogenic shock on an unspecified date, which were reported as fatal. The clinical course was reported as: The patient first experienced hypotonic-hyporesponsive episode with loss of consciousness and was taken to the hospital for observation. The patient later experienced sudden cardiac arrest by the mechanism of bradyarrhythmia, myocardial infarction with ST segment elevation in the lower wall, and cardiogenic shock. The patient died on 31Jan2021 at 03:00. The cause of death was assessed as hypotonic-hyporesponsive episode, sudden cardiac arrest, bradyarrhythmia, inferior myocardial infarction with ST segment elevation, and cardiogenic shock. It was not reported if an autopsy was performed. The causality assessment was reported as possible for inferior myocardial infarction with ST segment elevation, cardiogenic shock, sudden cardiac arrest, and bradyarrhythmia and as unclassifiable for hypotonic-hyporesponsive episode from National Competent Authorities (NCA). Sender''s Comments: Name of the vaccine Comirnaty- COVID-19 vaccine (mRNA) - The form indicates the hypotonic-hyporesponsive episode that occurs according to the definition in children up to 2 years of age. The application concerns an adult. The episode was marked by a physician because the vaccine adverse event does not allow you to select the appropriate symptoms that are present in adults. In the opinion of the URPL, an adult hypotonic-hyporesponsive episode should not be taken into account in the assessment. In such a case, symptoms should be assessed: syncope or presyncope. Fainting with a loss of consciousness is an expected reaction after vaccination with Comirnaty. Sudden cardiac arrest, bradyarrhythmia, myocardial infarction with inferior ST segment elevation, cardiogenic shock are unexpected side effects. Until 08Feb2021, cases of cardiac arrest, acute myocardial infarction, and cardiogenic shock were reported in the EVDAS database. No cases of bradyarrhythmia have been reported. No information has been made available as to whether the patient who was an elderly person was taking medication, and we do not know his medical history. The temporal relationship speaks for a cause-and-effect relationship. The person reporting vaccine adverse event qualified it as severe. URPL assessed the vaccine adverse event as heavy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypotonic-hyporesponsive episode; Sudden cardiac arrest; Bradyarrhythmia; Inferior myocardial infarction with ST segment elevation; Inferior myocardial infarction with ST segment elevation; Cardiogenic shock


VAERS ID: 1067906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood pressure measurement, Body temperature, Heart rate, Myocardial ischaemia, Oxygen saturation
SMQs:, Myocardial infarction (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis; Essential hypertension; Hypertensive heart disease; Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure NYHA class II; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/100 mmHg; Test Date: 20210122; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210122; Test Name: Heart rate; Result Unstructured Data: Test Result:97; Comments: beats per minute; Test Date: 20210122; Test Name: Oxygen saturation; Test Result: 92 %
CDC Split Type: ROPFIZER INC2021198094

Write-up: Acute coronary syndrome; ischemic heart disease; This is a spontaneous report downloaded from the Regulatory Authority RO-NMA-2021-SP39064. A 73-year-old female patient received bnt162b2 (COMIRNATY, lot number was EL1491, expiration date was 30Apr2021) via an unspecified route of administration on 22Jan2021 at 15:30 at single dose for covid-19 immunisation. Ongoing medical history included obesity, hypertensive heart disease, essential hypertension (Grade I-II), aortic stenosis and type 2 diabetes mellitus. Other medical history included heart failure (NYHA Class II) and sequelae of ischemic stroke. The patient''s concomitant medications were not reported. Parameters recorded at the time of vaccination (15:30 on 22 January 2021) included body temperature 36.8 centigrade, blood pressure 160/100 mmHg, heart rate 97 beats per minute, oxygen saturation 92%. After vaccination, the patient was under surveillance for 15 minutes where she did not show any post-vaccine reaction. At 16:05 on 22Jan2021, according to the medical record from the emergency unit, the patient presented to this emergency unit with dyspnoea and post-vaccine malaise and ventricular fibrillation immediately after admission to the emergency unit. The patient did not respond to resuscitation maneuvers and died. The diagnosis was acute coronary syndrome without response to resuscitation, suspicion of acute coronary syndrome, ischemic heart disease and hypertensive heart disease, type 2 diabetes mellitus, obesity, condition after COVID-19 vaccination (approximate 30 minutes after vaccination). Because it was transmitted only with acute coronary syndrome without response to resuscitation, the medical assessor of the Competent Authority requested the result of the investigation at National Centre for Communicable Diseases Surveillance and Control (CNSCBT), Bucharest for investigation. Following investigation of the case by CNSCBT, Bucharest the final conclusions were coincidental adverse events following immunization (AEFI). The patient died on 22Jan2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute coronary syndrome; ischemic heart disease


VAERS ID: 1067921 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, General physical health deterioration, Hypophagia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic obstructive pulmonary disease; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021208065

Write-up: STOPPED EATING; VERY TIRED AND POWERLESS; MUSCLE PAIN; DETERIORATION OF GENERAL CONDITION; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB SE-MPA-2021-005029, other case identifiers SE-MPA-1613549310413. A 78-year-old male patient received BNT162B2 (COMIRNATY) in Jan2021 intramuscularly at single dose for COVID-19 immunisation. Medical history included Chronic obstructive pulmonary disease, Stroke, Cardiac failure, all from unspecified date and unknown if ongoing. Concomitant medications were not reported. Two days after vaccination (Jan2021) the patient had a deterioration of general condition, he stopped eating, was very tired and powerless and had muscle pain. The patient has died and the outcome is stated as fatal by the reporter. The report does not state how many days there are between the vaccination and the patient''s death. No follow-up attempts possible, information about lot/batch number cannot be obtain.; Reported Cause(s) of Death: STOPPED EATING; VERY TIRED AND POWERLESS; MUSCLE PAIN; DETERIORATION OF GENERAL CONDITION


VAERS ID: 1068320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: TRIMBOW; DOCUSATE; CARBOCISTEINE; PARACETAMOL
Current Illness: Frailty (Severe frailty of old age); Palliative care (in a nursing home, was on our palliative care list); Unable to swallow (or take her regular medications)
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; COPD; Goitre nodular; Talus fracture; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021041095

Write-up: No reaction on previous exposure to vaccine/She passed away within the expected span and did not have any new illness since the vaccine; This is a spontaneous report by Pfizer from The regulatory authority report number is GB-MHRA-WEBCOVID-202101151149396330. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 24599755. A contactable physician reported that a 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0141), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing palliative care (in a nursing home, was on our palliative care list), ongoing severe frailty of old age, ongoing unable to swallow or take her regular medications, nodular goitre from an unspecified date in 1992, TIA (Transient ischaemic attack) from an unspecified date in 2015 to an unspecified date, fracture of talus from an unspecified date in 2017 to an unspecified date, COPD/chronic obstructive pulmonary disease from an unspecified date in 2020, bedridden/bed bound from an unspecified date in Jan2020. Concomitant medication included beclometasone dipropionate, formoterol fumarate, glycopyrronium bromide (TRIMBOW, Inhaler), docusate at 50mg/5ml, carbocisteine at 250mg/5ml and paracetamol (Formulation: Soluble tablet) at 500mg. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No recorded reactions. Patient has not tested positive for COVID-19 since having the vaccine. No investigations as not relevant. Patient was progressing through severe frailty. Patient passed away within the expected span on 15Jan2021 and did not have any new illness since the vaccine. She has been deteriorating slowly for some time and her death seems natural. We were told, must report every death within 28 days of having the vaccine. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test, COVID-19 virus test: Negative. The outcome of the event was fatal. The patient died on 15Jan2021. Cause of death was not reported. No autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: No reaction on previous exposure to vaccine/She passed away within the expected span and did not have any new illness since the vaccine


VAERS ID: 1069027 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma; Gout; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death NOS; Feeling sick; A regulatory authority report (France) was received from a health care professional concerning a female patient of 92-year-old, who received Moderna''s COVID-19 vaccine(mRNA-1273) and felt sick and died. The patients medical history,as provided by the reporter, included hypertension arterial, glaucoma and gout. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: 300042722) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced feeling sick and passed away. No treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The patient died on 15 Feb 2021. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 92-year-old, female, patient, who received first of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042722) and felt sick and died. Very limited information regarding the reported events has been provided at this time. However, patient''s advanced age along with medical history of hypertension may have ben contributory.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1069329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   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: Coronary heart disease; COVID-19; Dementia; Polyneuropathy; Renal insufficiency (NINS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021221804

Write-up: COVID-19 post Infection/COVID-19 respiratory infection/COVID-19 PCR test on 28Jan2021; COVID-19 post Infection/COVID-19 respiratory infection/COVID-19 PCR test on 28Jan2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB via Regulatory Authority with Regulatory Authority number: AT-BASGAGES-2021-07099. An 88-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EL1491), via an unspecified route of administration on 15Jan2021 (at unspecified age) at single dose for covid-19 immunisation. Medical history included ongoing Renal insufficiency (NINS), ongoing Polyneuropathy, ongoing COVID-19, ongoing Coronary heart disease, ongoing Dementia. The patient''s weight was not reported, and height was not reported. No concomitant medication reported. "A possible connection between deaths and COVID vaccinations carried out shortly before is suspected. The people were all vaccinated against COVID-19 on 15Jan2021 (1st vaccination with Comirnaty, batch EL1491), tested positive 4 to 13 days later (one patient 32nd Days later) and died 10 to 20 days after the vaccination (said patient 37 days later). A comparable number of deaths has not occurred in the nursing home in recent years." COVID infection has been circulating in the home since January. All 12/14 deceased have been tested positive for Sars-CoV2 by PCR. The patient in this NW report also tested positive for Sars-CoV2 by PCR (28Jan2021), then died of his COVID infection at the home on 16Feb2021. On Jan2021 the patient experienced COVID-19 death. The patient''s outcome was fatal for COVID-19. The patient died on 16Feb2021 from COVID-19 respiratory infection. The patient underwent lab tests and procedures which included COVID-19 PCR test: Positive on 28Jan2021. The patient died on 16Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 respiratory infection/COVID-19 post Infection


VAERS ID: 1069334 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021221087

Write-up: respiratory distress; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 93-year-old male patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 23Feb2021 [Batch/lot number: unknown] (at age of 93-year-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. A few hours after the second dose, the patient experienced respiratory distress on 23Feb2021 and was treated with oxygen. Because the patient improved on 24Feb2021, the oxygen was no longer administrated. The patient died shortly after on the same day (24Feb2021). It was not reported if an autopsy was performed. The cause of death was not reported, while the outcome of event respiratory distress was reported as fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1069344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-03
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: 2021-02-27
   Days after onset: 26
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: CRPFIZER INC2021223423

Write-up: heart attack; This is a spontaneous report from a non-contactable consumer received from a Pfizer colleague. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was found her deceased at her home on 27Feb2021. Apparent cause of death was heart attack (event onset date: Feb2021). The patient died on 27Feb2021. It was not reported if an autopsy was performed. The outcome of event heart attack was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: heart attack


VAERS ID: 1069361 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-18
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; Dementia; Depression; Essential hypertension; Incontinence urinary; Mobility decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222120

Write-up: Geromarasmus; Cardiovascular failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB, Regulatory Authority number: DE-PEI-PEI2021002879. A non-contactable physician reported that a 97 years old female patient received the bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6796) at the age of 97 years old via an unspecified route of administration on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included dementia, depression, essential hypertension, incontinence urinary, chronic pain, mobility decreased, all unknown if ongoing. Concomitant medication was not reported. On 18Jan2021 after vaccination the patient developed cardiovascular failure (cardiac failure), lasting for unknown. The patient was dead on 18Jan2021. Death cause was reported as geromarasmus. An autopsy was not performed. The outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiovascular failure; Geromarasmus


VAERS ID: 1069365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Dizziness, Fall
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021222251

Write-up: fall on the head; brain massive bleeding; intensified dizziness in the days after the 1st vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech, manufacturer control number: 18836, license party for Comirnaty. A male patient of an unknown age received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 as a single dose (1 DF) for COVID-19 immunisation, lot number: not known. Medical history and concomitant medications were not provided. Report of a vaccination damage (as reported). On 21Jan2021, patient received the first dose against Covid 19 with the active of the company Biontech and Pfizer in a vaccination center. In the days thereafter, the patient suffered from intensified dizziness (onset date Jan2021). On 24Jan2021, he fell on his head at home. Since he had taken a blood thinning agent he experienced a brain massive bleeding. Due to this, he passed away on unknown date. It was unknown if an autopsy was performed. Outcome of the event dizziness was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: brain massive bleeding; fall on the head


VAERS ID: 1069387 (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: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Heart rate, Hyperhidrosis, Oxygen saturation, SARS-CoV-2 antibody test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: CYMBALTA; LORAZEPAM; FUROSEMIDA [FUROSEMIDE]; ALMAX FORTE; OMEPRAZOL; PARACETAMOL; SIMVASTATINA; FENTANILO [FENTANYL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer (Cardiovascular disease (excluding hypertension)); AV block; Constipation; COVID-19; Dyslipidaemia; Gonarthrosis (bilateral, more severe on the right); Hiatus hernia; Hip arthrodesis (left hip, when he was 18 years old, due to a tumor); Hip surgery; Hyperplasia of prostate (benign); Hypoacusis; Inguinal hernia repair; Intracerebral hematoma (post-traumatic, right fronto-basal); Left cataract extraction; Macular degeneration; Normochromic normocytic anemia; Prostate cancer (adenoma); Prostatectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: blood pressure; Result Unstructured Data: Test Result:156/76; Test Date: 20210111; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210130; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210111; Test Name: heart rate; Result Unstructured Data: Test Result:76; Test Date: 20210111; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210130; Test Name: oxygen saturation; Test Result: 64 %; Test Date: 20210130; Test Name: oxygen saturation; Test Result: 74 %; Comments: after 5 lpm oxygen; Test Date: 202008; Test Name: COVID-19 serology test; Result Unstructured Data: Test Result:positive; Comments: IgG
CDC Split Type: ESPFIZER INC2021208062

Write-up: cardio-respiratory arrest; sweaty; Acute respiratory distress syndrome/low saturation 64%/desaturations; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-755248. A 90-year-old male patient received bnt162b2 (COMIRNATY) second dose (lot number: EK9788) on 29Jan2021 11:00 a.m intramuscularly on left arm at single dose for COVID-19 immunisation, Medical history included COVID-19 (The course is asymptomatic, serology in August with positive IgG), Artificial cardiac pacemaker wearer (Cardiovascular disease (excluding hypertension)) from 2016, Dyslipidaemia, AV block, Intraparenchymal hematoma (post-traumatic, right fronto-basal) from 2015, hiatus hernia, Constipation, normochromic normocytic anemia, hip arthrodesis (left hip, when he was 18 years old, due to a tumor), Gonarthrosis (bilateral, more severe on the right), benign Prostate hyperplasia, Prostate cancer (adenoma), macular degeneration, Hypoacusia, Prostatectomy from 2010, Cataract removal, left hip surgery, Macular degeneration, Hypoacusis. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lorazepam, furosemide (FUROSEMIDA), almagate (ALMAX FORTE), omeprazole (OMEPRAZOL), paracetamol, simvastatina, fentanyl (FENTANILO). The patient previously took bnt162b2 (COMIRNATY) first dose (lot number: EJ6796) on 08Jan2021 on left arm at single dose for COVID-19 immunisation and experienced stuporous picture and suicide attempt. The resident did not present any other symptoms, or any other apparent cause. The second dose of vaccine is administered on 29Jan2021 in the morning at 11:00 a.m., he does not have any symptoms or adverse effects, he maintains good general condition, performing his usual activities without incident, until the early morning (30Jan2021) when at 2:00 a.m. he is sweaty, no pain, reactive, with shortness of breath, low saturation 64%, temp 36.3C. Oxygen is placed at 5 bpm, it rises to 74%, no fever, no rashes, no vomiting, no breath sounds, no other symptoms. Saturation improves with 60 mg of Urbason IM, but after minutes he presents desaturations again, with only response to pain stimuli, he presents cardio-respiratory arrest at 3:00 a.m., despite CPR, it is not possible to resuscitate him. He did not present any symptoms in the previous hours, at 1:00 he was fine. In the certificate doctor include the suspicion of a possible reaction, but doctor cannot confirm it either. The resident had a pacemaker, due to Left Heart Failure, so it cannot be ruled out that it was a cardiovascular cause, although he did not present other symptoms. Also refer, despite not presenting with the same picture, that in the 1st dose administered on 08Jan2021, the resident on the morning of 09Jan2021 presents a stuporous picture, with only response to painful stimuli, maintains normal vital capacities, not respiratory failure, 60mg of Urbason IM is administered due to suspecting an adverse effect to the vaccine, as well as heparin for not ruling out a thrombus. It is NOT possible at that time to refer to the hospital, because it coincides with the snowfall, he remains stable, he slowly regains consciousness at times until the early morning of 10Jan2021, which tells us that he has taken about 8 lorazepam 1 mg pills, for which is referred to Psychiatry, ruling out the reaction of the vaccine. But since another incident coincides with the 2nd vaccine, it makes us doubt if everything is related to the vaccine. Emphasizing that since he returned from hospital discharge in Psychiatry, he has maintained controls and measures to avoid self-harm. And he has maintained a good conduct and general condition. High emergency report 11Jan2021: Temperature: 36.7 T. Systolic: 156T. Diastolic: 76 Heart Rate: 76 Oxygen Saturation: 95. Reason for consultation: Suicidal behavior. Background:- Dyslipidemias: Yes - Complete AV block with implantation of a left prepectoral DDD pacemaker in 2016. He had decompensated heart failure on that admission, without structural heart disease - Post-traumatic right fronto-basal intraparenchymal hematoma in 2015 - Hiatal hernia. Chronic constipation - Chronic normochromic normocytic anemia - Left hip arthrodesis when he was 18 years old due to a tumor. Bilateral gonarthrosis, more severe on the right - Benign prostatic hyperplasia and Ca of the prostate operated in 2010, since then undergoing treatment with androgen blockade - Macular degeneration, hearing loss. - Surgeries: prostate adenoma (In follow-up by Urology (operated in 2010)). Cataract removal (left eye) surgery intervention. Surgery (left hip) Prostatectomy. Inguinal hernia. No Psychiatric history in mental health, neither admissions nor previous suicidal behaviors. - Baseline Situation: - Functional: Independent for all basic activities of daily life except bathroom and partially dressing up, continent, walks a few steps with the walker independently to his room, for the rest he handles the wheelchair. IB 75, FAC 4. Visual and hearing impairment - Mental; No cognitive impairment - Social; He lives in the residence, he has daughters. His wife with whom he lived in residence died of COVID in May 2020. - Others; Good oral intake, no falls. Current treatment: (10Jan2020): - Cymbalta 30 mg 1-0-0, Lorazepam 1 mg 0-0-2, Furosemide 40mg 0-0-1, almax forte 1.5 g 0-1-0, Omeprazole 20 mg 1-0-0, Paracetamol 1g, Simvastatin 20 mg 0-0-1, Eye drops, Fentanyl 25 mg / hour 1/72 hours. Current illness 11Jan2021: A 90-year-old man who was transferred by ambulance from the residence for drug overdose for self-harm. This is a user of a residence zone (90 years old) who apparently presented a suicidal behavior yesterday. Apparently, initially during the episode he is confused with an acute cardio-respiratory or neurological organic origin, revealing its nature when the state of consciousness improves and the patient gives information about what happened. He has been in a stuporous state, reactive to painful stimuli only, with dyspneic breathing and O2 saturation at 92%. Once recovered, the user acknowledged that he took 8-9 tablets of lorazepam 1mg the day before with self-harm interest (he tells them that "I wanted to meet with my wife"). This treatment was part of his own in an amount of 2 mg / night for evolving insomnia, indicating a previous planification. The patient is tearful, somewhat frustrated and sometimes threatening (by throwing himself out of bed), a suicide risk protocol has been initiated. They refer that, in recent months, the patient had been found with a depressed mood, a tendency to cry and adaptive difficulties congruent with a grief in pathological evolution (death of his wife due to COVID disease in May 2020, also a roommate). In the interview in the emergency room, he is calm, making complete criticism of the attempt and denying current suicide planning. However, labile and tearful when the subject of his wife''s death is brought up. It is agreed with residence, family and patient to brief admission of observation in Psychiatry. Psychopathological exploration: Conscious, globally oriented. Without acute cognitive deficits and good baseline condition. Depressive mood referred from months of evolution of reactive type - grief. Tendency to cry, frustration and querulance in the last hours (with regressive tinge). At this moment, he does not criticize the gesture (method: drug, lethality: low / medium, recoverability: high, reported: no, Context: depressive affect). The depth of the previous planning as well as the degree of impulsiveness in the act is unknown. Maintains suicidal communication according to third parties. They deny psychoticism or sensory-perceptual alterations. They deny previous rhythmopathies. Reality judgment preserved. Clinical judgment: Axis I Diagnosis: Voluntary drug overdose. Grief (probable pathological event with depressive clinic installation). Derivation: Voluntary admission to the brief hospitalization units. Treatment upon admission to the brief hospitalization units (11Jan2021): - Cymbalta 60mg 1-0-0 - Lormezepam 1mg 0-0-2 (restart after 24 hours from this moment). Organic treatment without changes. Admission 11Jan2021 to 19Jan2021 - evolution summary: He remains admitted for 8 days for containment and observation of ideas / autolytic behaviors. The admission is uneventful. From the first day the patient verbalizes complete criticism of the attempt and denies suicidal planning at all times. Lability and a tendency to cry are observed when talking about his wife or meeting his daughters, but reactive to a normal grieving process. The daughters also say that he has a sensitive personality and a tendency to worry. In the interviews, no signs of major affective disorder were observed. The antidepressant treatment with duloxetine (Cymbalta) is increased to 60 mg / day, well tolerated, seeking a reduction in levels of anxiety and less lability. In addition, Traumatology was consulted for hip pain (CT: intra-articular penetration of the cephalic screw and collapse of pertrochanteric fracture, no major changes compared to previous X-ray. Institutionalized patient, most of the day lying in residence, hardly wandering. Tolerable pain and high surgical risk due to age. Conservative treatment for now. Scheduled analgesia). In accordance with the patient, the daughters and the residence, he is discharged from residence. Previously, Covid-19 PCR was performed, which was negative. Clinical trial: Axis I Diagnosis: Voluntary drug overdose. Complicated grief. Treatment: - Cymbalta 60mg 1-0-0 - Lormetazepam 2 mg 0-0-1. Rest of medical treatment unchanged. Other recommendations: Family visits are recommended for the emotional well-being of the patient. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome/low saturation 64%/desaturations; cardio-respiratory arrest


VAERS ID: 1069400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: OXYNORM; ORLOC; FURESIS; DINIT [ISOSORBIDE DINITRATE]; EBIXA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Hypertension; Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021212903

Write-up: natural death; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB FI-FIMEA-20210865. A 95-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, LOT# EL1491, expiration date: unknown) intramuscularly on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included heart failure, hypertension and osteoarthritis. Concomitant medication included oxycodone hydrochloride (OXYNORM), bisoprolol fumarate (ORLOC), furosemide (FURESIS), isosorbide dinitrate (DINIT), memantine hydrochloride (EBIXA). The patient died on 24Jan2021, reported as natural death. Unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: natural death


VAERS ID: 1069401 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
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: 2021-01-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021212852

Write-up: Death; This is a spontaneous report from a contactable physician via downloaded from the Regulatory Authority-WEB FI-FIMEA-20210869. A 85-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 20Jan2021 at single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced death on 25Jan2021. The patient lived in the housing service unit of the elderly social care and he died on 25Jan2021. It was not reported if an autopsy was performed. The death is not suspected to be caused by the covid vaccine. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on limited information and drug profile, the reported death of the patient is assessed as unrelated to suspected drug BNT162B2.; Reported Cause(s) of Death: Death


VAERS ID: 1070294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4176/PF / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Cardiomegaly, Condition aggravated, Contusion, Death, Decreased appetite, Fatigue, Ocular hyperaemia, Pain in extremity, Productive cough, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; BISOPROLOL; CETIRIZINE; CO-CODAMOL; DOXAZOSIN; DOXYCYCLINE; FINASTERIDE; IPRATROPIUM BROMIDE; LOSARTAN; NICORANDIL; TAMSULOSIN; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cardiomegaly; COPD; Fatigue; Hypertension; IHD; Productive cough; Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021214861

Write-up: Death NOS; sepsis; cardiomegaly; bruising; bloating; worsening productive cough; worsening productive cough; fatigue; sore arm; blood shot eyes; poor appetite; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102250858124940, Safety Report Unique Identifier GB-MHRA-ADR 24832873. A 70-year old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176/PF), via an unspecified route of administration on 15Feb2021 at single dose for covid-19 immunisation. Medical history included productive cough, cardiomegaly, fatigue, chronic obstructive pulmonary disease, IHD (Ischaemic heart disease), hypertension and benign prostatic hyperplasia. The reporter was unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included amlodipine for hypertension, acetylsalicylic acid (ASPIRIN) for Ischaemic heart disease, atorvastatin for Ischaemic heart disease, bisoprolol for Ischaemic heart disease, cetirizine, codeine phosphate, paracetamol (Co-codamol), doxazosin , doxycycline for COPD exacerbation from 25Jan2021, finasteride, ipratropium bromide, losartan, nicorandil, tamsulosin for benign prostatic hypertrophy and zopiclone. The patient experienced Death NOS on 15Feb2021 (as reported). On an unspecified date in Feb2021 the patient experienced sepsis, cardiomegaly, bruising, bloating, worsening productive cough, fatigue, sore arm, blood shot eyes and poor appetite. The patient died on 24Feb2021 (as reported). It was not reported if an autopsy was performed. At the time of death the outcome of sepsis, cardiomegaly, bruising, bloating, worsening productive cough, fatigue, sore arm, blood shot eyes and poor appetite was unknown. The clinical course was reported as follows: Had consulted, regarding ongoing symptoms of productive cough and fatigue since late Dec2020. Had vaccination on 15Feb2021, daughter reports that after vaccination he became increasingly unwell over next few days with sore arm blood shot eyes worsening cough poor appetite and sever fatigue, plan was to call GP if no better the next day but daughter found dead the next day, paramedic reported bloating of body and bruising suggesting sepsis. Death has been reported to PF. Death may be unrelated to vaccine but daughter feels may have contributed since he seemed to suddenly deteriorate after it. Hence reporting this to you. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH NOS


VAERS ID: 1070308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Hypokinesia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 34
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: ASPIRIN (E.C.); ATORVASTATIN; SINEMET; SOTALOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease Parkinson''s; Ischaemic heart disease; Pre-diabetes; Respiratory failure; Comments: Parkinsons Pre- diabetes Ischaemic heart Disease Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021217899

Write-up: respiratory failure; guillain barre syndrome; Movements reduced; This is a spontaneous report from a contactable physician received from The regulatory authority report number is GB-MHRA-ADR 24840407. Safety Report Unique Identifier is GB-MHRA-WEBCOVID-202102260910458050. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 for COVID-19 vaccination. The patient''s relevant medical history included Disease Parkinson''s, Pre-diabetes, Ischaemic heart Disease. The patient had not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications included:acetylsalicylic acid (ASPIRIN), atorvastatin, carbidopa, levodopa (SINEMET) and sotalol. On 20Jan2021 the patient was admitted to hospital with reduced mobility (movements reduced). It was further reported that the patient was diagnosed with Guillain Barre Syndrome on 20Jan2021.The reporting physician believed this ultimately lead to his respiratory failure occurred on unknown date and death occurred on 23Feb2021. It was not reported whether autopsy was carried out. On 19Jan2021 a COVID-19 virus test was taken and result was negative. Patient had not tested positive for COVID-19 since having the vaccine. The physician considered the events serious due to being medically important events. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Movements reduced


VAERS ID: 1070309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Computerised tomogram thorax, Dyspnoea, Musculoskeletal pain, Neutropenia, Pericarditis, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myeloid leukaemia; Body mass index high; Cardiac arrest; Chest pain; Gastrooesophageal reflux disease; High cholesterol; Hypertension; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Comments: Not normally a patient of our Trust PMH: AML, HTN. T"DM. High BMI, High Cholesterol, GORD Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial Patient history: Start: N/A Stop: N/A AML Continuing? Unknown.
Allergies:
Diagnostic Lab Data: Test Name: CTPA; Result Unstructured Data: Test Result:pericardial effusion and bilateral basl; Comments: atelectasis (no failure); Test Date: 20210221; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021217760

Write-up: cardiac arrest; interscapular pain; shortness of breath; Pericarditis; chest pain; neutropenic; This is a spontaneous report from a contactable other health professional received from the MHRA. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202102261055561130. Safety Report Unique Identifier GB-MHRA-ADR 24841076. A 72-year-old female patient received first dose of BNT162B2 (BNT162b2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included cardiac arrest, chest pain, high cholesterol (unknown if ongoing), neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), acute myeloid leukaemia (unknown if ongoing), hypertension (unknown if ongoing), body mass index high (unknown if ongoing) and gastrooesophageal reflux disease (GORD, unknown if ongoing). The patient''s concomitant medications were not reported. The patient previously took ado-trastuzumab emtansine. The patient was not normally a patient of the trust of the reporter. Patient was not enrolled in clinical trial. The patient experienced chest pain on 21Feb2021 with outcome of unknown, cardiac arrest on 25Feb2021 with outcome of unknown, pericarditis on 21Feb2021 with fatal outcome on 26Feb2021, interscapular pain on 21Feb2021 with outcome of unknown, shortness of breath on 21Feb2021 with outcome of unknown, neutropenic in Feb2021 with outcome of unknown. The patient was hospitalized due to the events on 21Feb2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 21Feb2021, computerised tomogram (CTPA): pericardial effusion and bilateral basl atelectasis (no failure) on unknown date. Patient was diagnosed with pericarditis on 21Feb2021. On 25Feb2021 patient experienced cardiac arrest 2 times with return of spontaneous circulation (ROSC) in between then pulseless electrical activity (PEA) arrest. The patient died on 26Feb2021 due to pericarditis. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pericarditis


VAERS ID: 1070333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Blood pressure measurement, Bradycardia, Cardiac arrest, Circulatory collapse, Heart rate, Hemiparesis, Hypotension, Syncope, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; XARELTO; BISOPROLOL; SALOFALK [MESALAZINE]
Current Illness: Atrial fibrillation; Crohn''s disease; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:barely measurable blood pressure; Test Date: 20210213; Test Name: Heart rate; Result Unstructured Data: Test Result:weak arrhythmic pulse
CDC Split Type: HUPFIZER INC2021213553

Write-up: collapsed; right sided body weakness; aphasia; Circulatory and respiratory collapse; hypotension; bradycardia; asystolia; ventricular fibrillation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-073421. An 85-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EL0725, expiry date: Mar2021), intramuscular on 13Feb2021 at 9:45 at 0.3 mL, single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation, hypertension and Crohn''s disease. Concomitant medication included amlodipine from 2010 for hypertension, rivaroxaban (XARELTO) from 2018 for atrial fibrillation, bisoprolol from 2010 for hypertension, mesalazine (SALOFALK, formulation: tablet) at 500 mg from 2007 for Crohn''s disease. On 13Feb2021 at 10:50, the patient fainted after going up a 30 steps-stair in a cemetery. Clinical course: when the paramedics arrived, the patient was unconscious, had barely measurable blood pressure, he had a weak arrhythmic pulse. One ampoule of TONOGEN 1 mg/ml solution for injection (epinephrine, MAH: Richter Gedeon Nyrt.) was injected intramuscularly. After resuscitation, the patient was transported to the hospital at 12:17. During transport, right sided body weakness and aphasia was observed with hypotension, with returned consciousness. Circulatory and respiratory collapse, bradycardia, asystolia occurred in the hospital. Immediate intubation and thoracic compression were performed, a total of 4 ampoule of TONOGEN were given and 200 J defibrillation was performed twice due to ventricular fibrillation. Following an unsuccessful cardiopulmonary resurrection (CPR), on 13Feb2021, at 12:35 pm, the patient died. Official autopsy was performed due to the extraordinary death; the cause of death was a partial rupture of the main artery of the heart (aortic dissection, which resulted more blood entering the pericardium). The medical expert stated that the vaccine was not associated with the death. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on available information, the reported events are more likely intercurrent and are assessed as unrelated to the suspect drug. The events are due to a partial rupture of the main artery of the heart (aortic dissection, which resulted more blood entering the pericardium).; Reported Cause(s) of Death: Aortic dissection; Autopsy-determined Cause(s) of Death: Aortic dissection


VAERS ID: 1070344 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness
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)

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: DECORTIN; METHOTREXATE; FOLIC ACID; PREDNISOLON [PREDNISOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (He has frequent heart rythm irregularities despite having a pacemaker); Artificial cardiac pacemaker wearer; Condition aggravated (In Jan2021 the patients condition was worsening); Condition worsened (condition was deteriorating); Edema (had tophi, sausage fingers, edema and ligament inflammation); Fingers swollen feeling of (had tophi, sausage fingers, edema and ligament inflammation); Gouty arthritis (active rheumatic disease, treated. Had tophi, sausage fingers, edema and ligament inflammation); Heart disorder (unspecified); Illness (chronically ill); Ligament inflammation (had tophi, sausage fingers, edema and ligament inflammation); Musculoskeletal disorder (problems buttoning his shirt, playing piano, using fork +knife the past weeks prior to passing away); Pain foot (had bad pain in his foot around the end of 2020, beginning of 2021 and was hospitalised for 1 night)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021213222

Write-up: Death; collapsed at home; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IS-IMA-1794. This case was received via an e-reporting system by IMA from a physician. An 89-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY) at single dose on 21Jan2021 for covid-19 immunisation. Medical history included gouty arthritis (active rheumatic disease) from 1990 and was being treated for this condition, unspecified heart disease and had a pacemaker. Patient was chronically ill. The patients condition was deteriorating. He had tophi, sausage fingers, edema and ligament inflammation. He had problems buttoning his shirt, playing the piano and using a fork and knife the past weeks prior to passing away. Fluid came from the tophi on his foot in 2018/2019 and from his finger in Nov2020. He has frequent heart rythm irregularities despite having a pacemaker. The patient had bad pain in his foot around the end of year 2020, beginning of 2021 and was hospitalised for one night, this is 3-4 weeks prior to his death. The patient is dismissed in the morning. In Jan2021 the patients condition was worsening. He could not use his hands due to inflammation and edema. He only moved between his bed and armchair. He needed help to get out of the chair. His wife helped him get dressed and fed him. His general condition was quite bad at this point and on 23Jan2021 the patient was prescribed methotrexate 7 tablets per day, all on the same day. Concomitant medication included prednisone (DECORTIN) 2.5 - 10 mg/per day as needed, methotrexate (manufacturer unknown) 7 tablets per day form 23Jan20201 for arthritis gout, folic acid (manufacturer unknown) 5mg, prednisolon (manufacturer unknown), NSAID, PPI and unspecified cardiac medicines in unknown doses for an unknown duration of time. The patient previously took diclofenac sodium (VOSTAR), allopurinol for many years but it is unclear if he took the medicine as prescribed. On 26Jan2021 night/27Jan2021 early morning the patient collapsed at home. On 30Jan2021 the patient passed away. An autopsy was not performed. Reporter''s comments: The reporting physician states that this was a patient with long-term underlying illnesses, which was being treated for a difficult rheumatic disease. The patients treating physician was not contacted prior to administration of the vaccine. He considers the administration of the vaccine to this patient to be not in line with the instructions on the website of the directorate of health, dated 19Jan2021. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reporter''s Comments: The reporting physician states that this was a patient with long-term underlying illnesses, which was being treated for a difficult rheumatic disease. The patients treating physician was not contacted prior to administration of the vaccine. He considers the administration of the vaccine to this patient to be not in line with the instructions on the website of the directorate of health, dated 19Jan2021.; Reported Cause(s) of Death: The death certificate dated 03-FEB-2021, issued following the autopsy states that the cause of death is unclear.


VAERS ID: 1070405 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC2021216740

Write-up: Death occurred 15 minutes post vaccine; This is a spontaneous report from a contactable physician via Pfizer colleague. An 84-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration, at 84-year-old, on an unspecified date as a single dose for COVID-19 immunization. Medical history included severe Alzheimer. Concomitant medications were not reported. On an unspecified date, the patient experienced death occurred 15 minutes post vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the batch number has been requested.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. A causal association between BNT162B2 and the reported death cannot be completely excluded based on a compatible temporal relation. Note however that patient''s medical history and concomitant medications are not provided in this report. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death occurred 15 minutes post vaccine


VAERS ID: 1070417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: Hospitalization; Rehabilitation therapy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dementia; Femoral neck fracture; Hip prosthesis insertion
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: CT value 25; Test Date: 20210111; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: CT value 35
CDC Split Type: NLPFIZER INC2021213098

Write-up: Heart failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00446835. A 77-years-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 30Dec2020, mild dementia, femoral neck fracture, hip prosthesis insertion. Patient was admitted for rehabilitation on 03Dec2020 after a femoral neck fracture and hip replacement; was discharged home on 28Jan2021 (the day of vaccination). Due to the pandemic, SARS-CoV-2 test was taken which turned out to be positive (CT value 25) on 30Dec2020. She had been nursed in isolation until 11Jan2021. She had not had any corona related complaints at all. On 11Jan2021, the SARS-CoV-2 test was still positive (CT value 35), on the basis of the new FMS guideline, she had been declared non-infectious and the isolation had been lifted. The patient did not have any COVID-19 related symptoms during her stay. The patient had no cardiac history. Concomitant medications were not reported. On 08Feb2021, the general practitioner visited her because of symptoms of heart failure, which was treated with furosemide. On 12Feb2021, she was found lifeless by her husband; CPR was performed without successful. The patient died due to heart failure on 12Feb2021. It was unknown if an autopsy was done or not. Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; heart failure and death. Additional information ADR: Patient was admitted for rehabilitation after a neck fracture and hip replacement; was discharged home on 28Jan2021 (the day of vaccination). On 08Feb2021 the GP visited her because of signs of heart failure, on 12Feb2021 she was found lifeless by her husband; resuscitation was unsuccessful. Important info: she was admitted to our rehabilitation center on 03Dec2020. Due to the pandemic, a corona PCR test was taken which turned out to be positive CT value 25. She has been nursed in isolation until 11Jan2021. She has not had any corona related complaints at all. On 11Jan2021 the PCR was still positive (CT value 35). On the basis of the new FMS guideline, she has been declared non-infectious and the isolation has been lifted. The remaining stay in the rehabilitation center also had no complaints. Secondary diagnosis: her mild dementia was not familiar with cardiac problems, so the development of heart failure is striking. Vaccinated 4 weeks apart from pos PCR on the basis of National Institute for Public Health and the Environment guideline. COVID19: Previous COVID-19 infection: disease symptoms: none Other diagnostic procedures: no No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past therapy (Comirnaty): no; heart failure and death. On 08Feb2021 the GP visited her due to heart failure, on 12Feb2021 she was found lifeless; resuscitation was unsuccessful. Important info: on 30Dec2020, PCR test positive. On 11Jan2021 PCR still positive. Secondary diagnosis: her mild dementia was not familiar with cardiac problems, so the development of heart failure is striking. Vaccinated 4 weeks apart from pos PCR. Previous COVID19: no disease symptoms; no other diagnostic procedures.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1070418 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Mesenteric artery thrombosis, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

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: COLECALCIFEROL; SITAGLIPTINE JANUVIA; TOLBUTAMIDE; FERROFUMARAAT; OMEPRAZOL; ACETYLSALICYLZUUR; METOPROLOL; NIFEDIPINE; SIMVASTATINE; ISOSORBIDEMONONITRAAT; LISINOPRIL; CYANOCOBALAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal adenoma; Atherosclerosis; Breast carcinoma; Hypertension; Infarction; Iron deficiency anaemia; MGUS; Non STEMI; Sarcoidosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021212816

Write-up: Intestinal ischemia; superior mesenteric artery thrombosis; refractory shock; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NL-LRB-00446969. An 88-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included adrenal adenoma, hypertension, breast carcinoma from 2012, monoclonal gammopathy of undetermined significance (MGUS) from 2020, iron deficiency anaemia, atherosclerosis, type 2 diabetes mellitus, non stemi from 2018, sarcoidosis from 1973 and infarction from 2004. The patient''s concomitant medications included colecalciferol, sitagliptine (SITAGLIPTINE JANUVIA), tolbutamide, ferrous fumarate (FERROFUMARAAT), omeprazole (OMEPRAZOL), acetylsalicylzuur, metoprolol, nifedipine, simvastatine, isosorbide mononitrate (ISOSORBIDEMONONITRAAT), lisinopril, cyanocobalamine. Patient experienced intestinal ischemia (death) following administration of covid-19 vaccine. Drugs and latency between covid-19 vaccin pfizer and intestinal ischemia was 2 days after start. Clinical course reported as follow: the patient experienced a superior mesenteric artery thrombosis leading to colon ischaemia. This lead to refractory shock and eventually to circulation stop and resuscitation. Patient had output again but because of bad prognosis and wish of the patient, no further treatment was performed. The patient deceased an unknown period after vaccination. It was unknown if an autopsy was performed. The report was assessed as serious. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reported Cause(s) of Death: superior mesenteric artery thrombosis; refractory shock; intestinal ischemia


VAERS ID: 1070419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration, Somnolence, Vomiting
SMQs:, Acute pancreatitis (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: 2021-02-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: quite); Parkinson''s disease aggravated; Parkinsonism
Allergies:
Diagnostic Lab Data: Test Name: CT brain; Result Unstructured Data: Test Result:showed no abnormalities; Test Date: 20200328; Test Name: corona, bevestigd met test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021212821

Write-up: Aspiration pneumonia; Vomiting; Somnolence; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00448059. An 85-year-old male patient received BNT162B2 (COMIRNATY, Batch/lot number: EM0477), via an unspecified route of administration on 04Feb2021 at 0.3 mL, single for covid-19 immunisation, clozapine (strength: 6.25mg tablet) via an unspecified route of administration from 2020 at 12.5 mg once daily for severe hallucinations in advanced Parkinson''s. Medical history included parkinsonism, advanced Parkinson''s, previous COVID-19 infection on 28Mar2020 (disease symptoms: quite). Concomitant medication included paracetamol (strength: 500mg). It was reported that patient experienced somnolence/no drowsiness on 06Feb2021 (2 days after use of covid-19 vaccine) and requiring treating with a short-term hospitalization and visiting a neurologist. The patient developed aspiration pneumonia on 10Feb2021 (6 days after use of covid-19 vaccine) due to vomiting on 07Feb2021 (3 days after use of covid-19 vaccine) leading to aspiration and required hospitalization. The patient with advanced Parkinson''s eventually died on 10Feb2021. Clozapine tablet was also considered suspect. The patient underwent lab test which included "corona, bevestigd met test": positive on 28Mar2020 and diagnostic procedure CT brain by neurologist which showed no abnormalities (undated). The action taken in response to the events for clozapine was dose reduced. The patient died on 10Feb2021. The reported cause of death was vomiting and aspiration pneumonia. It was not reported if an autopsy was performed. The outcome of vomiting and aspiration pneumonia is fatal, the outcome of somnolence is unknown. Reporter''s Comments: Hospitalization information: re-submitted due to vomiting where aspiration also occurred, eventually died on 10Feb2021, so 6 days after vaccination the patient with advanced Parkinson''s died due to aspiration pneumonia. Additional information ADR: reduced approachable vomiting. Hospitalization information: resent due to vomiting where aspiration also occurred, eventually died on 10Feb2021, so 6 days after vaccination the patient with advanced Parkinson''s died as a result of aspiration pneumonia. Confounding factors: advanced Parkinson''s. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: aspiratiepneumonie bij vergevorderde m Parkinson; vomiting


VAERS ID: 1070420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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: 2021-02-14
   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: FOSINOPRIL;HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021212813

Write-up: heart arrest (father died suddenly; suspected acute cardiac arrest); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00448420. An 86-year-old male patient received bnt162b2 (COMIRNATY) (lot number: unknown) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fosinopril/hydrochlorothiazide. The patient experienced heart arrest (death) (father died suddenly; suspected acute cardiac arrest) on 14Feb2021, 6 days after vaccination. No previous COVID-19 infection. No other diagnostic procedures. It was not reported if an autopsy was performed. The outcome of the event is fatal. Health Authority Comment: BioNTech / Pfizer vaccine (Comirnaty): Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, deceased. Additional information ADR: father died suddenly; suspected acute cardiac arrest. COVID19: Previous COVID-19 infection: No. Other diagnostic procedures: no. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: heart arrest (father died suddenly; suspected acute cardiac arrest)


VAERS ID: 1070421 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021220946

Write-up: Painful arm; Headache; Nausea; This is a spontaneous report from a contactable consumer received via Pfizer employee. An 83-year-old male patient received first dose bnt162b2 (COMIRNATY, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history included cardiac disorder (heart patient), cardiac pacemaker insertion (had a pacemaker). The patient''s concomitant medications were not reported. The patient experienced painful arm (death) on 25Feb2021, headache (death) on 25Feb2021, nausea (death) on 25Feb2021. The reporter mentioned: ''''Today a friend of mine called about his grandfather who received his first Comirnaty vaccine yesterday. This morning his Grandfather (PRIVACY) died. The complaints overnight and right until he died were painful arm, headache and nausea. The general practitioner PRIVACY) will report this potential side effect as well.'''' The patient died on 26Feb2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: painful arm; headache; nausea


VAERS ID: 1070426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, General physical health deterioration, Loss of consciousness
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)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (advanced); Immobile; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: C-reactive protein; Result Unstructured Data: Test Result:156
CDC Split Type: NOPFIZER INC2021213102

Write-up: REDUCED GENERAL CONDITION; unconscious; CRP was 156; This is a spontaneous report from contactable physician downloaded from the Regulatory Authority-WEB regulatory authority or other manufacturer number NO-NOMAADVRE-FHI-2021-Unmrz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015989. A 79-year-old male patient received bnt162b2 (COMIRNATY, lot: EJ6789), intramuscular on 09Feb2021 12:14 at single dose on right arm for covid-19 immunisation. Medical history included living in residential institution, he had advanced dementia and had been immobile for a long time, but he could sit. The concomitant medications were not reported. On evaluation on 11Feb2021 he had severely reduced general condition, was unconscious, and palliative treatment was started. Two days after the second vaccination on 11Feb2021 CRP was 156, and treatment with cefotaxime sodium (CEFOTAXIM) IV was initiated due to relatives wishes. The patient died two days later on 13Feb2021. It was not reported if an autopsy was performed. The outcome of reduced general condition was fatal, of other events was unknown. Sender''s Comment: A nursing home patient with advanced dementia and immobility received vaccine dose no. 2 and died four days later. It is stated that the patient just over a week earlier had been assessed with severely reduced AT, not contactable and was placed on a palliative care package. Two days after the second dose was set, the CRP was measured at 156. The patient was put on a regimen of Cefotaxin iv at the request of relatives. The patient died two days later. Comment: The most commonly reported adverse reactions for Comirnaty in clinical trials were injection site tenderness (63.7%), injection site pain (54.2%), headache (52.6%), fatigue (53.1%), myalgia (44, 0%), malaise (44.2%), fever (including fever (33.6%) and fever$g 38 ? C (7.9%)), chills (31.9%), arthralgia (26.4% ) and nausea (21.9%). The majority of adverse reactions were mild to moderate in severity and resolved within a few days after vaccination. Systemic side effects are often more pronounced after the second dose than after the first dose of this vaccine. The information in the report may indicate that the patient had an infection that resulted in high CRP and reduced general condition. CRP elevation is not indicated under adverse reactions in the approved Summary of Product Characteristics for Comirnaty, but theoretically it is conceivable that an acute inflammation associated with the vaccination may cause a slight transient CRP elevation. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else random, at the same time a cause that has nothing to do with the vaccination in question. Normally, between 300 and 400 people die per week in nursing homes and similar institutions in Norway. In a Norwegian study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and find, among other things, that the risk of death is increased in the first four months after hospitalization, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebro-vascular disease accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (~ 20%), respiratory and infectious diseases (including pneumonia and sepsis) (~ 15%), and cancer (~ 10%). 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. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION


VAERS ID: 1070427 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Lethargy, Pneumonia, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: 2021-02-08
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APOCILLIN
Current Illness: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: X-ray; Result Unstructured Data: Test Result:showed pleural fluid
CDC Split Type: NOPFIZER INC2021212836

Write-up: REDUCED GENERAL CONDITION; LETHARGY; LABORED BREATHING; PNEUMONIA; This is a spontaneous report from contactable physician (patients son) downloaded from the Regulatory Authority-WEB regulatory. Authority number NO-NOMAADVRE-FHI-2021-Uqpnx, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00015367. A 96-years-old male patient received second dose of bnt162b2 (COMIRNATY, Lot # EJ6795), intramuscular on 27Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing living in nursing home. Concomitant medication included phenoxymethylpenicillin potassium (APOCILLIN) for pneumonia. The patient previously received first dose of bnt162b2 on 06Jan2021 for covid-19 immunisation and experienced lethargy. The patient experienced reduced general condition on 27Jan2021, labored breathing in Jan2021, pneumonia in Jan2021, lethargy on 27Jan2021. Clinical course reported as: 27Jan2021: After the second vaccine dose, he seemed completely "knocked out" for the rest of the day. A physician who came on a planned visit had to leave without achieving contact / dialogue. He didn''t answer his phone in the afternoon, and according to the staff he had fatigue after the vaccination. The next day everything seemed normal (as before the vaccination) on the phone. A couple of days later, he gradually became more lethargy/fatigue and a little heavier in his breath. Signs of obstruction were pointed out, maybe also signs of pneumonia, after examination by doctor. Later, pneumonia was confirmed and Apocillin per os was started. He gradually got worse. 02Feb2021: In the evening he had not had any intake of any food, drink or tablets, and at the staff did not get in touch with him. 03Feb2021. The next day antibiotics were started intravenous and X-rays showed pleural fluid. Diuretics was also started. From physician point of view, at first it seemed as if he was responding to the treatment. 07Feb2021 he become so much worse and it was decided to discontinue antibiotics and intravenous (fluid) and switch to palliative treatment and oxygen. 08Feb2021 the next day he was uncontactable, and in the afternoon he died. (The treatment facility has not considered it to be a connection between the vaccine and the event and has not found reason to report it as a side effect. The reporter has conferred with NOMA and was encouraged to report suspected ADR.) It was not reported if an autopsy was performed. Cause of death was not explicitly stated by the reporter; however pneumonia seems as a probable cause according to the reporters explanation of the incident. Sender Comment: The studies that the temporary approval of the vaccine is based on, included very few people over the age of 85. We therefore know little about how any side effects will affect the very elderly. However, we assume that the side effects will largely be the same in the elderly as in those over 65 years of age. The large clinical studies have shown that most people who receive mRNA vaccines experience discomfort a few days after vaccination; such as stab wound pain, lethargy, headache, muscle and joint pain, nausea and fever. For most people, the ailments are just unpleasant and disappears within a couple of days. However, we cannot rule out that such relatively mild side effects as lethargy, fever and nausea may lead to a more severe course in severely debilitated patients. Systemic side effects are often more pronounced after the second dose than after the first dose of this vaccine. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else random, at the same time a cause that has nothing to do with the vaccination in question. 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.; Reported Cause(s) of Death: REDUCED GENERAL CONDITION; LABORED BREATHING; PNEUMONIA; LETHARGY


VAERS ID: 1071062 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-17
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (no medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Unknown cause of death; A regulatory report received from a Physician concerning, a 58-year-old, female patient who received Moderna COVID-19 vaccine and died. The patient''s medical history was not included. Patient''s concomitant was not included. On 15 FEB 2 021, the patient received their second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042698) intramuscularly for prophylaxis of COVID-19 infection. First dose was given on 18 JAN 2021. Patient received the second dose of the Moderna COVID-19 vaccine on 15 FEB 2021 and patient passed away on 17 FEB 2021. No other information was report. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was fatal.; Reporter''s Comments: This case concerns a 58-year-old, female, patient, who received second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 300042698) and died due to unknown cause. The medical history and concomitant medication is not provided. Very limited information regarding the event of death has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1071882 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Circulatory collapse, Hyperpyrexia, SARS-CoV-2 test, Vaccination complication
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: LASIX [FUROSEMIDE]; COUMADIN; DAPAROX [PAROXETINE HYDROCHLORIDE]
Current Illness: Atherosclerosis; Atrial fibrillation; Atrial flutter; Chronic renal insufficiency; Cognitive disorder; COPD; Depression; Hypertensive heart disease; Monoclonal gammopathy; Unspecified hypertensive heart disease without congestive heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Decompensation cardiac; Cardiovascular collapse; Hyperpyrexia; Vaccination adverse reaction; A regulatory authority report (Italy) was received from a health professional concerning a 98-year-old, female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced vaccination adverse reaction /MedDRA PT: vaccination complication, hyperpyrexia, cardiovascular collapse/ MedDRA PT: circulatory collapse, and decompensation cardiac/ MedDRA PT: cardiac failure. The patient''s medical history included cognitive disorder, atherosclerosis, chronic obstructive pulmonary disease (COPD), atrial flutter, monoclonal gammopathy, unspecified hypertensive heart disease without congestive heart failure, hypertensive heart disease, atrial fibrillation, depression, and chronic renal insufficiency. Products known to have been used by the patient, within two weeks prior to the event, included furosemide, warfarin sodium, and paroxetine hydrochloride. On 10 Feb 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient experienced vaccination adverse reaction, hyperpyrexia, cardiovascular collapse, and decompensation cardiac. Treatment information was not provided. The patient died on 14 Feb 2021. The cause of death was reported as decompensation cardiac. There was no autopsy performed.. Action taken with the second dose of mRNA-1273 in response to the event was reported as not applicable. The outcome for the events of vaccination adverse reaction, hyperpyrexia, cardiovascular collapse, and decompensation cardiac was fatal.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1072559 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, 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: 2021-02-02
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC2021221810

Write-up: COVID-19 PCR test Positive; COVID-19 respiratory infection; COVID-19 PCR test Positive/COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority AT-BASGAGES-2021-04882. A 93-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number EL1491), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing COVID-19 Infection. Concomitant medications were not reported. In Jan2021 the patient experienced COVID-19 respiratory infection. The patient''s COVID-19 PCR test was Positive on 25Jan2021. The patient died on 02Feb2021 from COVID-19 respiratory infection. No autopsy was done. The outcome of the events was fatal. Relatedness of Comirnaty to AE assessed by BASGAGES as Unlikely. No follow-up attempts are possible. No further information is expected. Lot/batch number was provided.; Reported Cause(s) of Death: COVID-19 respiratory infection


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