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

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1211719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Malaise, 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: 2021-03-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NU-SEALS; FUROSEMIDE; RANEXA; PANTOPRAZOLE; PROLIA; COVERSYL [PERINDOPRIL ERBUMINE]; LIPITOR [ATORVASTATIN CALCIUM]; CARDICOR; ZOPITAN; AVODART; NEURONTIN; XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Benign prostatic hyperplasia; CABG; Congestive cardiac failure; Coronary arterial stent insertion; Coronary artery disease (cor artery disease and stents); Gastrooesophagitis; Heart failure; Hypertension; Neuropathy; Osteoarthritis; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370907

Write-up: DIED SUDDENLY; SHIVERY; UNWELL; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. This is a report received from Regulatory Authority (RA) Regulatory authority number IE-HPRA-2021-070237. An 89 years old male patient received second dose of BNT162B2 (COMIRNATY, Lot Number: ER7812) via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunisation. Medical history included coronary artery disease "cor artery disease and stents", hypertension, coronary arterial stent insertion, gastrooesophagitis, osteoporosis, angina pectoris, heart failure, neuropathy, osteoarthritis, CABG, benign prostatic hyperplasia and congestive cardiac failure. Historical vaccine was reported as first dose of Comirnaty on 17Feb2021. Concomitant medications included acetylsalicylic acid (NU-SEALS) taken for coronary artery disease and stents, furosemide taken for cardiac failure, ranolazine (RANEXA) taken for angina, pantoprazole taken for gastrooesophagitis, denosumab (PROLIA) taken for osteoporosis, perindopril erbumine (COVERSYL) taken for hypertension, congestive cardiac failure, atorvastatin calcium (LIPITOR) taken for coronary artery disease, bisoprolol fumarate (CARDICOR) taken for congestive cardiac failure and angina, zopiclone (ZOPITAN) taken for hypnotic, dutasteride (AVODART) taken for benign prostatic hyperplasia (BPH), gabapentin (NEURONTIN) taken for neuropathy feet, alfuzosin hydrochloride (XATRAL) taken for benign prostatic hyperplasia (BPH), start and stop date were not reported. The patient experienced shivery and unwell on 21Mar2021 and died suddenly on 22Mar2021. The events were assessed as serious (death). It was reported that the patient was well after vaccination. On the night of 21Mar2021, the patient was unwell and shivery. On 22Mar2021, at 6 am, the patient was found dead. It was reported that the patient died suddenly. The outcome of all the events was fatal. The Coroner was informed and a post mortem was advised. The patient died on 22Mar2021. It''s unknown if an autopsy was performed. The cause of death was shivery, unwell and died suddenly. The reporter outlined it was unclear if the death was vaccine related. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SHIVERY; UNWELL; DIED SUDDENLY


VAERS ID: 1211776 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Electrocardiogram, Hypotensive crisis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), 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: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN POTASICO HIDROCLOROTIAZIDA; PANTOPRAZOLE; AVODART; MADOPAR; TAMSULOSIN HYDROCHLORIDE; TRITTICO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Barrett''s esophagus; Benign prostatic hypertrophy; Bladder cancer; Cognitive deterioration; Extrapyramidal syndrome; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: blood sugar; Test Result: 115 mg/dl; Test Date: 20210326; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no pathological abnormalities; Test Date: 20210326; Test Name: blood pressure; Result Unstructured Data: Test Result:improvement; Comments: after 1 hour
CDC Split Type: ITPFIZER INC2021380399

Write-up: Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-707250. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: ER9470; expiration date: 31Jul2021), intramuscular, administered in arm right on 26Mar2021 15:07 as single dose (at the age of 83-years-old) for covid-19 immunisation. Medical history included cognitive deterioration, bladder cancer, barrett''s oesophagus, extrapyramidal syndrome, benign prostatic hypertrophy and hypertension arterial; all from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN POTASICO HIDROCLOROTIAZIDA); pantoprazole; dutasteride (AVODART); benserazide hydrochloride, levodopa (MADOPAR); tamsulosin hydrochloride; trazodone hydrochloride (TRITTICO); all were taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis. The patient underwent lab tests and procedures which included blood sugar: 115 mg/dl and electrocardiogram (ECG): no pathological abnormalities both on 26Mar2021. The patient was treated with physiological solution, adrenaline, betamethasone and emergency 118 intervention. After about 1 hour, the patient returned to being alert with improvement in blood pressure. The patient was stable until 10:00 PM, time of death. The patient died on 26Mar2021. Cause of death were loss of consciousness and severe hypotensive crisis. The outcome of the events was fatal. It was unknown if an autopsy was performed. Sender Comment: The Patient is a resident in a nursing home. Clinical report will follow. Update of 30Mar2021: the clinical report drawn up by the reporting doctor and the 118 intervention report are attached. It should be noted that the doctor, informed by the emergency medical service who has ascertained the death of the case, has notified the carabinieri; a post-mortem swab was requested by the Public Prosecutor''s Office. Update 01Apr2021: the autopsy examination will be performed on 02Apr2021 on the request of the Prosecutor''s Office. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis; Loss of consciousness 30 minutes after the vaccine with severe hypotensive crisis


VAERS ID: 1211839 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1742 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021386391

Write-up: patient who is found in his car without vital signs; This is a spontaneous report from a non-contactable healthcare professional received from Regulatory Authority (COFEPRIS) via email. Regulatory authority report number is 11810-4. A 63-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 intramuscular, administered in left arm on 12Mar2021 (Batch/Lot Number: ER1742) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was found in his car without vital signs on 13Mar2021 at around 8:30 hours. He is given CPR (cardiopulmonary resuscitation), he was transferred to a hospital arriving without signs, advanced CPR was given, he was declared dead at 9:20 hours. Treatment given was 2 ampoules of adrenaline in two time and a Bicarnat vial. Treatment received before receiving medical attention was none. The patient died on 13Mar2021 at 9:20 hours. It was not reported if an autopsy was performed. Case was reported as serious, hospitalization required. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient who is found in his car without vital signs


VAERS ID: 1211889 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Embolism, Pyrexia, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection (mild COVID-19 course)
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: Body temperature; Result Unstructured Data: FATAL; Test Date: 20210302; Test Name: Body temperature; Result Unstructured Data: FATAL
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Sudden cardiac arrest; Seizures; Embolism; Body temperature increased to 39.7; Subfebrile body temperature; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Sudden cardiac arrest), SEIZURE (Seizures), EMBOLISM (Embolism), PYREXIA (Body temperature increased to 39.7) and PYREXIA (Subfebrile body temperature) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 infection (mild COVID-19 course) from October 2020 to November 2020. Previously administered products included for an unreported indication: ELIQUIS. On 25-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 27-Feb-2021 at 1:00 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Subfebrile body temperature) (seriousness criterion death). On 02-Mar-2021, the patient experienced CARDIAC ARREST (Sudden cardiac arrest) (seriousness criterion death), SEIZURE (Seizures) (seriousness criterion death), EMBOLISM (Embolism) (seriousness criterion death) and PYREXIA (Body temperature increased to 39.7) (seriousness criterion death). The patient died on 02-Mar-2021. The reported cause of death was sudden cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 37.5 degree Celsius (abnormal) Fatal. On 02-Mar-2021, Body temperature: 39.7 degree Celsius (High) Fatal. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. Treament was not reported/ unknown. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 77-year-old male subject with a medical history of recent SARS-CoV-2 infection but unknown other conditions, who died 5 days after receiving a dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Sudden cardiac arrest


VAERS ID: 1211906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMPUGAN [FUROSEMIDE]; CLOPIDOGREL; DIVISUN; SYMBICORT; ATORVASTATIN; SPIRIVA; ALLOPURINOL; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension; Late effects of cerebral stroke; Renal failure; Transient ischaemic attack (hospitalized for 2 days for suspected TIA (transient ischemic attack)); Weakness left or right side
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021380344

Write-up: unclear death in the home; she may have fallen; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-021308. Safety Report Unique Identifier SE-MPA-1616078200533. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as 0.3 mL, single for COVID-19 immunization. Medical history included hypertension, renal failure, hospitalized for 2 days for suspected TIA (transient ischemic attack) from 23Feb2021, weakness left or right side, cerebral stroke in 2004, and cardiac failure. Concomitant medications included furosemide (IMPUGAN), clopidogrel, colecalciferol (DIVISUN), budesonide, formoterol fumarate (SYMBICORT), atorvastatin, tiotropium bromide (SPIRIVA), allopurinol, and omeprazole. The patient experienced unclear death in the home in Mar2021. The woman had recently been hospitalized for 2 days for suspected TIA (transient ischemic attack). Almost two weeks later, the woman was vaccinated with Comirnaty. A relative tried to reach the patient on the phone eight days later, but got no answer. The next day, the home care staff find her lying dead on the bathroom floor, according to the reporter, she may have fallen. Outcome: Fatal. Report assessed as serious, death. Autopsy will not be performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: unclear death in the home; she may have fallen


VAERS ID: 1211907 (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: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: TIA
Allergies:
Diagnostic Lab Data: Test Name: coronary x-ray; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: SEPFIZER INC2021380325

Write-up: heart attack/MYOCARDIAL INFARCTION; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB. Regulatory Authority report number is SE-MPA-2021-021846. A 97-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number: EL 1484) as SINGLE DOSE for covid-19 immunization. Medical history included TIA (transient ischaemic attack) from 2014. The patient previously received the 1st dose of COMIRNATY (lot:EL 1484) for covid-19 immunization. The patient''s concomitant medications included blood pressure medications (not specified). The reporter stated that the patient was healthy for her age, managed to walk to the vaccinations 1.4 km both times. Four days after her 2nd vaccination (Feb2021), the patient had a heart attack/myocardial infarct and after about a week of hospitalization, the woman had another heart attack and died. The patient underwent lab tests and procedures which included coronary x-ray: with unknown results;it was decided that a pacemaker would be inserted after her second heart attack but patient died. It was reported that patient received a treatment due to the event. It was not reported if an autopsy was performed. The event was assessed as "serious, causing patient''s death". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: heart attack/MYOCARDIAL INFARCTION


VAERS ID: 1211913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine increased, General physical health deterioration, Hepatic enzyme increased, Infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTAN; BRILIQUE; ALVEDON; ATORVASTATIN ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost (a few days before second dose of vaccine); Cholesterol high; Feeling unwell (a few days before second dose of vaccine); Headache (a few days before second dose of vaccine); Hypertension; Myocardial infarct; Nausea (a few days before second dose of vaccine); Pain (a few days before second dose of vaccine); Stomachache (a few days before second dose of vaccine)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021384548

Write-up: suspected severe infection; increased creatinine value; deterioration in general condition; increased liver value; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-023979. A 94 years old female patient received second dose of BNT162B2 (Comirnaty, solution for injection) on Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Hypertension, Cholesterol high, myocardial infarct on Feb2021. The patient received first dose of vaccine on Feb2021. It was also informed that patient had for a few days before second dose of vaccine felt unwell with a little headache, body pain and stomachache, nausea and reduced appetite. Concomitant medications included losartan, ticagrelor (BRILIQUE), paracetamol (ALVEDON) and atorvastatin calcium trihydrate (ATORVASTATIN ACCORD). On Mar2021 the same day after second dose general health condition was reduced and at the evening the woman went to the hospital. Laboratory values showed creatinine increased and elevated liver enzymes. She also had a suspected severe infection. Reported suspect adverse events from the physician were creatinine increased, elevated liver enzymes, infection, reduced general condition. The patient died the day after vaccination. All reported events were assessed as fatal. It was unknown if an autopsy was perfofmed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: creatinine increased; Hepatic enzyme increased; General physical health deterioration; suspected severe infection


VAERS ID: 1213587 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Pyrexia, SARS-CoV-2 antibody test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (with an antibody level of 145)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antibody; Result Unstructured Data: Test Result:145
CDC Split Type: BEPFIZER INC2021400096

Write-up: she had diarrhea and fever before dying; diarrhea; fever; This is a spontaneous report from a contactable physician via Medical Information. An 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 infection from an unknown date and unknown if ongoing with an antibody level of 145. The patient''s concomitant medications were not reported. The patient experienced she had diarrhea and fever before dying on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: 145 on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of diarrhea and fever was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: she had diarrhea and fever before dying


VAERS ID: 1213603 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gas gangrene
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRITTICO; ATORVASTATINE [ATORVASTATIN]; QUETIAPINE; PANTOPRAZOLUM; ASPIRIN CARDIO; MADOPAR DR; CALCIMAGON [CALCIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021403563

Write-up: Gas gangrene on foot; This is a spontaneous report received from a contactable consumer via a regulatory authority. Regulatory authority report number CH-SM-2021-12813. A 94-year-old female received second dose of intramuscular BNT162B2 (COMIRNATY) on 12Feb2021 at single dose for Covid-19 immunisation at the age of 94-year-old. Medical history was unknown. Concomitant medications included trazodone hydrochloride (TRITTICO), atorvastatine, quetiapine, pantoprazolum, acetylsalicylic acid (ASPIRIN CARDIO), benserazide hydrochloride, levodopa (MADOPAR), calcium (CALCIMAGON). Vaccination history included first dose of intramuscular BNT162B2 (COMIRNATY) on 13Jan2021 for Covid-19 immunisation. On 12Feb2021, reported gaseous gangrene in the foot, then spread to the body. On 22Feb2021, death due to gas gangrene. Not known therapy received, not known if hospitalization or further course. It was unknown if an autopsy was performed. A causal relationship between Comirnaty and death and gas gangrene was assessed as being unlikely. A regulatory authority assessed this case as serious, results in death. Reporter comment: Report of death after 2nd Corona vaccination. Inquiry: Dear Sir or Madam, on behalf of my mother-in-law I unfortunately have to report a death 10 days after the 2nd Corona Biotech vaccination. Patient died very unexpectedly of gas gangrene 10 days after the 2nd vaccination. She was otherwise in generally good health. Sender''s comment: Elderly 94-year-old female. No known personal history. Weight 48 kg, height 160 cm. Chronic therapy with: Trittico, Atorvastatin, Quetiapine, Pantoprazol, Aspirin cardio, Madopar no parkinson, Calcimagon. Second dose of Comirnaty on 12Feb2021. On 21Feb2021 reported Gas Gangrene to the foot, then spread to the body. On 22Feb2021, death. Further information requested from reporter, not received. Gas Gangrene, death are adverse events not noted in the country monograph for Comirnaty. They are not reported in two different countries monographs. In resource, they do not appear as adverse events for covid-19 mRNA vaccines. In resource, we do not find any cases of Gas Gangrene following Covid-19 vaccination. The adverse events described, without knowledge of possible concomitant causes (multi-medicated patient), without data in the literature, with a delayed timing (9 and 10 days after vaccination) are judged unlikely. The event resulted in death (serious). No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reporter''s Comments: Report of death after 2nd Corona vaccination. Inquiry: Dear Sir or Madam, on behalf of my mother-in-law I unfortunately have to report a death 10 days after the 2nd Corona Biotech vaccination. Patient died very unexpectedly of gas gangrene 10 days after the 2nd vaccination. She was otherwise in generally good health.; Sender''s Comments: Fatal event gaseous gangrene represents an intercurrent medical condition and unrelated to BNT162B2 .; Reported Cause(s) of Death: Gas gangrene


VAERS ID: 1213609 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hemithyroidectomy; Neck surgery (about 15 years ago); Neurofibromatosis, type 1 (von Recklinghausen''s disease) (surgery several times about 15 y ago in the neck/cervical spine region (C3-D1 stabilization in 2001)); Spinal operation (about 15 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021402504

Write-up: Death; Asphyxiation; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021- 14151. A 34-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 27Mar2021 (Batch/Lot Number: unknown) as single dose (at the age of 34) for covid-19 immunisation. Medical history included neurofibromatosis, type 1 (von Recklinghausen''s disease) (surgery several times about 15 years ago in the neck and cervical spine region (C3-D1 stabilization in 2001)), hemithyroidectomy from 2008 to an unknown date. She had no known allergies. The patient''s concomitant medications were not reported. On 27Mar2021 she received the first administration of COMIRNATY without any problems. On 29Mar2021 (the day of her death) she first accused severe pain in her left arm, later she declared that she felt her neck swelling on the left. Her parents noticed a swelling that grew "visibly", to the point of compromising the airways. After alarming the emergency sercice they started a heart massage. Upon arrival of the rescuers, an asystole and a complete obstruction of the upper respiratory tract was found. An intubation was attempted which was not feasible, followed by a successful cricotomy, but despite the resuscitation with 100% oxygen for 15'' there was no sign of recovery (always in asystole). The parents specifically asked not to extend the resuscitation maneuvers any longer. Given the rapid evolution of the swelling, the hypothesis is that of an arterial hemorrhage. The doctors explained to the parents the need to perform an autopsy to know the exact cause of death but they were against it and therefore it was not performed. The patient''s illness in Jul2020 was defined as stable. The patient experienced death on 29Mar2021, fatal asphyxiation on 29Mar2021. An autopsy was not performed. This case was reported as serious with seriousness criterion Results in death. A causal relationship between COMIRNATY and the events death and Asphyxiation was assessed as being unlikely. Sender''s comment: Sudden death of a young patient known for neurofibromatosis two days after administration of Comirnaty. Death occurred from asphyxia due to an obstruction of the airways. Sudden arm pain, latency time (2 days) and unilateral swelling speak against a possible anaphylactic allergic cause due to the vaccine. In the first hypothesis there is a possible arterial dissection with bleeding that has obstructed the soft parts with consequent asphyxiation. Neurofibromatosis as a risk factor for arterial dissection: Update (1): "Other manifestations - .... Other vascular lesions may cause stenosis of major vessels, including the internal carotid, resulting in moyamoya disease. In rare instances, arterial dissection can occur, sometimes leading to life-threatening hemorrhage. " Therefore, despite the absence of an autopsy to support the hypothesis of haemorrhage, given the patient''s disease (neurofibromatosis) and the elements that speak against edema on anaphylaxis, we judged the causal correlation with the vaccine as unlikely. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender''s Comments: In concurring with the reported physician, the reported fatal event of Asphyxiation represents an intercurrent medical condition and unrelated to bnt162b2 .; Reported Cause(s) of Death: Asphyxiation


VAERS ID: 1213610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021390509

Write-up: was found dead at her home; This is a spontaneous report from a contactable physician. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On the day of reporting (09Apr2021), patient was found dead at her home in the early morning. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: was found dead at her home


VAERS ID: 1213633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Asthenia, Back pain, Cardiac disorder, Death, Electrocardiogram, Electrocardiogram abnormal, Gallbladder disorder, Gastric ulcer, Gastrointestinal disorder, Gastrointestinal examination, Joint swelling, Myocardial infarction, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal ulceration (narrow), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified ((ECG finding stable for long time)); Nonsmoker
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: ECG; Result Unstructured Data: Test Result:weak heart with respect to age; Comments: weak heart with respect to age; Test Date: 20210323; Test Name: ECG; Result Unstructured Data: Test Result:disarranged; Test Date: 202103; Test Name: Gastrointestinal examination; Result Unstructured Data: Test Result:gastro possibly normal
CDC Split Type: CZPFIZER INC2021389799

Write-up: weak heart; "disarranged" ECG; stomach ulcer; Death; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; suspicion of heart attack or irritated gallbladder; Nausea; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; Weakness; Swollen ankles; Pain from abdominal to heart and back/stomach pain radiating to the heart and back; suspicion of heart attack or irritated gallbladder; suspected of gastrointestinal problems; paler than usual; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority- CZ-CZSUKL-21003462. A 90-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included heart disease, unspecified (ECG finding stable for long time), nonsmoker and has no obesity with above average health condition. The patient''s concomitant medications were not reported. The patient experienced nausea, pain from abdominal to heart and back, weakness, and swollen ankles on Mar2021. The patient died on 24Mar2021. It was reported that the patient experienced sudden weakness, nausea, stomach pain radiating to the heart and back (patient had a suspicion of heart attack or irritated gallbladder after meal) 3 weeks after the vaccination with Comirnaty vaccine (Mar2021). The pain was not severe, rather unpleasant, suspected of gastrointestinal problems. The patient took Famosan for stomach ulcer (unspecified date), took commonly on prescription - pain subsided. He was happier but sicker and paler than usual and his ankles were swollen according to his daughter. The same problems were repeated the next day, Wednesday 23Mar2021, again in the afternoon. In the evening, at 6 PM, an ambulance was called just for affirmation. Ambulance finding was weak heart and "disarranged" ECG; he was transferred to intensive care unit. Gastrointestinal examination and ECG were performed, according to the physician he had a weak heart with respect to age, gastro possibly normal. The patient died on 24Mar2021. Therapeutic measures were taken as a result of nausea, and pain from abdominal to heart and back. The outcome of the events was unknown. The patient died on 24Mar2021 due to an unknown cause. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1213634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arthralgia, Headache, Influenza like illness, Nausea, Oropharyngeal pain
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021389788

Write-up: Infarct; nausea; headache; joint pain; Flu-like symptoms; Sore throat; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority- CZ-CZSUKL-21003489. An 85-year-old male patient received first dose of BNT162B2 (COMIRNATY; lot number and expiry date were unknown), intramuscular on 12Mar2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 in early Dec2020, no difficult course, no hospitalization, infection detected by accident after admission to the spa, no health consequences and no health problems. Concomitant medications were not reported. On 18Mar2021, the patient began to experience symptoms of nausea, headache and joint pain reported as flu-like symptoms and sore throat. On 22Mar2021, the medical condition was resolved with a district physician who started antibiotic treatment. Outcome of the events nausea, headache, joint pain, flu-like symptoms and sore throat was recovered on 22Mar2021. The patient died on 30Mar2021 and the doctor stated a heart attack resulting in death, also reported as infarct/acute myocardial infarction. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1213640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Heart failure; Nausea; Vomiting
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: DEPFIZER INC2021389404

Write-up: Acute myocardial infarction/Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021042553. A 80-year-old male patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), intramuscular on 22Mar2021 (Batch/Lot Number: ER2659) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included ongoing hypertension, high blood pressure, nausea with vomiting and heart failure factors or previous illnesses from unspecified dates. There were no concomitant medications. The patient experienced acute myocardial infarction/infarct myocardial on 30Mar2021. The patient died on 30Mar2021. The patient''s outcome was fatal for acute myocardial infarction. It was not reported if an autopsy was performed. This report is serious - death. Sender Comment (verbatim): Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses High blood pressure / nausea with vomiting, heart failure No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction/Infarct myocardial


VAERS ID: 1213641 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Dizziness, Incorrect route of product administration, Laryngeal oedema, Leukaemia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Haematological malignant tumours (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of the prostate stage I; Arterial hypertension; Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Conjunctivitis; Erectile dysfunction
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Arterial pressure NOS decreased; Result Unstructured Data: Test Result:decreased
CDC Split Type: DEPFIZER INC2021389412

Write-up: Malignant pleural effusion on the right side./edema of the larynx; Leukaemia; low blood pressure, dizziness and weakness/arterial blood pressure decreased; low blood pressure, dizziness and weakness; low blood pressure, dizziness and weakness; Comirnaty via intravenous; This is as spontaneous report received from a non-contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021043445, Safety report unique identifier DE-PEI-202100031181. A 91-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number and expiration date were not reported), intravenous on 06Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing diabetes, ongoing arterial hypertension, adenocarcinoma of the prostate stage I from 2004 and ongoing, erectile dysfunction from 2004, and right conjunctivitis. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on 15Jan2021 for COVID-19 immunisation. On 06Feb2021, the patient experienced low blood pressure, dizziness and weakness. On 26Feb2021, the patient experienced leukaemia. On 04Mar2021, the patient experienced malignant pleural effusion on the right side. It was further reported that patient experienced asthenia and not specified arterial blood pressure decreased both on 06Feb2021, and edema of the larynx on 04Mar2021. The patient underwent lab tests and procedures which included arterial pressure NOS decreased: decreased on 06Feb2021. The patient died on 14Mar2021. It was not reported if an autopsy was performed. The patient had not yet recovered from low blood pressure, dizziness and weakness while events malignant pleural effusion on the right side and leukaemia both resulted in fatal outcome. Sender Comment: Are you or the person concerned aware of any allergies? If yes, which ones? no Information. On risk factors or previous illnesses Diabetes, arterial hypertension, prostate carcinoma ED (erectile dysfunction) 2004, right conjunctivitis. Relatedness of drug to reaction(s)/event(s): Laryngeal oedema, Lightheadedness, Asthenia, Arterial pressure NOS decreased, Source of assessment: PEI, Result of Assessment: D. Unclassifiable.; Reported Cause(s) of Death: Leukaemia; Malignant pleural effusion on the right side


VAERS ID: 1213645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021389408

Write-up: Unknown cause of death; increasing deterioration; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-PEI2021003965. A 95-year-old female patient received first dose bnt162b2 (COMIRNATY; Lot Number: not reported) intramuscular, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 30Jan2021, after vaccination, the patient developed Reduced general condition and Unknown cause of death. The patient died on 30Jan2021. The events were considered as serious (medically significant). Outcome of Reduced general condition was fatal. Causes of death was reported as unknown cause of death and Reduced general condition. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Reduced general condition


VAERS ID: 1213646 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-14
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021389406

Write-up: Unknown cause of death; especially vaccination reaction; especially vaccination reaction; This is as spontaneous report received from a non-contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003966. A 97-year-old female patient received BNT162B2 (COMIRNATY; lot number and expiry date were not reported), intramuscular on Jan2021 (at the age of 97-years-old) at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that after vaccination, the patient developed "especially vaccination reaction" also reported as reduced general condition on 14Feb2021. Outcome of the events vaccination reaction and reduced general condition was unknown. The patient died on 14Feb2021. It was not reported if an autopsy was performed. Death cause was reported as unknown cause of death. The company assessment of the event with the drug was unclassifiable. No follow-up attempts are; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1213649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Death, Dyspnoea, Restlessness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:decrease
CDC Split Type: DEPFIZER INC2021400138

Write-up: dyspnea; decrease of blood pressure; restlessness; death after second vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech, license party for Comirnaty (reference no.: 33877). An elderly female patient received bnt162b2 (COMIRNATY), first dose (Lot Number: EP2163) on 07Mar2021 and second dose (Lot Number: ER7812) on 28Mar2021; both were via an unspecified route of administration as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician wanted to report that a female patient died after second dose of bnt162b2. She was vaccinated on 07Mar2021 with first dose with lot EP2163 and on 28Mar2021 with second dose with lot ER7812. Since 29Mar2021, the patient experienced dyspnea, blood pressure decrease, restlessness; on 30Mar2021 admission to hospital via ambulance; on 01Apr2021 at 11:30 a.m. the patient died in hospital. the physician thinks the interval between first and second vaccination was too small. It is too strenuous for the organism, especially for elderly people. Cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events dyspnea, blood pressure decrease, restlessness was unknown.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. A causal association between the reported dyspnea, blood pressure decrease and restlessness cannot be completely excluded based on temporal association. 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


VAERS ID: 1215191 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-21
Onset:2020-12-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram, Fibrin D dimer, Platelet count, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIGOXIN; FINASTERIDE; FUROSEMIDE; SALBUTAMOL; SOLIFENACIN; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: GI bleed
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: CT scan; Result Unstructured Data: Test Result:showed possible clot in middle cerebral artery ter; Comments: showed possible clot in middle cerebral artery territory; Test Date: 20201228; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown if greater than 4000; Test Date: 20201228; Test Name: Platelet count; Result Unstructured Data: Test Result:less than 150 x10 9/l
CDC Split Type: GBPFIZER INC2021391870

Write-up: middle cerebral artery CVA; platelet count that was less than 150 x10 9/l; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104080848015550; Safety Report Unique Identifier GB-MHRA-ADR 25101411. An 85-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot Number: EJ0553) dose: 1, via an unspecified route of administration on 21Dec2020, as a single dose for covid-19 immunization. Medical history included gastrointestinal bleed. The patient denied having any previous reactions to medications, especially heparin or anticoagulants, and it was unknown if any anti-PF4 antibodies were identified. The patient has not had symptoms associated with COVID-19, has not had a COVID-19 test, and is not enrolled in a clinical trial. Concomitant medications included digoxin taken for atrial fibrillation from 21May2020, finasteride, furosemide, salbutamol, solifenacin, and tamsulosin. The patient previously took the direct oral anticoagulant rivaroxaban for atrial fibrillation and experienced GI bleed. It was reported that one month prior to this report, the patient was admitted to the hospital with a gastrointestinal bleed when the rivaroxoaban was stopped. On 28Dec2020, the patient experienced middle cerebral artery cerebrovascular accident. The patient was admitted to the hospital with right-sided weakness and a middle cerebral artery cerebrovascular accident on 28Dec2020. The patient underwent lab tests and procedures, which included a CT scan that showed a possible clot in the middle cerebral artery territory on 28Dec2020, a platelet count that was less than 150 x10 9/l on 28Dec2020, and a fibrin d dimer that was unknown if it was greater than 4000 on 28Dec2020. The patient has not tested positive for covid-19 since having the vaccine. The outcome of the middle cerebral artery cerebrovascular accident was fatal, for event platelet count that was less than 150 x10 9/l was unknown. The patient died on 04Jan2021. It was not reported if an autopsy was performed and the reported cause of death was middle cerebral artery cerebrovascular accident. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: middle cerebral artery CVA


VAERS ID: 1215192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2021-01-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688/V0007 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Haemorrhagic stroke, Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis); Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021391930

Write-up: Hypertension.; coma; Haemorrhagic stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202104080925179560, Safety Report Unique Identifier: GB-MHRA-ADR 25101425. An 80-years-old male patient received first dose of BNT162B2, lot no. EJ1688/V0007, via an unspecified route of administration on 23Dec2020 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (taking medicines for multiple sclerosis) and thrombosis. He has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. Concomitant medications included warfarin taken for thrombosis and unspecified medicines for multiple sclerosis. The patient experienced haemorrhagic stroke on 04Jan2021 (fatal per HA assessment). Case narrative: Taken to hospital and went into coma. Passed away from incebral haemorage and hypertension. Not unwell before vaccine. No relevant investigations or tests conducted. The patient died on 04Jan2021 due to haemorrhagic stroke and hypertension. The outcome of coma was unknown. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Hypertension


VAERS ID: 1215280 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-08
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021398357

Write-up: Ventricular fibrillation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21101289.?? A 51-year-old (reported as 51-year and 4-month-old) male patient received bnt162b2 (COMIRNATY, Lot Number: EP9605; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration on 25Mar2021 11:39 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.6 degrees Centigrade. On 08Apr2021 at after 0:00, just after midnight (14 days after the vaccination), the patient experienced ventricular fibrillation and was admitted to the hospital. The course of the event was as follows: On 08Apr2021, after 0:00, just after midnight (14 days after the vaccination), the patient was found in respiratory arrest in his sleep. Cardiopulmonary resuscitation (CPR) was initiated, and the patient was transferred to a hospital. CPR was continued, but the patient died. The reporting physician was told by the patient''s family that the cause of death was ventricular fibrillation. The reporting physician noted the details of the clinical course were unknown because it was hearsay. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not reported. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 25Mar2021 before vaccination. The patient died on 08Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 1215381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Malaise, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever: 38 to 40.5 degrees Celsius Centigrade; Test Date: 20201228; Test Name: SARS-CoV-2 test positive; Test Result: Positive
CDC Split Type: NLPFIZER INC2021399242

Write-up: Sudden breathlessness, followed by death; not feeling well/malaise; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority NL-LRB-00497586. A 75-years-old female patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 01Apr2021 (Lot Number: ET3674) as single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Dec2020 without disease symptoms and cardiovascular disease. Concomitant medication(s) included haloperidol and clopidogrel. On 04Apr2021, the patient experienced sudden shortness of breath and not feeling well/malaise, after which death. Adverse event came about suddenly. The patient also experienced fever: 38 to 40.5 degrees Celsius on 04Apr2021. There were no diagnostic procedures. The patient underwent SARS-COV-2 test positive on 28Dec2020. The patient died on an unspecified date. It was not reported if an autopsy was performed. The event outcome for events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden breathlessness, followed by death; Malaise; Fever: 38 to 40.5 degrees Celsius


VAERS ID: 1215590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Staphylococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALENDRONATE SANDOZ; ACETYLSALISYLSYRE ACTAVIS; AMLODIPINE ACCORD; COAPROVEL; CALCIGRAN FORTE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021389409

Write-up: Sepsis with yellow staphylococci; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-U7jppw, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00024234. An 88-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 05Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ongoing alendronate sodium (ALENDRONAT SANDOZ); acetylsalicylic acid (ACETYLSALISYLSYRE ACTAVIS); amlodipine besilate (AMLODIPIN ACCORD); all taken for unspecified indications; ongoing hydrochlorothiazide, irbesartan (COAPROVEL) taken for hypertension and ongoing calcium carbonate, colecalciferol (CALCIGRAN FORTE) taken for an unspecified indication. The patient experienced sepsis with yellow staphylococci (staphylococcal sepsis) on 12Feb2021. The patient died on 26Feb2021 due to staphylococcal sepsis. It was not reported if an autopsy was performed. The outcome of the event was fatal. It was also reported that the event stop date was on 27Feb2021. Reporter''s comment: Contact with healthcare professionals: Physician. Daughter-in-law reported that patient died due to SEPSIS with YELLOW STAPHYLOCOCCUS , one week after VACCINATION. Patient was described as healthy before the ADR, without any other signs of infections, Autopsy was not mentioned by reporter. Sender Comment: Daughter-in-law signed up on behalf of her mother-in-law. Patient info was changed to Mother-in-law''s patient data. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician. Daughter-in-law reported that patient died due to SEPSIS with YELLOW STAPHYLOCOCCUS , one week after VACCINATION. Patient was described as healthy before the ADR, without any other signs of infections, Autopsy was not mentioned by reporter.; Reported Cause(s) of Death: STAPHYLOCOCCAL SEPSIS


VAERS ID: 1215596 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Asthenia, Cardiac arrest, Chills, Feeling cold, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021389413

Write-up: Contact loss; Feeling cold; weakness (lack of strength, lack of energy); Chills; Circulatory arrest; Uncontrolled stools; This is a spontaneous report from a contactable consumer (patient daughter) downloaded from a regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.189.2021. A 94-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: ER2659), intramuscular on 04Mar2021 (at the age of 94-year-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure and cholesterol (disorder). The patient was taking medications for high blood pressure and cholesterol. On 05Mar2021, the patient experienced feeling cold, chills, weakness, lack of strength, lack of energy, circulatory arrest (cardiac arrest), uncontrolled stools, loss of contact/contact loss. The patient died on 08Mar2021 due to the reported events. The outcome of the events was fatal. An autopsy was not performed. Sender comments: Chills, weakness (lack of strength, lack of energy) are expected side effects for the vaccine. Feeling cold, uncontrolled stools, loss of contact, cardiac arrest are unexpected side effects for the vaccine. The feeling of coldness and diarrhea after using the Comirnaty vaccine have already been reported in the database. Death occurred in an elderly person with a history of hypertensive disease, a coincidence cannot be ruled out. The temporal relationship speaks for a cause-and-effect relationship. A regulatory authority assessed the application as severe (death). Comirnaty/ all events/ Neurocirculatory Asthenia, Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Circulatory arrest; contact loss; feeling cold; chills; weakness (lack of strength, lack of energy); uncontrolled stools


VAERS ID: 1215599 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: LANSOPRAZOLE; ATORVASTATIN; VIGANTOL [COLECALCIFEROL]; TRAJENTA; QUETIAPINE
Current Illness: Chronic renal failure (stage 4 chronic renal failure)
Preexisting Conditions: Medical History/Concurrent Conditions: Atheromatosis (aorta and coronary); Emphysematous cystitis (hospitalization in February 2021); Glucose increased (high glucose since the above hospitalization.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021389483

Write-up: cause of death is unknown; sudden malaise; This is a spontaneous report from a contactable physician from a regulatory authority-WEB, regulatory authority is PT-INFARMED-G202103-2995. An 81-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1, intramuscular on 18Mar2021 (Batch/Lot Number: ET3620) as 0.3 mL, single for COVID-19 immunisation. Medical history included atheromatosis of aorta and coronary, ongoing chronic renal failure (stage 4 chronic renal failure), emphysematous cystitis from 17Feb2021 (hospitalization in February 2021) and high glucose since the above hospitalization. Concomitant medications included lansoprazole, atorvastatin, colecalciferol (VIGANTOL [COLECALCIFEROL]), linagliptin (TRAJENTA) and quetiapine, all taken for an unspecified indication, start and stop date were not reported. The patient had sudden malaise 2 days after administration of the 1st dose of the vaccine. Date of death was 20Mar2021. The cause of death is unknown. It is unknown if an autopsy was performed. The cause of death is unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cause of death is unknown; sudden malaise


VAERS ID: 1215613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CPAP; Hypothyreosis; Ischemic heart disease; Percutaneous coronary intervention; Pulmonary embolism; Sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021389516

Write-up: Cardiac arrest; comirnaty administered via subcutaneous; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is SE-MPA-2021-023470, other case identifier number SE-MPA-1616707176996. A 78-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date not reported), subcutaneous on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history included ischemic heart disease, Hypothyreosis, sleep apnea uses CPAP (continuous positive airway pressure) at night, pulmonary embolism and previous percutaneous coronary intervention in 2005. The patient''s concomitant medications were not reported. According to a relative, the patient has been feeling well lately. On the same day that the patient was vaccinated with Comirnaty, on 25Mar2021, the patient experienced cardiac arrest in the evening. The patient died the same day despite CPR (cardiopulmonary resuscitation) for nearly 60 minutes. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1215614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
SMQs:, Myocardial infarction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Essential hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:ST-T segment elevation
CDC Split Type: SEPFIZER INC2021389525

Write-up: Chest pain; ST-T segment elevation; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-024468). A contactable physician (contactable through Regulatory Authority only) reported that an 84-year-old female patient received BNT162B2 (COMIRNATY, Lot number: EP2166; Expiration date was not reported), intramuscular in Mar2021 as a single dose for COVID-19 immunization. Medical history included essential hypertension and hypothyroidism; both were unknown if ongoing. The patient''s concomitant medications were not reported. In Mar2021, 8 days after the vaccination, the patient had chest pain. The patient did not seek medical attention, then called the health center a week later, and was referred to the emergency room. The patient''s electrocardiogram (ECG) in Mar2021 ST-T segment elevation. The patient had underwent percutaneous coronary intervention for the reported events. The patient had died on an unspecified date in 2021 after two days of hospitalization. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; ST-T segment elevation


VAERS ID: 1215618 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Death, Dyspnoea, Myocardial infarction, Pallor
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN; CHOLESTEROL TABLET
Current Illness: High cholesterol
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SGPFIZER INC2021393107

Write-up: On the same day 9pm he suddenly out of breath, cold sweat, turn pale; On the same day 9pm he suddenly out of breath, cold sweat, turn pale; On the same day 9pm he suddenly out of breath, cold sweat, turn pale; died after he had his 1dose of COVID 19 vacation; Doctor immediately attend to him, after half an hour doc came out and said he had heart attack n heart beat has stopped; This is a spontaneous report from a contactable consumer received via a sales representative. An 81-year-old male patient received bnt162b2 (BNT162B2), dose 1 via intramuscular route of administration on 06Apr2021 08:30 (Batch/Lot number was not reported) as an unspecified dose (at the age of 81-year-old) for covid-19 immunisation. The patient medical history included ongoing bit high cholesterol. The patient was healthy and strong. No major sickness before. The patient''s concomitant medications included ongoing vitamins and on cholesterol tablets (drug names not reported). Prior vaccination (within 4 weeks) were none. On 06Apr2021 the patient cycled to and fro to nearby clinic and took his 1st dose of vaccine at 08:30 am. The patient reached home and had his regular meals as per normal. On the same day 9 pm he was suddenly out of breath, cold sweat, turned pale. Immediately, family members called ambulance and rushed him to hospital. The patient was still conscious when he left the house and when reached hospital. Doctor immediately attended to the patient, after half an hour doctor came out and said he had heart attack and heart beat stopped. They cannot retrieve him and the patient died on 06Apr2021. Autopsy was performed and cause of death was ischaemic heart disease. No follow-up attempts are needed, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if 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: ischaemic heart disease


VAERS ID: 1217122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 4
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:
Current Illness: Carcinoma bladder (in treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Massive pulmonary embolism; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive pulmonary embolism) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in January 2021 and Carcinoma bladder (in treatment) since an unknown date. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criterion death). The patient died on 17-Mar-2021. The reported cause of death was Pulmonary embolism. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1217164 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

Administered by: Unknown       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: 2021-03-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 22-Mar-2021. The reported cause of death was Cardio-respiratory arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was reported. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1217281 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; BELOC ZOK; COMILORID; FELODIPIN; CELECOXIB; DUODART; OMEZOL LYO
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct; Renal failure; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in an 86-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Myocardial infarct, Stroke and Renal failure. Concurrent medical conditions included Diabetes mellitus and Hypertension. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL SUCCINATE (BELOC ZOK), AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE (COMILORID), FELODIPIN, CELECOXIB, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART) and OMEPRAZOLE SODIUM (OMEZOL LYO) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (death) to be unlikely related. Treatment was not provided. On 22-Mar, he was visited by the attending physician for non-specific symptoms (fluctuating vertigo, mild chest tightness, arterial hypotension), partly known but aggravated symptoms. Clinical examination and ECG without pathological findings, D-Dimer negative, Troponin-T non-pathological in view of age and concomitant chronic renal failure.; Sender''s Comments: This is a case of death in a 86-year-old male subject with a medical history of Diabetes mellitus, Hypertension. Myocardial infarct, Stroke and Renal failure, who died 5 days after receiving the first dose of vaccine. Based on reporter''s causality that patient''s age and clinical condition with several known pathologies, the death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1217331 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616410261153

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history provided.). On 18-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on March 2021 The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: Concomitant Product use was not provided. Treatment information was not provided. This case refers to a 75-year-old elderly female patient who died after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1218470 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: Death NOS; This case was received via another Manufacturer (Reference number: QTS-210413-110) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 23-Mar-2021 The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 63-year-old male subject with unknown medical history of, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1218478 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 70068 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease; Paranoid schizophrenia; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Exitus letalis; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Exitus letalis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 70068) for COVID-19 vaccination. The patient''s past medical history included Nicotine abuse and Alcohol abuse. Concurrent medical conditions included Crohn''s disease, Paranoid schizophrenia and Renal insufficiency. On 26-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-Mar-2021 The patient died on 29-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Action taken with the mRNA-1273 was not applicable Very limited information regarding the event of death has been provided at this time. No further information has been requested. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of death has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1218479 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-10
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722; 3000 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Cerebrovascular accident, Echocardiogram, Electrocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, International normalised ratio, Loss of consciousness, Neutrophil count, Platelet count, Troponin T, White blood cell count
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), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: ELTROXIN; KALEORID; LERCATIO; HEART MAGNIL; SPIRIVA; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Atherosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Alanine aminotransferase; Test Result: Inconclusive ; Result Unstructured Data: 248 Unit not specified; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: occlusion of the left ICA; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in the left a. Cerebri media; Test Date: 20210310; Test Name: CT angiography; Test Result: Inconclusive ; Result Unstructured Data: stenosis of the left a. Carotis interna; Test Date: 20210310; Test Name: Albumin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Alkaline phosphatase; Test Result: Inconclusive ; Result Unstructured Data: 145 Unit not specified; Test Date: 20210310; Test Name: Bilirubin; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 187 Unit not specified; Test Date: 20210310; Test Name: Arterial blood gases; Test Result: Inconclusive ; Result Unstructured Data: Metabolic acidosis Unit not specified; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: LDH; Test Result: Inconclusive ; Result Unstructured Data: 1080 Unit not specified; Test Date: 20210310; Test Name: Lactate; Test Result: Inconclusive ; Result Unstructured Data: 11 to 14 Unit not specified; Test Date: 20210310; Test Name: Potassium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Sodium; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Urea; Test Result: Inconclusive ; Result Unstructured Data: 10.5 Unit not specified; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: thrombus in coronary artery; Test Date: 20210310; Test Name: EKG; Test Result: Inconclusive ; Result Unstructured Data: Inferior STEMI; Test Date: 20210310; Test Name: Fibrin D dimer; Test Result: Inconclusive ; Result Unstructured Data: $g35, too high to measure Unit not specified; Test Date: 20210310; Test Name: GGT; Result Unstructured Data: Normal; Test Date: 20210310; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 6.8 Unit not specified; Test Date: 20210310; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 1.11 Unit not specified; Test Date: 20210310; Test Name: Neutrophil count; Test Result: Inconclusive ; Result Unstructured Data: 19.3 Unit not specified; Test Date: 20210310; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: 303 Unit not specified; Test Date: 20210310; Test Name: Troponin T; Test Result: Inconclusive ; Result Unstructured Data: 3130 Unit not specified; Test Date: 20210310; Test Name: Leukocyte count; Test Result: Inconclusive ; Result Unstructured Data: 22 Unit not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: Apoplexy; Brought to the hospital unconscious; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Apoplexy) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 300042722; 3000489 and 300042722; 3000489) for COVID-19 vaccination. The patient''s past medical history included Atherosclerosis since an unknown date. Previously administered products included for an unreported indication: VESICARE in 2016. Concurrent medical conditions included Apoplexy. Concomitant products included ACETYLSALICYLSYRE (HEART MANGIL) from 23-Jun-2014 to an unknown date for Anticoagulant therapy, TIOTROPIUM BROMIDE (SPIRIVA) from 23-Jun-2014 to an unknown date for Chronic obstructive pulmonary disease, LERCANIDIPINE HYDROCHLORIDE (LERCATIO) from 24-Mar-2014 to an unknown date and LOSARTAN POTASSIUM (LOSARSTAD) from 19-Feb-2014 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (ELTROXIN) from 24-Apr-2014 to an unknown date for Hypometabolism, POTASSIUM CHLORIDE (KALEORID) for Potassium supplementation. On 09-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Apoplexy) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Brought to the hospital unconscious) (seriousness criterion death). The patient died on 10-Mar-2021. The reported cause of death was Apoplexy and Unconscious. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Alanine aminotransferase: 248 248 Unit not specified. On 10-Mar-2021, Angiogram: occlusion of the left ICA, thrombus in the left a. Middle Cerebral and stenosis of the left artery Carotid On 10-Mar-2021, Blood albumin: (normal) Normal. On 10-Mar-2021, Blood alkaline phosphatase: 145 145 Unit not specified. On 10-Mar-2021, Blood bilirubin: (normal) Normal. On 10-Mar-2021, Blood creatinine: 187 187 Unit not specified. On 10-Mar-2021, Blood gases: Metabolic acidosis Unit not specified. On 10-Mar-2021, Blood glucose: mg/dl (normal) Normal. On 10-Mar-2021, Blood lactate dehydrogenase: 1080 1080 Unit not specified. On 10-Mar-2021, Blood lactic acid: 11-14 11 to 14 Unit not specified. On 10-Mar-2021, Blood potassium: (normal) Normal. On 10-Mar-2021, Blood sodium: (normal) Normal. On 10-Mar-2021, Blood urea: 10.5 10.5 Unit not specified. On 10-Mar-2021, C-reactive protein: (normal) Normal. On 10-Mar-2021, Echocardiogram: thrombus in coronary artery. See Sender comments. On 10-Mar-2021, Electrocardiogram: inferior stemi Inferior STEMI. On 10-Mar-2021, Fibrin D dimer: $g35 $g35, too high to measure Unit not specified. On 10-Mar-2021, Gamma-glutamyltransferase: (normal) Normal. On 10-Mar-2021, Haemoglobin: 6.8 6.8 Unit not specified. On 10-Mar-2021, International normalised ratio: 1.11 1.11 Unit not specified. On 10-Mar-2021, Neutrophil count: 19.3 19.3 Unit not specified. On 10-Mar-2021, Platelet count: 303 303 Unit not specified. On 10-Mar-2021, Troponin T: 3130 3130 Unit not specified. On 10-Mar-2021, White blood cell count: 22 22 Unit not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Echocardiography, 10 Mar2021: Thrombus in coronary artery. Confirmed by elevated troponin T and high D dimer. Severe aortic stenosis, initial localised inferior hypokinesia, later takotsubo like heart failure, likely due to the apoplexies. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Reporter did not allow further contact.; Sender''s Comments: Very limited information regarding the reported fatal events has been provided at this time. However, patient''s advanced age and underlying cardiovascular comorbidities may have been contributory. No further information has been requested.; Reported Cause(s) of Death: Apoplexy; Unconscious


VAERS ID: 1218495 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; COVID-19; Dementia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616333419620

Write-up: fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 30-Dec-2020, Chronic ischemic heart disease, unspecified, Dementia and Hypertension. In March 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1. In March 2021, the patient experienced PYREXIA (fever) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Fever


VAERS ID: 1225005 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASAFLOW; INEGY; LISINOPRIL; SINTROM; TARDYFERON; TENORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioplasty (angioplasty stenting); Ischemic heart disease; Myocardial necrosis (patient with a history of antero-septal myocardial necrosis); Thrombocytopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021398715

Write-up: Sudden death during an effortless walk this 26mar2021 after the vaccine no adverse effects before, no complaints before the walk; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number BE-FAMHP-DHH-N2021-86449. A 72-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EP9605), via an unspecified route of administration on 23Mar2021 13:30 as single dose for COVID-19 immunization. Medical history included ischemic heart disease, antero-septal myocardial necrosis, angioplasty stenting, and stable isolated thrombocytopenia, all from an unknown date. Concomitant medications included acetylsalicylic acid (ASAFLOW), ezetimibe, simvastatin (INEGY), lisinopril, acenocoumarol (SINTROM), ferrous sulfate (TARDYFERON), and atenolol (TENORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death during an effortless walk this 26Mar2021 after the vaccine no adverse effects before, no complaints before the walk. The patient died on 26Mar2021. It was not reported if an autopsy was performed. Reporter comment: Treatment - Evolution of the ADR - Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Health Agency. Method of assessment: WHO. Result of Assessment : unclassifiable. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Health Agency. Method of assessment: WHO. Result of Assessment : unclassifiable.; Reported Cause(s) of Death: sudden death


VAERS ID: 1225006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Cardiac arrest, Chills, Constipation, Faecal vomiting, Gastric dilatation, Intestinal obstruction, Investigation, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: ATORVASTATIN; ALLOPURINOL; LYSANXIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Per-resuscitation ultrasound: Fluid content of the; Comments: Per-resuscitation ultrasound: Fluid content of the digestive loops.
CDC Split Type: BEPFIZER INC2021398719

Write-up: cardiac arrest around 30h post-vaccination; fecaloid vomiting; abdominal dilation; Bowel obstruction; no bowel movements; Abdominal pain; shivering; Vomiting; Asthenia; Nausea; This is a spontaneous report from a contactable physician downloaded from a regulatory authority. Regulatory Authority Report Number: BE-FAMHP-DHH-N2021-86590. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was stated as: the patient''s general condition was good, no significant history. Concomitant medications included atorvastatin; allopurinol; prazepam (LYSANXIA), all were taken for an unspecified indication, start and stop date were not reported. On 26Mar2021, the patient experienced shivering, nausea, asthenia, abdominal pain, vomiting, no bowel movements, bowel obstruction, stomach dilatation, fecal vomiting. On 27Mar2021, the patient experienced cardiac arrest around 30h post-vaccination. The events were assessed as serious, lead to death. Examinations - Per-resuscitation ultrasound: Fluid content of the digestive loops. ADR description - Within a few hours of vaccination, asthenia, chills. A few hours later, abdominal pain and vomiting. Persistence of abdominal pain with absence of stool and false need. EMS support for cardiac arrest approximately 30 hours after vaccination. Table of intestinal obstruction with abdominal dilation +++, per-resuscitation fecaloid vomiting, fluid content of the digestive loops on per-resuscitation ultrasound. Death of the patient. The patient died on 28Mar2021. It was not reported if an autopsy was performed. Treatment of events includes Buscopan, Ibuprofen. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Treatment - Buscopan, Ibuprofen; Evolution of the ADR - Death; Examinations - Per-resuscitation ultrasound: Fluid content of the digestive loops. ADR description - Within a few hours of vaccination, asthenia, chills. A few hours later, abdominal pain and vomiting. Persistence of abdominal pain with absence of stool and false need. EMS support for cardiac arrest approximately 30 hours after vaccination. Table of intestinal obstruction with abdominal dilation +++, per-resuscitation fecaloid vomiting, fluid content of the digestive loops on per-resuscitation ultrasound. Death of the patient.; Reported Cause(s) of Death: cardiac arrest; fecaloid vomiting; abdominal dilation; Bowel obstruction; no bowel movements; Abdominal pain; shivering; Vomiting; Asthenia; Nausea


VAERS ID: 1225007 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pyrexia, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bacterial infection NOS (Bacterial problems); Bed sore (Bed sores); General physical condition decreased (my dad was paralyzed and not in the best health shape); Iodine allergy (allergy to iodine); Paralyzed (Paralyzed for 23 years); Sepsis (multiple blood infections, chronic blood infections)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021405803

Write-up: Bacterial infection/Sepsis shock; Fever; not feeling well; This is a spontaneous report from a contactable consumer. A 60-year-old male patient (father of the reporter) received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 60-year-old) (Lot Number: EP2166) as single dose for COVID-19 immunisation. Relevant medical history included multiple blood infections and chronic blood infections, paralysis from 1997 (paralyzed for 23 years), bed sores, bacterial problems, general physical health deterioration (the patient was paralyzed and not in the best health shape) and iodine allergy. Concomitant medications were not reported. The patient died 3 days after receiving the vaccine. He had a blood infection and the doctor decided that it was ok to give him the vaccine. He had a fever and was not feeling well on 05Mar2021. The patient was hospitalized for the events. The patient died on 08Mar2021. An autopsy was not performed. The patient did not receive corrective treatments. The reporter commented that his dad was paralyzed and not in the best health shape and he was not sure why was he given the vaccine. The doctor told the reporter that he died from bacterial infection and the cause of death was septic shock (onset date 05Mar2021).; Reported Cause(s) of Death: Sepsis Shock


VAERS ID: 1225011 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: Carcinoma; Lung nodule (Unknown if patient was born with one lung or if a pneumonectomy took place); Pneumonectomy (Unknown if patient was born with one lung or if a pneumonectomy took place)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021404159

Write-up: My father died 15Mar2021, 50 minutes after receiving the vaccine/Patient collapsed and died after 30min of resuscitation/sudden death; This is a spontaneous report received from a contactable consumer (patient''s child) via a regulatory authority. Regulatory authority report number CH-SM-2021-14212. A 73-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EP2163), intramuscular on 15Mar2021 as a single dose (at the age of 73-years-old) for covid-19 immunisation. The patient medical history included carcinoma; one lung and a new nodule on the remaining lung and it was unknown if patient was born with one lung or if a pneumonectomy took place. The patient''s concomitant medications were not reported. The consumer reported that his/her father (patient) died 50 minutes after receiving the vaccine on 15Mar2021. Clinical course details: He was at the parking, he was going to his car to get his ticket when he collapsed on his 2 knees while holding his chest or belly (these are the surveillance cameras) which was filmed. He had 30 minutes of resuscitation in vain on the spot. The patient died on 15Mar2021. Cause of death reported as "Patient collapsed and died after 30min of resuscitation". An autopsy was performed and results were not provided. A causal relationship between Comirnaty and Death was assessed as being conditional/unclassified. This case was reported as serious (fatal outcome). Sender''s comment: Sudden death 50 minutes after vaccination in an oncology patient with a single lung who had been diagnosed with a nodule. The autopsy is in progress that will explain the death and that we will integrate in the report as soon as it is received. At the moment, we don''t have other details, we judged the causal correlation with the vaccine as conditional/unclassified. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient collapsed and died after 30min of resuscitation


VAERS ID: 1225015 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute respiratory failure; Adipositas; Arterial hypertension; Autoimmune thyroiditis; Bipolar affective disorder; Bronchial pneumonia; COPD; Hashimoto''s encephalopathy; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398796

Write-up: The body was found on 26Mar2021 at around 8 a.m.; This is a spontaneous report from a non-contactable other healthcare professional (HCP) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100032180. A 57-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER7812, expiry date not reported), via an unspecified route of administration on 25Mar2021 18:25 at 0.3 mL, single for covid-19 immunisation. Medical history included Hashimoto''s encephalopathy, acute respiratory failure, and bronchial pneumonia, all on unknown dates (not ongoing); and COPD, bipolar affective disorder, sleep apnoea syndrome, adipositas, autoimmune thyroiditis, arterial hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had the first dose of Comirnaty for COVID-19 immunisation at 0.3ml on 09Feb2021. The patient''s body was found on 26Mar2021 at around 8 a.m. The patient died on 26Mar2021 with unknown cause of death. It was unknown if an autopsy was performed. Sender comments: 2nd vaccination Comirnaty on 25Mar21 at 6:25 pm. After that, well-being. The corpse was found on March 26Mar21 at around 8 h. Comirnaty/ death/ Regulatory Authority, D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225016 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, 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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC2021398798

Write-up: The lethal outcome with asystole 20:20h; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is DE-PEI-202100031681. A 78-year-old male patient received BNT162B2 (COMIRNATY, lot number: ER9480 and expiration date not reported), via an unspecified route of administration on 06Apr2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 06Apr2021 20:20 the patient experienced lethal outcome with asystole. ECG (Electrocardiography), Cardiopulmonary Resuscitation through Ramus diagonalis. The patient died on 06Apr2021. It was not reported if an autopsy was performed. The event was assessed as serious (death, life threatening). Relatedness of drug to reaction/event by Regulatory Authority was D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The lethal outcome with asystole


VAERS ID: 1225018 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: CLOTRIMAZOL; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ACTILYSE; QUETIAPIN; NOVALGIN [METAMIZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Dementia; Diabetes; Lung embolism; Renal insufficiency; Right ventricular failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398803

Write-up: Lung embolism; Cerebral infarction; This is a spontaneous report from a non-contactable healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100031683. A 79-year-old male received BNT162B2 (COMIRNATY), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: Unknown) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included arteriosclerosis, renal insufficiency, lung embolism, right ventricular failure, dementia and diabetes; all unknown if ongoing. Concomitant medications included clotrimazol; pantoprazole sodium sesquihydrate (PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); alteplase (ACTILYSE); quetiapine fumarate (QUETIAPIN); and metamizole sodium (NOVALGIN [METAMIZOLE SODIUM]); and "HCT 12" and "Torein" (unspecified, pending clarification); all taken for an unspecified indication, start and stop date were not reported. The patient took the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunisation. On 03Mar2021, the patient experienced cerebral infarction. On 07Mar2021, the patient experienced a lung embolism. The patient has not recovered from cerebral infarction. The regulatory authority assessed lung embolism as serious, death, hospitalization and life-threatening; while cerebral infarction as serious requiring hospitalization and life-threatening. The patient died on 07Mar2021. It was unknown if an autopsy was performed. Sender Comment: He was suddenly found dead in the hospital bed. It is unclear whether he died in connection with the vaccination. Previous illness: Vascular damage to the legs, already several operations. Relatedness of drug to reaction(s)/event(s) for all events Result of Assessment D. Unclassifiable Comirnaty batch/lot number: unknown; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1225021 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-13
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-03-13
   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 INC2021398820

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100032174. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously receive first dose of COMIRNATY for Prophylactic vaccination on 27Jan2021. On 13Mar2021, it was reported that the patient died. The cause of death was unknown. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225022 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-28
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398822

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100032176. A 97-year-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 31Dec2020 at 0.3 ml for Covid-19 immunisation. On 28Feb2021, the patient died of an unknown cause. An autopsy was not performed. Comirnaty and death was assessed by Regulatory Authority as unclassifiable. No follow-up attempts possible. No further information expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225023 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-12
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Echocardiogram, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer
Allergies:
Diagnostic Lab Data: Test Name: echocardiogram; Result Unstructured Data: Test Result:no results; Test Name: Transesophageal echocardiography; Result Unstructured Data: Test Result:no results
CDC Split Type: DEPFIZER INC2021398829

Write-up: Unknown cause of death; Lung embolism; This is a spontaneous report from a non-contactable physician reporting for a patient downloaded from the regulatory authority, company number DE-PEI-202100032178. An 82-year-old female patient received bnt162b2 (COMIRNATY) reported as "mRNA TOZINAMERAN", via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation, at 82 years old. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took COMIRNATY on 07Jan2021 for Prophylactic vaccination. The patient experienced unknown cause of death on an unspecified date and lung embolism on 12Feb2021. The patient underwent lab tests and procedures which included echocardiogram: no results, and Transesophageal echocardiography: no results on unspecified dates. Seriousness criteria was provided as death, hospitalization (unspecified date), and life threatening. The patient died on an unspecified date. It was not reported if an autopsy was performed. Causality was provided as Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-18
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: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398831

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100032179. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of COMIRNATY on 12Feb2021 at 0.3 ml for COVID-19 immunization. The patient experienced unknown cause of death on 24Mar2021. The patient died on 24Mar2021. An autopsy was not performed. Relatedness of drug to reaction/event: Unclassifiable Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225025 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398825

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number DE-PEI-202100032180. An 86-year-old female patient received bnt162b2 (COMIRNATY also reported as mRNA TOZINAMERAN), at vaccination age of 86-year-old via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 0.3 mL single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 11Mar2021, the patient experienced cause of death unknown. The outcome of the event was fatal. The patient died on 11Mar2021. An autopsy was not performed. Comirnaty/ death/ Regulatory Authority , D. Unclassifiable No follow-up attempts possible. Batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225026 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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 INC2021398833

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority -WEB, regulatory authority number DE-PEI-202100032181. A 90-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 22Jan2021 (Lot number was not reported) as 0.3 mL, single for covid-19 immunization at age 90 years old. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of COMIRNATY on 31Dec2020 as 0.3 mL, single for COVID-19 immunization at age 90 years old The patient experienced unknown cause of death on 12Feb2021. The patient died on 12Feb2021. An autopsy was not performed. The relatedness of Comirnaty to death was unclassifiable as per PEI. No follow-up attempts are possible. No further information is expected. Batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225027 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pacemaker insertion (cardiac)
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm; Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398811

Write-up: lethal outcome 18h after Comirnaty; This is a spontaneous report from a non-contactable other health care professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100032187. A 92-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: Unknown) at the age of 92-years-old as single dose for covid-19 immunisation. Medical history included arterial hypertension, aneurysm from an unknown date and unknown if ongoing, ongoing pacemaker. The patient''s concomitant medications were not reported. The patient experienced lethal outcome 18h after comirnaty (death) on 30Mar2021. The patient died on 30Mar2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Sender Comment: Pacemaker Comirmaty/ Death/ PEI/ Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225028 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398819

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB DE-PEI-202100032189. A 90-year-old male patient received bnt162b2 (COMIRNATY; lot number and expiration date unspecified), via an unspecified route of administration on 26Feb2021 as 0.3 mL, single for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. On 03Mar2021, the patient experienced cerebral haemorrhage. The patient died on 25Mar2021 due to the event. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) Source of assessment PEI Result of Assessment D. Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1225034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: Heart insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021400068

Write-up: death; shortness of breath; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from a regulatory authority. An 80-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. Medical history included heart insufficiency from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient was vaccinated on 08Apr2021 with the 1st dose of BioNtech corona vaccine. The patient has been doing well so far. Shortness of breath began around 24 hours late (09Apr2021). Then patient died on 10Apr2021 due to an unknown cause of death. It was not reported if an autopsy was performed. Outcome of shortness of breath was unknown. Follow-up (12Apr2021): New information received by Pfizer from a contactable physician via BioNTech (license number: 36038), license party for COMIRNATY. Batch/lot number: EW8904.; Sender''s Comments: Lacking any details on the circumstances and cause of patient''s demise, the reported death is considered as related to BNT162B2 as a cautionary measure only. 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: 1225055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood sodium, Cerebral haemorrhage, Coagulation test, Computerised tomogram head, Haemoglobin, Mean cell haemoglobin, Mean cell volume, Neutrophil count, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dyslipidemia; Fall; Glaucoma; Hip injury; Ischaemic stroke; Transurethral resection of bladder tumor
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: creatinine; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: fibrinogen; Result Unstructured Data: Test Result:79.75; Test Date: 202103; Test Name: glucose; Test Result: 160 mg/dl; Test Date: 202103; Test Name: potassium; Result Unstructured Data: Test Result:3.7 mEq/l; Test Date: 202103; Test Name: sodium; Result Unstructured Data: Test Result:153 mEq/l; Test Date: 202103; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Date: 20210329; Test Name: CT skull; Result Unstructured Data: Test Result:corresponding to hematoma; Comments: corresponding to hematoma in acute evolutionary phase with associated vasogenic edema; Test Date: 202103; Test Name: hemoglobin; Result Unstructured Data: Test Result:98 g/l; Test Date: 202103; Test Name: MCH; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: MCV; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: neutrophils; Result Unstructured Data: Test Result:neutrophilia 8650; Test Date: 202103; Test Name: platelets; Result Unstructured Data: Test Result:normal; Test Date: 202103; Test Name: leukocytes; Result Unstructured Data: Test Result:leukocytosis 12100
CDC Split Type: ESPFIZER INC2021398873

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB ES-AEMPS-816333. An 89-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included ischaemic stroke from 2013 to an unknown date, arterial hypertension, glaucoma, dyslipidaemia from an unknown date and unknown if ongoing, transurethral bladder resection from 2007 to an unknown date, fall from 15Mar2021 and joint injury from 15Mar2021 to an unknown date. Concomitant medication included acetylsalicylic acid taken for an unspecified indication, start and stop dates were not reported. The patient experienced cerebral haemorrhage on 29Mar2021. Clinical course was as follows: Patient''s background: stroke in 2013; Hypertension; Glaucoma; Dyslipidemia; Transurethral resection of bladder tumor in 2007; Fall on 15Mar2021 without head trauma. Hip contusion, so the dose of ASA is reduced from 300 to 100 mg. Complementary examinations on admission: Patient in coma, with closed eyes without verbal response to the stimuli. To the pain stimulus, no eye opening, no verbal response and with decerebrate movements in both arms. Dysphoric right pupil due to history of surgical intervention, middle left pupil with slow photomotor. Focused gaze. Absence of oculocephalic movements. Left facial asymmetry to the Marie-Foix maneuver. Bilateral extensor plantar reflex. No abnormal movements. General analysis: Hb 98 g / L, MCV and normal MCH. Leukocytes 12100 with neutrophilia 8650. Normal platelets. Normal coagulation. Glucose 160mg / dl. Creatinine normal, Fibrinogen 79.75. Na 153mEq / L, K 3.7 mEq / L. CT 29Mar2021: Cranial CT: hyperdense intraparenchymal lesion of 60x30 mm with maximum axial diameters, located in the right midsemioval center with ipsilateral capsulo-lenticular caudal extension, with peripheral hypodense area, suggestive of corresponding to hematoma in acute evolutionary phase with associated vasogenic edema. It determines a compressive effect on the adjacent structures, altering the morphology of the ipsilateral ventral lateral nucleus, with displacement of midline structures (approximately 8mm). Free base and peritroncular cisterns. Ventricular system of conserved size and asymmetric morphology in relation to what was previously described. No images of fracture in the bone structures studied. CONCLUSION: Hematoma in acute evolutionary phase located in the right semioval center with ipsilateral capsulo-lenticular extension, which determines a compressive effect on the ipsilateral ventral lateral nucleus and displacement of midline structures (approximately 8mm). To assess probable hypertensive origin. Exitus 01Apr2021: Torpid evolution in the first 24 hours, remaining in a comatose state, without responding to stimuli, decerebrate movement to the painful stimulus, absence of oculocephalic reflex, weak corneal and middle pupil reflex with little photoreactivity. Given neurological deterioration without being a candidate for aggressive measures due to age, multiple pathologies and torpid evolution in less than 24 hours with signs of possible uncal herniation, together with the family they decided to prioritize comfort measures. The outcome of the events was fatal. The patient died on 01Apr2021. An autopsy was performed that revealed decerebration. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Autopsy-determined Cause(s) of Death: Decerebration


VAERS ID: 1225056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Chronic obstructive pulmonary disease
SMQs:, Cardiac failure (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: Medical History/Concurrent Conditions: Anaemia megaloblastic; Aortic stenosis; Arteriosclerotic cardiovascular disease; COPD; External carotid artery stenosis; Fibrillation atrial; Hypertension arterial; Sigmoid diverticulosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021398884

Write-up: Decompensation cardiac; COPD exacerbation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number [ES-AEMPS-816748]. A 91-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: ep2163), intramuscular on 04Mar2021 as single dose for COVID-19 vaccination. Medical history included anaemia megaloblastic, hypertension arterial, aortic stenosis, fibrillation atrial, external carotid artery stenosis, arteriosclerotic cardiovascular disease, sigmoid diverticulosis, COPD (chronic obstructive pulmonary disease). The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 11Feb2021 for COVID-19 vaccination. The patient experienced COPD exacerbation on 10Mar2021 (6 days after the second vaccination) and decompensation cardiac on 20Mar2021 (16 days after the second vaccination). The patient died on an unspecified date. Cause of death were COPD exacerbation and decompensation cardiac. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: COPD exacerbation; decompensation cardiac


VAERS ID: 1225058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), 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: 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: HIDROFEROL; SINTROM; DEPRAX [FLUOXETINE HYDROCHLORIDE]; DUODART; RAMIPRIL CINFA; METFORMIN [METFORMIN]; ROSUVASTATIN CINFA; BISOPROLOL CINFA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Benign prostatic hyperplasia; DVT; Fibrillation paroxysmal atrial; Hepatic cyst; Hypertension arterial; Hypertensive heart disease; Obstructive sleep apnea hypopnea syndrome; Pulmonary thromboembolism; Sigmoid diverticulitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021398620

Write-up: Ventricular fibrillation; asystole; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB manufacturer report number ES-AEMPS-818055. An 83-year-old male patient received bnt162b2 (COMIRNATY, lot number and expiry date were unknown), intramuscular on 24Mar2021 as single dose for COVID-19 immunization. Medical history included hypertensive heart disease, hepatic cyst, abdominal aortic aneurysm, sigmoid diverticulitis, pulmonary thromboembolism in 2014, obstructive sleep apnea hypopnea syndrome, hypertension arterial, fibrillation paroxysmal atrial, DVT and benign prostatic hyperplasia. Concomitant medications included calcifediol (HIDROFEROL); acenocoumarol (SINTROM); fluoxetine hydrochloride (DEPRAX); dutasteride, tamsulosin hydrochloride (DUODART); ramipril (RAMIPRIL CINFA); metformin (METFORMINA); rosuvastatin calcium (ROSUVASTATINA CINFA); bisoprolol fumarate (BISOPROLOL CINFA). Four (4) days after vaccination on 28Mar2021, the patient experienced ventricular fibrillation and asystole. Course of events were as follows: when starting dinner, being previously well, he shouted and falled unconscious. He was treated urgently and found ventricular fibrillation, which progressed to asystole in 20 minutes. The patient died on an unspecified date. Cause of death was ventricular fibrillation and asystole. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: ventricular fibrillation; asystole


VAERS ID: 1225064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, General physical health deterioration, Mobility decreased, Nausea, Poor quality sleep
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LINATIL; ELIQUIS; HUMIDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Cardiac pacemaker insertion (insertion of a permanent VV1 pacemaker); Gallstones removal (gallstone removal, monitored from 2002 onwards); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021398633

Write-up: Unknown cause of death; Mobility decreased; Sleep restless; Nausea; Dizziness; General physical health deterioration; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number FI-FIMEA-20211659. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EJ6790) as single dose for COVID-19 immunisation. Medical history included VV1 pacemaker (cardiac pacemaker insertion) on 31Jan2020: insertion of a permanent VV1 pacemaker, gallstone removal from the beginning of 2020: "monitored from 2002 onwards", hypertension and anticoagulant therapy. Concomitant medications included enalapril maleate (LINATIL) taken for hypertension, start and stop date were not reported; apixaban (ELIQUIS) taken for anticoagulant therapy, start and stop date were not reported; calcium chloride dihydrate, potassium chloride, sodium chloride (HUMIDOSE) taken for an unspecified indication, start and stop date were not reported. On 23Feb2021, the patient experienced mobility decreased, sleep restless, nausea, dizziness and general physical health deterioration. The day after the vaccination there was difficulty moving due to dizziness, he had to take support from the walls while walking and had nausea and restless sleep. On 09Mar2021, he had difficulty getting out of bed. His overall condition deteriorated after vaccination. The patient died (unknown cause of death) on 09Mar2021. The results of the forensic autopsy research were not yet available. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1225069 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: Auricular fibrillation; Gout; Hypothyroidism; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021398740

Write-up: Tachycardia, death; This is a spontaneous report from a contactable Consumer downloaded from a regulatory authority-WEB FR-AFSSAPS-BR20211119 and received via a pharmaceutical company. A 85-years-old female patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular on 14Mar2021 as single dose for COVID-19 immunization. Medical history included Gout, Hypothyroidism, Auricular fibrillation from Aug2017, Infarct myocardial from Jan2017. The patient''s concomitant medications were not reported. The patient experienced tachycardia, death (fatal tachycardia) on 17Mar2021. The patient died on 17Mar2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Tachycardia, death


VAERS ID: 1225084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021398759

Write-up: Death NOS; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20212736. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. The patient had no history of COVID. The patient''s concomitant medications were not reported. The patient experienced death nos (no further information) on 31Mar2021. The patient died on 31Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1225102 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Hypertension, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Breathing difficult; Carotid artery dissection; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80; Test Date: 20210309; Test Name: heart rate; Result Unstructured Data: Test Result:120; Comments: 120 bpm
CDC Split Type: FRPFIZER INC2021363175

Write-up: Hypertension arterial; Tachycardia; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211393. An 85-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP9605), dose 1 intramuscular, administered in Arm Left on 09Mar2021 14:30 (at the age of 85years) as single dose for Covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing; and breathing difficult on 07Mar2021. The patient''s concomitant medications were not reported. History: treatment with blood pressure medication (name of medication not given); mention of old carotid dissection according to the medical examiner; the doctor does not want to communicate about the patient''s history. According to the attending physician, he came on Sunday 07Mar2021 at 1 pm to check the patient''s blood pressure, she had breathing difficulties during the weekend. Declaration by a forensic doctor of the death of a patient who received the Comirnaty vaccine the same day: the physician transferred the information because of the ongoing forensic investigation autopsy in progress. On 09Mar2021, the patient was vaccinated with Comirnaty vaccine, lot number: EP9605, left arm, first injection on 09Mar2021 at 2:30 pm. During the pre-vaccination consultation, nothing to report; on 09Mar2021: around 7:50 pm, BP at 140/80 but dyspnea stage II (as since Sunday according to the attending physician) and especially tachycardia at 120 bpm and the attending physician specifies "in this context, there is every reason to look for a latent coronary insufficiency". The doctor writes his letter to the emergency room and contacts a cab to take her to the emergency room; the cab driver discovers the patient face down on the ground, he informed the attending physician who contacts the Emergency medical services; the Emergency medical services takes charge of the patient: he notices traces of blood in the mouth, blood on the internal face of the surgical mask resuscitation gestures carried out: external cardiac massage, intubation, ventilatory maneuvers, infusion of adrenaline 6 mg, thrombolysis 7 ml were given; death noted on 09Mar2021 at 9:13 pm by the doctor of the Emergency medical services. Conclusion: unexplained death within 24 hours after the vaccination, not attributable to the only effects presented on 09Mar2021 and described by the attending physician without precise information on the patient''s medical history. The patient died on 09Mar2021. An autopsy was performed, and results were not available.; Reported Cause(s) of Death: Hypertension arterial; Tachycardia; Dyspnoea


VAERS ID: 1226499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Lung neoplasm malignant, Pulmonary embolism, SARS-CoV-2 test, X-ray
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Lung operation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210113; Test Name: X-ray; Result Unstructured Data: Test Result:all clear
CDC Split Type: GBPFIZER INC2021394552

Write-up: Pulmonary embolism; lung cancer; Breath shortness; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104021551278950. A 81-year-old male patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) unspecified route of administration, on 06Jan2021, as single dose for COVID-19 immunisation. Medical history included lung neoplasm malignant and lung operation from Sep2020. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism and lung cancer on an unspecified date; and breath shortness on 08Jan2021. The patient had negative COVID-19 test on unspecified date. The reported outcome for the events lung cancer and breath shortness was not recovered. The patient died on 15Jan2021. The cause of death was pulmonary embolism. It was not reported if an autopsy was performed. The clinical course was reported as follows: patient began complaining of a shortness of breath two days later and described it as felt as though the oxygen wasn''t getting to the bottom of his legs. On the 13Jan2021, patient went to the hospital appointment for an X-ray of his lungs as a check up following a lung cancer operation in Sep2020 and received an all clear results. On 15Jan2021, Friday morning between 9 and 10 am patient collapsed at home and passed away. The coroners report stated cause of death as bilateral pulmonary emboli. 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: bilateral pulmonary emboli


VAERS ID: 1226526 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Back pain, Blood pressure decreased, Blood pressure measurement, Body temperature, Chest pain, Cold sweat, Communication disorder, Confusional state, Decreased appetite, Illness, Malaise, Musculoskeletal chest pain, Myocardial infarction, Sepsis, Unresponsive to stimuli, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 54
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: General physical health deterioration (He was in a poor state of health.); Parkinson''s disease (He has had Parkinson''s disease for 30 years.); Recurrent urinary tract infection; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally).)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: Blood pressure; Result Unstructured Data: Test Result:No results provided; Test Date: 20210328; Test Name: Blood pressure; Result Unstructured Data: Test Result:Dropping rapidly; Test Date: 20210328; Test Name: temperature; Result Unstructured Data: Test Result:No results provided
CDC Split Type: GBPFIZER INC2021393710

Write-up: sickness/a bit sick; RIb pain; Chest pain; abnormal behaviour/acting strange; back pain/having terrible pains in his back; Communication disorder/inability to be understood; Blood pressure decreased; only ate a small amount of his dinner; Unresponsive to stimuli; feeling unwell; clammy/clammy to touch; Confusion; sepsis; Urinary tract infection/urine infection; heart attack; This is a spontaneous report from a contactable consumer or other non healthcare professional received from a Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104030643017380. Safety Report Unique Identifier GB-MHRA-ADR 25075357. A male patient of an unspecified age received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; batch/lot number: EN3924; expiration date not provided), via an unspecified route of administration on 31Jan2021 as single dose for COVID-19 immunisation. Patient''s medical history included ongoing steroid therapy [reported as ''Taking regular steroid treatment (e.g. orally or rectally)], ongoing Parkinson''s disease (reported as ''He has had Parkinson''s disease for 30 years''), ongoing general physical health deterioration (reported as ''He was in a poor state of health''), and ongoing recurrent urinary tract infection (also reported as ''recurring water infections''). This was further reported as Patient has had Parkinson''s disease for 30 years and was in a poor state of health with recurring water infections. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced sepsis, ''urinary tract infection/urine infection'', and heart attack on 29Mar2021; feeling unwell, ''clammy/clammy to touch'', ''sickness/a bit sick'', rib pain, chest pain, ''abnormal behaviour/acting strange'', ''back pain/having terrible pains in his back'', ''Communication disorder/inability to be understood'', blood pressure decreased, unresponsive to stimuli, and ''only ate a small amount of his dinner'' on 28Mar2021; confusion on 02Feb2021. Patient''s clinical course is as follows: ''Confusion'', it was reported that patient had a bad reaction 2 days after receiving the vaccine. The first time the patient had the reaction, he was confused and didn''t seem to know what he was doing, and he was more or less out of it all day. Patient''s wife thought she would leave the patient until the next day to see if the patient was any better. Patient did seem better but looked awful in his face. Then 2 days later, he had the same reaction but not so severe. Patient seemed to be ok for a while then on Sunday 28th March, he woke up feeling unwell but didn''t mentioned it to his wife. As the day wore one, patient was a bit sick at lunch time and said he was hurt across his chest, under his ribs. It was reported that patient only ate a small amount of his dinner, then watched the football in the kitchen in his wheelchair, then patient''s wife pushed the patient in the lounge with her and turned on the television. After 30 minutes, patient was acting strangely and wife asked if the patient was ok, then patient started having terrible pains in his back, so wife prayed for the patient and called an ambulance. They couldn''t get a lot of sense from him as to where the pain was, so they took the patient to hospital where wife met them and was allowed to go in because of patient''s inability to be understood. Patient was put on a drip et cetera, took his temperature, and blood pressure, then took him to another ward and put him in a cubicle. They didn''t check the patient, then the nurse came and said they were moving him to another ward and putting him in a more comfortable bed. They moved the patient up the trolley as his feet were sticking out. Then wife said to the nurse that patient was clammy to touch. So, she moved the drip up higher, and the other nurse did check the patient''s blood pressure again, and it was dropping rapidly. So, the patient became unresponsive and died. They gave the cause of death as urine infection and sepsis set in causing a heart attack, but wife would like to know how they could tell that without a postmortem. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure with no result provided on 28Mar2021 and with result of ''Dropping rapidly'' on 28Mar2021; and temperature with no result provided on 28Mar2021. The outcome of the events ''sepsis'', ''urinary tract infection/urine infection'', and ''heart attack'' was fatal; outcome of the events ''feeling unwell'', ''clammy/clammy to touch'', and confusion was not recovered; outcome of the remaining events was unknown. The patient died on 29Mar2021. It was reported that an autopsy was not performed. The reported causes of death were ''sepsis'', ''urinary tract infection/urine infection'', and ''heart attack''. Follow-up attempts are completed. No further information is expected; Reported Cause(s) of Death: Urinary tract infection/urine infection; Sepsis; Heart attack


VAERS ID: 1226606 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Embolism, Sudden death, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: ESTRADOT; FLUOXETINE; FOSTAIR; MIRENA; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dyspepsia; Hormone replacement therapy; Low mood
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021393940

Write-up: Death; died suddenly and unexpectedly/sudden death; Thromboembolic event/thrombocytopenia; Thromboembolic event/thrombocytopenia; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104071207356460. Safety Report Unique Identifier GB-MHRA-ADR 25094370. A 58-year-old female patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH; batch/lot number: ER1741; expiration date not provided), via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for COVID-19 immunisation. Patient''s medical history included low mood, asthma, hormone replacement therapy, and dyspepsia all from unspecified dates and unknown if ongoing. It was unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. It was unsure if patient is enrolled in clinical trial. Concomitant medications included estradiol (ESTRADOT) for hormone replacement therapy, fluoxetine for low mood, beclometasone dipropionate, formoterol fumarate (FOSTAIR) for asthma, levonorgestrel (MIRENA) for an unspecified indication, and omeprazole for dyspepsia. All concomitant medications from unspecified dates and unknown if ongoing. The patient experienced ''death'', ''died suddenly and unexpectedly/sudden death'', and Thromboembolic event/thrombocytopenia'' on 03Apr2021 (as reported). Patient''s clinical course is as follows: It was reported that the patient died suddenly and unexpectedly 9 days after receiving second dose of Pfizer vaccine. It was reported that a post mortem is planned on 07Arp2021 but at present, there was no indication of the cause of death. Reporter mentioned that this report is being submitted now due to the recent vaccination but has no indication that the vaccine caused sudden death until a post mortem report is available. When probed if the report relates to possible blood clots or low platelet counts, reported responded "Yes" thromboembolic event/thrombocytopenia. It was also stated that "Not known if it was as post mortem pending". It was unknown if the platelet count was <150 A-109/L, if was D-dimer $g4000, and if anti-PF4 antibodies were identified. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events was fatal. It was unknown if an autopsy was performed. The reported causes of death were ''death'', ''died suddenly and unexpectedly/sudden death'', and Thromboembolic event/thrombocytopenia''. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died suddenly and unexpectedly/sudden death; Thromboembolic event/thrombocytopenia; Thromboembolic event/thrombocytopenia; death


VAERS ID: 1226608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021393990

Write-up: Dyspnoea; This is a spontaneous report from a contactable physician. This report is received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104081152037820. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial.The patient experienced dyspnoea on 31Mar2021. The patient died on an unspecified date. The cause of death was dyspnea. An autopsy was not performed. Clinical course was reported as follows: patient received vaccine with no acute side effects on 31Mar2021. Observed for at least 90 minutes at the hub by staff including GP (prolonged wait as waiting for transport), during which time was alert and not in extremis. Reported to be breathless at home over 4 hours after vaccine administration (reported to her family who were unable to respond at the time). Found unresponsive at home the following morning 01Apr2021. CPR through paramedics unsuccessful. Currently awaiting post mortem report to detail cause of death.; Reported Cause(s) of Death: dyspnoea


VAERS ID: 1226613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Motor neurone disease
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021394244

Write-up: Death/ Unexpected death; This is a spontaneous report from a contactable healthcare professional. This report was received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104091148082320. Safety Report Unique Identifier GB-MHRA-ADR 25111212. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER1749) as single dose for COVID-19 immunisation. The patient medical history included motor neurone disease. It was unsure if patient has had symptoms associated with COVID-19, unsure if patient was enrolled in clinical trial. Concomitant medications included aspirin [acetylsalicylic acid] from 13May2016, bisoprolol from 08Nov2007, and Irbesartan from 08Nov2007; all taken for unspecified indications and with unspecified stop dates. The patient experienced death/unexpected death on 05Apr2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unspecified date and unspecified investigations and tests conducted (results unknown) were in the hands of the coroner. The patient died on 05Apr2021. Cause of death was unknown. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Death/ Unexpected death


VAERS ID: 1226662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: PERINDOPRIL; DELORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Sleep disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398771

Write-up: Vomiting/vomiting episode with traces of blood; Cardiac arrest; This is a spontaneous report downloaded from the regulatory authority-WEB [Regulatory authority number IT-MINISAL02-710856]. A contactable physician reported an 82-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular administered on arm left on 01Apr2021 10:35 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as SINGLE DOSE for COVID-19 immunization. Medical history included arterial hypertension and sleep disorder (reported as sleeping). Concomitant medications included perindopril (PERINDOPRIL) taken for arterial hypertension and delorazepam (DELORAZEPAM) taken for sleep disorder (sleeping disorder) both taken since unknown therapy dates. On 02Apr2021 (reported as 24 hours after administration), the patient had vomiting episode with traces of blood. After access to the patient, she was transferred to perform esophago-gastro-duodenoscopy but died of the patient due to cardiac arrest on that same day of 02Apr2021. It was not reported if an autopsy was performed. The patient died due to vomiting and cardiac arrest. Sender''s comments: On 06Apr2021 request for a clinical report and if an autopsy examination was carried out. Reporter''s comment: death of the patient 24 hours after the administration of the vaccine. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: death of the patient 24 hours after the administration of the vaccine.; Reported Cause(s) of Death: Vomiting/ vomiting episode with traces of blood; cardiac arrest


VAERS ID: 1226663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398757

Write-up: The person was vaccinated at home and found in asystole, the 118 was called and the person died.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, manufacturer report number IT-MINISAL02-710964. A 55 years male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: ER9470), via an unspecified route of administration on 03Apr2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On 04Apr2021, the patient was vaccinated at home and found in asystole, the 118 was called. On 06Apr2021 request for a clinical report and whether an autopsy was carried out. It was unknown whether the autopsy was performed or not. The patient died due to asystole. ; Reported Cause(s) of Death: he person was vaccinated at home and found in asystole, the 118 was called and the person died.


VAERS ID: 1226665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-18
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Gait disturbance, Motor dysfunction
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398828

Write-up: Difficulty coordinating movements and speech difficulties; Difficulty coordinating movements and speech difficulties; Difficulty coordinating movements and speech difficulties; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-711634. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: unknown) via intramuscular route of administration on arm right on 26Feb2021 at 0.3 ug dose as SINGLE DOSE for COVID-19 immunization. The patient medical history included cardiac pacemaker insertion from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 18Mar2021, the patient had difficulty in coordinating movements and speech difficulties (aphasia, gait disturbance and motor dysfunction) (death). The patient died on an unknown date and the outcome of all events reported as fatal. It was not reported/unknown if an autopsy was performed or not. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: My father wore a pacemaker in his heart.


VAERS ID: 1226666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Incorrect route of product administration, Malaise, Presyncope, Vertigo
SMQs:, Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398772

Write-up: patient received second dose of BNT162B2 ,subcutaneous at right shoulder; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; from 10 days onset of asthenia and generalized malaise On April 2, a vertiginous and pre-syncopal episode; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-712306. A 74-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: ET 7205) subcutaneous at right shoulder on 02Apr2021 12:00 as 0.3 mL, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced from 10 days onset of asthenia and generalized malaise on april 2, a vertiginous and pre-syncopal episode (vertigo) (death) on 02Apr2021. Therapeutic measures were taken as a result of the events. The patient died on 03Apr2021. It was not reported if an autopsy was performed.


VAERS ID: 1226797 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery disease, Malaise
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Respiratory disorder ((not specified))
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021399196

Write-up: acute coronary event/considering the medical history of the patient; Not feeling well; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB with regulatory authority number NL-LRB-00443919 and Safety Report Unique Identifier is NL-LRB-00498609. An 85-year-old male patient received bnt162b2 (COMIRNATY reported as COVID-19 VACCINE NOT SPECIFIED INJVLST), via an unspecified route of administration on 11Feb2021 (Lot Number: EJ6788) as a single dose for covid-19 immunisation. Medical history included respiratory disorder (not specified) and heart failure. The patient''s concomitant medications were not reported. This serious spontaneous report from a physician concerns a male aged 85 years, with malaise (death) following administration of covid-19 vaccine not specified injvlst (action taken: not applicable) for covid 19 immunization. The patient was resuscitated. The reporter described that another cause of death (acute coronary event) could not be excluded, considering the medical history of the patient. It was reported that the patient was not feeling well and acute coronary event on 11Feb2021 (also reported as 1 day after vaccination). Following death, the physician have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event). The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comment''s: -unknown- Past drug therapy I don''t know: No BSN available: Yes -confounding factors- confounding factors: underlying heart failure, lung problems -COVID-19- Previous COVID19 infection: No -Other- diagnostic procedures: Resuscitation remarks report from: Following death I have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event) No follow-up attempts possible. No further information expected.; Reporter''s Comments: -unknown- Past drug therapy I don''t know:No BSN available:Yes -confounding factors- confounding factors: underlying heart failure, lung problems -COVID-19- Previous COVID19 infection:No -Other- diagnostic procedures:Resuscitation remarks report from: Following death I have been in contact with the medical examiner, there will be a report via mental health care to a regulatory authority. Given the history, another cause of death cannot be completely ruled out (acute coronary event); Reported Cause(s) of Death: malaise; acute coronary event/considering the medical history of the patient


VAERS ID: 1226798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood pressure measurement, Chest X-ray, Chest scan, Dyspnoea, Hypotension, Laboratory test, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VASELINE CETOMACROGOL CREAM; MOVICOLON; DURATEARS [DEXTRAN 70;HYPROMELLOSE]; LISINOPRIL; COLECALCIFEROL; PANTOPRAZOL [PANTOPRAZOLE]; FUROSEMIDE; LIXIANA; CLOPIDOGREL; METOPROLOL [METOPROLOL SUCCINATE]; AMLODIPINE
Current Illness: Cardiac pacemaker insertion (DDD pacemaker); Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Collapse cardiovascular (due to sick sinus syndrome); Ischaemic stroke; Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 202102; Test Name: CT-thorax; Result Unstructured Data: Test Result:opacification; Comments: ground-glass opacification, no pulmonary embolism; Test Name: Lung photo; Result Unstructured Data: Test Result:Suggesting COVID-19; Test Name: Lab values; Result Unstructured Data: Test Result:Suggesting COVID-19; Test Name: antibody corona test; Test Result: Negative ; Test Date: 20210213; Test Name: coronatest; Test Result: Negative ; Test Date: 20210213; Test Name: coronatest; Test Result: Negative ; Test Date: 20210215; Test Name: coronatest; Test Result: Negative
CDC Split Type: NLPFIZER INC2021399139

Write-up: severe breathlessness, clinical picture of covid; Non STEMI; low blood pressure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00444364. A 93-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EJ6788) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing cardiac pacemaker insertion DDD pacemaker, ongoing dementia , non-hodgkin''s lymphoma from 2007, circulatory collapse from 2020 due to sick sinus syndrome, ischaemic stroke from 2013. Concomitant medications included cetomacrogol, paraffin, liquid, propylene glycol, white soft paraffin (VASELINE CETOMACROGOL CREAM); macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON); dextran 70, hypromellose (DURATEARS [DEXTRAN 70;HYPROMELLOSE]); lisinopril; colecalciferol; pantoprazol; furosemide; edoxaban tosilate (LIXIANA); clopidogrel; metoprolol succinate; amlodipine (AMLODIPINE). One day after vaccination, the patient experienced dyspnoea. Two days after vaccination, the patient was hospitalised with severe dyspnoea, corresponding clinical presentation of Covid. Laboratory results and X-ray also matched with covid. However, the patient was tested 3 times negative for SARS Cov 2 and once for antibodies. The patient had need for supplemental oxygen. The patient was treated with dexamethasone and antibiotics. Initially, some improvement, no clear due to which medication. After 4 days, the dexamethasone and antibiotics were withdrawn. Three days later low blood pressure (value unknown). In the following days increased need for oxygen and chest pressure. Appeared to be non stemi on 20Feb2021. On CT thorax ground-glass opacification was seen, no pulmonary embolism. 13 days after vaccination, palliative care was started and the patient deceased 17 days after vaccination. The event dyspnea was assessed as serious (life-threatening, hospitalization). The outcome of dyspnoea and low blood pressure is unknown. The patient underwent lab tests and procedures which included blood pressure measurement: low on 20Feb2021, chest scan: opacification on Feb2021 ground-glass opacification, no pulmonary embolism , chest x-ray: suggesting covid-19 on an unspecified date, laboratory test: suggesting covid-19 on an unspecified date, sars-cov-2 antibody test: negative on an unspecified date, sars-cov-2 test: negative on 13Feb2021, sars-cov-2 test: negative on 13Feb2021, sars-cov-2 test: negative on 15Feb2021. Therapeutic measures were taken as a result of non stemi (acute myocardial infarction), severe breathlessness, clinical picture of covid (dyspnoea), and low blood pressure. The patient died on 28Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Non STEMI


VAERS ID: 1226799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Malaise, Nausea, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; ZOLPIDEM; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: covid test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021399191

Write-up: developing a respiratory infection resulting in death/pneumonia; Fatigue/tired; varyingly stuffy/varyingly short of breath/dyspnoea; sick/became ill/feeling sick; Nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority number NL-LRB-00451954, Safety Report Unique Identifier NL-LRB-00499075. An elderly female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medications included pantoprazole, zolpidem and clopidogrel. The patient experienced developing a respiratory infection resulting in death, fatigue, varyingly stuffy, sick and nausea with latency of 1 day after start of covid-19 vaccine injection (17Feb2021). The patient had respiratory tract infection, feeling sick, nausea, fatigue and dyspnoea following administration of covid-19 vaccine. A covid test was done on the day she died; the test was negative. Patient was in good shape and still lived on her own without any help in the household etc. The day after vaccination, she developed a pneumonia. She alerted her physician after one week of feeling sick. When the physician saw her, it was already too late, and antibiotics couldn''t cure/help her. Physician mentioned that the vaccination may have played a role in lowering her immune system and thus making her more susceptible for other infections, such as pneumonia. The reporter commented the patient was developing a respiratory infection resulting in death. The day after the side effect, patient became ill, nauseated, unwell, tired and varyingly short of breath, no fever, she did not call the reporter as a doctor because she did not want hospitalization anymore, when the reporter was consulted today it was too late and she died in-house a few hours after the reporter''s visit. The patient had no previous COVID-19 infection. The patient was actually extremely fit for her age, lived independently without any help from home care, there was no dementia, etc. The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling the reporter as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections. The patient died on 22Feb2021 due to the events. An autopsy was not performed. Reporter Comment: - I do not know Past drug therapy I don''t know: no - developing a respiratory infection resulting in death - Additional information ADR: the day after the side effect, patient became ill, nauseated, unwell, tired and varyingly short of breath, no fever, she did not call me as a doctor because she did not want hospitalization anymore, when I was consulted today it was too late and she died in-house a few hours after my visit - COVID-19 Previous COVID-19 infection: No. - Other diagnostic procedures: covid test, result unknown - Follow up 25Feb2021 Follow-up received: death on 22 Feb. covid test was negative, taken on date of death no autopsy The patient was actually extremely fit for her age, lived independently without any help from home care, there was no dementia, etc. The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling me as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections. Assessor Lareb: FU received. Date of death and autopsy data entered. COVID test added. Case narrative completed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: The day after the vaccine she got sick, probably got pneumonia from another virus or bacteria. By calling me as a doctor late (almost a week after becoming ill) it was too late to be able to save her, e.g. with antibiotics. The vaccine may have played a role in (temporarily) weakening her immune system and thus making it more susceptible to other infections.; Reported Cause(s) of Death: developing a respiratory infection resulting in death/pneumonia; Fatigue/tired; varyingly stuffy/varyingly short of breath/dyspnoea; sick/became ill/feeling sick; nausea


VAERS ID: 1226803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Echocardiogram, Electrocardiogram, Exercise electrocardiogram, Malaise, Myocardial infarction, Radial pulse
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: LORAZEPAM; COLECALCIFEROL; FUROSEMIDE; CLOPIDOGREL; GABAPENTINE; METOPROLOL SUCCINATE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal) (upset stomach); Acute renal insufficiency (in renal infarction, component of moderate intake); Asthma cardiac (triggered by Acute renal insufficiency); Carpal tunnel syndrome (right); Cataract; CVA (start in 2021); Hypertensive crisis (Ischemia in the right hemisphere, catchment area a cerebri media); Left anterior hemiblock (ECG: LAHB); Pneumonia; Renal artery stenosis; Renal infarction (Crisis indicated by renal infarction based on severe origostenosis); Shoulder dislocation (shoulder luxation); Supraventricular extrasystoles; Tear film insufficiency, unspecified; Thoracic pain; Total knee replacement (left knee hemiprosthesis, Total Knee Prosthesis right); Uterine ablation (uterine extirpation); Ventricular extrasystoles (2016 Palpitations in frequent premature atrial contraction (PACs))
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Comments: not measurable (lost due to infarction); Test Name: TTE; Result Unstructured Data: Test Result:normal left ventricular function; Comments: no valve vitium; Test Date: 20210321; Test Name: ECG; Result Unstructured Data: Test Result:myocard infarct; Comments: showed an infarction (unknown old or new); Test Name: ergometry; Result Unstructured Data: Test Result:normal; Test Date: 20210321; Test Name: pulse; Result Unstructured Data: Test Result:low
CDC Split Type: NLPFIZER INC2021399220

Write-up: myocardial infarction due to / with concomitant heart failure; Passing away. The patient turned 20Mar2021which persisted until afternoon 21Mar2021 when suddenly unresponsive, ECG showed myocardial infarction. died in the night; Malaise; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00483468, Safety report unique identifier NL-LRB-00485214. A 92-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Pfizer), first dose via an unspecified route of administration on 18Mar2021 (lot number: ER7812) as single dose for COVID-19 immunisation. Medical history included CVA (Cerebrovascular accident), hypertensive crisis start in 2021 (Ischemia in the right hemisphere, catchment area a cerebri media, due to hypotension after hypertensive crisis treatment), total knee replacement (left knee hemiprosthesis, Total Knee Prosthesis right), cataracts and afterwards in right eye insufficient tear film, carpal tunnel syndrome (right), shoulder dislocation, uterine ablation (uterine extirpation), acid reflux (esophageal) (upset stomach), left anterior hemiblock (ECG: LAHB), supraventricular extrasystoles from 2016, ventricular extrasystoles (2016 Palpitations in frequent premature atrial contraction (PACs) / Premature ventricular contractions(PVCs)), asthma cardiac (triggered by Acute renal insufficiency), Acute renal insufficiency (in renal infarction, component of moderate intake), renal infarction (Crisis indicated by renal infarction based on severe origostenosis a. Renalis left, dd embolization of walled plaque aorta descendens), renal artery stenosis, cardiac history in 2003 the patient had non-specific thoracic complaints, and pneumonia. The patient was not previous COVID-19 infected. Before the vaccination, the patient was admitted to a rehabilitation department in a nursing home. She was still living independently at home, but after a CVA (Cerebrovascular accident) / hypertensive crisis she came to rehabilitate. She was doing well on the ward clinically, but after the infarction, there was difficulty with mobilization and independence for which a Protected living with intensive care and nursing indication had been requested. patient was going to move to a somatic ward. The patient''s condition in the weeks / days before vaccination was good. No deteriorating health. No corona test was conducted around the time of vaccination. The patient previously (before vaccination) took TTE (transthoracic echocardiogram) showed normal left ventricular function, no valve vitium, ergometry showed normal. Concomitant medications included gabapentine (capsule strength: 100 mg), pantoprazol (tablet strength: 20 mg),lorazepam (tablet strength: 1 mg), clopidogrel (tablet strength: 75mg),furosemide (tablet strength: 40 mg), metoprolol succinate (tablet strength: 50 mg), colecalciferol (capsule strength: 800IU). There was no adjustment in the medication around the time of vaccination. Patient''s weight was 74.4 kg, height was 161 cm. On 18Mar2021, she had the vaccination at the GGD. On Saturday evening 20Mar2021 she got malaise complaints (feeling full, not well/not feeling well) which persisted until Sunday afternoon 21Mar2021. On Sunday afternoon she suddenly became unapproachable with immeasurable blood pressure (not measurable (lost due to infarction) ) and low pulse. The diagnostic procedures ECG was made. This showed a myocardial infarction. After that, the whole evening was difficult to approach and not tasty. This lasted until patient was found not to be approachable. Then deterioration and death. The patient died on 22Mar2021 (5:15 AM, also reported as ''Died in the night''). The recorded cause of death was myocardial infarction due to / with concomitant heart failure, malaise. An autopsy was not performed. Possibly react genic side effects of vaccination was malaise and feeling full / unwell in the evening. There was probably no relationship between events and BNT162B2, but the reporter still want to report these events. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Malaise; myocardial infarction due to / with concomitant heart failure; myocardial infarction due to / with concomitant heart failure


VAERS ID: 1226808 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Chest pain, Dyspnoea exertional, Myocardial infarction, Restlessness, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: ISOSORBIDE MONONITE; PANTOPRAZOLE; MOVICOLON; CLOPIDOGREL; TILDIEM; SIMVASTATINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm repair; Aortic aneurysm (infrarenal); CABG (LIMA D1-LAD, graft CX, peripheral arterial disease); Ischaemia myocardial; Peripheral arterial disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021399173

Write-up: Dyspnoea/ Dyspnoea exertional; Chest pain; not approachable; cardiogenic shock after myocardial infarction; cardiogenic shock after myocardial infarction; Unrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. The regulatory authority number is NL-LRB-00493652. A 91-year-old male patient received his first dose of BNT162B2 (COMIRNATY, lot number: ET3674) at the age of 91-years-old, via an unspecified route of administration on 01Apr2021 at 11:30 at single dose for COVID-19 immunisation. Medical history included aortic aneurysm (infrarenal, for which patient had an EVAR), ischaemia myocardial, and CABG (LIMA D1-LAD, graft CX, peripheral arterial disease). The patient has no previous COVID-19 infection. Concomitant medications included isosorbide mononitrate (ISOSORBIDE MONONITE) modified-release tablet; pantoprazole gastro-resistant coated tablet; macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON) powder for oral solution; clopidogrel tablet; diltiazem hydrochloride (TILDIEM) modified-release capsule, hard; and simvastatine film-coated tablet. The patient experienced unrest (also reported as agitation) on 01Apr2021; and dyspnoea/ dyspnoea exertional, chest pain, and not approachable on 02Apr2021. The course of events was as follows: In the night on the day of vaccination, the patient was unrest. The day after, he experienced dyspnoea exertional, chest pain and was unresponsive to verbal stimuli. He went to bed where he passed away suddenly. Cause of death was probably cardiogenic shock due to a myocardial infarction. The patient died on 02Apr2021. The causes of death were Unrest, Dyspnoea/ Dyspnoea exertional, Chest pain, not approachable, and cardiogenic shock after myocardial infarction. It was unknown if autopsy was performed. Reporter''s Comment: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): No. Agitation, chest pain, shortness of breath: Additional information on ADRs: the patient was very restless the night after vaccination (vaccinated around 11:30 am), spent a lot of time in/out of bed, the day after short of breath with exertion, chest pain, and not easily approachable. Eventually, shortly after lying down, sudden death was observed in a patient on a no-CPR policy. Death as of natural causes after consultation with the municipal coroner, presumably on the basis of cardiogenic shock after myocardial infarction. Confounding factors: Extensive cardiac history: EVAR associated with infrared aortic aneurysm, cardiac ischemia requiring CABG. Note: CABG: LIMA D1-LAD, graft CX, peripheral arterial disease. Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): No. Agitation, chest pain, shortness of breath: Additional information on ADRs: the patient was very restless the night after vaccination (vaccinated around 11:30 am), spent a lot of time in/out of bed, the day after short of breath with exertion, chest pain, and not easily approachable. Eventually, shortly after lying down, sudden death was observed in a patient on a no-CPR policy.; Reported Cause(s) of Death: cardiogenic shock after myocardial infarction; cardiogenic shock after myocardial infarction; Unrest; Dyspnoea/ Dyspnoea exertional; Chest pain; not approachable


VAERS ID: 1226809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC2021399127

Write-up: Cerebral haemorrhage/Multiple brain hemorrhages; several strokes; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority is NL-LRB-00494657. An 84-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 03Mar2021 17:15, as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. On 04Mar2021 at 13:15 (20 hours after start), the patient experienced cerebral haemorrhage/multiple brain hemorrhages and several strokes. Laboratory test included scan on an unspecified date with unknown result. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if autopsy was performed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage/Multiple brain hemorrhages; several strokes


VAERS ID: 1226811 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Echocardiogram, Ejection fraction, Electrocardiogram, Laboratory test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: DESLORATADINE; AMLODIPINE; COLECALCIFEROL; EDOXABAN; TEMAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 202011; Test Name: LVEF; Test Result: 70 %; Comments: normal; Test Date: 2021; Test Name: LVEF; Test Result: 15 %; Comments: poor; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: lab; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021399227

Write-up: Dyspnoea/shortness of breath; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number NL-LRB-00496928. This is the first of two reports. An 83-years-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Lot number: ET3674) as single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included desloratadine; amlodipine; colecalciferol; edoxaban; temazepam. The patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Feb2021 as single dose for covid-19 immunization and on 05Mar2021, she experienced malaise, general physical health deterioration and abdominal pain. The patient did not have previous COVID-19 infection. On 26Mar2021, 3 hours after the 2nd vaccination, the patient experienced dyspnoea that caused death, life threatening and caused or prolonged hospitalization. A few hours after 2nd vaccination increasing shortness of breath. The patient underwent lab tests and procedures which included in Nov2020, patient still completely normal left ventricular function (70%), and now in 2021 she had a very poor left ventricular function (15%). In 2021, patient had diagnostic procedures of ECG, lab, echocardiogram with unknown results. Treatment measures for dyspnoea was treated with Hartfalenmedicatie. The outcome of the event was fatal. It was not reported if an autopsy was performed. This report was assessed by the reporting physician was serious. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Dyspnoea/shortness of breath


VAERS ID: 1226812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398891

Write-up: found dead in bed 5-6 days after vaccination; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB NL-LRB-00502142. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was found dead in bed by the police late afternoon on 06Apr2021 after reporting from neighbors that the curtains had been closed for several days. The doctor did not want to come for the autopsy. The last contact was on April 1 in the course of the afternoon. Then no complaints indicated. Given the state of decomposition of the body, he probably died 5-6 days ago in Apr2021. An examination in the house shows from the papers present that he had a Covid vaccination with the Pfizer vaccine on 31Mar2021 at the vaccination location in [PRIVACY]. The health statement contained all the answers to no. BSN available: yes. The patient died on an unspecified date in Apr2021. It was not reported if an autopsy was performed. Drugs and latency: covid-19 vaccin pfizer inj found dead: 1 day after start Case Summary and Reporters Comments Text: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no found dead in bed 5-6 days after vaccination 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 found dead in bed 5-6 days after vaccination; Reported Cause(s) of Death: Found dead


VAERS ID: 1226813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398893

Write-up: Sudden death 4 days after vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00502183. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had sudden death on 07Apr2021, 4 days after vaccination. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no. Sudden death 4 days after vaccination - additional information on ADR: It is not clear whether this is due to the vaccine. BSN available: yes. Previous COVID-19 infection: No No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Sudden death 4 days after vaccination- Additional information on ADR: It is not clear whether this is due to the vaccine. BSN available: yes Previous COVID-19 infection: No; Reported Cause(s) of Death: Sudden death


VAERS ID: 1226814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Chest X-ray, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: FUROSEMIDE; GLUCIENT SR; METOPROLOL SUCCINATE; SIMVASTATINE; ACETYLSALICYLZUUR; AMIODARON [AMIODARONE]; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness: Cardiomyopathy (Known cardiac pump dysfunction)
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic cardiomyopathy (Confounding factors: ischemic cardiomyopathy)
Allergies:
Diagnostic Lab Data: Test Name: X thorax; Result Unstructured Data: Test Result:Enlarged heart; Comments: Enlarged heart. Central some busy blurred lung vasculature. Also some kerley-B lines, progressive, suspecting some overfilling. New consolidation in midfield left, suspected of infection. Some pleural fluid, especially on the right.
CDC Split Type: NLPFIZER INC2021398894

Write-up: acute heart failure with known poor pumping function; possibly also pneumonia; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00502413. A 87-years-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. Medical history included ongoing cardiomyopathy (Known cardiac pump dysfunction), ischemic cardiomyopathy (Confounding factor). BSN available was reported as yes. There was no previous COVID-19 infection. Concomitant medications included furosemide; metformin hydrochloride (GLUCIENT SR); metoprolol succinate; simvastatine; acetylsalicylzuur; amiodarone (AMIODARON); pantoprazole sodium sesquihydrate (PANTOZOL). The patient previously took first dose of bnt162b2 (COMIRNATY), for COVID-19 immunization and experienced no adverse reaction. On 29Mar2021 (4 days after start), the patient experienced acute heart failure with known poor pumping function (cardiac failure acute) (death, hospitalization) and possibly also pneumonia (death, hospitalization). The patient was treated with diuretics and antibiotics. The patient underwent lab tests and procedures which included x-thorax: Enlarged heart. Central some busy blurred lung vasculature. Also some kerley-B lines, progressive, suspecting some overfilling. New consolidation in midfield left, suspected of infection. Some pleural fluid, especially on the right. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comment: acute heart failure with known poor pump function, possibly also pneumonia No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Reporter comment: acute heart failure with known poor pump function, possibly also pneumonia; Reported Cause(s) of Death: acute heart failure with known poor pumping function; possibly also pneumonia


VAERS ID: 1226815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: Artificial cardiac pacemaker user; Coronary atherosclerosis; Heart failure; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: Autopsy; Result Unstructured Data: Test Result:Preliminary results; Comments: Preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent. Kidneys with decreased cortical thickness. CRP post-mortem 86 mg/L.
CDC Split Type: NOPFIZER INC2021398932

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uyj7r8. A 78-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: ET3674), intramuscular on 24Mar2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included artificial cardiac pacemaker user, heart failure, coronary atherosclerosis, and renal failure. The patient''s concomitant medications were not reported. The patient was found dead on 27Mar2021. The last time anyone had been in contact with the patient was on the evening of 26Mar2021. No information was available for the reporter, as to whether the patient had any symptoms after vaccination and before he was found dead. The police has asked for an autopsy. An autopsy was performed on 29Mar2021 that revealed: preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent. Kidneys with decreased cortical thickness. CRP post-mortem 86 mg/L. The reporter stated by phone that microscopy and toxicology was yet to be performed, but at the time it was not established any clear cause of death. The reporter stated that it was uncertain whether there was a relationship between the vaccination and the patient being found dead, but chose to report it due to close temporal relationship. The patient outcome was fatal at the time of the report. Additional information received from reporter by phone on 07Apr2021 which confirmed date of death and exact date of autopsy. Reporter also gave information about the patient having a cardiac pacemaker and that the last time anyone had been in contact with the patient was on the evening of 26Mar2021. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported event as Possible. Sender Comment: The report concerns a patient in his 70s, who was found dead three days after the first dose of the Covid-19 vaccine Comirnaty. The reporter states that it is uncertain whether there is a connection between the vaccination and the death, but reports due to a close time relationship. Preliminary autopsy results show no clear cause of death, but the patient had several underlying diseases that can predispose to sudden death. When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including deaths, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition. In Norway, we have received and processed more than 100 reports of deaths after vaccination of elderly people in need of care, most of whom were nursing home patients. For several of the deaths, reporters have stated that they do not suspect a connection with vaccination and that the incident is due to a serious underlying disease in the patient. The Norwegian Medicines Agency has established an expert group that will review the deaths of frail elderly people after vaccination. The expert group will, among other things, assess whether there are any common features in these patients, which may have contributed to a fatal outcome. In each case, it is difficult to know whether the death is due to the vaccine, the patient underlying disease or something else accidental, at the same time a cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, we assess the causal link between the vaccination and the death 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 message is also classified as serious, although a causal relationship with vaccination has not been established. No follow-up attempts are possible. No information is expected.; Autopsy-determined Cause(s) of Death: Preliminary results shows slightly enlarged heart with scarring after previous myocardial infarctions and severe coronary atherosclerosis (with stenosis). The lungs are heavy and rich in pleural fluid. The spleen''s consistency is somewhat diffluent.


VAERS ID: 1226816 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021400170

Write-up: patient was fully vaccinated and more than 7 days had passed between dose 2 and when the patient got COVID-19; patient was fully vaccinated and more than 7 days had passed between dose 2 and when the patient got COVID-19; This is a spontaneous report from a contactable consumer at the Institute of Public Health. An elderly patient of an unspecified gender received the first and second dose of bnt162b2 (vaccine, Batch/Lot numbers were not reported), via an unspecified route of administration on Jan2021 both as single doses, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There has been an outbreak of infection among six fully vaccinated residents of a nursing home. They had received the Pfizer vaccine. There are five infected and one who died, among elderly nursing home residents who were all fully vaccinated in January. The National Institute of Public Health has received 1 fatal report for the patient. No other reports were received. The patient was fully vaccinated, and more than 7 days had passed between dose 2 when the patient got COVID-19. No other information was available at the moment. The outcome of the events was fatal. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: The patient was fully vaccinated and more than 7 days had passed since dose 2 and when the patient got COVID-19; The patient was fully vaccinated and more than 7 days had passed since dose 2 and when the patient got COVID-19


VAERS ID: 1226817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-12
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021399015

Write-up: Death from natural causes; This is a spontaneous report from a contactable physician downloaded from the regulatory authority PT-INFARMED-B202103-2360. A 97-year-old male patient received (COVID-19 mRNA vaccine (with modified nucleoside) (Comirnaty), concentrate for dispersion for injection, 30 mcg/0.3 ml, batch EP2166, CAUL: 09621, dose of 0.3 ml) intramuscular as a single dose for COVID-19 immunization. Medical history included cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension. Concomitant medications were unknown. The patient died 15 days after the administration of the suspected vaccine. The reported cause of death was "death by natural causes". The patient had emergency medical care and was hospitalized. Oxygen therapy (1.5 L / min) was required due to unknown respiratory disease with pulmonary hypertension. There is also reference to previous heart failure. The Reporter is unaware of the usual medication of the patient. Outcome of ADR: Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Reporter Method of assessment: unknown, Result of Assessment: improbable. No follow-up attempts possible. No information expected.; Reporter''s Comments: Concomitant Medication-Unknown Did a Medication Error occur? -No Other information-Previous cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension; Reported Cause(s) of Death: Death from natural causes


VAERS ID: 1226830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Blood pressure measurement, Brain natriuretic peptide, Bundle branch block left, C-reactive protein, Cardiac arrest, Cardiac failure, Cough, Dyspnoea, Echocardiogram, Glomerular filtration rate, Glomerular filtration rate decreased, Heart rate, Investigation, Oedema peripheral, Oxygen saturation, Polymerase chain reaction, Radioisotope scan, Respiratory failure, Respiratory rate, Troponin, Wheezing, White blood cell count increased, White blood cell disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; CANDESARTAN SANDOZ; JANUVIA [SITAGLIPTIN PHOSPHATE]; SIMVASTATIN BLUEFISH; ALLOPURINOL NORDIC DRUGS; CARBOCAIN; NITROGLYCERIN; SERTRALIN HEXAL; IOMERON; LANTUS; BETOLVEX [CYANOCOBALAMIN]; TEGRETOL R
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (moderate); Cardiac failure; Gout; Hemiparesis (right); Hypertension; Insulin-requiring type 2 diabetes mellitus; Living in nursing home; Meningioma; Oedema peripheral (uses a supporting stockings during the day); Pulmonary oedema; Surgery (2007 and 2015); Weakness left or right side; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:144/90; Test Date: 202103; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:4913 ng/L; Test Date: 202103; Test Name: CRP; Result Unstructured Data: Test Result:58; Test Date: 202103; Test Name: echocardiogram; Result Unstructured Data: Test Result:severe reduced mobility in the heart; Comments: interpreted by a cardiologist as terminal heart failure; Test Date: 202103; Test Name: GFR; Result Unstructured Data: Test Result:too low; Test Date: 202103; Test Name: heart rate; Result Unstructured Data: Test Result:87; Test Date: 202103; Test Name: Examination; Result Unstructured Data: Test Result:well-oriented, left bundle branch block; Comments: has aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right, had so earlier in 2015, have supporting stockings during the day. Has no fever, heart pain or palpitations, systolic wheezing I2 right; Test Date: 202103; Test Name: saturation; Test Result: 70 %; Test Date: 202103; Test Name: saturation; Test Result: 88 %; Comments: on room air; Test Date: 202103; Test Name: saturation; Test Result: 95 %; Comments: with oxygen; Test Date: 202103; Test Name: saturation; Test Result: 95 %; Comments: on 1 L of oxygen; Test Date: 202103; Test Name: PCR; Test Result: Negative ; Test Date: 202103; Test Name: Pulmonary scintigraphy; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: no pulmonary embolism; Test Date: 202103; Test Name: respiratory rate; Result Unstructured Data: Test Result:16; Test Date: 202103; Test Name: TnT; Result Unstructured Data: Test Result:32 ng/L; Test Date: 202103; Test Name: leukocytes; Result Unstructured Data: Test Result:11.4 x10 9/l
CDC Split Type: SEPFIZER INC2021399146

Write-up: heart failure (terminal); respiratory insufficiency; cardiac arrest; aspiration; increasing difficulty breathing; dry cough/ coughing from time to time; left bundle branch block; aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right; leukocytes 11.4 x 10^9/L (Reference value: 3.5-8.8); too low GFR; has a high respiratory rate and wheezing breathing sounds; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is SE-MPA-2021-020845 and the other case number is SE-MPA-1615987881383. An 83-year-old female patient received her second dose of BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure, insulin-requiring type 2 diabetes mellitus, hypertension, gout, meningioma in 2007 and had surgery on 2007 and 2015, thereafter she developed right sided hemiparesis. She also had weakness on the left or right side. In addition, the patient has moderate aortic valve stenosis, pulmonary oedema, and pitting oedema bilaterally in legs which she uses a supporting stockings during the day, all in 2015. She lived in a special nursing home and was a wheelchair user. Concomitant medications included metoprolol succinate (METOPROLOL SANDOZ) prolonged-release tablet; candesartan cilexetil (CANDESARTAN SANDOZ) tablet; sitagliptin phosphate (JANUVIA) film-coated tablet; simvastatin (SIMVASTATIN BLUEFISH) film-coated tablet; allopurinol (ALLOPURINOL NORDIC DRUGS) tablet; mepivacaine hydrochloride (CARBOCAIN) solution for injection/infusion; nitroglycerin solution for injection/infusion; sertraline hydrochloride (SERTRALIN HEXAL) film-coated tablet; iomeprol (IOMERON) solution for injection/infusion; insulin glargine (LANTUS) solution for injection/infusion; cyanocobalamin (BETOLVEX) film-coated tablet; carbamazepine (TEGRETOL RETARD) prolonged-release tablet; furosemide (FURIX) tablet; sodium chloride (NATRIUMKLORID BAXTER) solution for injection/infusion; acetylsalicylic acid (TROMBYL) tablet; and heparin sodium (HEPARIN LEO) solution for injection/infusion. The patient received her first dose of BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on Feb2021 at single dose for COVID-19 immunisation. The patient experienced heart failure (terminal) on Mar2021. The course of events was as follows: She arrived at the emergency room on Mar2021 due to dyspnoea (conversational). About a week earlier, she received the second dose of COMIRNATY. The patient has had increasing difficulty breathing and dry cough last week (Mar2021). Examination on Mar2021 included PCR negative, well-oriented, left bundle branch block, heart rate 87, blood pressure 144/90, respiratory rate 16, saturation 88% on room air, 95% with oxygen, has aggravated leg swelling, pitting oedema bilaterally, left leg more swollen than right, had so earlier in 2015 which she uses a supporting stockings during the day. Has no fever, heart pain or palpitations, systolic wheezing I2 right. Lab samples: ProBNP (brain natriuretic peptide) 4913ng/L (increasing), TnT 32ng/L, CRP (C-reactive protein) 58, leukocytes 11.4 x 10^9/L (Reference value: 3.5-8.8). Suspicion of heart insufficiency in the first place, received 40 mg of furosemide(FURIX) in the emergency room, the patient was hospitalized and has been stable overnight, saturation 95% on 1 L of oxygen, received food and drink, insulin (LANTUS) received later than usual. The next morning, the patient was clear-minded, adequate, and has eaten. She has a high respiratory rate and wheezing breathing sounds, also coughing from time to time. Before the examination, she has normal breathing, pulse and blood pressure, possibly mild tachycardia, latent hypo-hypertension. The next day, the patient will have a pulmonary scintigraphy, because CT of the thorax cannot be performed due to too low GFR (glomerular filtration rate). Prior to this, the patient received 3 L of oxygen and laid flat on the couch, which she has not been used to as she has had a more sitting-sleeping position for the past 6 years. She then experienced a decrease in POX, which has led to an increased supply of oxygen, later alarm about cardiac arrest. First asystole, then PEA (pulseless electrical activity), no defibrillation. She experienced aspiration because of CPR. Unclear genesis to this. Hypoxia? Bradycardia? The patient was resuscitated but failed respiratory and circulatory. Taken to intensive care and on arrival, the patient was intubated and required 100% oxygen in the ventilator, saturated around 70% despite intubation. Probable aspiration because of cardiac arrest. Pulmonary scintigraphy showed no pulmonary embolism. Bedside echocardiogram was performed and showed severe reduced mobility in the heart, interpreted by a cardiologist as terminal heart failure. Palliative care was started. The patient was sedated with intermittent doses of fentanyl and midazolam. She was unstable in blood pressure and was given norepinephrine and dobutamine as inotropic and vasopressor support. She oscillates between sinus bradycardia 40-50 and sinus tachycardia and received 2 doses (injection) of atropine. The patient moved her arms on a few occasions, CAD was planned to be inserted, but the patient died a few hours later. She had a cardiac arrest about a week after receiving the second dose of COMIRNATY. Probably not caused by COVID-19 vaccine. However, deterioration in cardiopulmonary status after vaccination cannot be ruled out. Autopsy was not performed. It was assessed as a natural death due to terminal heart failure. Cause of death was also reported as respiratory insufficiency. The patient died on Mar2021. The causes of death were cardiac failure/terminal heart failure and respiratory insufficiency. The outcome of other events was unknown. Autopsy was not performed. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac failure/ terminal heart failure; Respiratory insufficiency


VAERS ID: 1226834 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; ATORVASTATIN; TROMBYL; SPIRONOLACTONE; SERTRALINE; ENALAPRIL; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021399131

Write-up: Death; found dead in bed; Fallen and hit his head; Fallen and hit his head; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority Report Number: SE-MPA-2021-023862). A contactable physician reported that a 77-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166) at the age of 77 years, intramuscular, in Mar2021, at a single dose, for COVID-19 immunization. The patient''s medical history included heart failure. The patient''s concomitant medications included furosemide (FURIX), atorvastatin, acetylsalicylic acid (TROMBYL), spironolactone, sertraline, enalapril, and metoprolol. The reported suspected adverse reaction was death. In Mar2021, the patient had fallen some day before he died and had hit his head. In Mar2021 the patient was found dead in bed 3 days after the vaccination (Mar2021). In conversations with the physician, he informs that an autopsy will not be performed. The outcome of event reported as "Death; found dead in bed", fatal, the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; found dead in bed


VAERS ID: 1226835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-03-01
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amino acid level increased, C-reactive protein increased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL SANDOZ; INSUMAN BASAL; ESOMEPRAZOL KRKA; ATORBIR; ONDANSETRON; BETAMETASON ALTERNOVA; FURIX [CEFUROXIME]; STESOLID; ALLOPURINOL NORDIC DRUGS; ACETYLSALICYLSYRA TEVA; SERTRALIN HEXAL; GEMCITABINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Coronary artery surgery; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: TPK; Result Unstructured Data: Test Result:133; Test Date: 20210208; Test Name: TPK; Result Unstructured Data: Test Result:114; Test Date: 20210209; Test Name: TPK; Result Unstructured Data: Test Result:109; Test Date: 20210210; Test Name: TPK; Result Unstructured Data: Test Result:56; Test Date: 20210211; Test Name: TPK; Result Unstructured Data: Test Result:57; Test Date: 20210215; Test Name: TPK; Result Unstructured Data: Test Result:109; Test Date: 20210308; Test Name: TPK; Result Unstructured Data: Test Result:149; Test Date: 20210316; Test Name: TPK; Result Unstructured Data: Test Result:7; Test Date: 20210209; Test Name: CRP; Result Unstructured Data: Test Result:293; Test Date: 20210210; Test Name: CRP; Result Unstructured Data: Test Result:247; Test Date: 20210211; Test Name: CRP; Result Unstructured Data: Test Result:decreasing CRP; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:77; Test Date: 20210316; Test Name: CRP; Result Unstructured Data: Test Result:247
CDC Split Type: SEPFIZER INC2021398895

Write-up: THROMBOCYTOPENIA; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-025116. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; gemcitabine, intravenous from 03Mar2021 (Batch/Lot number was not reported) to 03Mar2021, at 1824 mg, 1000 mg/m2 for an unspecified indication; gemcitabine, intravenous from 10Mar2021 (Batch/Lot Number: Unknown) to 10Mar2021, at 1824 mg, 1000 mg/m2 for pancreatic carcinoma metastatic; gemcitabine, intravenous from 03Feb2021 (Batch/Lot number was not reported) to 03Feb2021, at 1824 mg, 1000 mg/m2 for an unspecified indication. Medical history included cardiac failure, diabetes mellitus, coronary artery surgery. Concomitant medications included bisoprolol fumarate (BISOPROLOL SANDOZ) from 13Mar2020; insulin human injection, isophane (INSUMAN BASAL) from 06May2020 to an unspecified stop date; esomeprazole magnesium (ESOMEPRAZOL KRKA) taken for an unspecified indication from 20May2020 to an unspecified stop date; atorvastatin calcium (ATORBIR) taken for an unspecified indication from 22May2020; ondansetron from 27Jan2021 to an unspecified stop date; betamethasone sodium phosphate (BETAMETASON ALTERNOVA) from 27Jan2021 to an unspecified stop date; cefuroxime (FURIX [CEFUROXIME]) from 22May2020 to an unspecified stop date; diazepam (STESOLID) taken for an unspecified indication from 27Jan2021 to an unspecified stop date; allopurinol (ALLOPURINOL NORDIC DRUGS) taken for an unspecified indication from 06May2020 to an unspecified stop date; acetylsalicylic acid (ACETYLSALICYLSYRA TEVA) taken for an unspecified indication from 22May2020 to an unspecified stop date; sertraline hydrochloride (SERTRALIN HEXAL) taken for an unspecified indication from 22May2020 to an unspecified stop date. In Mar2021, the patient experienced thrombocytopenia. The patient underwent lab tests and procedures which included amino acid level increased: 133 on 21Jan2021, amino acid level increased: 114 on 08Feb2021, amino acid level increased: 109 on 09Feb2021, amino acid level increased: 56 on 10Feb2021, amino acid level increased: 57 on 11Feb2021, amino acid level increased: 109 on 15Feb2021, amino acid level increased: 149 on 08Mar2021, amino acid level increased: 7 on 16Mar2021, c-reactive protein increased: 293 on 09Feb2021, c-reactive protein increased: 247 on 10Feb2021 , c-reactive protein increased: decreasing crp on 11Feb2021, c-reactive protein increased: 77 on 15Feb2021, c-reactive protein increased: 247 on 16Mar2021. The action taken in response to the event, for gemcitabine was unknown , for gemcitabine was unknown, for gemcitabine was unknown. The patient died on an unspecified date due to the event thrombocytopenia. It was not reported if an autopsy was performed. The agency has requested the medical records and the autopsy protocol. No follow-up attempts possible. No further information expected. Batch/lot number was not provided and cannot be obtained.; Reported Cause(s) of Death: THROMBOCYTOPENIA


VAERS ID: 1227497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-03-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021398605

Write-up: cerebral haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number AT-BASGAGES-2021-21256. An 87-year-old female patient received bnt162b2 (vaccine, Batch/Lot number was not reported), intramuscular on 21Feb2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Mar2021, the patient experienced death from cerebral haemorrhage. The patient died on 09Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death from cerebral haemorrhage


VAERS ID: 1227505 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

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: 2021-03-24
   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: ELIQUIS; ZYLORIC; DUODART; OGASTORO; TOREM [TORASEMIDE SODIUM]; SPIRIVA; SERETIDE; TRAJENTA; DAFALGAN; BELOC ZOK; FRESUBIN [CAFFEINE;CARBOHYDRATES NOS;FATS NOS;FIBRE, DIETARY;MINERALS NOS;PROTEINS NOS;VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency (unknown severity); Diabetes mellitus; Heart insufficiency (unknown severity); Respiratory insufficiency (unknown severity)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021403593

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable healthcare professional via regulatory authority with regulatory authority report number is CH-SM-2021-13652. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Mar2021 (Lot Number: EP9605) as a single dose for covid-19 immunisation. Medical history included heart insufficiency (unknown severity), respiratory insufficiency (unknown severity), chronic renal insufficiency (unknown severity) and diabetes mellitus. The patient received the first dose of Comirnaty first dose via intramuscular route of administration on Feb2021 (Lot number: EP9605 [also reported as unknown]) for Covid-19 immunisation but no suspected adverse reactions were reported. It is not known if the patient had allergies. Concomitant medication(s) included apixaban (ELIQUIS); allopurinol (ZYLORIC); dutasteride, tamsulosin hydrochloride (DUODART); lansoprazole (OGASTORO); torasemide sodium (TOREM); tiotropium bromide (SPIRIVA); fluticasone propionate, salmeterol xinafoate (SERETIDE); linagliptin (TRAJENTA); paracetamol (DAFALGAN); metoprolol succinate (BELOC ZOK); and caffeine, carbohydrates nos, fats nos, fibre, dietary, minerals nos, proteins nos, vitamins nos (FRESUBIN), all indication, start and stop date were not reported. The day after the second dose (24Mar2021), in a context of extreme vulnerability (the patient no longer left home), his wife called emergency services at 07:00 am for cardio-respiratory arrest. Death occurred on 24Mar2021. The outcome of the event was fatal. The patient died on 24Mar2021. It was not reported if an autopsy was performed. This case was reported as serious with seriousness criterion results in death. A causality between death and Comirnaty was reported as being unlikely by regulatory authority. Reporter''s comment: Death occurring 24 hours after the 2nd dose Pfizer injection in the context of extreme vulnerability, the patient no longer left his home. His wife called emergency services at 07 a.m. for cardio-respiratory arrest. SENDER''s COMMENT: Death occurred the day after administration of the second dose of Comirnaty vaccine in a very vulnerable 80-year-old male patient. Sudden deaths following Covid-19 mRNA vaccines are not reported neither in this country''s monograph nor in the foreign ones. Even in the literature there are no documented cases of death in causal correlation with these vaccines. The patient was extremely vulnerable in the presence of severe comorbidities and already did not leave home anymore, in particular heart insufficiency, respiratory insufficiency and renal insufficiency. Therefore, in view of the advanced age and the very compromised health status of the patient, given that no adverse reactions of any kind occurred after the first dose, and given that the treating physician hypothesizes a cardiovascular arrest as the cause of death, at the current state of knowledge, despite the temporal correlation of <24h, we assess the causal correlation as unlikely between the vaccine and death.; Reporter''s Comments: Death occurring 24 hours after the 2nd dose Pfizer injection in the context of extreme vulnerability, the patient no longer left his home. His wife called emergency services at 07 a.m. for cardio-respiratory arrest.; Sender''s Comments: Based on the available information, the Company considered there was not a reasonable possibility that the reported event Cardio-respiratory arrest (with fatal outcome) was related to the suspect product Comirnaty (BNT162B2), this 80-year-old patient with severe comorbidities, including heart failure, respiratory and renal insufficiency. The event is more likely related to patient''s undelying conditions. 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: Cardio-respiratory arrest


VAERS ID: 1227511 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 40
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: 20210202; Test Name: Covid-19 virus test; Result Unstructured Data: Test Result:yes-positive
CDC Split Type: DEPFIZER INC2021398821

Write-up: Unknown cause of death; COVID-19 virus test: yes-positive; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The regulatory authority number is DE-PEI-202100032177. A 90-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiration date were unknown) at the age of 90-years-old, via an unspecified route of administration on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient died on 15Mar2021 due to an unknown cause. The patient underwent lab test and procedure which included COVID-19 virus test: yes-positive on 02Feb2021. The outcome of the event COVID-19 was unknown. The patient died on 15Mar2021. The cause of death was unknown. An autopsy was not performed. Relatedness of the drug to unknown cause of death was reported as unclassifiable. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1227514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Allergy to antibiotic (such as Doxyfloxacin, Doxycyclin und Novaminsulfon); CABG; Coronary heart disease; Gout; Hypertension; Hypothyreosis; Parkinson''s disease; Renal failure NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021404017

Write-up: died of cerebral haemorrhage 6 days after the 2nd vaccination; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 35043], license party for vaccine. A contactable consumer (relative) reported that a male patient of an unspecified age (reporter''s father in law) received the second dose of bnt162b2 (vaccine), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson''s disease, hypertension, coronary heart disease, coronary artery bypass graft (CABG), hypothyreosis, gout, renal failure grade 3, and allergy to several antibiotics such as Doxyfloxacin, Doxycyclin and Novaminsulfon. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (vaccine) on an unspecified date for COVID-19 immunisation. The patient died of cerebral haemorrhage 6 days after the 2nd vaccination on an unspecified date. It was not reported if an autopsy was performed. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: died of cerebral haemorrhage 6 days after the 2nd vaccination


VAERS ID: 1227701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: ROPINIROLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021404941

Write-up: Death; This is a spontaneous report from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104130004534830; Safety Report Unique Identifier: GB-MHRA-ADR 25129126. A contactable consumer reported that a 71-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 04Feb2021 (lot number and expiry date: unknown) at a single dose for COVID-19 immunisation. The patient''s medical history included Parkinson''s disease. Concomitant medications included ropinirole taken for Parkinson''s disease. The patient previously received first dose BNT162B2 of COVID-19 immunisation. The patient underwent lab tests and procedures which included COVID: no - negative on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The consumer reported patient''s death which occurred less than 24 hours post vaccination. The patient died on 04Feb2021 due to an unknown cause. Postmortem was ongoing. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1227707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Brain death, Cardiac arrest, Cardiac failure, Heart rate, Oxygen saturation, Physical examination, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORIZAL PLUS; VESOMNI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: blood pressure; Result Unstructured Data: Test Result:160/80; Test Date: 20210327; Test Name: Pulse; Result Unstructured Data: Test Result:62; Test Date: 20210327; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210327; Test Name: examination; Result Unstructured Data: Test Result:hemodynamically stable; Comments: without fever, in a good mood; Test Name: rapid COVID-19 test; Test Result: Negative
CDC Split Type: GRPFIZER INC2021409488

Write-up: Lack of cardiac function; Absence of brainstem reflexes; cardiac asystole; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency -WEB (GR-GREOF-20212005). A 63-year-old male patient received the second dose of BNT162B2 (vaccine), intramuscularly, on 27Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate, hydrochlorothiazide, olmesartan medoxomil (ORIZAL PLUS) from 30Oct2017 to 27Mar2021 and solifenacin succinate, tamsulosin hydrochloride (VESOMNI) from 01Nov2019 to 27Mar2021. The patient previously received the first dose of BNT162B2 (vaccine) on 06Mar2021 for COVID-19 immunisation and experienced no side effects. The patient did not receive any other vaccines within 15 days prior to the vaccination. The patient experienced lack of cardiac function, absence of brainstem reflexes, and cardiac asystole on an unspecified date, which were reported as fatal and medically significant. The clinical course was reported as follows: From the examination after vaccination on 27Mar2021, the patient was hemodynamically stable with oxygen saturation: 98% and pulse: 62, without fever, in a good mood, with blood pressure: 160/80 at the time before vaccination. He had not received acetylsalicylic acid (ASPIRIN) or anticoagulants in the past. It was also mentioned that he had never presented any anaphylactic episode in the past and neither injectable drugs had been needed to treat severe allergies. The patient remained in the health center for 15-20 minutes approximately, after the vaccination (following the protocol) and he left with his wife at 13:15. It was confirmed that the patient was transferred to the health center in the emergency department at 19:30 on an unspecified date with cardiac asystole and absence of cerebral reflexes. Cardiopulmonary resuscitation was performed according to the protocol, after repeated defibrillations and intravenous administration of 3 amp of adrenaline (MANUFACTURER UNKNOWN), there was no recovery or any electrocardiographic activity. A rapid COVID-19 test was performed on an unspecified date, which was negative. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on an unspecified date. The cause of death was reported as cardiac failure, brain death, and cardiac asystole. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac failure; brain death; cardiac asystole


VAERS ID: 1227708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; COPD; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Covid 19 Positive via PCR nasal / pharyngeal swab.; Comments: Covid 19 Positive via PCR nasal / pharyngeal swab.; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:did not have any COVID-19 symptoms prior to vaccin
CDC Split Type: IEPFIZER INC2021409428

Write-up: COVID-19/ COVID INFECTION; CONDITION DETERIORATED; RTI; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, IE-HPRA-2021-066081. This is a report received from the regulatory authority. A 90 -year- old male patient received first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6134), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation . Medical history included type 2 diabetes mellitus, atrial fibrillation and chronic obstructive pulmonary disease. There were no concomitant medications. The patient did not have any COVID-19 symptoms prior to vaccination. On 21Jan2021, the patient was vaccinated and It was reported that no adverse reactions were noted post vaccination. On 28Jan2021, the patient tested positive for COVID-19 following a PCR nasal/pharyngeal swab. It was reported that the patient''s condition deteriorated in the days prior to death. The patient was seen by a General Practitioner (GP). The patient was treated for a respiratory tract infection (RTI) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. However, there were no significant improvements. A palliative care pathway was commenced. On 10Feb2021, at 12.10pm, the patient died. The reported fatal events were Covid-19/COVID infection, condition deteriorated and respiratory tract infection (RTI). On 11Feb2021 a Coroner reported that the patient ''s death occurred as a result of COVID-19 following vaccination with COVID-19 vaccine. Follow-up information was received by the regulatory authority from a healthcare professional on 16Mar2021: It was reported that the patient''s death certificate had been completed as ''''COVID, vaccine related''''. Follow-up attempts are completed. No further information is expected; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066080 regulatory authority; Reported Cause(s) of Death: COVID-19


VAERS ID: 1227731 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021411383

Write-up: thrombosis/a huge thrombus that they were not able to break and unfortunately obstructed the entrance to the lung; This is a spontaneous report from a contactable consumer received via email. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), on an unspecified date in Mar2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombosis on an unspecified date in Mar2021, which led to death. The patient died on 31Mar2021 and had between 2 1/2 weeks from being vaccinated and the physician commented it was all symptoms from vaccine, he was detected a huge thrombus that they were not able to break and unfortunately obstructed the entrance to the lung he did not suffer from any disease. It was not reported if an autopsy was performed. Information on lot/batch number has been requested.; Reported Cause(s) of Death: big thrombo which obstructed lung entrance


VAERS ID: 1227735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial flutter, C-reactive protein, Cardiac asthma, Computerised tomogram, Condition aggravated, Left ventricular failure, Pneumonia, Respiratory failure, SARS-CoV-2 test, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BROMFENAC; NITROGLYCERINE; CLOPIDOGREL; DEXAMETHASON [DEXAMETHASONE]; FLUOXETINE; AMLODIPINE; METOPROLOL [METOPROLOL SUCCINATE]; FRAXIPARINE (NADROPARIN CALCIUM); PANTOPRAZOL [PANTOPRAZOLE]; EPLERENONE
Current Illness: Fatigue; Hypertension; Parkinsonism
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac asthma; Chest pain; Fall (possibly with parkinsonism or foot lift paresis with an the emergency room visit after fall); Heart failure; Leg paresis (with an the emergency room visit after fall); Myocardial infarction; Percutaneous transluminal coronary angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: CT; Result Unstructured Data: Test Result:extended bilateral infiltrative abnormalities righ; Comments: extended bilateral infiltrative abnormalities right, CORADS 4; Test Date: 20210227; Test Name: CRP; Result Unstructured Data: Test Result:75; Test Date: 20210227; Test Name: Covid test pcr; Test Result: Negative ; Test Date: 20210227; Test Name: leukocyte; Result Unstructured Data: Test Result:11.5
CDC Split Type: NLPFIZER INC2021399040

Write-up: Cardiac asthma; Pneumonia; Atrial flutter; asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency; left ventricular function impairment; respiratory insufficiency; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority [Regulatory authority number NL-LRB-00461716]. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EJ6790) as 0.3 mL, single for COVID-19 immunization. Medical history included percutaneous transluminal coronary angioplasty (PTCA) procedure of the left anterior descending coronary artery (LAD) in Jan1992, ongoing hypertension, cardiac asthma, ongoing parkinsonism, ongoing fatigue, infero-lateral infarction in 1992, cardiac failure, and fall possibly with parkinsonism or foot lift paresis (02Feb2021) with an the emergency room visit after fall. Concomitant medications included glyceryl trinitrate (NITROGLYCERINE) taken for chest pain from unknown dates; bromfenac (BROMFENAC), clopidogrel (CLOPIDOGREL), dexamethasone (DEXAMETHASON), fluoxetine (FLUOXETINE), amlodipine (AMLODIPINE), metoprolol succinate (METOPROLOL), nadroparin calcium (FRAXIPARINE); pantoprazol (PANTOPRAZOL) and eplerenone (EPLERENONE) all taken for an unspecified indications and therapy dates. It was reported that the patient was self-reliant before vaccination. Five days after vaccination (27Feb2021), the patient was hospitalized due to cardiac asthma, pneumonia and atrial flutter. During hospitalization, the patient had high infection parameters with C-reactive protein (CRP) of 75 and leukocyte (L) of 11.5 (unit of measure and normal range not provided). The patient had COVID-19 suspected but negative PCR on that same date. Extensive bilateral infiltrative abnormalities on the right side, but CORADS 4 on the CT was noted in Feb2021. The patient''s health deteriorated. The patient deceased 8 days after vaccination (02Mar2021). The cause of death was asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency. An autopsy was not performed. The reporter considers the vaccination may have resulted in bilateral pneumonia and the family thinks about the possibility of developing pneumonia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: asthma cardiac recurrence with underlying left ventricular function impairment and a pulmonary infection (pneumonia) and atrial flutter with clinical deterioration and respiratory insufficiency; clinical deterioration and respiratory insufficiency; a


VAERS ID: 1227737 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021399129

Write-up: Cerebral hemorrhage; This is as spontaneous report received from a contactable consumer or other non-health professional downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is NL-LRB-00479926, Safety report unique identifier NL-LRB-00501383. A 93-year-old male patient received bnt162b2 (vaccine), via an unspecified route of administration on 14Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebral hemorrhage on 19Feb2021, 5 days after vaccination. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on an unspecified date. The patient died on an unspecified date due to cerebral hemorrhage. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Information on lot# obtained.; Reported Cause(s) of Death: cerebral haemorrhage


VAERS ID: 1227748 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pneumonia
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), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021398920

Write-up: Fulminant pneumonia; Multiple cardiac arrests; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is PL-URPL-3-470-2021. An 88-year-old male patient received the second dose BNT162B2 (vaccine; lot number: ER2659; expiration date: 06Mar2021) intramuscular, administered on the left arm on 03Mar2021 09:49 at a single dose for COVID-19 immunisation. Medical history included ongoing Alzheimer''s disease. The patient''s concomitant medications were not reported. Date of the reaction on 04Mar2021, at 11:55. In the submitted report of an adverse reaction after vaccination, the following symptoms were listed: Patient admitted to the emergency room in critical condition after multiple sudden cardiac arrests; cardiovascular system supported by norepinephrine infusion, mechanically assisted breathing - respirator. The patient was on day 0 after receiving the 2nd dose of vaccine vaccine against SARS-CoV-2. Postmortem autopsy revealed severe fulminant pneumonia which became the direct cause of the patient''s death. A relationship between the intake of a dose of the vaccine and death seems likely. Relatedness of drug to reactions/events: Pneumonia and cardiac arrest per NCA was considered possible. The patient died on 04Mar2021 due to fulminant pneumonia and multiple sudden cardiac arrests. An autopsy was performed that revealed postmortem autopsy revealed severe fulminant pneumonia, which was the direct cause of the patient''s death. (pneumonia). Reporter comment: A relationship between the intake of a dose of the vaccine and death seems probable. Sender comment: Name of the vaccine vaccine- COVID-19 vaccine (mRNA). Sudden cardiac arrest and severe fulminant pneumonia were unexpected symptoms for vaccine. There was a time relationship between the intake of the second dose of the vaccine and the occurrence of side effects. Cases of cardiac arrest and pneumonia have been reported in the EVDAS database until 06Apr2021. Although the occurrence of severe pneumonia after vaccination, which was the cause of the patient death, raises doubts, the assessment took into account the doctor''s opinion that pneumonia was likely to be associated with the vaccine. The person reporting adverse reaction following immunisation qualified it as serious. ARMP assessed the adverse events as heavy. No follow-up attempts possible. No further information expected.; Reporter''s Comments: A relationship between the intake of a dose of the vaccine and death seems probable.; Reported Cause(s) of Death: Direct cause of the patient''s death - fulminant pneumonia; multiple sudden cardiac arrests; Autopsy-determined Cause(s) of Death: Postmortem autopsy revealed severe fulminant pneumonia, which was the direct cause of the patient''s death.


VAERS ID: 1228050 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Chest pain
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: PANTOPRAZOLE; METOPROLOL; PERINDOPRIL; SOLIFENACINE [SOLIFENACIN]; CLOPIDOGREL; BECLOMETASONE;FORMOTEROL; COLECALCIFEROL; GLICLAZIDE; PRAVASTATIN
Current Illness: Diabetes mellitus; Hypercholesteraemia
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Coronary bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Bradycardia; Acute chest pain; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia) and CHEST PAIN (Acute chest pain) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included Cerebrovascular accident and Coronary bypass. Concurrent medical conditions included Hypercholesteraemia and Diabetes mellitus. Concomitant products included PANTOPRAZOLE, METOPROLOL, PERINDOPRIL, SOLIFENACINE [SOLIFENACIN], CLOPIDOGREL, BECLOMETASONE;FORMOTEROL, COLECALCIFEROL, GLICLAZIDE and PRAVASTATIN for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion death) and CHEST PAIN (Acute chest pain) (seriousness criterion death). The patient died on 25-Mar-2021. The reported cause of death was Cardiac death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1228055 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Breast cancer; Chronic obstructive pulmonary disease; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1616764386368

Write-up: D?DSFALL; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (D?DSFALL) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3000493 and 3000493) for COVID-19 vaccination. The patient''s past medical history included Asthma, Breast cancer in 2009, Chronic obstructive pulmonary disease and Obesity. Concurrent medical conditions included Diabetes and Hypertension. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. In March 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. Death occurred in March 2021 The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231470 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dizziness, Loss of consciousness, Somnolence
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: MORPHINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No information on risk factors or previous illnesses.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.), SOMNOLENCE (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) and DIZZINESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No information on risk factors or previous illnesses.). Concomitant products included MORPHINE for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death), SOMNOLENCE (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death) and DIZZINESS (Abwesenheit, benommen, m?de, schwindel, wie auf "drogen"... eingeschlafen--tot.) (seriousness criterion death). The patient died on 24-Jan-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Within two hours of the vaccination, the patient was no longer normal and was delirious. He kept losing consciousness and gradually became colder and colder until he no longer woke up. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 81-year-old male subject with unknown medical history, who died on the same day after receiving the Moderna COVID-19 vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   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: SARS-CoV-2 PCR test positive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Malignant ischaemic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Malignant ischaemic stroke) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. The patient''s past medical history included SARS-CoV-2 PCR test positive on 11-Aug-2020. On 26-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 26-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (Malignant ischaemic stroke) (seriousness criterion death). The patient died on 27-Mar-2021. The reported cause of death was ictus isqu?mico. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was reported. This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 82-year-old male subject with unknown medical history and history of SARS-CoV-2 PCR test positive on 11-Aug-2020, who died one day after receiving the mRNA-1273 Moderna vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: ischemic stroke.


VAERS ID: 1231833 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Respiratory failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418775

Write-up: Dyspnoea; Respiratory failure; Vomiting; This is a spontaneous report from a contactable other health professional via the Medical Agency . Regulatory authority report number is 531342. An 84-year-old male patient received BNT162B2 (vaccine, solution for injection, lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 25Mar2021, the patient developed dyspnea, respiratory failure, and vomiting for which he died on unknown date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dyspnoea; Respiratory failure; Vomiting


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