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

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



Case Details

This is page 98 out of 150

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VAERS ID: 1259925 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-04-14
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: EFFEXOR; CANDESARTAN; KARDEGIC; XATRAL; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiolitis obliterans with organising pneumonia; Cardiac failure (with cardiac stimulator); Mixed dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021442233

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, reference c2d1f6bd-24d0-416e-8d31-b94eba35978c. A 92-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 24Feb2021 11:00 am (Batch/Lot Number: EP9598) as SINGLE DOSE for covid-19 immunisation. Vaccinations done in a nursing home / senior Living Facility. Medical history included cardiac failure with cardiac stimulator, mixed dementia, Bronchiolitis Obliterans Organising Pneumonia (BOOP). Concomitant medications included venlafaxine hydrochloride (EFFEXOR LP 37.5 mg); candesartan 4 mg (unspecified trade name); acetylsalicylate lysine (KARDEGIC 75 mg); alfuzosin hydrochloride (XATRAL LP); prednisolone 30mg (unspecified trade name). Historical Vaccine included COMIRNATY for covid-19 immunisation dose 1 intramuscular, administered in Arm Left on 03Feb2021 10:45 am (Batch/Lot Number: EJ6788) as SINGLE DOSE. The patient experienced sudden death on 14Apr2021 at 06:45 pm. It was not reported if an autopsy was performed. No symptomatic treatment given. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, the event sudden death most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1260394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-28
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiovascular examination, Dyspepsia, Ischaemia, Pallor, Paraesthesia, Pericardial haemorrhage, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hypotonic-hyporesponsive episode (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Felt faint; Jaw disorder; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:fine; Test Date: 202008; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:clear; Test Date: 20210326; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021437898

Write-up: pale; indigestion; temporary tingling in right arm; Haemopericardium; Ischaemia; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104182304304820, Safety Report Unique Identifier GB-MHRA-ADR 25158189. A 75-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 18Feb2021 at a single dose for covid-19 immunisation. Medical history included jaw disorder, felt faint, non-smoker. It was reported that parents had heart history. Patient has not had symptoms associated with covid-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were reported as none. It was reported that the patient is fit, downhill skier who had walked in the alps everyday of lockdown over the past year. On unspecified date, the patient experienced pale, indigestion and temporary tingling in right arm. On 28Mar2021, the patient experienced ischaemia and haemopericardium. The patient underwent lab tests and procedures which included covid-19 virus test: no - negative covid-19 test on 26Mar2021; cardiovascular examination which showed clear in Aug2020; and blood test which showed fine on unspecified date. The patient has not tested positive for covid-19 since having the vaccine. Outcome of the events pale, indigestion and temporary tingling in right arm was unknown. Outcome of the event ischaemia was not recovered. The patient died on 28Mar2021 due to haemopericardium. An autopsy was performed and results were not provided. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Haemopericardium


VAERS ID: 1260399 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; ATORVASTATIN; BISOPROLOL; DIGOXIN; MIRTAZAPINE; MISOPROSTOL; OMEPRAZOLE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Atrial fibrillation; Back ache (chronic); Depression; Hypertension; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021443349

Write-up: Myocardial infarction; Pulmonary oedema; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202104191602038740. Safety Report Unique Identifier GB-MHRA-ADR 25161734. A 79-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: not known) for covid-19 immunisation. Medical history included anxiety, depression, back ache chronic, atrial fibrillation, hypertension, transient ischaemic attack. Patient received the first dose of BNT62B2 on unknown date for COVID-19 immunization. It was unsure if patient has had symptoms associated with COVID-19, unsure if patient was enrolled in clinical trial. Concomitant medications included apixaban, atorvastatin, bisoprolol, digoxin, mirtazapine, misoprostol, omeprazole, tamsulosin. The patient experienced myocardial infarction and pulmonary oedema, both on 16Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: results negative. The patient died on 16Apr2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Outcome of the events was fatal. The report did not relate to possible blood clots or low platelet counts. This report is serious with seriousness criteria-results in death. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction; Pulmonary oedema


VAERS ID: 1260407 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021443016

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202104201828117220-UJ5GE]. Safety Report Unique Identifier is [GB-MHRA-ADR 25166165]. A patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY) at single dose on 17Apr2021 for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. COVID-19 virus test was no - negative. Patient had not tested positive for COVID-19 since having the vaccine. The report did not relate to possible blood clots or low platelet counts. Patient experienced death on 19Apr2021. It was unknown if an autopsy was performed or not. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1260409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Ischaemic heart disease; Myocardial infarction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021443290

Write-up: myocardial infarction; acute coronary syndrome (ACS); out of hospital cardiac arrest; unwell; Death; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104210741496200-JCVKJ. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Not Known) dose: 2, via an unspecified route of administration on 27Mar2021, as a single dose for covid-19 immunisation. Medical history included ischaemic heart disease (four times from unspecified dates), myocardial infarction (two times from unspecified dates), and type 2 diabetes. 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 were not reported. The patient experienced death on 31Mar2021; and out of hospital cardiac arrest secondary to acute coronary syndrome (ACS)/myocardial infarction and unwell, all on unspecified dates. The reporter denied that the report relates to possible blood clots or low platelet counts. It was reported that there were no concerns after the vaccination and that the patient was entirely well on 29Mar2021 before suddenly becoming unwell. The patient died on 31Mar2021. An autopsy was not performed and the reported causes of death were myocardial infarction, ischaemic heart disease, and type 2 diabetes. It was reported that because of the time frame this was not thought to be related to the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial Infarction; Ischaemic Heart Disease; Type 2 Diabetes


VAERS ID: 1260457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0866 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021440958

Write-up: Was found dead in his apartment; This is a spontaneous report from a contactable other hcp via Regulatory Authority. A 35-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER0866) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. It was reported that the patient was found dead in his apartment on an unspecified date. Time range: 1 week. The other hcp reported "Please see attached a file with reports on death and hospitalization in the vicinity of receiving a vaccine against Corona. Transferred to the medical examiner, no autopsy report yet". The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern 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 in his apartment


VAERS ID: 1260458 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER6166 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, 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), 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: 2021-03-31
   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: Cardiovascular disorder; Diabetes; Hypertension; Kidney disorder; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021441071

Write-up: Suddenly lost consciousness and died; coughed couple of times; This is a spontaneous report received from a contactable other HCP via a regulatory authority. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 at 09:20 at age of 87 years old (Batch/Lot Number: ER6166) as single dose for covid-19 immunisation. Medical history included hypertension, cardiovascular and blood vessels, diabetes, kidney disease, osteoporosis. The patient''s concomitant medications were not reported. The vaccine was done on 31Mar2021 during the morning hours at 09:20, after the vaccine without complaints, without allergic reactions, vital signal were normal without complaints during the visit and the follow up conversation this morning with the treating nurse. During the day without complaints, felt normal, according to her at night she asked to drink, after she drank she coughed, lost consciousness and died. Emergency ambulance was invited, attempts to bring back to life without successes. Circumstances of death: During the night she woke up, asked to drink, coughed couple of times and suddenly lost consciousness. Time range reported as 12 hours. The outcome of event cough was unknown. The outcome of event lost consciousness was fatal. The patient died on 31Mar2021. It was not reported if an autopsy was performed. No follow up attempts are possible, no further information is expected.; Sender''s Comments: The fatal event loss of consciousness is likely intercurrent and unrelated to the suspect drug BNT162B2. Case to be reassessed should a follow-up information becomes available.,Linked Report(s) : IL-PFIZER INC-2020517122 Same product, different event, different patient (Master case); Reported Cause(s) of Death: Suddenly lost consciousness and died


VAERS ID: 1260459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0866 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood iron, Blood iron decreased, Body temperature, Cardiogenic shock, Chest pain, Chills, Dizziness, Fatigue, Myocarditis, Pyrexia, Troponin, Troponin increased, Vitamin B12, Vitamin B12 decreased
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis
Allergies:
Diagnostic Lab Data: Test Name: iron; Result Unstructured Data: Test Result:decrease in iron; Test Name: fever; Result Unstructured Data: Test Result:a sense of fever; Test Name: troponin; Result Unstructured Data: Test Result:10,000; Test Name: troponin; Result Unstructured Data: Test Result:270,000; Test Name: B12; Result Unstructured Data: Test Result:decrease in B12
CDC Split Type: ILPFIZER INC2021441169

Write-up: Myocarditis/fluminant myocarditis; Cardiogenic shock; chest pain/Pressure pain in the middle of the chest; general feeling of weakness/weakness; chills; sense of fever; fatigue; dizziness; decrease in iron and b12; Drastic increase in troponin from 10,000 to 270,000; decrease in iron and b12; This is a spontaneous report received from a contactable other HCP via Israeli MOH Epidemiology department. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER0866) as single dose for COVID-19 immunisation. Medical history included atopic dermatitis. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 for COVID-19 immunisation. The patient experienced myocarditis/fluminant myocarditis (death, hospitalization) on an unspecified date (Time range: 11 days), cardiogenic shock (death, hospitalization) on an unspecified date, chest pain/pressure pain in the middle of the chest (hospitalization) on an unspecified date, general feeling of weakness/weakness (hospitalization) on an unspecified date, chills (hospitalization) on an unspecified date, sense of fever (hospitalization) on an unspecified date, fatigue on an unspecified date, dizziness (hospitalization) on an unspecified date, decrease in iron and b12 (hospitalization) on an unspecified date, drastic increase in troponin from 10,000 to 270,000 (hospitalization) on an unspecified date. The clinical course was reported as follows : Arrived to the emergency room with chest pain and general feeling of weakness. In addition felt chills, with a sense of fever, fatigue and weakness and dizziness while standing. Pressure pain in the middle of the chest which ease while lying and worsened while breathing, not radiating. During the last months, decrease in iron and b12. Drastic increase in troponin from 10,000 to 270,000. She was with fulminant myocarditis and Cardiogenic shock. died.The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events myocarditis/fluminant myocarditis and Cardiogenic shock was fatal. The outcome of other events was unknown. No follow up attempts are possible, no further information is expected.; Reported Cause(s) of Death: Myocarditis/fluminant myocarditis; Cardiogenic shock


VAERS ID: 1260460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER6166 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021441263

Write-up: Circumstances of death : collapsed in the house of the employer; This is a spontaneous report received from a contactable other HCP via a regulatory authority. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ER6166) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced circumstances of death: collapsed in the house on an unspecified date in Apr2021. Time range was 5 days. The patient died on an unspecified date in Apr2021. It was not reported if an autopsy was performed. The serious criteria was reported as death and hospitalization. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on event-vaccine chronological association, causality between event death (unknown cause) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Circumstances of death : collapsed in the house


VAERS ID: 1260474 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: FUROSEMIDE TEVA; NORVASC; NEURABEN; PANTORC; CARDURA; KAYEXALATE; ZEMPLAR; QUETIAPINA TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Shock cardiogenic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and CARDIOGENIC SHOCK (Shock cardiogenic) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included FUROSEMIDE (FUROSEMIDE TEVA) from 23-Mar-2021 to 05-Apr-2021, AMLODIPINE BESILATE (NORVASC) from 23-Mar-2021 to 05-Apr-2021, BENMETIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE (NEURABEN) from 23-Mar-2021 to 05-Apr-2021, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTORC), DOXAZOSIN MESILATE (CARDURA) from 23-Mar-2021 to 05-Apr-2021, SODIUM POLYSTYRENE SULFONATE (KAYEXALATE) from 23-Mar-2021 to 05-Apr-2021, PARICALCITOL (ZEMPLAR) from 23-Mar-2021 to 05-Apr-2021 and QUETIAPINE FUMARATE (QUETIAPINA TEVA) from 23-Mar-2021 to 05-Apr-2021. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 dosage form in total. On 05-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Death) (seriousness criterion death) and CARDIOGENIC SHOCK (Shock cardiogenic) (seriousness criterion medically significant). The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, CARDIOGENIC SHOCK (Shock cardiogenic) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment not provided. This is a case of death in a 77-year-old male subject with unknown medical history, who died on an unknown date after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 77-year-old male subject with unknown medical history, who died on an unknown date after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.


VAERS ID: 1260490 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Delusion, Disorientation, Hallucination, auditory, Hallucination, visual, Investigation, Pain, Somnolence, Speech disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 24
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ELIQUIS; SEROQUEL; LASIX [FUROSEMIDE]; LANOXIN; MICARDIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic atrial fibrillation; COPD; Dysphoria; Hypertension arterial; Hyperuricaemia
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC2021398768

Write-up: the patient died; speech disorder, delusions and sound and visual hallucinations;; disorientation; sleepy; pain; speech disorder, delusions and sound and visual hallucinations;; speech disorder, delusions and sound and visual hallucinations; speech disorder, delusions and sound and visual hallucinations;; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority- WEB. The regulatory authority number is IT-MINISAL02-712396. An 88-year-old female patient received her first dose of BNT162B2 (COMIRNATY, lot number and expiration date were unknown) at the age of 88-years-old, intramuscular in left arm (also reported as left shoulder) on 12Mar2021 at 19:45 at single dose COVID-19 immunisation. Medical history included hyperuricaemia, chronic atrial fibrillation, dysphoria, hypertension arterial, cardiac failure, and COPD. Concomitant medications included allopurinol tablet for hyperuricaemia, apixaban (ELIQUIS) tablet for chronic atrial fibrillation, quetiapine fumarate (SEROQUEL) tablet for dysphoria, furosemide (LASIX) tablet for hypertension arterial, digoxin (LANOXIN) tablet for cardiac failure, and telmisartan (MICARDIS) tablet for hypertension arterial. The patient experienced speech disorder on 15Mar2021; and delusions, sound and visual hallucinations on an unspecified date in 2021. The course of events was reported as follows: Following the first dose of COMIRNATY vaccine, the patient was sleepy for two days since 12Mar2021, and upon awakening on the third day, 15Mar2021, she experienced disorientation and difficulty speaking. While the disorientation subsided, the difficulties in speaking fluctuated until the disorientation worsened to the point of not recognizing her children, and visual and auditory hallucinations appeared (animals on the floor or imaginary interlocutors were visualized and talks were held with the aforementioned imaginary subjects) on an unspecified in 2021. For two days these disturbances continued day and night, continuously. Sometimes the speech was clearly understandable (during the waking state), sometimes, probably in the most sleepy stages, the words were slurred and possibly incomprehensible. The patient took quetiapine 50 mg daily as directed by the physician. In the last few days, the patient was no longer able to express herself verbally, she could only express the pain (on an unspecified date in 2021) by moaning and by facial expressions; on 06Apr2021 the patient died. Impact on quality of life was reported as 10/10 on unspecified date. Therapeutic measures were taken as a result of the events speech disorder, delusion, sound and visual hallucinations, and disorientation. The patient died on 06Apr2021. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of the event pain was unknown and not recovered for all other events. The events speech disorder, delusion and sound and visual hallucinations were reported as serious, causing disability. Reporter''s comment: atrial fibrillation, arterial hypertension, COPD. Sender''s Comment: 02Apr2021 Regulatory Authority: requests for further information from the reporter such as the lot, the clinical history, the possible resolution of the adverse reaction. Information about the lot/batch number cannot be obtained.; Reporter''s Comments: atrial fibrillation, arterial hypertension, COPD; Reported Cause(s) of Death: the patient died


VAERS ID: 1260491 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cyanosis, Death, Deep vein thrombosis, Oedema, Pain in extremity, Pyrexia, Ultrasound Doppler, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   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: FUROSEMIDE; RAMIPRIL; GLYCERYL TRINITRATE; POTASSIUM CANRENOATE; IVABRADINE; LOPRESOR [METOPROLOL FUMARATE]
Current Illness: Angina pectoris; Cardiac failure; Hyperaldosteronism; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: body temperature; Result Unstructured Data: 37.2 degree celsius; Test Name: Ultrasound Doppler; Test Result: Inconclusive ; Result Unstructured Data: not provided
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY, OEDEMA , PYREXIA , CYANOSIS and VOMITING in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. Concurrent medical conditions included Cardiac failure, Hypertension arterial, Angina pectoris and Hyperaldosteronism. Concomitant products included GLYCERYL TRINITRATE and IVABRADINE for Angina pectoris, FUROSEMIDE for Cardiac failure, POTASSIUM CANRENOATE for Hyperaldosteronism, RAMIPRIL and METOPROLOL FUMARATE (LOPRESOR [METOPROLOL FUMARATE]) for Hypertension arterial. On 01-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 05-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (seriousness criterion medically significant), PAIN IN EXTREMITY (seriousness criterion medically significant), OEDEMA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant), CYANOSIS (seriousness criterion medically significant) and VOMITING (seriousness criterion medically significant). The patient died on 06-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY, OEDEMA, PYREXIA , CYANOSIS and VOMITING outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 37.2 degree celcius (abnormal) 37.2 degree celsius. On an unknown date, Ultrasound Doppler: not provided (Inconclusive) not provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event of death added as none of the reported events are likely to directly result in death but could have contributed to the fatal outcome. 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. Event of death added as none of the reported events are likely to directly result in death but could have contributed to the fatal outcome.; Reported Cause(s) of Death: Death


VAERS ID: 1260497 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: ALPRASOX; NEBIVOLOL; SIMVASTATIN; CARDIRENE; PALEXIA; COTAREG
Current Illness: Glaucoma; Hypertension arterial; IHD; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: 05/03/2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of VOMITING (05/03/2021) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042723) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, IHD, Hypertension arterial and Glaucoma. Concomitant products included ALPRASOX, NEBIVOLOL, SIMVASTATIN, ACETYLSALICYLATE LYSINE (CARDIRENE), TAPENTADOL HYDROCHLORIDE (PALEXIA) and HYDROCHLOROTHIAZIDE, VALSARTAN (COTAREG) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 04-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VOMITING (05/03/2021) (seriousness criterion death). The patient died on 05-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. Company comment: This case of a 92-year-old female patient who experienced vomiting on the same day after the administration of mRNA-1273 and died the following day. Based on the information which shows a strong temporal association between the onset of vomiting and the fatal outcome, a causal association cannot be excluded.; Sender''s Comments: This case of a 92-year-old female patient who experienced vomiting on the same day after the administration of mRNA-1273 and died the following day. Based on the information which shows a strong temporal association between the onset of vomiting and the fatal outcome, a causal association cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1260500 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cyanosis, Hyperpyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CYANOSIS and CHILLS in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form(s) in total. On 08-Apr-2021, the patient experienced CYANOSIS (seriousness criterion death), HYPERPYREXIA (seriousness criterion death) and CHILLS (seriousness criterion death). The patient died on 09-Apr-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. No concomitant medications reported by investigator. Treatment was not reported. Company Comment: Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1260506 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-25
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   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: Chronic kidney disease (Chronic renal insufficiency)
Preexisting Conditions: Medical History/Concurrent Conditions: End ileostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Thoracic pain; This case was received via an unknown source (no reference has been entered for a health authority or Regulatory Authority) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and CHEST PAIN (Thoracic pain) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included End ileostomy. Concurrent medical conditions included Chronic kidney disease (Chronic renal insufficiency). On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 25-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and CHEST PAIN (Thoracic pain) (seriousness criterion medically significant). On 06-Apr-2021, CHEST PAIN (Thoracic pain) outcome was unknown. The patient died on 06-Apr-2021. The reported cause of death was Thoracic pain. 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 concomitant medication was reported. No treatment drug was reported. The patient underwent ileostomy (25 Mar 2021 to 06 Apr 2021). Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 87-year-old female subject with a medical history of chronic renal insufficiency, who died one day after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 87-year-old female subject with a medical history of chronic renal insufficiency, who died one day after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Thoracic pain


VAERS ID: 1260508 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive heart disease ; Ischemic leukoencephalopathy ; Transient ischaemic attacks
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA and ASTHENIA in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Hypertensive heart disease , Ischemic leukoencephalopathy and Transient ischaemic attacks . On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (seriousness criterion death) and ASTHENIA (seriousness criterion death). The patient died on 02-Apr-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. Concomitant product use was not provided. Treatment information was not provided. Sender''s Case Number 713706 Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded.; Sender''s Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded.; Reported Cause(s) of Death: see case description.


VAERS ID: 1260509 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Malaise, Oxygen saturation decreased
SMQs:, Dementia (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Ischaemic heart disease ("cardiopatia ischemica (pregressa PTCA)")
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon ("pregresso K del colon"); Angina pectoris ("episodi anginosi in soggetto diabetico"); Percutaneous transluminal coronary angioplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Oxygen saturation low; General malaise; Fuzzy head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), MALAISE (General malaise) and FEELING ABNORMAL (Fuzzy head) in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The patient''s past medical history included Adenocarcinoma of colon ("pregresso K del colon"), Percutaneous transluminal coronary angioplasty and Angina pectoris ("episodi anginosi in soggetto diabetico"). Concurrent medical conditions included Ischaemic heart disease ("cardiopatia ischemica (pregressa PTCA)") and Diabetes mellitus. On 19-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion death), MALAISE (General malaise) (seriousness criterion death) and FEELING ABNORMAL (Fuzzy head) (seriousness criterion death). The patient died on 21-Mar-2021. The reported cause of death was Oxygen saturation low, General malaise and Fuzzy head. 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 medication was not reported. Company Comment This is a case of death of an 81-year-old female patient 2 days post mRNA-1273 vaccination. Patient experienced oxygen saturation low, general malaise and fuzzy head prior to death. Based on temporal association between the use of the product and onset of oxygen saturation lo, general malaise and fuzzy head, a causal relationship cannot be excluded. The primary cause of death was not provided and hence cannot be assessed. No further information is expected.; Sender''s Comments: This is a case of death of an 81-year-old female patient 2 days post mRNA-1273 vaccination. Patient experienced oxygen saturation low, general malaise and fuzzy head prior to death. Based on temporal association between the use of the product and onset of oxygen saturation lo, general malaise and fuzzy head, a causal relationship cannot be excluded. The primary cause of death was not provided and hence cannot be assessed. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation low; general malaise; fuzzy head


VAERS ID: 1260511 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-31
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pseudomonas infection, Urine output decreased
SMQs:, Acute renal failure (broad), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Infection Pseudomonas aeruginosa; Urinary output diminished; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PSEUDOMONAS INFECTION (Infection Pseudomonas aeruginosa) and URINE OUTPUT DECREASED (Urinary output diminished) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 31-Mar-2021, the patient experienced PSEUDOMONAS INFECTION (Infection Pseudomonas aeruginosa) (seriousness criterion death) and URINE OUTPUT DECREASED (Urinary output diminished) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Infection Pseudomonas aeruginosa and Urinary output diminished. 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 No relevant concomitant medications were reported No treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD. Both events reported as resulting in death in SD and conservatively retained as serious / fatal; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD. Both events reported as resulting in death in SD and conservatively retained as serious / fatal; Reported Cause(s) of Death: Infection Pseudomonas aeruginosa; Urinary output diminished


VAERS ID: 1260513 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: LANSOPRAZOLE SANDOZ; IMBRUVICA; BACTRIM; ACICLOVIR
Current Illness: Chronic lymphatic leukemia (Chronic lymphatic leukemia patient with pulmonary infiltrates being treated with Imbruvica); Pulmonary infiltration (being treated with Imbruvica)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021435831

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB IT-MINISAL02-715352. A 50-years-old male patient received bnt162b2 (COMIRNATY), intramuscular at left arm on 07Apr2021 11:45 as first dose (Batch/Lot Number: ET7205; exp date 31Jul2021) as 0.3 mL, single for SARS-CoV-2 vaccination. Medical history included ongoing chronic lymphocytic leukaemia described as Chronic lymphatic leukemia patient with pulmonary infiltrates being treated with Imbruvica. Concomitant medications included lansoprazole (LANSOPRAZOLO SANDOZ GMBH); ibrutinib (IMBRUVICA) taken for pulmonary infiltrates since and unknown date and ongoing; sulfamethoxazole, trimethoprim (BACTRIM), ACICLOVIR. The patient experienced death on 11Apr2021. It was not reported if an autopsy was performed. Reporter comment: The patient administers the FIRST dose of the vaccine on 07Apr2021, 11:45 am, left arm. lot: ET7205 expiry: 31Jul2021 Patient suffering from Chronic Lymphatic Leukemia with pulmonary infiltrates. He takes Imbruvica, Bactrim, Lansoprazole and Aciclovir without reporting the Company (from the poorly understood writing he could also take Adenuric). The patient died at home and therefore the supporting clinical report is not available. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: The patient administers the FIRST dose of the vaccine on 07Apr2021, 11:45 am, left arm. lot: ET7205 expiry: 31Jul2021 Patient suffering from Chronic Lymphatic Leukemia with pulmonary infiltrates. He takes Imbruvica, Bactrim, Lansoprazole and Aciclovir without reporting the Company (from the poorly understood writing he could also take Adenuric). The patient died at home and therefore the supporting clinical report is not available ; Reported Cause(s) of Death: Death


VAERS ID: 1260514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, 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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: TENORMIN; CARDIOASPIRIN; AMLODIPINE; PERINDOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021435841

Write-up: severe asthenia and death for cardiac arrest; severe asthenia and death for cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-715475. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included atenolol (TENORMIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (CARDIOASPIRIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; perindopril (PERINDOPRIL) taken for hypertension, start and stop date were not reported. The day after the second dose of the Pfizer vaccine the patient complained of severe asthenia; 2 days after vaccination, due to the worsening of the symptom, Emergency medical service was called and soon confirmed his death. The patient received the second dose of Pfizer vaccine on 09Apr2021; the following day he complained of severe asthenia which worsened with the passing of the hours; Emergency medical service was called and the operators, arriving a few minutes later, note his death. The patient''s physician (reporter) carried out an inspection after death has already occurred and drawed up an anamnestic report of death due to cardiac arrest. The patient died on 11Apr2021. The autopsy was performed. Update on 15Apr: following an interview with the referring doctor, we learn that the patient had vaccinated at 6 pm on 09Apr2021; the Vaccination Center was contacted to trace the lot but they did not find the patient''s documentation. The reporting physician stated that he has not drawn up any clinical report nor deemed it appropriate to request an autopsy; he referred that he only sent the death notification after learning of the death at 10:59 on 11Apr2021. Reporter''s comment: 14Apr2021: I carried out an inspection at the home of my patient after death has already occurred; I can consider death to be related to cardiac arrest following a hypertensive crisis; for lot number I will try to contact the patient''s son (the partner of the patient is affected by Alzheimer''s and she could not collaborate) not knowing which is the Vaccinal Center where the patient had gone; I will try to pursue the anamnestic report as requested. Sender''s comment: CRFV request for clinical report with anamnestic connection and vaccine lot 13Apr2021: request to the reporting physician (GP) of n. lot of the vaccine and anamnestic clinical report drawn up on ascertaining the death.; Reporter''s Comments: 14Apr2021: I carried out an inspection at the home of my patient after death has already occurred; I can consider death to be related to cardiac arrest following a hypertensive crisis; for lot number I will try to contact the patient''s son (the partner of the patient is affected by Alzheimer''s and she could not collaborate) not knowing which is the Vaccinal Center where the patient had gone; I will try to pursue the anamnestic report as requested.; Reported Cause(s) of Death: asthenia; cardiac arrest


VAERS ID: 1260515 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205-57-034 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: ALENDRONATE SODIUM; COLECALCIFEROL; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign breast lump removal (followed by radiotherapy treatment); Breast neoplasm female; Chemotherapy; Hypertension (About 10 years ago); Mastectomy (Approximately 30 years ago right mastectomy followed by chemotherapy treatment); Radiotherapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021435980

Write-up: Saturday 10Apr and Sunday 11Apr dyspnea on the stairs. on day 12Apr at 5.00 right chest pain. The symptoms refer to possible pulmonary embolism.; Saturday 10Apr and Sunday 11Apr dyspnea on the stairs. on day 12Apr at 5.00 right chest pain. The symptoms refer to possible pulmonary embolism.; Saturday 10Apr and Sunday 11Apr dyspnea on the stairs. on day 12Apr at 5.00 right chest pain. The symptoms refer to possible pulmonary embolism.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-715631. An 83-year-old female patient received first dose of BNT162B2 (COMIRNATY) (Batch/Lot Number: ET7205-57-034) via intramuscular at right arm (right shoulder) on 01Apr2021 as single dose for covid-19 immunisation. The patient medical history included approximately 30 years ago right mastectomy followed by chemotherapy treatment. About 10 years ago, mild hypertension was found. In 2018, removal of left breast growth followed by radiotherapy treatment. Concomitant medications included ramipril taken for hypertension; alendronate sodium; colecalciferol. The events were serious for fatal and described as Saturday 10Apr2021 and Sunday 11Apr2021 dyspnea on the stairs. On 12Apr2021 at 5:00 right chest pain. The symptoms referred to possible pulmonary embolism (10Apr2021). The patient died on 12Apr2021. The reported cause of death was dyspnoea, chest pain, pulmonary embolism. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Saturday 10Apr and Sunday 11Apr dyspnea on the stairs. on day 12Apr at 5.00 right chest pain. The symptoms refer to possible pulmonary embolism.; Saturday 10Apr and Sunday 11Apr dyspnea on the stairs. on day 12Apr at 5.00 right chest pain. The sympto


VAERS ID: 1260516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Myocardial ischaemia
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Other ischaemic heart disease (narrow), 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: Medical History/Concurrent Conditions: Atrial flutter; Cardiomyopathy; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441482

Write-up: acute cardiac ischaemia and acute cardiorespiratory failure; acute cardiac ischaemia and acute cardiorespiratory failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-715933. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW2246; Expiration Date: 31Jul2021) via intramuscular route of administration on 13Apr2021 at 09:00 as 0.3 mL, cyclic for covid-19 immunization. Medical history included Parkinson, cardiomyopathy and atrial flutter from Oct2020 to an unknown date. The patient''s concomitant medications were not reported. On 14Apr2021, the patient experienced acute cardiac ischaemia and acute cardiorespiratory failure. The patient died on an unspecified date.The cause of death was Acute heart ischemia and Cardio-respiratory failure. It was unknown if an autopsy was performed. It was stated that, Multi-pathological fragile patient, Parkinson''s, heart disease (atrial flutter in Oct2020), on 13APr2021 administration of Pfizer Comirnaty vaccine and today death from acute cardiac episode. The outcome of the event was fatal.; Reporter''s Comments: Multi-pathological fragile patient, Parkinson''s, heart disease (atrial flutter in Oct2020), on 13APr2021 administration of Pfizer Comirnaty vaccine. Today death from acute cardiac episode; Reported Cause(s) of Death: Acute heart ischemia; Cardio-respiratory failure


VAERS ID: 1260517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: SIRIO; FRIPASS; FINASTERIDE; AZILECT; SINEMET; MANTADAN; ONGENTYS; SILODYX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy (not walking); Parkinson''s disease (for about 20 years); Prostatic hypertrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021435922

Write-up: sudden death; cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-715977. An 82-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EW2246), intramuscularly at left deltoid on 14Apr2021 10:30 at single dose for COVID-19 immunisation. Medical history included Parkinson''s disease for about 20 years, not walking, lower limb arterial disease, and prostatic hypertrophy. Concomitant medications included carbidopa/melevodopa (SIRIO), cilostazol (FRIPASS), finasteride, rasagiline mesylate (AZILECT 1 mg tablets), carbidopa/levodopa (SINEMET), amantadine hydrochloride (MANTADAN), opicapone (ONGENTYS 25 mg hard capsules), and silodosin (SILODYX). The patient experienced sudden death on 15Apr2021. Family members reported that upon awakening the patient was fine, the daughter saw him before going to work, the wife reported that she lifted him and took him to the kitchen, she went away to retrieve the dentures in the bathroom from which she heard a noise (breath) wheezing, on arriving in the kitchen she found her husband not breathing, alerted the emergency health service, the doctor found the patient in cardio-respiratory arrest. The patient''s family had expressed, in writing, that they did not want to proceed with the diagnostic check for further information on the causes of death. Autopsy was not performed. Outcome of the event was fatal. Follow-up attempts completed. No further information expected.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1260523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Chest X-ray, Dyspnoea, Haemoglobin, Heart rate, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Pyrexia, Respiratory failure, SARS-CoV-2 test, Superinfection bacterial, White blood cell count
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (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: NEBIVOLOL; OLMESARTAN MEDOXOMIL/AMLODIPINE
Current Illness: Arterial hypertension; Idiopathic pulmonary fibrosis (on waiting list for lung transplant)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure (on waiting list for lung transplant)
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: Blood pH; Result Unstructured Data: Test Result:7,33 iU; Comments: INTERNATIONAL UNIT(S)-(UNDER 100); Test Date: 20210327; Test Name: Blood pH; Test Result: 7.28 [iU]; Test Date: 20210327; Test Name: k; Result Unstructured Data: Test Result:4.8; Test Date: 20210327; Test Name: k; Result Unstructured Data: Test Result:4.6; Test Date: 20210327; Test Name: blood pressure; Result Unstructured Data: Test Result:123/92 mmHg; Test Date: 20210327; Test Name: blood pressure; Result Unstructured Data: Test Result:135/80 mmHg; Test Date: 20210327; Test Name: Na; Result Unstructured Data: Test Result:142; Test Date: 20210327; Test Name: Na; Result Unstructured Data: Test Result:143; Test Date: 20210324; Test Name: Body temperature; Result Unstructured Data: Test Result:38,7 Centigrade; Test Date: 20210327; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210324; Test Name: CXR; Result Unstructured Data: Test Result:unknown results; Test Date: 20210327; Test Name: CXR; Result Unstructured Data: Test Result:unknown results; Test Date: 20210327; Test Name: C-reactive protein; Test Result: 56 mg/dl; Test Date: 20210327; Test Name: Hb; Result Unstructured Data: Test Result:16.7; Test Date: 20210327; Test Name: Hb; Result Unstructured Data: Test Result:16; Test Date: 20210327; Test Name: heart rate; Result Unstructured Data: Test Result:123 bpm; Test Date: 20210327; Test Name: O2 saturation; Test Result: 56 %; Test Date: 20210327; Test Name: O2 saturation; Test Result: 76 %; Test Date: 20210327; Test Name: O2 saturation; Test Result: 82 %; Test Date: 20210327; Test Name: O2 saturation; Test Result: 93 %; Test Date: 20210327; Test Name: pCO2; Result Unstructured Data: Test Result:66; Test Date: 20210327; Test Name: pCO2; Result Unstructured Data: Test Result:77; Test Date: 20210327; Test Name: pO2; Result Unstructured Data: Test Result:32; Test Date: 20210327; Test Name: pO2; Result Unstructured Data: Test Result:51; Test Date: 20210327; Test Name: COVID-19 molecular test; Result Unstructured Data: Test Result:negative; Test Date: 20210327; Test Name: White blood cells; Result Unstructured Data: Test Result:23 x10 9/l; Test Date: 20210327; Test Name: Spo2; Test Result: 56 %; Test Date: 20210327; Test Name: Spo2; Test Result: 82 %
CDC Split Type: ITPFIZER INC2021441435

Write-up: severe desaturation; progressive worsening of respiratory failure; worsening dyspnoea; fever; probable bacterial superinfection on exacerbation of the underlying disease".; This is a spontaneous report from a contactable physician downloaded from regulatory authority-WEB, regulatory authority number IT-MINISAL02-716356. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 24Mar2021 12:27 (Batch/Lot Number: ET3620; Expiration Date: Jun2021) as 0.3 mL for covid-19 immunisation. Medical history included ongoing idiopathic pulmonary fibrosis on waiting list for lung transplant, ongoing hypertension, chronic respiratory failure from an unknown date and unknown if ongoing on waiting list for lung transplant. Concomitant medication''s included nebivolol, amlodipine besilate, olmesartan medoxomil for hypertension, start and stop date were not reported. On 24Mar2021 the patient experienced fever, severe desaturation, progressive worsening of respiratory failure and worsening dyspnoea. Laboratory tests on 24Mar2021 included body temperature: 38,7 centigrade, chest x-ray unknown results on 24Mar2021. Lab tests and procedures on 27Mar2021 which included blood ph: 7,33 iu on 27Mar2021 INTERNATIONAL UNIT(S)-(UNDER 100), blood ph: 7.28 iu, blood potassium: 4.8, blood potassium: 4.6, blood pressure measurement: 123/92 mmhg, blood pressure measurement: 135/80 mmhg, blood sodium: 142, blood sodium: 143, body temperature: 36 centigrade, chest x-ray: unknown results, c-reactive protein: 56 mg/dl, haemoglobin: 16.7, haemoglobin: 16, SARS CoV2 negative antigenic swab. Clinical course of events included: Patient suffering from Idiopathic Pulmonary Fibrosis since June 2018, not on antifibrotic therapy due to the severity of the disease, referred for evaluation for inclusion in the lung transplant list since June 2018. Since August 2018, complicated by respiratory failure. Comorbidities: arterial hypertension under treatment with olmesartan amlodipine and nebivolol. Proposed to the patient, as per ministerial instructions, anti SARS CoV 2 vaccination with Comirnaty vaccine, performed on 24Mar2021. A few hours after administration reported fever up to 38.7 C for which the patient took paracetamol 1 g with resolution. Progressively reported worsening of respiratory failure with the need to increase the oxygen requirement from 5 l min to 10 l min. On the morning of 27Mar2021 patient transported from staff of emergency number to the emergency room due to worsening dyspnea and severe desaturation. The following information can be learned from the emergency room report 27Mar2021 at 7 am. On arrival vital signs HR 123 bpm, SpO2 56 percent in BLB mask. Arterial blood gas analysis h 07.53: pH 7.33, pCO2 66, pO2 32, Hb 16.7, K 4.8, Na 142, Lac 2.4, Glu 188. Positioned non-invasive mechanical ventilation with FiO2 1.0, PEEP 10, PS 10, given morphine 10mg iv, SpO2 76 percent. Resuscitator consultation 27Mar2021, h 9.14 am soporous but awakened state, SpO2 82 percent in NIV in PSV 12, PEEP 12, FiO2 1, BP 135 80 mmHg, anuric, reduced PEEP to 5 cmH20, PSV at 10. Continued maximal medical therapy in consideration of end organ stage disease, in the absence of the possibility of currently performing Ultiva lung transplantation in ic at 1 ml hr to treat respiratory discomfort. Infectious disease consultancy, 27Mar2021, h. 14.38 Patient with idiopathic pulmonary fibrosis in home oxygen therapy with usual 93 percent SpO2. Previous repeated isolations of multisensitive P. aeruginosa are reported. Currently patient in severe clinical conditions, soporous but awakened, SpO2 82 percent in NIV in PSV 12, PEEP 5, FiO2 1, stable hemodynamics, anuric. At the exams, neutrophilic leukocytosis WBC 23,000, procalcitonin within the limits, CRP 56 mg dl. Infectious disease consultation h15.21 very serious clinical conditions. Apyretic, dyspnoic, although the current clinical picture is certainly not attributable to bacterial superinfection rather than to an exacerbation of the underlying disease, recommended therapy with meropenem 2 g every 8 hours iv ciprofloxacin 400 mg every 8 hours iv, Bactrim 4 ampoules every 6 ev. nEGA in progress of NIPPV h 8.29 with FiO2 1.0, PEEP 10, PS 10 pH 7.28, pCO2 77, pO2 51, Hb 16, K 4.6, Na 143, Glu 173, Lac 1.0, BE 10 Overall administered: Morphine 10mg iv, Prednisone 160mg, MgSO4 2 vials, Salbutamol 1vial.h 09.45 Patient in the Covid Red Room, maintains multi-parameter monitoring. Venous catheter positioned, 50cc anuric patient. Positioned 2 AVPs, hydration, ventilation via NIV. In progress Remifentanil 5mg at 1ml h in syringe pump. 15.30 very serious conditions persist, picture compatible with bacterial superinfection on exacerbation of the underlying disease at 18.00 confirmed death. Diagnosis of discharge: Died in the emergency room. COVID19 negative. Acute respiratory failure in idiopathic pulmonary fibrosis awaiting transplant with probable bacterial superinfection on exacerbation of the underlying disease. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of evens was fatal.


VAERS ID: 1260529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / 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: 2021-04-14
   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: ITPFIZER INC2021441445

Write-up: Cardio-respiratory arrest in patient with hypertensive heart disease and chronic renal insufficiency to which the first dose of anti SARS-COV-2 COMINARTY vaccine was administered on 13Apr2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-716456. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly in left shoulder on 13Apr2021 10:18 am (Batch/Lot Number: EW2246; Expiration Date: 31Jul2021) as 30 ug, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021, Cardio-respiratory arrest in patient with hypertensive heart disease and chronic renal insufficiency to which the first dose of anti SARS-COV-2 COMINARTY vaccine was administered on 13Apr2021. The patient died on 14Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest in patient with hypertensive heart disease and chronic renal insufficiency to which the first dose of anti SARS-COV-2 COMINARTY vaccine was administered on 13Apr2021


VAERS ID: 1260535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Femur fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441472

Write-up: Deep vein thrombosis in the leg with death due to probable massive pulmonary embolism; Deep vein thrombosis in the leg with death due to probable massive pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-716464. A 82-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET7205), via an unspecified route of administration in right shoulder on an unspecified date at 17:01 PM as single dose for COVID-19 immunization. Patient''s medical history included femur fracture from 01Aug2019 to unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced embolism lung and DVT on 12Apr2021. The event described as deep vein thrombosis in the leg with death due to probable massive pulmonary embolism. The seriousness was fatal. The patient died on 12Apr2021. It was not reported if an autopsy was performed. The outcome of event was fatal.; Reported Cause(s) of Death: probable massive pulmonary embolism


VAERS ID: 1260547 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Body temperature, Body temperature decreased, Cardio-respiratory arrest, Dyschezia, Dysuria, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: XOTERNA; SIMVASTATIN; CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (in oxygen treatment); Smoker; Tabaquism
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: body temperature; Result Unstructured Data: Test Result:35.5 Centigrade
CDC Split Type: ITPFIZER INC2021441488

Write-up: body temperature of 35.5 ? C; CARDIO-RESPIRATORY ARREST; DIFFICULTY DEFECATING; MALAISE DAYS AFTER VACCINATION; DIFFICULTY URINATING; ABDOMINAL BLOATING; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-716697. A 75-year-old male patient received bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 08Apr2021 (Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included Tabaquism, COPD (in oxygen treatment), smoker; all from unknown date and unknown if ongoing. Concomitant medications included glycopyrronium bromide, indacaterol maleate (XOTERNA); simvastatin; acetylsalicylic acid (CARDIOASPIRIN). The patient experienced abdominal bloating, difficulty urinating, difficulty defecating, malaise days after vaccination, cardio-respiratory arrest on 10Apr2021. The patient in the days following vaccination complained of abdominal swelling, difficulty in urinating (he urinated little) and defecating (he did not defecate) and a sense of general malaise. At 18.00 of 10Apr2021 measured a body temperature of 35.5 ? C at 19:00 lies down to rest, is found lifeless at about 21:30 by family members. The intervention of the first aid station ascertained the death for cardio-circulatory arrest. The outcome of the events was fatal. The patient died on 10Apr2021 due to events. No autopsy was performed. Sender comment: 16Apr2021 Pharmacovigilance manager, reporter informs that no autopsy examination will be performed. Asked the reporter for clinical documentation Pending.; Reported Cause(s) of Death: body temperature of 35.5 ? C; CARDIO-RESPIRATORY ARREST; DIFFICULTY DEFECATING; MALAISE DAYS AFTER VACCINATION; DIFFICULTY URINATING; ABDOMINAL BLOATING


VAERS ID: 1260554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-08
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coronavirus test, Multiple organ dysfunction syndrome, Septic shock, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis multiple; Atrial fibrillation paroxysmal; Depressive symptom; Embolism pulmonary; Hyperthyroidism; Intestinal resection; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: quick swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021441421

Write-up: THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic shock and multi-organ failure (MOF) that resulted in the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic shock and multi-organ failure (MOF) that resulted in the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic shock and multi-organ failure (MOF) that resulted in the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic shock and multi-organ failure (MOF) that resulted in the death of the patient; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-716828. An 86-years-old female patient received 2nd dose of BNT162B2 (Pfizer vaccine, Formulation: Solution for injection) intramuscular on 24Mar2021 (Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. Medical history included pulmonary embolism, depressive symptom, intestinal, atrial fibrillation, hyperthyroidism, osteoarthritis, type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 08Apr2021, the patient experienced the vaccination failure, coronavirus infection, septic shock and multiple organ dysfunction syndrome and was positive to nasopharyngeal tampon. On 12 Apr 2021, she was admitted for septic shock and multi-organ failure (mof) that resulted in the death of the patient. Reporter comment: The death was related to multi-organ failure in the course of septic shock in covid-19 positive post-vaccination (16 days interval between second vaccination and positive swab and symptomatology). The action taken in response to the events for bnt162b2 was not applicable. Actions taken (Non-invasive ventilation with CPAP modality, empiric IV antibiotic therapy with ceftriaxone, meropenem and vancomycin, high-flow oxygen therapy, administration of vasoactive amines, EBPM at anticoagulant dosage, hydration and bicarbonate supplementation. Performance of hemocultures with positive finding for Staphylococcus Capitis). The patient died on 12Apr2021. It was not reported weather an autopsy was performed or not.; Reporter''s Comments: The death was related to multi-organ failure in the course of septic shock in covid-19 positive post-vaccination (16 days interval between second vaccination and positive swab and symptomatology).; Reported Cause(s) of Death: THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic shock and multi-organ failure (MOF) that resulted in the death of the patient; THE PA


VAERS ID: 1260570 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest scan, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: chest; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021441475

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-716938. A 48-year-old male patient received second dose bnt162b2 (COMIRNATY, Batch/Lot Number: ER9470), via an unspecified route of administration on 31Mar2021 at 09:47 as 0.3 mL cyclic for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 10Apr2021. The event was reported as follows: Death, on which cause, an investigation by the judicial authority covered by confidentiality is underway, which occurred ten days after the administration of the 2nd dose of Pfizer vaccine. Performed in life, before death, Chest CT scan of which the outcome is unknown. The outcome of the event was fatal. Reporter''s comment: 1st dose of the Anti-Covid vaccination performed on 09Mar2021 with Pfizer vaccine - lot EP2166; 2nd dose with Pfizer Covid vaccine - lot ER9470 on 31Mar2021. No routine follow-up is possible for EV-WEB ICSRs. Follow-up should be performed according to GVP module VI only.; Reporter''s Comments: 1st dose of the Anti-Covid vaccination performed on 09Mar2021 with Pfizer vaccine - lot EP2166; 2nd dose with Pfizer Covid vaccine - lot ER9470 on 31Mar2021.; Reported Cause(s) of Death: death


VAERS ID: 1260577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Aortic stenosis; Heart disease pulmonary; Heart failure NYHA class III
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441483

Write-up: The patient died on 12Apr2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-717031. A 92-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly at left arm on 10Apr2021 12:00 (Lot Number: EW2246; Expiration Date: 31Jul2021) at 0.3 mL, single dose for COVID-19 immunization. Medical history included pulmonary heart disease and tight aortic stenosis NYHA class 3, all ongoing. The patient''s concomitant medications were not reported. The patient died on 12Apr2021. It was unknown if an autopsy was performed. Reporter Comment: as of 16Apr cause of death is unknown. No follow-up attempts are possible. No furthermore information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1260588 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: TICLOPIDINA [TICLOPIDINE]; CARDIOASPIRIN; QUETIAPINE FUMARATE; OMNIC
Current Illness: Dementia; Paraplegia
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemia (Reported by family members previous unspecified ischemic episodes); Prostatic hypertrophy (benign)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021441454

Write-up: First dose of given at 12.40. After vaccination and an appropriate monitoring period, the daughter led the father in the car. Shortly after the departure, he collapsed on the seat; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB, regulatory authority number IT-MINISAL02-717045. A 96-year-old male patient received the first dose of bnt162b2 (Vaccine), intramuscular on 17Apr2021 12:40 (Lot Number: EX0893) as single dose for covid-19 immunisation. Medical history included benign prostatic hyperplasia, ongoing dementia, ischaemia, ongoing paraplegia. Concomitant medications included ticlopidina (ticlopidine); acetylsalicylic acid (CARDIOASPIRIN); quetiapine fumarate; tamsulosin hydrochloride (OMNIC). First dose of given at 12:40. After vaccination and an appropriate monitoring period, the daughter led the patient in the car. Shortly after the departure, patient collapsed on the seat. Sudden death occurred on 17Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: First dose of given at 12.40. After vaccination and an appropriate monitoring period, the daughter led the father in the car. Shortly after the departure, he collapsed on the seat.


VAERS ID: 1260672 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-26
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021450256

Write-up: Death; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and expiration date not reported) at a single dose for COVID-19 immunisation. The reporting pharmacist heard of death after the second dose of BNT162b2 in a patient (hospital staff). On an unspecified date after the second vaccination, the patient died. The cause of death was not reported. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1260673 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Axillary pain, Body temperature, Cardiac failure acute, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; RISEDRONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection; Atrial fibrillation; Cerebral infarction; Heart disease, unspecified; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021450583

Write-up: Cardiac failure acute; Rubbing around the axilla, she complained that the region ached; loss of consciousness; faecal incontinence; vomiting; This is a spontaneous report from a contactable physician (inoculator) received from the regulatory authority. Regulatory authority report number is v21102891. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: ET3674, expiration date: 31Jul2021), via an unspecified route of administration on 20Apr2021 10:00 (at 90-year-old) at single dose for COVID-19 immunisation. The patient had a medical history of heart disease, hypertension, aortic dissection from 2012, atrial fibrillation from 2021, cerebral infarction, and osteoporosis. Body temperature before vaccination was 36.7 degrees Centigrade on 20Apr2021. There were no points to be considered on the vaccine screening questionnaire (no allergies, no vaccinations and illnesses within the last one month, no convulsion). Concomitant medications included acetylsalicylic acid (BAYASPIRIN) and risedronate sodium (RISEDRONATE). On the morning of 21Apr2021 (1 day after the vaccination), she had faecal incontinence and loss of consciousness. In the morning and afternoon, two physicians consulted her. Vital signs were stable. Speech could be clearly heard. She experienced vomiting at dinner. On 22Apr2021 at 00:40 (1 day, 14 hours and 40 minutes after the vaccination), the patient experienced cardiac failure acute. About 36 hours after the vaccination (as reported), On 22Apr2021 around 00:40, the sensor was operating. When visiting the room, the patient sat on the bed, saying "I don''t know what''s happening." Rubbing around the axilla, she complained that the region ached. Immediately after lying down on the bed, she rolled her eyes back. It looked like that breathing had stopped. Therefore, this was reported quickly. Cardiopulmonary resuscitation (CPR) and oxygen administration were initiated. That was mandibular breathing and breathing became shallow little by little. Emergency response team arrived. Performing designated procedures, they took the patient to a hospital, not a reporting hospital because other patients (cardiopulmonary arrest (CPA) and pyrexia) had already been transported and under treatment in the reporting hospital. Although intubated and administered adrenaline, the patient did not respond. At 2:32, the patient''s death was confirmed. It was confirmed by phone that death certificate described that the patient died from cardiac failure acute 2 hours after the onset. Myocardial infarction and other cardiac disease were suspected. Blood collection and imaging were not performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was described above. The reporting physician commented as follows: Causal relationship was unknown. The elderly patient had a history of cardiac disease and more than 24 hours passed after the vaccination. Causal relation between the death and BNT162b2 could not be determined, but they report this case because of fatal case.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1260675 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Computerised tomogram, Electrocardiogram, Investigation
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: 2021-03-20
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210320; Test Name: CT; Result Unstructured Data: Test Result:acute aortic dissection and cardiac tamponade; Test Date: 20210320; Test Name: ECG; Result Unstructured Data: Test Result:PEA; Test Date: 20210320; Test Name: Ai imaging; Result Unstructured Data: Test Result:Stanford Type A aortic dissection; Comments: Stanford Type A aortic dissection with a cardiac tamponade
CDC Split Type: JPPFIZER INC2021450827

Write-up: cardio-respiratory arrest; cardiac tamponade; Type A aortic dissection; This is a spontaneous report from a contactable physician via regulatory authority. Regulatory authority report number is v21103103. The 46-year-old and 9-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021) via an intramuscular route in the arm left on 19Mar2021 at 16:00, as a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. The patient had no family history. Concomitant medication was not reported. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had back pain since the morning of the day after vaccination. The patient visited the orthopedic department of his local physician. The patient was instructed that it was not an orthopedic problem and was advised to see an internist if he was concerned. After returning home, while eating bread, the patient suddenly started snore-like breathing and was unresponsive, so emergency service was called. On 20Mar2021 at 15:35 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. When the paramedics contacted the patient, the ECG showed PEA (Pulseless Electrical Activity). The patient was still the same on arrival at the hospital and was immediately intubated and adrenaline was used for a total of 3 ampules. However, there was no change from cardiac arrest, and death was confirmed at 16:27. AI imaging showed a Stanford Type A aortic dissection with a cardiac tamponade. The patient''s family was informed that the direct cause of death was acute aortic dissection. An autopsy was not performed as of the reporting date, and the reported cause of death was acute aortic dissection and cardiac tamponade on CT. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was fatal on 20Mar2021 with treatment including cardiopulmonary resuscitation. The reporting physician commented the causality between the event and BNT162b2 was unassessable, and other possible cause of the event such as any other diseases was acute aortic dissection. The direct cause of death was acute aortic dissection. The age of onset of the event was somewhat young, and it could not be concluded that there was no causal relationship with the vaccine at all. ; Reported Cause(s) of Death: Cardiac tamponade; Acute aortic dissection


VAERS ID: 1260706 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Loss of consciousness, Malaise, Nausea, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Transient ischaemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEIZURE and LOSS OF CONSCIOUSNESS in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ACENOCOUMAROL tablet for TIA. The patient''s past medical history included Transient ischaemic attack. In 2011, the patient started ACENOCOUMAROL (unknown route) 1 mg. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death), SEIZURE (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), MALAISE and NAUSEA. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE, LOSS OF CONSCIOUSNESS, MALAISE and NAUSEA outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Cause of death was not specifically reported so event of death added; Reported Cause(s) of Death: Death


VAERS ID: 1260715 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-10-13
Onset:2021-03-30
   Days after vaccination:1995
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hyperammonaemia
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULATARD HUMAN; CARVEDILOL; PANTOPRAZOL [PANTOPRAZOLE]; NOVORAPID; METFORMINE [METFORMIN]; IRBESARTAN; PREDNISON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; idiopathische hyperammoniaemie; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and HYPERAMMONAEMIA (idiopathische hyperammoniaemie) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Co-suspect product included non-company product TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) capsule for an unknown indication. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (INSULATARD HUMAN), CARVEDILOL, PANTOPRAZOL [PANTOPRAZOLE], INSULIN ASPART (NOVORAPID), METFORMINE [METFORMIN], IRBESARTAN and PREDNISONE (PREDNISON) for an unknown indication. On 13-Oct-2015, the patient started TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) (unknown route) 2d1. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERAMMONAEMIA (idiopathische hyperammoniaemie) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. On 14-Oct-2014 the patient started additional Co-suspect non company product PREDNISON TABLET (brand name not specified) for an unknown indication, action taken dose increased. Additional concomitant medications included Gliclazide and Irbesartan for an unknown indication. Company comment: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No specific follow-up information recorded.; Sender''s Comments: This is a case of death in a 69-year-old male subject with a medical history of HTN and DM, who died 5 days after receiving the first dose of 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: 1260717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: LEVOTHYROXINE; SPIRONOLACTONE; FUROSEMIDE; NOVORAPID; LISINOPRIL; IMBRUVICA; METOPROLOL SUCCINATE
Current Illness: Leukaemia lymphocytic chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021435852

Write-up: acute death, possibly cardiac; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NL-LRB-00509644, received from Regulatory Authority. An 80-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 26Mar2021 at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing leukaemia lymphocytic chronic. The patient had no previous COVID-19 infection. Concomitant medications included levothyroxine, spironolactone, furosemide, insulin aspart (NOVORAPID), lisinopril, ibrutinib (IMBRUVICA), metoprolol succinate. The patient experienced acute death, possibly cardiac on 14Apr2021 following administration of covid-19 vaccine pfizer Injectable solution. The outcome of sudden cardiac death was fatal. It was unknown if autopsy was performed. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no - acute death Additional information ADR: unexpected death Citizen service number available: yes confounding factors: chronic leukemia Chronic Lymphocytic Leukemia COVID-19 Previous COVID-19 infection: No. 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 - acute death Additional information ADR: unexpected death Citizen service number available: yes confounding factors: chronic leukemia Chronic Lymphocytic Leukemia COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: acute death, possibly cardiac


VAERS ID: 1260721 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Body temperature, Coma scale, Computerised tomogram head, Depressed level of consciousness, Electroencephalogram, Glomerular filtration rate, Haemoglobin, Heart rate, Intraventricular haemorrhage, Lumbar puncture, Mini mental status examination, Neutrophil count, Oxygen saturation, Platelet count, Red blood cell sedimentation rate increased, Respiratory rate, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LOSARTAN KRKA [LOSARTAN]; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]; ELIQUIS; METOPROLOL; SOMAC
Current Illness: Atrial fibrillation; Bronchiectasis; COPD; Esophagitis (Esophagitis/gastritis. Negative H.pylori test.); Hypertension; Liver cirrhosis; Palliative care; Pancreatic calcification; Psoriasis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: Creatinine; Result Unstructured Data: 105 umol/L; Test Date: 20210226; Test Name: Potassium; Result Unstructured Data: 3.9 mmol/L; Test Date: 20210226; Test Name: Diastolic blood pressure; Test Result: 78 {DF}; Result Unstructured Data: 78 mmHg; Test Date: 20210226; Test Name: systolic blood pressure; Test Result: 166 {DF}; Result Unstructured Data: 166 mmHg; Test Date: 20210226; Test Name: Sodium; Result Unstructured Data: 141 mmol/L; Test Date: 20210226; Test Name: Body temperature; Result Unstructured Data: 37 degrees Celsius; Test Date: 20210226; Test Name: Glasgow coma scale; Test Result: Inconclusive ; Result Unstructured Data: 12-10; Test Date: 20210226; Test Name: Head CT; Test Result: Inconclusive ; Result Unstructured Data: Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.; Test Date: 20210226; Test Name: EEG; Result Unstructured Data: Slow activity, not epileptiform activity.; Test Date: 20210226; Test Name: GFR; Test Result: Inconclusive ; Result Unstructured Data: 41 mL/min/1.73m^2; Test Date: 20210226; Test Name: Hemoglobin; Result Unstructured Data: 12.2 g/dL; Test Date: 20210226; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 83 /min; Test Date: 20210226; Test Name: Spinal tap; Test Result: Inconclusive ; Result Unstructured Data: Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.; Test Date: 20210226; Test Name: MMSE; Test Result: Inconclusive ; Result Unstructured Data: 25 out of a total of 30; Test Date: 20210226; Test Name: Neutrophils; Test Result: Inconclusive ; Result Unstructured Data: 8 x 10^9/L; Test Date: 20210226; Test Name: Oxygen saturation; Result Unstructured Data: 98%; Test Date: 20210226; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 263 x 10^9/L; Test Date: 20210226; Test Name: Raised ESR; Test Result: Inconclusive ; Result Unstructured Data: 30 mm/hr; Test Date: 20210226; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: 20 /min; Test Date: 20210226; Test Name: sars-cov-2 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210226; Test Name: Cardiac troponin; Test Result: Inconclusive ; Result Unstructured Data: 26 ng/L; Test Date: 20210226; Test Name: White blood cells; Test Result: Inconclusive ; Result Unstructured Data: 12.5 x 10^9
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: Intraventricular hemorrhage; Depressed level of consciousness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) and DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Psoriasis, Palliative care, Esophagitis (Esophagitis/gastritis. Negative H.pylori test.) since 2008, Liver cirrhosis since January 2020, Pancreatic calcification since January 2020, Atrial fibrillation, COPD, Hypertension and Bronchiectasis. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, LOSARTAN (LOSARTAN KRKA [LOSARTAN]), FLUTICASONE PROPIONATE, SALMETEROL (SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL]) and METOPROLOL for an unknown indication, PANTOPRAZOLE SODIUM SESQUIHYDRATE (SOMAC). On 24-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) (seriousness criteria death, hospitalization and medically significant). On 26-Feb-2021, the patient experienced INTRAVENTRICULAR HAEMORRHAGE (Intraventricular hemorrhage) (seriousness criteria death, hospitalization and medically significant). DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood creatinine: 105 (abnormal) 105 umol/L. On 26-Feb-2021, Blood potassium: 3.9 (abnormal) 3.9 mmol/L. On 26-Feb-2021, Blood pressure diastolic: 78 mmHg (abnormal) 78 mmHg. On 26-Feb-2021, Blood pressure systolic: 166 mmHg (abnormal) 166 mmHg. On 26-Feb-2021, Blood sodium: 141 (abnormal) 141 mmol/L. On 26-Feb-2021, Body temperature: 37 (abnormal) 37 degrees Celsius. On 26-Feb-2021, Coma scale: 12-10 (Inconclusive) 12-10. On 26-Feb-2021, Computerised tomogram head: intraventricular hemorrhage (Inconclusive) Intraventricular hemorrhage with small hematoma in posterior horn of lateral ventricles, mostly left side. Somewhat reduced discrepancy between gray and white matter frontally left side. Age-corresponding surface relief and ventricular caliber. Open basal cisterns.. On 26-Feb-2021, Electroencephalogram: slow activity, not epileptiform activity (abnormal) Slow activity, not epileptiform activity.. On 26-Feb-2021, Glomerular filtration rate: 41 (Inconclusive) 41 mL/min/1.73m^2. On 26-Feb-2021, Haemoglobin: 12.2 g/dL (normal) 12.2 g/dL. On 26-Feb-2021, Heart rate: 83 /min (Inconclusive) 83 /min. On 26-Feb-2021, Lumbar puncture: leukocytes: 79 (Inconclusive) Leukocytes: 79 (primarily mononuclear cells). Some blood in the ventricular system.. On 26-Feb-2021, Mini mental status examination: 25 (Inconclusive) 25 out of a total of 30. On 26-Feb-2021, Neutrophil count: 8 10^9/L (Inconclusive) 8 x 10^9/L. On 26-Feb-2021, Oxygen saturation: 98 % (normal) 98%. On 26-Feb-2021, Platelet count: 263 10^9/L (Inconclusive) 263 x 10^9/L. On 26-Feb-2021, Red blood cell sedimentation rate increased: 30 mm/hr (Inconclusive) 30 mm/hr. On 26-Feb-2021, Respiratory rate: 20 /min (Inconclusive) 20 /min. On 26-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 26-Feb-2021, Troponin: 26 ng/L (Inconclusive) 26 ng/L. On 26-Feb-2021, White blood cell count: 12.5 10^9/L (Inconclusive) 12.5 x 10^9. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected. Reporter did not allow further contact; Reporter''s Comments: NIPH will request additional information from hospital. 25 / Mar / 2021 NIPH: Additional information received from hospital, the report is updated (posted under "Person" and "Disease", "Product" and "Lab"). Background: A woman in her late 80s was vaccinated with COVID-19 vaccine Moderna in January and February 2021. According to the report, she has subsequently had several admissions due to impaired consciousness, GCS 9-10. Thoroughly investigated. Spinal fluid with leukocytes of 79, primarily mononuclear cells, but some blood in the gastric system for unexplained reason. Proven less deep cerebral infarction right side. No explanation the patient''s condition based on the report. Sign up for inflammation of the spinal fluid, without the agent becoming proven after thorough investigation. Possible immunological reaction to the vaccine? Transition to palliative care treatment. Comment: The current event is per now no known side effect of this vaccine, but your message is important to increase knowledge about side effects which may not have been discovered in the studies. Unexpected and serious incidents after vaccination are monitored and assessed, both continuously and collectively, as a acquires further experience from completed vaccination. In this case, it is difficult to know whether the symptoms can be attributed to the vaccine or another, random simultaneous cause that has nothing to do with it current vaccine to do. If the reporter has more information that may be relevant for the assessment of causal connection, then these can be communicated to us. Information that is of interest is details about the course of events, onset of symptoms in relation to vaccination time, any relevant comorbidity and drugs in use. It can be said to be a temporal connection between the current medical history and time for vaccination, and on that basis we have therefore considered it to be a possible causal relationship. According to international criteria, a possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to underlying disease, other drugs or chemicals (1). References: Adverse reactions: definitions, diagnosis and management. Lancet 2000; 356: 1255-59.; Sender''s Comments: Very limited information regarding these events has been provided at this time. . Patient''s advanced age along with the presence of multiple comorbidities may have been contributory for the occurrence of the death. No further follow-up information is expected.


VAERS ID: 1260723 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, General physical health deterioration
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: Dementia; Frailty; Life expectancy shortened; Ovarian cancer metastatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION and DEATH in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30001176) for COVID-19 vaccination. Concurrent medical conditions included Ovarian cancer metastatic, Life expectancy shortened, Frailty and Dementia. On 30-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION(seriousness criterion death). The patient died in April 2021. The reported cause of death was Reduced general condition. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered GENERAL PHYSICAL HEALTH DETERIORATION and DEATH to be possibly related. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Company comment:This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 81year-old female subject with a medical history of Ovarian cancer metastatic, who died next day after receiving the vaccine. Based on patient''s age and comorbid conditions the death and other events are assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown cause of death; Reduced general condition


VAERS ID: 1260813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Tobacco abuse; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021435958

Write-up: Pulmonary stasis; Cough; lung congestion; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number PL-URPL-3-509-2021. The reporter is contactable to HA only. An 81-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot ER0641, exp. 31May2021) at single dose intramuscular in left arm on 10Feb2021, 1:13 PM for Covid-19 immunization. Medical history included Type 2 diabetes mellitus, Tobacco abuse, Heart failure, all ongoing. Concomitant drug was not provided. Serious adverse event was reported as pulmonary stasis and cough with onset date of 12Feb2021 at 12:45 and seriousness criterion of death. Outcome of the events was fatal. The clinical course was reported as follows: lung congestion was found after vaccination and the dose of diuretics was increased. The patient was in a mediocre condition and complained of a cough. On 12Feb2021, she was pronounced dead. Sender''s comments: Lung congestion and coughing are unexpected symptoms following Comirnaty vaccination. Until 08Apr2021, the database reported 1 case of pulmonary congestion and 1470 cases of cough. However, the congestion in the lungs was probably caused by comorbidities (diagnosed heart failure, diabetes) and not by the administered vaccine. The cough could be a symptom of lung congestion. Information about the patient''s health indicates a possible time coincidence between vaccination and the occurrence of adverse reactions. The person reporting post vaccination adverse reaction qualified it as serious. URPL assessed the post vaccination adverse reaction as serious. Assessment for reactions Cough, Pulmonary stasis: Source of assessment: NCA; Method of assessment: WHO scale: unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary stasis; Cough


VAERS ID: 1260820 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-30
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-26
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: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Bladder neoplasm. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 30-Mar-2021 The patient died on 30-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. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.; ; Reported Cause(s) of Death: death


VAERS ID: 1260851 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Implantable defibrillator user; Ischemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1617257859120

Write-up: Death NOS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and DEATH (Death NOS) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Implantable defibrillator user and Ischemic cardiomyopathy. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (seriousness criterion death) and DEATH (Death NOS) (seriousness criterion death). The reported cause of death was Cardiac 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. No concomitant medication reported. No treatment information was provided. On unspecified date in 2021, patient received the vaccination. On unspecified date in 2021, patient had cardiac arrest. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment:This case of a cardiac arrest and death of a 78-year-old male patient after the administration of mRNA-1273. Very limited information regarding this event/s has been provided at this time. Dates of mRNA-1273 administration and onset of the reported events are lacking. No further information is expected.; Sender''s Comments: This case of a cardiac arrest and death of a 78-year-old male patient after the administration of mRNA-1273. Very limited information regarding this event/s has been provided at this time. Dates of mRNA-1273 administration and onset of the reported events are lacking. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Death NOS


VAERS ID: 1260885 (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: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardiac arrest, Dizziness, Dyspnoea, Gastric haemorrhage, Gastrointestinal haemorrhage, Haematemesis, Haemoglobin, Platelet count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), 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), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Vestibular disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diffuse large B-cell lymphoma recurrent; Metastases NOS; Metastases to liver; Metastases to spleen
Allergies:
Diagnostic Lab Data: Test Name: CT angio; Result Unstructured Data: Test Result:no clear vessel could be identified; Comments: no clear vessel could be identified for therapeutic embolisation; Test Date: 202103; Test Name: B-Haemoglobin; Result Unstructured Data: Test Result:113 g/l; Test Date: 202103; Test Name: B-Thrombocytes; Result Unstructured Data: Test Result:180 x10 9/l
CDC Split Type: SEPFIZER INC2021435871

Write-up: GI bleeding/large melena /melena; Acute haematemesis/bloody vomiting; acute ventricle/stomach haemorrhage; dyspnea; dizzy; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-027596. An 81-year-old male received BNT162B2 (COMIRNATY) at single dose via an unknown route on an unknown date in Mar2021 for COVID-19 immunisation. Medical history included diffuse large recurrent diffuse large B-cell lymphoma spread to the ventricle wall, spleen and liver. A recurrence of the man''s lymphoma had been discovered a few days prior and the man was informed of this. Concomitant drug was not provided. Reported suspected adverse events were acute haematemesis and gastrointestinal haemorrhage with onset date on Mar2021. Outcome of the events was fatal. Cause of death was acute ventricle/stomach haemorrhage. The clinical course was reported as follows: Patient received vaccination in March 2021 and one day later debut of melena. Haemoglobin (reference: 130-170 g/L ) was 113 and thrombocytes (reference: 150-350 10(9)/L) was 180. Patient was hospitalised and treated with prednisolone (DELTISON), blood transfusions and intravenous fluids. Treatment with allopurinol was initiated. At an unknown time, the man developed rectal bleeding. Two days after the vaccination; dyspnea, dizzy, large melena and bloody vomiting. The man was considered hemodynamically unstable. He received a ventricle tube and blood came out. Treatment with tranexamic acid (CYKLOKAPRON) and esomeprazole (NEXIUM) was started. A CT angio was performed, no clear vessel could be identified for therapeutic embolisation. The symptoms persisted throughout the day and in the evening, the man went into cardiac arrest. CPR was started immediately, intubation was attempted but difficult due to blood in the respiratory tract. The man was treated 4 times with adrenaline, but as he only had pulseless electrical activity, defibrillation was not possible. After 20 minutes, CPR was terminated. The reporter stated that the large recurrent lymphoma in the ventricle wall, spleen and liver was a very clear cause for the heamorrhage and that correlation to the vaccine was difficult for the reporter to assess, but that it''s clear that the man had both a recurrent lymphoma and that there was a time correlation between the reported suspected adverse events and the vaccination. Report assessed the report as serious with seriousness criteria of death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: acute haematemesis; GI bleeding/large melena /melena; acute ventricle/stomach haemorrhage


VAERS ID: 1260934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Diabetes mellitus, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR on COVID; Test Result: Negative
CDC Split Type: SIPFIZER INC2021436333

Write-up: Cardio-respiratory failure; Diabetes mellitus exacerbated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0419_0419. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number: EW2239 and expiration date: 31Jul2021), via intramuscular, on 01Apr2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced diabetes mellitus exacerbated on 03Apr2021, and cardio-respiratory failure on 04Apr2021. The patient died on 04Apr2021 18:20. On 03Apr2021, patient was examined on internistic first aid (IPP) due to derailed diabetes mellitus. The patient was brought back in terminal phase on 04Apr2021. The patient''s condition deteriorated greatly during the treatment, the patient became poorly responsive despite adequate blood glucose lowering, hydration and antibiotic therapy. According to the decision of the council, they did not decide on intensive treatment, but on palliative measures, a signed palliative letter. The relatives were informed about the situation, and the physician called the nurse at the nursing home. The physician noted that the patient was in the terminal phase and could die at any time. Instructions were given for infusion and possible relief of morphine problems 3 mg pp sc. PCR on COVID was negative. The patient was returned to a nursing home, unconscious, in respiratory and circulatory failure. An epidemiologist on duty was consulted. Palliative visit on return to the nursing home. The patient died at 18:20, and was sent for sanitary autopsy, epidemiologist was notified by telephone. This case report was assessed as medically significant. The patient underwent lab tests and procedures, which included PCR on COVID was negative. The outcome of the events was fatal. The cause of death was diabetes mellitus exacerbated and respiratory failure. An autopsy was performed and results was not available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory failure; diabetes mellitus exacerbated


VAERS ID: 1261888 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20210

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 2 dosage form. Death occurred on 27-Mar-2021 The patient died on 27-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The action taken with mRNA-1273 in response to the events was not applicable. Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded 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: 1261890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2020-04-04
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 365
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: ITMODERNATX, INC.MOD20210

Write-up: sudden death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (sudden death) in a 95-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. The patient died on 04-Apr-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. No concomitant medications were provided. Treatment information was not provided. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD for confirmation of events and dates. SD currently has reaction start date captured as 4-apr-2020 which is likely an error as the event is sudden death and this date is a year prior to the stop date (the death of the patient) Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: no new information; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Awaiting translation of SD for confirmation of events and dates. SD currently has reaction start date captured as 4-apr-2020 which is likely an error as the event is sudden death and this date is a year prior to the stop date (the death of the patient); Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1261891 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: ITMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 01-Apr-2021. The reported cause of death was Death sudden. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. It is unclear if the sudden death occurred after the first or second dose of vaccine as the SD senders comments suggest first dose administered on 02-mar-2021 while the fields completed in the SD suggest first dose occurred on 30-mar-2021 02/03/2021 - 300042723)"; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. It is unclear if the sudden death occurred after the first or second dose of vaccine as the SD senders comments suggest first dose administered on 02-mar-2021 while the fields completed in the SD suggest first dose occurred on 30-mar-2021; Reported Cause(s) of Death: Death sudden


VAERS ID: 1262005 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Hyperlipidaemia; Hypertension arterial; Type 2 diabetes mellitus (Diabetes mellitus Typ 2)
Preexisting Conditions: Comments: Diabetes mellitus Typ 2, art. Hypertonie
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: Arteria Basilarisverschluss; This regulatory authority case was reported by a physician and describes the occurrence of BASILAR ARTERY OCCLUSION (Arteria Basilarisverschluss) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. Diabetes mellitus Typ 2, art. Hypertonie. Concurrent medical conditions included Hyperlipidaemia, Type 2 diabetes mellitus (Diabetes mellitus Typ 2) and Hypertension arterial (art. Hypertonie). On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form once a day. On 01-Apr-2021, the patient experienced BASILAR ARTERY OCCLUSION (Arteria Basilarisverschluss) (seriousness criterion death). The patient died on 01-Apr-2021. The reported cause of death was Basilar artery occlusion. 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 concomitant medication reported. No treatment information was provided. Company Comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded, although the elderly patient had a number of underlying conditions that could have contributed to the arterial occlusion and death.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded, although the elderly patient had a number of underlying conditions that could have contributed to the arterial occlusion and death; Reported Cause(s) of Death: Basilar artery occlusion


VAERS ID: 1262015 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: Arterial hypertension; Fibrosis lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Fibrosis lung since an unknown date and Arterial hypertension since an unknown date. On 23-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 01-Apr-2021. The reported cause of death was Sudden death. An autopsy was not 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 provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; 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: Sudden death


VAERS ID: 1262028 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arterial haemorrhage, Hypovolaemic shock
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: ENALAPRIL; CARVEDILOL
Current Illness: Duchenne muscular dystrophy; Endotracheal intubation; Percutaneous endoscopic gastrostomy; Respiration failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: IN SHOCK; This regulatory authority case was reported by a physician and describes the occurrence of ARTERIAL HAEMORRHAGE, IN SHOCK and HYPOVOLAEMIC SHOCK, in a 26-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. Concurrent medical conditions included Endotracheal intubation, Respiration failure, Percutaneous endoscopic gastrostomy and Duchenne muscular dystrophy. Concomitant products included ENALAPRIL and CARVEDILOL for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 10-Apr-2021, the patient experienced ARTERIAL HAEMORRHAGE (IN SHOCK) (seriousness criterion death) and HYPOVOLAEMIC SHOCK (IN SHOCK) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was Hypovolaemic shock and Arterial haemorrhage. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. There is also limited information with regards the conditions captured as history / current conditions and it is unclear if any of these are associated with the recorded events; Reported Cause(s) of Death: Hypovolaemic shock; Arterial haemorrhage


VAERS ID: 1262030 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE - TABLETS; BENDROFLUAZIDE; ATENOLOL; VALSARTAN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTMODERNATX, INC.MOD20210

Write-up: cardiogenic shock; myocardial infarction; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock) and MYOCARDIAL INFARCTION (myocardial infarction) in a 76-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE (AMLODIPINE - TABLETS), BENDROFLUMETHIAZIDE (BENDROFLUAZIDE), ATENOLOL and VALSARTAN for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criterion death) and MYOCARDIAL INFARCTION (myocardial infarction) (seriousness criterion death). The reported cause of death was Cardiogenic shock and Myocardial infarction. It is unknown if an autopsy was performed. Treatment information was not provided. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is not clear if the sender''s comment of "side-effects are unexpected" was a specific statement that the captured events were not related so as reported causality retained as not provided.; Reporter''s Comments: Side-effects are unexpected. challenge; compatible Re-challenge: RO De-challenge; inconclusive Signs and symptoms: compatible Lab test: L0 Alternate explanation: present Outcome I 1 uncertain.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is not clear if the sender''s comment of "side-effects are unexpected" was a specific statement that the captured events were not related so as reported causality retained as not provided.; Reported Cause(s) of Death: Cardiogenic shock; Myocardial infarction


VAERS ID: 1262034 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Myalgia, Nausea, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history information reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Unknown cause of death; Nausea; Generalized joint pain; Neuralgia; Fatigue; Myalgia; Headache; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death), NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history information reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Apr-2021, the patient experienced NEURALGIA (Neuralgia) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and MYALGIA (Myalgia) (seriousness criterion medically significant). On 02-Apr-2021, the patient experienced ARTHRALGIA (Generalized joint pain) (seriousness criterion medically significant). On 04-Apr-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, NEURALGIA (Neuralgia), ARTHRALGIA (Generalized joint pain), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Myalgia), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; 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: Unknown cause of death


VAERS ID: 1264984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 4815 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MARCOUMAR; THIAMAZOL
Current Illness: Atrial fibrillation; Basedow''s disease (Morbus Basedow, Thiamazol Therapie); Coagulation disorder (Factor 5 coagulation disorder,reported by daughter to the vaccinating physician only after the death); Heart insufficiency; Hypertension; Insulin-requiring type II diabetes mellitus; Thrombosis; Ulcus cruris (residual Ulcera cruris)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021447105

Write-up: suspected cerebral bleeding; Exitus letalis 1 day after Comirnaty vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is AT-BASGAGES-2021-22949. A 78-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 15Apr2021 (lot number: EW 4815; expiration date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included an ongoing coagulation disorder: factor 5 coagulation disorder, reported by daughter to the vaccinating physician only after the death; ongoing heart insufficiency; ongoing insulin-requiring type II diabetes mellitus; ongoing atrial fibrillation; ongoing Basedow''s disease: Morbus Basedow, Thiamazol Therapie; ongoing thrombosis; ongoing hypertension; and ongoing ulcus cruris: residual ulcera cruris. Concomitant medications included phenprocoumon (MARCOUMAR) and thiamazole; both taken for an unspecified indication, start and stop date were not reported. On 16Apr2021, the patient experienced death and cerebral bleeding: Exitus letalis, 1 day after vaccination with BioNTech Pfizer vaccine, suspected cerebral bleeding, medical autopsy required, several pre-existing risks. The patient died on 16Apr2021; an autopsy was performed results have not been provided. Sender Comment: BASGAGES-comment: Follow-up information requested. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Exitus letalis 1 day after Comirnaty vaccination; suspected cerebral bleeding


VAERS ID: 1264985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021444537

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 536538. An 81-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1264991 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea exertional, General physical health deterioration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: ASAFLOW; CLOPIDOGREL; BIPRESSIL
Current Illness: Morbid obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol (no alcoholism); Myocardial infarction; Non-tobacco user (no tobacco user); Treatment noncompliance (Bad medication compliance, tendency to refuse care); Treatment refused due to patient''s wishes
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021453637

Write-up: General physical health deterioration in the days following; Dyspnoea on effort; Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number BE-FAMHP-DHH-N2021-87727. A 57-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ER9480), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. Medical history included ongoing morbid obesity, myocardial infarction from an unknown date and not ongoing, no alcoholism, non-tobacco user and bad medication compliance, tendency to refuse care treatment noncompliance from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASAFLOW), clopidogrel and bisoprolol fumarate, perindopril arginine (BIPRESSIL), all taken for an unspecified indication, start and stop dates were not reported. This male patient with a history of myocardial infarction and a weight of 162 kg, was vaccinated on 01Apr2021 with Comirnaty (second dose administered) and died 5 days after vaccination (sudden death). The patient experienced general physical health deterioration in the days following, dyspnoea on effort and sudden death on 02Apr2021. The outcome of the events was fatal. The patient died on 05Apr2021. An autopsy was not performed. Reporter comment: Treatment: No - Evolution of ADR: death - Examinations no - ADR description: Alteration of general state in the following days (heteroanamnesis little contributory), dyspnea with mild effort. Sudden death on 05Apr2021, 5 days after vaccination. Patients with a history of myocardial infarction. No autopsy performed. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Death Examinations - / ADR description - Alteration of general state in the following days (heteroanamnesis little contributory), dyspnea with mild effort. Sudden death on 05Apr2021, 5 days after vaccination. Patients with a history of myocardial infarction. No autopsy performed.; Reported Cause(s) of Death: general physical health deterioration; dyspnoea on effort; sudden death


VAERS ID: 1265003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Dehydration, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPIN ACTAVIS; ASPIRIN CARDIO; LAMOTRIGIN ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Femur fracture; Polyarthritis; Seizures; Small bowel resection; Stroke; Vascular dementia, with delirium
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021452636

Write-up: Death; dehydration; circulation/cardiac arrest; Fever; Vomiting; This is a spontaneous report received from a contactable physician via Agency Regulatory Authority. Regulatory authority report number CH-SM-2021-12970. An 86-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via intramuscular on 09Feb2021 (Batch/Lot Number: EM0477) as single dose for COVID-19 immunisation. Medical history included vascular dementia moderate with BPSD (behavioral and psychological symptoms of dementia), moderate aortic valve stenosis Dec2019, focal epilepsy with recurrent secondary generalized seizures in status after stroke in 2014, Seronegative polyarthritis with dominant involvement of hand and finger joints, status after femur fracture in May 2020, status after small bowel segment resection by mechanic ileus 2015. Concomitant medications included quetiapine fumarate (QUETIAPIN ACTAVIS), acetylsalicylic acid (ASPIRIN CARDIO), lamotrigine (LAMOTRIGIN ACTAVIS), all taken for an unspecified indication, start and stop date were not reported. On 09Feb2021, she received a vaccination with BNT162B2 (first dose, batch number unknown). From 10Feb2021 she manifested fever and vomiting. The woman died on 14Feb2021 from dehydration after multiple vomiting and circulation/cardiac arrest. Further course not known. An autopsy was not performed. A causal relationship between Comirnaty and death, fever and vomiting was assessed as being unlikely. This case was reported as serious (fatal outcome). Sender''s comment: Fever and vomiting occurred in close temporal correlation (the day after) with Comirnaty vaccination, in an elderly polymorbid woman and with concomitant medications. The reporter reported that due to the state of dehydration given by fever and vomiting and cardiovascular arrest, the woman died 5 days after receiving the vaccination. An autopsy was not performed. Fever is known side effect for Comirnaty from monograph, vomiting is not. The attached Regulatory Authority monograph mentions vomiting as a known adverse reaction on Comirnaty (frequency <1-2%). Based on the available information, it is thought possible that the vaccine, by causing fever and vomiting, contributed to worsening the condition of the elderly woman, who was already known to have numerous comorbidities. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Circulation/cardiac arrest; fever; vomiting; Dehydration; death


VAERS ID: 1265004 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Circulatory collapse, Myocardial infarction
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: ASPIRIN CARDIO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021453383

Write-up: Development of chest pain, loss of consciousness and onset of death.; myocardial infarction; acute circulatory failure; This is a spontaneous report received from a contactable physician via Regulatory Authority, the regulatory authority. Regulatory authority report number CH-SM-2021-14653. A 69-year-old male patient received first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: EP 9605) via intramuscular on 15Apr2021 as single dose for covid-19 immunisation. Medical history included previous heart disease. Concomitant medication included acetylsalicylic acid (ASPIRIN CARDIO). On 15Apr2021, patient received the first dose of BNT162B2. 5 hours later, at home, he experienced chest pain, loss of consciousness and died (15Apr2021). The autopsy reports revealed that "cardiomegaly, coronary artery disease with subtotal stenosis, fresh myocardial infarction as cause of acute circulatory failure". This case was assessed as serious with seriousness criterion results in death. A causality between death and BNT162B2 was reported as being unlikely by Regulatory Authority. The patient died on 15Apr2021. An autopsy was performed that revealed cardiac failure acute, cardiomegaly, coronary artery disease with subtotal stenosis, fresh myocardial infarction, acute circulatory failure and the reported cause of death was cardiac failure acute, myocardial infarction, acute circulatory failure. Outcome of the events was fatal. Regulatory Authority assessment: Death in temporal correlation with first vaccination with Comirnaty in elderly man with previous heart disease. Indeed, the autopsy showed cardiomegaly and subtotal coronary artery stenosis. The cause of death was myocardial infarction with acute circulatory failure. It is believed that there was only a temporal correlation with vaccination. At the current state of knowledge, there is no data in the literature regarding a possible association between Comirnaty and ischemic cardiac impairment (i.e., myocardial infarction), and the causal link is therefore considered unlikely (a judgment that does not exclude that with increasing knowledge of the safety of the vaccine a causal role of the same may be found).; Reported Cause(s) of Death: Cardiac failure acute; acute circulatory failure; fresh myocardial infarction; Autopsy-determined Cause(s) of Death: Cardiac failure acute; cardiomegaly; coronary artery disease with subtotal stenosis; coronary artery disease with subtotal stenosis; fresh myocardial infarction; acute circulatory failure


VAERS ID: 1265007 (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: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021447162

Write-up: Pneumonia; Renal failure; Fever, pain of the whole body; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB with regulatory authority number CZ-CZSUKL-21004242. A 70-year-old female patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 25Mar2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever, pain of the whole body, pneumonia, renal failure and death after vaccination with COMIRNATY on 25Mar2021. The patient was hospitalized for pneumonia and renal failure. Event fever, pain of the whole body was reported as serious, medically significant. Outcome of the event fever, pain of the whole body was not recovered. The patient died on 02Apr2021 due to pneumonia and renal failure. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia; Renal failure


VAERS ID: 1265017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Pneumonia, Pyrexia, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (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: 2021-01-18
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LOSARTANKALIUM/HYDROCHLORTHIAZID "KRKA"; BUPRENORPHINE TEVA [BUPRENORPHINE HYDROCHLORIDE]; MUCOLYSIN [ACETYLCYSTEINE]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PLAVIX; OXYNORM; PANODIL; CALCIUM AND VITA
Current Illness: Chronic obstructive airways disease; Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Expectoration; Hypertension; Pain; Thrombosis prophylaxis; Vitamin supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021430029

Write-up: Pneumonia; affected respiration/abnormal breathing; Tiredness; Fever; unknown cause of death but maybe Chronic obstructive airways disease and from natural causes; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number DK-DKMA-WBS-0060972. A 95-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jan2021 (Lot Number: EM0477; Expiration Date: 30Apr2021) as a single dose for covid-19 immunisation. Medical history included ongoing dementia, ongoing chronic obstructive pulmonary disease, hypertension, expectoration (productive cough), constipation, thrombosis prophylaxis, pain and vitamin supplementation. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTANKALIUM/HYDROCHLORTHIAZID "KRKA") therapy dates not reported for hypertension; buprenorphine hydrochloride (BUPRENORPHINE TEVA) for pain from 05Nov2020 to an unspecified stop date; acetylcysteine (MUCOLYSIN) for expectoration from 12Nov2020 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation from 08Apr2020 to an unspecified stop date; clopidogrel bisulfate (PLAVIX) therapy dates not clearly reported (reported as start date unknown but at least since 23Jul2019) for thrombosis prophylaxis; oxycodone hydrochloride (OXYNORM) for pain from 07Oct2020 to an unspecified stop date; paracetamol (PANODIL) for pain from 05Oct2020 to an unspecified stop date; and calcium carbonate, ergocalciferol (CALCIUM AND VITAMIN D) for vitamin supplementation from 17Sep2020 to an unspecified stop date. The report received on 31mar2021 from a physician which describes the occurrence of abnormal breathing (affected respiration), fever (fever), pneumonia (pneumonia), tiredness (tiredness) in a 95 years old female patient vaccinated with COMIRNATY (tozinameran). On 08Jan2021, the patient developed fever, tiredness, abnormal breathing (affected respiration) and on 10Jan2021 pneumonia. The patient had unknown cause of death but maybe chronic obstructive airways disease and from natural causes on 18Jan2021. The Patient died on 18Jan2021 (not related to vaccination). There is no information regarding test results. The causality was reported as that the reporting physician does not suspect that side effects are related to the death of the patient. Stated that it is a coincidence and more likely related to the patient''s age and other illness. The outcome of the events respiration abnormal, fatigue, pyrexia and pneumonia were recovered in Jan2021 while the outcome of the other event was fatal. The patient died on 18Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Death with unknown cause is assessed related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death. ; Reported Cause(s) of Death: unknown cause of death but maybe Chronic obstructive airways disease and from natural causes.


VAERS ID: 1265026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood pressure systolic, Cardiac tamponade, Cardiogenic shock, Coronary artery stenosis, Ejection fraction, International normalised ratio, Mitral valve incompetence, Multiple organ dysfunction syndrome, Pericardial haemorrhage, Pulmonary arterial pressure increased, Vasoplegia syndrome, Ventricular hypokinesia
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (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), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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? No
Previous Vaccinations:
Other Medications: BISOCE; EUPANTOL; LERCAN
Current Illness: Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome (requiring the placement of active stents); Arterial hypertension; Artificial cardiac pacemaker user; Atrial fibrillation; Atrioventricular block complete (with permanent cardiac pacemaker); Chronic unstable angina; Dialysis (3 times a week); Dyslipidemia; End stage renal disease (ESRD); Hypothyroidism; Ketosis-prone diabetes mellitus; Stent insertion NOS (circumflex artery,common trunk and proximal left anterior descending artery)
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: coronary angiography; Result Unstructured Data: Test Result:reveals a very tight intrastent stenosi; Comments: very tight intrastent stenosis of the common trunk and the right coronary artery; Test Date: 20210329; Test Name: systolic pulmonary artery pressure; Result Unstructured Data: Test Result:45 mmHg; Test Date: 20210329; Test Name: Left ventricular ejection fraction; Result Unstructured Data: Test Result:35-40 %; Comments: apical hypokinesia, restrictive grade 2 mitral insufficiency; Test Date: 20210329; Test Name: INR; Result Unstructured Data: Test Result:2.75
CDC Split Type: FRPFIZER INC2021447074

Write-up: apical hypokinesia; grade 2 mitral insufficiency; PAPS (systolic pulmonary artery pressure) at 45mmHg; very tight intrastent stenosis of the common trunk and the right coronary artery; Multiple organ failure; mixed shock (cardiogenic and vasoplegic); mixed shock (cardiogenic and vasoplegic); Haemopericardium; Tamponade cardiac; This is a spontaneous report from a contactable physician downloaded from a regulatory authority- WEB FR-AFSSAPS-AM20210929, Safety Report Unique Identifier FR-AFSSAPS-2021037085, received from the regulatory authority. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in the left deltoid on 24Mar2021 (Lot Number: ER9470) as single dose for covid-19 vaccination; warfarin sodium (COUMADINE), oral from an unspecified date to 29Mar2021, at 2 mg, daily for atrial fibrillation; acetylsalicylate lysine (KARDEGIC), oral from 2020 to 29Mar2021, at 75 mg, daily for anti atherothrombosis prevention; and ticagrelor (BRILIQUE), oral from 2020 to 29Mar2021, at 90 mg, daily for anti atherothrombosis prevention. Medical history included heavy cardiovascular history: ischemic heart disease since 2018 and ongoing, acute coronary syndrome from 2020 requiring the placement of active stents (circumflex artery, common trunk and proximal left anterior descending artery), atrioventricular block complete with permanent cardiac pacemaker, chronic unstable angina from 2017. This patient also has atrial fibrillation, Ketosis-prone diabetes mellitus, arterial hypertension, dyslipidemia, hypothyroidism from 2018, end-stage renal disease (ESRD) on dialysis 3 times a week. Concomitant medications included bisoprolol fumarate (BISOCE); pantoprazole sodium sesquihydrate (EUPANTOL); and lercanidipine hydrochloride (LERCAN). The patient experienced haemopericardium and tamponade cardiac; both on 29Mar2021, fatal events. On 24Mar2021, patient was vaccinated by COMIRNATY. On 29Mar2021, significant chest pain, motivating his hospitalization. LVEF (Left ventricular ejection fraction) at 35-40%, apical hypokinesia, restrictive grade 2 mitral insufficiency, PAPS (systolic pulmonary artery pressure) at 45mmHg. The coronary angiography reveals a very tight intrastent stenosis of the common trunk and the right coronary artery. Surgical management for triple coronary artery bypass grafting. INR = 2.75. Prior antagonization with PPSB (Prothrombin-Proconvertin-Stuart factor B), vitamin K, red blood cells. Post-surgical complication by a compressive hemopericardium associated with hemodynamic degradation. Multiple organ failure table. Resumption in the operating room in emergency but state of mixed shock (cardiogenic and vasoplegic) requiring the administration of a high dose of catecholamines. Despite intensive resuscitation, the condition did not improve and patient died on 01Apr2021. It was not reported if an autopsy was performed. The action taken in response to the events for warfarin sodium, acetylsalicylate lysine, and for ticagrelor was reported as permanently withdrawn on 29Mar2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hemopericardium; tamponade cardiac; stenosis of the common trunk and the right coronary artery; PAPS (systolic pulmonary artery pressure) at 45mmHg; grade 2 mitral insufficiency; apical hypokinesia; mixed shock (cardiogenic and vasoplegic); mixed sho


VAERS ID: 1265029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-16
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, 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: 2021-04-02
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dementia; Meningioma surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021447014

Write-up: Vaccination failure/Patient PCR + (positive) COVID on 16Mar2021, 39 days after the second dose; Patient PCR + (positive) COVID on 16Mar2021, 39 days after the second dose; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BX20213213. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 05Feb2021 (lot number: EJ6788) as single dose, and dose 1 intramuscular, administered in right arm on 16Jan2021 (lot number: EJ6795) as single dose for COVID-19 immunisation. Medical history included dementia, meningioma surgery, arterial hypertension; all from an unknown date and unknown if ongoing, and ongoing residing in nursing homes. The patient''s concomitant medications were not reported. The patient experienced vaccination failure/patient PCR + (positive) COVID on 16Mar2021, 39 days after the second dose. Lung deterioration 3 days later, implementation of comfort care in agreement with the family, death on 02Apr2021. No information on the variant. The patient underwent COVID-19 PCR test: positive on 16Mar2021. The patient died on 02Apr2021 due to COVID-19 infection. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infection COVID


VAERS ID: 1265030 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of lung (treatment in progress, if any, not specified); Non-insulin-dependent diabetes mellitus (treatment in progress, if any, not specified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021446917

Write-up: Lung infection; Decreased appetite; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213276 with safety report unique identifier FR-AFSSAPS-2021039850. A 71-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number EP2166), intramuscularly administered in the left arm on 26Feb2021 at a single dose for covid-19 immunization. Medical history included non-insulin-dependent diabetes mellitus and, cancer of lung - "treatment in progress, if any, not specified". The patient has not had covid-19. The patient''s concomitant medications were not reported. The patient experienced decreased appetite on 27Feb2021 with outcome of not recovered. At 1 month of vaccination, on 26Mar2021, the patient had lung infection with aggravation and hospitalization for 15 days (from an unspecified date in 2021 to an unspecified date in 2021) - the outcome was fatal. It was also reported "death of the patient - cause unknown" (pending clarification). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The patient has not been tested for covid-19 since the vaccination. Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures.; Reported Cause(s) of Death: lung infection


VAERS ID: 1265031 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-04-14
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Haemoglobin, Heart rate, Oxygen saturation
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: 2021-04-14
   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: FUROSEMIDE; ALPRAZOLAM; TARDYFERON; HALOPERIDOL; THERALENE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cognitive disorders (unlabeled cognitive disorders (shouting, slapping, insulting)); Iron deficiency anemia (hemoglobin at 8.4g / dL on 03Mar2021 and 7.3 g / dL on 12Feb2021 - N = 12-16 g / dL)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:6/3; Test Name: blood pressure; Result Unstructured Data: Test Result:115/60 mmHg; Comments: Post vaccination constants at 9:58 am; Test Name: blood pressure; Result Unstructured Data: Test Result:80/60 mmHg; Test Date: 20210212; Test Name: hemoglobin; Result Unstructured Data: Test Result:7.3 g/dl; Test Date: 20210303; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.4 g/dl; Test Name: pulse; Result Unstructured Data: Test Result:76 bpm; Comments: Post vaccination constants at 9:58 am; Test Name: Oxygen saturation; Test Result: 95 %; Comments: Post vaccination constants at 9:58 am
CDC Split Type: FRPFIZER INC2021446992

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority-WEB, regulatory authority FR-AFSSAPS-CN20211258, Safety Report Unique Identifier FR-AFSSAPS-2021038541. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 14Mar2021 09:49 (Batch/Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included arterial hypertension, iron deficiency anemia (hemoglobin at 8.4g / dL on 03Mar2021 and 7.3 g / dL on 12Feb2021 - N = 12-16 g / dL) and unlabeled cognitive disorders (shouting, slapping, insulting). The patient has no history of COVID-19 and PCR test history. Concomitant medications included furosemide, alprazolam, ferrous sulfate (TARDYFERON), haloperidol and alimemazine tartrate (THERALENE). The patient experienced cardio-respiratory arrest on 14Apr2021. The patient was vaccinated at 9:49 AM in the presence of her daughter. Post vaccination constants at 9:58 am: BP 115/60 mmHg, Pulse 76 bpm and Sat O2 at 95%. She then stayed in bed to rest until the caregiver arrived for toilet assistance. Usual behavior at the start of treatment: the patient screams and slaps. During the nursing treatment at 10:45 AM, the patient became unwell including loss of consciousness, cyanosis and mottling, the caregiver put the patient back to bed and called the nurse (10:50 am). The vaccination team intervened immediately and carried out cardio-pulmonary resuscitation: O2 15l.mn in a high concentration mask, BP 6/3, impregnable pulse and saturation, raised legs, no trace on the ECG. After a few minutes, BP at 80/60 mmHg dextro 1.28 with injection of 2 pens of adrenaline 300 in s / c. Put patch for shock to the defibrillator; shock was not advised by the PLC; new injection of 0.3mg of adrenaline. Upon arrival of firefighters, cardiac massage and BAVU performed. On SMUR (The Mobile Emergency and Resuscitation Service) arrival, cardiopulmonary resuscitation, IV line installation, and administration of adrenaline done; ineffective resuscitation noted, reaction stop and O2 installation at 15l.mn while waiting for the family. In total, there was a cardiopulmonary arrest on the day of the vaccination, resulting in the death of the patient. The patient died around 13:05. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1265032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-30
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Deep vein thrombosis; Dependence on ventilator (Dependence on non-invasive nocturnal ventilation); Diabetes; Hypertensive heart disease; Ischaemic heart disease; Peripheral arteritis
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: nasopharyngeal PCR screening of SARS CoV2; Test Result: Positive ; Comments: 20l / 501Y.V1
CDC Split Type: FRPFIZER INC2021446970

Write-up: myocardial suffering/cardiac decompensation; Vaccination failure/ bronchopneumonia/ PCR which was carried out on 31Mar2021 with a positive result; COVID-19 confirmed by positive COVID-19 test/ bronchopneumonia; This is a spontaneous report received from a contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-DJ20210848, Safety report unique identifier FR-AFSSAPS-2021035663. A 92-year-old male patient received BNT162B2 (COMIRNATY), first dose intramuscular on 12Jan2021 as a single dose, then second dose intramuscular on 02Feb2021 as a single dose for COVID-19 vaccination. Medical history included AFib/ complete arrhythmia by atrial fibrillation, Hypertensive heart disease, Peripheral arteritis/arteritis of the lower limbs, COPD (chronic obstructive pulmonary disease), Diabetes, Deep vein thrombosis, Ischaemic heart diseasea and Dependence on ventilator/ Dependence on non-invasive nocturnal ventilation. The patient is residing in a residential establishment for dependent elderly people. The patient presented the first symptoms of bronchopneumonia on 30Mar2021. The attending physician examined him on 30Mar2021 and recommended a PCR which was carried out on 31Mar2021 with a positive result at the end of the day. The patient was asthenic, dyspneic and fluctuating oxygen-dependent. The patient has COVID-19 confirmed by positive COVID-19 test. He was transferred to a hospital but died on 04Apr2021 in a context of myocardial suffering linked to the COVID infection which led to cardiac decompensation. His condition deteriorated despite treatment with oxygen therapy at 3L/min, amoxicillin, clavulanic acid (AUGMENTIN) and prednisone (CORTANCY) at 40 mg/day and aerosols. The receipt of the nasopharyngeal PCR screening of SARS CoV2: English variant 20l / 501Y.V1 on 31Mar2021. In total: vaccine failure with COVID infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure/ bronchopneumonia/ PCR which was carried out on 31Mar2021 with a positive result; COVID-19 confirmed by positive COVID-19 test/ bronchopneumonia; myocardial suffering/cardiac decompensation


VAERS ID: 1265033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: FRPFIZER INC2021453387

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer (patient''s daughter) from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-DJ20210927. An 80 years old female patient received the second dose of (COMIRNATY, Lot/batch no. EJ6789) intramuscularly at single dose for COVID-19 immunisation on 23Feb2021. Relevant history and concomitant drug was unknown. COVID-19 disease history: NO. Relevant history and concomitant drugs were unknown. The patient''s daughter reported the occurrence of her mother''s death on 28Feb2021. She explained, "This is not really a side effect but rather a fact. Mom died 5 days after the second dose of the vaccine. Apparently the cause of death is cardiac arrest." No autopsy was performed. The death certificate mentioned a death at home. Comments: In total, death of a patient at D + 5 of the injection of a second dose of the COMIRNATY vaccine. No other additional information in the declaration (history, tolerance of the vaccine, context of death). request for additional information made to the reporter but no response to date. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1265034 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Coma scale abnormal, Disturbance in attention, Hemiplegia, International normalised ratio, Magnetic resonance imaging head, Mydriasis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: DIGOXIN; BISOPROLOL; ATORVASTATIN; ESOMEPRAZOLE; DITROPAN; DICETEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Atrial fibrillation; Bowel obstruction; Cataract; Gastroesophageal reflux disease; Hysterectomy; Lumbar pain (Narrow lumbar canal operated in 2015 with chronic pain); Ovariectomy; Rectal prolapse; Surgery (Narrow lumbar canal operated in 2015); Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Name: INR; Result Unstructured Data: Test Result:3.77; Test Name: INR; Result Unstructured Data: Test Result:1.48; Test Name: Brain MRI; Result Unstructured Data: Test Result:large right hemispherical intraparenchymal hemato; Comments: large right hemispherical intraparenchymal hematoma with ventricular flooding
CDC Split Type: FRPFIZER INC2021446963

Write-up: glasgow 4 coma; onset of sudden left hemiplegia; disturbances in vigilance; areactive right mydriasis; Haematoma cerebral; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-GR20211253, Safety Report Unique Identifier FR-AFSSAPS-2021039228. An 80-year-old female patient received the second dose of bnt162b2 (COMIRNATY; Lot Number: EP2166), intramuscular on 29Mar2021 at 30 ug, single for covid-19 immunization and fluindione (PREVISCAN [FLUINDIONE]), oral from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 20 mg: alternating 1/4 tablet and 1/2 tablet every other day for atrial fibrillation. Medical history included complete arrhythmia due to atrial fibrillation; concept of stroke /transient ischemic attack without further precision, gastroesophageal reflux disease, narrow lumbar canal operated in 2015 with chronic pain, bowel obstruction, appendectomy, hysterectomy, ovariectomy, rectal prolapse and cataract. Concomitant medications included digoxin (DIGOXIN); bisoprolol (BISOPROLOL); atorvastatin (ATORVASTATIN); esomeprazole (ESOMEPRAZOLE); oxybutynin hydrochloride (DITROPAN) and pinaverium bromide (DICETEL); all taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine Comirnaty (lot number: UNKNOWN) on 03Mar2021 at single dose for COVID-19 immunization. On 06Apr2021, onset of sudden left hemiplegia with deviation to the right of the head and eyes and disturbances in vigilance; HT surge with PAS$g 200 mmHg casued hospitalization. Unfavorable neurological evolution with persistence of vigilance disorder, glasgow 4 coma then areactive right mydriasis. Overall, the patient presented with an intracerebral hematoma on 06Apr2021. The patient underwent lab tests and procedures which included international normalised ratio: 3.77 on an unspecified date, international normalised ratio: 1.48 on an unspecified date and magnetic resonance imaging brain: large right hemispherical intraparenchymal hematoma with ventricular flooding. The patient died on 09Apr2021. An autopsy was not performed. No follow-up attempts are possible. Information about lot/batch number of 1st dose cannot be obtained.; Reported Cause(s) of Death: neurological sequelae following an intracerebral hematoma


VAERS ID: 1265035 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary stent user; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021453650

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-MA20211367 Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021040308. A 64-years-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular in the left arm on 09Apr2021 (Batch/Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included Cardiovascular (IAS), stented ischemic heart disease, patient at risk of developing severe form of COVID disease, no history of COVID disease. The patient''s concomitant medications were not reported. The patient died on 10Apr2021. An autopsy was not performed. No follow-up attempts are possible.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1265037 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-15
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood osmolarity, Blood pressure measurement, Blood sodium, Blood sodium increased, Blood urea, Body temperature, Brain natriuretic peptide, C-reactive protein, COVID-19, COVID-19 pneumonia, Dehydration, Disorientation, Fibrin D dimer, Heart rate, Imaging procedure, Investigation, Neutrophil count, Oxygen saturation, Platelet count, Renal function test, SARS-CoV-2 test, Superinfection, Troponin, Vaccination failure, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 20
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: Bronchopulmonary disease; Calculus biliary; Follicular B-cell non-Hodgkin''s lymphoma; Macular degeneration; Prostate adenoma; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: serum creatinine; Result Unstructured Data: Test Result:137 umol/l; Test Date: 20210329; Test Name: osmolarity; Result Unstructured Data: Test Result:338 mosm/L; Test Date: 20210329; Test Name: blood pressure; Result Unstructured Data: Test Result:152/75 mmHg; Test Date: 20210329; Test Name: Na; Result Unstructured Data: Test Result:153 mmol/L; Test Date: 20210329; Test Name: urea; Result Unstructured Data: Test Result:14.7 mmol/L; Test Date: 20210329; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210329; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:34 pg/mL; Test Date: 20210329; Test Name: crp; Result Unstructured Data: Test Result:237 mg/l; Test Date: 20210329; Test Name: ddimer; Result Unstructured Data: Test Result:1300; Test Date: 20210329; Test Name: heart rate; Result Unstructured Data: Test Result:65; Comments: FC: 65 bpm; Test Date: 20210329; Test Name: Imaging; Result Unstructured Data: Test Result:Covid19; Comments: Covid19 type pneumonia with severe involvement (50/70%); Test Date: 20210329; Test Name: BU: Leuco / Nitrites / Blood; Result Unstructured Data: Test Result:- / - / traces; Comments: details: pro +; Test Date: 20210329; Test Name: gb; Result Unstructured Data: Test Result:15000; Comments: without lymphopenia; Test Date: 20210329; Test Name: GC; Result Unstructured Data: Test Result:1.06 g/l; Test Date: 20210329; Test Name: ScGw; Result Unstructured Data: Test Result:15 = Y4 / V5 / M6; Test Date: 20210329; Test Name: PNN; Result Unstructured Data: Test Result:83.7 g/l; Test Date: 20210329; Test Name: O2 saturation; Result Unstructured Data: Test Result:92%; Test Date: 20210329; Test Name: platelet; Result Unstructured Data: Test Result:191 x10 9/l; Test Date: 20210329; Test Name: ckd; Test Result: 40 mL; Test Date: 20210315; Test Name: PCR COVID; Test Result: Positive ; Test Date: 20210329; Test Name: troponin; Result Unstructured Data: Test Result:73; Test Date: 20210329; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:15 g/l
CDC Split Type: FRPFIZER INC2021431434

Write-up: Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); COVID-19 complicated by superinfection; severe dehydration; disoriented; Na: 153 mmol/l; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NC20211590. This healthcare professional reported similar events for two patients. This is the first of two reports. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Batch/Lot Number: EJ6788/EJ6788) as single dose; and dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included prostate adenoma, macular degeneration, renal failure, biliary lithiasis, follicular B lymphoma in remission and post-chemotherapy pulmonary disease from 2014. The patient''s concomitant medications were not reported. The GIR2 patient residing in nursing house was vaccinated with COMIRNATY carried out on 28Jan2021 (D1) and 16Feb2021 (D2). On 15Mar2021, the patient tested PCR + for SARSCov2; the patient also presented abnormal "facies". Stability at first then degradation with desaturation which motivated his hospitalization on 29Mar2021. On admission (29Mar2021), PAS/PAD: 152/75 mmHg, FC (heart rate): 65 bpm , SAT/O2: 92% /6 l/min, T: 36.2 degrees C, GC: 1.06 g/l, ScGw: 15 = Y4/V5/M6, BU: Leuco/Nitrites/Blood: -/-/traces, details: pro +. Clinically, patient was conscious but disoriented, under O2 mask 6 l/min, cough, crackling of the 2 fields, supple calves, no other sign of HF. Biology showed D dimer 1300, BNP 34 pg/ml, CKD 40ml, gb 15000 without lymphopenia, tropo 73, hyperleukocytosis at 15 G/l at PNN (83.7 G/l), platelet 191 G/l, CRP 237 mg/l, Na: 153 mmol/l, urea: 14.7 mmol/l, serum creatinine 137 umol/l and osmolality 338 mosm/l. Imaging showed Covid-19 type pneumonia with severe involvement (50/70%). Diagnosis of COVID-19 complicated by superinfection and context of severe dehydration. No variant analysis performed at the time of his hospitalization. However, for all positive patients who were tested for a variant, the variant was found. Patient was placed on corticosteroids, Lovenox and augmentin before hospitalization. Other treatments inlcuded tamsulosin and Seresta. Rapid deterioration in hospital with fatal outcome on 04Apr2021 in the evening. Conclusion: Vaccine ineffectiveness with fatal outcome. The outcome of the events was unknown. The patient died on 04Apr2021 due to vaccination failure, COVID-19 and COVID-19 pneumonia. It was unknown if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures " No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021431443 same reporter/drug, similar events, diferent patients; Reported Cause(s) of Death: Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination failure/tested PCR + for SARSC


VAERS ID: 1265038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Computerised tomogram, General physical health deterioration, Loss of consciousness, Malaise, SARS-CoV-2 test, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Atrial fibrillation; Chronic haemodialysis; Ischaemic heart disease; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell lymphoma (large cell B lymphoma treated in 2006 in remission); Factor V Leiden carrier
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: CT scan; Result Unstructured Data: Test Result:minimal to moderate impairment.; Test Date: 20210302; Test Name: PCR Covid; Test Result: Positive ; Test Date: 20210303; Test Name: PCR Covid; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021447087

Write-up: Vaccination failure; Positive COVID test/COVID-19 pneumonia/COVID pneumonitis (variant); general condition deteriorated with malaise; general condition deteriorated with malaise; loss of consciousness; This is a spontaneous report received from a contactable pharmacist downloaded from the Medicine Agency (MA) Database-WEB. Regulatory authority report number is FR-AFSSAPS-NY20210769. A 75-year-old male patient received BNT162B2 (COMIRNATY), first dose on 26Jan2021 (Lot Number: EJ6788, unknown expiration) and second dose on 16Feb2021 (Lot Number: EJ6789, unknown expiration), both via intramuscular as a single dose for COVID-19 immunisation. Medical history included ongoing Type II diabetes mellitus, ongoing ischaemic heart disease, chronic haemodialysis since 2012, Factor V Leiden carrier, large cell B lymphoma treated in 2006 in remission, ongoing atrial fibrillation, and ongoing arterial hypertension. The patient''s concomitant medications were not reported. On 02Mar2021, the patient''s general condition deteriorated with malaise and loss of consciousness. Positive COVID test. Possible intrafamilial contamination. The patient experienced vaccination failure. The patient was hospitalized. On 03Mar2021, after intra-familial probable contamination, he developed COVID-19 pneumonia/COVID pneumonitis (South African variant); confirmation of the positive COVID test, variant V2 (South African), and died a few days later. CT scan showed minimal to moderate impairment. Management with oxygen therapy and dexamethasone 6 mg/d, antibiotic therapy and continued anticoagulant treatment with COUMADINE. Due to hydrosodic overload, a regular decrease of his dry weight in dialysis was necessary. Unfavorable evolution with respiratory deterioration requiring a high concentration mask that the patient regularly removed. Refusal of care. Decision of comfort care. Outcome of general condition deteriorated with malaise and loss of consciousness were unknown. The patient died on 18Mar2021 due to vaccination failure and positive COVID test/COVID-19 pneumonia/COVID pneumonitis (South African variant). It was unknown if an autopsy was performed. Reporter''s comment: Deadline of 15 days after vaccination. No information on the exact date of onset of the deterioration in general condition. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Positive COVID test/COVID-19 pneumonia/COVID pneumonitis (South African variant); Vaccination failure


VAERS ID: 1265040 (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: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Chest pain, Dyspnoea, Electrocardiogram, Full blood count, Laboratory test, Pulmonary embolism, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: APIXABAN; EPLERENONE; IRBESARTAN; LERCANIDIPINE; FLUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Hypertrophic cardiomyopathy (for at least 7 years which was well controlled); Sleep apnoea syndrome; Struma nodosa
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: blood electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20200720; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm and a 1st degree AVB; Comments: regular sinus rhythm and a 1st degree AVB; Test Date: 20210305; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210305; Test Name: biological assessment; Result Unstructured Data: Test Result:normal: Complete blood count, blood electrolyte; Comments: normal: Complete blood count, blood electrolytes, no renal failure
CDC Split Type: FRPFIZER INC2021447019

Write-up: Suspicion of infection with COVID-19; shortness of breath, dyspnea; chest pain; Suspicion of pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211802, Safety Report Unique Identifier FR-AFSSAPS-2021039411. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EW2239), intramuscularly (IM), administered in the right arm on 03Apr2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included struma nodosa, atrial fibrillation paroxysmal, hypertrophic cardiomyopathy (for at least 7 years which was well controlled), and sleep apnoea syndrome. Concomitant medications included apixaban, eplerenone, irbesartan, lercanidipine, and fluvastatin; all taken for unspecified indications, start and stop dates were not reported. The patient has not had COVID-19 and has not been tested. He has had a history of hypertrophic cardiomyopathy for at least 7 years which was well controlled and paroxysmal atrial fibrillation. The last cardiological assessment dated from 20Jul2020 with an ECG showing a regular sinus rhythm and a 1st degree AV block. The last biological assessment of 03Mar2021 was normal: Complete blood count, blood electrolytes, no renal failure. On 03Apr2021, the patient had the injection of the first dose of COMIRNATY vaccine lot EW2239 IM in the right arm. On 04Apr2021, at the start of the night, the patient presented with shortness of breath, dyspnea and chest pain. The ED was called. 05Apr2021 at 1 am, the patient''s death was noted. The suspicion of pulmonary embolism was raised. On 06Apr2021, the patient''s wife and several family members have tested positive for COVID-19. The patient himself was not tested and did not have symptoms suggestive of COVID-19. However, according to those around him, the patient was unusually tired a few days before receiving the vaccine injection. Request for additional information was made (as reported). The outcome of shortness of breath, dyspnea and chest pain was unknown. The patient died on 05Apr2021 due to suspicion of pulmonary embolism and suspicion of infection with COVID-19. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspicion of pulmonary embolism; Suspicion of infection with COVID-19


VAERS ID: 1265041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Blood pressure measurement, Death, Discomfort, Malaise, Oxygen saturation, Vaccination site pain
SMQs:

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Depressive disorder; Stroke; Urothelial carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: rapid post-mortem antigenic test; Result Unstructured Data: Test Result:negative; Test Date: 20210401; Test Name: BP; Result Unstructured Data: Test Result:18; Test Date: 20210402; Test Name: BP; Result Unstructured Data: Test Result:15; Test Date: 20210401; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021446929

Write-up: Death NOS/recognition of the patient''s death; not feeling "very well"; general discomfort; pain in the arm around the injection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-RE20211000, Safety Report Unique Identifier FR-AFSSAPS-2021035193. A 96-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: ET7205 and expiration date not provided), intramuscular, administered in Arm Left first dose on 01Apr2021 16:30 at single dose for covid-19 immunisation. The patient''s medical history included Depressive disorder, Urothelial carcinoma, COVID-19 in Nov2020, Arterial hypertension, and Stroke in 2018. The patient''s concomitant medications were not reported. On 01Apr2021, the patient received the vaccine and no reaction noted immediately after injection. Around 7PM the patient complains of general discomfort with pain in the arm around the injection. BP measurement at 18, normal oxygen saturation. Prescription of paracetamol (unknown laboratory) 1 g. On 02Apr2021 around 4AM, patient not feeling "very well" and blood pressure at 15. At 6AM, recognition of the patient''s death/ death NOS. Performed a rapid post-mortem antigenic test: negative. The patient died on 02Apr2021. It was not reported if an autopsy was performed. The outcome of the event death was fatal and unknown for the remaining events. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: Death NOS/recognition of the patient''s death


VAERS ID: 1265043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-09
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bacterial sepsis, Bacterial test positive, Blood creatinine, Blood culture, C-reactive protein, Cell death, Computerised tomogram, Culture urine, Death, Hyperleukocytosis, Inflammation, Pulmonary arterial hypertension, Pyelonephritis, Troponin, White blood cell count
SMQs:, Malignancy related conditions (narrow), Pulmonary hypertension (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:1607 IU/l; Test Name: AST; Result Unstructured Data: Test Result:3664 IU/l; Test Name: blood creatinine; Result Unstructured Data: Test Result:114 umol/l; Test Date: 20210309; Test Name: blood culture; Result Unstructured Data: Test Result:gram + cocci; Test Name: thoraco-abdomino-pelvic and skull CT scan; Result Unstructured Data: Test Result:no suspicious lesion; Comments: Heterogeneous enhancement of the right liver, more hypodense without individualizable mass; Test Name: c-reactive protein; Result Unstructured Data: Test Result:$g 100 mg; Test Date: 20210309; Test Name: c-reactive protein; Test Result: 160 mg; Test Date: 20210309; Test Name: urine culture; Result Unstructured Data: Test Result:E.coli in urine; Test Name: troponin; Result Unstructured Data: Test Result:10490 ng/L; Test Name: white blood cell count; Result Unstructured Data: Test Result:Hyperleukocytosis 18000 /mm3; Test Date: 20210309; Test Name: white blood cell count; Result Unstructured Data: Test Result:Hyperleukocytosis at 19,000 /mm3
CDC Split Type: FRPFIZER INC2021447046

Write-up: major inflammatory syndrome; suspicion of pyelonephritis; Hyperleukocytosis; severe cytolysis; chronic pulmonary arterial hypertension; Death unexplained; septic process by gram + cocci on blood cultures; E.coli in urine; This is as spontaneous report received from a contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-RN20211082, Safety report unique identifier FR-AFSSAPS-2021038794. An 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Batch/Lot Number: EJ6788) as a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY, first dose, lot number: EM0477, on 13Jan2021 for COVID-19 immunisation. The patient experienced death unexplained on 10Mar2021. The patient died on 10Mar2021, unexplained death. Further ADR description stated that the patient was hospitalized on 07Mar2021 for major inflammatory syndrome on suspicion of pyelonephritis. Biology report included: Hyperleukocytosis 18000/mm3, C-reactive protein (CRP)$g 100 mg/L, severe cytolysis (ALT at 1607 IU/L, AST=3664IU/L, Troponin$g 10490ng/L on probable sepsis, blood creatinine at 114umol/L..). On 09Mar2021, Hyperleukocytosis at 19,000/mm3, CRP at 160 mg/L, decrease in cytolysis and therefore septic process by gram + cocci on blood cultures and E.coli in urine treated with Tazocillin and Daptomycin. Performing a thoraco-abdomino-pelvic and skull CT scan: no suspicious lesion. Heterogeneous enhancement of the right liver, more hypodense without individualizable mass. Predominant global cardiomegaly in the right cavities and dilation of the trunk of the portal aorta to 38mm: hypothesis of chronic pulmonary arterial hypertension. It was not reported if an autopsy was performed. The outcome of death unexplained was fatal while unknown for other events. No follow-up attempts are possible. No further information is expected. Information on lot number obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1265051 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, B-cell lymphoma, Body temperature, Chills, Haemophagocytic lymphohistiocytosis, Influenza, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary disease
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 test nasal swab; Test Result: Negative ; Test Date: 20210219; Test Name: temperature; Result Unstructured Data: Test Result:39
CDC Split Type: FRPFIZER INC2021453304

Write-up: macrophage activation syndrome linked to B lymphoma possibly activated; macrophage activation syndrome linked to B lymphoma possibly activated; fever at 39; chills; adenopathy; asthenia; flu syndrome; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority, sender''s case report number FR-COVAES-6b696838-e86e-48ae-86bf-8f9cf4a27df3. A 76-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coronary disease and arterial hypertension. The patient''s concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. The patient experienced fever at 39, chills, lymphadenopathy, asthenia, flu syndrome. Death due to macrophage activation syndrome linked to B lymphoma possibly activated / accelerated by the vaccine. The events onset on 19Feb2021 and resulted in doctor or other healthcare professional office / clinic visit and emergency room / department or urgent care. Patient received treatment for the events included paracetamol. COVID-19 test nasal swab on 11Mar2021 was negative. The patient died on 09Apr2021. An autopsy was not performed. This case was reported as serious with seriousness criteria: death, Hospitalized for 10 days and Life-threatening. Outcome of the events was fatal. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: fever at 39; chills; lymphadenopathy; asthenia; flu syndrome; macrophage activation syndrome linked to B lymphoma possibly activated; macrophage activation syndrome linked to B lymphoma possibly activated


VAERS ID: 1265495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Angina pectoris; Dementia (in Alzheimer''s disease); Depressive episode; Gastritis; Hypertension; IHD; Transient cerebral ischaemia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:not tested positive since having the vaccine; Test Date: 20201127; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021449708

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104211121410910-NY1ZZ, Safety Report Unique Identifier GB-MHRA-ADR 25173874. A 91-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER1741) on 28Mar2021 at single dose for COVID-19 immunisation. Medical history included transient cerebral ischaemia from 24Feb2021, moderate depressive episode from 24Feb2021, hypertension, gastritis from 24Feb2021, dementia from 24Feb2021 (dementia in Alzheimer''s disease), Alzheimer from 24Feb2021, ischemic heart disease (IHD), angina from 24Feb2021. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously took CALCI-D 1000mg/1000 units chewable tablets one daily from 19Jan2021, memantine 20mg tablets one daily from 19Jan2021, lansoprazole 30mg gastro-resistant capsules one once daily from 19Jan2021, folic acid 5mg tablets one daily from 19Jan2021 and from 27Jan2021 400microgram tablets one daily, clopidogrel 75mg tablets one once daily from 19Jan2021, atorvastatin 20mg tablets one daily from 19Jan2021, nitrofurantoin 100mg modified-release capsules one twice daily for three days for UTI in females from 12Feb2021 to 15Feb2021, mirtazapine 45mg tablets one tablet at night from 19Jan2021. The patient experienced death on 30Mar2021. It was reported that the patient was found deceased. She had second BNT162b2 vaccine two days before which could be coincidence. The report was not related to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Nov2020 and not tested positive for COVID-19 since having the vaccine. The patient died on 30Mar2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1265500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-04-12
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Anticoagulation drug level below therapeutic, Atrial fibrillation, Autoscopy, Cerebral infarction, Cerebral thrombosis, Cerebrovascular accident, Cognitive disorder, Computerised tomogram head, Confusional state, Delirium, Haemorrhage, Headache, Hemiparesis, Inappropriate schedule of product administration, International normalised ratio, Investigation, Off label use, Oxygen saturation, Oxygen saturation decreased, Pain, Platelet count, Platelet count decreased, Prothrombin time, Pulmonary haemorrhage, Pulmonary oedema, Renal impairment, SARS-CoV-2 test, Somnolence, Thrombocytopenia, Transient ischaemic attack, Vertebral artery stenosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (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 (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; CEPHALEXIN [CEFALEXIN]; VITAMIN E [VITAMIN E NOS]; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Atrial fibrillation; Catheter placement; Hemiparesis; Non-smoker; Platelet count decreased (platelet count (usual normal range 150-450) as 131); Renal embolism; Renal impairment; Renal infarction; UTI; Comments: Self catheterises. UTIs. Atrial fibrillation Renal infarction (embolic) 2016, anticoagulated since then. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: aPTT; Test Result: 24.7 s; Test Date: 20210412; Test Name: CTA; Result Unstructured Data: Test Result:some right vertebral artery stenoses; Comments: some right vertebral artery stenoses, but otherwise patent vessels; Test Date: 20210418; Test Name: CT head; Result Unstructured Data: Test Result:extensive clot in left MCA and established infarct; Comments: extensive clot in left MCA and established infarction; Test Date: 20210412; Test Name: INR; Result Unstructured Data: Test Result:subtherapeutic; Test Date: 20210414; Test Name: INR; Result Unstructured Data: Test Result:1.1; Test Date: 20210418; Test Name: Haemorrhage; Result Unstructured Data: Test Result:15.58; Comments: Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: bleeding from lungs.; Test Date: 20210418; Test Name: saturations; Result Unstructured Data: Test Result:dropping; Test Date: 20210412; Test Name: Platelets; Result Unstructured Data: Test Result:less than 150 a - 109/l; Test Date: 20210413; Test Name: Platelets; Result Unstructured Data: Test Result:low; Test Date: 20210414; Test Name: Platelets; Result Unstructured Data: Test Result:132; Test Date: 20190702; Test Name: Platelets; Result Unstructured Data: Test Result:131; Test Date: 20210417; Test Name: Platelets; Result Unstructured Data: Test Result:130; Test Name: PT; Result Unstructured Data: Test Result:11.3; Test Date: 20210417; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021454985

Write-up: pain; 7 seconds; renal impairment; bleeding; cognitive impairment; hemiparesis; atrial fibrillation; confusion; delirium; pulmonary oedema; Drowsy; Dose 1 on 21Jan2021/dose 2 on 21Mar2021; Dose 1 on 21Jan2021/dose 2 on 21Mar2021; extensive clot in left MCA and established infarction; extensive clot in left MCA and established infarction; lungs bleeding/ Frothy blood on suctioning; dropping saturations; headache; stroke/ mild right hand weakness and word-finding difficulties; Low platelets; Subtherapeutic INR; platelet count less than 150 A - 109/L; TIA/episode of transient visual loss (? hemianopia); right vertebral artery stenoses; This is a spontaneous report from a contactable physician by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104211738274670-CRIYX, Safety Report Unique Identifier GB-MHRA-ADR 25176403. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: Not known) as single dose, dose 2 via an unspecified route of administration on 21Mar2021 (Batch/Lot Number: not known) as single dose for covid-19 immunisation; apixaban (APIXABAN), via unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication; Medical history included Atrial fibrillation; Renal impairment; Hemiparesis; Self catheterizes; UTIs; Renal infarction (embolic) from 2016 anticoagulated since then; platelet count (usual normal range 150-450) as 131 on 02Jul2019; currently was non-smoke. The patient did not have a history of, or concurrent, intracranial malignancy and did not have concurrent or recent intracranial infections. The patient hadn''t had recent surgical or medical interventions to the central nervous system (including lumbar puncture) and hadn''t had a recent trauma/head injury. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included bisoprolol (BISOPROLOL) taken for atrial fibrillation; cephalexin [cefalexin] (CEPHALEXIN [CEFALEXIN]) taken for catheter management; vitamin e nos (VITAMIN E [VITAMIN E NOS]); warfarin (WARFARIN). The patient previously took heparin. The patient experienced stroke/ mild right hand weakness and word-finding difficulties (death) on 17Apr2021, atrial fibrillation (death) on an unspecified date, confusion (death) on an unspecified date, delirium (death) on an unspecified date, pulmonary oedema (death) on an unspecified date, headache (death) on 17Apr2021, pain (death) on an unspecified date, 7 seconds (autoscopy) (death) on an unspecified date, renal impairment (death) on an unspecified date, bleeding (death) on an unspecified date, cognitive impairment (death) on an unspecified date, hemiparesis (death) on an unspecified date, subtherapeutic INR (death) on 12Apr2021, low platelets (non-serious) on 13Apr2021, platelet count less than 150 a - 109/l (Medically Significant) on 12Apr2021, TIA/episode of transient visual loss (? hemianopia) on 12Apr2021, right vertebral artery stenoses on 12Apr2021, Drowsy on an unspecified date, extensive clot in left MCA and established infarction on 18Apr2021, lungs bleeding/ Frothy blood on suctioning on 18Apr2021, dropping saturations on 18Apr2021. The patient underwent lab tests and procedures which included CT head: shows extensive clot in left MCA and established infarction on 18Apr2021; INR: 1.1 on 14Apr2021; INR: subtherapeutic on 12Apr2021; platelet count: 132 on 14Apr2021; platelet count: less than 150 a - 109/l on 12Apr2021; platelet count: low platelets on 13Apr2021; platelet count after vaccine (usual normal range 150-450) and measured as 130 on 17Apr2021; platelet count before vaccine measured (usual normal range 150-450) as 131 on 02Jul2019; vascular imaging (CTA): showed some right vertebral artery stenoses, but otherwise patent vessels on 12Apr2021; No Infectious screen (eg HIV, hepatitis C/B, herpes zoster/ CMV); PT was "11.3". Activated Partial Thromboplastin Clotting Time (aPTT) was "24.7 seconds"; Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: bleeding from lungs; dropping saturations on 18Apr2021; COVID-19 virus test: no - negative covid-19 test on 17Apr2021. Patient had not tested positive for COVID-19 since having the vaccine. The clinical course provided as follows: He had had a fatal stroke due to known atrial fibrillation. I''m doing the yellow card because it was so strange his INR suddenly going subtherapeutic after years of perfect control. Also platelets a bit low. I''ve discussed with the son who is happy for me to fill this in. Background of AF and renal impairment - hence was on warfarin. Had been 100% in target INR range of 2-3 since 2016. Son, who lives with him (and also wife, but she has cognitive impairment), are both confident he had not missed any doses of warfarin, had taken the recommended dosage, hadn''t started or stopped any other medications including vitamins and supplements, and had no dietary changes which may have caused his sub-therapeutic INR. Seen (by me) in clinic 14Apr2021 after episode of transient visual loss (? hemianopia) on 12Apr2021 - vascular imaging (CTA) at the time showed some right vertebral artery stenoses, but otherwise patent vessels. INR was 1.1. Platelets 132. New warfarin dosing instructions given the same day. Re-presented to ED 17Apr2021 morning: mild right hand weakness and word-finding difficulties, which were improving. NIHSS equal to 1, INR 1.1 again. Changed to apixaban, not for TPA in view of mild deficit. Discharged on apixaban. Re-presented later that day, diagnosed with confusion and delirium. Also headache. Further deterioration 18Apr2021 morning. CT head 18Apr2021 shows extensive clot in left MCA and established infarction. On assessment: Drowsy - localising to pain. Right hemiparesis. No reaction to painful stimuli on right, withdraws on left. No reaction to voice or visual threat. Bilaterally extensor plantars. End of life care initiated. The patient died on 21Apr2021. It was unknown if an autopsy was performed. The report relate to possible blood clots or low platelet counts. TIA then minor stroke then fatal stroke". This was diagnosed via Clinical (TIA and minor stroke) and CT (major stroke). The date of diagnosis First TIA was 12Apr2021, Major stroke was 17Apr2021. The platelet count was less than 150 A - 109/L on 12Apr2021. It was unknown of the D-dimer more than 4000 and if anti-PF4 antibodies were identified. The patient had had no any previous reactions to medications, especially heparin or anticoagulants. The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient didn''t have history of, or current, malignancy. The lowest platelet count after vaccine (usual normal range 150-450) and measured as 130 on 17Apr2021. The last platelet count before vaccine measured (usual normal range 150-450) as 131 on 02Jul2019. The patient was not reviewed by a haematologist. Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: Has now also developed bleeding from? pharynx, ? lungs, dropping saturations. Frothy blood on suctioning. No sign of pulmonary oedema, and this looks like blood. The last action taken in response to the events for apixaban was not applicable. The outcome of the event Low platelets was not recovered, of platelet count less than 150 A - 109/L, TIA/episode of transient visual loss (? hemianopia), right vertebral artery stenoses, Drowsy, extensive clot in left MCA and established infarction, lungs bleeding/ Frothy blood on suctioning, dropping saturations, Dose 1 on 21Jan2021/dose 2 on 21Mar2021 was unknown, of the other events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: stroke/ mild right hand weakness and word-finding difficulties; atrial fibrillation; confusion; delirium; pulmonary oedema; headache; pain; 7 seconds; renal impairment; bleeding; cognitive impairment; hemiparesis; Subtherapeutic INR


VAERS ID: 1265510 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Disease recurrence, Lethargy, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 28
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: ZOLOFT; NITRONG; EXELON PATCH 10; SALOSPIR; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lethargic (LETHARGIC EPISODES 2-3 DAYS DURATION); Pericarditis NOS (NO CARDIOLOGICAL PROBLEM DESPITE THE CONCOMITANT DRUGS ADMINISTRATION.); Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021453391

Write-up: Death; Pulmonary embolism; lethargic episode; lethargic episode; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-20212503. This is a report received. An 83-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included vascular dementia presented the last 7 years, pericarditis from 1999 (no cardiological problem despite the concomitant drugs administration), and lethargy (lethargic episodes 2-3 days duration, during these episodes seemed half asleep with the ability to recognise the familiars, she was under feeding support, after these episodes she was functional). Concomitant medications included sertraline hydrochloride (ZOLOFT) for depression, glyceryl trinitrate (NITRONG), rivastigmine (EXELON PATCH 10) for vascular dementia and Alzheimer''s disease, acetylsalicylic acid (SALOSPIR) for anticoagulant therapy, and furosemide (LASIX). The patient experienced pulmonary embolism on 13Mar2021, and death on 11Apr2021. 2 days since the vaccination, patient presented another lethargic episode on 15Mar2021. After 15 days she stopped feeding and called physician. On 02Apr2021 she was admitted to hospital. This case was reported as serious with seriousness criteria death, hospitalization, medically significant, and life threatening. The patient died on 11Apr2021. Outcome of event lethargic episode was unknown. 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: pulmonary embolism


VAERS ID: 1265519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-07
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Cardiopulmonary failure, Chest X-ray, Drug ineffective, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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: FRONTIN; MILURIT; EBRANTIL [URAPIDIL]; FENOSWISS; NORMODIPINE; ROSUVASTATIN; COVERCARD PLUS; ACETYLSALICYLIC ACID; NOOTROPIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery stenosis; Cholecystectomy; Diabetes; Diabetic nephropathy; Hypertension; Hypertensive encephalopathy; Ischemic heart disease; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral multifocal infiltration, congestion and; Comments: bilateral multifocal infiltration, congestion and cardiomegaly; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Test Result:94.8 mg/l; Test Date: 20210307; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021455369

Write-up: Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency due to COVID-19; This is a spontaneous report downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: HU-OGYI-201721). A contactable healthcare professional (contactable through Regulatory Authority only) reported that an 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EL0725; Expiration date was not reported), intramuscularly on the right arm on 17Feb2021 as a single dose for COVID-19 immunization. Medical history included hypertension, cholecystectomy, carotid artery stenosis, diabetic nephropathy, vertebrobasilar insufficiency, ischemic heart disease, hypertensive encephalopathy and diabetes; all were not ongoing. Concomitant medications included alprazolam (FRONTIN), allopurinol (MILURIT), urapidil (EBRANTIL), fenofibrate (FENOSWISS), amlodipine besilate (NORMODIPINE), rosuvastatin, amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS), acetylsalicylic acid and piracetam (NOOTROPIL). On 07Mar2021, the patient had tested positive to COVID-19 antigen test (symptoms described as dizzy, weak, and had headache and cough). The patient''s chest X-ray showed bilateral multifocal infiltration, congestion and cardiomegaly and C-reactive protein was 94.8 mg/l; both on 10Mar2021. On 22Mar2021, the patient had cardiorespiratory insufficiency. The patient had died on 22Mar2021, and the cause of death was cardiorespiratory insufficiency due to COVID-19. It was unknown if an autopsy was performed. The causal relationship between the reported death and Comirnaty was considered unlikely. Follow-up activities have been closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of Death: cardiorespiratory insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19


VAERS ID: 1265520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Cardiac failure, Chest X-ray, Haematoma
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cardiomyopathy; Cerebral circulatory disorder; COPD; Decubitus; Glaucoma; Hypertension; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Chest X-ray; Result Unstructured Data: Test Result:fluid, bronchovascular leasions; Comments: dilated, calcified aorta, globally dilated heart, slight increase in venous pressure in the pulmonary circulation
CDC Split Type: HUPFIZER INC2021455489

Write-up: haematoma on leg; symptoms of cardiac decompensation; Acute exacerbation of chronic bronchitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-206621. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Lot Number: Unknown) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, cardiomyopathy, appendectomy, vertebral circulatory disorder, COPD, glaucoma, decubitus, and the patient also have been in a wheelchair-user and on oxygen therapy for a while. Concomitant medications were not reported. The patient experienced acute exacerbation of chronic bronchitis on 24Mar2021, haematoma on leg on 22Mar2021, symptoms of cardiac decompensation on 22Mar2021 with fatal outcome. The patient died on 30Mar2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: On 22Mar2021, the patient was taken to the GP because of a painful lump on her left leg, which looked like a haematoma, the patient probably punched her leg into something. She was referred to a hospital due to the haematoma and incipient decompensation symptoms. In admission status, subcutaneous suffusions were seen throughout the body, massive edema on both legs, surgically treated leg ulcer, lip- and acrocyanosis, chest deformed due to emphysema kyphosis, hypersonic percussion sound, congestive rash, congestive and bronchial murmurs, enlarged heart, normotension, negative nervous system status, slightly aggressive behavior due to hypoxia. Acute exacerbation of chronic bronchitis, exacerbated by chronic decompensated cor pulmonale was found in the background of the patient''s complaints. On 24Mar2021, chest X-ray showed fluid, bronchovascular leasions; dilated, calcified aorta; globally dilated heart; slight increase in venous pressure in the pulmonary circulation. Parenteral steroids, expectorants, bronchodilators, diuretics, oxygen inhalation and LMWH prophylaxis were used as therapy. The patient''s condition stabilized and showed a slight improvement, however, on 29Mar2021, recurrent symptoms of acute exacerbation of chronic spastic bronchitis, respiratory failure occurred, increased doses of parenteral steroids, and broad-spectrum antibiotics were initiated. The patient''s condition did not improve for adequate treatment, on 30Mar2021, the patient died at 05:30 am due to respiratory and circulatory insufficiency. Sender''s Comment: The reported events are neither listed nor expected adverse event of Comirnaty. TTO was 5 days, and the 91-year-old patient died 13 days after vaccination due to respiratory and circulatory insufficiency. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: circulatory and respiratory insufficiency; circulatory and respiratory insufficiency


VAERS ID: 1265529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER6166 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021446854

Write-up: IUFD; This is a spontaneous report received from a contactable other HCP. This other hcp reported information for both mother and fetus/baby. This is a maternal report. A 21-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER6166) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced iufd (Foetal death in utero, death, hospitalization) on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Trimester pregnant at the onset of the event. The patient died on an unspecified date. It was not reported if an autopsy was performed. Time range was one week. The clinical course was reported as follows: A pregnant woman at week 39 went to the emergency room because her water broke, noted that she did not feel fetal movements from the night denying contractions or bleeding. The anatomical scans during pregnancy were normal. In the emergency room, a fetus was found without a pulse, a normal amount of amniotic fluid, an estimated weight of 2700 grams. Are interested in performing a genetic test. No follow-up attempts are possible. No further information 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 event cannot be totally 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: IUFD


VAERS ID: 1265699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Malaise, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Chronic ischemic heart disease, unspecified; Diabetic polyneuropathy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021453722

Write-up: Cardiorespiratory arrest (likely acute myocardial infarction); Cardiorespiratory arrest (likely acute myocardial infarction); General malaise; Fever; This is a spontaneous report downloaded from the regulatory authority-WEB (Regulatory Authority report number: IT-MINISAL02-717656). A contactable physician (contactable through Regulatory Authority only) reported that an 85-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EW2246; Expiration date was not reported) on 11Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included chronic ischemic heart disease, type 2 diabetes mellitus and diabetic polyneuropathy. The patient''s concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 12Apr2021, the patient had general malaise, fever and cardiorespiratory arrest (likely acute myocardial infarction). The patient had died on 12Apr2021. The reported causes of death were general malaise, fever and cardiorespiratory arrest (likely acute myocardial infarction). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiorespiratory arrest (likely acute myocardial infarction); cardiorespiratory arrest (likely acute myocardial infarction); General malaise; Fever


VAERS ID: 1265758 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardio-respiratory arrest
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021456519

Write-up: Cardiac failure; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 16Apr2021 at 14:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization at nursing home/senior living facility. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medications included unspecified prescribed drugs within two weeks of vaccination; all taken for an unspecified indication from an unspecified date to an unspecified date. On 17Apr2021 at 07:15, the patient experienced: cardio-respiratory arrest (death/ medically significant). On an unspecified date, the patient experienced: cardiac failure (death/ medically significant). The patient did not receive any treatment for the events (as reported). It was also reported: emergency room/department or urgent care was performed (as reported). The clinical outcome of the events was fatal. The patient died on 17Apr2021 due to cardio-respiratory arrest and cardiac failure. An autopsy was not performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender''s Comments: Limited information can not support a complete medical assessment. Based on temporal relationship, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of cardio-respiratory arrest and cardiac failure. Case will be re-assessed upon the additional information provided. 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: Cardiac failure; Cardio-respiratory arrest


VAERS ID: 1265759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-26
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021460815

Write-up: Death; cardio-respiratory arrest; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 40-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Apr2021, the patient experienced cardio-respiratory arrest (death, medically significant) and death (death, medically significant). The clinical course was reported as follows: in the morning of 26Apr2021, the patient was brought to the emergency room in cardio-respiratory arrest. An autopsy was performed (result was not provided). The cause of death was not provided. The reporting physician assessed the event as serious (death). The clinical outcome of the events was fatal. The patient died on 26Apr2021 due to an unknown cause of death (as reported) and cardio-respiratory arrest. An autopsy was performed, and results were not provided. The causality assessment from the reporting person was not reported. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender''s Comments: Lacking information surrounding on the details and cause of death, the case is managed as if there was a reasonable possibility that this patient''s death is related to administration of the suspect product. This case will be reassessed should additional information becomes available.; Reported Cause(s) of Death: cardio-respiratory arrest; Unknown cause of death


VAERS ID: 1265760 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Marasmus
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: LANDSEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021466157

Write-up: Geromarasmus; This is an initial spontaneous report from a contactable physician received from the ER9470. The regulatory authority report number is v21103555.?? A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 22Apr2021 at 15:00 (Lot Number: ER9480; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included epilepsy and bedridden. Concomitant medications included clonazepam (LANDSEN) taken for epilepsy. The patient experienced geromarasmus on 25Apr2021 at 14:37, which was reported as fatal. The patient underwent lab tests and procedures which included body temperature: 37.2 Centigrade on 22Apr2021 before vaccination. The patient died on 25Apr2021 at 14:37. The cause of death was reported as geromarasmus. It was not reported if an autopsy was performed. The reporting physician assessed that the event was unrelated to BNT162B2. Other possible causes of the event, such as any other diseases, was reported as geromarasmus.; Sender''s Comments: Based on available information the reported geromarasmus was unrelated to BNT162B2 . This was due to patient''s comorbidities. Case will be reassessed if additional information is received.; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1265767 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-12
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: LEVODOPA; PRAMIPEXOLE; PREGABALIN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021464383

Write-up: myocardial infarction; This is a spontaneous report from a contactable healthcare professional via Pfizer sales representative. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 unknown on 26Mar2021 (Batch/Lot Number: unknown) as single dose (at the age of 86 years old) for COVID-19 immunisation. Medical history included Parkinson from 2006. Concomitant medications included levodopa, pramipexole, pregabalin and paracetamol, all taken for an unspecified indication, start and stop date were not reported. The patient suffered a myocardial infarction. She died of a myocardial infarction on 12Apr2021. 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 reported myocardial infarction 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1265771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-28
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Chills, Headache, Malaise, Myalgia, Scan
SMQs:, Rhabdomyolysis/myopathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 25
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: MICARDIS; CLOPIDOGREL MYLAN; DOXAZOSINE SANDOZ; ATORVASTATIN; PANTOPRAZOL TEVA; NIFEDIPINE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: scans; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021430628

Write-up: Cold shivers; Headache; Muscle pain; Not feeling well; 3 cerebral strokes/ cerebral infarction; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB manufacturer report number NL-LRB-00460598, Safety Report Unique Identifier NL-LRB-00509669. An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ6789) via unspecified route single dose for COVID-19 immunization on 18Feb2021. Medical history included: ongoing hypertension. Concomitant medications included: telmisartan (MICARDIS 40mg tablet) from 2007, clopidogrel hydrochloride (CLOPIDOGREL MYLAN, film-coated tablet 75mg) from 2007, doxazosin mesilate (DOXAZOSINE SANDOZ, 8mg modified-release tablet 8mg) from 2007, atorvastatine (80mg film-coated tablet) from 2007, pantoprazole sodium sesquihydrate (PANTOPRAZOL TEVA, 20mg gastro-resistant tablet) from 2007, nifedipine (10mg modified-release tablet) from 2007. The patient had 3 cerebral strokes/ cerebral infarction (death), cold shivers/ chills (hospitalization), headache (hospitalization), myalgia (hospitalization), malaise (hospitalization); all was on 10 days after vaccination (28Feb2021). Cerebral infarction was treated with ascal. The patient was died on 26Mar2021 due to 3 cerebral strokes. It was unknown if the patient had autopsy done. The patient had not recovered from chills, headache, malaise and myalgia; outcome of the event cerebral infarction was fatal. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no 3 strokes Additional information ADR: First infarction 10 days after pfizer injection, then 2 more, resulting in death COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: scans No follow-up attempts possible. No further information expected; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no 3 strokes Additional information ADR: First infarction 10 days after pfizer injection, then 2 more, resulting in death COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: scans; Reported Cause(s) of Death: 3 cerebral strokes


VAERS ID: 1265796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021446890

Write-up: death: found dead at home 1 week after vaccination; Had contact with children 2 days before; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00511307. A 77-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced death: found dead at home 1 week after vaccination; had contact with children 2 days before. The patient died on 15Apr2021. Outcome of the event was fatal. It was not reported if an autopsy was performed (unknown). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death: found dead at home 1 week after vaccination; Had contact with children 2 days before


VAERS ID: 1265797 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-04-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021446899

Write-up: short of breath; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is NL-LRB-00512549. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot Number was not reported) as single dose for COVID-19 vaccination. Medical history included hypertension. The patient''s concomitant medications were not reported. The patient was seemed short of breath on 15Apr2021, 7 days after vaccination. The patient died on 17Apr2021 due to the event. It was not reported if an autopsy was performed. Reporter''s comments: Patient passed away unexpectedly on 17Apr2021. Additional information ADR: Found dead in backyard, supine, no suspicious circumstances (in consultation with forensic doctor and police). Small crack at the back of the head which has hardly bled, from this concluded that at the time of falling there was probably already a circulatory arrest. Patient had been seen 2 days before death by a neighbor, who thought he seemed somewhat short of breath, in telephone conversation 1 day before death this had not been noticed. Of course it is uncertain whether the vaccine is the cause of this. Confounding factors: Hypertension. Previous COVID-19 infection: No. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of reporter''s comment: Patient passed away unexpectedly on 17Apr2021. Found dead in backyard, supine, no suspicious circumstances (in consultation with forensic doctor and police). Small crack at the back of the head which has hardly bled, from this concluded that at the time of falling there was probably already a circulatory arrest. Patient had been seen 2 days before death by a neighbor, who thought he seemed somewhat short of breath.; Reported Cause(s) of Death: short of breath


VAERS ID: 1265798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Parkinson's disease
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINEMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021453678

Write-up: Parkinson''s disease; Death in a sleep; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB and received via Regulatory Authority NL-LRB-00513004. An 82-year-old female patient received bnt162b2 (COMIRNATY, Pfizer injection fluid), first dose via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunization. Medical history included Parkinson''s disease. Concomitant medication included carbidopa, levodopa (SINEMET, Modified-release tablet, 100/25mg) taken for an unspecified indication, start and stop date were not reported. The patient experienced death in a sleep on 08Feb2021. The patient underwent lab tests and procedures which included blood test: unknown results. The patient died on 08Feb2021 with natural cause from old age or Parkison''s disease. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain ; Reported Cause(s) of Death: Old age; Parkinson''s disease


VAERS ID: 1265799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Intestinal ischaemia, Multiple organ dysfunction syndrome, Renal infarct, Spleen disorder
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Ischaemic colitis (narrow), Renovascular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 15
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: 20210316; Test Name: CT scan abdomen; Result Unstructured Data: Test Result:Bilateral renal infarcts. Spleen infarcts. Picture; Comments: CT scan abdomen: Bilateral renal infarcts. Spleen infarcts. Picture of small bowel ileus, cave intestinal ischemia. No evidence of an aortic dissection. No evidence of a ruptured aneurysm. No pulmonary embolisms. Large diaphragmatic hernia.
CDC Split Type: NLPFIZER INC2021453676

Write-up: Renal infarction; Intestinal ischaemia; Spleen infarcts; Multi-organ failure; This is as spontaneous report received from a contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00513396. An 80-year-old female patient received bnt162b2 (COMIRNATY, Pfizer injection fluid), second dose via an unspecified route of administration on 15Mar2021 at 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient experienced renal infarction, intestinal ischaemia, spleen infarcts, all on 16Mar2021. The patient died on 17Mar2021 with cause of death multi-organ failure. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporter''s Comments: Intestinal ischemia. Additional information Adverse Drug Reaction: 1 day after the 2nd vaccination, the patient developed intestinal ischaemia in combination with spleen and kidney infarcts. The cause remained unknown, possibly due to low-flow state. There was no evidence of thromobosis. BSN available: yes. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: computerised tomogram (CT) scan of the abdomen: Bilateral renal infarcts. Spleen infarcts. Image of small intestine ileus, cave intestinal ischemia. No evidence of aortic dissection. No evidence of a ruptured aneurysm. No pulmonary embolisms. Large diaphragmatic hernia. Information on the batch number has been requested. ; Reporter''s Comments: Summary of Reporter Comment: Intestinal ischemia. Additional information Adverse Drug Reaction: 1 day after the 2nd vaccination, the patient developed intestinal ischaemia in combination with spleen and kidney infarcts. The cause remained unknown, possibly due to low-flow state. There was no evidence of thromobosis.; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1265803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-07
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9568 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Computerised tomogram thorax, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: PREDNISOLONE; ZYTIGA; GOSERELIN
Current Illness: Bone metastases; Brain metastases; Carcinoma of lung; Metastases to lymph nodes; Prostate cancer metastatic; Skin metastases
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer
Allergies:
Diagnostic Lab Data: Test Date: 202011; Test Name: CT lung; Result Unstructured Data: Test Result:Lung changes visible. The lung changes were not...; Comments: Lung changes visible. The lung changes were not biopsied, but probable lung metastases/carcinomatosis.; Test Date: 20210307; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increased
CDC Split Type: NOPFIZER INC2021447072

Write-up: RESPIRATION FAILURE; suspected pneumonia; Increased C-reactive protein; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Ueewq9. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Feb2021 (Batch/Lot Number: EP9568) as single dose for COVID-19 immunization. Medical history included ongoing carcinoma of lung, ongoing prostate cancer metastatic (Advanced and aggressive prostate cancer with spread to skeleton, lungs, paraaortic lymph nodes, subcutaneous lesions and to brain), ongoing skeleton metastases, ongoing paraaortic lymph nodes metastases, ongoing metastatic subcutaneous lesions, ongoing brain metastases and cancer. Concomitant medication included prednisolone, abiraterone acetate (ZYTIGA) and goserelin (GOSERELIN) taken for cancer. The patient previously took first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization. On 07Mar2021, the patient was acutely admitted to hospital with respiratory failure 11 days after vaccination with the second dose of covid-19 vaccine (Comirnaty). Pneumonia was suspected. Increased C-reactive protein. Treated with antibiotics without response. The patient''s condition worsened and required ventilatory support. The patient got CPAP/BiPAP without improvement of the situation. The patient died 19 days after vaccination with the second dose. Multimorbid patient with advanced and aggressive prostate cancer with metastases to the skeleton, lungs, paraaortic lymph nodes, subcutaneous lesions and to the brain. The reporter and colleagues consider that the probable cause of the death is increasing cancer-related pulmonary carcinoma which led to the lung failure. The physician still chooses to report the condition as a possible side effect, according to the relatives'' wishes. The patient died on 15Mar2021. An autopsy was not performed. Reporter''s comments: Hospitalized 07Mar2021. Pneumonia was suspected. Increased C-reactive protein. Treated with antibiotics without response. The patient''s condition worsened and required ventilatory support. The patient got CPAP/BiPAP without improvement of the situation. He died with family members present. No autopsy, due to the patients wish. The relatives are of the opinion that covid-19 vaccination (second dose) is the basis for the patients lung condition and death. The patient was widely discussed between colleagues at the hospital. Pneumonitis is not a known side effect of medications the patient was treated with. The reporter and colleagues consider that the probable cause of the death is increasing cancer-related pulmonary carcinoma which led to the lung failure. The physician still chooses to report the condition as a possible side effect, according to the relatives'' wishes. Prostate cancer not treated with chemotherapy.; Reported Cause(s) of Death: RESPIRATION FAILURE; suspected pneumonia; Increased C-reactive protein


VAERS ID: 1265804 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-12
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Cerebral haemorrhage, Fatigue, Headache
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:220 mmHg; Comments: Measured by the GP; Test Date: 20210412; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:150 mmHg; Comments: Blood pressure measured on arrival hospital
CDC Split Type: NOPFIZER INC2021453500

Write-up: CEREBRAL HEMORRHAGE; new-onset headaches and was very tired and exhausted; new-onset headaches and was very tired and exhausted; blood pressure systolic: 220 mmhg on 12Apr2021 (Measured by the GP), and 150 mmhg on 12Apr2021 (Blood pressure measured on arrival at hospital).; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uxz3gm. An 85-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EP2166) intramuscularly on 25Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY, batch number unknown) on 04Feb2021 for COVID-19 vaccination. On 12Apr2021, the patient developed cerebral hemorrhage. Relevant laboratory findings and investigations included blood pressure systolic: 220 mmHg on 12Apr2021 (Measured by the GP), and 150 mmHg on 12Apr2021 (Blood pressure measured on arrival at hospital). The primary reporter stated that she was unsure of the causal link between vaccination and cerebral hemorrhage and pointed out that for this patient a hypertensive hemorrhage was also a possibility. The doctor further wrote that the patient after vaccination (2021) experienced new-onset headaches and was very tired and exhausted. The condition became acutely worse on 12Apr2021 and the patient was hospitalized on 12Apr2021. The patient died on 14Apr2021 for cerebral hemorrhage. It was not reported if an autopsy was performed. The outcome of other events was unknown. The case was considered to be Serious. The Regulatory Authority has assessed the causal relationship between the suspect product and the cerebral hemorrhage as Possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CEREBRAL HEMORRHAGE


VAERS ID: 1265805 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cerebrovascular accident, Death, Fall, Illness, Moaning, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 33
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: SOBRIL; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; ESOMEPRAZOL PENSA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral bleeding (reduced function (one-sided),misalignment in one foot and reduced force/power); Chronic hepatic failure (Due to previous alcoholism.); Emotional disturbance NOS; Ex-alcoholic; Heartburn; Hypertension; Living in residential institution (Resident in a 24-hour staffed home.); Malignant neoplasm of prostate; Musculoskeletal malfunction arising from mental factors; Nausea; Pale skin; Urinary tract infection; Vascular dementia (Vascular dementia gradually developed.); Weakness; Yellow skin
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: C-reactive protein; Result Unstructured Data: Test Result:51 mg/l; Comments: elevated
CDC Split Type: NOPFIZER INC2021453496

Write-up: suspected stroke; groaning/moaning; no verbal contact; DEATH; Fall; became ill; This is a spontaneous report from a contactable other hcp downloaded from a regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uyj4e2. A 77-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly administered in arm left on 28Jan2021 (Lot Number: EM0477) at vaccination age of 77 years old at 0.3 mL single for covid-19 immunisation. Medical history included chronic hepatic failure (due to previous alcoholism), prostate cancer, living in residential institution (resident in a 24-hour staffed home), cerebral haemorrhage from 2013 (with reduced function (one-sided), including misalignment in one foot and reduced force/power, he walked on his own, no aids), vascular dementia, ex-alcoholic, somatic symptom disorder from 2013, emotional disorder, hypertension, dyspepsia, Gradually weakened, nausea, yellow and pale skin, small infections (like urinary tract infection). Concomitant medications included oxazepam (SOBRIL) taken for emotional disorder; metoprolol succinate (METOPROLOL SANDOZ) taken for hypertension; esomeprazole sodium (ESOMEPRAZOL PENSA) taken for dyspepsia. The patient had previously received the first dose of bnt162b2 (COMIRNATY) on 07Jan2021 at single dose for covid-19 immunisation. The patient died six days after vaccination with covid-19 vaccine, second dose. Observed for 30 minutes after the vaccine. He then fell on his way back to his room. He got up on his feet again, with help. A few days passed without anything special and he went with his wife on a car trip. Then he became ill after a couple of days. Three days after the vaccination he was sitting in a chair groaning/moaning, leaned over to the right side and with open eyes, but with no verbal contact. Hospitalized with suspicion of stroke. He received thrombolysis without improvement. He was discharged to the residential institution the next day, with a focus on palliative care. He had slightly elevated CRP the recent time, and it was elevated the day before the second dose. Relatives wanted to report this event for research purposes. No information obtained about the cause of death registered in the death certificate. The patient died on 03Feb2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included c-reactive protein: 51 mg/l (upper normal limit 4 mg/l) on 27Jan2021. The outcome of events suspected stroke, groaning/moaning and no verbal contact was not recovered. The outcome of events fall and illness was unknown. The regional pharmacovigilance center assessed the causal relationship between the suspect product and death as possible. Reporter''s comments: Observed for 30 minutes after the vaccine. He then fell on his way back to his room. He got up on his feet again, with help. A few days passed without anything special and he went with his wife on a car trip. Then he became ill after a couple of days. Three days after the vaccination he was sitting in a chair groaning/moaning, leaned over to the right side and with open eyes, but with no verbal contact. Hospitalized with suspicion of stroke. He received thrombolysis without improvement. He was discharged to the residential institution the next day, with a focus on palliative care. Relatives wanted notification for research purposes. During the whole winter: Gradually weakened, with nausea, yellow and pale skin and small infections (like urinary tract infection). The municipal chief physician was asked if the patient could receive the vaccine. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: RELIS: We have not been able to get hold of information (through contacting the reporter) about the registered cause of death in the death certificate.; Reported Cause(s) of Death: DEATH


VAERS ID: 1265806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Body temperature, Condition aggravated, Cough, Death, Diarrhoea, Hyperhidrosis, Oxygen saturation decreased, PCO2 abnormal, Pyrexia, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:38 degrees Celsius; Test Name: COVID test; Result Unstructured Data: Test Result:negative; Test Name: COVID test; Result Unstructured Data: Test Result:positive (repeat test)
CDC Split Type: PLPFIZER INC2021448064

Write-up: saturation decreased; kidneys stopped functioning; did not excrete CO2; cough; fever; Diarrhea; abdominal pain; sweating; weakness; condition worsened; patient died; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 22Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY; Lot Number: ER7812), via an unspecified route of administration on 16Mar2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported at first that the husband felt well. Later cough appeared, that was intensifying every day. After about 2 weeks following events occurred: fever, diarrhea, abdominal pain, sweating, intense cough, weakness. After fever reached 38 degrees Celsius both reporter and her husband took COVID test. The reporter received positive results , while her husband received negative result. A physician recommended to repeat the test to the husband. After repeat test the result was positive. Later the condition of the patient worsened day by day. Patient''s saturation was decreasing so the reporter called an ambulance. The patient was admitted to a hospital. In the hospital he was hooked up to a respirator. The patient was under respirator 6-7 days. Then the patient''s kidneys stopped working, he was not excreting C02, but after 2-3 days kidneys started to work again, patient was excreting C02 again. He was unplugged from the respirator and transferred onto internal medicine unit where he was for 7 days. He died on 16Apr2021. The patient underwent lab tests and procedures which included body temperature: 38 degrees celsius on an unspecified date, sars-cov-2 test: negative on an unspecified date and sars-cov-2 test: positive (repeat test) on an unspecified date. The patient died on 16Apr2021. It was not reported if an autopsy was performed. The outcome of kidneys stopped functioning and did not excrete co2 was recovered on an unspecified date while other events were unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1265809 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021447038

Write-up: Brain stem stroke resulted in the death; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB (regulatory authority number: PL-URPL-DML-MLP.4401.2.235.2021). An 88-year-old female patient received the first dose bnt162b2 (COMIRNATY, Solution for injection, lot number: ET3674), intramuscular on 18Mar2021 (received at 88-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced brain stem stroke resulted in the death on 25Mar2021. The patient was hospitalized for brain stem stroke resulted in the death for 6 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter did not assess the severity of the event. Basing on the nature of adverse events, hospitalization (6 days) and death of the patient, classified this report as serious. Sender''s Comments: Comirnaty is a mRNA vaccine against COVID-19 (nucleoside modified) Reported adverse event has not so far in this term been listed in a regulatory authority. Up until 13Mar2021 in the database, in association with administration of Comirnaty, 1 brain stem stroke case (brain stem stroke) and 655 cases under HLT: Central nervous system haemorrhages and cerebrovascular accidents. Temporal relation suggest causality. The reporter did not assess the severity of the event. Basing on the nature of adverse events, hospitalization (6 days) and death of the patient, classified this report as serious. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: brain stem stroke resulted in the death


VAERS ID: 1265821 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac) (At 45 years old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021447263

Write-up: Stroke; Aspiration pneumonia; Tiredness aggravated; Tiredness aggravated; This is a spontaneous report from a contactable consumer, the patient''s daugther. An 80-years-old female patient received bnt162b2 (COMIRNATY), dose 2 on 31Mar2021 at 14:00 (Batch/Lot number EW2239) as 0.3 mL, single for covid-19 immunisation. Medical history included cardiac pacemaker insertion in 19Nov1985 (at 45 years old). The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 3Mar2021 at 15:00 and complained of vaccination site pain (left arm) and tiredness, which persisted until intake of dose 2. Following administration of dose 2, the patient experienced tiredness aggravation at the end of 31Mar2021, persisting until 2Apr2021. On the dawn of 3Apr2021, the patient experienced an extensive stroke (right side), detected on early morning. The patient was hospitalized with reserved prognosis due to lesions from stroke and pulmonar lesions - aspiration pneumonia, occurred as a consequence of stroke. The patient died on 8Apr2021 at 10:00 (at 80 years old). The patient died on 08Apr2021. It was not reported if an autopsy was performed. The reported cause of death was stroke and pulmonar lesions - aspiration pneumonia. Follow up information has been requested.; Sender''s Comments: Linked Report(s) : PT-PFIZER INC-2021448703 Events experienced following dose 1; Reported Cause(s) of Death: Extensive stroke; Aspiration pneumonia


VAERS ID: 1266191 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-03
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20210

Write-up: Sudden death; This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN DEATH (Sudden death) in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. In February 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 03-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Limited information regarding the death of this elderly man has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1266206 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: EUTIROX; ATENOLOLO EG; LASIX [FUROSEMIDE]; COAPROVEL; HUMALOG
Current Illness: Artificial cardiac pacemaker wearer; Diabetes mellitus; Hypertension; Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypertension, Hyperthyroidism and Artificial cardiac pacemaker wearer. Concomitant products included LEVOTHYROXINE SODIUM (EUTIROX), ATENOLOL (ATENOLOLO EG), FUROSEMIDE (LASIX [FUROSEMIDE]), HYDROCHLOROTHIAZIDE, IRBESARTAN (COAPROVEL) and INSULIN LISPRO (HUMALOG) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 05-Apr-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 events was not Applicable. treatment information not provided. Company comment:Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Minor change to name of Concomitant medication from Lasix vials to Lasix tablets; 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: 1268442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Asymptomatic COVID-19, Renal failure, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARVEDILOL; VALSARTAN; FUROBEXAL; THYREX; SPIRONO; TRAMADOL HCL RET; ZINKOROTAT
Current Illness: Atrial fibrillation (atrial fibrillation under Marcoumar); Cardiac insufficiency (heart insufficiency); Chronic renal insufficiency (Chronic renal insufficiency, acute to chronic renal insufficiency Mar2021); Hypertension arterial (Hypertension arterial); Lung nodule (round lesion on the right lower lobe since 2012); Strumectomy (Strumectomy - substitution hypothyroidism)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: SARS-CoV-NPS-PCR; Result Unstructured Data: Test Result:positiv, Cycle threshold value 22; Comments: positiv, Cycle threshold value 22; Test Date: 20210408; Test Name: SARS-CoV-NPS-PCR; Result Unstructured Data: Test Result:positiv, Cycle threshold value 24; Comments: positiv, Cycle threshold value 24; Test Date: 20210413; Test Name: SARS-CoV-NPS-PCR; Result Unstructured Data: Test Result:negativ; Comments: negativ; Test Date: 20210415; Test Name: SARS-CoV-NPS-PCR; Result Unstructured Data: Test Result:positiv, Cycle threshold value 26; Comments: positiv, Cycle threshold value 26
CDC Split Type: ATPFIZER INC2021453709

Write-up: Asymptomatic COVID-19, Covid positiv PCR cycle threshold value 22; no typical covid symptoms; exacerbation of chronic renal failure; exacerbation of chronic renal failure/Acute renal failure; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-23201. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 02Feb2021 (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) as single dose, and dose 1 via an unspecified route of administration on 13Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing atrial fibrillation under Marcoumar, Lung nodule from 2012 (round lesion on the right lower lobe), thyroidectomy (Strumectomy - substitution hypothyroidism), cardiac failure (heart insufficiency), chronic renal insufficiency and hypertension arterial; all ongoing. Concomitant medications included carvedilol from 18Jun2020 to 17Apr2021; valsartan taken for cardiac disorder from an unspecified start date to 15Apr2021; furosemide (FUROBEXAL) taken for polyuria from 2017 to an unspecified stop date; levothyroxine sodium (THYREX) taken for hypothyroidism from 14Feb2017 to an unspecified stop date; spironolactone (SPIRONO) taken for polyuria from 2017 to an unspecified stop date; tramadol hcl (TRAMADOL HCL RET) taken for an unspecified indication from Feb2017 to an unspecified stop date; zinc orotate (ZINKOROTAT) taken for an unspecified indication from 06Apr2021 to an unspecified stop date. The patient experienced exacerbation of chronic renal failure and acute renal failure on Mar2021, no typical covid symptoms (such as fever, cough / shortness of breath, sore throat, nausea / vomiting, muscle or joint pain or headache) and covid positiv pcr cycle threshold value 22 on 01Apr2021. The patient underwent lab tests and procedures which included SARS-CoV-NPS-PCR: positiv, cycle threshold value 22 on 01Apr2021, positiv, cycle threshold value 24 on 08Apr2021 positiv, negativ on 13Apr2021, and cycle threshold value 26 on 15Apr2021 positiv. Patient was home quarantine from 03Apr2021 to 15Apr2021. The patient died on 17Apr2021 due to exacerbation of chronic kidney failure and acute renal failure. An autopsy was not performed. Events no typical covid symptoms and covid positiv pcr cycle threshold value 22 was not recovered. No follow-up attempts needed. No further information is expected.; Reported Cause(s) of Death: exacerbation of chronic kindey failure; acute renal failure


VAERS ID: 1268462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Pulmonary embolism, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Mental retardation; Psychosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431565

Write-up: sudden vomiting at home; Malaise; Dyspnoea; reanimation with suspected lung embolism, patient died; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100035456. A 39-years-old male patient received BNT162B2 (COMIRNATY, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 09Apr2021 as 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history included psychosis, mental retardation and arterial hypertension. Concomitant medications were not reported. On an unspecified date, the patient experienced sudden vomiting at home, with malaise and dyspnoea, which led to hospitalization. On 12Apr2021, the patient experienced reanimation with suspected lung embolism in the hospital. Therapeutic measures with clozapin were taken as a result of reanimation with suspected lung embolism, not verified. Patient died on 14Apr2021 due to lung embolism. It was not reported if an autopsy was performed. The reporter reported this report as serious - death, hospitalization, life threatening. Outcome of the event lung embolism was fatal. Outcome of all other events was unknown. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority. ; Reported Cause(s) of Death: reanimation with suspected lung embolism, patient died


VAERS ID: 1268464 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Cerebral venous sinus thrombosis, Epilepsy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021453768

Write-up: Brain death; Extensive sinus vein thrombosis with congestive bleeding; Extensive sinus vein thrombosis with congestive bleeding; Symptomatic epilepsy; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority WEB regulatory authority number:DE-PEI-202100039895. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: EW8904) as single dose for covid-19 immunisation/prophylactic vaccination. The patient''s medical history was not reported. There were no concomitant medications. The patient experienced extensive sinus vein thrombosis with congestive bleeding on 17Apr2021, brain death on 19Apr2021 and symptomatic epilepsy on 17Apr2021. The events were assessed as serious due to being life-threatening and causing hospitalization. The outcome of the events extensive sinus vein thrombosis with congestive bleeding and symptomatic epilepsy were unknown. The patient died on 19Apr2021 due to brain death. It was unknown if an autopsy was performed. Sender Comment: CCT+C-MRT. Brain death diagnostics19Apr2021. Findings: For comparison, the CT of the skull of the same days is available. Slightly limited sound capability due to movement artifacts. Central interhemispheric gap. T2 hyperintense signal changes subarachnoidal in both cerebral hemispheres and intracerebral left temporal as well as left temporal subarachnoid. Diffusely distributed diffusion disturbances in both cerebellar hemispheres and temporally on both sides as well as punctiform small diffusion disturbances also on the right in the frontal lobe and on the right highly parietal. Smaller punctiform diffusion disturbances also on the left frontobasal. Also susceptibility artifacts over both cerebellar hemispheres and temporally on the left. Normal width of the inner and outer cerebrospinal fluid spaces. No signs of intracranial pressure, the sella and pituitary glands are normal. Paraseilar structures normal, no pathological changes in the cerebellopontine angle area on both sides, thrombus formations surrounded by contrast medium almost in the entire sinus sagittalis superior, sinus rectus, both sides in the sinus transversus, both sides in the sinus sigmoid and also on the left in the vena jugularis interna as well as in smaller paravertebral ones Veins and also in individual smaller bridging veins. Normal arrangement and free pneumatization of the shown paranasal sinuses and mastoid cells, orbital contents normal, no pathological changes in the skullcap. T2-hyperintense edema zones both highly parietal in the scalp. Evaluation: Evidence of an extensive acute sinus thrombosis with the extent mentioned above. Congestive infarction and congestive bleeding especially on the left temporal and in the Cerebellar hemispheres. Also subarachnoid bleeding components on both sides at the level of the cerebellar hemispheres and temporally on the left. Isolated smaller congestive infarcts also on the right temporal side and frontal on both sides. No CSF circulatory disorder yet. Possibly post-traumatic edema formation in the scalp on both sides in the high parietal region. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Brain death


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