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

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 120 out of 172

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VAERS ID: 1355661 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-03-02
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; SIMCORA; CONCOR; CALCIMAGONA D3; BECOZYM [VITAMIN B NOS]; LEXOTANIL; PROLIA
Current Illness: Adiposis; Arterial hypertension; Nicotine abuse
Preexisting Conditions: Medical History/Concurrent Conditions: Breast ductal carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Acute heart failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute heart failure) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 300042723 and 300042460) for COVID-19 vaccination. The patient''s past medical history included Breast ductal carcinoma in 2010. Concurrent medical conditions included Arterial hypertension, Adiposis and Nicotine abuse. Concomitant products included LISINOPRIL, SIMVASTATIN (SIMCORA), BISOPROLOL FUMARATE (CONCOR), CALCIUM CARBONATE, COLECALCIFEROL (CALCIMAGONA D3), VITAMIN B NOS (BECOZYM [VITAMIN B NOS]), BROMAZEPAM (LEXOTANIL) and DENOSUMAB (PROLIA) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute heart failure) (seriousness criteria death and medically significant). The patient died on 02-Mar-2021. The reported cause of death was Acute heart failure. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute heart failure) to be unlikely related. Teatment information not provided. Very limited information regarding this event has been provided at this time. However, patient''s underlying medical condition (arterial hypertension) remains a confounder. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. However, patient''s underlying medical condition (arterial hypertension) remains a confounder. Further information can''t be requested.; Reported Cause(s) of Death: Acute Heart Failure


VAERS ID: 1355669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-22
Onset:2021-01-15
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: RIVAROXABAN; RAMIPRIL; METHOTREXATE; SIMVASTATIN; BUMETANIDE; AMLODIPINE; SITAGLIPTIN
Current Illness: Penicillin allergy (Allergic to penicillin.)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bypass surgery (40 years ago.); Hip surgery; Hypertension; Pericarditis; Sciatica; Stent placement (5 years ago.); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021582382

Write-up: Death; This is a spontaneous report received from a contactable other healthcare professional by Pfizer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25321367. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 22Dec2020 (Batch/Lot Number: Unknown) as unknown, single for covid-19 immunisation. Medical history included ongoing drug hypersensitivity Allergic to penicillin, atrial fibrillation unknown if ongoing , pericarditis unknown if ongoing , type 2 diabetes mellitus unknown if ongoing , hypertension unknown if ongoing , sciatica unknown if ongoing , hip surgery not ongoing, vascular graft not ongoing 40 years ago , stent placement not ongoing 5 years ago. Concomitant medications included rivaroxaban (RIVAROXABAN) , ramipril (RAMIPRIL) , methotrexate (METHOTREXATE) , simvastatin (SIMVASTATIN) , bumetanide (BUMETANIDE) , amlodipine (AMLODIPINE) , sitagliptin (SITAGLIPTIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 15Jan2021. The patient died due to fatal reaction on 15Jan2021. 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: Death


VAERS ID: 1355735 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
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:Inconclusive test
CDC Split Type: GBPFIZER INC2021533625

Write-up: Genital rash; This is a spontaneous report from two contactable consumers downloaded from the regulatory authority GB-MHRA-WEBCOVID-202105081858230790-OHQKL, Safety Report Unique Identifier GB-MHRA-ADR 25266880. A patient of unspecified age and gender received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: not known) as single dose for covid-19 immunization. The patient medical history was not reported. Unsure if patient had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications were not reported. The patient experienced genital rash on an unspecified date with fatal outcome. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive test on an unspecified date. The patient died on 01May2021. 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: Genital rash


VAERS ID: 1356417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Glycosylated haemoglobin, Haemoglobin, Platelet count, 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: 2021-05-17
   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: ASPIRIN [ACETYLSALICYLIC ACID]; HYDROXYCARBAMIDE; LEVEMIR; NOVORAPID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Polycythaemia vera; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HbA1c; Result Unstructured Data: Test Result:46; Test Name: Hb; Result Unstructured Data: Test Result:140; Test Name: platelet; Result Unstructured Data: Test Result:411
CDC Split Type: GBPFIZER INC2021575409

Write-up: Death sudden; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105191331183570-IZPGZ. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW4109) as 2nd dose, single for covid-19 immunisation . Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for polycythaemia vera, start and stop date were not reported; hydroxycarbamide (HYDROXYCARBAMIDE) taken for polycythaemia vera, start and stop date were not reported; insulin detemir (LEVEMIR) taken for type 1 diabetes mellitus, start and stop date were not reported; insulin aspart (NOVORAPID) taken for type 1 diabetes mellitus, start and stop date were not reported. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced death sudden on 17May2021. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 46 on unknown date, haemoglobin: 140 on unknown date, platelet count: 411 on unknown date. The patient died on 17May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Sudden expected death 5 days after second Covid Pfizer vaccination Patient has not tested positive for COVID-19 since having the vaccine. The report is not relate to possible blood clots or low platelet counts. Bloods the week previous were normal. Now referred to coroner. Patient notes: well controlled diabetes A1c 46. bloods last week showed normal FBC - Hb 140, plts 411. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1356420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-19
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Catheterisation cardiac, Coronary artery occlusion, Intra-aortic balloon placement, Myocardial infarction, Platelet count, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery atherosclerosis (in the right coronary (40% lumenal occlusion))
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: Cardiac catheterisation; Result Unstructured Data: Test Result:coronary artery occlusion; Comments: Coronary artery catheterisation with stent insertion into the left anterior descending coronary artery.; Test Name: aortic baloon pump; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210319; Test Name: Platelet count; Result Unstructured Data: Test Result:160; Test Date: 20210319; Test Name: Platelet count; Result Unstructured Data: Test Result:less than 150 x 109/L; Test Date: 20210325; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021582066

Write-up: cardiac arrest; segmental myocardial infarct; Coronary occlusion; This is a spontaneous report received from a contactable physician from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105191659291340-LTTHX, Safety Report Unique Identifier GB-MHRA-ADR 25323171. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: unknown) as 1st dose, single for covid-19 immunization. Medical history included: Arteriosclerosis coronary artery (40% lumenal occlusion). Used protein supplements to aid fitness. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient had not confirmed or suspected autoimmune or inflammatory disease (including vasculitis). The patient dose not currently smoke. The patient did not have history of, or current, malignancy and intracranial malignancy. The patient did not have concurrent or recent intracranial infections. The patient had not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had not had a recent trauma/head injury. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 20Mar2021, segmental myocardial infarct on an unspecified date, coronary occlusion on 19Mar2021. Patient suffered out of hospital cardiac arrest with estimated 40 min downtime. Was admitted to hospital on 22Mar2021 (as reported) underwent coronary artery catheterisation with stent insertion into the left anterior descending coronary artery. Patient died later that day. Post mortem confirmed anterior segmental myocardial infarct estimated be within 12-24 hours old. Also coronary artery atherosclerosis in the right coronary (40% lumenal occlusion) and a stent in the left anterior descending coronary artery. Some atherosclerosis was seen proximal to the stent, but no residual thrombus was present. In the presence of atherosclerosis the reporter thought there was unlikely to be a link with the COVID vaccine, but given the uncertainty about this vaccine reporter was reporting the sequence of events. Patient has not tested positive for COVID-19 since having the vaccine. COVID-19 virus test: No - Negative COVID-19 test on 25Mar2021. The reporter considered the case related to possible blood clots or low platelet counts. Relevant investigations or tests conducted included: cardiac catheterization, stent insertion, and aortic baloon pump. Coronary artery occlusion was diagnosed by cardiac catherization on 19Mar2021. The platelet count was less than 150 x 109/L on 19Mar2021. Also reported lowest platelet count after vaccine (usual normal range 150-450): 160 on 19Mar2021. No haemorrhage identified. The patient died on 20Mar2021. An autopsy was performed. Seriousness criteria was death and life threatening. Outcome of segmental myocardial infarct, coronary occlusion was not recovered, of cardiac arrest was fatal. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: anterior segmental myocardial infarct; coronary artery occlusion


VAERS ID: 1356425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphoma, SARS-CoV-2 test
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC2021583922

Write-up: Lymphoma; This is a spontaneous report received from a contactable consumer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105201311298760-QVHLO, Safety Report Unique Identifier GB-MHRA-ADR 25329351. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Known) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced lymphoma on an unspecified date with fatal outcome. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date. The patient died on 19May2021. It was not reported if an autopsy was performed. The reporter stated that two weeks following vaccination my grandmother''s health collapsed, resulting in a cancer diagnosis and her death one week later. Her health had been generally good before vaccination with no obvious complications. No follow-up attempts are possible. Information on batch/lot number cannot be obtained .; Reported Cause(s) of Death: Lymphoma


VAERS ID: 1356427 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021582014

Write-up: Pulmonary embolism; This is a spontaneous report received from a contactable consumer or other non health professional from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105202138505940-STQZR, Safety Report Unique Identifier GB-MHRA-ADR 25332658 A 74-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose at the age of 74-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. He had not a COVID-19 test. Patient was not enrolled in clinical trial. The patient received bnt162b2 (BNT162B2), dose 1 on an unknow date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient experienced pulmonary embolism on 19Apr2021, considered fatal: he passed away 24 days later with a blood clot on the lung and no underlying health issue. The patient died on an unspecified date in May2021. An autopsy was not performed. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1356428 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Family history of cardiovascular disorder (family history of venous and arterial thrombosis); Morbid obesity; Sleep apnoea; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021584039

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable other health care professional from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105220903226590-HUMUR, Safety Report Unique Identifier GB-MHRA-ADR 25342894. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 19May2021 at single dose for COVID-19 immunisation. Relevant medical history included tobacco user, morbid obesity, sleep apnea and back pain. Unsure if patient has had symptoms associated with COVID-19, Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. The patient did not have a recent trauma/head injury. The patient had a family history of venous and arterial thrombosis. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) administered on unknown date as single dose for COVID-19 immunisation. On 22May2021, the patient had a sudden unexplained cardiac arrest at home. It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1356481 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:hypertensive heart disease; Test Name: samples of his viscera; Result Unstructured Data: Test Result:were obtained
CDC Split Type: GRPFIZER INC2021611223

Write-up: cardiac arrest; This is a spontaneous report from a non-contactable consumer through a Pfizer employee. It was published at a website that a 52-year-old male patient BNT162B2 (COMIRNATY, Lot unknown, unknown if first or second dose) solution for injection intramuscular on an unknown date (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. One day after vaccination the patient experienced cardiac arrest and died (unspecified date). The death certificate mentions hypertensive heart disease as the cause of death. The death of the 52-year-old and more was due to hypertensive heart disease specifically after the necropsy - autopsy, performed by a regulatory authority and which was completed late on Wednesday afternoon, when the relevant death certificate was issued. More specifically, the medical examiner on duty, the certificate issued by signs refers to natural death and as a cause of death mentions hypertension heart disease. From the body of the 52-year-old carpenter who worked in a large hotel unit, according to information, samples of his viscera were obtained in order to be sent for laboratory tests. These tests may answer the question of whether the vaccine is responsible for the deterioration of his health and finally for his death. The outcome of the event cardiac arrest was fatal. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: hypertensive heart disease; cardiac arrest


VAERS ID: 1356485 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: HKPFIZER INC2021605484

Write-up: COMA; UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable consumer and healthcare professional via a regulatory authority (Regulatory authority report number: not provided) based on information received by Pfizer from BIONTECH-SE (manufacturer control number: HK-Fosun-2021FOS001298), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable consumer reporting for a 44-year-old female patient. On 12May2021, 9 days prior to the patient''s death, she received 2nd dose of bnt162b2 (COMIRNATY) (lot number: unknown) via unknown route at unspecified dosing frequency for COVID-19 immunization. There was no record of complaint of feeling unwell during observation at the community vaccination centre. The 1st dose was received on an unknown date. Medical history, concomitant medications and past product were not reported. At about 09:00 AM in the morning of 21May2021, the patient fell into a coma. The patient was sent to the hospital by ambulance for rescue and admitted to Accident and Emergency Department. The patient passed away on the same day. No provision of clinical evidence to indicate event caused by vaccine. The case was referred to Coroner. Per the Health Authority, there was no clinical evidence to support event caused by vaccine, will pass the case to a regulatory authority for causality assessment. The events ''coma'' and ''unknown cause of death'' met the seriousness criterion of death. The actions taken for bnt162b2 (COMIRNATY) were not applicable. The patient died on 21May2021. An autopsy would be performed and the cause of death was unknown. Initial report was received on 21May2021. Follow-up (24May2021): New information reported from a non-contactable HCP received via a regulatory authority, which was processed together with the initial report. No further follow-up information was available. Causality assessment Coma Per Reporter=Possible Per Company=Possible Causality assessment Unknown cause of death Per Reporter=Unlikely Per Company=Unlikely No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Coma; UNKNOWN CAUSE OF DEATH


VAERS ID: 1356543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 RA / 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: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malignant neoplasm of ventral surface of tongue; Tumour excision
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021579929

Write-up: Sudden death/died suddenly; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority- WEB, the Regulatory Authority number is HU-OGYI-319421. A 62-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EX6537), intramuscular, administered in arm right on 29Apr2021 as 2nd dose, 0.3ml single dose for COVID-19 immunisation. Medical history included tumour excision from 16Jul2020 to an unknown date and malignant neoplasm of ventral surface of tongue from an unknown date and unknown if ongoing. The patient previously received radiation therapy (received postoperative irradiation based on the proposal of the onco team on 29Jul2020). The patient''s concomitant medications were not reported. The patient previously received the first dose of COMIRNATY (Batch/Lot Number: ET7205), intramuscularly, left arm on 29Mar2021 for COVID-19 immunisation. The patient experienced sudden death/died suddenly on 02May2021. An autopsy was performed, and results were not provided. Sender Comment: The 62-year-old patient died suddenly 3 days after Comirnaty vaccination. Autopsy was requested, further information is expected. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1356553 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 21
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: ZYLLT; COVIOGAL; ROSUVASTATIN; QUAMATEL; RANBAPRIL; MEMORIL [PIRACETAM]; ASPIRIN PROTECT
Current Illness: Cardiomyopathy; Diabetes mellitus; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021579928

Write-up: COVID-19; COVID-19; This is a spontaneous report downloaded from the Regulatory Authority- WEB (Regulatory Authority report number: -OGYI-333921). A contactable physician (contactable through Regulatory Authority only) reported that a 79-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported), intramuscularly on the right arm on 07Apr2021 as a 2nd dose, single dose, for COVID-19 immunization. Medical history included ongoing diabetes mellitus; ongoing hypertension; ongoing cardiomyopathy; and myocardial infarction (unknown if ongoing). Concomitant medications included clopidogrel bisulfate (ZYLLT), bisoprolol fumarate (COVIOGAL), rosuvastatin, famotidine (QUAMATEL), perindopril erbumine (RANBAPRIL), piracetam (MEMORIL) and acetylsalicylic acid (ASPIRIN PROTECT). 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 10Apr2021, the patient had started to have fever, cough and dyspnea. The patient''s COVID-19 antigen test was positive on 10Apr2021. The patient was hospitalized on 16Apr2021 with pneumonia affecting the 70% of his lung. The patient had died on 01May2021 due to the severe symptoms of COVID-19. It was unknown if an autopsy was performed. Sender Comment: The patient was diagnosed to have COVID-19 three days after the second dose of COMIRNATY. Immunity may have not developed within 3 days after the second dose of vaccine. The case is serious because the patient died. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1356560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: COVEREX AS; SYNCUMAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adnexectomy; Atrial fibrillation; Hernia repair; Hypertension; Hysterectomy; Ischemic heart disease; Pacemaker insertion (cardiac); Tonsillectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210302; Test Name: Chest X-ray; Result Unstructured Data: Test Result:confirmed pneumonia; Comments: COVID-19 pneumonia; Test Date: 20210302; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:positive
CDC Split Type: HUPFIZER INC2021579926

Write-up: COVID-19 antigen test positive; COVID-19 pneumonia; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority- WEB, the Regulatory Authority number is HU-OGYI-334721. An 85-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EL0725), via an unspecified route of administration, administered in left arm on 27Feb2021 as 1st dose, 0.3ml single to prevent Covid-19. Medical history included atrial fibrillation, hypertension, ischemic heart disease, hernia surgery, pacemaker insertion, hysterectomy, tonsillectomy and adnexectomy. Concomitant medications included perindopril arginine (COVEREX AS); acenocoumarol (SYNCUMAR). The patient was hospitalized on 02Mar2021 with symptoms of fever and confusion. On 02Mar2021, Covid-19 antigen test was positive and chest X-ray confirmed pneumonia (COVID-19 pneumonia). The patient received COVID therapy but her general condition continuously deteriorated and passed away on 09Mar2021 at 20:00. Cause of death were COVID-19 antigen test positive, COVID-19 pneumonia and COVID-19. An autopsy was not performed. Sender Comment: According to the HA of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with the virus 3 days after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 antigen test positive; COVID-19


VAERS ID: 1356579 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0866 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, C-reactive protein, Cardiac failure, Chest X-ray, Chest pain, Cough, Death, Echocardiogram, Electrocardiogram, Fibrin D dimer, Myalgia, Pleural effusion, Pulmonary congestion, Pyrexia, Sinus tachycardia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart failure; Paroxysmal atrial fibrillation; Thrombocytopenia
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: CTA; Result Unstructured Data: Test Result:enlarged spleen; Comments: no evidence of embolism; Test Name: body temperature; Result Unstructured Data: Test Result:Increased; Test Date: 20210325; Test Name: chest X-ray; Result Unstructured Data: Test Result:congestion and bilateral pleural fluid; Test Name: CRP; Result Unstructured Data: Test Result:no increase; Test Date: 20210325; Test Name: Echocardiogram; Result Unstructured Data: Test Result:decrease in global systolic function; Comments: significant decrease in global systolic function with global hypokinesis; Test Date: 20210325; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: no evidence of active ischemia; Test Date: 20210325; Test Name: D-Dimer; Result Unstructured Data: Test Result:2200; Test Date: 20210325; Test Name: troponin; Result Unstructured Data: Test Result:30
CDC Split Type: ILPFIZER INC2021566784

Write-up: Worsening of heart failure; fever increased; pressing pain appeared on the front right side of the chest; widespread muscle pain and nocturnal cough; widespread muscle pain and nocturnal cough; sinus tachycardia; congestion and bilateral pleural fluid; In chest X-ray, congestion and bilateral pleural fluid; patient passed away; This is a spontaneous report received from a contactable other HCP via regulatory authority. A 35-year-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 at the age of 35-year-old for covid-19 immunisation. Medical history included diabetes mellitus, cardiac failure, paroxysmal atrial fibrillation, thrombocytopenia. The patient''s concomitant medications were not reported. The patient experienced worsening of heart failure, fever increased, pressing pain appeared on the front right side of the chest, widespread muscle pain and nocturnal cough, sinus tachycardia, congestion and bilateral pleural fluid on an unspecified date for which he was hospitalized and passed away on an unspecified date. The course of events was as follows: The night after the second dose fever increased, two days later, pressing pain appeared on the front right side of the chest, intensified during deep breathing and a change of posture, later also appeared widespread muscle pain and nocturnal cough. On 16Mar2021 he arrived to a local clinic and received codilac treatment, without any improvement in his condition. Later respiratory worsening, shortness of breath and orthopnea. On 25Mar2021 he went to the clinic again, in ECG sinus tachycardia was observed, with no evidence of active ischemia. In chest X-ray, congestion and bilateral pleural fluid. Referred to emergency room. In emergency room tachycardic, bilateral pulmonary edema, D-Dimer 2200 in CTA enlarged spleen with no evidence of embolism, troponin 30. Echocardiogram demonstrated significant decrease in global systolic function with global hypokinesis. The patient underwent other lab tests and procedures which included: body temperature: increased on an unspecified date, C-reactive protein: no increase on an unspecified date. The hospitalization summary stated that it was unlikely that it was myocarditis or ischemic myocardial damage since there was no increase in CRP. The outcome of death was fatal, of all other events was unknown. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on an implied chronological connection to the vaccine a causal relationship between events worsening of heart failure and death (unknown cause) and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information including the cause of death 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: Unknown cause of death


VAERS ID: 1356588 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Drop attacks, Hypoaesthesia oral, Tongue paralysis, Transient ischaemic attack
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; SIVASTIN; EUTIROX; LASIX [FUROSEMIDE]; CONGESCOR; UROREC; RELVAR ELLIPTA [FLUTICASONE PROPIONATE;VILANTEROL TRIFENATATE]; OMEPRAZEN [OMEPRAZOLE]; SPIRIVA
Current Illness: Benign prostatic hypertrophy; Bronchitis chronic; Dyslipidemia; Fibrillation; Post surgical hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aneurysm; Cognitive deterioration; Incontinence; Other hernia; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK, HYPOAESTHESIA ORAL, TONGUE PARALYSIS , DROP ATTACKS and CONFUSIONAL STATE in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Other hernia, Abdominal aneurysm, Thoracic aortic aneurysm, Incontinence and Cognitive deterioration. Concurrent medical conditions included Fibrillation since 04-May-2021, Bronchitis chronic, Dyslipidemia, Post surgical hypothyroidism and Benign prostatic hypertrophy. Concomitant products included APIXABAN (ELIQUIS), SIMVASTATIN (SIVASTIN), LEVOTHYROXINE SODIUM (EUTIROX), FUROSEMIDE (LASIX [FUROSEMIDE]), BISOPROLOL FUMARATE (CONGESCOR), SILODOSIN (UROREC), FLUTICASONE PROPIONATE, VILANTEROL TRIFENATATE (RELVAR ELLIPTA [FLUTICASONE PROPIONATE;VILANTEROL TRIFENATATE]), OMEPRAZOLE (OMEPRAZEN [OMEPRAZOLE]) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication. On 27-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml in total. On 28-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (seriousness criterion death), HYPOAESTHESIA ORAL (seriousness criterion death), TONGUE PARALYSIS (seriousness criterion death), DROP ATTACKS (seriousness criterion death) and CONFUSIONAL STATE (seriousness criterion death). The patient died on 27-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. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received included death details On 24-May-2021: Additional information received included medical history details and concomitant medication details.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1356661 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Test Name: cluster; Result Unstructured Data: Test Result:a specific countries variant; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021580392

Write-up: tested positive to Covid 19; tested positive to Covid 19; This is a spontaneous report received from a contactable physician via a Pfizer sales representative, reporting same events under the same suspect product COMIRNATY for 33 patients. This is one of 33 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The physician reported a cluster of Sars Cov 2 in one nursing home which is the subject of an investigation and an article in writing. The cluster is of a specific countries variant. Average age 88 years. This patient tested positive to COVID-19 virus test on an unspecified date, and was hospitalized. This patient died on an unspecified date. He/she was found "not responder". It was unknown if an autopsy was performed. Outcome of the events is fatal. Information on lot number has been requested.; Sender''s Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. 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.,Linked Report(s) : IT-PFIZER INC-2021589084 same reporter, vaccine and AE, different patient; Reported Cause(s) of Death: tested positive to Covid 19; tested positive to Covid 19


VAERS ID: 1356662 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Test Name: cluster; Result Unstructured Data: Test Result:English variant; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021580529

Write-up: tested positive to Covid 19; tested positive to Covid 19; This is a spontaneous report received from a contactable physician via a Pfizer sales representative, reporting same events under the same suspect product COMIRNATY for 33 patients. This is one of 33 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The physician reported a cluster of Sars Cov 2 in one nursing home which is the subject of an investigation and an article in writing. The cluster is of English variant. Average age 88 years. This patient tested positive to COVID-19 virus test on an unspecified date, and was hospitalized. This patient died on an unspecified date. He/she was found "not responder". It was unknown if an autopsy was performed. Outcome of the events is fatal. Information on lot number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is 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.,Linked Report(s) : IT-PFIZER INC-2021589084 same reporter, vaccine and AE, different patient; Reported Cause(s) of Death: tested positive to Covid 19; tested positive to Covid 19


VAERS ID: 1356798 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral haemorrhage, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: Body temperature; Result Unstructured Data: Test Result:34.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021585087

Write-up: Cerebral haemorrhage (severe); Found on the ground; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21108402. An 80-year- and 7-month-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20May2021 15:00 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose at the age of 80-year- and 7-month-old for COVID-19 immunisation, administered at the reporting hospital. Medical history included cerebral infarction, hypertension, dyslipidaemia. Body temperature on 20May2021 before vaccination was 36.4 degrees centigrade. Family history was not reported. The patient''s concomitant medications were not reported. On 21May2021 at 17:10 (1 day after the vaccination), the patient experienced cerebral haemorrhage (severe) and was found on the ground. The patient underwent lab tests and procedures which included body temperature: 34.4 centigrade on 20May2021 before vaccination. Therapeutic measures were taken as a result of cerebral haemorrhage and found on the ground. On 21May2021 (1 day after the vaccination), the patient died, and the outcome of the events was fatal. It was not reported if an autopsy was performed. The course of the events was as follows: On 20May2021 at 15:00 (the day of vaccination), the patient was vaccinated for the new coronavirus at the reporting hospital. He had no problem during the observation and went home. On the following 21May2021 (1 day after the vaccination), the patient had normal physical condition and was working in the field in the morning through the afternoon without problem. Just after 17:00, the patient headed from the field toward the house. A passerby found him on the ground 50 meters away from the field. The patient was transported to local Medical Center by ambulance. The patient was noted to have cerebral haemorrhage (severe) and died at 20:56. The reporting physician classified the events as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible(s) cause of the events such as any other diseases was cerebral haemorrhage. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the events are most likely complications of the underlying conditions cerebral infarction, hypertension, dyslipidaemia hence unrelated to bnt162b2 (COMIRNATY).; Reported Cause(s) of Death: Cerebral haemorrhage (severe)


VAERS ID: 1356800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Colostomy; Large intestine carcinoma; Pneumonia aspiration; Surgery; Swelling of legs
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021586266

Write-up: death; This is a spontaneous report from a non-contactable physician. The patient was an 86-year-old male. The patient had a medical history of large intestine carcinoma, and he underwent colostomy and he also had surgery to remove an artificial anus. He had atrial fibrilla, cardiac failure and swelling of legs as well. Concomitant drugs included edoxaban tosilate (LIXIANA) for the treatment of atrial fibrilla and diuretic for the treatment of swelling of legs. No information on family history was reported. On 21May2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) intramuscularly as a single dose for COVID-19 immunization. On 22May2021, the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. The course of the event was as follows: The patient originally had large intestine carcinoma, and he underwent colostomy. But he underwent surgery to remove an artificial anus with the patient''s wish (because he wanted to bathe in the hot springs), and then he developed atrial fibrilla, cardiac failure and pneumonia aspiration. Thereafter, his condition became worsened. For the treatment of atrial fibrilla, he was taking LIXIANA. The patient had swelling of legs at that time, so he additionally took diuretic. On 21May2021, the reporting physician gave the patient an injection of COMIRNATY (first dose). On 22May2021, the patient was transferred to a different hospital from the reporter''s. The hospital where the patient was transferred attempted to contact the reporter, but it could not reach him because of Saturday. The reporter was informed by the police that the patient died after he died. The cause of the death was uncertain because the reporter did not examine the patient directly. The reporting physician considered that the causal relationship between the event and BNT162b2 was uncertain and the possibility of BNT162b2 being the cause was fairly low. The reporting physician thought that the patient had a high risk of death considering his advanced age of 86 years and his underlying conditions, but there was no reason he should not take the vaccination and so he determined that it was possible for him to take the vaccination. The reporting physician classified the event as serious (Fatal outcome).; Sender''s Comments: Per current guidance, the Company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. Underlying large intestine carcinoma, atrial fibrillation, cardiac failure and aspiration pneumonia may have contributed to the demise of this elderly patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1356802 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dehydration, Diarrhoea, Heart rate, Myocardial ischaemia, Volume blood
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: Arteriosclerosis coronary artery; Diabetes mellitus; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: body temperature; Result Unstructured Data: Test Result:not reported; Test Name: blood volume; Result Unstructured Data: Test Result:decreased; Test Name: heart rate; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC2021588793

Write-up: Myocardial ischaemia; severe dehydration; diarrhoea; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21108499. A 91-year-old female patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 19May2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included arteriosclerosis coronary artery, postoperative status of the stent expansion and diabetes mellitus. No family history was provided. The patient''s concomitant medications were not reported. The patient experienced myocardial ischaemia on an unspecified date, severe dehydration on 19May2021 at 13:00, and diarrhoea on 19May2021 at 13:00. Body temperature before vaccination was not reported. The clinical course was as follows: on 19May2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 19May2021 at 13:00 (3 hours after the vaccination), the patient experienced diarrhoea and severe dehydration. This was further described as: on 19May2021 from afternoon of the day of the vaccination, diarrhoea was continued to occur. On 21May2021 (2 days after the vaccination), the patient was found dead lying on the futon. Blood volume was decreased and heart rate was increased on an unknown date. The clinical outcome of the events was fatal. On 21May2021 (2 days after the vaccination), the patient died due to myocardial ischaemia, severe dehydration, and diarrhoea. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was related to BNT162b2. Arteriosclerosis coronary artery, postoperative status of the stent expansion and diabetes mellitus were reported as other possible causes of the event. REPORTER COMMENT: it was possibly considered as follows: as dehydration due to diarrhoea had not been corrected, circulating blood volume decreased, furthermore heart rate increased because of her poor physical condition, which led to relative myocardial ischaemia. No follow- up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Myocardial ischaemia; severe dehydration; diarrhoea


VAERS ID: 1356803 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Body temperature, Cardio-respiratory arrest, Fibrin D dimer, International normalised ratio, Malaise, Myocardial infarction, Pulmonary embolism, Pyrexia, Troponin I
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), Embolic and thrombotic events, venous (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: 2021-05-14
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: APTT(activated partial thromboplastin time); Result Unstructured Data: Test Result:61.0; Test Date: 20210512; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210514; Test Name: D-dimer; Result Unstructured Data: Test Result:36.7; Test Date: 20210514; Test Name: PTINR (Prothrombin Time and International Normalized Ratio); Result Unstructured Data: Test Result:1.79; Test Date: 20210514; Test Name: Troponin I; Result Unstructured Data: Test Result:117.6
CDC Split Type: JPPFIZER INC2021589065

Write-up: Cardiopulmonary arrest; Pulmonary embolism; Myocardial infarction; Pyrexia; Malaise; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21108547. A 94-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 12May2021 at 14:02 at a single dose for covid-19 immunisation. There was no medical history. The patient''s concomitant medications were not reported. The family history was not reported. There were no points to be considered on the vaccine screening questionnaire. On 14May2021, the patient experienced cardiopulmonary arrest. On 14May2021 at 10:00, the patient experienced pyrexia and malaise. On an unspecified date, the patient experienced pulmonary embolism and myocardial infarction. The patient was hospitalized for cardiopulmonary arrest from 14May2021 to an unknown date. The events, cardiopulmonary arrest, pulmonary embolism, and myocardial infarction, were serious for death. The clinical course was as follows: on 12May2021 at 14:02 (the day of vaccination), the patient received the first dose of BNT162b2. On 14May2021 (one day, 19 hours, and 58 minutes after the vaccination), the patient experienced pyrexia, malaise at 10:00 and cardiopulmonary arrest. On 14May2021 (2 days after the vaccination), the patient was admitted to the hospital. This was further described as: on 14May2021 at 10:00 (2 days after vaccination), the patient had pyrexia and malaise, and she visited the reporting hospital (in the daytime). After she was examined, she went back to the institution. On 14May2021 (2 days after vaccination), at night, the patient had cardiopulmonary arrest (CPA) and was transferred. After the patient received resuscitation, she was admitted to the hospital. The blood examination at that time showed PTINR of 1.79, APTT of 61.0, D-dimer of 36.7, and troponin I of 117.6. On the same day, at 23:25 (2 days, 9 hours, and 23 minutes after vaccination), the patient died. The causes of death were assumed to be pulmonary embolism and myocardial infarction. The patient underwent lab tests and procedures which included body temperature: 36.5 degrees Centigrade on 12May2021 before vaccination. On 14May2021 (2 days after the vaccination), the outcome of the events, cardiopulmonary arrest, pulmonary embolism, and myocardial infarction, was fatal (death). The patient died on 14May2021 due to cardiopulmonary arrest, pulmonary embolism, and myocardial infarction. It was not reported if an autopsy was performed. The clinical outcome of the events, pyrexia and malaise, was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. REPORTER COMMENT: the causality between the event and BNT162b2 could not be ruled out.; Reported Cause(s) of Death: Cardiopulmonary arrest; Pulmonary embolism; Myocardial infarction


VAERS ID: 1356805 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Dialysis; Renal failure chronic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021594574

Write-up: Severe diarrhoea; Dehydration; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 87-year-old male received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. Relevant medical history included ongoing dialysis due to renal failure chronic. Family history and concomitant medication were not reported. On the same day of the vaccination, the patient experienced severe diarrhoea. Subsequently, the patient died because of dehydration. It was unknown if autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the events "diarrhea and dehydration" onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: Severe diarrhoea; Dehydration


VAERS ID: 1356806 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: MEMANTINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrest; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021594728

Write-up: Died three days later; This is a spontaneous report from a contactable physician received via a regulatory authority. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number ET3674 with Expiration Date 31Jul2021), via intramuscular, on 18May2021 at 16:15 (at the age of 82-year-old) at single dose for COVID-19 immunisation. Relevant medical history included dementia and recovery from cardiac arrest. Relevant concomitant medications included memantine hydrochloride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 21May2021 at 23:00, the patient died. An autopsy was not performed, and the reported cause of death was unknown.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Died three days later


VAERS ID: 1356832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Interstitial lung disease
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2021-04-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrosis lung
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Progressive fibrosing interstitial lung disease
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP); Toename van dyspnoe; This regulatory authority case was reported by a physician and describes the occurrence of INTERSTITIAL LUNG DISEASE (Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP)) and DYSPNOEA (Toename van dyspnoe) in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fibrosis lung. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERSTITIAL LUNG DISEASE (Progressie van onderliggend fibrotische longafwijking (fibrotiserende NSIP)) (seriousness criteria death, hospitalization and medically significant) and DYSPNOEA (Toename van dyspnoe) (seriousness criteria death and hospitalization). The patient died on 23-Apr-2021. The reported cause of death was euthanasie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram thorax: abnormal (abnormal) Progressive fibrosing interstitial lung disease. 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. The concomitant medications and treatment details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Euthanasie


VAERS ID: 1356843 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal behaviour, Amnesia, Body temperature, Fall, Fatigue, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: METFORMIN; BIPERIDEN; AMLODIPINE BESILATE; SIMVASTATIN; APIXABAN; GLICLAZIDE; METOPROLOL TARTRATE; DEPAKINE ENTERIC
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: pyrexia; Result Unstructured Data: 38-40.5 degrees celsius
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ABNORMAL BEHAVIOUR, FALL, AMNESIA , FATIGUE, MALAISE and PYREXIA in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN, BIPERIDEN, AMLODIPINE BESILATE, SIMVASTATIN, APIXABAN, GLICLAZIDE, METOPROLOL TARTRATE and VALPROATE SODIUM (DEPAKINE ENTERIC) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (seriousness criterion death) and MALAISE (seriousness criterion death). On 24-Apr-2021, the patient experienced ABNORMAL BEHAVIOUR (seriousness criteria death and hospitalization), FALL (seriousness criteria death and hospitalization) and AMNESIA (seriousness criteria death and hospitalization). On an unknown date, the patient experienced PYREXIA (seriousness criterion death). The patient died on 03-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Body temperature: 38-40.5 (High) For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: A 74-year-old female patient who received mRNA-1273 experienced ABNORMAL BEHAVIOUR and FALL after 2 days and was hospitalized. Patient died 10 days after the first dose. No medical conditions or conmeds were given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided. Further information is not expected.; Sender''s Comments: A 74-year-old female patient who received mRNA-1273 experienced ABNORMAL BEHAVIOUR and FALL after 2 days and was hospitalized. Patient died 10 days after the first dose. No medical conditions or conmeds were given. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1356903 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021573801

Write-up: difficulty in breathing which resulted to death; This is a spontaneous report from a contactable consumer via a sales representative. A 74-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Patient had underlying medical conditions but not specific information was given. The patient''s concomitant medications were not reported. On 19May2021, the patient with co morbid condition had difficulty in breathing hours after vaccination (10am). By 7pm patient complained of the same difficulty in breathing which resulted to death. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: difficulty in breathing which resulted to death


VAERS ID: 1356975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Administration site pain, Blood fibrinogen, Body temperature, Cerebral haemorrhage, Deep vein thrombosis, Disseminated intravascular coagulation, Electrocardiogram, Fibrin D dimer increased, Influenza like illness, Platelet count, Prothrombin time, Prothrombin time shortened, Superior sagittal sinus thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: was not on hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: above 200 g/L; Test Date: 20210514; Test Name: EKG; Result Unstructured Data: not reported; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: 25 g/L; Test Date: 20210519; Test Name: Fibrin D dimer abnormal; Result Unstructured Data: over 35000; Test Date: 20210519; Test Name: Fibrinogen; Result Unstructured Data: 91; Test Date: 20210519; Test Name: APTT; Result Unstructured Data: ratio 1.19; Test Date: 20210519; Test Name: Thrombocyte count; Result Unstructured Data: 50 g/L; Comments: (40 on citrate); Test Date: 20210519; Test Name: Prothrombin time; Result Unstructured Data: 48 %
CDC Split Type: SIJNJFOC20210550911

Write-up: DISSEMINATED INTRAVASCULAR COAGULATION; CEREBRAL HEMORRHAGE; VENOUS THROMBOSIS OF SAGITTAL SINUS THROMBOSIS; Fibrin D dimer increased; Prothrombin time decreased; DEEP VEIN THROMBOSIS IN THE CALF; THROMBOCYTOPENIA; INFLUENZA LIKE ILLNESS; administration site pain; This spontaneous report was received from a physician and pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, SI-JAZMP-NCPHV-2021SI0598_0598, PBE-FAMHP-DHH-N2021-92848] and from online article, and concerned a 37 year old female. The patient''s height, weight, and medical history were not reported. The patient''s was not on hormonal contraception. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, vaccination site not reported, batch number: XD955 expiry: 28/2/2023) 1 dosage form, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 07-MAY-2021, the same day as receiving the vaccine, the patient experienced administration site pain. On 10-MAY-2021, (3 days post vaccine) the patient had flu-like symptoms including chills, sore throat with linings and was diagnosed angina tonsillitis, difficulty swallowing, malaise, myalgia, headache, tiredness, arthralgia, body temperature 39 degrees Celsius. On 14-MAY-2021, the patient had consultation for influenza like illness. She had normal thrombocytes $g 200 g/L and ECG (result not reported). On 17-MAY-2021, detection of a deep vein thrombosis in the calf. Treatment started low molecular weight heparin, Innohep (tinzaparine) 10.000 once a day for 2 injections total despite thrombocytopenia 25 g/L. On 19-MAY-2021, patient was seen at emergency service for disturbance of consciousness and hemiplegia during the night. It was detected that patient had disseminated intravascular coagulation and cerebral hemorrhage (bilateral, intraparenchymatous) facilitated by a venous thrombosis of sagittal sinus thrombosis, thrombocytopenia due to vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) and anticoagulation treatment (coded to thrombocytopenia). Laboratory data included: APTT ratio 1.19, Fibrin D-dimer abnormal over 35000, fibrinogen 91 (fibrogenopenia), prothrombin time 48%, and thrombocyte count 50 g/L (40 on citrate); normal ranges not reported for all results. Patient was admitted to intensive care unit, intubated, placed on mechanical ventilation and sedation. Treatment medications included mannitol 15 g in 15 minutes, polyvalent immunoglobulins 1g/kg/day for 2 days. Innohep (tinzaparine sodium) was discontinued and switch to Orgaran (danaparoid sodium) with monitoring of "anti Xa activity", dexamethasone 40 mg per day for 4 days. Patient died on 20-MAY-2021 (also reported as 21-MAY-2021). The cause of death was not reported. It was unknown whether an autopsy was performed. On 25-MAY-2021, positive test result was received for heparin-induced thrombopenia (HIT II). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient outcome for the events venous thrombosis of sagittal sinus thrombosis, deep vein thrombosis, disseminated intravascular coagulation, cerebral hemorrhage, thrombocytopenia, Fibrin D dimer increased, prothrombin time decreased was fatal. Outcome for influenza like illness and administration site pain was unknown. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). This case is linked to duplicate cases 20210550864, 20210550753.; Sender''s Comments: V0: This spontaneous report received from a physician and pharmacist via a regulatory authority and from online article concerned a 37-year-old woman who died after experiencing thrombocytopenia (platelet nadir: 25,000) on day 10 and sagittal sinus thrombosis (CVST) on day 12 after vaccination. Medical history was not reported. Concomitant medications included paracetamol and the patient was not taking hormonal contraception. On day 3 after vaccination, the patient had flu-like symptoms including chills, sore throat, difficulty swallowing, malaise, myalgia, headache, tiredness, arthralgia, and fever. On day 7, the patient had normal platelet count ($g200,000). On day 10, a deep vein thrombosis was detected in the calf. Treatment was initiated with low molecular weight heparin despite new thrombocytopenia (25,000). On day 12, the patient presented to the emergency department for disturbance of consciousness and hemiplegia during the night. The patient had disseminated intravascular coagulation (DIC) and cerebral hemorrhage facilitated by a venous thrombosis of sagittal sinus thrombosis. Laboratory data included: high D-dimer ($g 35000), low fibrinogen (91), low platelet count (50,000; 40,000 on citrate). Patient was intubated and placed on mechanical ventilation. Treatment medications included mannitol and polyvalent immunoglobulins for 2 days and dexamethasone for 4 days; Innohep (tinzaparine) was discontinued and switched to Orgaran (danaparoid). Patient died on day 13 of unreported cause. It was unknown whether an autopsy was performed. On day 18, a positive test result was received for heparin-induced thrombopenia (HIT II). Although the use of heparin may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition) and considering the low platelet count prior to heparin use and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.


VAERS ID: 1357482 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210548097

Write-up: DEATH; This spontaneous report received from a patient via a company representative concerned a 4 decade old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry :Unknown) dose, start therapy date were not reported, total 1 dose was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death around 10 days after receiving the vaccine. It was not reported, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0 - 20210548097 - Covid-19 vaccine ad26.cov2.s - DEATH . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1357547 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-29
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021591168

Write-up: Stroke; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021051614. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number EW2246), via intramuscular, on 10Apr2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 29Apr2021, the patient developed stroke for which she was hospitalized (admission date not provided). Then, the patient died due to the event. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1359103 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (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:
Current Illness: Decompensation cardiac; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Malaise cardiaque-Heart attack; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Malaise cardiac-Heart attack) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Parkinson''s disease and Decompensation cardiac. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CARDIAC FAILURE (Malaise cardiac-Heart attack) (seriousness criteria death and medically significant). The patient died on 14-Apr-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. No relevant concomitant medication information provided. The patient suffered from heart failure appeared to have not withstood the trauma. Examinations - The link of causality was mentioned by the emergency doctor that accompanied the SMUR [Emergency Medical Services] during the attempt to resuscitate. Treatment included resuscitation. Very limited information regarding this event has been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Translation provided for the Reporter''s comments; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1359459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-03
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Malaise, Palpitations, Pneumonia, SARS-CoV-2 test, Transient ischaemic attack
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021568357

Write-up: Flu-like symptoms; Palpitations; Pneumonia; became very ill; Ministroke; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105172040589720-ON4J5; Safety Report Unique Identifier is GB-MHRA-ADR 25311016. A 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization and experienced feeling unwell (became very ill). On 03May2021, the patient experienced ministroke (also reported as "Stroke, ministroke"). The patient (who had no history of heart disease) became very ill after each jabs, started with a racing heart (palpitations) and suspected mini stroke in the case of second jab, and the onset of flu-like symptoms and pneumonia despite shielding and not coming into contact with anyone basically. Refused to go to hospital for fear of catching COVID and slowly went down hill after second jab caused same reaction plus suspected mini stroke, before sadly passing. Flu-like symptoms, palpitations, and pneumonia were assessed as serious with criteria of life-threatening. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. "Was under the 111 virtual Intensive Care Unit (ICU) ward (with visits from paramedics/ PRIVACY)" was reported. The patient underwent COVID-19 virus test with results "No - Negative COVID-19 test" on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event ministroke was fatal; outcome of other events was unknown. The patient died on 03May2021. It was unknown whether an autopsy was performed. The cause of death was ministroke. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ministroke


VAERS ID: 1359463 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Fibrin D dimer, Platelet count, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: ASPIRIN; ATORVASTATIN; BISOPROLOL; BUMETANIDE; IVABRADINE; OMEPRAZOLE; SACUBITRIL;VALSARTAN; SALBUTAMOL; SERTRALINE; TRIMBOW
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intracranial haemorrhage; Non-smoker; Comments: Unsure if patient has had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:unknown results; Comments: unknown if anti-PF4 antibodies identified; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was not $g4000; Test Date: 20210505; Test Name: platelet count; Result Unstructured Data: Test Result:no platelet count <150 - 109/L; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021568496

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable other healthcare professional (HCP). This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202105181314162040-H2DO5, Safety Report Unique Identifier GB-MHRA-ADR 25315430. A 59 male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 at single dose for COVID-19 immunisation. Medical history included haemorrhage intracranial, non-tobacco user. There was not any additional medical history, not already provided, that relates to previous venous or arterial thromboses. The patient had not had 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 did not have history of, or current, malignancy. The patient did not currently smoke. The patient did not have a history of, or concurrent, intracranial malignancy. The patient did not have concurrent or recent intracranial infections. The patient had not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had not had a recent trauma/head injury. Past drug included heparin. Concomitant medications included aspirin, atorvastatin, bisoprolol, bumetanide, ivabradine, omeprazole, sacubitril; valsartan, salbutamol, sertraline, beclometasone dipropionate, formoterol fumarate, glycopyrronium bromide (TRIMBOW). Reported the report relate to possible blood clots or low platelet counts. It was reported the thromboembolic event / thombocytopenia additional questions detail was pulmonary embolism, occurred on 04May2021, and date of diagnosis was on 05May2021. Patient has not tested positive for COVID-19 since having the vaccine (No-Negative COVID-19 test). There was no platelet count <150 - 109/L measured on 05May2021. There was no D-dimer $g4000. It was unknown if anti-PF4 antibodies identified. Outcome of event was fatal. Death date was on 12May2021. It is unknown if autopsy was done. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1359467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Coronary artery thrombosis, Echocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; BISOPROLOL; DULOXETINE; FLUCLOXACILLIN; GLYCERYL TRINITRATE; HUMULIN I; ISOSORBIDE; LANSOPRAZOLE; PHENYTOIN; PICOLAX [CITRIC ACID;MAGNESIUM OXIDE;SODIUM PICOSULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amblyopia; Angina pectoris; Cerebrovascular accident; Chronic kidney disease stage 3; Epilepsy; Essential hypertension; Heart failure; Left ventricular systolic dysfunction; Non ST segment elevation myocardial infarction; Overweight (Obese class II (body mass index 35.0 - 39.9)); Type II diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Name: body mass index; Result Unstructured Data: Test Result:35.0 - 39.9; Test Name: echocardiogram; Result Unstructured Data: Test Result:left ventricular systolic dysfunction
CDC Split Type: GBPFIZER INC2021568502

Write-up: Coronary thrombosis; This is a spontaneous report from a contactable Other HCP (Other Health Professional) from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105181504072910-LJYGX, Safety Report Unique Identifier is GB-MHRA-ADR 25316160. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EJ6790) at single dose on an unspecified date for COVID-19 immunisation. Medical history included left ventricular dysfunction, chronic kidney disease stage 3, type 2 diabetes mellitus, cerebrovascular accident, essential hypertension, acute non-ST segment elevation myocardial infarction, vascular dementia, echocardiogram showed left ventricular systolic dysfunction, cardiac failure, epilepsy, obese class II (body mass index 35.0 - 39.9), amblyopia, angina. It was unsure if patient had had symptoms associated with COVID-19, patient had not a COVID-19 test. It was unsure if patient was enrolled in clinical trial. Concomitant medications included amlodipine; acetylsalicylic acid (ASPIRIN); atorvastatin; bisoprolol; duloxetine; flucloxacillin; glyceryl trinitrate; insulin human injection/isophane (HUMULIN I); isosorbide; lansoprazole; phenytoin; citric acid/magnesium oxide/sodium picosulfate (PICOLAX). Patient experienced coronary thrombosis with seriousness criteria life-threatening. It was diagnosed by post mortem. Patient was found dead in bed. The report was related to possible blood clots or low platelet counts. It was unknown if the platelet count was less than 150 A- 109/L, unknown if the D-dimer was more than 4000; unknown if anti-PF4 antibodies were identified. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Coronary thrombosis; Autopsy-determined Cause(s) of Death: Coronary thrombosis


VAERS ID: 1359507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021592196

Write-up: Death; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105231242001450-6EXXU. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unknown route, on 13May2021 at single dose for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in a clinical trial. The patient did not have a relevant medical history. It was also reported that the patient was on health state for his age and had no other problems. No relevant concomitant medications were provided. On 13May2021, the patient experienced death. The cause of death was not provided. 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: death


VAERS ID: 1359521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (not seen at surgery since 2017)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021600105

Write-up: Sudden 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-202105240935512940-BFV9V, Safety Report Unique Identifier GB-MHRA-ADR 25347642. A 66-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW4109), on 12May2021 at 2nd dose, single for COVID-19 immunisation. Medical history included surgery from an unspecified date to 2017, not seen at surgery since 2017. Patient was fit and well. Unsure if patient had symptoms associated with COVID-19. The patient had not a COVID-19 test and was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant medications were not reported. The patient experienced sudden death on 21May2021. It was reported that the patient was found dead. The event occurred within 2 weeks after the second dose. This report was not related to possible blood clots or low platelet counts. The patient died on 21May2021. The outcome of the event was fatal. It was unknown if an autopsy was performed, referred to coroner and await PM. The causality assessment was reported as ?? related. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1359530 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral cyst
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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: GBPFIZER INC2021600084

Write-up: Cerebral cyst; This is a spontaneous report received from a contactable consumer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105241417294830-C3GOX, Safety Report Unique Identifier GB-MHRA-ADR 25349606. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced cerebral cyst on 06May2021. The patient died due to the event on 10May2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: cerebral cyst


VAERS ID: 1359596 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; GERD; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Cardiac insufficiency; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Cardiac insufficiency) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042698) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Schizophrenia, GERD and Cardiac insufficiency. On 12-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 18-Feb-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC FAILURE (Cardiac insufficiency) (seriousness criteria death and medically significant). The patient died on 18-Feb-2021. The reported cause of death was Cardiac insufficiency. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided/ unknown. Treatment was not provided/ unknown.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1359613 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001946 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUOPLAVIN; PANTORC; RANEXA; TILDIEM
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA and PAIN in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001946) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included RANOLAZINE (RANEXA) and DILTIAZEM HYDROCHLORIDE (TILDIEM) for Angina attack, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTORC) for Hiatal hernia, ACETYLSALICYLIC ACID, CLOPIDOGREL BISULFATE (DUOPLAVIN) for Ischemic heart disease prophylaxis. On 28-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (seriousness criterion death) and PAIN ((seriousness criterion death). The patient died on 05-May-2021. The reported cause of death was Dyspnea and Diffuse 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. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24 MAY 2021 and does not contain any new information. On 25-May-2021: Follow-up information received on 25 May 2021, does not contain any significant information.; Reported Cause(s) of Death: Dyspnea; Diffuse pain


VAERS ID: 1359643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiogram, Cardiac arrest, Colonoscopy, Coma scale, Computerised tomogram, Death, Intestinal infarction, Livedo reticularis, Loss of consciousness, Melaena, Metabolic acidosis, Pupils unequal, Shock, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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 Date: 202105; Test Name: abdominal CT angiography; Result Unstructured Data: Test Result:unknown results; Test Date: 202105; Test Name: colonoscopy; Result Unstructured Data: Test Result:unknown results; Test Date: 202105; Test Name: GCS; Result Unstructured Data: Test Result:4-5; Test Date: 202105; Test Name: CT skull thorax abdomen; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021590675

Write-up: patient died; Intestinal infarct; 2 episodes of cardiocirculatory arrest; shock; transient loss of consciousness; abdominal pain in the morning; melena; emesis of dark material; marbled skin; anisocoria; metabolic acidosis; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-730882. A 74-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), intramuscular, administered in Arm Left on 09May2021 16:18 (Batch/Lot Number: FA5831; Expiration Date: 31Aug2021) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16May2021, the patient experienced intestinal infarct. It was reported that, on 16May2021 02:07 pm: access to the (Emergency Department) at the hospital for transient loss of consciousness, abdominal pain in the morning, melena, emesis of dark material. At the onset of shock, GCS (Glasgow coma scale) 4-5, anisocoria right$g left, marbled skin, metabolic acidosis, fluid resuscitation and intubation performed, amino support, transfused 1 red blood cell bag, appearance of 2 episodes of cardiocirculatory arrest resumed after CPR of 3 and 4 min, performed angioCT skull + chest + abdomen showing. The patient underwent lab tests and procedures which included angiogram: unknown results on May2021, colonoscopy: unknown results on May2021, coma scale: 4-5 on May2021, computerised tomogram: unknown results on May2021. The patient died on 17May2021. It was not reported if an autopsy was performed. Outcome of events was fatal.; Reported Cause(s) of Death: Intestinal infarct


VAERS ID: 1359776 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac tamponade, Cardio-respiratory arrest, Echocardiogram, Pericardial effusion, Pulseless electrical activity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: Test Date: 20210519; Test Name: Echocardiography; Result Unstructured Data: Test Result:Pericardial effusion
CDC Split Type: JPPFIZER INC2021573467

Write-up: Swooning; CPA; Pericardial effusion; Cardiac tamponade; Pulseless electrical activity (PEA) went into asystole; Pulseless electrical activity (PEA) went into asystole; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 09May2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 19May2021, the patient experienced swooning, CPA (cardiopulmonary arrest), pericardial effusion, cardiac tamponade, pulseless electrical activity (PEA) went into asystole. Events required emergency room visit. Outcome of events was fatal. The patient died on 19May2021. The events were also reported as follows: on 19May2021 (10 days after the vaccination), the patient had swooning during playing tennis. Emergency services was called. Cardiopulmonary arrest (CPA) was noted, and the patient was emergently transferred. Echocardiography showed pericardial effusion, for which drainage was performed. Pulseless electrical activity (PEA) went into asystole, and the patient died. The patient underwent lab tests and procedures which included echocardiogram: pericardial effusion on 19May2021. Therapeutic measures were taken as a result of pericardial effusion and cardiac tamponade includes drainage; it was unknown if patient received treatment for other events. It was unknown if an autopsy was performed. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had any known allergies to medications, food, or other products. It was unknown if the patient was tested for COVID-19 since the vaccination.; Sender''s Comments: The events most likely considered as intercurrent conditions and unlikely related to suspect bnt162b2 (COMIRNATY), dose 1 intramuscular on 09May2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. The events occurred 10 days after the vaccination. Additional information is required to make a more meaningful medical assessment including complete medical history and toxicology reports.; Reported Cause(s) of Death: Cardiac tamponade; Pulseless electrical activity (PEA) went into asystole; Pulseless electrical activity (PEA) went into asystole; Pericardial effusion; CPA; Swooning


VAERS ID: 1359777 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E3674 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021586392

Write-up: Cardiac failure acute suspected; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 91-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: E3674), via an unspecified route of administration on 21May2021 10:30 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 21May2021, the patient experienced cardiac failure acute suspected, which was serious for death. The clinical course was as follows: On 21May2021 at unknown time (the day of vaccination), the patient received a dose of BNT162b2. On 21May2021 (the day of vaccination), the patient experienced cardiac failure acute suspected and died. This was further described as: on 21May2021 at 10:30 (the day of vaccination), the patient was vaccinated. On the same date at 16:00, the patient died. The reporting physician judged that the causality with BNT162b2 could not be excluded completely. He speculated that cardiac failure acute could be the cause considering the patient''s advanced age but said that he was uncertain because no autopsy was performed. On 21May2021 (the day of vaccination), the outcome of the event was fatal. The patient died on 21May2021 due to cardiac failure acute suspected. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cardiac failure acute. The reported event likely represent intercurrent medical condition in this elderly 91 year old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure acute suspected


VAERS ID: 1359778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bilirubin, Coma scale, Haemoglobin, Haemolytic anaemia, Loss of consciousness, Pyrexia, Thrombotic thrombocytopenic purpura
SMQs:, Torsade de pointes/QT prolongation (broad), Haemolytic disorders (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 2
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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Bilirubin; Result Unstructured Data: Test Result:24.9; Test Date: 20210524; Test Name: Coma Scale ; Result Unstructured Data: Test Result:3-digit level; Test Date: 20210524; Test Name: Haemoglobin; Result Unstructured Data: Test Result:4.9
CDC Split Type: JPPFIZER INC2021586420

Write-up: Loss of consciousness; Suspected fulminant TTP; Severe haemolytic anaemia; Pyrexia; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient''s medical history was reported as none. There were no concomitant medications. On 22May2021, the patient experienced pyrexia (non-serious). On 24May2021 03:00, the patient experienced loss of consciousness (death, medically significant). On 24May2021, the patient experienced suspected fulminant TTP (death, medically significant), severe haemolytic anaemia (death, medically significant). The events suspected fulminant thrombotic thrombocytopenic purpura, severe haemolytic anaemia, and loss of consciousness, required a visit to the emergency room. The clinical course was reported as follows: The patient was an 88-year-old female. The patient had no historical condition or concomitant medications. On 19May2021 at unknown time (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 22May2021 at unknown time (3 days after the vaccination), the patient experienced pyrexia. On 24May2021 around 03:00 (5 days after the vaccination), the patient experienced loss of consciousness. On 24May2021 at unknown time (5 days after the vaccination), the patient experienced suspected fulminant thrombotic thrombocytopenic purpura and severe haemolytic anaemia. On 24May2021 (5 days after the vaccination), the outcome of the events (suspected fulminant thrombotic thrombocytopenic purpura, severe haemolytic anaemia, and loss of consciousness) was fatal, while the outcome of pyrexia was not provided. The course of the events was as follows: On 19May2021 (the day of vaccination), the patient was vaccinated. On 22May2021 (3 days after the vaccination), the patient experienced pyrexia. On 24May2021 around 03:00 (5 days after the vaccination), the patient experienced loss of consciousness. The Coma Scale was at 3-digit level. The patient was transported by ambulance. Haemoglobin was 4.9, and bilirubin 24.9. Severe haemolytic anaemia was noted. Fulminant thrombotic thrombocytopenic purpura was suspected. The exact seriousness of pyrexia was not reported. The reporting physician said hemolysis was seen for this patient. The reporting physician classified the other events as serious (death) and also stated couldn''t deny the causality of BNT162b2. The reporting physician commented as follows: The causal relationship could not be excluded. The patient underwent lab tests and procedures which included bilirubin: 24.9 on 24May2021, Coma Scale: 3-digit level on 24May2021, haemoglobin: 4.9 on 24May2021. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the events: suspected fulminant thrombotic thrombocytopenic purpura, severe haemolytic anaemia, and loss of consciousness, was fatal. The patient died on 24May2021 due to suspected fulminant thrombotic thrombocytopenic purpura, severe haemolytic anaemia, and loss of consciousness. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, COMIRNATY, were not provided and will be requested during follow up.; Sender''s Comments: The paucity of clinical details precludes a full assessment and does not allow the company to completely exclude a reasonable possibility that the suspect drug BNT162B2 contributed to the reported events fulminant thrombotic thrombocytopenic purpura, severe hemolytic anemia, and loss of consciousness based on a temporal relationship. 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: suspected fulminant thrombotic thrombocytopenic purpura; Loss of consciousness; Severe haemolytic anaemia


VAERS ID: 1359779 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Heart disease, unspecified; Hypertension; Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021593737

Write-up: Acute myocardial infarction suspected; This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 94-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 23May2021 at 15:00 at a single dose for covid-19 immunisation. Medical history included heart disease, prostatic hyperplasia, cerebral infarction, and hypertension. Concomitant medication included acetylsalicylic acid (BAYASPIRIN). The patient previously received the first dose of the bnt162b2 on 02May2021 for covid-19 immunization. On 24May2021, the patient experienced acute myocardial infarction suspected, which was serious for death. The clinical course was as follows: on 23May2021 at around 15:00 (the day of vaccination), the patient received the second dose of BNT162b2. After the vaccination, the patient was having dinner as usual and went to bed. On 24May2021 (1 day after the vaccination), since the facility staff noticed that the patient had not gotten up, they went to confirm him and found him dead. According to the investigation by the police, it was suggested that the patient had acute myocardial infarction suspected and there was no causal relationship with BNT162B2. The patient underwent lab tests and procedures which included body temperature: 36.5 degrees Centigrade on 23May2021 before vaccination. The patient died on 24May2021 due to acute myocardial infarction suspected. It was not reported if an autopsy was performed. The seriousness assessment of the event was not provided. The reporting physician considered the same way, but he also stated that the causal relationship with BNT162B2 could not be denied. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information currently available the event acute myocardial infarction suspected is attributed to patient''s advanced age and multiple underlying risk factors including heart disease, hypertension and cerebral infarction and assessed unlikely related to BNT162B2 (COMIRNATY) vaccine. 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: Acute myocardial infarction suspected


VAERS ID: 1359780 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021594930

Write-up: Pancreatitis acute; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) at 69-years-old as a single dose for COVID-19 immunisation. The patient''s medical history (or family history) and concomitant medications were not reported. On 22May2021, five days after the vaccination, the patient experienced pancreatitis acute, which was assessed as medically significant and resulted in death. On 25May2021, the reporting physician was informed of that by the patient''s son on the phone. Further information was to be confirmed with the patient''s family. The clinical outcome of the event was fatal. The patient died on 22May2021 due to pancreatitis acute. It was unknown if an autopsy was performed. The assessment of causality between the event and bnt162b2 was not provided. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender''s Comments: There is no sufficient evidence that the reported acute pancreatitis, although temporally related, may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review 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: Pancreatitis acute


VAERS ID: 1359782 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism venous
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Open heart surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC2021587858

Write-up: VTE 1 Month following 2nd dose of vaccine; This is a spontaneous report from a contactable physician received through Pfizer colleague. An 88-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. Medical history included Heart Failure, Open Heart Surgery. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient experienced VTE (Venous thromboembolism) 1 Month following 2nd dose of vaccine, Patient Passed Away. The patient died on an unspecified date. It was unknown if an autopsy was performed. information on the lot/batch number has been requested.; Sender''s Comments: Based on known disease pathophysiology, the serious event is assessed as not related to the BNT162B2 and more likely due to the intercurrent and/or underlying medical conditions in this 88 years old patient. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: VTE 1 Month following 2nd dose of vaccine


VAERS ID: 1359795 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-05-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fibrin D dimer, Haptoglobin, Platelet count, Reticulocyte count, 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: 2021-05-05
   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: BENDEKA
Current Illness: Fibrillation atrial
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Cerebrovascular accident; Fracture; Lymphocytic lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: d-dimeer; Result Unstructured Data: measured 48 hours after collection -which is not validated; Test Date: 20210506; Test Name: Haptoglobine; Result Unstructured Data: test of 04-05-2021 resulted on 06-05-2021; Test Date: 20210504; Test Name: thrombocyten; Result Unstructured Data: 115 10/9 per liter; Test Date: 20210506; Test Name: Reticulocyten; Result Unstructured Data: test of 04-05-2021 resulted on 06-05-2021
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Fracture, Cerebrovascular accident and Aneurysm aortic. Concurrent medical conditions included Lymphocytic lymphoma and Fibrillation atrial. Concomitant products included BENDAMUSTINE HYDROCHLORIDE (BENDEKA) for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 05-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Platelet count: 115 10/9 per liter 115 10/9 per liter. On 06-May-2021, Fibrin D dimer: 0.99 milligram per litre measurement 48 hours after collection-which is not validated. On 06-May-2021, Haptoglobin: 1.24 gram per litre test of 04-05-2021 resulted on 06-05-2021. On 06-May-2021, Reticulocyte count: 49.4 10/9 per liter test of 04-05-2021 resulted on 06-05-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.; Reported Cause(s) of Death: Unclear, given setting, a thrombotic event could have played a role, but unclear whether this is vaccination related. Also known in the past with atrial fibrillation, CVA and aneurysm of the thoracic aorta (which on this week''s CT did not change).


VAERS ID: 1359816 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Myocardial infarction; Embolism limb; This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and PERIPHERAL EMBOLISM (Embolism limb) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Atherosclerosis and Diabetes. On 27-Feb-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Mar-2021 at 10:30 AM, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant) and PERIPHERAL EMBOLISM (Embolism limb) (seriousness criterion death). 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) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. 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. Event terms, onset dates and outcomes captured per SD Authority reporting. Seriousness per Authority assessment and IME listing; 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. Event terms, onset dates and outcomes captured per HA Authority reporting. Seriousness per Authority assessment and listing; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1359838 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIMODERNATX, INC.MOD20211

Write-up: Unresponsive to stimuli; Difficulty breathing; Hemoptysis; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Difficulty breathing), HAEMOPTYSIS (Hemoptysis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001654) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion death) and HAEMOPTYSIS (Hemoptysis) (seriousness criterion death). On 24-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criteria death and medically significant). The reported cause of death was Difficulty breathing, Hemoptysis and Unresponsive to stimuli. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DYSPNOEA (Difficulty breathing), HAEMOPTYSIS (Hemoptysis) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) to be unlikely related. Concomitant medications were not reported Treatment information was not provided; Reported Cause(s) of Death: Difficulty breathing; Hemoptysis; Unresponsive to stimuli


VAERS ID: 1360115 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Private       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: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Severe Obstructive Sleep Apnea, using cpap
Preexisting Conditions: Recently diagnosed to have high prolactin (used 8 doses of pituitary gland medication)
Allergies: No known Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac arrest and death.


VAERS ID: 1360651 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; AMLOC [AMLODIPINE BESILATE]; IRON SULPHATE; LASIX [FUROSEMIDE]; SLOW K; ZOCOR; STILNOX; ACTRAPHANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amputation (due to diabetes mellitus complications); Cardiac failure; Diabetes mellitus (IDDM); Hypertension; Kidney dysfunction; Obesity; Treatment noncompliance (often hyperglycemic/hypoglycemic)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:150/90; Test Name: Temperature; Result Unstructured Data: Test Result:36.5
CDC Split Type: ZAPFIZER INC2021568155

Write-up: found dead; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE), the first dose via unspecified route of administration on 17May2021 (Batch/Lot Number: EY4834; Expiration Date: 17May2021), as single dose for covid-19 immunization. The vaccine was reconstituted at the pharmacy, vaccination was done at the vaccination site. Medical history included cardiac failure, diabetes mellitus (IDDM), renal impairment, bilateral amputation (due to diabetes mellitus complications), hypertension, diabetes treatment noncompliance (often hyperglycemic/hypoglycemic), obesity. Concomitant medications included enalapril; amlodipine besilate (AMLOC); iron sulphate; furosemide (LASIX), potassium chloride (SLOW K); simvastatin (ZOCOR); zolpidem tartrate (STILNOX); human insulin injection, isophane (ACTRAPHANE). According to the nurse who administered the vaccine, the patient was stable prior & during vaccination, alert and responsive, he had no signs and symptoms and was clinically stable post vaccination. He was observed and discharged. The patient was reported to have had no previous reaction (after immunization) history; it was unknown if he had any history of allergies (vaccine, food, drugs), it was unknown if he had any family history (allergies) or diseases. The patient was reported to have died on 18May2021. The patient was reported to have found dead in his room at 16h45. It was unknown if autopsy was performed. According to the physician, it was reported that there was no error in prescribing or non-adherence to recommendations for use of vaccine, the vaccine was sterile, the physical conditions (e.g. color, turbidity, foreign substances) were normal at the time of administration, no error in vaccine reconstitution/preparation by the vaccinator, no error in handling, the vaccine was administered correctly. The patient underwent lab test included blood pressure: 150/90 on an unspecified date; temperature: 36.5 on an unspecified date. The outcome of the event was fatal.; Sender''s Comments: The causal relationship between BNT162B2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: found dead


VAERS ID: 1362702 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Apathy, Asthenia, Cardiovascular examination, Concomitant disease aggravated, Confusional state, Decreased appetite, Dysphagia, Fall, Haematoma, Head titubation, Memory impairment, Pneumonia, SARS-CoV-2 test, Tremor, Urinary incontinence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLEOVIT D3; CALCIDURAN VIT. D3; ABILIFY; MOLAXOLE; AMLODIPINE; VENLAFAXINE; SAROTEN
Current Illness: Cardiac insufficiency; General debility; Lower extremities weakness of; Pulmonary function impairment; Scoliosis; Urine incontinence
Preexisting Conditions: Medical History/Concurrent Conditions: Birth trauma; Neonatal hypoxia
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: ; Result Unstructured Data: Test Name: COVID-19 PCR test; Test Result: Negative; Result Unstructured Data: PCR-Test; Test Name: COVID-19; Test Result: Negative; Result Unstructured Data: PCR-Test
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Neonatal hypoxia and Birth trauma. Concurrent medical conditions included Scoliosis, Pulmonary function impairment, Cardiac insufficiency, Lower extremities weakness of, General debility, and Urine incontinence. Concomitant products included OLEOVIT D3, CALCIUM CARBONATE, COLECALCIFEROL (CALCIDURAN VIT. D3), ARIPIPRAZOLE (ABILIFY), MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOLAXOLE), AMLODIPINE, VENLAFAXINE and AMITRIPTYLINE HYDROCHLORIDE (SAROTEN) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced CONCOMITANT DISEASE AGGRAVATED. On 24-Mar-2021, the patient experienced MEMORY IMPAIRMENT, HEAD TITUBATION, TREMOR, DECREASED APPETITE, ASTHENIA, CONFUSIONAL STATE, AGITATION, APATHY, and URINARY INCONTINENCE. On 25-Mar-2021, the patient experienced FALL. On 26-Mar-2021, the patient experienced HAEMATOMA. On 22-Apr-2021, the patient experienced DYSPHAGIA. On 25-Apr-2021, the patient experienced PNEUMONIA(seriousness criteria death and medically significant). The patient died on 26-Apr-2021. The reported cause of death was PNEUMONIA. It is unknown if an autopsy was performed. At the time of death, DYSPHAGIA, FALL and HAEMATOMA outcome was unknown and MEMORY IMPAIRMENT, HEAD TITUBATION, TREMOR, DECREASED APPETITE, ASTHENIA, CONFUSIONAL STATE, CONCOMITANT DISEASE AGGRAVATED, AGITATION, APATHY and URINARY INCONTINENCE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Cardiovascular examination: On an unknown date, SARS-CoV-2 test: negative (Negative) PCR-Test and negative (Negative) PCR-Test For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. 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. Event terms, onset dates, seriousness and outcomes captured per Regulatory Authority reporting; 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. Event terms, onset dates, seriousness and outcomes captured per Regulatory Authority reporting; Reported Cause(s) of Death: PNEUMONIA.


VAERS ID: 1362706 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEXALEN; ACEMIN [ACECLOFENAC]; OLEOVIT D3; ELIQUIS; CONCOR; VIMOVO; CAL-D-VITA; SEDACORON
Current Illness: Atrial fibrillation; Cardiac insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma (2015/2016, 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Lymphoma (2015/2016, 2020) in 2015. Concurrent medical conditions included Atrial fibrillation and Cardiac insufficiency. Concomitant products included PARACETAMOL (MEXALEN), ACECLOFENAC (ACEMIN [ACECLOFENAC]), COLECALCIFEROL (OLEOVIT D3), APIXABAN (ELIQUIS), BISOPROLOL FUMARATE (CONCOR), ESOMEPRAZOLE MAGNESIUM, NAPROXEN (VIMOVO), CALCIUM CARBONATE, COLECALCIFEROL (CAL-D-VITA) and AMIODARONE HYDROCHLORIDE (SEDACORON) for an unknown indication. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PNEUMONIA BACTERIAL (seriousness criteria death and medically significant). The patient died on 26-Apr-2021. The reported cause of death was Pneumonia bacterial and Cardiac insufficiency. An autopsy was not performed. Treatment information was not provided. Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Additional information received on 20 May 2021. Updated death details and cause of death. Added concomitant medications.; Reporter''s Comments: Sender''s Comments: Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Reported Cause(s) of Death: Pneumonia bacterial; Cardiac insufficiency


VAERS ID: 1362783 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vascular stent thrombosis
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: WARFARIN
Current Illness: Chronic ischaemic heart disease, unspecified; Essential hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Obesity; Ventricular fibrillation; Ventricular flutter
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a pharmacist and describes the occurrence of VASCULAR STENT THROMBOSIS in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Obesity, Ventricular flutter, Ventricular fibrillation and Aortic valve insufficiency. Concurrent medical conditions included Essential hypertension and Chronic ischaemic heart disease, unspecified. Concomitant products included WARFARIN for an unknown indication. On 25-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VASCULAR STENT THROMBOSIS (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 28-Apr-2021. The reported cause of death was coronary stent thrombosis of the left anterior descending artery. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. This is a case of death in a 64 -year-old male subject with a hx of Obesity, Essential Hypertension, Ventricular flutter, Ventricular fibrillation, Chronic ischaemic heart disease, unspecified and Aortic valve insufficiency, who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Medical history and concomitant medications added. Narrative updated.; Sender''s Comments: This is a case of death in a 64 -year-old male subject with a hx of Obesity, Essential Hypertension, Ventricular flutter, Ventricular fibrillation, Chronic ischaemic heart disease, unspecified and Aortic valve insufficiency, who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Coronary stent thrombosis of the left anterior descending artery


VAERS ID: 1362915 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20211

Write-up: Cerebral infarction; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL INFARCTION (Cerebral infarction) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBRAL INFARCTION (Cerebral infarction) (seriousness criteria death and medically significant). It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Regulatory Authority reporting.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Regulatory Authority reporting


VAERS ID: 1362928 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deficiency mental; Glaucoma; Hypercholesterolaemia; Hypertension arterial; Myocardial necrosis
Allergies:
Diagnostic Lab Data: Test Date: 20201124; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial, Glaucoma, Hypercholesterolaemia, Deficiency mental and Myocardial necrosis. On 14-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 03-May-2021 The patient died on 03-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Company comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1362957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 RA / 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: 2021-05-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021591106

Write-up: Death sudden; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory Authority report number FR-AFSSAPS-2021054646]. A 75-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular in arm right, on 11May2021 (Lot Number: EX7823), as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death sudden (death) on 13May2021. Patient was found deceased at home by firefighter. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1362958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Neurological symptom, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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: Disease Parkinson''s; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210551265

Write-up: SHOCK; NEUROLOGICAL SYMPTOM; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-2021056660] concerned an 80-year-old male. The patient''s weight was 80 kilograms, and height was 170 centimeters. The patient''s past medical history included disease Parkinson''s, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955) 1 dosage forms, 1 total administered on 30-APR-2021 for covid-19 vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient had neurological symptom. On 02-MAY-2021, he had shock. On the same day, he died from shock, and neurological symptom. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210551265-Covid-19 vaccine ad26.cov2.s-Shock, neurological symptoms. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s; Reported Cause(s) of Death: SHOCK; NEUROLOGICAL SYMPTOM


VAERS ID: 1362993 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Reduced general condition; This regulatory authority case was reported by a physician and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Aortic valve replacement. Concurrent medical conditions included Hypertension arterial. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In April 2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) (seriousness criterion death). The patient died on 03-May-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 medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021049969 Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Sender''s Comments: Very limited information regarding the event has been provided at this time. However, the patient''s advanced age and underlying medical conditions remains as confounders. Further information can''t be requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363034 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer; Atrial fibrillation; Cardiac failure; Hypertension arterial; Infarct myocardial; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Infarct myocardial; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Infarct myocardial) in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Infarct myocardial, Atrial fibrillation, Cardiac failure, Type 2 diabetes mellitus, Hypertension arterial, Artificial cardiac pacemaker wearer and Vascular dementia. On 27-Apr-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 29-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 29-Apr-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications and treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Company Comment: Although very limited amount of details has been provided at this time, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Although very limited amount of details has been provided at this time, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1363318 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021629387

Write-up: stroke; bleed on brain; This is a spontaneous report from a contactable consumer reporting information for herself and her father. This is the second of two reports, reported for father. The first report is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105142205030910-CTOOA, Safety Report Unique Identifier GB-MHRA-ADR 25301867. A male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included stroke. Concomitant medications were unknown. He died 2 days after 2nd vaccine on 25Feb2021. He had a stroke and bleed on brain. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021548646 same reporter / drug, different patient / event; Reported Cause(s) of Death: bleed on brain; stroke


VAERS ID: 1363336 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

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-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (death) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 07-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 30-Apr-2021 The patient died on 30-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 medication reported. No treatment information was provided. Company Comment: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonia, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Musculoskeletal disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021599142

Write-up: hypostatic pneumonia; COVID-19 confirmed by positive PCR COVID-19 test; COVID-19 confirmed by positive PCR COVID-19 test; Fever; This is a spontaneous report from a contactable healthcare professional downloaded from the regulatory authority [HU-OGYI-322221], received from the agency. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 30Jan2021 (Batch/Lot Number: EJ6134) as 0.3 ml single for covid-19 immunisation. Medical history included musculoskeletal disorder and hypertension, dates unknown. The patient''s concomitant medications were not reported. The patient had covid-19 confirmed by positive PCR covid-19 test on 16Feb2021 (fatal outcome), hypostatic pneumonia on 25Feb2021 (fatal outcome), and high fever on 15Feb2021 with outcome of unknown. The patient experienced physical weakness and subfebrility, and died on 25Feb2021 due to COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR test positive on 16Feb2021. The patient died on 25Feb2021. An autopsy was not performed. Sender Comment: COVID-19 PCR test was positive 17 days after, and the patient died 26 days after Comirnaty vaccination due to COVID-19. Autopsy was not done. The event is not related to Comirnaty vaccination. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia hypostatic; COVID-19; Drug ineffective


VAERS ID: 1363339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, COVID-19, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
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: 2021-03-16
   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: EUCREAS; AMPRILAN; FUROSEMIDE; MILURIT; KALDYUM; ELIQUIS; EPLERENONE; ADEXOR; CONCOR
Current Illness: Atrial fibrillation; Hypertension; Ischaemic heart disease; NIDDM
Preexisting Conditions: Medical History/Concurrent Conditions: Suicidal plans; Uterine prolapse
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Blood gases; Result Unstructured Data: Test Result:metabolic acidosis, increased lactate levels, hypo; Comments: metabolic acidosis, increased lactate levels, hypoxia, hyperkalaemia; Test Date: 20210316; Test Name: Blood test; Result Unstructured Data: Test Result:increased DDI, increased inflammatory parameters,; Comments: increased DDI, increased inflammatory parameters, increased necroenzyme levels; Test Date: 20210316; Test Name: Chest X-ray; Result Unstructured Data: Test Result:diagnose of COVID-19 pneumonia, hydrothorax; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021599139

Write-up: Cardiac failure; Drug Ineffective; COVID-19 pneumonia; COVID-19 virus test positive; COVID-19; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-335221. A 80-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Mar2021 (Batch/Lot Number: ET1831) as 0.3mL single for covid-19 immunisation . Medical history included ongoing type 2 diabetes mellitus , ongoing hypertension , ongoing myocardial ischaemia , uterine prolapse , suicidal ideation ongoing atrial fibrillation. Concomitant medications included metformin hydrochloride, vildagliptin (EUCREAS) taken for an unspecified indication, start and stop date were not reported; ramipril (AMPRILAN) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported; allopurinol (MILURIT) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KALDYUM) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; eplerenone (EPLERENONE) taken for an unspecified indication, start and stop date were not reported; trimetazidine hydrochloride (ADEXOR) taken for an unspecified indication, start and stop date were not reported; bisoprolol fumarate (CONCOR) taken for an unspecified indication, start and stop date were not reported. On an unknown date the patient received the first dose of BNT162B2 vaccine. The patient experienced drug ineffective on Mar2021 , covid-19 pneumonia on Mar2021 , Covid-19 virus test positive on Mar2021 , Covid-19 on Mar2021 , cardiac failure . All the reported events led to patient''s death on 16Mar2021. The patient underwent lab tests and procedures which included blood gases on 16Mar2021: metabolic acidosis, increased lactate levels, hypoxia, hyperkalaemia , blood test: on 16Mar2021 increased DDI, increased inflammatory parameters, increased necroenzyme levels , chest x-ray: diagnose of covid-19 pneumonia, hydrothorax on 16Mar2021 , sars-cov-2 test: positive. The patient died on 16Mar2021. It was not reported if an autopsy was performed. Course of the events: On 10Mar2021, the 80-year-old female patient received the second dose of 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; batch number: ET1831, expiry date: unknown, intramuscularly, in the left arm) for COVID-19 immunisation. On 16Mar2021, the patient was sent to the hospital, due to dyspnoea, fatigue and weakness. The patient''s COVID-19 test was positive, COVID-19 was diagnosed. Several tests were initiated. Chest x-ray showed COVID-19 pneumonia, hydrothorax. Blood gas analysis showed metabolic acidosis, increased lactate levels, hypoxia and hyperkalaemia. Blood test showed impaired renal function, increased DDI, increased inflammatory parameters and increased necroenzyme levels. The patient received diuretic therapy and oxygen supplementation, but died on the same day, on 16Mar2021. According to the death certificate, the direct cause of death was cardiac failure and acute respiratory failure. The patient''s primary disease was COVID-19, which escalated to hyperkalaemia and COVID-19 pneumonia. No further information is expected. Sender Comment: COVID-19 and COVID-19 pneumonia are not expected after vaccination with Comirnaty. TTO (Time Trade -Off) is 6 days until the patient''s death but COVID-19 symptoms occurred earlier. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to fatal outcome.; Reported Cause(s) of Death: cardiac failure; acute respiratory failure


VAERS ID: 1363340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Chest X-ray, Dyspnoea, Echocardiogram, Electrocardiogram, International normalised ratio, Laboratory test, Multiple organ dysfunction syndrome, SARS-CoV-2 test, Ultrasound abdomen
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 9
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; Decompensation cardiac; Hypertension; Ischemic heart disease; Obesity; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Chest X-ray; Result Unstructured Data: Test Result:hydrothorax; Test Date: 20210424; Test Name: Echocardiogram; Result Unstructured Data: Test Result:right heart insufficiency, pulmonary hypertension; Comments: right heart insufficiency, pulmonary hypertension; Test Date: 20210424; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation, repolarization disorder; Comments: atrial fibrillation, repolarization disorder; Test Date: 20210427; Test Name: INR; Result Unstructured Data: Test Result:3.9; Comments: 3.9; Test Date: 20210426; Test Name: Laboratory test; Result Unstructured Data: Test Result:anaemia, imparied renal function, hyperkalaemia; Comments: anaemia, imparied renal function, hyperkalaemia; Test Date: 20210424; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Comments: negative; Test Date: 20210427; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:hepatomegaly, cholelitiasis; Comments: hepatomegaly, cholelitiasis, free intra-abdominal fluid
CDC Split Type: HUPFIZER INC2021599144

Write-up: Multiple organ failure; Dyspnoea; Anaemia; This is a spontaneous report from a contactable physician (patient). This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-335321. An 85-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 21Apr2021 (Batch/Lot Number: EW4815) as 0.3 mL, single for covid-19 immunisation. Medical history included Ischemic heart disease, Decompensation cardiac, Renal insufficiency, atrial fibrillation, obesity, hypertension. The patient''s concomitant medications were not reported. The patient had received the first dose of vaccine on unknown date. On 24Apr2021, the patient was hospitalized due to anaemia and dyspnoea. COVID-19 rapid test was negative, ECG showed atrial fibrillation and repolarization disorder. Echocardiogram confirmed right heart insufficiency and pulmonary hypertension. Chest X-ray on 26Apr2021 confirmed hydrothorax. On 27Apr2021, abdominal ultrasound showed hepatomegaly, cholelithiasis and free intra-abdominal fluid. The patient was disoriented and restless. Laboratory tests showed macrocyter anaemia, impaired renal function, hyperkalaemia, and elevated INR (3.9) due to Syncumar (acenocumarol) overdose. Echocardiogram confirmed right heart insufficiency and pulmonary hypertension. A pulmonological cause was suspected in the background of her complaints. The patients condition gradually deteriorated, and she died due to multiple organ failure on 03May2021 at 18:50. There is no information whether autopsy was done. Sender Comment: The 85-year-old patient died 12 days after Comirnaty vaccination due to multiple organ failure. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: multiple organ failure


VAERS ID: 1363341 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6534 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021599145

Write-up: death; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-335821. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 02May2021 (Batch/Lot Number: EX6534) as 0.3 mL, single for covid-19 immunisation. Nor medical history nor concomitant medication was reported. The patient had received the first dose of vaccine from Batch/lot number: ET3620 on 28Mar2021. On 05May2021 the patient died. There is no information about the cause of death, an autopsy was requested. Autopsy results were not available. Sender Comment: The 91-year-old patient died 3 days after Comirnaty vaccination. There is no information about the cause of death, autopsy was requested. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363342 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale, Dyspnoea, Oxygen saturation, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: Aortic valve disease (artificial valve inserted); Atrial fibrillation (He has been taking anticoagulants); Bladder catheterisation; COPD; GERD; Malignant urinary tract neoplasm; Prostatic hyperplasia; Spondylitis ankylopoietica
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder catheter replacement; Cholelithiasis
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: O2 saturation; Result Unstructured Data: Test Result:Normal; Test Date: 20210419; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021599149

Write-up: death; dyspnoea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-342121. This is a report received from the agency. Regulatory authority report number HU-OGYI-342121. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Apr2021 (Batch/Lot Number: PAA165994; Expiration Date: Aug2021) as 2nd dose, 0.3 mL single at the age of 74-year-old for covid-19 immunisation. Medical history included ongoing malignant urinary tract neoplasm, ongoing benign prostatic hyperplasia, ongoing gastrooesophageal reflux disease (GERD), cholelithiasis, ongoing spondylitis ankylopoietica, ongoing chronic obstructive pulmonary disease (COPD), aortic valve disease from 2000 and ongoing artificial valve inserted, ongoing bladder catheterisation, ongoing atrial fibrillation and he had been taking anticoagulants. He has been taking anticoagulants, as well, for atrial fibrillation. On 19Apr2021, he has been on catheter replacement, that time, his COVID-19 test was negative, his O2 saturation was normal. The patient''s concomitant medications were not reported. The first dose of bnt162b2 (COMIRNATY) was administered intramuscular on 26Mar2021 for covid-19 immunisation. On 08May2021, the patient started to have dyspnoea with outcome of unknown. He died on 09May2021. The patient underwent lab tests and procedures which included oxygen saturation: normal, Sars-cov-2 test: negative. Autopsy has been done, cause of death was cor pulmonale. COVID-19 test was negative. Based on the patient''s physicians opinion, the death was not related to vaccination. Sender Comment: Death is not expected adverse events of COMIRNATY. It might be caused by the patients chronic diseases. TTO was 10 days. Based on the above, causality between death and vaccination is not related. The case is serious because the patient died. No further information is expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: The 74-year-old male patient had medical history included malignant urinary tract neoplasm, chronic obstructive pulmonary disease (COPD), aortic valve disease and artificial valve inserted, and atrial fibrillation. Autopsy has been done, and cause of death was cor pulmonale. Based on information available, the reported cor pulmonale with death outcome was most likely caused by patient''s underlying chronic diseases, and unlikely related to vaccine bnt162b2 (COMIRNATY).; Reported Cause(s) of Death: cor pulmonale


VAERS ID: 1363343 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-19
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Appendectomy; Atrial fibrillation; Cholecystectomy; COVID-19; COVID-19 pneumonia; Eye operation NOS; Hypertension; Tonsillectomy; Varicose veins NOS (Varicectomy)
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: Chest X-ray; Result Unstructured Data: Test Result:confirmed pneumonia; Comments: confirmed pneumonia; Test Date: 20210319; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021599137

Write-up: Vaccination failure; COVID-19 pneumonia; COVID-19; COVID-19 antigen test positive; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB [HU-OGYI-343221]. This is a spontaneous report from a contactable other hcp. This is a report received from the agency. Regulatory authority report number HU-OGYI-343221]. A 84-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EP2163) as 0.3 mL, single, and dose 1 intramuscular on 17Feb2021 (Batch/Lot Number: EL0725) as 0.3 mL, single for covid-19 immunisation . Medical history included covid-19 from an unknown , hypertension, covid-19 pneumonia , appendicectomy , hypersensitivity , tonsillectomy , cholecystectomy , atrial fibrillation , varicose vein (Varicectomy) , eye operation. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 19Mar2021 , covid-19 pneumonia on 19Mar2021 , covid-19 on 19Mar2021 , covid-19 antigen test positive on 19Mar2021. All the reported events caused patient hospitalization and led to patient''s death on 22Mar2021. The patient underwent lab tests and procedures which included chest x-ray: confirmed pneumonia on 19Mar2021 , sars-cov-2 test: positive on 19Mar2021 . The patient died on 22Mar2021. An autopsy was not performed. Course of the event: The patient was admitted to the hospital because of breathing difficulty, diarrhea, and general weakness. Covid-19 antigen test was positive, and chest X-ray confirmed pneumonia. The patient received covid therapy, but his condition worsened, and passed away on 22Mar2021 at 04:30 due to cardiorespiratory insufficiency. Sender Comment: The patient got infected with Covid-19 nine days after the second dose, therefore vaccination failure is considered possible. The case is serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1363344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-28
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ileus paralytic, Neoplasm malignant
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: Cholecystectomy; Lung cancer; Osteoporosis; Retroperitoneal sarcoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021599146

Write-up: paralytic ileus; Neoplasm malignant; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number HU-OGYI-343521. A 82-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 08Mar2021 (Batch/Lot Number: EP2163) as 0.3 ml single for covid-19 immunisation. Medical history included soft tissue sarcoma from 2020 to an unknown date, lung neoplasm malignant from 2020 to an unknown date, cholecystectomy from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 28Mar2021 the patient was admitted in the hospital in a weak condition because of ileus paralyticus. The patient received therapy, but as her vital parameters gradually deteriorated, she passed away on 05Apr2021 at 14:00. In 2020 the patient was diagnosed with abdominal cancer and pulmonary metastases but oncological treatment was not possible due to her weak condition. Based on the hospital discharge summary and death certificate, the cause of death was the patient''s primary disease, incurable cancer. Sender Comment: According to the patient''s hospital discharge summary, the causal relationship is unlikely between the suspected drug and the adverse event as it was assessed as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Neoplasm malignant


VAERS ID: 1363353 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-20
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; NovoRapid insulin; LINAGLIPTIN; CLOPIDOGREL; ATENOLOL; ADENURIC; LANTUS; ISOSORBIDE MONONITRATE; LISINOPRIL; LERCANIDIPINE
Current Illness: Hypertension; Insulin-requiring type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Gout; Hyperlipidaemia; IHD; Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20211

Write-up: RIP; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (RIP) in a 77-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3001177 and 3001177) for COVID-19 vaccination. The patient''s past medical history included Unspecified cerebrovascular disease, Chronic renal failure, Gout, Hyperlipidaemia and IHD. Concurrent medical conditions included Insulin-requiring type 2 diabetes mellitus and Hypertension. Concomitant products included FEBUXOSTAT (ADENURIC) from 01-Jan-2000 to 20-Apr-2021 for Gout, LISINOPRIL from 01-Jan-2000 to 20-Apr-2021 and LERCANIDIPINE from 01-Jan-2000 to 20-Apr-2021 for Hypertension, CLOPIDOGREL from 01-Jan-2000 to 20-Apr-2021, ATENOLOL from 01-Jan-2000 to 20-Apr-2021 and ISOSORBIDE MONONITRATE from 01-Jan-2000 to 20-Apr-2021 for IHD, ATORVASTATIN from 01-Jan-2000 to 20-Apr-2021 for IHD and Hypercholesterolaemia, NovoRapid insulin from 01-Jan-2000 to 20-Apr-2021, LINAGLIPTIN from 01-Jan-2000 to 20-Apr-2021 and INSULIN GLARGINE (LANTUS) from 01-Jan-2000 to 20-Apr-2021 for Insulin-requiring type 2 diabetes mellitus. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to First dose. Death occurred on 20-Apr-2021 The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1363380 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY OEDEMA (01/05/2021) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 01-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milligram in total. On 06-May-2021, the patient experienced PULMONARY OEDEMA (01/05/2021) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The reported cause of death was Edema lung. 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 was given. No laboratory details was given. No treatment information was given. Very limited information regarding the event has been provided at this time. Further information is not expected.; Reporter''s Comments:; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Edema lung


VAERS ID: 1363457 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / OT

Administered by: Other       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: 2021-05-17
   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: MEDROL [METHYLPREDNISOLONE]; METHOTREXATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriatic arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021604155

Write-up: Death resulting from cardiac arrest; Death resulting from cardiac arrest; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB (IT-MINISAL02-732494). A 68-year-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscular on 17May2021 at 13:20 (at the age of 68-year-old) (Batch/Lot Number: FA4597; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Relevant medical history included psoriatic arthritis. Concomitant medications included methylprednisolone (MEDROL) taken for an unspecified indication, start and stop date were not reported and methotrexate taken for psoriatic arthropathy, start and stop date were not reported. On 17May2021 at 14:00, the patient experienced cardiac arrest and, at 15:20, she died resulting from cardiac arrest. The patient underwent advanced cardiovascular resuscitation arranged for diagnostic finding. The patient died in the emergency room about 2 hours after administration of COMIRNATY vaccine (2nd dose) following cardiac arrest which occurred about 40 minutes after vaccination. An autopsy was performed that revealed asystole. Reporter comment: In emergency room death of the patient about 2 hours after administration of COMIRNATY vaccine (2nd dose) following cardiac arrest which occurred about 40 minutes after vaccination at the hub center. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In emergency room death of the patient about 2 hours after administration of COMIRNATY vaccine (2nd dose) following cardiac arrest which occurred about 40 minutes after vaccination at the hub center.; Reported Cause(s) of Death: Arrest cardiac; Autopsy-determined Cause(s) of Death: Asystole


VAERS ID: 1363510 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral aneurysm (unruptured) (approximately 10 mm in size)
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: Head CT; Result Unstructured Data: Test Result:subarachnoid haemorrhage
CDC Split Type: JPPFIZER INC2021601373

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21108935. The patient was an 84-year and 5-month-old female. Body temperature before vaccination was uncertain. The patient had a medical history of cerebral aneurysm (unruptured). It was unknown if the patient was receiving concomitant medications or having a family history. On 23May2021 at around 12:00 (the day of vaccination), the patient received the first dose of BNT162b2 (Lot number and Expiration date were reported as unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. Age at vaccination: 84 years old. On 23May2021 at around 20:30 (8 hours and 30 minutes after the vaccination), the patient experienced subarachnoid haemorrhage. On 24May2021 at around 02:00 (14 hours after the vaccination), the patient died of subarachnoid haemorrhage. It was not reported if an autopsy was performed. The course of the event was as follows: The cerebral aneurysm (unruptured) of approximately 10 mm was pointed out and her clinical course was being followed with an imaging test at a different hospital. On 23May2021 around noon, the patient received the vaccination. On 23May2021 at around 20:30, the patient was found lying down in the bathroom at her home, and she was emergently transferred to the reporter''s hospital. She was in deep coma and she had gasping respiration. Based on the result of head CT, a diagnosis of subarachnoid haemorrhage was made. Life-saving procedures were difficult to be done. On 24May2021 at around 02:00, the patient died. The reporting physician classified the event as serious (Fatal) and assessed the causality between the event and BNT162b2 as unassessable. It was uncertain if there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: Subarachnoid haemorrhage occurred on the day of the vaccination, however, the causal relationship with BNT162b2 was uncertain. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1363565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-05-17
   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: GREPID; PANTOPRAZOL [PANTOPRAZOLE]; FUROSEMIDE; MONO CEDOCARD; AMLODIPINE; HYDROXYCARBAMIDE; SPIRONOLACTON; METOPROLOL; TRAMADOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021591082

Write-up: Sudden cardiac death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB [Regulatory Authority report number NL-LRB-00547032]. An 83-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 16May202, as single dose, for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included clopidogrel besylate (GREPID), pantoprazole (PANTOPRAZOL), furosemide (unknown manufacturer), isosorbide mononitrate (MONO CEDOCARD), amlodipine (unknown manufacturer), hydroxycarbamide (unknown manufacturer), spironolactone (SPIRONOLACTON), metoprolol (unknown manufacturer), tramadol (unknown manufacturer). Previously the patient received the 1st dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation. 21 hours after vaccination the patient experienced sudden cardiac death (death) on 17May2021. The patient died on 17May2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1363566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Headache
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: 2021-05-03
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021590989

Write-up: Cerebrovascular accident; Severe headache.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00548338. A 75-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01May2021, the patient experienced cerebrovascular accident and severe headache. The events were serious, fatal. The patient died on 03May2021. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Severe headache; CVA


VAERS ID: 1363577 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-24
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: CSF white blood cell count, Computerised tomogram head, Encephalitis brain stem, Magnetic resonance imaging head
SMQs:, Noninfectious encephalitis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPIN SANDOZ [AMLODIPINE BESILATE]; ATENOLOL MYLAN; AEROBEC; AIROMIR [SALBUTAMOL]; VISCOTEARS; SOMAC; ATACAND; BUMETANIDE; LEVAXIN; CIRCADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal); Asthma; Diuretic therapy; Dry eye; Hypertension; Hypothyroidism; Insomnia
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: CT brain scan; Result Unstructured Data: Test Result:without findings of central pathology; Comments: CT caput x 2 and MR caput incl. TOF angio (Time of flight angiography) x 2 without findings of central pathology, but increasing symptoms with added non-tireless vertical downbeat nystagmus, increased dizziness, tendency to fall and dysdiadokinesia; Test Date: 20210424; Test Name: Cerebrospinal fluid white cell count NOS; Result Unstructured Data: Test Result:Increased leucocytes; Comments: Increased leucocytes to respectively 16*/13* without detected viral or bacterial agents. SOX-1 antibodies was detected in spinal fluid, which can be seen in connection with SCLC / lung cancer, and this is suspected to be the cause of her symptoms.; Test Date: 20210424; Test Name: Head MRI; Result Unstructured Data: Test Result:nystagmus, increased dizziness, tendency to fall; Comments: CT caput x 2 and MR caput incl. TOF angio (Time of flight angiography) x 2 without findings of central pathology, but increasing symptoms with added non-tireless vertical downbeat nystagmus, increased dizziness, tendency to fall and dysdiadokinesia
CDC Split Type: NOPFIZER INC2021591116

Write-up: Cerebral stem encephalitis (SOX-1 antibody positive); This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number NO-NOMAADVRE-FHI-2021-Uapanz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00029452. An 88-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 31Mar2021 (Batch/Lot Number: ET3674) as single for covid-19 immunisation. Medical history included hypothyroidism, asthma, dry eye, gastrooesophageal reflux disease, diuretic therapy, insomnia and hypertension. The patient had received the first dose of vaccine on unknown date. Concomitant medications included amlodipine besilate (AMLODIPIN SANDOZ) taken for hypertension, start and stop date were not reported; atenolol (ATENOLOL MYLAN) taken for hypertension, start and stop date were not reported; beclometasone dipropionate (AEROBEC) taken for asthma, start and stop date were not reported; salbutamol (AIROMIR [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; carbomer (VISCOTEARS) taken for dry eye, start and stop date were not reported; pantoprazole sodium sesquihydrate (SOMAC) taken for gastrooesophageal reflux disease, start and stop date were not reported; candesartan cilexetil (ATACAND) taken for hypertension, start and stop date were not reported; bumetanide taken for diuretic therapy, start and stop date were not reported; levothyroxine sodium (LEVAXIN) taken for hypothyroidism, start and stop date were not reported; melatonin (CIRCADIN) taken for insomnia, start and stop date were not reported. On 24Apr2021, the patient developed encephalitis brain stem. Acute symptoms with dizziness on 24Apr2021. Admitted primarily with questions about stroke, and on income 25Apr2021 findings of left-sided dysdiadokokinesia and dizziness. The patient underwent lab tests which included computerised tomogram head: without findings of central pathology on 24Apr2021, (CT caput x 2 and MR caput incl. TOF angio (Time of flight angiography) x 2 without findings of central pathology, but increasing symptoms with added non-tireless vertical downbeat nystagmus, increased dizziness, tendency to fall and dysdiadokinesia); CSF white blood cell count: increased leucocytes on 24Apr2021 (Increased leucocytes to respectively 16*/13* without detected viral or bacterial agents), magnetic resonance imaging head: nystagmus, increased dizziness, tendency to fall on 24Apr2021 (CT caput x 2 and MR caput incl. TOF angio (Time of flight angiography) x 2 without findings of central pathology, but increasing symptoms with added non-tireless vertical downbeat nystagmus, increased dizziness, tendency to fall and dysdiadokinesia). Treated with high-dose methyl-prednisolone 1 g x 1 for 5 days (30Apr2021-04May2021), then intravenous immunoglobulins for 5 days (05May2021-09May2021). Investigated with suspected malignancy as the cause of what was clinically appropriate with a paraneoplastic cerebral stem encephalitis / cerebelitis, only findings of enlarged lymph nodes in the mediastinum. Detected SOX-1 antibodies in spinal fluid, which can be seen in connection with SCLC / lung cancer, and this is suspected to be the cause of her symptoms. Unable to conduct lymph node sampling, and from pulmonary medicine not properly or ethically to treat with chemotherapy for suspected lung cancer as a focus. Died 16May2021. Relatives want this to be reported as a possible side effect of Comirnaty. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Uncertain. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 20May2021: requested additional information. If new medical information is received, report will be updated.; Reported Cause(s) of Death: ENCEPHALITIS BRAIN STEM


VAERS ID: 1363604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
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: PTPFIZER INC2021591172

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, PT-INFARMED-T202105-196. A 78-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 0.3ml, single dose for COVID-19 immunisation. Lot number was EW2243. Medical history and concomitant medications were unknown. On 14Apr2021, the patient died due to an unknown cause; it was unknown If an autopsy was performed. Relatedness of drug to reaction/event: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Probable. Reporter''s comments: Concomitant drug: Unknown. Electronic Medical Prescription blocked and without appointments with me.; Reporter''s Comments: Concomitant drug: Unknown. Electronic Medical Prescription blocked and without appointments with me.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1363661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

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: Heart valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021591237

Write-up: Myocardial infarct; Breathlessness; Vomited; This is a spontaneous report from a contactable consumer downloaded from the A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY) at single dose, on 23Feb2021, for COVID-19 immunisation. Medical history included heart valve replacement on an unspecified date. Concomitant medications were unknown. On 25Feb2021, two days later she became breathless and vomited heavily. Later, on an unspecified date, in Mar2021, she got myocardial infarct, was at a cardiac intensive care unit at hospital. After more than a week, on an unspecified date, in 2021, she died due to myocardial infarct. Clinical outcome of the all events was reported as fatal. It is unknown if autopsy was done. Report assessed as serious, death, other medically important event. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarct; Vomited; Breathlessness


VAERS ID: 1363664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH REQUESTED / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Inappropriate schedule of product administration, Off label use
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALVEDON; OMEPRAZOLE
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021591409

Write-up: Cerebral bleeding; Second dose beyond 42 days; Second dose beyond 42 days; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB SE-MPA-2021-038045. A 86-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Mar2021 (Batch/Lot Number: REQUESTED) as single dose for covid-19 immunisation . Medical history included hypertension from 2012 and ongoing. Concomitant medication(s) included paracetamol (ALVEDON) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 vaccine on 02Feb2021. The patient experienced cerebral bleeding on Mar2021 causing patient''s death. Also the patient received the second dose beyond 42 days (off label use) on 21Mar2021 with outcome of unknown. The patient died on an unspecified date. An autopsy was not performed. Course of the event: Reported suspected adverse event is Cerebral bleeding. Fainted, had heart palpitations, two days after dose 2. Went to emergency unit at hospital. Was hospitalized overnight. Felt good the next day. Discharged from hospital. Died later the same evening. Cause of Death is Cerebral haemorrhage. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1363666 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-04
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARAN; FELODIPIN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Stroke; This regulatory authority case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no.) for COVID-19 vaccination. The patient''s past medical history included Stroke in 1980. Concomitant products included WARFARIN SODIUM (WARAN), FELODIPINE (FELODIPIN) and METOPROLOL for an unknown indication. On 26-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 04-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Stroke. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Very limited information regarding this event has been provided at this time.; Sender''s Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Stroke


VAERS ID: 1363668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021591186

Write-up: Anaphylaxis; Unconsciousness for 5-10 seconds at two times followed by shock; This is a spontaneous report received from a contactable physician via regulatory authority and downloaded from the regulatory authority, regulatory authority number is SE-MPA-2021-039580. A 55-year-old female patient received BNT162B2 (COMIRNATY, lot number EX6537), on unspecified date in May2021 as 1st dose, single for COVID-19 immunisation. There was no information about any concomitant or previous disease, neither about any previous adverse reactions of drugs. The patient''s concomitant medications were not reported. It was reported that 5 minutes after vaccination she developed manifest anaphylaxis, with short unconsciousness for 5-10 seconds at two times followed by shock. EPIPEN adrenaline twice and intravenous fluids were given. Ambulance alarm was made. The woman recovered slightly to the ambulance transport after about 15 minutes. Later the woman died, there was no information about the cause of death. Reported suspect adverse event was anaphylaxis. The case was assessed as serious with life-threatening and death criteria. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Anaphylaxis; Unconsciousness for 5-10 seconds at two times followed by shock


VAERS ID: 1363673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: Eosinophilic asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021591253

Write-up: Aortic rupture; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [SE-MPA-2021-040476]. A 77-year-old male patient received first dose of BNT162B2 (Comirnaty, solution for injection, lot number: EW2239) on Apr2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included ongoing Eosinophilic asthma. Concomitant medications were not reported. Approximately four hours later vaccination he was outside walking when he had a sudden chest pain and cardiac arrest. Death was established at the hospital in the afternoon. The autopsy report established Aortic rupture as the cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Aortic rupture


VAERS ID: 1364342 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021599051

Write-up: died suddenly two days after the 2nd COVID-19 vaccination/heart attack; This is a spontaneous report from a contactable consumer, received via Pfizer Colleague. A patient of an unspecified age and gender received the second dose of BNT162b2 (COMIRNATY, Lot number unknown) via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient died suddenly two days after the second COVID-19 vaccination. An autopsy has been ordered (no results available). The patient died due to a heart attack.; Reported Cause(s) of Death: heart attack


VAERS ID: 1364343 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Myocardial infarction, Pain, Vaccination site pain
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery occlusion; Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021604203

Write-up: Three heart attacks; Coma with artifical respiration; Pain in the left upper arm (the vaccinated arm) radiating to the left half of the body; Pain in the left upper arm (the vaccinated arm) radiating to the left half of the body; The initial case was missing the following minimum criteria: identifiable reporter. Upon receipt of follow-up information on 26May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient''s daughter) via the Pfizer-sponsored program. A 54-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number/expiration date not provided), via an unspecified route of administration, administered in the left arm on 24May2021 13:00 (at the age of 54-years-old) as 1st dose, single for COVID-19 immunization. Medical history included thrombosis and blocked coronary artery. The patient was on several unspecified concomitant medications. On 24May2021 at 13:00 PM, the patient was vaccinated with the 1st dose of BNT162B2 at his general practitioner. The patient suffered from a pain at the left upper arm (the vaccinated arm) which radiated to the left half of the body on 24May2021. On 25May2021 at 06:00 AM, the patient broke down and experienced three heart attacks. The emergency doctor diagnosed a heart attack. The patient was admitted to the hospital where he was in a coma with artificial respiration. The patient had to be reanimated 6 times in the night of 25May2021 to 26May2021. The patient''s daughter mentioned that the patient was still working prior to his vaccination. The outcome of the events vaccination site pain and radiating pain was unknown. On 26May2021 at 14:00 PM, the patient died due to three heart attacks. It was unknown if an autopsy was performed. The lot/batch number has been requested.; Reported Cause(s) of Death: Three heart attacks


VAERS ID: 1364391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-22
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite
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 INC2021600687

Write-up: Decreased appetite; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority number 554002. A 93 years old female patient received the second single dose of BNT162B2 (COMIRNATY) on an unknown date in Apr2021, for COVID-19 immunisation. The first dose of Comirnaty was administered on an unknown date in 2021. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. On 22Apr2021 the patient experienced decreased appetite which was reported with a fatal outcome. Onset time was reported as 2 days from the second dose and as 23 days from the first dose. The patient died on an unknown date in 2021 due to decreased appetite. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Decreased appetite


VAERS ID: 1364392 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
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 INC2021601003

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 554127. An 88-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 88-year-old 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. The outcome of the event was fatal. 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. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1364393 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Cough, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC2021601004

Write-up: Contusion; Cough; Dyspnoea; Oxygen saturation decreased; Wheezing; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 554503. A 91-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 at the age of 91-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced contusion, cough, dyspnoea, oxygen saturation decreased, wheezing on 06May2021. The patient underwent lab tests and procedures which included oxygen saturation: decreased. The patient died on an unspecified date. The outcome of all events was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Contusion; Cough; Dyspnoea; Oxygen saturation decreased; Wheezing


VAERS ID: 1364394 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021601005

Write-up: Somnolence; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 554579. A 92-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 at the age of 92-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced somnolence on 15May2021 with outcome fatal. 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. No further information is expected.; Reported Cause(s) of Death: Somnolence


VAERS ID: 1364395 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601006

Write-up: Respiratory arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 554665. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced respiratory arrest (death, medically significant) on 17May2021. 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. No further information is expected.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1364396 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-23
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601007

Write-up: Abdominal pain; Vomiting; This is a spontaneous report from a contactable other health professional via the . Regulatory authority report number is 554711. A 92-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 at the age of for COVID-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced abdominal pain and vomiting on 23Apr2021, with outcome fatal. 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. No further information is expected.; Reported Cause(s) of Death: Abdominal pain; Vomiting


VAERS ID: 1364397 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-26
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601008

Write-up: Abdominal distension; Abdominal pain; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 554717. A 95-years-old male 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 abdominal distension and abdominal pain both on 26Apr2021 causing patient death. 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. No further information is expected.; Reported Cause(s) of Death: Abdominal distension; Abdominal pain


VAERS ID: 1364398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-08
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Fall, Hypotension, Traumatic intracranial haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601009

Write-up: Aortic aneurysm rupture; Fall; Hypotension; Traumatic intracranial haemorrhage; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 554730. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of BNT162B2 vaccine. The patient experienced aortic aneurysm rupture, fall , hypotension , traumatic intracranial haemorrhage all on 08May2021. All the reported events caused patient''s death. 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. No further information is expected.; Reported Cause(s) of Death: Traumatic intracranial haemorrhage; Aortic aneurysm rupture; Fall; Hypotension


VAERS ID: 1364399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021601010

Write-up: Loss of consciousness; Malaise; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 555025. A 88-years-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 loss of consciousness and malaise both on 01May2021. Both the reported events caused patient''s death. 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. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness; Malaise


VAERS ID: 1364400 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-20
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601011

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 555187. A 75-years-old male 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 cerebrovascular accident on 20Apr2021 leading to patient death on an unknown date. 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. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1364401 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-18
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601012

Write-up: Dyspnoea; Hyperhidrosis; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 555216. A 94-years-old male 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 dyspnoea and , hyperhidrosis all on 18May2021. Both the reported events caused patient''s death. 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. No further information is expected.; Reported Cause(s) of Death: Dyspnoea; Hyperhidrosis


VAERS ID: 1364402 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC2021601013

Write-up: Hyperhidrosis; Oxygen saturation decreased; This is a spontaneous report from a contactable health care professional received from the regulatory authority. Regulatory authority report number is 556062. A 94-year-old male 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. On an unspecified date the patient experienced hyperhidrosis and oxygen saturation decreased. The events were serious for death with fatal outcome. The patient underwent lab tests and procedures which included oxygen saturation decreased on unspecified date. 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. No further information is expected.; Reported Cause(s) of Death: Hyperhidrosis; Oxygen saturation decreased


VAERS ID: 1364403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601014

Write-up: Myocardial infarction; This is a spontaneous report from a contactable health care professional received from the regulatory authority. Regulatory authority report number is 556634. A 92-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 myocardial infarction (death) on an unspecified date. The outcome was fatal. 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. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1364411 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Death, Hypoxia, Pneumonia, SARS-CoV-2 antibody test, Ultrasound scan, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; XELJANZ; MEDROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis (Epicura -Notion of ethyl cirrhosis (alcoholism weaned since 2018)); Elbow bursitis (MSSA bursitis in the right elbow one year ago, currently cured); Seronegative rheumatoid arthritis (Seronegative rheumatoid arthritis or psoriatic arthritis)
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: IgG antiSARCOV2; Result Unstructured Data: 611.4AU/mL, 86.9 BAU/mL Very few SARS-CoV-2 IgG antibodies 15days after second vaccine; Test Date: 2021; Test Name: ultrasound scan; Result Unstructured Data: typical ground glass attack occupying more than 30% of the lung fields (compatible with Covid-19 infection)
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Infection COVID-19 vaccination; Infection COVID-19 vaccination; Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Infection COVID-19 vaccination), COVID-19 (Infection COVID-19 vaccination), DEATH (Death), HYPOXIA and PNEUMONIA in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Seronegative rheumatoid arthritis (Seronegative rheumatoid arthritis or psoriatic arthritis), Alcoholic cirrhosis (Epicura -Notion of ethyl cirrhosis (alcoholism weaned since 2018)) and Elbow bursitis (MSSA bursitis in the right elbow one year ago, currently cured). Concomitant products included ALLOPURINOL, TOFACITINIB CITRATE (XELJANZ) and MEDROL for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Infection COVID-19 vaccination) (seriousness criterion death), COVID-19 (Infection COVID-19 vaccination) (seriousness criterion death), DEATH (Death) (seriousness criteria death and medically significant), HYPOXIA (seriousness criteria death and medically significant) and PNEUMONIA (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was refractory hypoxemia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 antibody test: low (Low) 611.4AU/mL, 86.9 BAU/mL Very few SARS-CoV-2 IgG antibodies 15days after second vaccine. In 2021, Ultrasound scan: abnormal (abnormal) typical ground glass attack occupying more than 30% of the lung fields (compatible with Covid-19 infection). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The patient was admitted on 25-Apr-2021 for bilateral hypoxemic pneumonia. The patient was an immunosuppressed patient who developed very fewantiSARSCOV2 antibodies. He received plasma containing antiSARSCOV2 Abs from convalescent patients on, without gain. No bacterial or other viral superinfection was demonstrated. It was reported that the patient died in the context of refractory hypoxemia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Company Comment: This is a case of death in a 74 -year-old male subject with hx of Seronegative rheumatoid arthritis, Alcoholic cirrhosis and Elbow bursitis who died on 09May2021, after receiving second dose of vaccine (date unknown). Very limited information has been provided at this time. No further information has been requested. Based on biological implausibility the event of COVID-19 causality is assessed as not applicable in relation to mRNA-1273.; Sender''s Comments: This is a case of death in a 74 -year-old male subject with hx of Seronegative rheumatoid arthritis, Alcoholic cirrhosis and Elbow bursitis who died on 09May2021, after receiving second dose of vaccine (date unknown). Very limited information has been provided at this time. No further information has been requested. Based on biological implausibility the event of COVID-19 causality is assessed as not applicable in relation to mRNA-1273.; Reported Cause(s) of Death: refractory hypoxemia


VAERS ID: 1364420 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Diarrhoea, Feeling abnormal, Nausea, SARS-CoV-2 test
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), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: covid test; Test Result: Negative
CDC Split Type: BRPFIZER INC2021600389

Write-up: Cardiac arrest; feel really bad; nausea; diarrhea; This is a spontaneous report from a contactable physician. A 45 years old non-pregnant female patient received the first single dose of BNT162B2 (COMIRNATY) on 15May2021 (at the age of 45 years), for COVID-19 immunisation. Medical history included anaemia. Concomitant medications were not reported. On 16May2021, one day after the vaccination, the patient started to feel nausea and diarrhea and this situation was sustained for a few more days. On 19May2021 she underwent a COVID test, which was negative. On 25May2021 in the morning she started to feel really bad and went to the hospital where she had a cardiac arrest and died. The events required Doctor or other healthcare professional office/clinic visit. It was unknown if the events required any treatment. The patient died on 25May2021 due to cardiac arrest. It was unknown if an autopsy was performed. The outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1364441 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood chloride, Blood culture, Blood sodium, C-reactive protein, Cheyne-Stokes respiration, Computerised tomogram, Computerised tomogram head, Culture urine, Haemoglobin, Lumbar puncture, Pyrexia, SARS-CoV-2 test, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
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; COPD; Diabetes mellitus (Diabetes Typ II); Vascular dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Chloride; Test Result: Borderline ; Result Unstructured Data: boarder line; Test Date: 20210331; Test Name: Blood culture; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Sodium; Test Result: Borderline ; Result Unstructured Data: borderline; Test Date: 20210331; Test Name: chest cT scan; Test Result: Negative ; Result Unstructured Data: Chest ct scan negative; Test Date: 20210331; Test Name: Head Ct; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: C-reactive protein; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210331; Test Name: urine culture; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Haemoglobin; Result Unstructured Data: normal; Test Date: 20210331; Test Name: Lumbar puncture; Test Result: Negative ; Result Unstructured Data: Negative - no infection focus with elevated CRP; Test Date: 20210331; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20210331; Test Name: Leucocyte count; Test Result: Inconclusive ; Result Unstructured Data: 8.5
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Cheyne Stokes; This regulatory authority case was reported by a physician and describes the occurrence of CHEYNE-STOKES RESPIRATION and PYREXIA in an 84-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Vascular dementia, COPD, Diabetes mellitus (Diabetes Typ II) and Arterial hypertension. On 25-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEYNE-STOKES RESPIRATION (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 06-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood chloride: 109 (Borderline) boarder line. On 31-Mar-2021, Blood culture: negative (Negative) negative. On 31-Mar-2021, Blood sodium: 147 (Borderline) borderline. On 31-Mar-2021, C-reactive protein: 80.6 (Positive) positive. On 31-Mar-2021, Computerised tomogram: negative (Negative) Chest ct scan negative. On 31-Mar-2021, Computerised tomogram head: negative (Negative) negative. On 31-Mar-2021, Culture urine: negative (Negative) negative. On 31-Mar-2021, Haemoglobin: 12 (normal) normal. On 31-Mar-2021, Lumbar puncture: negative (Negative) Negative - no infection focus with elevated CRP. On 31-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 31-Mar-2021, White blood cell count: 8.5 (Inconclusive) 8.5. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided Patient was treated with Piperacillin-Tazobactam (from 31-Mar-2021 to 03-Apr-2021) with a rapid clinical improvement. The tests performed on Mar 03, 2021 do not reveal any abnormality nor any sign of infection. This is a case of death in a 84-year-old male subject with a medical history of Vascular dementia, COPD, Diabetes Type II and Arterial hypertension, who died 12 days after receiving the second dose of vaccine. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: translated document added; Sender''s Comments: This is a case of death in a 84-year-old male subject with a medical history of Vascular dementia, COPD, Diabetes Type II and Arterial hypertension, who died 12 days after receiving the second dose of vaccine. Based on the current available information, reporter''s causality and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1364443 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood pH, Oxygen saturation, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: Allergy (Allergies to ACE inhibitor, beta blocking agents, Tardyferon and massage oil.); Arterial hypertension; Balance disorder (chronic moderate gait and balance disorder); Cerebral infarction (previous cerebral infarction on 21Aug2020, known swallowing disorder in status after ischemic cerebral infarction on 21Aug2020.); Cognitive impairment (mild cognitive impairment); Drug allergy (Allergies to ACE inhibitor, beta blocking agents, Tardyferon and massage oil.); Drug therapy; Gait disorder (chronic moderate gait and balance disorder); Hypothyroidism; Malnutrition (severe malnutrition); Swallowing disorder (previous cerebral infarction on 21Aug2020, known swallowing disorder in status after ischemic cerebral infarction on 21Aug2020.)
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: Arterial blood gas analysis (ABGA); Result Unstructured Data: Test Result:marked acidosis (pH 7.19); Comments: marked acidosis (pH 7.19) with respiratory and metabolic components; Test Date: 20210311; Test Name: Blood PH; Result Unstructured Data: Test Result:7.19; Test Date: 20210311; Test Name: initial oxygen saturation; Test Result: 70 %; Comments: despite 15 L 02 /min over the mask with reservoir
CDC Split Type: CHPFIZER INC2021559380

Write-up: aspiration pneumonia; This is a spontaneous report received from a contactable physician via the regulatory authority. Regulatory authority report number CH-SM-2021-14663.. An 87-years-old male patient received second dose bnt162b2 (COMIRNATY), intramuscular on 11Mar2021 (at age of 87 year old) (Batch/Lot Number: EK9788) at single dose for COVID-19 immunisation. Medical history included previous cerebral infarction on 21Aug2020, severe malnutrition, chronic moderate gait and balance disorder, mild cognitive impairment, arterial hypertension and hypothyroidism, unknown home pharmacotherapy. No hepatic or renal problems. Allergies to ACE inhibitor, beta blocking agents, Tardyferon and massage oil. Known swallowing disorder in status after ischemic cerebral infarction on 21Aug2020. The patient previously received first dose bnt162b2 (COMIRNATY) in Feb2021 and tolerated without problems. The patient is vaccinated with the second dose of Comirnaty vaccine on 11Mar2021. On the same day the patient experienced acute general condition deterioration with nausea and recurrent vomiting and dyspnea due to suspected aspiration pneumonia about 6h after 2nd Covid-19 vaccination. Epicrisis: Referral for acute general condition deterioration after recurrent vomiting with aspiration followed by dyspnea. Clinically, the patient presented with tachy-dyspnea, hypotension, and unresponsiveness with ubiquitous pulmonary rales. An initial oxygen saturation was 70% despite 15 L 02 /min over the mask with reservoir. We administered Lasix once, Rocephin, and then switched to co-amoxicillin. This did not improve the respiratory situation. Arterial blood gas analysis (ABGA) showed marked acidosis (pH 7.19) with respiratory and metabolic components. For respiratory distress, we administered morphine boluses, which we changed to perfusor therapy in the course. In consultation with the relatives and in accordance with the patient''s known wishes, we discontinued further diagnostics and established comfort therapy. The patient died on 12Mar2021 in the presence of the relatives. Due to pre-existing conditions and general condition of the patient, aspiration is not unexpected. This case was reported as serious with seriousness criterion results in death. The patient died on 12Mar2021. An autopsy was not performed. A causality between death and Comirnaty was assessed as being unlikely. Sender''s comment (Health authority): Death occurred the day after administration of the second dose of Comirnaty vaccine in an 87-year-old, very frail, polymorbid elderly male patient with a swallowing disorder following a cerebral infarction in 2020. To date, there is no data in the literature to support a causal correlation between the administration of Covid-19 mRNA vaccines and sudden deaths in elderly patients. It is known that following the first dose of the vaccine, the patient did not experience any kind of adverse reaction. Consequently, this fact speaks slightly in favour of vaccine involvement. In the absence of data supporting a causal correlation between sudden death and the vaccine, despite the close temporal correlation of 1 day with the second dose, and given that the cause of death was attributed by medical staff to aspiration pneumonia (an event that was not unexpected) in this already severely compromised patient with risk factors, we judge the causal correlation between the administration of the Comirnaty vaccine and death to be unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: aspiration pneumonia


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