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

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



Case Details

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VAERS ID: 1486649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Dyspnoea, Fall, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   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: XALATAN; ENALAPRIL; ENALAPRIL HCT; EBRANTIL [URAPIDIL]; MOXONIBENE
Current Illness: Adipose; Coronary atherosclerosis (Coronary artery sclerosis); Hepatic fibrosis (incipient liver fibrosis); Hypertension arterial (arterial hypertension)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210617; Test Name: SARS-CoV-2 PCR Test (covid SARS-CoV-2 Test) before the autopsy; Test Result: Negative
CDC Split Type: ATPFIZER INC2021843018

Write-up: acute myocardial infarction as the cause of death; Cardiac arrest; shortness of breath; Unconscious/passed out; fell off the bench shortly afterwards; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB AT-BASGAGES-2021-34437. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Jun2021 (Batch/Lot Number: EW4815) as Dose 2, single for COVID-19 immunisation. Medical history included ongoing obesity (Adipositas), ongoing hepatic fibrosis incipient liver fibrosis, ongoing arteriosclerosis coronary artery, ongoing hypertension arterial. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 28Apr2021 (Batch: FD1921) as for COVID-19 immunisation. Concomitant medications included latanoprost (XALATAN) taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported; enalapril maleate, hydrochlorothiazide (ENALAPRIL HCT) taken for an unspecified indication, start and stop date were not reported; urapidil (EBRANTIL [URAPIDIL]) taken for an unspecified indication, start and stop date were not reported; moxonidine (MOXONIBENE) taken for an unspecified indication, start and stop date were not reported. The female patient complained of shortness of breath and shortly afterwards slipped off the bench and was passed out. After the 2nd vaccination, the patient complained of shortness of breath on June 14th at around 10:30 p.m., shortly afterwards fell from the bench and suffered cardiovascular arrest. Immediate lay animation by relatives, later continued by paramedics and emergency physicians. In asystole, at 10:55 p.m., 3 mg adrenaline was administered intravenously. After 40 minutes, the resuscitation was stopped because there was no more circulation. Adrenaline 3 mg, intravenous 22:55 14Jun2021 to 22:55 14Jun2021. Administration during resuscitation in asystole. Since there was no circulation or cardiac action, the resuscitation was ended at 11:05 pm and death was determined. Before that, no symptoms. Before the autopsy, a SARS-CoV-2 PCR test (covid SARS-CoV-2 test) was carried out on June 17, 2021; it was negative. On 14Jun2021 22:30 the patient experienced Unconscious, life threatening, Dyspnea, Fall. On 14Jun2021 22:30 the patient experienced Cardiac arrest, Death. The patient experienced also Acute myocardial infarction, Death. The patient''s outcome was not recovered/not resolved for Unconscious, not recovered/not resolved for Dyspnea, unknown for Fall, fatal for Cardiac arrest, fatal for Acute myocardial infarction. The patient died on 14Jun2021 from Acute myocardial infarction, Cardiac arrest. The autopsy determined cause of death was reported to be: Acute myocardial infarction. At the time of vaccination there were no signs of infection. There was no positive test result for SARS-CoV2. The casual relationship of Comirnaty and events Asystolia, Dyspnea and Unconscious assessed as possible by the Primary Source Reporter. Time of death was 23:05. The outcome of events shortness of breath, loss of consciousness was not recovered, for event fall was unknown and for other events was fatal. Sender comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest; Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1486710 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale abnormal, Oxygen saturation abnormal, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
CDC Split Type: AUPFIZER INC2021894527

Write-up: Coma scale abnormal; Oxygen saturation; Somnolence; This is a spontaneous report from a contactable other health professional received via a regulatory authority. Regulatory authority report number is 583673. An 80-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. On an unspecified date, the patient experienced coma scale abnormal (death, medically significant), oxygen saturation (death) and somnolence (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.; Reported Cause(s) of Death: Coma scale abnormal; Oxygen saturation; Somnolence


VAERS ID: 1486751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Obesity
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: BRPFIZER INC2021852170

Write-up: she was with COVID-19 when he took the vaccine / the condition aggravated and she evolved to death; This is a spontaneous report from a contactable consumer (patient''s friend) received by a Pfizer colleague reporting through a regulatory authority portal. An adult female patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on Jun2021, as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included obesity (reported as obese), covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On unspecified date in Jun2021, it was reported that the patient took the COVID-19 vaccine due being at the risk group (obese). It was also reported they believed that the patient was with COVID-19 when he took the vaccine, on June 2nd or 3rd (as reported). Then, the patient died on 29Jun2021. The reporter commented that the patient was hospitalized for some weeks, was intubated, the condition aggravated, and she evolved to death. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination and the result was positive. The patient died on 29Jun2021. 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: she was with COVID-19 when he took the vaccine / the condition aggravated and she evolved to death


VAERS ID: 1487581 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-05-23
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Electrocardiogram; Test Result: Negative ; Comments: normal, with no abnormalities
CDC Split Type: CHPFIZER INC2021857751

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable consumer or other non-HCP (son of patient) via a regulatory authority. Regulatory authority report number CH-SM-2021-16935. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Feb2021 (Batch/Lot Number: EJ6788) as single dose for covid-19 immunisation at the age of 85-year-old. Medical history included surgery in Feb2021 (for approximately six weeks, including rehabilitation). The patient''s concomitant medications were not reported. On 19Jan2021 she received her first dose of Comirnaty (Batch/Lot Number: EJ6796) via intramuscular as single dose for covid-19 immunisation at the age of 85-year-old. On 23May2021 the woman died of cardiac arrest after a 200 mt foot march. An electrocardiogram was performed during her hospitalization for surgery was normal, with no abnormalities in Feb2021. The patient died on 23May2021. An autopsy was not performed. A causal relationship between Comirnaty and cardiac arrest was assessed by the regulatory authority according to WHO as being unlikely. Regulatory Authority assessed this case as serious, results in death. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported event "Cardiac arrest" and suspect drug BNT162B2, 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 arrest


VAERS ID: 1487609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-10
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiopathy, Arterial occlusive disease, Arteriosclerosis coronary artery, Blood pressure measurement, Bundle branch block left, Cardiac failure acute, Cardiogenic shock, Chest pain, Echocardiogram, Ejection fraction, Electrocardiogram, Heart rate, International normalised ratio, Loss of consciousness, Oxygen saturation, SARS-CoV-2 test, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: TEZEO; RHEFLUIN; MILURIT; JANUVIA [SITAGLIPTIN PHOSPHATE]; SIOFOR; CONCOR COMBI; CILKANOL; LAGOSA; GLYCLADA; WARFARIN; EUTHYROX
Current Illness: Arterial hypertension; Diabetes mellitus; Persistent atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Blood pressure; Result Unstructured Data: Test Result:136/78 mmHg; Comments: on norepinephrine; Test Date: 20210510; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:mild systolic dysfunction; Comments: mild systolic dysfunction of the non-dilated left ventricle, hypokinetic apex and adjacent parts, diastolic dysfunction of the left ventricle, grade I; Test Date: 20210510; Test Name: Ejection fraction; Test Result: 45 %; Test Date: 20210510; Test Name: ECG; Result Unstructured Data: Test Result:Atrial fibrillation, left bundle branch block; Test Date: 20210510; Test Name: Heart rate; Result Unstructured Data: Test Result:110; Comments: Units:/min; Test Date: 20210510; Test Name: International normalised ratio; Result Unstructured Data: Test Result:2.9; Comments: on warfarin therapy; Test Date: 20210510; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210510; Test Name: antigen test; Test Result: Negative ; Test Date: 20210510; Test Name: Cardiac troponin; Test Result: Positive
CDC Split Type: CZPFIZER INC2021847962

Write-up: Ache across chest; Acute myocardial infarction; left bundle branch block; disease of the trunk and 2 arteries, occlusion of the left anterior descending artery with collateralization; disease of the trunk and 2 arteries, occlusion of the left anterior descending artery with collateralization; severe coronary finding with strongly calcified critical stenoses; Cardiac failure acute; Cardiogenic shock; Consciousness loss; This is a spontaneous report from a contactable other healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21007701. A 65-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Apr2021 (Batch/Lot Number: EW4815) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, hypertension, and persistent atrial fibrillation, all ongoing. No allergies. Concomitant medications included telmisartan (TEZEO); amiloride hydrochloride, hydrochlorothiazide (RHEFLUIN); allopurinol (MILURIT); sitagliptin phosphate (JANUVIA); metformin hydrochloride (SIOFOR); amlodipine besilate, bisoprolol fumarate (CONCOR COMBI); troxerutin (CILKANOL); silybum marianum (LAGOSA); gliclazide (GLYCLADA); warfarin; levothyroxine sodium (EUTHYROX); all taken for unspecified indications, start and stop date were not reported. The patient experienced ache across chest, acute myocardial infarction, and consciousness loss on 10May2021; cardiac failure acute and cardiogenic shock on 12May2021. Clinical course was reported as follows. On 10May2021, after approximately 17 hours of chest pain, she was admitted to the internal medicine clinic. Atrial fibrillation and left bundle branch block found on the ECG. Bradycardia, circulatory arrest, cardiopulmonary resuscitation with a resumption of spontaneous circulation within 10 minutes, connected to artificial lung ventilation, an image of pulmonary edema. Swelling of the lower limbs to the knees. Later progressive cardiogenic shock, suspected to be partially septic, no response to the therapy, exacerbating hypotension with no response to the therapy, circulatory arrest. The patient died on 12May2021. Tests and examinations on 10May2021: blood pressure 136/78 on norepinephrine, pulse 110/min, oxygen saturation on artificial lung ventilation 88%, antigen test negative, troponin slightly positive at the time of admission, INR 2.9 (on warfarin therapy), transthoracic echocardiogram - mild systolic dysfunction of the non-dilated left ventricle, ejection fraction 45 %, hypokinetic apex and adjacent parts, diastolic dysfunction of the left ventricle, grade I. State of consciousness: unconsciousness, orotracheal intubation with artificial lung ventilation, underwent ventilation. Diagnosis: Acute heart failure, cardiogenic shock, ischemic heart disease - myocardial infarction, left bundle branch block, disease of the trunk and 2 arteries, occlusion of the left anterior descending artery with collateralization. A severe coronary finding with strongly calcified critical stenoses of the distal trunk and proximal sections of the left anterior descending artery and circumflex artery, the left anterior descending artery is closed with collateralization from both homo- and heterocolaterals. Outcome of the events cardiac failure acute and cardiogenic shock was fatal, while for the rest of the events was unknown. The patient died on 12May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure acute; Cardiogenic shock


VAERS ID: 1487623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: Arterial hypertension; Chronic bronchitis; Nicotine abuse; Rheumatic disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843138

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100118677. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 17Jun2021 (at the age of 52years) as dose number unknown, 0.3ml single for Covid-19 immunization. Medical history included rheumatic disorder, arterial hypertension, chronic bronchitis, and nicotine abuse; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 18Jun2021, the patient experienced acute myocardial infarction. The patient died on 18Jun2021. An autopsy was performed that revealed acute myocardial infarction in coronary thrombus in the circumflex branch with broken fatty tissue in 3-vessel cad. Relatedness of drug to reaction(s)/event(s): Acute myocardial infarction was C. Inconsistent causal association to immunization (per Source of assessment: Institute, Result of Assessment). No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Event acute myocardial infarction represents an intercurrent medical condition and unrelated to bnt162b2 .; Autopsy-determined Cause(s) of Death: Acute myocardial infarction in coronary thrombus in the circumflex branch with broken fatty tissue in 3-vessel CAD


VAERS ID: 1487624 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Atrial fibrillation; Depression; Hyponatraemia; Language disorder; Phobic postural vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021842985

Write-up: Fall; Intra-cerebral hemorrhage; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB; the Regulatory Authority number is DE-PEI-202100118679. An 85-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 11Feb2021 (batch/lot number: EL8723) at 84 years old, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s medical history and concurrent conditions included apoplexy, hyponatraemia, atrial fibrillation, phobic postural vertigo, language disorder, and depression, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 26Feb2021, the patient experienced Fall, Intra-cerebral hemorrhage with fatal outcome. The patient died on 01Mar2021. It was not reported if an autopsy was performed. Causality assessment: The relatedness of drug to reaction(s)/event(s) employing the institute as the Source of assessment, resulted in Assessment: C. Inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fall; Intra-cerebral hemorrhage


VAERS ID: 1487626 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021842981

Write-up: Thrombosis; Thrombocytopenia; Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100118686. A 99-year-old female patient received BNT162B2 (COMIRNATY/mRNA TOZINAMERAN, formulation: solution for injection, Batch/Lot Number: ET3674), via an unspecified route of administration on 05Apr2021 (at the age of 99-years-old) as dose 2, single for COVID-19 immunisation. Medical history included dementia. Concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. It was reported that on 14Apr2021, the patient experienced thrombosis, thrombocytopenia, and pulmonary embolism. The events were serious (fatal and medically significant). The patient died as a result of events on an unspecified date. The outcome of the events was fatal. The result of assessment for all the events was reported as unclassifiable. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Thrombosis; Thrombocytopenia; Pulmonary embolism


VAERS ID: 1487631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Cerebral ischaemia, Hemiplegia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bronchopneumonia; Diabetes mellitus; Hypercholesteremia; Urinary tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843024

Write-up: Cerebral ischemia; Hemiplegia; Middle cerebral artery infarct; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100119818. An 80 year old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: 1D014A) as dose 2, 0.3 ML, single at the age of 80 years for covid-19 immunisation. The patient''s medical history included urinary tract infection from, diabetes mellitus, hypertension, hypercholesterolaemia, and bronchopneumonia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cerebral ischemia, hemiplegia, middle cerebral artery infarct on 27May2021. The outcome of the events was fatal. The patient died on 07Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Middle cerebral artery infarct; Hemiplegia; Cerebral ischemia


VAERS ID: 1487636 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843025

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100120086. An 82-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administrationa on 13Apr2021 (Lot Number: EW8904) at the age of 82-years-old as dose number unknown, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 14Apr2021. The outcome of the event was fatal. The patient died on 14Apr2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s): Source of assessment: Institute; Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1487649 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dementia, Gastrointestinal somatic symptom disorder, Mental fatigue, Urinary incontinence
SMQs:, Dementia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021848059

Write-up: General debility; Dementia; Mental exhaustion; Incontinence of urine; Gastrointestinal somatic symptom disorder; This is a spontaneous report from a non contactable physician downloaded from the Regulatory Authority-WEB: DE-PEI-202100121564. A 89-year-old female patient received second dose of BNT162B2 (COMIRNATY) Lot number ET3045, on 14Apr2021 at 0.3 ml single (at the age of 89-year-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 22Mar2021. On May2021 the patient experienced General debility, Mental exhaustion, Dementia, Gastrointestinal somatic symptom disorder, Incontinence of urine. The patient died on 02Jun2021. Autopsy was not done. The outcome of all events was fatal. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Mental exhaustion; Dementia; Gastrointestinal somatic symptom disorder; Incontinence of urine; General debility


VAERS ID: 1487652 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882876

Write-up: Unknown cause of death; Received first dose on 02May and second dose on 13Jun2021; This is a spontaneous report downloaded from the Regulatory Authority-WEB number DE-PEI-202100130823, received from a non-contactable Physician. A 61-year-old Male patient received bnt162b2 (COMIRNATY) second dose at the age of 61-year-old (lot: FC3095) on 13Jun2021 as 0.3 ml single dose for COVID-19 immunisation. Medical history and Concomitant medications were reported. The patient previously received bnt162b2 (COMIRNATY) first dose at the age of 61-year-old on 02May2021 (batch unknown) as 0.3 ml single dose for COVID-19 immunisation. On 16Jun2021 the patient experienced Unknown cause of death. This report is serious due to death. Event assessment included Comirnaty/ event/ I /Result of Assessment: D. Unclassifiable. It was unknown if Autopsy Done. The outcome of the event Unknown cause of death was Fatal, of others was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1487838 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-19
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct myocardial (10 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843134

Write-up: Sudden ventricular fibrillation followed by a fatal heart attack.; Sudden ventricular fibrillation followed by a fatal heart attack; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB with regulatory authority number DE-PEI-CADR2021101018. A 79-year-old male patient received bnt162b2 (COMIRNATY also reported as Comirnaty (mRNA TOZINAMERAN); reported strength: 0.3 mL), via an unspecified route of administration on 27Apr2021 (Lot Number: EX3599) as dose number unknown, single for covid-19 immunisation. Medical history included his first heart attack 10 years earlier (from 2011 to an unknown date which was not ongoing). Concomitant medications included unspecified medication. On 19May2021, the patient experienced sudden ventricular fibrillation followed by a fatal heart attack. It was mentioned that the patient had his first heart attack 10 years earlier and checks were carried out regularly. The patient''s medication was taken properly and there was no sign of illness. The patient''s condition was NOT getting progressively worse. An hour earlier on 19May2021, the patient''s grandfather was quite well. Suddenly, he became weak and felt that something was about to happen. They tried to calm him down. He suddenly passed out. Resuscitation attempts by the family and the emergency services were in vain. The outcome of infarct myocardial was fatal while the outcome of the other event was not recovered. The patient died on 19May2021. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses Had his first heart attack 10 years earlier. Checks were carried out regularly. Medication taken properly. / There was no sign of illness. His condition was NOT getting progressively worse. An hour earlier, it was my grandpa. quite well. Suddenly he became weak and felt that something was about to happen. We tried to calm him down. He suddenly passed out. Resuscitation attempts by the family and the emergency services were in vain. Comirnaty/ All events/ I/ Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1487842 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Central pain syndrome; Hypothyreosis (Hypothyroidism); Scoliosis
Preexisting Conditions: Medical History/Concurrent Conditions: Brain herniation; Ischemic stroke (in the right medial flow area); Malignant syndrome NOS; Thrombectomy; Thrombolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843158

Write-up: Ischemic stroke in the left medial flow area with subtotal occlusion of the entire middle cerebral artery; Ischemic stroke in the left medial flow area with subtotal occlusion of the entire middle cerebral artery; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021104240, Safety Report Unique Identifier is DE-PEI-202100099034. Additional reference number includes: DE-CADRPEI-2021104240. A 69-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: 1D014A), via an unspecified route of administration, on 10Jun2021 (at the age of 69 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history included ongoing central pain syndrome, ischemic stroke in the right medial flow area, ongoing scoliosis, ongoing arterial hypertension, ongoing hypothyreosis (reported as hypothyroidism), malignant medial syndrome with cerebral herniation, lysis therapy and thrombectomy. The patient''s concomitant medications were not reported. On 10Jun021, it was reported that the patient experienced ischemic stroke in the left medial flow area with subtotal occlusion of the entire middle cerebral artery (reported as middle cerebral artery thrombosis). The patient died on 10Jun2021. An autopsy was not performed 10Jun2021 and the reported cause of death was ischemic stroke. Sender''s comment: Ischemic stroke in the left medial flow area with subtotal occlusion of the entire middle cerebral artery. Are you or the person concerned known of any allergies? If yes, which? not known. Information on risk factors or previous illnesses Pre-existing illness: State after: Ischemic stroke in the right medial flow area Arterial hypertension Scoliosis Hypothyroidism Pain syndrome/lysis therapy, thrombectomy Malignant medial syndrome with cerebral herniation; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1487853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   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: DEPFIZER INC2021843081

Write-up: Unknown cause of death; Malaise; fatigue; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021113751. A 73-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Jun2021, the patient experienced malaise and fatigue. On 17Jun2021, the patient experienced unknown cause of death. Outcome of malaise was not recovered, while unknown for fatigue. The patient died on 17Jun2021. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? According to the bereaved, the first vaccination was tolerated without any problems. Information on risk factors or previous illnesses no pre-medication, no known previous illnesses with rare visits to the doctor / According to a friend two days after the vaccination, the person concerned reported complaints that could not be precisely determined (fatigue, malaise, feeling of illness) and therefore reported on 13Jun2021 drive home (living there alone). This was the last sign of life of the person concerned; In the following days no communication could be established. informed the son of the patient who gained access to the locked apartment and found the father lying dead in bed. There were no indications of external influence or suicide. The case was documented as an unexplained death during the inquest and the police were turned on. Relatedness of drug to reactions/events/Comirnaty/ all events/ I/ D. Unclassifiable. No follow-up attempts are possible; information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1487854 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C009A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Fatigue, Myocardial infarction, Nausea, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease; Hypertension (High blood pressure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843085

Write-up: After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours.; After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours.; After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours.; After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours.; After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021116540. A 76-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23May2021 (Lot Number: 1C009A) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing coronary heart disease. The patient''s concomitant medications were not reported. On 23May2021, after the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and infarct myocardial within a few hours. The patient died on 29May2021. An autopsy was not performed. The outcome of the other events was recovered on an unspecified date. Sender Comment: Information on risk factors or previous illnesses: High blood pressure, presumably CHD (coronary heart disease). The affected person wanted to receive full vaccination protection. A brief improvement followed on day 6 after the vaccination, the patient died due to heart failure and infarct myocardial.Drug-reactions/ events Matrix for events: vomiting , nausea, fatigue, and myocardial infarction: Source of assessment: Institute, Result of Assessment: D. Unclassifiable.; Reported Cause(s) of Death: After the vaccination, severe nausea with vomiting and total fatigue occurred. Six days after the vaccination, the affected person died of heart failure and Infarct myocardial within a few hours. After the vaccination, severe nausea with vomiting an


VAERS ID: 1487856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-06-15
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cardiac insufficiency; COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021843083

Write-up: Unknown cause of death; Dyspnoea; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB: DE-PEI-CADR2021116864 and Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100113946. Additional reference number DE-CADRPEI-2021116864. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06May2021 (Batch/Lot Number: EX8679) as DOSE 2, 0.3 mL SINGLE for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing cardiac insufficiency. The patient''s concomitant medications were not reported. On 15Jun2021 the patient experienced Dyspnoea. The patient experienced also Unknown cause of death. The patient''s outcome was: not recovered/not resolved for Dyspnoea, fatal for Unknown cause of death. The patient died on an unspecified date. An autopsy was not performed. Reaction(s) / Event(s) Assessed [death, Dyspnoea]: Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority: Result of Assessment: D. Unclassifiable. Sender Comments: Information on risk factors or previous illnesses: Well known heart failure and COPD (Chronic obstructive pulmonary disease) / Apparently dyspnea developed in well known. Heart failure and COPD a few days after the 2nd vaccination according to the attending doctor. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1487863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blind; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021882755

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB number DE-PEI-CADR2021130233, Safety Report Unique Identifier DE-PEI-202100127311, received from a non-contactable Consumer. An 87-Year-old Female patient received bnt162b2 (COMIRNATY) first dose on 22Mar2021 (lot: unknown) as 0.3 ml single dose for COVID-19 immunisation. Medical history included ongoing Dementia, Blind. Concomitant medications were not reported. On 27Mar2021 the patient experienced Unknown cause of death/sudden death. This report is serious due to death. Event assessment included Comirnaty/ event/Regulatory Authority/Result of Assessment : D. Unclassifiable. No Autopsy Done. The outcome of the event was Fatal. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no information on risk factors or previous illnesses dementia, blindness /. Event assessment : Comirnaty/ event/Regulatory Authority/Result of Assessment : D. Unclassifiable No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1487888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021849480

Write-up: death; This is a spontaneous report from the contactable health professionals based on information received by Pfizer from Biontech [manufacturer control number: 71619], license party for Comirnaty. A 13-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had died on an unknown date. Cause of death not provided. It was not reported if an autopsy was performed. Information regarding the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 on causing the event death cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1487899 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021858190

Write-up: death; This is a spontaneous report from a non-contactable other hcp based on information received by Pfizer from Biontech [manufacturer control number: 71805], license party for Comirnaty. A 72-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. The patient previously received bnt162b2 (COMIRNATY), dose 1 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 died/ experienced death 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.; Sender''s Comments: Lacking information on the cause of patient''s demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient''s death of unknown cause, The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: death


VAERS ID: 1487946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: Chronic renal failure; Diabetes; Ferropenic anaemia; Subvalvular aortic stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021843672

Write-up: Respiratory insufficiency; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [ES-AEMPS-844918]. A 91-year-old non-pregnant female patient received her first dose of BNT162B2 (COMIRNATY; lot number unknown), via unknown route of administration on 19Feb2021 (at an unspecified age) at dose 1, single for COVID-19 immunisation. Medical history included diabetes, subvalvular aortic stenosis, ferropenic anaemia, and chronic renal failure. The patient has no previous COVID-19 infection. The patient was not pregnant at the time of vaccination. The patient''s concomitant medications were not reported. On 20Feb2021, the day after administering the first dose of the vaccine, the patient experienced respiratory insufficiency that caused hospitalization on 28Feb2021. The patient died on 28Feb2021 due to respiratory insufficiency. It was unknown if autopsy was done. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Respiratory insufficiency


VAERS ID: 1488042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-06-08
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Blood bicarbonate, Blood bicarbonate decreased, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood fibrinogen increased, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood lactic acid increased, Blood potassium, Blood sodium, Blood urea, Blood urea increased, COVID-19 pneumonia, Chest X-ray, Chest X-ray abnormal, Fibrin D dimer, Fibrin D dimer increased, Glomerular filtration rate, Glomerular filtration rate decreased, Haematocrit, Haemoglobin, Leukocytosis, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, PO2 decreased, Platelet count, Polymerase chain reaction, Prothrombin time, Red cell distribution width, SARS-CoV-2 test positive, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract (left); Depression; Gonarthrosis; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Activated partial thromboplastin time; Test Result: 29 s; Test Date: 20210613; Test Name: GPT; Result Unstructured Data: Test Result:15; Test Date: 20210613; Test Name: Bicarbonate; Result Unstructured Data: Test Result:20; Test Date: 20210614; Test Name: Bicarbonate; Result Unstructured Data: Test Result:25.7; Test Date: 20210613; Test Name: calcium; Result Unstructured Data: Test Result:10; Test Date: 20210613; Test Name: chloride; Result Unstructured Data: Test Result:99; Test Date: 20210613; Test Name: CPK; Result Unstructured Data: Test Result:17; Test Date: 20210613; Test Name: Creatinine; Result Unstructured Data: Test Result:1.22; Test Date: 20210613; Test Name: Fibrinogen; Result Unstructured Data: Test Result:625; Test Date: 20210613; Test Name: Glucose; Result Unstructured Data: Test Result:160; Test Date: 20210613; Test Name: LDH; Result Unstructured Data: Test Result:239; Test Date: 20210613; Test Name: Lactate; Result Unstructured Data: Test Result:2.1; Test Date: 20210613; Test Name: potasium; Result Unstructured Data: Test Result:4.7; Test Date: 20210613; Test Name: sodium; Result Unstructured Data: Test Result:137; Test Date: 20210613; Test Name: Urea; Result Unstructured Data: Test Result:105; Test Date: 20210613; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:right lung volume reduction...; Comments: ..due to right diaphragmatic hemi-relaxation, cardiomegaly, aortic elongation, interstitial infiltrates of peripheral distribution in LSD and LII; Test Date: 20210613; Test Name: D Dimer; Result Unstructured Data: Test Result:528.32; Test Date: 20210613; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:40; Comments: ml/min/1.73m2; Test Date: 20210613; Test Name: Haematocrit; Result Unstructured Data: Test Result:45.2; Test Date: 20210614; Test Name: Haematocrit; Result Unstructured Data: Test Result:42.7; Test Date: 20210613; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.3; Test Date: 20210614; Test Name: Haemoglobin; Result Unstructured Data: Test Result:13.6; Test Date: 20210613; Test Name: Leukocytosis; Result Unstructured Data: Test Result:25150; Test Date: 20210614; Test Name: Leukocytosis; Result Unstructured Data: Test Result:16260; Test Date: 20210613; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1750; Test Date: 20210614; Test Name: Lymphocytes; Result Unstructured Data: Test Result:640; Test Date: 20210613; Test Name: Mean corpuscular hemoglobin; Result Unstructured Data: Test Result:28; Test Date: 20210614; Test Name: Mean corpuscular hemoglobin; Result Unstructured Data: Test Result:29; Test Date: 20210613; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:91; Test Date: 20210614; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:91; Test Date: 20210613; Test Name: Saturation O2; Test Result: 55 %; Test Date: 20210614; Test Name: Saturation O2; Test Result: 88 %; Test Date: 20210613; Test Name: pCO2; Result Unstructured Data: Test Result:32; Test Date: 20210614; Test Name: pCO2; Result Unstructured Data: Test Result:43.7; Test Date: 20210613; Test Name: pH; Result Unstructured Data: Test Result:7.4 pH units; Test Date: 20210614; Test Name: pH; Result Unstructured Data: Test Result:7.38 pH units; Test Date: 20210613; Test Name: Platelets; Result Unstructured Data: Test Result:290000; Test Date: 20210614; Test Name: Platelets; Result Unstructured Data: Test Result:264000; Test Date: 20210613; Test Name: pO2; Result Unstructured Data: Test Result:28.7; Test Date: 20210614; Test Name: pO2; Result Unstructured Data: Test Result:52.6; Test Date: 20210613; Test Name: PCR; Result Unstructured Data: Test Result:224.3; Test Date: 20210613; Test Name: Prothrombin time; Test Result: 14 s; Test Date: 20210613; Test Name: Red blood cell Distribution Width; Result Unstructured Data: Test Result:14.7; Test Date: 20210614; Test Name: Red blood cell Distribution Width; Result Unstructured Data: Test Result:14.2; Test Date: 20210608; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Test Date: 20210613; Test Name: Polymorphonuclear; Result Unstructured Data: Test Result:22030; Test Date: 20210614; Test Name: Polymorphonuclear; Result Unstructured Data: Test Result:15400
CDC Split Type: ESPFIZER INC2021848383

Write-up: Vaccination Failure; COVID-19 pneumonia; Oxygen saturation 55% on 13Jun2021 88 on 14Jun2021; Leukocytosis: 25150 on 13Jun2021 and 16260 on 14Jun2021; pO2 on 28.7 on 13Jun2021 and 52.6 on 14Jun2021; Glomerular filtration rate 40 ml/min/1.73m2 on 13Jun2021; Fibrin D dimer 528.32 on 13Jun2021; Thoracic Xray abnormal due to right diaphragmatic hemi-relaxation, cardiomegaly, aortic elongation, interstitial infiltrates of peripheral distribution in LSD and LII.; Blood urea 105 on 13Jun2021; Blood lactic acid 2.1 on 13Jun2021; Blood fibrinogen 625 on 13Jun2021; Blood bicarbonate 17 on 13Jun2021; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB ES-AEMPS-929727 An 86-year-old female patient received bnt162b2 (COMIRNATY- formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm on 23Feb2021 (Batch/Lot Number: EP2163) as single dose and dose 2 via an unspecified route of administration, administered in Arm on 16Mar2021 (Batch/Lot Number: ET3620) as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included Cataract (left), Type 2 diabetes mellitus, Depression, Gonarthrotic and Hypertension arterial from an unknown date and unknown if ongoing. It was unknown that patient had COVID-19 before vaccination. The patient''s concomitant medications were not reported. 86-year-old patient who was referred to the emergency room for dyspnoea of two days of evolution. No fever or other clinic. The patient reports feeling well but with some difficulty breathing for two days and do not cough. On 08Jun2021 - PCR SARS-CoV-2 - POSITIVE. Empirical antibiotic therapy with levofloxacin begins 09Jun2021. The patient received the complete vaccination, and on 14Jun2021, admitted to the hospital for bilateral pneumonia from covid 19. severe bilateral pneumonia due to sars cov-2 in a vaccinated patient with oxygen saturation less than 94% at admission unfavourable evolution: death (exits). The patient underwent lab tests and procedures which included activated partial thromboplastin time: 29 seconds on 13Jun2021, alanine aminotransferase: 15 on 13Jun2021, blood bicarbonate: 20 on 13Jun2021, blood bicarbonate: 25.7 on 14Jun2021, blood calcium: 10 on 13Jun2021, blood chloride: 99 on 13Jun2021, blood creatine phosphokinase: 17 on 13Jun2021, blood creatinine: 1.22 on 13Jun2021, blood fibrinogen: 625 on 13Jun2021, blood glucose: 160 on 13Jun2021, blood lactate dehydrogenase: 239 on 13Jun2021, blood lactic acid: 2.1 on 13Jun2021, blood potassium: 4.7 on 13Jun2021, blood sodium: 137 on 13Jun2021, blood urea: 105 on 13Jun2021. Thorax X-ray: due to right diaphragmatic hemi-relaxation, cardiomegaly, aortic elongation on 13Jun2021, Fibrin D dimer 528.32 on 13Jun2021, Glomerular filtration rate: 40 ml/min/1.73m2 on 13Jun2021, Haematocrit: 45.2 on on 13Jun2021 and 42.7 on 14Jun2021, Haemoglobin: 14.3 on 13Jun2021 and 13.6 on 14Jun2021, Leukocytosis: 25150 on 13Jun2021 and 16260 on 14Jun2021, Lymphocyte count: 1750 on 13Jun2021 and 640 on 14Jun2021, Mean cell haemoglobin: 28 on 13Jun2021 and 29 on 14Jun2021, Mean cell volume: 91 on 13Jun2021 and 91 on 14Jun2021, Oxygen saturation: 55 percentage on 13Jun2021 and 88 on 14Jun2021, PCO2: 32 on 13Jun2021 and 43.7 on 14Jun2021, pH body fluid: 7.4pH on 13Jun2021 and 7.38pH on 14Jun2021, Platelet count: 290000 on 13Jun2021 and 264000 on 14Jun2021, PO2: 28.7 on 13Jun2021 and 52.6 on 14Jun2021, Polymerase chain reaction: 224.3 on 13Jun2021, Prothrombin time: 14 second on 13Jun2021, Red cell distribution width: 14.7 on 13Jun2021 and 14.2 on 14Jun2021, SARS-CoV-2 test positive on 08Jun2021 and White blood cell count 22030 on 13Jun2021 and 15400 on 14Jun2021. Therapeutic measures were taken as a result of the events with levofloxacin. The outcome of the events Vaccination Failure and COVID-19 pneumonia and reported as fatal and rest all were unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown


VAERS ID: 1488045 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Blood fibrinogen, Blood glucose, Blood pressure measurement, Body temperature, C-reactive protein, CSF test abnormal, Cerebral venous thrombosis, Computerised tomogram, Computerised tomogram abnormal, Heart rate, International normalised ratio, Oxygen saturation, Platelet count, Subarachnoid haemorrhage
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, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Test Date: 20210625; Test Name: Activated partial thromboplastin time; Test Result: 32.8 s; Test Date: 20210627; Test Name: APTT; Result Unstructured Data: Test Result:TTPAr 3.45; Test Name: CT angiography; Result Unstructured Data: Test Result:CT angiography study of the TSAs; Comments: In the CT angiography study of the TSAs, no alterations in origin, caliber and trajectory of the carotid trees and their intracranial branches are observed. Later circulation without notable findings. Suspicious structures for intracranial aneurysms or other vascular malformations are not visible.; Test Date: 20210625; Test Name: Fibrinogen; Test Result: 3 mg/dl; Test Name: glucose; Result Unstructured Data: Test Result:149; Test Name: blood pressure; Result Unstructured Data: Test Result:165/89 mmHg; Test Date: 20210628; Test Name: blood pressure; Result Unstructured Data: Test Result:220/122 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210628; Test Name: cranial CT scan; Result Unstructured Data: Test Result:cranial CT scan; Comments: cranial CT scan was performed showing progression of hydrocephalus and increased subarachnoid bleeding.; Test Date: 20210625; Test Name: Computerised axial tomography abnormal; Result Unstructured Data: Test Result:CT without Contrast; Comments: CT without Contrast I.V. Skull (06/25/2021): Subarachnoid hemorrhage is identified predominantly in the prebulbar, prepontine and perimesencephalic cistern, which is distributed through the rest of the cisternae of the base, a small amount in the cisterna magna, a small amount of intraventricular blood is also visualized in the declining zone of both occipital horns of the lateral ventricles, III and IV ventricles probably due to recirculation. Mild dilation of the ventricular system with an Evans index of 0.33, probably related to a mild degree of arreabsorptive hydrocephalus, without identifying periependymal edema. There is no midline deviation or displacement of structures. There is no current or evolving ischemic event data. LOES suggestive of a neoformative process are not defined.; Test Date: 20210626; Test Name: Computerised axial tomography abnormal; Result Unstructured Data: Test Result:Subarachnoid hemorrhage; Comments: TC s.c. of control skull (06/26/2021): Subarachnoid hemorrhage predominantly perimesencephalic persists of a similar amount and extension than in a previous study, with the presence of bleeding also in the cisterna magna, prebulbar and prepontine. The component located in the chiasmatic cistern has disappeared as well as its bilateral peripheral extension. The same component of subarachnoid hemorrhage is observed in the sulci of both convexities, mainly frontal. The intraventricular component persists located in both occipitals of both lateral ventricles and IV ventricle. Associated hydrocephalus remains stable (Evans score of 0); Test Date: 20210628; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21 mg/l; Test Date: 20210628; Test Name: CSF abnormal; Result Unstructured Data: Test Result:High pressure serohematic CSF.; Test Name: heart rate; Result Unstructured Data: Test Result:70; Comments: bpm; Test Date: 20210627; Test Name: INR; Result Unstructured Data: Test Result:1.10; Test Name: Sat O2; Test Result: 99 %; Test Date: 20210625; Test Name: Platelet count; Result Unstructured Data: Test Result:235 x 10^9
CDC Split Type: ESPFIZER INC2021843221

Write-up: Hemorrhage subarachnoid; Cerebral venous thrombosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-930009. A 50-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FA5833), via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hemorrhage subarachnoid and cerebral venous thrombosis on 24Jun2021. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 32.8 seconds on 25Jun2021; activated partial thromboplastin time (APTT): TTPar 3.45 on 27Jun2021; CT angiography: CT angiography study of the TSAs, no alterations in origin, caliber and trajectory of the carotid trees and their intracranial branches are observed. Later circulation without notable findings. Suspicious structures for intracranial aneurysms or other vascular malformations are not visible on an unspecified date; fibrinogen: 3 mg/dl on 25Jun2021; glucose: 149 on an unspecified date; blood pressure: 165/89 mmHg on and unspecified date and 220/122 mmHg on 28Jun2021; body temperature: 36.4 Centigrade on an unspecified date; cranial CT scan: cranial CT scan was performed showing progression of hydrocephalus and increased subarachnoid bleeding on 28Jun2021; computerized axial tomography abnormal: CT without Contrast I.V. Skull (06/25/2021): Subarachnoid hemorrhage is identified predominantly in the prebulbar, prepontine and perimesencephalic cistern, which is distributed through the rest of the cisternae of the base, a small amount in the cisterna magna, a small amount of intraventricular blood is also visualized in the declining zone of both occipital horns of the lateral ventricles, III and IV ventricles probably due to recirculation. Mild dilation of the ventricular system with an Evans index of 0.33, probably related to a mild degree of arreabsorptive hydrocephalus, without identifying periependymal edema. There is no midline deviation or displacement of structures. There is no current or evolving ischemic event data. LOES suggestive of a neoformative process are not defined on 25Jun2021 and subarachnoid hemorrhage, TC s.c. of control skull (06/26/2021): Subarachnoid hemorrhage predominantly perimesencephalic persists of a similar amount and extension than in a previous study, with the presence of bleeding also in the cisterna magna, prebulbar and prepontine. The component located in the chiasmatic cistern has disappeared as well as its bilateral peripheral extension. The same component of subarachnoid hemorrhage is observed in the sulci of both convexities, mainly frontal. The intraventricular component persists located in both occipitals of both lateral ventricles and IV ventricle. Associated hydrocephalus remains stable (Evans score of 0) on 26Jun2021; C-reactive protein: 21 mg/l on 28Jun2021; CSF abnormal: high pressure serohematic CSF on 28Jun2021; heart rate: 70 bpm on an unspecified date; international normalised ratio (INR): 1.10 on 27Jun2021; Sat O2: 99% on an unspecified date; platelet count: 235 x 10^9 on 25Jun2021. The patient died on 28Jun2021. It was not reported if an autopsy was performed. The reported cause of death were cerebral venous thrombosis, cerebral haemorrhage and cardiac arrest. The outcome of the events were fatal. The clinical course was reported as follows: 50-year-old patient, with no relevant pathological history or usual treatment. . Vaccinated on 07Jun2021 with the first dose of COMIRNATY (LOT FA5833). On 24Jun2021, he presented with an intense headache while riding a horse, followed by up to 3 vomiting, after which the headache improved a little, although it persisted. No fall or syncope. No loss of strength or sensitivity, no sphincter relaxation. Conscious at all times. He comments on headache the previous days. Affected by pain. TA 165/89 Glucose 149 mg / dl Sat O2 99% baseline HR 70 bpm Temp 36.4?C Neurological examination without current pathological findings. scale 15. PINLA. MOEC. No nystagmus. No loss of strength or sensitivity. No dysdiadochokinesias. No alt of the march. No stiff neck or meningeal signs. No current focus. ACR. Rhythmic tones without murmurs. BMV without pat noise Abdomen soft and depressible, not painful. not masses or megalies. No MMII peritonism. No edema, no signs of current DVT, ECG. RS at 70 bpm, normal axis. PR and normal QRS. No sharp alt of the current repolarization. 25Jun2021: Sharp frontal stabbing headache from tonight around 9:00 p.m. He has presented 3 episodes of vomiting later, transferred to the hospital emergency room. MMII without edema or signs of DVT. CT without Contrast I.V. Cranial (25Jun2021): Subarachnoid hemorrhage is identified predominantly in the prebulbar, prepontine and perimesencephalic cistern, which is distributed through the rest of the cisternae of the base, a small amount in the cisterna magna, a small amount of intraventricular blood is also seen in the declining area of both occipital horns of lateral ventricles, III and IV ventricles probably due to recirculation. Mild dilatation of the ventricular system with an Evans index of 0.33, probably related to a slight degree of arreabsorptive hydrocephalus, without identifying periependymal edema. There is no midline deviation or displacement of structures. There is no current or evolving ischemic event data. LOES suggestive of a neoformative process are not defined. In the CT angiography study of the TSAs, no alterations in origin, caliber and trajectory of the carotid trees and their intracranial branches are observed. Later circulation without notable findings. Suspicious structures for intracranial aneurysms or other vascular malformations are not visible. CONCLUSION: Findings related to subarachnoid hemorrhage predominantly in anterior infratentorial cisterns, which are distributed throughout all cranial base cisterns. Intraventricular blood content. Mild arreabsorptive hydrocephalus. No aneurysms or other vascular malformations are seen in the CT angiography study. Transfer to Hospital Neurosurgery: Patient with subarachnoid hemorrhage, with finding of thrombosis of the transverse sinus, sigmoid and left jugular vein in arteriography. of uncertain chronology and etiology. Complementary Tests: Platelets 235x10e9 / normal LEBC. APTT 20.4 sec Creatinine 1.15 mg / dl. Currently heparin pc iv at 12 mg / h 25Jun2021 Complementary Tests: Platelets 235x10e9 / normal LEBC. APTT 20.4 sec Creatinine 1.15 mg / dl. Clinical Judgment: 1) Perimesencephalic SAH without justifying vascular malformation, possibly secondary to CVT. 2) Secondary mild hydrocephalus. 3) Venous thrombosis of the left transverse, sigmoid and jugular sinuses of uncertain chronology and etiology. TC s.c. of control skull (26Jun2021): Subarachnoid hemorrhage predominantly perimesencephalic persists of a similar amount and extension than in a previous study, with the presence of bleeding also in the cisterna magna, prebulbar and prepontine. The component located in the chiasmatic cistern has disappeared as well as its bilateral peripheral extension. The same component of subarachnoid hemorrhage is observed in the sulci of both convexities, mainly frontal. The intraventricular component persists located in both occipitals of both lateral ventricles and IV ventricle. The associated hydrocephalus remains stable (Evans index 0.33) There is no midline deviation or obvious herniation of structures. There is no current or evolving ischemic event data. LOES suggestive of a neoformative process are not defined, and no other findings of interest. CONCLUSION: Stability of the findings visualized in CT of 25Jun2021, with subarachnoid hemorrhage predominantly perimesencephalic (which has minimally decreased) and in both convexities. He presents associated hemoventricle and mild hydrocephalus, also unchanged. 27Jun2021: Complementary Tests: TTPAr 3.45 INR 1.10 Fibrinogen 4. Action Plan: We recommend: - Continue the IV heparin pc at 13 ml / h - New aPTT control (r) tomorrow at 8:30 a.m. 28Jun2021: Clinical worsening of the patient associated with a blood pressure peak of 220/122 mmHg. Due to this, a s / c skull CT is requested for a new radiological control. During transfer to the CT room, the patient presented pupillary anisocoria together with asystole in dich or moment. IOT and advanced cardiopulmonary resuscitation are performed in the emergency room in the HRT emergency room, where the heart rhythm is reversed. After hemodynamic stabilization, a s / c cranial CT scan was performed showing an increase in ventricular size together with an increase in blood volume in the perimesencephalic and intraventricular cistern. Examination: Upon arrival, the patient did not respond to verbal or algesic stimuli, he presented non-reactive miotic pupils. 28Jun21: suffered neurological deterioration and an emergent cranial CT scan was performed showing progression of hydrocephalus and increased subarachnoid bleeding. He is transferred to ICU. High pressure serohematic CSF. C / c cranial CT, where an increase in the HTIC data is appreciated with loss of gray matter-white matter differentiation with obliteration of cerebral sulci due to diffuse parenchymal edema, more evident than the previous CT. At all times BILATERAL MIDRIASIS. After correcting the ionic, metabolic and temperature alterations, a complete neurological examination is performed, verifying: CS 3/15 points, together with absence of reflexes from all cranial nerves bilaterally (absence of oculomotor, oculovestibular, oculocephalic reflex, absence of response to stimuli in the trigeminal territory, absence of swallowing and cough reflex, absence of cardioaccelerator response to the administration of 3mg of atropine, absence of oculocardiac response, absence of inspiratory stimulus after performing the apnea test). In view of the aforementioned findings, DTC is performed, which shows a pattern compatible with Brain Death. TIME: 19.05 DATE: 28Jun2021. Immediate cause. Brain edema.- Fundamental cause. Cerebral venous thrombosis.- Intermediate cause. Subarachnoid hemorrhage. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cerebral venous thrombosis; Cerebral haemorrhage; Cardiac arrest


VAERS ID: 1488068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Cerebral artery thrombosis, Fibrin D dimer, Immunology test, Platelet count, Portosplenomesenteric venous thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Platelet count; Result Unstructured Data: 14.000; Test Date: 20210706; Test Name: Fibrin D dimer; Result Unstructured Data: 128000; Test Date: 20210707; Test Name: ELISA; Result Unstructured Data: Positive
CDC Split Type: ESJNJFOC20210736305

Write-up: THROMBOCYTOPENIA; PORTOMESENTERIC VEIN THROMBOSIS; CEREBRAL ARTERIAL THROMBOSIS; ANTI-PLATELET ANTIBODY; This spontaneous report was received from a physician via a regulatory authority, case reference number ES-AEMPS-936765, and concerned a 36 year-old male patient. The patient''s weight was 92 kilograms and his height was 180 centimeters. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 21C17-04, expiry date not reported), dose not reported, administered once in total on 25-JUN-2021 for COVID-19 (prophylactic) vaccination. No concomitant medications were reported. On 01-JUL-2021, on day 6 after receiving the vaccine, the patient experienced thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis and anti-platelet antibody, and was hospitalized on an unspecified date. On 06-JUL-2021, the patient''s platelet count was "14.000" and fibrin D-dimer was 128000 (units and normal ranges [NRs] not reported). On 06-JUL-2021, it was reported that the patient died from middle cerebral artery infarct and multi-organ failure. It was reported as unknown if an autopsy was performed. On 07-JUL-2021, the ELISA (enzyme-linked immunosorbent assay) test result came back as positive. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis and anti-platelet antibody was reported as fatal. This report was serious (death, life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous report was received from a physician via a regulatory authority (ID: ES-AEMPS-936765) concerned a 36-year-old male patient who experienced thrombocytopenia, portomesenteric vein thrombosis, cerebral arterial thrombosis, and anti platelet antibody 6 days after vaccine. No past medical history or concomitant medications were reported. On day 11, the patient''s platelet count was 14,000 and D-dimer was 128,000 (units and normal ranges not reported). On day 11, it was reported that the patient died from middle cerebral artery infarct and multi-organ failure. It was unknown if an autopsy was performed. On day 12, the ELISA test result came back as positive. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from a regulatory authority), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: MIDDLE CEREBRAL ARTERY INFARCT; MULTI-ORGAN FAILURE


VAERS ID: 1488091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Hot flush, Infarction, Intestinal obstruction, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident (stroke two months ago); Cow pox; Hospitalization; Memory impairment; respiratory syndrome; Rehabilitation therapy; Ventricular asystole
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021844086

Write-up: cardiac arrest; Infarction; Vomiting; felt nauseous; hot flashes; occlusion; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021051663. A 75-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. Medical history included memory impairment, respiratory syndrome, Cow pox, stroke two months ago, after 3 weeks of hospitalization in neurology at the hospital, she was admitted to a rehabilitation center and ventricular asystole. The patient''s concomitant medications were not reported. The patient had a stroke two months ago, after 3 weeks of hospitalization in neurology at the hospital, she was admitted to a rehabilitation center. The patient was benefiting from the care, and they were seeing the improvement every day. She wanted to be vaccinated and she was injected with the Pfizer on 13Apr2021. After about 48 hours, on 15Apr2021 (also reported as 19Apr2021), the patient felt nauseous, she vomited, she felt hot flashes. The doctors at the center thought of an occlusion and performed an enema, there was stool. This condition lasted over the weekend and resulted the patient being rushed to the hospital very early. The family were contacted at 7:30 am to tell them that their mother could not be saved. They were told that all of her organs began to malfunction and that resulted in cardiac arrest. Shocked by this sudden death, the reporter came across an article which mentioned cases of endocarditis after an injection of the Pfizer vaccine, so they made a connection with what had happened to their mother. The reporter would like an investigation to be carried out. The patient experienced infarction on 19Apr2021. The patient underwent lab test and procedures which included SARS-CoV-2 test: negative on Feb2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The events infarction, vomiting and cardiac arrest were fatal. The outcome of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest; infarction; vomiting


VAERS ID: 1488120 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-05-18
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: patient presented a positive PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC2021874042

Write-up: Vaccination failure; COVID-19 respiratory infection; This is a spontaneous report from a contactable other hcp downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021072761. Case originating from a professional health report via a regulatory authority portal number 20210610205827945. A 94-year-old female patient received bnt162b2 (COMIRNATY) first dose (lot EM0477, Expiration Date: 30Apr2021), Intramuscularly in left arm on 14Jan2021, second dose (lot EJ6788, Expiration Date: 30Apr2021), Intramuscularly in left arm on 05Feb2021, both as single dose for COVID-19 immunisation. Medical history and concomitant medications included no documented history or documented long-term treatment. COVID-19 history was not specified. The patient experienced Vaccination failure proven. On 18May2021, the patient presented a positive PCR. Symptoms included asthenia, anorexia and slight dyspnea requiring oxygen therapy. On 08Jun2021, the patient died. A regulatory authority included, the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot EJ6788 and lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. A regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required for Lot EJ6788, a regulatory notification was required for Lot EM0477. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No Autopsy Done. The outcome of the event was Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure: covid infection with dyspnea and oxygen therapy


VAERS ID: 1488142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-04-09
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, C-reactive protein, Diabetes mellitus inadequate control, Encephalopathy, Gait disturbance, General physical health deterioration, Glycosylated haemoglobin, Nystagmus, Respiratory disorder, Speech disorder
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 11
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: KARDEGIC; DIAMICRON; LERCANIDIPINE BIOGARAN; COAPROVEL; TAHOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes mellitus (non-insulin dependent)
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:96 mg/ml; Test Name: glycosylated hemoglobin; Test Result: 9.3 %
CDC Split Type: FRPFIZER INC2021843468

Write-up: Brittle diabetes; Balance disorder; Disorder speech; Nystagmus; Asthenia; Encephalopathy; Disorder gait; Reduced general condition; Respiratory degradation; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-2021079856. An 83-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular, administered in arm left on 03Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included arterial hypertension and non-insulin dependent diabetes mellitus from an unknown date. Concomitant medications included acetylsalicylate lysine (KARDEGIC, 75 mg); gliclazide (DIAMICRON, 60 mg); lercanidipine hydrochloride (LERCANIDIPINE BIOGARAN, 20 mg); hydrochlorothiazide, irbesartan (COAPROVEL, 300 mg / 12.5 mg); atorvastatin calcium (TAHOR, 10 mg); all taken for an unspecified indication, start and stop date were not reported. On 09Apr2021, the patient experienced brittle diabetes, balance disorder, disorder speech, nystagmus, asthenia, encephalopathy, disorder gait and reduced general condition. As per the reporter all events seriousness criteria reported as death, hospitalization. It was described as gait and balance disorders, background of asthenia without loss of weight, without alteration of the general condition (as reported), speech disorders, imbalance of diabetes and glycosylated hemoglobin at 9.3%. CRP at 96mg / ml. Multidirectional nystagmus. According to the declarant: the patient presented a picture of encephalopathy of undetermined origin. Hospitalization. Respiratory degradation followed by death on 20Apr2021. The patient underwent lab tests and procedures on unspecified date which included c-reactive protein: 96 mg/ml and glycosylated hemoglobin: 9.3%. The outcome of the events was fatal. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Brittle diabetes; Balance disorder; Disorder speech; Nystagmus; Asthenia; Encephalopathy; Disorder gait; Reduced general condition; Respiratory degradation


VAERS ID: 1488187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-24
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 4815 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Body mass index, Chest pain, Constipation, Diarrhoea, Dyspnoea, Intestinal infarction, Myocardial infarction, Pain of skin, Peripheral swelling, Peritonitis, SARS-CoV-2 test, Speech disorder, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUCREAS; PLAVIX; IMPORTAL; DIAMICRON
Current Illness: Type 2 diabetes mellitus (treated and stabilized)
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Prostate cancer (total remission); Prostate resection; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: BMI; Result Unstructured Data: Test Result:26.6; Comments: kg per m2; Test Date: 20210525; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021843070

Write-up: Vomiting; enlargement of the abdomen; constipation; diarrhea; Abdominal pain; Chest pain/pain under the ribs and under the chest; Swelling of the legs; Shortness of breath; difficulty in speaking; myocardial infarction; occlusive syndrome with peritonitis on perforation; mesenteric infarction; bilateral epigastric and subcutaneous pain; bilateral epigastric and subcutaneous pain; This is a spontaneous report from a contactable consumer (patient''s relative) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-2021084132. An 89-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left arm on 20Apr2021 (Batch/Lot Number: EW 4815) as dose number unknown, single for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (treated and stabilized), prostate cancer (total remission) from 2018 to 2020, stroke from 2001, prostate resection in 2014 and cholecystectomy. The patient has no COVID-19 history. Concomitant medications included metformin hydrochloride, vildagliptin (EUCREAS); clopidogrel bisulfate (PLAVIX); lactitol (IMPORTAL); and gliclazide (DIAMICRON); all taken for an unspecified indication, start and stop date were not reported. At Day 34 (D34), on 24May2021: the notifier reported an enlargement of the abdomen with constipation, diarrhea, vomiting, abdominal pain, pain under the ribs and under the chest (also reported as chest pain) as well as swelling of the legs and shortness of breath with difficulty in speaking. At Day 35 (D35), on 25May2021: the vomiting increased, requiring a transfer to the hospital. The patient died during the trip. The emergency room report specifies a usual treatment with EUCREAS, IMPORTAL, DIAMICRON and BIOCALIPTOL as well as a history of the disease stating 48 hours without bowel movement, after an episode of profuse diarrhea and the notion of bilateral epigastric and subcutaneous pain. The diagnoses evoked by the emergency physician to explain the death were inferior myocardial infarction, occlusive syndrome with peritonitis on perforation, mesenteric infarction. No additional post-mortem examination was performed. The patient underwent lab tests and procedures which included body mass index: 26.6 kg per m2 on 25May2021 and sars-cov-2 test: negative on 25May2021. Outcome of events was fatal. The patient died on 25May2021. No autopsy was performed. Summary based on additional observations collected by the Investigators. In conclusion: death of supposed cardiac or digestive cause on day 35 of a COMIRNATY vaccine booster in an elderly patient. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting; enlargement of the abdomen; constipation; diarrhea; Abdominal pain; Chest pain/pain under the ribs and under the chest; Swelling of the legs; Shortness of breath; difficulty in speaking; myocardial infarction; occlusive syndrome with perito


VAERS ID: 1488188 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Blood glucose, Blood glucose decreased, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Coma, Dyspnoea, Electrocardiogram, General physical health deterioration, Heart rate, Heart rate increased, Hyperpyrexia, Investigation, Neurological examination, Oxygen saturation, Protein urine present, Respiratory disorder, SARS-CoV-2 test, Tachypnoea, Urine analysis, Urine cytology, Visual analogue scale, Vomiting, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MODOPAR; MANTADIX; MODOPAR; NEUPRO; MODOPAR; STALEVO [CARBIDOPA;ENTACAPONE;LEVODOPA]; BUSPIRONE HYDROCHLORIDE; PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arterial hypertension; Asthma; Bedridden; Chronic respiratory failure; COPD; Cyst ovary; Fall; Parkinson''s disease; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Blood glucose test; Result Unstructured Data: Test Result:1.30 mmol/L; Test Date: 20210616; Test Name: Potassium; Result Unstructured Data: Test Result:4; Test Date: 20210616; Test Name: Natremia; Result Unstructured Data: Test Result:138; Test Date: 20210616; Test Name: Temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210616; Test Name: Temperature; Result Unstructured Data: Test Result:42 Centigrade; Test Date: 20210616; Test Name: CRP; Result Unstructured Data: Test Result:less than 0.6; Test Date: 20210616; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm 96/min; Comments: regular sinus rhythm 96/min; Test Date: 20210616; Test Name: Heart rate; Result Unstructured Data: Test Result:108; Comments: 108 beats/min; Test Date: 20210616; Test Name: investigation; Result Unstructured Data: Test Result:No signs of struggle, no sensorimotor deficit; Comments: no facial paralysis, regular heartbeat, no murmur, no sign of heart failure, no sign of deep vein thrombosis, vesicular murmur +, no additional noise; abdomen soft and painless, hydroaeric noises +, and no functional urinary signs; Test Date: 20210616; Test Name: Neurological examination; Result Unstructured Data: Test Result:no facial paralysis, no aphasia, no sensorimotor; Comments: no facial paralysis, no aphasia, no sensorimotor deficit and with known involuntary movements; Test Date: 20210616; Test Name: Sa02; Test Result: 98 %; Test Date: 20210617; Test Name: PCR SARS-CoV2; Test Result: Negative ; Test Date: 20210616; Test Name: Dipstick urinalysis; Result Unstructured Data: Test Result:trace proteins; Test Date: 20210616; Test Name: Cytobacteriological examination of urine; Result Unstructured Data: Test Result:cocci G+; Test Date: 20210616; Test Name: Visual analogue scale; Result Unstructured Data: Test Result:11; Test Date: 20210616; Test Name: white blood cell; Result Unstructured Data: Test Result:9.6
CDC Split Type: FRPFIZER INC2021843386

Write-up: Cardio-respiratory arrest; Coma/febrile coma; Dyspnea; fever/febrile coma at 42?C/febricula; altered general condition; heart rate: 108 beats/min; blood glucose test: 1.30 mmol/L; Dipstick urinalysis: trace proteins; polypneic; cytobacteriological examination of the urine: some cocci G+; respiratory discomfort; vomiting; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021084203. A 67-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 15Jun2021 (Batch/Lot Number: FD0168) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included fall, arterial hypertension, stroke, appendectomy, chronic obstructive pulmonary disease (COPD), type 2 diabetes mellitus, Parkinson''s disease from 2000, asthma from 2014, chronic respiratory failure, cyst ovary and bedridden. The patient has no history of covid-19. The patient is considered to be at risk of developing a severe form of COVID-19 disease because of her age, her cardiovascular pathologies (hypertension, stroke), her chronic respiratory insufficiency and her Parkinson''s disease. The patient is bedridden at home with a medical bed, wheelchair, daily care by state registered nurses at home. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR) taken for disease parkinson''s, amantadine hydrochloride (MANTADIX) taken for disease parkinson''s, benserazide hydrochloride, levodopa (MODOPAR) taken for disease parkinson''s, rotigotine (NEUPRO) taken for disease parkinson''s, benserazide hydrochloride, levodopa (MODOPAR) taken for disease parkinson''s, carbidopa, entacapone, levodopa (STALEVO [CARBIDOPA;ENTACAPONE;LEVODOPA]) taken for disease parkinson''s, buspirone hydrochloride, and paroxetine hydrochloride hemihydrate. The patient experienced coma on 17Jun2021, dyspnea on 16Jun2021, and cardio-respiratory arrest on 17Jun2021. On 16Jun2021 around 12:30, the patient goes to the emergency room for altered general condition, fever and dyspnea. On arrival, temperature: 36.8 degrees Celsius, heart rate: 108 beats/min, Sa02: 98%, blood glucose test: 1.30 mmol/L. No signs of struggle, no sensorimotor deficit, no facial paralysis, regular heartbeat, no murmur, no sign of heart failure, no sign of deep vein thrombosis, vesicular murmur +, no additional noise; abdomen soft and painless, hydroaeric noises +, and no functional urinary signs. Neurological examination showed no facial paralysis, no aphasia, no sensorimotor deficit and with known involuntary movements. ECG showed regular sinus rhythm 96/min, no tachycardia, and no arrhythmia. Biological workup showed Na: 138, K: 4, CRP < 0.6, white blood cell count: 9.6, Dipstick urinalysis: trace proteins, cytobacteriological examination of urine: cocci G+. Arterial pressure and respiratory rate not available, but the patient appears to be polypneic. For the past week, increased symptoms of her Parkinson''s disease noted. Conclusion: respiratory discomfort, no desaturation, no fever, no biological inflammatory syndrome, no ionic disorder, cytobacteriological examination of the urine: some cocci G+ (no treatment, patient not febrile, no urinary functional signs). The patient went home at about 6:30 pm. At about 10:15 pm: care at home with febrile coma at 42?C with placement of 6L of O2. On arrival: temperature was 42 degrees Celsius, visual analogue scale: 11, and vomiting. On 17Jun2021 around 0h40: cardiorespiratory arrest. According to the notifier, the fever is probably due to the vaccine. PCR SARS-CoV2 was negative. Evolution: death. In total, onset of general condition alteration with febricula and dyspnea the day after COMIRNATY Dose 2, followed by febrile coma and cardiorespiratory arrest on Day 3. The patient died on an unspecified date due to coma, dyspnea and cardio-respiratory arrest. It was unknown if an autopsy was performed. The outcome of the other events was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Coma; dyspnea; cardio-respiratory arrest


VAERS ID: 1488222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-06-18
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Heart rate, Incorrect route of product administration, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Drug abuse and dependence (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic respiratory failure; Cognitive disorders; Fibrillation atrial; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: Heart rate; Result Unstructured Data: Test Result:100bpm; Test Date: 20210621; Test Name: Oxygen saturation; Test Result: 78 %; Comments: under 3 L; Test Date: 20210621; Test Name: Oxygen saturation; Test Result: 88 %; Comments: under 5 L; Test Date: 20210618; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Delta screened on 19Jun2021
CDC Split Type: FRPFIZER INC2021848060

Write-up: Vaccination failure; Inappropriate route of vaccination; SARS-CoV-2 test positive; This is a spontaneous report from a contactable other health care professional downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-2021084542. Safety Report Unique Identifier: FR-AFSSAPS-BX20216262. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: ET7205), via subcutaneous route of administration on 01Apr2021 and second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EX0893), via subcutaneous route of administration on 22Apr2021 as single for covid-19 immunization. Medical history included atrial fibrillation, cognitive disorder, chronic respiratory failure, arterial hypertension, ischaemic heart disease. The patient''s concomitant medications included anticoagulant therapy not specified. On 18Jun2021, approximately 2 months after the second dose of Comirnaty, in a 92-year-old patient in which a delta variant COVID cluster was declared. On 21Jun2021, almost 2 months after 2nd dose patient experienced COVID infection and apyretic. The patient underwent lab tests and procedures which included heart rate at 100 bpm on 21Jun2021, oxygen saturation resulted as 78% saturation under 3 L oxygen on 21Jun2021, oxygen saturation resulted as 88% under 5 L on 21Jun2021, PCR test on 18Jun2021 and delta screened on 19Jun2021. On 08Jul2021, patient died (no details on the cause of death). The reported event vaccination failure led to patient''s hospitalization on an unspecified date. Reporter considered vaccine failure as serious. New information received from Product Complaint Team. New information provided from division company included: Conclusion field from that investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5916125 (see File attachment in this investigation record) The complaint for PFIZER BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX0893. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion field from that investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5840524 (see File attachment in this investigation record) The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The outcome of vaccination failure was fatal, while with other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1488228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Acute kidney injury, Blood creatinine, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Body temperature, C-reactive protein, Coma scale, Condition aggravated, Decreased appetite, Decubitus ulcer, Dehydration, Disseminated intravascular coagulation, Dyspnoea, Ejection fraction, Electrocardiogram, Heart rate, Hyperkalaemia, Hyperlactacidaemia, Hyperleukocytosis, Inflammation, Mini mental status examination, Multiple organ dysfunction syndrome, Nausea, Procalcitonin, Prothrombin time, SARS-CoV-2 test, Septic shock, Urine analysis, Vomiting, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; CLINDAMYCIN; BACTRIM; PARACETAMOL; MACROGOL; SPECIAFOLDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Cognitive disorders; Colonoscopy; Colostomy; Deep vein thrombosis; Edema lower limb; Fecal impaction; Haemorrhagic stroke; Malnutrition; Multiple sclerosis; Non-insulin-dependent diabetes mellitus; Osteitis; Pressure sore; Pulmonary embolism; Weight loss
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Creatinine; Result Unstructured Data: Test Result:69.8 umol/l; Comments: normal renal function; Test Date: 20210622; Test Name: Blood glucose capillary; Result Unstructured Data: Test Result:0.34 g/l; Test Date: 20210622; Test Name: Lactate; Result Unstructured Data: Test Result:14.8 mmol/L; Comments: hyperlactatemia; Test Date: 20210622; Test Name: Potassium; Result Unstructured Data: Test Result:6.9 mmol/L; Comments: hyperkalaemia; Test Date: 20210622; Test Name: Blood pressure; Result Unstructured Data: Test Result:10/5 mmHg; Comments: rose after filling; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:34.6 Centigrade; Test Date: 20210622; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:15; Comments: conscious but inconsistent (cognitive disorders); Test Date: 20210614; Test Name: CRP; Result Unstructured Data: Test Result:107.85 mg/l; Test Date: 20210622; Test Name: CRP; Result Unstructured Data: Test Result:51 mg/l; Test Date: 202102; Test Name: LVEF; Test Result: 60 %; Test Date: 202102; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm; Test Date: 20210622; Test Name: Cardiac frequency; Result Unstructured Data: Test Result:89 bpm; Test Date: 202102; Test Name: MMS; Result Unstructured Data: Test Result:7/30; Test Date: 20210622; Test Name: pH; Result Unstructured Data: Test Result:7.08 mmol/L; Comments: marked acidosis; Test Date: 20210622; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.27; Test Date: 20210622; Test Name: PT; Test Result: 10 %; Comments: disseminated intravascular coagulation; Test Date: 20210618; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:no result provided; Test Date: 20210614; Test Name: Urinalysis; Result Unstructured Data: Test Result:detection of C albicans; Comments: leukocyturia at 156,000/ml and hematuria $g1.000.000/ml, Kass 10^5, detection of C albicans; Test Date: 20210617; Test Name: Urinalysis; Result Unstructured Data: Test Result:increased leukocyturia; Comments: leukocyturia at 356,000/ml and hematuria more than 1,000,000/ml. Culture with E Coli 10^6 resistant to Bactrim and E faecalis 10^5 resistant to Bactrim and C albicans 10^5; Test Date: 20210614; Test Name: Leucocyt count; Result Unstructured Data: Test Result:no hyperleukocytosis g/l; Test Date: 20210622; Test Name: Leucocyt count; Result Unstructured Data: Test Result:13.7 g/l; Comments: polynuclear neutrophils
CDC Split Type: FRPFIZER INC2021843037

Write-up: Multi organ failure; Disseminated intravascular coagulation with prothrombin time 10%; hyperlactatemia 14.8 mmol/L; Septic shock; marked acidosis with pH 7.08 mmol/L; acute renal failure; hyperkalaemia 6.9 mmol/L; hyperleukocytosis with 13.7 G/L; inflammatory syndrome; dyspnea without initial desaturation; pressure ulcer gradually worsened, more and more extensive and deepening with 2 bone contacts; pressure ulcer gradually worsened, more and more extensive and deepening with 2 bone contacts; Anorexia; Emesis; Nausea; lack of hydration; This is a spontaneous report from a contactable physician, downloaded from a regulatory authority-WEB, Regulatory Authority Number: FR-AFSSAPS-2021084691. A 65-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in the left arm on 18Jun2021 (Batch/Lot Number: FD0168) as DOSE 1, SINGLE for COVID-19 immunisation; and metformine [metformin] (METFORMINE [METFORMIN]), oral from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 850 mg 3xday for Non-Insulin Dependent Diabetes Mellitus (NIDDM). Relevant medical history included deep sacral pressure sore +/- osteitis, treated with bi-antibiotic therapy since 18May2021, multiple sclerosis since 1997 with paraplegia, multiple bilateral pulmonary embolism (under Eliquis), non-insulin dependent diabetes, undernutrition, hemorrhagic stroke, cognitive sequelae/advanced cognitive disorders. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; clindamycin (CLINDAMYCIN) taken for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported; paracetamol (PARACETAMOL) taken for an unspecified indication, start and stop date were not reported; macrogol (MACROGOL) taken for an unspecified indication, start and stop date were not reported; folic acid (SPECIAFOLDINE) taken for an unspecified indication, start and stop date were not reported. The patient was hospitalized in Feb2021 for an assessment of edema of the lower limbs and abdominal pain. Several problems were then highlighted and taken care of including multiple pulmonary embolisms with deep vein thrombosis of the two superficial femoral muscles treated with Eliquis, lower limb edemas which resolve under Lasilix (heart echo LVEF 60%, ECG regular sinus rhythm), fecal impaction expelled during a colonoscopy, advanced cognitive disorders with fluctuating confusion, mini mental status examination (MMS) 7/30 on 14Feb2021, type 2 diabetes treated with Metformin 850 mg x 3 per day, very significant weight loss (weighed more than 150 kg before) and malnutrition treated with CNO (supplement), bedridden with very deep sacral eschar aggravated by incontinence and non-compliance of the discharge and requiring surgical removal and Vacuum-Assisted Closure (VAC) therapy (stopped since), as well as a colostomy. Superinfection of multi-resistant Staphylococcus aureus pressure ulcers with probable osteitis with negative blood cultures treated with Clindamycin and Bactrim bi-antibiotic therapy since 18May2021. Transfer to nursing home on 21May2021. On 14Jun2021, notion of concentrated urine without symptoms. Laboratory assessment: no hyperleukocytosis, normal renal function with creatinine 69.8 umol/L, CRP 107.85 mg/L. An (urine examination) ECBU is prescribed in principle: 14Jun2021: ECBU with leukocyturia at 156,000/ml and hematuria $g1.000.000/ml, Kass 10^5, detection of C albicans. On 17Jun2021, ECBU with leukocyturia at 356,000/ml and hematuria more than 1,000,000/ml. Culture with E Coli 10^6 resistant to Bactrim and E faecalis 10^5 resistant to Bactrim and C albicans 10^5. In the absence of fever, contamination was considered. Prescription of subcutaneous hydration. On 18Jun2021, vaccination against COVID-19 with the Comirnaty vaccine: 1st dose lot FD0168 in the left arm. On the day of vaccination, the patient was afebrile. COVID PCR test also done that day. On 19Jun2021, nausea, anorexia with lack of hydration as well as vomiting/emesis were experienced by the patient. On 21Jun2021, it was noted that since the patient entered, the pressure ulcer gradually worsened, more and more extensive and deepening with 2 bone contacts. He has been treated with bi-antibiotic therapy for 4 weeks. Rejected by the surgeon for failure to comply with pressure ulcer relief measures. On 22Jun2021, in the evening, dyspnea without initial desaturation. At around 11 p.m., the patient was hospitalized urgently for a state of shock with multiple organ failure. On admission, the patient has Glasgow at 15 conscious but inconsistent (cognitive disorders). Blood pressure rose to 10/5 mmHg after filling, hypothermia at 34.6 C, acute respiratory distress with decrease in vesicular murmur (MV) in right base, no wheezing or crackling, ASDI pocket colostomy in place, rash already known, frequency cardiac 89 bpm, capillary blood glucose 0.34 g / L. Emergency physicians concluded a state of septic shock with multiple organ failure. Biology / additional examinations / etiological research including laboratory assessment showed an inflammatory syndrome with hyperleukocytosis with 13.7 G/L of PNN, CRP 51 and procalcitonin positive at 0.27 (VN 0.05), marked acidosis with pH 7.08 mmol/L, hyperlactatemia 14.8 mmol/L, hyperkalaemia 6.9 mmol/L, disseminated intravascular coagulation with prothrombin time 10%, and renal failure. No blood culture or other bacteriology samples. Summary of management included vascular filling and comfort care. Evolution was provided as clinical-biological severity with limitation of active therapies. Conclusion was digestive disorders with nausea, vomiting and anorexia beginning the day after vaccination then 3 days after, shock with multiple organ failure. Diagnosis of septic shock was made by emergency physicians in the context of a sacral ulcer with probable osteitis as well as a positive ECBU a few days earlier. Very high hyperlactatemia with severe acidosis and acute renal failure in a patient treated with metformin. Complex file with inability to conclude septic shock, metformin overdose, digestive disorders with anorexia and lack of hydration associated with the vaccine having decompensated kidney function. Other treatments: Eliquis, Clindamycin, Bactrim, Paracetamol, Macrogol, Speciafoldine. The action taken in response to the events for metformin was dose not changed. The patient died on 23Jun2021. The outcome of the events multi organ failure, disseminated intravascular coagulation with prothrombin time 10%, hyperlactatemia 14.8 mmol/L, septic shock, marked acidosis with pH 7.08 mmol/L, acute renal failure, hyperkalaemia 6.9 mmol/L, hyperleukocytosis with 13.7 G/L, and inflammatory syndrome was fatal. The events anorexia, nausea had not resolved, emesis resolved on an unspecified date in 2021, while the outcome of the rest of the events was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Disseminated intravascular coagulation; Hyperlactatemia; Septic shock; Acidosis; acute renal failure; inflammatory syndrome; hyperleukocytosis with 13.7 G/L; hyperkalaemia 6.9 mmol/L; Multiple organ failure


VAERS ID: 1488235 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cerebral haemorrhage, Fall, Head injury, Hypotension, Scan brain
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm cerebral; Ataxia; Breast cancer (in remission for 5 and a half years); Gastrostomy; Headache; Hemorrhage subarachnoid; Hydrocephalus; Pneumothorax; Vomiting
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: brain scan; Result Unstructured Data: Test Result:significant recurrence of bleeding
CDC Split Type: FRPFIZER INC2021843066

Write-up: Haematencephalon; Fall; Hypotension; Skull trauma/head trauma; Asthenia; This is a spontaneous report from a contactable physician downloaded from FD0168-WEB [FR-AFSSAPS-2021084988]. A 75-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FC3143), intramuscular on 18Jun2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization. Medical history included pneumothorax, breast neoplasia in remission for 5 and a half years, gastrostomy installation from 2021, persistent ataxia. On 24Mar2021 Subarachnoid hemorrhage (HSA) with intraventricular invasion on a ruptured aneurysm of the left anterior cerebral and hydrocephalus, with a background of headache and vomiting. Concomitant medications included alfuzosin hydrochloride (XATRAL) from 10Jun2021 to Jun2021. The patient experienced haematencephal (Cerebral haemorrhage) on 25Jun2021, fall on 22Jun2021, hypotension on 22Jun2021, asthenia on 18Jun2021,and skull trauma on 22Jun2021. Course of events as follows: On 24Mar2021 Subarachnoid hemorrhage (HSA) with intraventricular invasion on a ruptured aneurysm of the left anterior cerebral and hydrocephalus, with a background of headache and vomiting. Neurosurgical support by placing an external ventricular shunt (EVD). In the aftermath of neurosurgical support, persistent ataxia motivates the transfer to neurology (from 01Jun2021 to 10Jun2021) then to Follow up and Rehabilitation for multidisciplinary rehabilitation (from 10Jun2021). During hospitalization: Patient with poor oral nutrition (gastrostomy installation). On 10Jun2021, failed bladder catheter weaning hence introduction of XATRAL. The patient received first injection intramuscular of Covid-19 Vaccine COMIRNATY on18Jun2021 in Follow up and Rehabilitation unit. Development is marked by asthenia post anti-Covid-19 vaccination, hypotension and a fall with head trauma on Day5 (as reported) (despite stopping XATRAL) of the vaccination leading to a significant recurrence of bleeding (brain scan on 25Jun2021) at the origin of his death on 25Jun2021. The outcome of the events was fatal. The patient died on 25Jun2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypotension; Asthenia; Skull trauma; fall; recurrent bleeding (brain scan)/haematencephal


VAERS ID: 1488243 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-12
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood creatinine, Blood electrolytes, Blood fibrinogen, Blood glucose, Blood pressure measurement, Blood urea, Body mass index, Body temperature, Borrelia test, C-reactive protein, Cerebrovascular accident, Coagulation factor, Computerised tomogram head, Confusional state, Disorientation, Echocardiogram, Electroencephalogram, Facial paralysis, Factor Xa activity test, Glomerular filtration rate, HIV test, HTLV test, Haemoglobin, Haemorrhagic transformation stroke, Headache, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Hepatitis E virus test, Investigation, Language disorder, Lumbar puncture, Magnetic resonance imaging head, Oxygen saturation, Platelet count, Prothrombin time, Red blood cell count, Subarachnoid haemorrhage, Treponema test, Ultrasound Doppler, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALPRAZOLAM; RACECADOTRIL
Current Illness: Anxiodepressive syndrome; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: APTT ratio; Result Unstructured Data: Test Result:0.89; Test Date: 20210614; Test Name: APTT ratio; Result Unstructured Data: Test Result:1.18; Test Date: 20210524; Test Name: Creatinine; Result Unstructured Data: Test Result:174 umol/l; Comments: Mild renal insufficiency; Test Date: 20210524; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20210524; Test Name: Fibrinogen; Result Unstructured Data: Test Result:3.8 g/l; Test Date: 20210524; Test Name: Blood glucose; Result Unstructured Data: Test Result:1.42 g/l; Test Date: 20210524; Test Name: BP; Result Unstructured Data: Test Result:143/78; Test Date: 20210524; Test Name: Urea; Result Unstructured Data: Test Result:17 mmol/L; Comments: Mild renal insufficiency; Test Name: BMI; Result Unstructured Data: Test Result:31; Comments: kg / m2; Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210616; Test Name: lyme serology; Test Result: Negative ; Test Date: 20210614; Test Name: cofactors II, V VII and X; Result Unstructured Data: Test Result:cofactors II, V VII and X normal; Test Date: 20210525; Test Name: brain ct; Result Unstructured Data: Test Result:absence of large intra or peri-cerebral bleeding.; Comments: absence of large intra or peri-cerebral bleeding. Absence of hemorrhagic transformation within hemispherical lesions.; Test Date: 20210528; Test Name: brain ct; Result Unstructured Data: Test Result:Absence of hemorrhagic transformation within multi; Comments: Absence of hemorrhagic transformation within multiterritorial punctiform ischemic lesions. Appearance of a llama with upper left parietal subarachnoid hemorrhage; Test Date: 20210602; Test Name: brain ct; Result Unstructured Data: Test Result:Absence of haemorrhagic transformation in multite; Comments: Absence of haemorrhagic transformation in multiterritorial punctiform ischemic lesions. Regression of the upper left parietal subarachnoid hemorrhage blade; Test Date: 20210616; Test Name: brain ct; Result Unstructured Data: Test Result:without and with injection: large right fronto-pa; Comments: without and with injection: large right fronto-parieto-temporal intraparenchymal hematoma complicated by 16 mm sub-falcor involvement to the left and right internal temporal involvement. Hydrocephalus and hemorrhagic sediment of the left lateral ventricle. Appearance of hematoma of the left frontal semi-oval center, frontal subcortical and right temporopolar associated with an HSA blade. Stigmata of intracranial hypertension with marked delay in opacification of the middle and anterior cerebral arteries. Note a doubt about an occlusion of the right internal carotid. In late stages there is no cerebral venous thrombosis. Minimum permeability with very thin appearance of the middle cerebral arteries; Test Date: 20210524; Test Name: CRP; Result Unstructured Data: Test Result:4.7 mg/l; Test Date: 20210524; Test Name: trans thoracic ultrasound; Result Unstructured Data: Test Result:looking for endocarditis: negative; Comments: A trans thoracic ultrasound looking for endocarditis: negative; Test Date: 20210527; Test Name: EEG; Result Unstructured Data: Test Result:presence of slow elements in the left frontotempor; Comments: presence of slow elements in the left frontotemporal region. No graphoelement of the epileptic series; Test Date: 20210603; Test Name: EEG; Result Unstructured Data: Test Result:diffuse slowdown in electrogenesis, non-specific.; Comments: diffuse slowdown in electrogenesis, non-specific. No argument in favor of an epileptic origin or in favor of a metabolic or toxic encephalopathy; Test Date: 20210609; Test Name: EEG; Result Unstructured Data: Test Result:some slow elements in the left frontotemporal regi; Comments: some slow elements in the left frontotemporal region, absence of epileptic seizure or status epilepticus.; Test Date: 20210614; Test Name: anti XA heparins; Result Unstructured Data: Test Result:0.48 IU/ml; Test Date: 20210524; Test Name: DFG; Result Unstructured Data: Test Result:26 ml/min; Comments: Mild renal insufficiency; Test Date: 20210524; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5 g/dl; Test Date: 20210616; Test Name: HAV; Test Result: Negative ; Test Date: 20210616; Test Name: HBV; Test Result: Negative ; Test Date: 20210616; Test Name: HCV; Test Result: Negative ; Test Date: 20210616; Test Name: HEV; Test Result: Negative ; Test Date: 20210616; Test Name: HIV; Test Result: Negative ; Test Date: 20210616; Test Name: HTLV1 / 2; Test Result: Negative ; Test Date: 20210609; Test Name: Biochemistry; Result Unstructured Data: Test Result:hyperproteinorachia and hyperglycorachia; Comments: hyperproteinorachia at 2.5 g / L [0.15-0.40] and hyperglycorachia at 4.13 mmol / L [2.22-3.89]. Chlorurorachia is normal at 129 mmol / l [117-130].; Test Date: 20210616; Test Name: EBV and CMV; Result Unstructured Data: Test Result:testifying to a long-standing infection; Test Date: 20210616; Test Name: Toxoplasmosis; Result Unstructured Data: Test Result:ongoing; Test Date: 20210609; Test Name: lumbar puncture; Result Unstructured Data: Test Result:Negative bacteriology in culture and multiplex PCR; Test Date: 20210524; Test Name: cerebral MRI; Result Unstructured Data: Test Result:shows punctiform ischemic lesions constituted at t; Comments: shows punctiform ischemic lesions constituted at the subacute occipital and frontal left and right parietal stage, a hemorrhage under arachnoid cortical fronto parietal left at the subacute stage with the presence of some superficial micro bleeds of the hemisphere left and an old right occipital cortical hematoma. These latest findings suggest a possible amyloid angiopathy.; Test Date: 20210524; Test Name: O2 saturation; Test Result: 97 %; Test Date: 20210524; Test Name: Platelets; Result Unstructured Data: Test Result:209 x10 9/l; Test Date: 20210524; Test Name: PT; Test Result: 85 %; Test Date: 20210614; Test Name: PT; Test Result: 93 %; Test Date: 20210609; Test Name: red blood cells; Result Unstructured Data: Test Result:584 /mm3; Test Date: 20210616; Test Name: Syphlis; Test Result: Negative ; Test Date: 20210524; Test Name: venous doppler echo of the lower limbs; Test Result: Negative ; Test Date: 20210609; Test Name: leukocyte; Result Unstructured Data: Test Result:2 /mm3; Test Date: 20210524; Test Name: Leuocytes; Result Unstructured Data: Test Result:8.6 x10 9/l
CDC Split Type: FRPFIZER INC2021874299

Write-up: temporo-spatial disorientation; confusion; Language disorder; Headache; right facial paralysis; Haemorrhagic transformation stroke; CVA; Subarachnoid bleeding; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB FR-AFSSAPS-2021086302. A 68-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly in arm left on 26Apr2021 (batch/lot number: ET6956) at single dose for COVID-19 immunisation, valpromide (DEPAMIDE), orally from an unspecified date to Jun2021 at 300 mg twice a day for an unspecified indication, and sertraline hydrochloride (SERTRALINE SANDOZ), orally from an unspecified date to Jun2021 at 2 dose form (DF) once a day for an unspecified indication. Medical history included ongoing hypertension arterial, and ongoing anxiodepressive syndrome. Patient had no history of COVID-19 and not been tested. Concomitant medications included alprazolam, and racecadotril. The patient experienced haemorrhagic transformation stroke on 16Jun2021, CVA (cerebrovascular accident) on 24May2021, subarachnoid bleeding on 24May2021, language disorder on 12May2021, headache on 12May2021, temporo-spatial disorientation on an unspecified date, confusion on an unspecified date, and right facial paralysis on an unspecified date. Patient BMI was 31 kg / m2. On Day 16, 12May2021: The patient was described as having speech disorders and headaches. On Day 28, 24May2021: The patient was hospitalized in the emergency room for confusion and temporo-spatial disorientation. The initial assessment found: Reassuring clinical constants: BP = 143/78, HR = 67 / min, 97% saturation in ambient air, T = 36.5 degrees C, dextro = 1.42g / l, neurologically there was no no sensitivo motor deficit, it was found a lack of the word and a temporo-spatial disorientation, as well as a doubt on a right facial paralysis. The cardiopulmonary exam was normal: Biology: Did not show any inflammatory syndrome: CRP = 4.7mg / l [0-5], fibrinogen = 3.8g / l [1.9-4.3], leukocytes = 8.6 10p9 / L [3, 8-9.5]. No coagulation disorders: PT = 85%, APTT ratio = 0.89. Platelets were discreetly reduced = 209 10p9 / L [230-359] as well as hemoglobin = 11.5g / 100ml [11.8-15]. Normal electrolytes. Mild renal insufficiency: Urea = 17mmol / l and creatinine = 174 umol / l, ie a GFR = 26 ml / min. The radiology consisted of a cerebral MRI and showed punctiform ischemic lesions constituted at the subacute occipital and frontal left and right parietal stage, a hemorrhage under arachnoid cortical fronto parietal left at the subacute stage with the presence of some superficial micro bleeds of the hemisphere left and an old right occipital cortical hematoma. These latest findings suggested a possible amyloid angiopathy. From 25May2021 (day 29) to 08Jun2021, hospitalization in neurology including: Radiological examinations: CT c of 25May2021: absence of large intra or peri-cerebral bleeding. Absence of hemorrhagic transformation within hemispherical lesions. CT c of 28May2021: Absence of hemorrhagic transformation within multiterritorial punctiform ischemic lesions. Appearance of a llama with upper left parietal subarachnoid hemorrhage. CT c of 02Jun2021: Absence of haemorrhagic transformation in multiterritorial punctiform ischemic lesions. Regression of the upper left parietal subarachnoid hemorrhage blade. EEGs: 27May2021: presence of slow elements in the left frontotemporal region. No graphoelement of the epileptic series. 03Jun2021: diffuse slowdown in electrogenesis, non-specific. No argument in favor of an epileptic origin or in favor of a metabolic or toxic encephalopathy. A trans thoracic ultrasound looking for endocarditis: negative. A venous doppler echo of the lower limbs: negative. Since 08Jun2021 (day 43): Hospitalization in intensive care for disorders of consciousness and pneumopathy. Examinations include: A lumbar puncture (09Jun2021): Negative bacteriology in culture and multiplex PCR, leukocyte = 2 / mm3, red blood cells = 584 / mm3, standards 0-5 / mm3. Biochemistry showing hyperproteinorachia at 2.5 g / L [0.15-0.40] and hyperglycorachia at 4.13 mmol / L [2.22-3.89]. Chlorurorachia was normal at 129 mmol / l [117-130]. An EEG (09Jun2021): some slow elements in the left frontotemporal region, absence of epileptic seizure or status epilepticus. Biology: Haemostasis on 14Jun2021: PT = 93%, APTT ratio = 1.18 with anti XA heparins at 0.48 IU / ml, cofactors II, V VII and X normal. Serology: virology of 16Jun2021: HIV, HAV, HBV, HCV, HEV negative, HTLV1 / 2 negative, EBV and CMV testifying to a long-standing infection. Syphilis negative. Ongoing toxoplasmosis. Negative lyme serology. Imaging: CT scan of 16Jun2021 without and with injection: large right fronto-parieto-temporal intraparenchymal hematoma complicated by 16 mm sub-falcor involvement to the left and right internal temporal involvement. Hydrocephalus and hemorrhagic sediment of the left lateral ventricle. Appearance of hematoma of the left frontal semi-oval center, frontal subcortical and right temporopolar associated with an HSA blade. Stigmata of intracranial hypertension with marked delay in opacification of the middle and anterior cerebral arteries. Note a doubt about an occlusion of the right internal carotid. In late stages there is no cerebral venous thrombosis. Minimum permeability with very thin appearance of the middle cerebral arteries. The action taken in response to the events for valpromide, and sertraline hydrochloride was not applicable. The patient died on 16Jun2021. Outcome of events speech disorders and headaches was not resolved, and of other events was unknown. An autopsy was not performed.; Reported Cause(s) of Death: Haemorrhagic transformation stroke; Subarachnoid bleeding; CVA


VAERS ID: 1488245 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 LA / 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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; Hypothyroidism; Peripheral arterial occlusive disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874052

Write-up: Stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FR-AFSSAPS-2021087978 received via regulatory authority. An 87-year-old female patient received BNT162B2 (COMIRNATY), second dose intramuscularly, administered in arm left on 22Jun2021 (Lot Number: FC5435) as single dose for covid-19 immunisation. Medical history included peripheral arterial occlusive disease, hypothyroidism, arteriopathy of the lower limbs. Patient being considered at risk of developing a severe form of the COVID-19 disease, not having contracted COVID-19, not having performed a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced stroke on 01Jul2021. The patient presented with a cerebrovascular accident on 01Jul2021. The patient died on 01Jul2021. It was not reported if an autopsy was performed. The outcome of event stroke was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1488247 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874076

Write-up: cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021088660. A 21-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Jun2021 (Batch/Lot Number: FC1526) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. No history of Covid-19. The patient experienced cardiac arrest on 14Jun2021. Urgent medical intervention was performed. The patient died on 14Jun2021 from cardiac arrest. An autopsy was performed and results were pending. The outcome of the event cardiac arrest was fatal. Attribution made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1488248 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Epilepsy; Sleep apnoea
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874275

Write-up: Suspicion of heart attack; Death sudden; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FR-AFSSAPS-2021089489, Safety Report Unique Identifier FR-AFSSAPS-LM20211748 An 85 years old male patient received BNT162B2 (COMIRNATY, lot# EW4815) Intramuscular on 22Apr2021 at single dose for COVID-19 immunisation. Medical history included Arterial hypertension, Epilepsy and Sleep apnoea. Patient was found dead at the foot of his bed on the morning of 09May2021 by the nurse usually managing care. Suspicion of heart attack. No autopsy asked. Patient was followed regularly by his cardiologist and pulmonologist. Last seen in Jul2020 and in stable condition. Lack of recent introduction of new treatment. Outcome of the event was fatal. Comments: Approximate period of onset of the adverse reaction:If the side effect is immediate, delay: Hospitalization service: Specify. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspicion of heart attack; Sudden death, cause unknown


VAERS ID: 1488289 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Choking, Hypotension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; ELIQUIS; PREGABALINE; CERIS; ECONAZOLE ARROW; BISOCE; AMITRIPTYLINE; OXYCODONE ARROW; ZYMAD; VENLAFAXINE ARROW; FUROSEMIDE ACCORD [FUROSEMIDE]; FUROSEMIDE ARROW; IMOVANE; KALEORID; SULFAMETHOXAZOLE;TRIMETHOPRIM; TIAPRIDAL; DEXP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy ((AOMI)); Cardiac insufficiency; Chronic depression; Cognitive impairment; Coronary stent placement; Hypotension orthostatic; Ischaemic heart disease; Minor ischemic stroke; NIDDM; Recurrent pulmonary embolism ((Repeated))
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: blood pressure; Result Unstructured Data: Test Result:140/54; Comments: hypotension; Test Date: 20210611; Test Name: blood pressure; Result Unstructured Data: Test Result:controlled at 90/52; Test Date: 20210611; Test Name: blood pressure; Result Unstructured Data: Test Result:103/51; Test Date: 20210611; Test Name: blood pressure; Result Unstructured Data: Test Result:100/55
CDC Split Type: FRPFIZER INC2021843048

Write-up: Choked on food; cardio respiratory arrest; Arterial hypotension/ hypotension measured at 140/54; This is a spontaneous report from a contactable pharmacist, downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority number is FR-AFSSAPS-LY20217118 with Safety Report Unique Identifier: FR-AFSSAPS-2021083222. An 89-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly on 11Jun2021 at the age of 89 years old (Batch/Lot Number: FA8016, Expiration date: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included chronic depression, hypotension orthostatic, cardiac insufficiency, non-insulin-dependent diabetes mellitus (NIDDM), minor ischemic stroke in 2014 and in 2015, recurrent (repeated) pulmonary embolism, stented ischaemic heart disease, arteriopathy obliterating of the lower limbs (AOMI), and mild cognitive impairment. The patient had no history of Covid. Concomitant medications (usual treatment) included amoxicillin; apixaban (ELIQUIS, Film-coated tablet); pregabalin; trospium chloride (CERIS); econazole nitrate (ECONAZOLE ARROW, strength: 1%); bisoprolol fumarate (BISOCE, Film-coated tablet, strength: 2.5 mg); amitriptyline (strength: 40 mg/mL); oxycodone hydrochloride (OXYCODONE ARROW); colecalciferol (ZYMAD, Oral solution, strength: 80000 IU); venlafaxine hydrochloride (VENLAFAXINE ARROW, Prolonged-release capsule, strength: 37.5 mg); furosemide (FUROSEMIDE ACCORD, strength: 20 mg); furosemide (FUROSEMIDE ARROW); zopiclone (IMOVANE, Coated tablet, strength: 3.75 mg); potassium chloride (KALEORID, Prolonged-release tablet, strength: 600 mg); sulfamethoxazole, trimethoprim (strength: 800 mg sulfamethoxazole and 160 mg trimethoprim); tiapride hydrochloride (TIAPRIDAL, Oral solution, strength: 138 mg/ml); dexpanthenol (Cutaneous liquid, strength: 5 %); lansoprazole (LANSOPRAZOLE MYLAN, strength: 15 mg); macrogol 4000; and lidocaine (strength: 5%); all taken for an unspecified indication, start and stop date were not reported. On 11Jun2021, the patient experienced choked on food and cardio respiratory arrest, which both led to death and also experienced arterial hypotension. It was further reported that on 11Jun2021, the patient had her vaccination with a first dose of COMIRNATY vaccine and in the following hour, there was an appearance of hypotension measured at 140/54, controlled at 90/52 immediately. On examination, the patient was conscious, without complaints, dyspnoea or signs of respiratory struggle. On 11Jun2021, blood pressure (BP) was measured twice at 103/51 then 100/55. A call from the nurse was received for cardiorespiratory arrest in the context of a false route of the sandwich at lunchtime. Heimlich manoeuvre and magill clamp manoeuvre were done for event choking; patient was in cardiorespiratory arrest; and death was declared at 12:50. The patient was not recovered from arterial hypotension. The patient died on 11Jun2021 at 12:50. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Choked on food; cardio respiratory arrest


VAERS ID: 1488294 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / 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: 2021-05-03
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palliative care
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: PCR test covid 19; Test Result: Positive ; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Unknown; Comments: Previous covid19 test: unknown
CDC Split Type: FRPFIZER INC2021848634

Write-up: COVID-19 aggravated; COVID-19 aggravated; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-MA20211653, Safety Report Unique Identifier FR-AFSSAPS-2021048296. A 83-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown) dose 2 via intramuscular route of administration on 21Apr2021(at the age of 83 years old) as single for COVID-19 immunisation. Medical history included palliative care from an unknown date and unknown if ongoing. The patient did not have any known allergies. The patient concomitant medications were not reported. The patient experienced covid-19 aggravated on 26Apr2021. At D6 of D2, she presents a positive PCR test to Covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Apr2021 and Previous covid19 test: unknown. The patient died on 03May2021.Outcome for the event Covid 19 was fatal while drug ineffective was unknown. Autopsy performed results were unknown. ; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1488295 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-13
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / 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: 2021-04-18
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disturbance
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: PCR covid 19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021848637

Write-up: COVID-19 aggravated; Day14 from Dose1, he presents positive PCR COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20211654 Safety Report Unique Identifier FR-AFSSAPS-2021048304. A 96-years-old male patient received the first dose of bnt162b2 (COMIRNATY), Solution for injection, Lot number and Expiry date: Unknown) intramuscularly on 31Mar2021 at the age of 96-years-old as a single dose for COVID-19 immunization. Medical history included cognitive disorder from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. On 13Apr2021 the patient experienced COVID-19 aggravated, day14 from dose1, he presented positive PCR COVID-19 test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. On 13Apr2021, the patient died on 18Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1488327 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   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: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Infarct myocardial; This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) and MYOCARDIAL INFARCTION (Infarct myocardial) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. No medical history was reported. On 28-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Infarct myocardial) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was Cardio-respiratory arrest and Infarct myocardial. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not provided. Treatment information was not provided. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-NC20212796. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (SD translation) is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Infarct myocardial


VAERS ID: 1488328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-06
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (active smoking); Comments: Tabac
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021882818

Write-up: Death sudden; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20212563. A 42-year-old male patient received BNT162B2 (COMIRNATY), first dose, intramuscularly, administered in arm left on 28May2021 (Batch/Lot Number: FA8016) at single dose for covid-19 immunisation. Medical history included smoker (active smoking). The patient''s concomitant medications were not reported. The patient experienced death sudden on 06Jul2021. Death of the patient was noted on 06Jul2021. The patient had not given any news for 24 hours. There was no family there. The patient''s only antecedent was active smoking, no toxicants were found at home, no notion of alcohol intake reported. The patient is found on the floor in his toilet. As the death did not seem to be atorture, there was no forensic autopsy requested. The declarer mentioned a sudden death of probable cardiovascular origin, in a context of vaccination against Covid-19, with Comirnaty. The patient died on 06Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Death sudden


VAERS ID: 1488330 (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: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: XARELTO; IRBESARTAN; ATORVASTATIN; SPIRONOLACTONE; BACLOFEN
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Diabetes (controlled by diet); Dyspnoea (for several years but no complaints from the patient); Obesity
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:15/8
CDC Split Type: FRPFIZER INC2021874261

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PA20210582. An 83-year-old (also reported as 84-year-old) male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EX0893), at the age of 83 years old, on 22Apr2021 at 14:30 at 0.3 ml single dose for COVID-19 immunisation. Medical history included obesity, diabetes controlled by diet, ongoing hypertension, alcohol consumption, dyspneic for several years but no complaints from the patient. Concomitant medications included rivaroxaban (XARELTO), irbesartan, atorvastatin, spironolactone (strength: 25 mg), baclofen taken for withdrawal. The patient previously received the first dose of BNT162B2 (COMIRNATY, lot number: ER9470) on 22Mar2021 at single dose for COVID-19 immunisation and well tolerated. The patient had just received his second dose of BNT162B2, 15-minute monitoring but no prior medical interview as the first dose well tolerated. The patient walked to the car park to get to his car, accompanied by his wife where he lost consciousness while sitting down. His wife called for help. A doctor from the centre went to the scene, the fire brigade then an Emergency Service. When the Emergency Service arrived, the patient was in cardio-respiratory arrest (no flow for at least 10 minutes). Despite the resuscitation manoeuvres, the patient died at 15:17. At this stage, the exact diagnosis was impossible. An autopsy and biological tests were planned. In total, cardiorespiratory arrest not recovered less than 40 minutes after a second dose of BNT162B2 in an 84-year-old man with comorbidities. The patient underwent lab tests and procedures which included blood pressure 15/8 in Feb2021. The outcome of the event cardio-respiratory arrest was fatal. The patient died on 22Apr2021 at 15:17. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488337 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Blood pressure measurement, Blood sodium, Bradykinesia, C-reactive protein, Chronic respiratory failure, Dehydration, Dementia, Diarrhoea infectious, Disorientation, General physical health deterioration, Haemoglobin, White blood cell count
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEDERFOLINE; ZYMA-D2; MACROGOL; AMLODIPINE; SERESTA; PARACETAMOL; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CLL (in remission (with relapse in spring 2019)); COVID-19; Vascular anomaly NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210221; Test Name: creatinine; Result Unstructured Data: Test Result:41.8 ml/min; Test Date: 20210220; Test Name: blood pressure; Result Unstructured Data: Test Result:116/64; Test Date: 20210221; Test Name: sodium; Result Unstructured Data: Test Result:150; Comments: mm; Test Date: 20210221; Test Name: CRP; Result Unstructured Data: Test Result:124.2 mg/l; Test Date: 20210221; Test Name: haemoglobin; Result Unstructured Data: Test Result:94 g/l; Test Date: 20210221; Test Name: White blood cells; Result Unstructured Data: Test Result:7008; Comments: 7008/mm3
CDC Split Type: FRPFIZER INC2021874257

Write-up: febrile diarrhea; deterioration of the general condition; asthenia; accentuated ideomotor slowing; chronic respiratory failure; dehydration; dementia; disoriented; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20211120, Safety Report Unique Identifier: FR-AFSSAPS-2021089260. An 82-year-old male patient received second dose of BNT162B2 (COMIRNATY), via intramuscular on 16Feb2021 (Lot Number: EK9788) as single dose for covid-19 immunisation. Medical history included chronic lymphocytic leukemia (CLL) in remission (with relapse in spring 2019), vascular degeneration and COVID-19 in Apr2020. Concomitant medications included calcium folinate (LEDERFOLINE); ergocalciferol (ZYMA-D2); macrogol; amlodipine; oxazepam (SERESTA); paracetamol; allopurinol. Patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Jan2021 (Lot Number: EJ6788) as single dose for covid-19 immunisation. Hospitalization in gastroenterology from 20Feb2021 to 02Mar2021 for deterioration of the general condition marked by significant asthenia with accentuated ideomotor slowing and febrile diarrhea appearing the day after vaccination on 17Feb2021. On admission: afebrile, blood pressure 116/64, slowed down, conscious and disoriented. Supple, painless abdomen. Regular heart without breath. Discrete crackling of the pulmonary bases. Soft and painless calves. Biology of 21Feb2021: sodium150mm, creatinine 41.8 ml/min, C-reactive protein (CRP) 124.2 mg/l, White blood cells 7008/mm3, haemoglobin 94 g/l. Evolution: Persistence of liquid stools at a rate of 2/day, afebrile. Diagnosis: post-vaccination feverish diarrhea associated with dehydration, chronic respiratory failure and dementia. The patient returned to a residential establishment for the elderly with Smecta and Imodium. On 16Mar2021, the patient died. In total, death of the 82-year-old patient, 1 month after D2 in a context of febrile diarrhea occurring the day after vaccination with associated deterioration in general condition. The outcome of the events "febrile diarrhea" and "deterioration of the general condition" was fatal, for other events was unknown. The patient died on 16Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: deterioration of the general condition; febrile diarrhea


VAERS ID: 1488338 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Cardiac insufficiency; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874498

Write-up: Cardio-respiratory arrest/cardiopulmonary arrest; cardiogenic pulmonary edema; heart failure; Malaise; asystole; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-PA20211126. Safety Report Unique Identifier: FR-AFSSAPS-2021089367. A 73-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via intramuscular on 23Apr2021 (lot number: EX0893) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension arterial, cardiac insufficiency, allergic asthma. Concomitant medications were not provided. Declaration by the Regulatory Authority of the death of a 73-year-old patient received 2nd dose of bnt162b2 on 23Apr2021. Malaise occurred in the parking lot of the vaccination center at the end of the 15 minutes of surveillance. When the mobile emergency and resuscitation structures arrived, the patient was in asystole which could be recovered. Transfer to intensive care unit. The agency (Pharmacovigilance Center) contacted the intensive care unit: the hospital report was to be transmitted but never received despite the reminders. The resuscitator who took charge of the patient indicates: cardiopulmonary arrest (cardio-respiratory arrest) on cardiogenic pulmonary edema in this woman patient with heart failure on 23Apr2021. No argument for anaphylaxis, nor for a vaccine cause. Death on 24Apr2021 with no autopsy done. All events had treatment received and with hospitalized. Outcome of events malaise and asystole was unknown, while of the other events was fatal. Notabene: Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Regulatory Authority; Reported Cause(s) of Death: Cardio-respiratory arrest/cardiopulmonary arrest; heart failure; Cardiogenic pulmonary oedema


VAERS ID: 1488339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: ECG; Result Unstructured Data: Test Result:asystole
CDC Split Type: FRPFIZER INC2021874503

Write-up: Cardio-respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20211129, Safety Report Unique Identifier: FR-AFSSAPS-2021089425. A 46-year-old female patient received bnt162b2 (COMIRNATY) intramuscular on Apr2021 (Batch/Lot Number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included asthma with Ventolin if needed. No tobacco alcohol poisoning. Concomitant medication included salbutamol (VENTOLIN). The patient experienced cardio-respiratory arrest (Death) on 28Apr2021. Declaration of death by doctor of the emergency medical service and resuscitation of a 46-year-old woman. Request for hospitalization report made by the Pharmacovigilance Center$g transmission of the intervention file from the emergency medical service and resuscitation. Apr2021: D1 Pfizer. 28Apr2021: 15 days after D1. Last seen at 8:05 am with notion of abdominal pain FIG since the day before. Found at 08:40 on the ground complaining of pain in the left iliac fossa. 09h00: arrival of the fire brigade$g external cardiac massage + adrenaline, no shock delivered. 09:14: arrival of the emergency medical and resuscitation service: patient lying on the ground in cardiorespiratory arrest, external heart massage in progress. No flow unknown (about 35 min), low flow 15 min. Start of cardiopulmonary resuscitation 9:15 a.m., orotracheal intubation at 9:20 a.m., no pulse, no return to activity. 1st shock at 9:40 a.m., 2nd at 9:42 a.m., 3rd at 9:44 a.m. Cordarone in direct infusion 300 mg$g no return to activity, continued cardiopulmonary resuscitation(in total, 10 mg of adrenaline delivered). $g$g bilateral areactive mydriasis, no pulse, ECG tracing in asystole. Stopping treatment$g Death on 28Apr2021 at 9:57 a.m., no obstacle. In total, unrecovered cardiorespiratory arrest of a 46-year-old patient with no medical history, 15 days after a D1 of Comirnaty with notion of left iliac fossa pain since the day before her death. The patient died on 28Apr2021. An autopsy was not performed.; Reported Cause(s) of Death: ACR


VAERS ID: 1488340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874059

Write-up: subcutaneous hematomas on the trunk; Chest pain; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician (geriatrician) downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PA20211131, Safety Report Unique Identifier FR-AFSSAPS-2021089486. A 96-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 12Apr2021 (Lot Number: EJ6795) as dose 2, 0.6 mL (pending clarify) single for covid-19 immunisation. Medical history included stroke, covid-19. The patient''s concomitant medications were not reported. On 16Apr2021, patient experienced subcutaneous hematomas on the trunk and hospitalization with the notion of healing in progress, Chest pain. 4 days after Dose2, patient degradation, more communication, amorphous and no otherwise specified Death. The patient experienced cardio-respiratory arrest in Apr2021. The outcome of event cardio-respiratory arrest was fatal and other events was unknown. The patient died on Apr2021. An autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488341 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Body mass index, Body temperature, COVID-19 pneumonia, Candida sepsis, Computerised tomogram thorax, Electroencephalogram, Investigation, Microbiology test, PCO2, PO2, Renal function test, SARS-CoV-2 test, pH body fluid
SMQs:, Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Depression (Treated); Hypercholesteremia; Obesity (BMI 26.75); Road traffic accident
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: bronchial sample; Result Unstructured Data: Test Result:positive for P aeruginosa and Stenotrophomonas; Comments: Bronchial samples: positive for P aeruginosa and Stenotrophomonas. put on Ceftamycin and Tavanic; Test Name: body mass index; Result Unstructured Data: Test Result:26.75; Test Date: 20210401; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210401; Test Name: chest ct; Result Unstructured Data: Test Result:extensive COVID lesions affecting 30% of the lungs; Test Date: 20210430; Test Name: EEG; Result Unstructured Data: Test Result:unknown results; Test Date: 20210401; Test Name: biology; Result Unstructured Data: Test Result:Inflammatory syndrome of little significance; Test Date: 20210414; Test Name: Bacteriological tests; Test Result: Positive ; Comments: positive for tazocillin-resistant E coli $g meropenic; Test Date: 20210401; Test Name: pco2; Result Unstructured Data: Test Result:41; Test Date: 20210401; Test Name: ph; Result Unstructured Data: Test Result:7.41; Test Date: 20210401; Test Name: pao2; Result Unstructured Data: Test Result:134; Test Date: 20210414; Test Name: renal function; Result Unstructured Data: Test Result:impaired renal function; Comments: dialysis; Test Date: 20210401; Test Name: sars-cov-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021874253

Write-up: COVID-19 pneumonia aggravated; C albicans sepsis; This is a spontaneous report from a contactable other healthcare professional (HCP) downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PA20211140. A 72-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01Apr2021 (Batch/Lot Number: ER9470) at the age of 72-years-old as 0.3 ML SINGLE for covid-19 immunisation. Medical history included Treated depression, Road traffic accident (AVP) in 2010 no further information, obesity BMI 26.75, Arterial hypertension, hypercholesterolaemia. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonia aggravated (death, hospitalization) on 01Apr2021. The clinical course was reported as follows: 30Mar2021: patient consults his GP who makes an appointment for vaccination. No auscultation. 01Apr2021: The patient told the nurse at home that he has a sore throat and runny nose. The nurse advises him to get tested as one of her colleagues (who is following the patient) is COVID+ (son''s writing), Dose 1 (D1) Comirnaty performed (batch ER9470) (without prior diagnostic test). 30 minutes later patient collapses, tests positive, 40 C, put on oxygen $g patient transported to emergency: febrile state, ventilatory problems requiring oxygen therapy. O2 4l, pH 7.41, PCO2 41 and PAO2 134. Inflammatory syndrome of little significance on biology. Chest CT scan shows extensive COVID lesions affecting 30% of the lungs. Aggravation in the emergency room, especially in terms of ventilation, with the need to increase O2 doses, corticosteroids and preventive antibiotic therapy. Transfer to another establishment on 02Apr2021, in the COVID medicine department then in intensive care on 05Apr2021 due to the aggravation: On arrival: mild respiratory distress, polypneic, on high dose oxygen. Hemodynamics stable without TR, abdomen supple, no sign of tissue hypoperfusion. Put on Optiflow at 80-100% concentration alternating with non-invasive ventilation (NIV). 07Apr2022: intubation of the patient then sedation then curarisation. 13Apr2021: while the patient was doing well in all aspects, sudden deterioration of his general condition with fever and desaturation with haemodynamic disorders with a state of septic shock probably pulmonary. New curarisation and empirical Antibiotic therapy (ATB) (tazocillin-amiklin) then, in view of the worsening, the patient was placed in prone position, well tolerated. 14Apr2021: improvement in all areas, especially respiratory. Oliguric patient with impaired renal function $g dialysis. Bacteriological tests: positive for tazocillin-resistant E coli $g meropenic. 20Apr2021: deterioration with a septic context without haemodynamic disorder. Bronchial samples: positive for P aeruginosa and Stenotrophomonas. Ceftamycin and Tavanic. When the haemodynamic state improved, sedation was stopped: no definite awakening but spontaneous ventilation was not very effective and assisted ventilation was required. Electroencephalogram (EEG) 30Apr2021: result not written. Further deterioration in a septic mode with haemodynamic and ventilatory failure. The patient died on 30Apr2021 following C albicans septicaemia. No search for a variant. In total, death of a 72 year old patient, with RF of severe COVID, receives a D1 Comirnaty while presenting with symptoms of a COVID infection for 24 hours. He will present with a severe form of COVID-19 with COVID superinfection complicated by Acute respiratory distress syndrome (ARDS) and 3 episodes of infection with septic shock. The patient died on 30Apr2021. It was unknown if an autopsy was performed. The outcome of the events covid-19 pneumonia aggravated and ''C albicans septicaemia'' was fatal.; Reported Cause(s) of Death: COVID-19 pneumonia aggravated; C albicans sepsis


VAERS ID: 1488348 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-07
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001657 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Insufficiency renal
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer of prostate
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in an 87-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001657) for COVID-19 vaccination. The patient''s past medical history included Cancer of prostate. Concurrent medical conditions included Hypertension arterial and Insufficiency renal. On 10-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. Death occurred on 07-Jun-2021 The patient died on 07-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not reported. This sender''s number was reported as PO20213284 Treatment medication were not reported. Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time. More details including concomitant medications, clinical condition prior to death and cause of death/ autopsy report is required for further assessment.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1488395 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-21
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Hypercholesterolaemia; Obesity; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death; Chest pain; Abdominal pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of SUDDEN DEATH (Sudden death), ABDOMINAL PAIN (Abdominal pain) and CHEST PAIN (Chest pain) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Obesity, Smoker and Hypercholesterolaemia. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion death). On 22-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death). The patient died on 23-Jun-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. The Sender''s (Case) Safety Report Unique Identifier is FR-AFSSAPS-RS20212053 No concomitant medications were provided by the reporter. This is a case of sudden death in a 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether an autopsy was performed. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 41-year-old male subject with a history of Obesity, Smoking and Hypercholesterolemia, who died 20 days after receiving first dose of vaccine with other reported serious unexpected events Chest pain and Abdominal pain. The cause of death was not specified and it is not known whether an autopsy was performed. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1488400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Fall, Haemorrhage intracranial, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: SUBUTEX; SERETIDE DISKUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addicted to heroin; Asthma; Recovered smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021874510

Write-up: intracranial hemorrhage; subdural hematoma; Cerebral haemorrhage; fall; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-TO20215292. A 60-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Jun2021 as dose 2, single for COVID-19 immunisation. Medical history included asthma, Recovered smoker (Tobacco stop 2020), Addicted to heroin from an unknown date to 2000 (Former heroin addict and cannabis, weaned since 2000), normotensive patient. Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for drug withdrawal maintenance therapy; fluticasone propionate, salmeterol xinafoate (SERETIDE DISKUS) Resp Inhalation taken for asthma. The patient experienced cerebral haemorrhage on 21Jun2021, fall on 21Jun2021. The patient died on 21Jun2021. An autopsy was performed that revealed cerebral haemorrhage. In the night of 20 to 21Jun2021: fall, she was found dead. Autopsy on 23Jun2021 indicated cerebral hemorrhage. In summary, death is secondary to the consequences of intracranial hemorrhage and in particular of subdural hematoma (asphyxia of central origin in particular). The latter, taking into account its characteristics and other per-autopsy findings is compatible in the first hypothesis with a traumatic origin that can be integrated in the context of a fall from its own height. A participation of the previous hepatic state (cirrhosis), in the form of coagulation disorders in particular, is not excluded. In conclusion, the death of the patient is secondary to a subdural hematoma in the first hypothesis with a traumatic origin such as a fall from his own height could cause it. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: fall; subdural hematoma; intracranial hemorrhage; Cerebral haemorrhage; Autopsy-determined Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1488411 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-04
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   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: PREVISCAN [FLUINDIONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:23
CDC Split Type: FRPFIZER INC2021845958

Write-up: CEREBRAL HEMORRHAGE LEADING TO DEATH; This is a spontaneous report from a contactable consumer (patient''s granddaughter). The consumer reported two cases for her grandmother and her grandfather. This case refers to the grandfather. A 76-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) at the age of 76-year-old as dose 2, single for COVID-19 immunisation. Medical history included transient ischemic attack and stroke; both from an unknown date. Concomitant medication included fluindione (PREVISCAN) taken for an unspecified indication, start and stop date were not reported. The patient previously received COMIRNATY as dose 1, single (unknown batch number) on 22Mar2021 for COVID-19 immunization. It was reported that, 15 days after the second dose of BNT162B2 , the patient (grandfather) had a cerebral hemorrhage on 04May2021 which led to his death on the same day. The patient had told his wife that he had heard like a gunshot in his head. Moreover, when he arrived at the hospital, his blood pressure was at 23. He was hospitalized in neurological intensive care. The outcome of the event was fatal. The patient died on 04May2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: CEREBRAL HEMORRHAGE


VAERS ID: 1488517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-01
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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021863628

Write-up: Rat-bite fever; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107061135289020-RKC3F, Safety Report Unique Identifier GB-MHRA-ADR 25602501. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 (unsure when symptoms started and unsure when symptoms stopped). Unsure if patient was enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced rat-bite fever on an unspecified date (also reported as "14Feb1987"). The event was reported as serious (congenital anomaly, life threatening and results in death). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The patient died on 01Jul2021 with rat-bite fever as the cause of death. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Rat-bite fever


VAERS ID: 1488561 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-05-01
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fetal death; This regulatory authority case was reported by a consumer and describes the occurrence of FOETAL DEATH (Fetal death) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 01-Jan-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FOETAL DEATH (Fetal death) (seriousness criteria death and medically significant). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment details were not provided. This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Fetal death in a 26-year-old reported as male patient (unable to confirm patient gender), 120 days after receiving second dose of vaccine (Lot number unknown). Very limited information regarding the clinical details pertaining to the fetal death in terms of gestational age at the time of vaccination and death, and the unconfirmed patient''s gender was provided at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1488678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-06-02
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Dyspnoea, Malaise, Respiratory failure, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: Alzheimer''s disease; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Head injury
Allergies:
Diagnostic Lab Data: Test Date: 20210226; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative; Test Date: 20210412; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: HUPFIZER INC2021846234

Write-up: sudden death; malaise; dyspnoea; circulatory and respiratory failure; circulatory and respiratory failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-433621. A 74-year-old female patient received second dose of BNT162B2 (COMIRNATY) intramuscular, administered in Arm Left on 06May2021 (Batch/Lot Number: FA5829) as DOSE 2, 0.3 ml single for covid-19 immunization. Medical history included ongoing Alzheimer''s disease, Covid-19 from 05Feb2021 to 26Feb2021, ongoing hypertension and head injury from Jan2021. The patient received first dose of Comirnaty on 02Apr2021 (intramuscular Dose 1, 0.3 ml single, Lot number unknown). The patient''s concomitant medications were not reported. The patient experienced sudden death, malaise, dyspnoea and circulatory and respiratory failure on 02Jun2021. It was reported that on 02Jun2021, the patient suddenly felt malaise, experienced dyspnoea that was followed by circulatory and respiratory failure. As a result, the patient died. As the cause of death, pulmonary embolism was suspected, based on the slight swollenness of the right leg, which may suggest deep vein thrombosis. Autopsy was requested, no autopsy report was provided. In the patient s medical history, there is Alzheimer s disease and hypertension. In January 2021, the patient experienced head injury and required hospitalization. The patient was hospitalized from January 2021 until death. From 05Feb2021 to 26Feb2021, the patient was diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Feb2021 and negative on 12Apr2021. The patient died on 02Jun2021. It was not reported if an autopsy was performed. Sender Comment: Sudden death after vaccination with Comirnaty is not expected. TTO is 27 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1488679 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-21
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Chronic anxiety; Dementia NOS; Hospitalisation (due to the deterioration of his psychological condition); Personality disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021781868

Write-up: sudden death, acute left ventricular failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The Regulatory Authority report number is HU-OGYI-456421. A 53-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: EW2239), dose 2, intramuscular, administered in the left arm on 06Apr2021 (at the age of 53-years-old) as dose 2, 0.3 mL, single for covid-19 immunisation. Medical history included ongoing personality disorder, hospitalisation from 2014 (due to the deterioration of his psychological condition) and ongoing, ongoing chronic anxiety and dementia from 2014 and ongoing. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) (lot number: EJ6790), dose 1, intramuscular, administered in the left arm on 02Mar2021 as DOSE 1, 0.3 mL, SINGLE for COVID-19 immunization with no reported adverse effects. On 21Apr2021, the patient suddenly died. The patient''s death certificate populated by the pathologist was based on the autopsy results. Cause of death was reported as acute left ventricular failure. The patient died on 21Apr2021. An autopsy was performed and results were acute left ventricular failure. The causal relationship between the suspect product and the event was considered not related. The case was considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute left ventricular failure


VAERS ID: 1488680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Chest X-ray, Dyspnoea, Hydrothorax, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Chronic renal failure; Hyperlipidaemia; Hypertension; Hyperuricaemia; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac; Left anterior descending coronary artery stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Chest X-ray; Result Unstructured Data: Test Result:hydrothorax; Test Date: 20210416; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210418; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021781866

Write-up: death; Hydrothorax; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from Regulatory Authority WEB HU-OGYI-456521. A 90-years-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 22Mar2021 (Batch/Lot Number: ET3620) as unknown dose number, 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing Type II diabetes mellitus, ongoing chronic renal failure, ongoing atrial fibrillation, left anterior descending coronary artery stenosis from 2015 and unknown if ongoing, ongoing hyperuricemia, ongoing hyperlipidaemia, and cardiac decompensation from Feb2021 and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced dyspnoea on 16Apr2021, hydrothorax on an unspecified date and congestive heart failure on an unspecified date. The clinical course is as follows: On 16Apr2021, the patient experienced serious dyspnoea. In the hospital, hydrothorax and cardiac decompensation were diagnosed. 1800 ml of chest fluid was drained with no complications. For further treatment, the patient was hospitalized. Dyspnoea was resolving but the patient''s general condition was fragile. Despite medical treatment, the patient''s condition did not improve. On 21Apr2021, the patient died. The cause of death was reported as congestive heart failure, autopsy was not performed. The patient underwent lab test and procedures which included Chest X-ray on 16Apr2021 which showed hydrothorax, and on 16Apr2021 and on 18Apr2021, the patient was tested with COVID-19 PCR test, both tests were negative. The clinical outcome of the dyspnoea and hydrothorax was unknown. The patient died on 21Apr2021 due to congestive heart failure. An autopsy was not performed. Sender (Health Authority) Comment: Death after vaccination with Comirnaty is not expected. TTO is 25 days until hospitalization. It is unclear if the vaccination on 22Mar2021 was with the first or the second dose of the vaccine. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event death is considered not related. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: congestive heart failure


VAERS ID: 1488681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-12
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood test, Cerebral infarction, Chest X-ray, Coma, Computerised tomogram head, Headache, Hypokalaemia, Loss of consciousness, Pneumonia, Pyrexia, Renal impairment, SARS-CoV-2 test, Subarachnoid haemorrhage, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: CT angiography; Result Unstructured Data: Test Result:diagnose of Middle cerebral artery stenosis; Test Date: 202105; Test Name: Blood test; Result Unstructured Data: Test Result:increased inflammatory parameters, renal..; Comments: function impaired, hypokalaemia; Test Date: 202105; Test Name: Blood test; Result Unstructured Data: Test Result:increased CK levels and increased liver..; Comments: function levels; Test Date: 20210510; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210506; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:diagnose of Brain infarction; Test Date: 20210506; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210506; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021781871

Write-up: subarachnoid bleeding; brain infarction; unconscious; coma-like state; pneumonia; impaired renal function; hypokalaemia; headache; vomitiing; fever; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB HU-OGYI-456621. This serious, spontaneous case was reported by a physician on 07Jun2021, concerning the occurrence of death after the use of COMIRNATY concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH). On 18Mar2021, the 76-year-old female patient received the first dose of 0.3 ml BNT162 (COMIRNATY) concentrate for dispersion for injection, batch number: EP2166, expiry date: not reported, intramuscularly, in the left arm, for COVID-19 immunisation. In the medical history, there was hypertension and tonsillectomy. The patient''s concomitant medicinal products were not reported. On 22Apr2021, the patient received the second dose of 0.3 ml Comirnaty concentrate for dispersion for injection, batch number: EW4815, expiry date: not reported, intramuscularly, in the left arm, for COVID-19 immunisation. On 05May2021, the patient experienced headache. On 06May2021, in his home, the patient vomited and became unconscious. The ambulance was called and the patient was found in a coma-like state. The patient was transported to the hospital. In the hospital, COVID-19 test, cranial CT and blood test was initiated. The patient''s COVID-19 PCR test and COVID-19 rapid POC test were both negative. The cranial CT showed brain infarction, middle cerebral artery stenosis and possible subarachnoid bleeding. The blood test showed increased CK levels and slightly increased liver function enzyme levels. On the third day of care, the patient developed fever. On 10May2021, chest x-ray showed pneumonia. The blood test showed increased inflammatory parameters, impaired renal function and slight hypokalaemia. Despite medical care, the patient''s condition did not improve. The outcome of all events except subarachnoid bleeding was unknown. On 12May2021, the patient died. The cause of death was reported as subarachnoid bleeding, autopsy was not performed. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 2 weeks and 1 day until hospitalization. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Subarachnoid bleeding


VAERS ID: 1488682 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-20
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Hepatic failure, Laboratory test, SARS-CoV-2 test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: Medical History/Concurrent Conditions: Chronic alcoholism; Fall (treated in the hospital from 05Apr2021 after a fall); Hepatic cirrhosis; Hospitalization (treated in the hospital from 05Apr2021 after a fall)
Allergies:
Diagnostic Lab Data: Test Name: laboratory parameters; Result Unstructured Data: Test Result:elevated; Test Name: laboratory parameters; Result Unstructured Data: Test Result:normalized; Test Date: 20210426; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210428; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021781869

Write-up: liver failure; in a weak general condition/ condition continued to worsen; Death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-456921. An 82-year-old male patient received BNT162b2 (COMIRNATY, concentrate for dispersion for injection, tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number: FA5829, Expiry date: 31Aug2021) via intramuscular route in the left arm on 11May2021 at 0.3 ml as a single dose to prevent COVID-19. Medical history included chronic alcoholism and hepatic cirrhosis, both from unspecified dates and unknown if ongoing, and fall on unspecified date. Concomitant medications were not reported. The patient was treated in the hospital from 05Apr2021 after a fall. His elevated laboratory parameters were normalised with treatment, but he required complete care and was in a weak general condition. Despite therapy, his condition continued to worsen and he passed away on 20May2021 at 09:10. COVID-19 PCR tests on 26Apr2021 and 28Apr2021 were both negative. The direct cause of death was assessed as liver failure. The outcome of the events was fatal. The patient died on 20May2021 at 09:10. No autopsy was performed. Sender Comment: The patient was treated in the hospital because of a fall and his general condition was inadequate due to his diseases. The direct cause of death was assessed as liver failure. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. 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: in a weak general condition/ condition continued to worsen; death; liver failure


VAERS ID: 1488684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety disorder; Dementia; Hypertension; Insomnia; Paranoid schizophrenia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block third degree; COVID-19; Pacemaker insertion (cardiac); Tachyarrhythmia
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: EKG; Result Unstructured Data: Test Result:atrial fibrillation; Test Date: 20210303; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021846240

Write-up: Cardiac asthma; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-543521. An 80-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FA5829), intramuscular, administered in arm left on 11May2021 as dose 2, 0.3 mL single for covid-19 immunisation. The patient medical history included ongoing hypertension, paranoid schizophrenia, dementia, anxiety disorder and insomnia. In 2018, the patient experienced tachyarrhythmia with atrial fibrillation, atrioventricular block third degree and a cardiac pacemaker insertion surgery was performed. On 03Jan2021, the patient was diagnosed with COVID-19. On 03Mar2021, the patient''s COVID-19 PCR test was negative. The patient has been treated in the psychiatric department in the hospital for years for paranoid schizophrenia, dementia, anxiety disorder and insomnia. The patient previously received bnt162b2 (COMIRNATY, Lot number: EW2239), intramuscular, administered in arm left on 06Apr2021 as dose 1, 0.3 mL single for covid-19 immunisation. The patient''s concomitant medications were not reported. On 21May2021, the patient was transferred to another department in the hospital due to the revision of her pharmacotherapy. On 23May2021, the patient experienced severe dyspnoea. EKG showed atrial fibrillation. Acute cardiac asthma was diagnosed. Due to medicinal therapy, the patients condition slightly improved but cardiac decompensation symptoms were still dominant. The patient''s condition deteriorated. On 29May2021, the patient died. It was unknown if an autopsy was performed. No autopsy report was provided. The outcome of the event was fatal. Cause of death was cardiac asthma. Sender''s comments: Cardiac asthma after vaccination with Comirnaty is not expected. TTO is 12 days until diagnose of cardiac asthma. TTO was calculated based on the administration of the second dose of the vaccine. 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. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac asthma


VAERS ID: 1488685 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Cardiopulmonary failure, Chest X-ray, Hemiplegia, Loss of consciousness, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMARYL [GLIMEPIRIDE]; PLAVIX; MERCKFORMIN; EROLIN; RENITEC PLUS; INDOMETACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure; Diabetes mellitus; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: Chest X-ray; Test Result: Positive ; Comments: COVID pneumonia; Test Date: 20210403; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021846238

Write-up: left side hemiplegia; loss of consciousness; COVID-19 pneumonia; COVID-19; cardiorespiratory insufficiency; This is a spontaneous report from a contactable physician, downloaded from regulatory authority. The regulatory authority number is HU-OGYI-543621. A 76-year-old female patient received bnt162b2 (COMIRNATY, also reported as "tozinameran," Solution for injection), intramuscularly on 29Mar2021 (Batch/Lot number and Expiration date were unknown) as dose 1, 0.3 mL single for COVID-19 immunization. Relevant medical history included diabetes mellitus, congestive heart failure, obesity, and hypertension, all from an unknown date and unknown if ongoing. Concomitant medications included glimepiride (AMARYL, Tablet) taken for an unspecified indication; clopidogrel bisulfate (PLAVIX, Film-coated tablet) taken for an unspecified indication; metformin hydrochloride (MERCKFORMIN, Film-coated tablet) taken for diabetes mellitus; loratadine (EROLIN, Tablet) taken for an unspecified indication; enalapril maleate, hydrochlorothiazide (RENITEC PLUS, Tablet) taken for an unspecified indication; and indometacin taken for an unspecified indication; all start and stop date were not reported. The patient experienced COVID-19 on 03Apr2021, COVID-19 pneumonia on 04Apr2021, and cardiorespiratory insufficiency on an unspecified date, which all led to death on 07Apr2021. The patient was also hospitalized for COVID-19 pneumonia and COVID-19 from 04Apr2021 to an unknown date. It was further reported that the known coronavirus positive patient was hospitalized on 04Apr2021 because of left side hemiplegia and loss of consciousness. Chest x-ray on 04Apr2021 showed COVID pneumonia (positive). The reason behind her neurological symptoms was a hypoglycemic episode, which was treated with glucose intravenously. The patient received covid therapy, but eventually passed away on 07Apr2021 at 17:30 due to cardiorespiratory insufficiency. The patient underwent further lab tests and procedures, which included COVID-19 antigen test: positive on 03Apr2021. Therapeutic measures were taken as a result of all the events. The outcome of left side hemiplegia and loss of consciousness was unknown. The patient died on 07Apr2021 at 17:30. An autopsy was performed and results were not provided. Sender Comment: According to the Comirnaty, immunity usually develops 7 days after the second dose of the vaccine. The patient got infected with the virus 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 event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known disease pathophysiology, the events COVID-19 and COVID-19 pneumonia are assessed as not related to suspect drug BNT162B2. Based on the available information in the case, the causal association between the events cardiopulmonary failure, hemiplegia, loss of consciousness and the suspect drug BNT162B2 cannot be excluded. 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: COVID-19; COVID-19 pneumonia; cardiorespiratory insufficiency


VAERS ID: 1488686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Functional gastrointestinal disorder, Left ventricular failure, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Gastrointestinal nonspecific inflammation (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetes mellitus; Hypertension; Ogilvie''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021846239

Write-up: colon passage problems; acute left ventricular insufficiency; pulmonary edema; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is HU-OGYI-543821. A 75-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: EW9127), via intramuscular, administered in left arm, on 09Apr2021, as dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus and atrial fibrillation. The patient has also known Ogilvie''s syndrome. The patient''s concomitant medications were not reported. On 06May2021, it was reported that the patient was hospitalized on 06May2021 with colon passage problems and required necessary surgery. After colectomy surgery, the passage problems resolved but later he experienced acute left ventricular insufficiency presenting with pulmonary edema. Despite of emergency treatment, the patient condition did not improve, and he passed away on 07May2021 at 23:30. The patient died on 07May2021. An autopsy was not performed. Sender''s comment: As the event was associated with the patient''s primary disease (Ogilvie''s syndrome), the causal relationship is not approved between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: colon passage problems; acute left ventricular insufficiency; pulmonary edema


VAERS ID: 1488687 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-08
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Circulatory collapse, Death, General physical health deterioration, Laboratory test, Leukopenia, Lung cancer metastatic, Pneumonia, Pyrexia, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BINOCRIT; DOCETAXEL; PANADOL; XARELTO; DOLFORIN; ZOLEDRONIC ACID; COVERCARD; CERUCAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal metastases; Bone metastases; Cachexia; Ex-smoker; Hepatic metastases; Lung cancer metastatic; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210608; Test Name: Laboratory test; Result Unstructured Data: Test Result:leukopenia; Test Date: 20210608; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021846241

Write-up: death; fever; deterioration of his condition; Leukopenia; pneumonia; circulatory failure; respiratory failure; Advanced metastatic lung cancer; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-551221. A 65-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Left arm on 10May2021 (Batch/Lot Number: FA5829) as dose 2, 0.3 ml, single for COVID-19 immunisation. Medical history included Adrenal metastases from Oct2020, Lung cancer metastatic from Sep2020, cachexia from an unknown date, Bone metastases from Oct2020, pulmonary embolism from Oct2020, Hepatic metastases from Oct2020, and an ex-smoker from an unknown date. Concomitant medications included epoetin alfa (BINOCRIT); docetaxel from 31May2021 to an unspecified stop date; paracetamol (PANADOL); rivaroxaban (XARELTO); fentanyl (DOLFORIN); zoledronic acid; amlodipine besilate, perindopril arginine (COVERCARD); and metoclopramide hydrochloride (CERUCAL); all taken for an unspecified indication. The patient previously took etoposide and cisplatin both from 05Nov2020 to 14Apr2021. The patient was previously vaccinated with dose 1 of BNT1622 (COMIRNATY, batch number: EW4815) on 19Apr2021, for COVID-19 immunisation. On 08Jun2021, the patient was hospitalized due to fever and deterioration of his condition. Leukopenia was seen in his laboratory test, and chest X-ray showed retention pneumonia on the left side; and COVID-19 PCR was negative, all on 08Jun2021. Combined broad-spectrum empirical antibiotic treatment was initiated with parenteral fluid replacement, but despite the applied treatment, the patient''s condition did not improve. On 09Jun2021 at 2:30 AM, the patient died among the symptoms of circulatory and respiratory failure. The cause of death was advanced metastatic lung cancer, autopsy was not performed. Senders comment: The patient died due to his underlying diseases 30 days after the second dose of Comirnaty. Autopsy was not done. The event and Comirnaty is considered not related. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: advanced metastatic lung cancer


VAERS ID: 1488688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021887207

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is HU-OGYI-568721 A 79-year-old male patient received bnt162b2 (COMIRNATY) concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH/Pfizer), (batch number: FD0785, expiry date: unknown) intramuscularly in the left arm on 10Jun2021 as 0.3 ml single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced death after COMIRNATY injection. On 24Jun2021, the patient was found dead in his home. According to the reporter physician, the patient did not experience adverse events after vaccination. Due to lack of information and unsuccessful follo-up, the causal relationship cannot be assessed between the suspected drug and the adverse event until further information is received. The case is considered serious because the outcome was fatal. It was unknown if Autopsy Done. The outcome of the event was Fatal. Sender Comment: Due to lack of information and unsuccessful follow-up, the causal relationship cannot be assessed between the suspected drug and the adverse event until further information is received. The case is considered serious because the outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1488690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-19
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Cardiac aneurysm, Cardiac failure, Myocardial necrosis
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Atrial fibrillation; Cardiac insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021846243

Write-up: myocardial necrosis; cardiac aneurysm; Cardiac insufficiency; acute left ventricular failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-577721. An 80-year-old male patient received the first dose of BNT162B2 (COMIRNATY, strength: 0.3 ml Solution for injection; lot number: EW4815), intramuscular in the left arm on 20Apr2021 as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included cardiac insufficiency and atrial fibrillation (both unknown if ongoing; patient was under treatment for both), and severe atherosclerosis. The patient''s concomitant medications were not reported. On 19May2021, the patient was found dead in his home. According to the autopsy report, the patient had severe atherosclerosis. As a complication of his underlying diseases, myocardial necrosis developed, which led to the formation of cardiac aneurysm on an unspecified date. The direct cause of death was acute left ventricular failure. It was reported that the cause of death was cardiac insufficiency and acute left ventricular failure. The outcome of the events cardiac insufficiency and acute left ventricular failure was fatal with treatment; while for the other events was unknown. The patient died on 19May2021. An autopsy was performed, and the results were not provided. Sender Comment: As the event is related to the patient primary cardiovascular diseases, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: acute left ventricular failure; Cardiac insufficiency


VAERS ID: 1488712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Leukaemia, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (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: ITJNJFOC20210732539

Write-up: MALAISE; SUDDEN FEVER; FULMINANT LEUKEMIA; This spontaneous report received from a company representative who reported in social media concerned a 48 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had sudden fever and malaise that had led to hospitalization. The patient had been treated with antibiotics. On an unspecified date, the patient had died from fulminant leukemia. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210732539-Covid-19 vaccine ad26.cov2.s-Fulminant leukemia. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210732539-Covid-19 vaccine ad26.cov2.s-Malaise and sudden fever. These events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: FULMINANT LEUKEMIA


VAERS ID: 1488717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-15
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Central nervous system lesion, Cognitive disorder, Coma, Hypersomnia, Investigation, Magnetic resonance imaging
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTORC; MONTEGEN; DIBASE; COAPROVEL; PLAQUENIL S; URSODEOXYCHOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to analgesics; Arthritis rheumatoid; Asthma bronchial; Cholelithiasis; Hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Geriatric examination; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:inoperable expansive lesion of basal nuclei
CDC Split Type: ITPFIZER INC2021453491

Write-up: Report cognitive deficits; coma; hypersomnia; inoperable expansive lesion of basal nuclei; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-717332. An 88-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number: Et7205), intramuscular in left deltoid (also reported as left shoulder) on 05Apr2021 at dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included cholelithiasis, asthma bronchial, arthritis rheumatoid, hypertensive heart disease, and allergy to NSAIDS. Concomitant medications included pantoprazole sodium sesquihydrate (PANTORC); montelukast sodium (MONTEGEN); colecalciferol (DIBASE); hydrochlorothiazide, irbesartan (COAPROVEL) film-coated tablet; hydroxychloroquine sulfate (PLAQUENIL S), and ursodeoxycholic acid. The patient previously received ASA and experienced allergy. On 15Apr2021, it was reported that the patient was with cognitive deficits which she did not previously have. It was reported that after the Pfizer vaccine, on an unspecified date in 2021, onset of hypersomnia and mnemic deficits occurred. She underwent geriatric examination on an unspecified date in 2021 with unknown results and was treated with vitamin and citicholine. An MRI was performed on an unspecified date in 2021 showing inoperable expansive lesion of basal nuclei. She was therefore entrusted to the district palliative care service and therapy with dexamethasone was initiated. Then, she went into coma on an unspecified date in 2021 and died. The patient died on 24May2021 at the age of 89-years-old. The cause of death was cognitive deficits. An autopsy was not performed. The outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected. Follow-up (07Jul2021): New information downloaded from the Agency Regulatory Authority-WEB; the regulatory authority report number is IT-MINISAL02-717332 includes: medical history, past drug, lab data, dose number, concomitant medications, and reaction data (Case was upgraded to serious as the event Cognitive disorder was reported to be fatal, treatment for this event was also updated; "coma", "hypersomnia", and "inoperable expansive lesion of basal nuclei" were added; and death details), and course of events. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cognitive deficits


VAERS ID: 1488790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   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: CARDIOASPIRIN; AMILORIDE HYDROCHLORIDE;HYDROCHLOROTHIAZIDE; METFORMINA ACTAVIS; OLMESARTAN MEDOXOMIL/AMLODIPINE; ATORVASTATINA EG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial; Hypertensive heart disease; Myocardial ischaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021842987

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-751332. A 67-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 14Jun2021 (Batch/Lot Number: FC3098) as a single dose for COVID-19 immunization. Medical history included hypertension, diabetes and was on oral antidiabetics from Jun2020, hypertensive heart disease from 01Jun2020 (ejection fraction % left ventricle moderately depressed), and myocardial ischaemia from 06Nov2020; all unknown if ongoing. Last admission 06Nov2020 for haemodynamic study for myocardial ischaemia induced by a recent stress echo. Concomitant medications included acetylsalicylic acid (CARDIOASPIRIN); amiloride hydrochloride;hydrochlorothiazide (AMILORIDE HYDROCHLORIDE;HYDROCHLOROTHIAZIDE); metformin hydrochloride (METFORMINA ACTAVIS); amlodipine besilate, olmesartan medoxomil (OLMESARTAN MEDOXOMIL/AMLODIPINE); and atorvastatin calcium (ATORVASTATINA EG). The patient experienced cardiac arrest on 17Jun2021 and died on the same day. An autopsy was not performed. Senders comments: 29Jun2021 Local Responsible of Regulatory Authority: Further information and autopsy report required.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1488808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Panic attacks (Sporadic anxiety states.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021843031

Write-up: Chest pain, sudden death in a healthy patient. Cause unknown. Autopsy report required.; Chest pain, sudden death in healthy patient. Cause unknown. Autopsy report required.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-751594. A 65-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 18Jun2021 (Batch/Lot Number: FC5089) as dose 2, single for COVID-19 immunisation. Medical history included panic attacks (sporadic anxiety states). There were no concomitant medications. The patient previously took first dose of COMIRNATY [(BIONTECH MANUFACTURING GMBH) (J07BX03)] on 14May2021 (Batch/Lot Number: FA4597) as single for COVID-19 vaccination. On 26Jun2021, the patient experienced chest pain, sudden death in a healthy patient. Cause unknown. Autopsy report required. Report of UNEXPECTED DEATH at 8 days after COMIRNATY (PFIZER) vaccination (dose number 2). The first dose of COMIRNATY (PFIZER) vaccine was performed on 14May2021. The GP stated that the patient was apparently in good health. She was not taking any medication. She was reluctant to have laboratory tests and general investigations. The husband asserted that shortly before her death the patient had a strong dorsal thoracic pain and shortly afterwards, she died. The necropsy doctor requested an autopsy. The patient died on 26Jun2021. Reporter comment: Death in healthy patient. Cause unknown. Autopsy report required. Sender comment: Pharmacovigilance Centre 30Jun2021 We receive an ADR report card of sudden death 8 days after Comirnaty (PFIZER) vaccination. Booster dose number 2. Request for autopsy by the necropsy doctor. Sheet will be updated as soon as we receive follow up of autopsy. Pharmacovigilance Centre 30Jun2021 updated adverse reaction fields, medicinal products taken history; clinical report requested. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Death in healthy patient. Cause unknown. Autopsy report required.; Reported Cause(s) of Death: Chest pain, sudden death in healthy patient. Cause unknown. Autopsy report required.; Sudden death, cause unknown/ Chest pain, sudden death in a healthy patient. Cause unknown. Autopsy report required.


VAERS ID: 1488881 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Cardio-respiratory arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before first dose vaccination; Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before second dose vaccination; Test Date: 20210617; Test Name: Body temperature; Result Unstructured Data: Test Result:over 37.5 Centigrade
CDC Split Type: JPPFIZER INC2021830260

Write-up: fatal arrhythmia; patient in cardio-respiratory arrest; fever of over 37.5 degrees Centigrade; This is a spontaneous report from a contactable physician received via the Agency and from the Regulatory Authority, via regulatory authority report number is v21117492. The patient was a 22-year-old and 2-month-old male. 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. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient had neither medical history nor allergies to drugs including other vaccines. On 26May2021 at 15:45, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization (at the age of 22 years old). On 16Jun2021 at 15:45 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital (at the age of 22 years old). On 19Jun2021 (3 days after the vaccination), the patient experienced fatal arrhythmia. The event resulted in death on 19Jun2021. The outcome of the event was fatal on 19Jun2021 without treatment. An autopsy was performed. The cause of death confirmed by autopsy was fatal arrhythmia. It was unknown if the patient has been tested for COVID-19 since the vaccination. The course of the events was as follows: Body temperature before vaccination was 36.8 degrees Centigrade (first dose) and 36.5 degrees Centigrade (second dose) and no abnormalities were noted, so it was considered possible for him to receive the vaccination. On 17Jun2021 (1 day after the second dose vaccination), the patient had a fever of over 37.5 degrees Centigrade. He was a student and took a class online on that day. On 18Jun2021 (2 days after the second dose vaccination), he went to a school to take a class as usual. On 19Jun2021 in the morning (3 days after the second dose vaccination), the patient did not get up, so his family went to woke him up, his family found the patient in cardio-respiratory arrest and they called an ambulance and he was transferred to an emergency medical facility, he was immediately transferred to a hospital by an ambulance, but resuscitation did not work. The reporter was informed that he died on that day. In consideration of the causal relationship with BNT162b2, an autopsy was performed at a hospital with his family''s consent. The reporter did not receive the result directly. After the 2nd dose of vaccination, he did not ask the reporter about adverse reactions. Three days after the vaccination, this case resulted in unfortunate outcome, and so it was reported. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. No follow-up attempts are possible; information about batch number was already obtained.; Autopsy-determined Cause(s) of Death: patient in cardio-respiratory arrest; fatal arrhythmia


VAERS ID: 1488891 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
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: Diabetes mellitus; Lower leg oedema; Pleural effusion
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210702; Test Name: SpO2; Test Result: 64 %
CDC Split Type: JPPFIZER INC2021830494

Write-up: Acute respiratory failure; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117461. A 96-year and 4-month-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration on 01Jul2021 at 12:00 at 96 years old as a single dose for COVID-19 immunization. Body temperature before vaccination on 01Jul2021 was 36.9 degrees centigrade. The family history was not provided. The patient had medical histories of lower leg oedema, pleural effusion, and diabetes mellitus. Concomitant medications were not reported. On 10Jun2021, the patient previously received the first dose of BNT162b2 (Lot# FA4597, Expiration date 31Aug2021) for COVID-19 immunisation. On 01Jul2021 at 12:00 (the day of vaccination), the patient received the second dose of BNT162b2. On 02Jul2021 (1 day after the vaccination), the patient experienced acute respiratory failure. On 02Jul2021, at around 06:00 (18 hours after vaccination), the SpO2 was 64%, and the patient had respiratory distress and cyanosis (the body temperature was 40 degrees Celsius). The patient visited the reporting hospital. At 08:00 and 09:00, methylprednisolone 1 g and oxygen were administered; however, the patient did not recover. At 10:42 (22 hours and 42 minutes after vaccination), the patient died. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were pleural effusion and diabetes mellitus.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1488894 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: Diabetes mellitus; Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021831429

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21117495. The patient was a 65-year and 11-month-old (at vaccination) male. The patient had no family history. Medical history included obesity, diabetes mellitus and hypertension. On 19Jun2021 at 10:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27Jun2021 at 06:40 (8 days after the vaccination), the patient experienced cardio-respiratory arrest. On 27Jun2021, the outcome of the event was fatal. The course of the event was as follows: On 27Jun2021 in the morning, the patient was in cardio-respiratory arrest. At around 06:40, the patient was emergently transferred. On the previous day, the patient was on duty (night shift) and went to bed at around 23:00. The patient did not wake up and come out and was found to fell on the passage in a night wear, for which ambulance was requested. Time of recognition was shortly after 06:00. At around 06:20, cardiopulmonary resuscitation (CPR) was initiated. CPR was performed for about 1 hour from the recognition but the patient was not resuscitated. At 07:07, death was confirmed. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were chronic diseases of obesity, diabetes mellitus and hypertension. The reporting physician commented as follows: Cerebral haemorrhage, cerebral ventricular rupture (as reported).; Reporter''s Comments: Cerebral haemorrhage, cerebral ventricular rupture (as reported).; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Hyperventilation, Oxygen saturation, Productive cough, Pyrexia, Respiratory arrest, Restlessness
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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: LIXIANA; PREDONINE [PREDNISOLONE]; BISOPROLOL FUMARATE; ENALAPRIL MALEATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Percutaneous endoscopic gastrostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:128/95; Comments: at 10:00; Test Date: 20210627; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:91/49; Comments: at 20:00; Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: shortly after 17:00; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 20:00; Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: in the morning; Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: in the afternoon; Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: at 20:00; Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 05:00; Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: at 10:00; Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: at 14:00; Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: at 20:00; Test Date: 20210627; Test Name: Pulse; Result Unstructured Data: Test Result:96; Test Date: 20210627; Test Name: Pulse; Result Unstructured Data: Test Result:unknown results; Comments: at 20:00; Test Date: 20210627; Test Name: SpO2; Test Result: 95 %; Comments: at 10:00 room air; Test Date: 20210627; Test Name: SpO2; Test Result: 97 %; Comments: at 14:00; Test Date: 20210627; Test Name: SpO2; Test Result: 92 %; Comments: at 20:00
CDC Split Type: JPPFIZER INC2021831431

Write-up: Respiratory arrest; Unrest; Hyperpnoea; sputum sticking; body temperature of 38.4 degrees centigrade; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117501. The patient was an non-pregnant 83-year and 1-month-old female. Body temperature before vaccination was 36.6 degrees centigrade. The patient had no family history. Medical history included percutaneous endoscopic gastrostomy (PEG). Concomitant medications included edoxaban tosilate (LIXIANA), prednisolone (PREDONINE), bisoprolol fumarate, and enalapril maleate, all taken for unspecified indications, start and stop dates were not reported. The following information was provided from the vaccine screening questionnaire: The patient has not been sick or had a fever in the past month. The patient was not feeling sick on the day of vaccination. The patient had never had convulsions or severe allergic reactions (such as anaphylaxis) to a medication or food. The patient had never been sick after receiving vaccination. The patient had not received any other vaccines in the past two weeks. On 23Jun2021 between 13:30 and 16:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as 0.3 mL single dose for COVID-19 immunization. On 25Jun2021 shortly after 17:00 (2 days after the vaccination), the patient had body temperature of 38.4 degrees centigrade but no other symptoms. At 20:00, body temperature was 38.2 degrees centigrade. On 26Jun2021 in the morning, body temperature was 37.4 degrees centigrade. Body temperature was 37.7 degrees centigrade in the afternoon. Consciousness level was unchanged and no other symptoms were observed. At 20:00, body temperature was 37.1 degrees centigrade. On 27Jun2021 at 05:00 (4 days after the vaccination), body temperature was 38.5 degrees centigrade. ANHIBA suppository 200 mg was used. The patient had sputum sticking, for which suction was performed in oral cavity only. At 10:00, body temperature was 36.6 degrees centigrade, 128/95, 96, and 95% (room air). At 14:00, body temperature was 38.0 degrees centigrade, ANHIBA, 97%. The patient was frightened by a loud voice and blood pressure measurement. Hyperpnoea was present. At 20:00, body temperature was 36.5 degrees centigrade, 91/49, pulse was unknown, and 92%. The patient had unrest. At 21:00, initiation of sleep was confirmed. At 22:34, the patient was in respiratory arrest. At 23:53, the patient was visited and death was confirmed. It was unknown if Autopsy was Done. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had PEG but general condition was stable. Two days after the vaccination, the patient suddenly developed unrest. After 2 days more, the patient died (sudden death); thus, it must be estimated that there was causal relationship.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1488902 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic valve stenosis, Body temperature, Oxygen saturation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; BISOPROLOL; ROZEREM; SPIRONOLACTONE; ASPARA POTASSIUM; CEFAMEZIN ALPHA; ELNEOPA NO.1; POTACOL R; ELNEOPA NO.2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Aortic valve stenosis and insufficiency; Cardiac failure chronic (required hospitalization); Cerebral infarction; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: 22:00; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: 23:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: 02:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: 08:00; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: 14:00; Test Date: 20210703; Test Name: SpO2; Result Unstructured Data: Test Result:92-93 %; Comments: 23:00
CDC Split Type: JPPFIZER INC2021839907

Write-up: Aortic valve stenosis; This is an initial spontaneous report from a contactable pharmacist received via a regulatory authority. The patient was a non-pregnant 86-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received lansoprazole (manufacture name not reported), bisoprolol (manufacture name not reported), ramelteon (ROZEREM), spironolactone (manufacture name not reported), potassium aspartate (manufacture name not reported), cefazolin sodium (CEFAMEZIN alpha), ELNEOPA NO.1, POTACOL R, and ELNEOPA NO.2 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cerebral infarction, cardiac failure chronic, hypertension, aortic valve stenosis and aortic valve incompetence. On 03Jul2021 at 15:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization at a hospital. On 03Jul2021 at 22:00 (the day of vaccination), body temperature was 37.1 degrees Centigrade, and shivering appeared. At 23:00, body temperature was 37.9 degrees Centigrade and SpO2 (oxygen saturation percutaneous) was 92-93%. On 04Jul2021 at 02:00 (1 day after the vaccination), body temperature was 39.4 degrees Centigrade. Acetaminophen (ALPINY suppository) was provided as treatment for the event. At 08:00, body temperature was 38.7 degrees Centigrade. At 14:00, body temperature was 37.7 degrees Centigrade. At 15:45, respiratory arrest was found. At 16:17, the patient''s death was confirmed. The cause of death was aortic valve stenosis. An autopsy was not performed. Causality assessment was not provided. Since the vaccination, the patient has not been tested for COVID-19. Follow-up (05Jul2021): New information reported from the same pharmacist via a Pfizer sales representative. New information was as follows: While the patient was being hospitalized for cardiac failure, she received the first dose of the vaccination.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event . The case will be reassessed once new 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.; Reported Cause(s) of Death: Aortic valve stenosis


VAERS ID: 1488911 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021840321

Write-up: Unknown cause of death/died; This is a spontaneous report from a contactable physician received via Agency Regulatory Authority. The patient was a non-pregnant 80-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included old myocardial infarction. On 07Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY5423, Expiration date 31Aug2021). On 28Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021), via intramuscular route of administration in the arm left for COVID-19 immunization. On 30Jun2021 (2 days after the vaccination), the patient experienced unknown cause of death. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as (death). Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 30Jun2021 (2 days after vaccination), the patient died. No Autopsy Done.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death/died


VAERS ID: 1488914 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Physical deconditioning, Pneumonia, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 13
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: ELIQUIS; IRSOGLADINE MALEATE; AMLODIPINE BESILATE; ROSUVASTATIN CALCIUM; SENNOSIDE A+B CALCIUM; PROPRANOLOL HYDROCHLORIDE; TAMSULOSIN HYDRCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Prostatic hypertrophy; Respiratory tract infection (Avium was detected on the sputum PCR test on hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: tested for COVID-19; Test Result: Negative ; Comments: Nasal Swab Smart Gene
CDC Split Type: JPPFIZER INC2021840347

Write-up: Pneumonia; physical deconditioning; This is a spontaneous report from a contactable physician received via a regulatory authority. The patient was a 93-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received apixaban (ELIQUIS), irsogladine maleate, amlodipine besilate (AMLODIPINE), rosuvastatin calcium, sennoside A+B calcium, propranorol hydrochloride, tamsulosin hydrochloride (TAMSULOSIN) within 2 weeks prior to the event onset. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included atrial fibrillation, prostatic hypertrophy, and respiratory tract infection chronic (Avium was detected on the sputum PCR test on hospitalization). On 01Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY) at the age of 93-year-old. On 22Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, solution for injection) via intramuscular at single dose at another medical institution for COVID-19 immunization at the age of 93-year-old. On 23Jun2021 (one day after the vaccination), the patient experienced pneumonia. The event resulted in hospitalization and death. The outcome of event pneumonia was fatal with treatment including administration of an antibiotic and a steroid pulse therapy. The reporting physician assessed the event as serious (death, hospitalization). Since the vaccination, the patient had been tested for COVID-19 (specimen; nasal swab / test name: smart gene) that was negative on 29Jun2021. The reported event was as follows: After the patient received the first dose of BNT162B2 vaccination on 01Jun2021, the patient had some kind of physical deconditioning. After the patient received the second dose of BNT162B2 vaccination on 22Jun2021 (the day of vaccination), the patient had physical deconditioning with outcome of unknown. On 26Jun2021 (4 days after vaccination), the patient visited his nearby hospital, and he had pneumonia. On 29Jun2021 (7 days after vaccination), the patient visited the reporting hospital. The patient was admitted to the hospital for treatment because he was suspected to have interstitial pneumonia or organizing pneumonia. On hospitalization, the patient had poor subjective symptoms. Although administration of an antibiotic was initiated, oxygenation was aggravated on 01Jul2021 (9 days after vaccination), and the patient had subjective symptoms. Although a steroid pulse therapy and others were performed, the patient died on 05Jul2021 (13 days after vaccination). Autopsy was not performed. The information on the lot/batch number has been requested.; Sender''s Comments: Based on the information provided in narrative, the causal association between the events Pneumonia and suspect vaccine BNT162B2 cannot be ruled out. Consider contributory role from medical history of respiratory tract infection chronic (Avium). 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: Pneumonia


VAERS ID: 1488919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-06-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Liver disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021841605

Write-up: Aortic dissection acute; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117660. A 72-year-old (also reported as 72-year and 2-month-old) female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27Jun2021 11:00 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included ongoing liver disorder. The family history was not provided. The patient was currently treated (with medications) for liver disorder. Body temperature before vaccination was 36.3 degrees centigrade. The patient had been told by her treating physician of the above disease that it was ok for her to receive this vaccination. On 28Jun2021 at 18:30 (one day/7 hours/30 minutes after the vaccination), the patient experienced aortic dissection acute. On 28Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jun2021 (the day of vaccination), at 11:00, the patient received the first dose of BNT162b2 vaccination. Thereafter, no adverse events were observed while the patient was waiting for 15 minutes. On 28Jul2021, at 18:30 (one day, 7 hours, and 30 minutes after vaccination), the patient complained of sudden back pain and chest pain, and she was transferred to her nearby hospital. At that time, the patient had brain death. The patient was diagnosed with aortic dissection acute. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was aortic dissection acute. The reporting physician commented as follows: Although the causality between the aortic dissection acute and BNT162b2 vaccination was unknown, the direct involvement was difficult to be suspected. This was the first time to receive Coronavirus Disease 2019 vaccine. The name of present local municipal government (who issues a Certificate of Residence for the patient) correctly printed on the coupon ticket. The patient had read a publication and understood its effect and potential side effects. The patient fell under any of the following priority vaccination groups (65-year-old or older). The patient was currently treated (with medications, etc.) for any disease (Liver disorder). The patient had been told by her treating physician of the above disease that it is OK for her to receive this vaccination. The patient had not been sick or had no fever in the past month. The patient was not feeling sick on the day of vaccination. The patient had never had convulsions (seizures). The patient had never had severe allergic reactions (anaphylaxis, etc.) to a medication or food. The patient had never been sick after receiving vaccination. The patient was not possibly pregnant (e.g. late period) or she was not currently breast-feeding. The patient had not received any other vaccines in the past two weeks. The patient did not have any questions about this vaccination. The patient died on 28Jun2021. It was not reported if an autopsy was performed.; Sender''s Comments: Base don information provided, the event of aortic dissection acute more likely represents an intercurrent illness which is unrelated to bnt162b2 (COMIRNATY). The case will be reassessed once more information become available.; Reported Cause(s) of Death: Aortic dissection acute


VAERS ID: 1488924 (history)  
Form: Version 2.0  
Age: 105.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Brain natriuretic peptide, Cardiac failure congestive, Heart rate, Oxygen saturation
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: blood pressure; Result Unstructured Data: Test Result:147/76; Test Date: 20210522; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: Before vaccination; Test Date: 20200306; Test Name: BNP; Result Unstructured Data: Test Result:268; Test Date: 20210309; Test Name: BNP; Result Unstructured Data: Test Result:722.9; Test Date: 20210522; Test Name: pulse rate; Result Unstructured Data: Test Result:70; Test Date: 20210522; Test Name: SpO2; Test Result: 94 %
CDC Split Type: JPPFIZER INC2021841623

Write-up: Congestive cardiac failure aggravated; blood pressure was 147/76; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117661. The patient was a 105-year and 3-month-old female. Body temperature before vaccination was 35.7 degrees centigrade. The patient had no particular family history. Medical history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 29Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# ET3674, Expiration date 31Jul2021). On 22May2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25May2021 at 09:30 (2 days/23 hours/30 minutes after the vaccination), the patient experienced congestive cardiac failure aggravated. On 25May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 25May2021 (3 days after the vaccination), the outcome of the event congestive cardiac failure aggravated was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 22May2021 (the day of vaccination), at 10:00, the patient received the second dose of BNT162 vaccination. The blood pressure was 147/76, the pulse rate was 70, and SpO2 was 94%. Thereafter, no significant changes or side reactions were observed. The reporting physician classified the event as serious (hospitalization and death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The death was caused by the congestive cardiac failure aggravated due to advanced age since 1 year ago (BNP of 268 on 06Mar2020 increased to BNP of 722.9 on 09Mar2021). Thus, the death was not caused by the vaccination.; Reported Cause(s) of Death: Congestive cardiac failure aggravated


VAERS ID: 1488929 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 2021-07-03
   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: Dementia; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021841742

Write-up: Respiratory arrest; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 75-year-old male. The patient family history was not provided. The patient had medical histories of schizophrenia and dementia. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at age of 75 years old as a single dose for COVID-19 immunization. On 03Jul2021 (4 days after the vaccination), the patient experienced respiratory arrest (death). On 03Jul2021 (4 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 03Jul2021 (4 days after vaccination), the patient suddenly died. The cause of death was respiratory arrest. The causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event respiratory arrest.This case will be reassessed when additional information, particularly the clinical course before death.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: Respiratory arrest


VAERS ID: 1488938 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Cardio-respiratory arrest, Embolic stroke, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUETIAPINE; DAYVIGO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardioembolic stroke; Dementia; Paresis cranial nerve
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: pyrexia of 37.8 degrees Centigrade in the evening
CDC Split Type: JPPFIZER INC2021841919

Write-up: Cardioembolic stroke; Cardio-respiratory arrest; Sudden death; Suspected cardiac death; pyrexia of 37.8 degrees Centigrade; This is a spontaneous report from a contactable physician received via a regulatory authority. This report was also received via Pfizer sales representative and another regulatory authority. The regulatory authority report number is v21117885. The patient was a 90-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received quetiapine (QUETIAPINE) 25 mg and lemborexant (DAYVIGO) 2.5 mg (both oral) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included cardioembolic stroke, atrial fibrillation, dementia, upper right cerebral paresis on 31May2021 (Since cardioembolic stroke was suspected, he was hospitalized). Body temperature before vaccination was 37.0 degrees Centigrade. On 03Jul2021 at 10:30 (the day of vaccination) (at the age of 90-years-old), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular in the left arm as dose 1, 0.3 ml single for COVID-19 immunization in the ward of the hospital while he was being hospitalized. On 04Jul2021 at 13:00 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest on the bed. After a while, the patient''s death was confirmed (this was also reported as sudden death). The cause of death could not be identified, but given his medical history, cardioembolic stroke was considered as a possible cause. An autopsy was not performed. The event resulted in prolonged hospitalization/death. The outcome of the event was fatal without treatment. The clinical course of the event was reported as follows: On 31May2021, the patient developed upper right cerebral paresis. Since cardioembolic stroke was suspected, he was hospitalized. The treatment of acute-stage cerebral infarction was completed, and his general condition was stable. Therefore, changing hospital was being arranged. On 03Jul2021, the patient received the first dose of BNT162b2. At that night, pyrexia of 37.8 degrees Centigrade was recognized in the evening. Thereafter, no marked change was noted. Until 04Jul2021 at 12:40, no change was seen. At 13:00, the patient was found in cardio-respiratory arrest. CPR (cardiopulmonary resuscitation) was not performed. The outcome of the event pyrexia was unknown; while for the rest of the events was fatal without treatment. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. Cardiac death could be considered as a possible cause. Since the vaccination, the patient has not been tested for COVID-19. Reporter''s comment: Causal relationship between the patient''s death and BNT162b2 was uncertain. Twenty minutes before the patient was found, no problems were noted, and when he was found, he had already been in cardiac arrest. Given those, the possibility of cardiac death was considered.; Reporter''s Comments: Causal relationship between the patient''s death and BNT162b2 was uncertain. Twenty minutes before the patient was found, no problems were noted, and when he was found, he had already been in cardiac arrest. Given those, the possibility of cardiac death was considered.; Reported Cause(s) of Death: Cardioembolic stroke; Cardio-respiratory arrest; Sudden death; cardiac death


VAERS ID: 1488941 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: BP; Result Unstructured Data: Test Result:111/70; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: around 13:30; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 16:00; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:normal Centigrade; Comments: in the morning; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 15:00; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:a low grade fever in 37s Centigrade; Comments: after 15:00; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 08:00; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 11:20; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: 15:30; Test Date: 20210704; Test Name: Pulse; Result Unstructured Data: Test Result:127; Test Date: 20210704; Test Name: SpO2; Result Unstructured Data: Test Result:76-78 %
CDC Split Type: JPPFIZER INC2021841971

Write-up: Respiratory arrest; Pyrexia; This is a spontaneous report from a contactable physician received from the Health Agency (HA). Regulatory authority report number is v21117675. The patient was a 100-year and 3-month-old female. Body temperature before vaccination was 36.6 degrees centigrade. The patient had no family history. Medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 30Jun2021 at 14:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 01Jul2021 at 13:30 (1 day after the vaccination), the patient experienced pyrexia. On 04Jul2021 at 08:13 (4 days after the vaccination), the patient experienced respiratory arrest. On 04Jul2021 (4 days after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 01Jul2021 around 13:30 (1 day after the vaccination), pyrexia of 37.7 degrees centigrade was noted, and only cooling was performed. At 16:00, the body temperature decreased to 36.8 degrees centigrade. No pyrexia was noted at night, and a wait-and-see approach was taken. On 02Jul2021 in the morning (2 days after the vaccination), the body temperature was normal, and no problem happened. However, at 15:00, pyrexia of 37.8 degrees centigrade was noted, after which a low grade fever in 37s degrees centigrade persisted. On 03Jul2021 (3 days after the vaccination), pyrexia still persisted with fluctuating levels of 38.2 degrees centigrade at 08:00, 37.3 degrees centigrade at 11:20, and 38.1 degrees centigrade at 15:30. Other than pyrexia, there were no findings of pneumonia, and the patient was able to talk almost as the same as usual. On 04Jul2021 at 07:00 (4 days after the vaccination), the patient was breathing with shoulder movements and had blood pressure (BP) of 111/70, pulse of 127, and SpO2 of 76-78%. Because of the sputum stuck in, the caregiver performed sputum suctioning. Suctioning was also done later, but the patient''s response became weaker. During the intervention, respiratory arrest was confirmed at 08:13 (the carotid artery was impalpable, and the pupils were dilated). The reporting physician classified the events as serious (death) and assessed that the events were related to BNT162b2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Because the patient was old with age of 100, the physician have to say that pyrexia which occurred as a side effect after the vaccination led to the significant physical deconditioning. In addition, the physician also thought that the low weight at 30 kg should be taken in consideration. ; Reported Cause(s) of Death: Respiratory arrest; Pyrexia


VAERS ID: 1488944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Acute myocardial infarction, Chest pain, Echocardiogram, Electrocardiogram
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Echocardiography; Result Unstructured Data: Test Result:left ventricular asynergy; Test Date: 20210702; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST segment elevation in V1 to V4
CDC Split Type: JPPFIZER INC2021842107

Write-up: acute coronary syndrome; Acute myocardial infarction; chest pain exertional; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117691. The patient was a 65-year and 1-month-old male. Body temperature before vaccination was not provided. The family history was not provided. Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) were not provided. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 30Jun2021 (the day of vaccination), the patient received the second 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 immunization. On 02Jul2021 (2 days after the vaccination) at 12:00, the patient experienced acute myocardial infarction. On 02Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Jul2021, at around 12:00 (2 days and 12 hours after vaccination), the patient had chest pain exertional and it did not improve, and at 18:00 (2 days and 18 hours after vaccination), the patient visited the previous hospital. The patient was diagnosed with acute coronary syndrome (ECG showed ST segment elevation in V1 to V4, and an echo showed left ventricular asynergy), and he was referred to the reporting hospital. In the ambulance, the patient had cardiopulmonary arrest (CPA) at 20:11 (2 days, 20 hours, and 11 minutes after vaccination), and cardiopulmonary resuscitation (CPR) was continued; however, no response was obtained. On 02Jul2021, at 20:53 (2 days, 20 hours, and 53 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. Information on the lot/batch number has been requested.; Reporter''s Comments: The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: chest pain exertional; acute coronary syndrome; Acute myocardial infarction


VAERS ID: 1488960 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Coma scale, Computerised tomogram head, Respiratory arrest, Subarachnoid haemorrhage, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 degree Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: CS; Result Unstructured Data: Test Result:300; Comments: after vaccination; Test Date: 20210704; Test Name: Head CT; Result Unstructured Data: Test Result:revealed subarachnoid haemorrhage; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021842358

Write-up: Consciousness disturbed; Head CT revealed subarachnoid haemorrhage; respiratory arrest was noted; fainted; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117728. A 74-year and 08-month-old male the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration on 04Jul2021 at 11:30 (the day of vaccination) (at the age of 74-year and 08-month-old), as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.8 degrees centigrade. Family history, medical history, and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jul2021 at around 14:00 (2 hours and 30 minutes after the vaccination), the patient fainted at home and was transported by ambulance. The consciousness level was 300 according to the Coma Scale (CS), and respiratory arrest was noted. Head CT revealed subarachnoid haemorrhage. The patient was put on a ventilator and admitted to the reporting hospital. On 05Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The reporting physician classified the events as serious (death, life-threatening, and hospitalization) and assessed the causality between the events and BNT162B2 as unassessable. It was not reported whether there were other possible causes of the events such as any other diseases.; Reported Cause(s) of Death: respiratory arrest was noted; Consciousness disturbed; subarachnoid haemorrhage


VAERS ID: 1488961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-02
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021842423

Write-up: Acute myocardial infarction; This is a spontaneous report from a consumer or other non-healthcare professional (HCP) via regulatory authority. The patient was a 93-year-old female. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 19Jun2021 at unknown time (the day of vaccination), the patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. On 02Jul2021 (13 days after the vaccination), the patient experienced acute myocardial infarction. On 02Jul2021, the outcome of the event was fatal; the patient died on 02Jul2021. It was unknown if an autopsy was performed. The course of the event was as follows: The patient was 93 years old. She had never been hospitalized and had been well, and on 19Jun2021 (the day of vaccination), she got the second vaccine shot. On 02Jul2021 in the morning (13 days after the vaccination), she died in the toilet. Because it was considered as unnatural death, a physician came and diagnosed acute myocardial infarction. Heart problems do not run in the family, and she usually had poor hearing alone. She went shopping regularly by herself although her legs and hips were very weak and was well on Tuesday when the day-care staff came. The seriousness and causality of the event were not reported. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1488962 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Interstitial pneumonia; Large intestine carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021842456

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117735. The patient was an 81-year and 2-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. The family history was not provided. The patient had medical histories of large intestine carcinoma and interstitial pneumonia. On 04Jun2021 at 10:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jul2021 at 03:00 (16 hours and 20 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 05Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021 (the day of vaccination), at 10:40, the patient received the first dose of BNT162b2 vaccination. After lunch, the patient went home. He lived alone. On 05Jul2021, at 03:00 (16 hours and 20 minutes after vaccination), when the patient''s son visited the patient in the morning, he was found to have cardio-respiratory arrest on the bed. The patient was emergently transferred. The patient did not respond to resuscitation, and he was confirmed to die at 07:56 (21 hours and 16 minutes after vaccination). 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 interstitial pneumonia. The reporting physician commented as follows: Since the change was after the resuscitation, it was difficult to be judged on the autopsy imaging (AI). However, the patient seemed to also have lung oedema. Since there was an image of interstitial pneumonia which was medical history, the degree of the new change was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488963 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Disseminated intravascular coagulation, Interstitial lung disease
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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: 2021-06-28
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021842459

Write-up: Multiple cerebral infarction; DIC; Interstitial pneumonia; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117727. The patient was an 86-year-old female. Body temperature before vaccination was not provided. The family history was not provided. The medical history and concomitant medications and others were unknown. On 13Jun2021 (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 immunization. On 15Jun2021 (2 days after the vaccination), the patient experienced interstitial pneumonia. Also, multiple cerebral infarction and DIC developed on unknown date. On 20Jun2021 (7 days after the vaccination), the patient was admitted to the hospital. On 28Jun2021 (15 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 15Jun2021 (2 days after vaccination), the patient had pyrexia. On 19Jun2021 (6 days after vaccination), the patient had dyspnoea. On 20Jun2021 (7 days after vaccination), the patient visited the reporting hospital. The patient had significant hyoxeamia and diffuse interstitial opacities on the both lung fields, and she was admitted to the hospital. A respiratory assistance, administration of broad-spectrum antibiotics, and a steroid pulse therapy were performed; however, the patient did not respond. This patient complicated with DIC and multiple cerebral infarction, and the patient died on 28Jun2021. The reporting physician classified the event of interstitial pneumonia as serious (hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were pneumonia bacterial and acute interstitial pneumonia.; Reported Cause(s) of Death: multiple cerebral infarction; DIC


VAERS ID: 1488964 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Aortic dissection, Body temperature, Cardio-respiratory arrest, Computerised tomogram
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic dissection
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery; Trochanteric femoral fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210622; Test Name: CT; Result Unstructured Data: Test Result:thoracic aortic dissection
CDC Split Type: JPPFIZER INC2021842462

Write-up: Thoracic aortic dissection; cardio-respiratory arrest; disturbed consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118258. The patient was a 94-year and 8-month-old female. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not provided. The patient had medical history of thoracic aortic dissection (underlying disease). On 22Jun2021 at 11:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7812, Expiration date 30Sep2021) via an unspecified route of administration as a dose 1, single (at the age of 94 years old) for COVID-19 immunization. On 22Jun2021 at 17:52 (6 hours/52 minutes after the vaccination), the patient experienced thoracic aortic dissection. On 22Jun2021 (the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was originally visiting another hospital for thoracic aortic dissection. The patient was told that the dissection could rupture at any time. On 05Apr2021, the patient underwent surgery for left trochanteric fracture. On 02Jun2021, the patient was transferred to the reporting hospital for rehabilitation. No abnormalities were observed in the general condition, and rehabilitation was favorable. On 22Jun2021 (the day of vaccination), at 11:00, the patient received the first dose of BNT162b2 vaccination. In the evening on the same day, the patient had disturbed consciousness and cardio-respiratory arrest. Cardiopulmonary resuscitation (CPR) was performed, and the patient was emergently transferred. At the hospital where the patient was transferred to, CPR was continued; however, the patient was confirmed to die on the same day. The patient was diagnosed that the cause of death was thoracic aortic dissection on the CT after the death. The outcome of the event disturbed consciousness was unknown while fatal for cardio-respiratory arrest and thoracic aortic dissection. 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 thoracic aortic dissection.; Reported Cause(s) of Death: thoracic aortic dissection


VAERS ID: 1488974 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021842585

Write-up: Cerebral haemorrhage; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 56-year-old male. The patient family history was not provided. The patient had medical histories of diabetes mellitus and myocardial infarction. On 30Jun2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular as a dose number unknown, single for COVID-19 immunization (at the age of 56 years old). On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced cerebral haemorrhage. On 05Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. On 05Jul2021 (5 days after vaccination), the patient died at the city medical center. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2. It was unknown if an autopsy was done. Information about lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event cerebral hemorrhage (fatal) and the suspect drug. 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: Cerebral haemorrhage


VAERS ID: 1488986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Multiple system atrophy
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple system atrophy (for 9 years)
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination; Test Date: 202106; Test Name: Whole body CT; Result Unstructured Data: Test Result:no significant finding; Comments: no significant finding suggestive of the cause of death
CDC Split Type: JPPFIZER INC2021843132

Write-up: Death due to Multiple system atrophy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117758. The patient was a 72-year-old male. Body temperature before vaccination was 37.0 degrees centigrade. The patient had no family history. Medical history included multiple system atrophy for 9 years. On 24May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY4834, Expiration date 31Aug2021). On 14Jun2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 (2 days after the vaccination), the patient experienced death due to multiple system atrophy. On 16Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient has been hospitalized and recuperating in the recuperation ward of the reporting hospital. Although the patient heavily required medical care, general condition remained stable. On 24May2021 and 14Jun2021, the patient was vaccinated. On 24May2021 after the vaccination, the patient had no side reaction or adverse reaction. On 14Jun2021 after the vaccination, the condition was not different from usual including symptoms that were considered as side reaction. On 16Jun2021 at 02:30 when round of visits was made, the patient was found in cardio-respiratory arrest. Cardiopulmonary resuscitation (CRP) was performed for 30 minutes; however, the patient was unresponsive and resuscitation was difficult. At 03:05, death was confirmed. Whole body CT was conducted as postmortem imaging but there was no significant finding suggestive of the cause of death. The event was not inconsistent as sudden death caused by autonomic nervous system disorder due to primary disease of multiple system atrophy; thus, it was diagnosed as death due to multiple system atrophy. 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 as follows: It was likely that it was sudden death caused by primary disease of multiple system atrophy. The reporting physician commented as follows: There were no clinical course, pathological condition, or test results that positively suggested causal relationship between the death and the vaccination; thus, it was likely that sudden death was caused by primary disease. However, it was judged that the case reporting was preferable for case series since it was sudden death on day 2 after the vaccination.; Reported Cause(s) of Death: Multiple system atrophy; Autopsy-determined Cause(s) of Death: Multiple system atrophy


VAERS ID: 1488987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic valve incompetence, Body temperature, Cardiac failure chronic, Cardio-respiratory arrest, Cholecystitis acute, Computerised tomogram, Pleural effusion
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Cardiac failure chronic; Dysphagia; Hospitalisation; Inappetence; Old cerebral infarction; Prostate cancer (post-treatment of prostate cancer)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 202106; Test Name: Head and thoracoabdominal CT; Result Unstructured Data: Test Result:finding of bilateral cardiac failure; Comments: finding of bilateral cardiac failure and pleural effusion
CDC Split Type: JPPFIZER INC2021843192

Write-up: cardio-respiratory arrest; Cardiac failure chronic aggravated; pleural effusion; aortic regurgitation (AR); Cholecystitis acute; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117759. The patient was a 91-year and 10-month-old male. Body temperature before vaccination was 36.9 degrees centigrade. Family history was not reported. Medical history included post-treatment of prostate cancer, old cerebral infarction, aortic valve stenosis, cardiac failure chronic, advanced dysphagia, and inappetence. On 24May2021 at 15:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jun2021 (11 days after the vaccination), the patient experienced cardiac failure chronic aggravated. On 04Jun2021 (11 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had been treated at nearby hospital due to old cerebral infarction, aortic valve stenosis, and cardiac failure chronic, etc. Due to advanced dysphagia and inappetence, the patient was hospitalized and investigated at the nearby hospital and it was assessed that the condition was age-related. On 19May2021, the patient was transferred to the reporting hospital for the purpose of palliative and terminal care. On 24May2021, at the request of family member, the patient received the first dose of the vaccine. On 27May2021, the patient developed vomiting and right upper quadrant pain, for which antimicrobial treatment was initiated as cholecystitis acute. Subsequent clinical course was relatively favorable. On 04Jun2021 at 03:00, when round of visits was made by a nurse, the patient had no abnormality in respiratory condition, etc. However, at 06:00, when round of visits was made by a nurse, the patient was found to be in cardio-respiratory arrest. A phone call was made to family member and the situation was explained. At 06:59, death was confirmed. Autopsy imaging (AI) (head and thoracoabdominal CT) was performed. There was finding of bilateral cardiac failure and pleural effusion; thus, it was considered that the patient experienced some kind of cardio-vascular event accompanying aortic regurgitation (AR) and cardiac failure chronic just before the cardio-respiratory arrest. There were no other findings that could identify the cause of death. It was explained to family member and cardiac failure chronic aggravated was described in the certificate. 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 cardiac failure chronic. The reporting physician commented as follows: At first, causality relationship between the event and the vaccine was considered unlikely; however, careful investigation was considered necessary since there were 2 other cases in which the patient who received the same lot number EY4834 experienced sudden death. In this case, the patient died about 16 days after the first vaccination; however other 2 patients died 2 days after the vaccination of the first dose EY4834 and the second dose FA2453.; Reported Cause(s) of Death: cardio-respiratory arrest; aortic regurgitation (AR); pleural effusion; Cardiac failure chronic aggravated; Autopsy-determined Cause(s) of Death: pleural effusion; bilateral cardiac failure; aortic regurgitation (AR)


VAERS ID: 1488988 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood test, Body temperature, Chest X-ray, Dyspnoea, Feeling cold, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Heart disorder (on treatment); Myocardial infarction old; Pulmonary metastases; Thyroid cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Pathological anatomy; Result Unstructured Data: Test Result:operated thyroid cancer, multiple metastases to; Comments: bilateral lungs, left pleural effusion, and myocardial infarction old, and there was no evident thrombus; Test Name: blood test; Result Unstructured Data: Test Result:no changes compared to the previous examination; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Name: chest X-ray; Result Unstructured Data: Test Result:no changes compared to the previous examination
CDC Split Type: JPPFIZER INC2021843211

Write-up: respiratory failure; Feeling cold; Dyspnoea; This is an initial spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117841. The patient was an 89-year and 2-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. The patient had no particular family history. Medical history included heart disorder (on treatment); previously operated thyroid cancer, thyroid cancer, multiple pulmonary metastases, myocardial infarction old. Concomitant medications were not reported. On 30Jun2021 at 09:30 (the day of vaccination, at the age of 89 years old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as the first single dose for COVID-19 immunisation. The patient went home after the vaccination. On 30Jun2021 at around 12:00 (2 hours and 30 minutes after the vaccination), the patient experienced feeling cold and dyspnoea and was therefore transported by ambulance. Results of chest X-ray and blood test (unknown date) showed no changes compared to the previous examination. The respiratory condition stabilized, and the patient was admitted to the hospital (on 30Jun2021) for observation. On 01Jul2021 at 06:41 (1 day after the vaccination), the patient died. Pathological anatomy (autopsy) was performed. Findings revealed heart disorder; included previously operated thyroid cancer, multiple metastases to bilateral lungs, left pleural effusion, and myocardial infarction old, and there was no evident thrombus. A diagnosis of death from respiratory failure (unknown date) due to the underlying diseases was made. The reporting physician classified the event as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible causes of the events such as any other diseases was thyroid cancer, multiple pulmonary metastases, and myocardial infarction old. The reporting physician commented as follows: The respiratory condition was stable at the time of consultation, and based on the findings from pathological anatomy, death due to the underlying diseases was considered. The relation with the vaccination was denied.; Sender''s Comments: Based on information provided, the events are more likely related to underlying diseases but unrelated to BNT162b2 (COMIRNATY).; Reported Cause(s) of Death: Feeling cold; Dyspnoea; Respiratory failure; Autopsy-determined Cause(s) of Death: Heart disorder; previously operated thyroid cancer; multiple metastases to bilateral lungs; left pleural effusion; myocardial infarction old


VAERS ID: 1488989 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Hallucination, auditory, Heart rate, Hyperkinesia, Oxygen saturation, Respiratory arrest, Soliloquy
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Cataract (historical conditions); Chronic respiratory failure; Delirium (historical conditions); Femur fracture; Hypertension (historical conditions); Mycobacterium avium complex infection (historical conditions); Oxygen therapy (historical conditions); Skin cancer (historical conditions); Trochanteric femoral fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: BP; Result Unstructured Data: Test Result:98/48; Comments: after vaccination; Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: after vaccination; Test Date: 20210629; Test Name: P; Result Unstructured Data: Test Result:67; Comments: after vaccination; Test Date: 20210629; Test Name: SpO2; Test Result: 94 %; Comments: after vaccination (O2 2L)
CDC Split Type: JPPFIZER INC2021843233

Write-up: Respiratory arrest; Hyperkinesis; soliloquy; Auditory hallucination; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117817. An 89-year-old female patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Jun2021 16:32 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunization. Medical history included chronic respiratory failure, cardiac failure chronic, Left trochanteric femoral fracture (femur fracture), Hypertension, Cataract, Pulmonary MAC (mycobacterium avium complex infection), Pulmonary MAK (HOT was introduced) (oxygen therapy), Skin cancer (face) and Delirium all from unknown dates. Medical history also included Right femur fracture on 16Jun2021 (The patient was transported by ambulance because of right femur fracture and was on conservative treatment under hospitalization in the reporting hospital). The patient''s concomitant medications were not reported. On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported). The patient experienced respiratory arrest on 30Jun2021 at 06:30, auditory hallucination on 29Jun2021 at 18:00 and hyperkinesis and soliloquy on 30Jun2021. It was reported that on 29Jun2021 at 16:32 (the day of vaccination), the patient received the second vaccination. At 18:00 (1 hour and 28 minutes after the vaccination), the patient experienced auditory hallucination but had no excitement or other symptoms. The body temperature (KT) was 36.8 degrees centigrade, the pulse (P) 67, the blood pressure (BP) 98/48, and the SpO2 94% (with oxygen (O2) 2L). The patient finished all amount of meal. On 30Jun2021 (1 day after the vaccination), hyperkinesis and soliloquy were noted until around 02:00, but the patient was confirmed asleep with breathing at 02:30. Her sleeping was also confirmed at 05:30. At 06:30, respiratory arrest was noted at visit to her room for temperature measurement. The attending physician was called. Her death was confirmed. The patient underwent lab tests and procedures which included BP (blood pressure measurement): 98/48 on 29Jun2021 after vaccination, body temperature: 36.7 centigrade on 29Jun2021 before vaccination and 36.8 centigrade on 29Jun2021 after vaccination, P (heart rate): 67 on 29Jun2021 after vaccination and SpO2 (oxygen saturation): 94 % on 29Jun2021 after vaccination (O2 2L). The patient died on 30Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the event(s) such as any other diseases were chronic respiratory failure and cardiac failure chronic. The reporting physician commented as follows: The causal relationship was unknown.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1488990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Arrhythmia, Body temperature, Cardio-respiratory arrest
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), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Mixed dementia; Renal disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021843276

Write-up: Sudden death (acute coronary syndrome or lethal arrhythmia suspected); Sudden death (acute coronary syndrome or lethal arrhythmia suspected); cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117757. The patient was a 94-year and 5-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not provided. The patient had medical histories of mixed dementia (dementia Alzheimer''s type and cerebrovascular dementia) and mild renal disorder. On 24May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY4834, Expiration date 31Aug2021) for COVID-19 immunization. On 14Jun2021 at 09:55 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jun2021 (2 days after vaccination), the patient had dinner as usual, and went to sleep at 19:00. At 21:00, the patient was found to have cardio-respiratory arrest. On 16Jun2021 at 21:29 (2 days after the vaccination), the patient experienced sudden death (acute coronary syndrome or lethal arrhythmia suspected). On 16Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 24May2021, the patient received the first dose of BNT162b2 vaccination. No abnormalities were observed. On 14Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 16Jun2021 (2 days after vaccination), the patient had dinner as usual, and went to sleep at 19:00. At 21:00, the patient was found to have cardio-respiratory arrest. The patient had a calm expression, and he died in his sleep without postural imbalance. According to the situation, cardiovascular event was strongly suspected. On 16Jun2021, at 22:47 (2 days after vaccination), the patient was diagnosed with death. Since the patient had already died, no examination which led to the diagnosis was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported about other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient suddenly died 2 days after the vaccination. According to the situation, the event was considered as cardiovascular event; however, the causality between the event and the vaccination was required to be considered.; Reported Cause(s) of Death: cardio-respiratory arrest; acute coronary syndrome suspected; lethal arrhythmia suspected


VAERS ID: 1488991 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021843279

Write-up: Suicide; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21118263. The patient was a 90-year and 8-month-old male. Body temperature on 22Jun2021 before vaccination was 36.6 degrees centigrade. The family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 22Jun2021 at 13:12 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number FA2453, expiration date 31Aug2021), at the age of 90-years-old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Jun2021 (3 days, 10 hours, 48 minutes after the vaccination), the patient experienced suicide. On 26Jun2021 (4 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: No side reactions were observed after the vaccination. 4 days later, the patient had suicide. The cause of the death was unknown. The causality between the event and the vaccination was not clear (but causality was checked as unrelated). Since the event occurred 4 days after the vaccination, this case was reported just in case. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162B2. Other possible cause of the event such as any other diseases was as follows: The patient lived with his wife. The wife had difficulty in walking, and she was managed with home medical care. Since the wife was unable to go to the vaccination site, she was to receive vaccination at home, and the husband (the patient) also decided to receive the vaccination at home. Immediately after the vaccination, no abnormalities were observed. The family contacted that the patient had suicide on 26Jun2021 (3 days, 10 hours, and 48 minutes after vaccination). The patient was willing to care for his wife, and he aggressively offered vaccination at home repeatedly. On the other hand, the patient had a trouble on the internet, and he consulted with his care manager. The reporting physician commented as follows: The causality between the suicide and the vaccination was unknown. On the other hand, considering that there was no speech and behavior implying suicide before, and that the suicide occurred on Day 4 after the vaccination, something like psychological symptoms could not be ruled out, and thus, this case was reported.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event . 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: Suicide


VAERS ID: 1488992 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: EUGLUCON; GLACTIV; AMLODINE [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021843290

Write-up: Suicide; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 78-year-old male. The patient had medical histories of diabetes mellitus and hypertension. The concomitant medications included oral glibenclamide (EUGLUCON Tablet) at 1.25 mg daily, oral sitagliptin phosphate hydrate (GLACTIV Tablet) at 50 mg daily, and oral amlodipine besilate (AMLODIN Tablet) at 5 mg daily. Historical vaccine included first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On 03Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On 05Jul2021 (2 days after the vaccination), the patient experienced suicide. On 05Jul2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 05Jul2021 (2 days after vaccination), the patient experienced suicide. The causality between the event and BNT162b2 vaccination was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Suicide


VAERS ID: 1488993 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood glucose, Body temperature, Cardio-respiratory arrest, Cyanosis, Diarrhoea, Loss of consciousness, Nausea, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 3
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: 20210704; Test Name: BS; Test Result: 381 mg/dl; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021843298

Write-up: Cardio-respiratory arrest; ventricular fibrillation; since it was found neither consciousness nor respiration was noted; cyanosis; diarrhoea; queasy; debility; This is a spontaneous report from a contactable physician received from the Health Agency (HA). Regulatory authority report number is v21117785. The patient was a 76-year and 6-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not provided. On 09Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jun2021 at 14:30 (at the age of 76-years-old as reported) (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5423, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jul2021 (1 day after the vaccination), the patient experienced diarrhoea and queasy. On 04Jul2021 (4 day after the vaccination), the patient died, and the outcome of the event was reported fatal. It was not reported if an autopsy was performed. The course of the events was as follows: On 01Jul2021 (1 day after the vaccination), diarrhoea and queasy were noted. The patient was getting debility. On 04Jul2021, the patient was still able to have a conversation. He had lunch but suddenly he stopped talking and developed cyanosis on his face. Therefore, an emergency service was requested and following their instruction, his consciousness and respiratory status were confirmed and since it was found neither consciousness nor respiration was noted, the patient''s son performed chest compression. At 16:51, 119 was dialed for a requesting ambulance. At 17:02, while the patient was being treated, he developed cardio-respiratory arrest. Since ventricular fibrillation was confirmed, DC (direct current) shock was performed once. Thereafter, it became to pulseless electrical activity (PEA). IV route was secured, and epinephrine was administered 8 times in total. After matters in the mouth were removed, a laryngeal tube was inserted, and the patient''s ventilatory status became favorable. In the ambulance, blood sugar was 381 mg/dL. At 17:58, upon arrival at the hospital, he developed cardiac arrest. Monitor indicated PEA (pulseless electrical activity) led to asystole. ACLS (advanced cardiovascular life support) was attempted. However, he did not respond to it. At 18:12, the patient''s death was confirmed. It was unknown if an autopsy was performed. Outcome of the other events was unknown (except for cardio-respiratory arrest - outcome was fatal). This was considered an adverse reaction after the vaccination, a post-mortem certificate was not issued at the reporter''s hospital, and this case was handed over to police. The causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were none. The reporting physician commented as follows: The causal relationship with BNT162b2 was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1488994 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood test, Cerebellar infarction, Magnetic resonance imaging, Muscle rigidity
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 1
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: LANSOPRAZOLE; TERAMURO; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]; CLOPIDOGREL; EQUMET; MOSAPRIDE [MOSAPRIDE CITRATE]; MITIGLINIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Blood test; Result Unstructured Data: Test Result:extensive cerebellar infarction; Test Date: 20210704; Test Name: MRI; Result Unstructured Data: Test Result:extensive cerebellar infarction
CDC Split Type: JPPFIZER INC2021843304

Write-up: Cerebellar infarction; Limb rigidity; consciousness disturbed; This is a spontaneous report from a contactable pharmacist received from a regulatory authority. Regulatory authority report number is v21117760. The patient was an 85-year and 1-month-old male. Body temperature before vaccination was not reported. Medical history included diabetes mellitus, cerebral infarction and hypertension. Family history was not provided. Concomitant medications orally taken included lansoprazole (LANSOPRAZOLE), amlodipine besilate/telmisartan (TERAMURO), tamsulosin hydrochloride (TAMSULOSIN), clopidogrel (CLOPIDOGREL), metformin hydrochloride/vildagliptin (EQUMET), mosapride citrate (MOSAPRIDE) and mitiglinide (MITIGLINIDE). On an unspecified date, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jul2021 in the morning (the day of vaccination, exact time not provided), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) an unspecified route of administration as a single dose, DOSE 2, SINGLE for COVID-19 immunization. On 04Jul2021 at 15:00 (the day of vaccination), the patient experienced cerebellar infarction. On 04Jul2021, the patient was hospitalized. On 05Jul2021 (1 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 04Jul2021 (the day of vaccination), since the patient''s wife found that the patient groaned and he was in the twilight state, so she called an ambulance. Limb rigidity and consciousness disturbed were noted. Blood test and MRI (magnetic resonance imaging) were performed and the results showed the presence of extensive cerebellar infarction. For the treatment, IV drip of HEPARIN and EDARAVONE was administered. The reporting pharmacist classified the event as serious (life-threatening) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases. ; Reported Cause(s) of Death: Cerebellar infarction


VAERS ID: 1488995 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-28
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Circulatory collapse, Electrocardiogram, Myocardial infarction, Pericardial effusion, Pulmonary oedema, Rib fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Diabetes mellitus; Old cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: Before vaccination; Test Date: 20210628; Test Name: electrocardiogram; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC2021843312

Write-up: pericardial effusion; pulmonary oedema; Rib fracture; Myocardial infarction; collapsed; asystole; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21117818. The patient was an 85-year and 7-month-old male. Body temperature before vaccination was 35.4 degrees Centigrade. Medical history included old cerebral infarction, diabetes mellitus and chronic kidney disease. Concomitant medications and family history were not provided. On 25Jun2021 (at the age of 85 years old) at around 10:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 28Jun2021 at around 17:30 (3 days after the vaccination), the patient experienced myocardial infarction. At 18:35, the patient died. AI (autopsy imaging) was performed but the cause of death could not be specified. The course of the events was as follows: On 28Jun2021, during daytime, the patient was spending his time as usual. At around 17:00, his wife saw him sitting on the legless chair and heard his voice. She took her eyes from him for a while. At around 17:30, she could not hear his voice and found him collapsed. There was no response when spoken to and he did not respond to pain stimulation, either. Therefore, an emergency service was requested, and he was transferred to the reporter''s hospital. At 18:19, the ambulance arrived at the hospital. On arrival, electrocardiogram indicated asystole. CRP (cardio pulmonary resuscitation) was continuously performed. Adrenaline was administered twice. However, ROSC (return of spontaneous circulation) did not occur. On 28Jun2021 at 18:35, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Myocardial infarction was considered as a possible cause. The reporting physician commented as follows: The cause of death could not be identified from the result of AI. Rib fracture, pericardial effusion and pulmonary oedema caused by LUCAS device (chest compression device) was noted, but there was no other traumatic injury. The outcome of the event myocardial infarction was fatal while the outcome of all other events was unknown.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1488996 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Renal failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Function kidney decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021843339

Write-up: Cardio-respiratory arrest; Renal insufficiency; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report numbers were v21118266 and v21118282. The patient was a 91-year and 5-month-old female. Body temperature on 30Jun2021 before vaccination was 36.4 degrees centigrade. The family history was not provided. The patient had medical history of hypertension, for which she was orally taking an antihypertensive drug. Other relevant medical history included function kidney decreased chronic. On unknown date in 2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, lot number and expiration date were unknown). On 30Jun2021 at 09:30 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number FC5295, expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jul2021 (1 day after the vaccination), the patient experienced cardio-respiratory arrest and renal insufficiency. On 01Jul2021 (1 day after the vaccination), the outcome of the events was fatal. The patient died due to cardio-respiratory arrest. It was unknown if an autopsy was performed. The course of the event was as follows: Approximately 36 hours after the vaccination, the patient was found to have cardio-respiratory arrest by her family member. The reporting physician did not perform physical examination. 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 renal insufficiency. The reporting physician commented as follows: Although the causality between the event and BNT162B2 vaccination was unknown, the event occurred 1 day after the vaccination, and thus, this case was reported as a vaccinator.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1489019 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021844391

Write-up: Found dead; This is a spontaneous report from a non-contactable pharmacist received via the Agency. The patient was an adult male. The patient''s medical history and concomitant medications were not reported. It was unknown whether the patient was not diagnosed with COVID-19 prior to vaccination. It was also unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY) Solution for injection (batch/lot number: FC5947 and expiration date: 30Sep2021) via intramuscular route of administration as DOSE 1, SINGLE for COVID-19 immunization. On unknown date in Jul2021 and after 5 days from the vaccination, the patient was found dead at warehouse of a company. It was unknown if an autopsy was performed. The reporting pharmacist classified the event as serious per fatal outcome. It was unknown whether the patient has not been tested for COVID-19 since the vaccination.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the event "death" and the suspect drug BNT162B2 cannot be excluded. 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: 1489034 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: JPPFIZER INC2021846718

Write-up: vaccination site pain; suspected acute cardiac death; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117855. The patient was a 92-year and 6-month-old male. Body temperature before vaccination was not performed. It was unknown if the patient had medical history or if he was receiving concomitant medications. On 02Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jun2021 (the day of vaccination) (at the age of 92 years old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) an unspecified route of administration as dose 2, single for COVID-19 immunization. On 05Jul2021 at around 06:00 am (12 days after the vaccination) also reported as 08:40 am, the patient experienced cardio-respiratory arrest and died. The course of the events was as follows: On 02Jun2021 and 23Jun2021, the patient received BNT162b2 at the same hospital. After the vaccination on an unspecified date, there were no marked problems other than vaccination site pain. On 05Jul2021 at around 08:40 in the morning, the patient was found in a state of cardio-respiratory arrest by his family. Although they called 119, it was deemed as social death, and so he was not transferred to a hospital. Postmortem examination was performed as abnormal death. Based on the postmortem examination, acute cardiac death was suspected. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event such as any other diseases. The reporting physician commented as follows: The reporter was in charge of the postmortem examination. The reporter had not met the patient while he was alive. The vaccination he received was BNT162b2, and any further information beyond this was uncertain.; Reported Cause(s) of Death: Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: suspected acute cardiac death


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