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

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



Case Details

This is page 135 out of 172

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VAERS ID: 1449928 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-05-01
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       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: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a nurse and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in a 32-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) to be unlikely related. No concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 was not applicable Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information (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 (translation) is expected; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1449945 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-05-12
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMIODARONE; ATORVASTATIN; COVERSUM; DUODART; ELIQUIS; PANTOPRAZOLO; SPASMO URGENIN; SYMBICORT; DUPHALAC [LACTULOSE]; MYSOLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Cirrhosis of liver; Orthostatic hypotension; Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Vaccination failure; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 and VACCINATION FAILURE (Vaccination failure) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EK9788) for COVID-19 vaccination. No medical history was reported. The patient''s past medical history included Orthostatic hypotension, Abdominal aortic aneurysm and Cirrhosis of liver. Concomitant products included PERINDOPRIL ERBUMINE (COVERSUM) for COVID-19 vaccination, AMIODARONE, ATORVASTATIN, DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE (DUODART), APIXABAN (ELIQUIS), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLO), ECHINACEA ANGUSTIFOLIA ROOT, SERENOA REPENS FRUIT, TROSPIUM CHLORIDE (SPASMO URGENIN), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LACTULOSE (DUPHALAC [LACTULOSE]) and PRIMIDONE (MYSOLIN) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced COVID-19 (seriousness criterion death). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). The patient died on 12-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 to be unlikely related and VACCINATION FAILURE (Vaccination failure) to have an unknown relationship. Treatment information was not provided. This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.; Sender''s Comments: "This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable"; Reported Cause(s) of Death: Unknown Cause of Death


VAERS ID: 1450762 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753058

Write-up: Unknown cause of death; Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the WEB, Safety Report Unique Identifier DE-PEI-202100102710. A 54-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Jun2021 at the age of 54 years old, as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 12Jun2021 the patient experienced Sudden cardiac death, Unknown cause of death. The patient died on 12Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) was D. Unclassifiable. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Sudden cardiac death


VAERS ID: 1450766 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753042

Write-up: Thrombosis; Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-PEI-202100102728. A 70-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY2172, 0.3 ml), via an unspecified route of administration on 05May2021 at the age of 70-year-old as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced thrombosis, lung embolism on 13May2021. The outcome of event was fatal. The patient died on 15May2021. An autopsy was performed, and results were not provided. This report is serious per death. Relatedness of drug to reaction(s)/event (s) ALL: Source of assessment PEI; Result of Assessment D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Thrombosis; Lung embolism


VAERS ID: 1450773 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 16
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; Depression; Ex-alcoholic; Lumbar spine degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753141

Write-up: Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-PEI-202100104159. A 70-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Strength: 0.3 ml), dose 2 via an unspecified route of administration at the age of 70-year-old on 19May2021 (Batch/Lot number was not reported) as 0.3 ml single for COVID-19 immunisation. Medical history included Lumbar spine degeneration, Arterial hypertension, Ex-alcoholic, Depression. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY) at the age of 70-year-old on 07Arp2021 for COVID-19 immunisation and no adverse event. On 19May2021 the patient experienced Pulmonary embolus. The patient''s outcome was fatal for Pulmonary embolus. This report is serious - death. The patient died on 04Jun2021. It was not reported if an autopsy was performed. The outcome of event was fatal. Relatedness of drug to reaction(s)/event(s) was Unclassifiable by PEI. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1450774 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-06
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: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac insufficiency; Cardiac pacemaker insertion; Coronary disease; Diabetes; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753149

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-PEI-202100104161. A 74-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Strength: 0.3 ml), dose 2 via an unspecified route of administration at the age of 74-year-old on 14May2021 (Batch/Lot number was not reported) as 0.3 ml single for COVID-19 immunisation. Medical history included Infarct myocardial, Arterial hypertension, Diabetes, Cardiac insufficiency, Cardiac pacemaker insertion, Coronary disease. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY) at the age of 74-year-old on 06Apr2021 for COVID-19 immunization and no adverse event. The patient experienced unknown cause of death in 2021. The clinical course was reported as follows: The patient experienced also Unknown cause of death. The patient''s outcome was: fatal for Unknown cause of death. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. PEI / B. Indeterminate. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1450785 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021753167

Write-up: first dose of bnt162b2 (COMIRNATY) on 05Mar2021 /second dose of bnt162b2 (COMIRNAT) on 07Jun2021; Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the WEB, Safety Report Unique Identifier DE-PEI-202100104278. A 50-years-old male patient received second dose of bnt162b2 (COMIRNATY strength 0.3ml), at the age of 50-years-old via an unspecified route of administration on 07Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) at the age of 50-years-old on 05Mar2021 for covid-19 immunisation. The patient experienced sudden death unexplained on 15Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) 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: 1452032 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumothorax, Pseudomonas infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210701672

Write-up: PNEUMOTHORAX; INFECTION PSEUDOMONAS AERUGINOSA; COVID-19; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-922572] concerned a 70 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-APR-2021 for covid-19 vaccination. The drug start period and drug last period were 7 days each. No concomitant medications were reported. On 06-MAY-2021, the patient experienced pneumothorax, infection pseudomonas aeruginosa and covid-19. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of pneumothorax, infection pseudomonas aeruginosa and covid-19 on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210656896-covid-19 vaccine ad26.cov2.s - Pneumothorax, infection pseudomonas aeruginosa and covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1452864 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coronary artery thrombosis, Death, Ischaemic cardiomyopathy
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: LIPITOR
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: thrombosis in anterior descending branch of the left coronary artery; Death; Ischemic cardiomyopathy; This regulatory authority case was reported by a consumer and describes the occurrence of CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery), DEATH (Death) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 25-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced CORONARY ARTERY THROMBOSIS (thrombosis in anterior descending branch of the left coronary artery) (seriousness criteria death and medically significant), DEATH (Death) (seriousness criteria death and medically significant) and ISCHAEMIC CARDIOMYOPATHY (Ischemic cardiomyopathy) (seriousness criteria death and medically significant). The patient died on 05-Jun-2021. The reported cause of death was atherosclerotic coronary lesions. An autopsy was performed, but no results were provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: atherosclerotic coronary lesions


VAERS ID: 1452956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / 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: 2021-06-14
   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: ITPFIZER INC2021752997

Write-up: sudden death; This is a spontaneous report received from a contactable pharmacist downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-743511. A 50-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 30May2021 14:58 (Lot Number: FC1131) as DOSE 1, 0.3 mL, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sudden death on 14Jun2021. The patient died on 14Jun2021. Outcome of the event was fatal. Reporter''s comment: This will be followed by additional information requested from 118. The results of the autopsy report will be entered as soon as available: inserted on 15Jun2021. No follow-up attempts possible. No further information expected.; Reporter''s Comments: This will be followed by additional information requested. The results of the autopsy report will be entered as soon as available. Medical Report: inserted on 15Jun2021.; Reported Cause(s) of Death: sudden death


VAERS ID: 1452992 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IPERTEN
Current Illness: Chronic anemia
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021753089

Write-up: Anticovid vaccination carried out at 4.00 pm on 12Jun2021 with Pfizer batch FC1526 vaccine. Death of the patient at 04.00 on 13Jun2021.; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-744134. A 95-year-old male patient received BNT162B2 (COMIRNATY), first dose, intramuscularly, administered in arm right (right shoulder) on 12Jun2021 16:00 (batch/Lot Number: FC1526; Expiration Date: 30Sep2021) as 0.3 ml single dose for covid-19 immunisation. Medical history included hypertension, ongoing chronic anemia, Alzheimer''s disease. Concomitant medication included manidipine hydrochloride (IPERTEN). The patient had anticovid vaccination carried out at 4.00 pm on 12Jun2021 with Pfizer batch FC1526 vaccine. Death of the patient at 04.00 on 13Jun2021. The patient was vaccinated by his GP. He was accompanied by his daughter and caregiver (he had Alzheimer''s). He waited a quarter of an hour, he was fine and was taken home. He dined regularly and when he went to sleep was fine. The caregiver found him dead in the night. Time of death 04.10 in the morning 13Jun2021. The patient died on 13Jun2021. No autopsy. Reporter''s comment: Patient death 12 hours after receiving anti-covid vaccination with Pfizer vaccine No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Patient death 12 hours after receiving anti-covid vaccination with Pfizer vaccine; Reported Cause(s) of Death: sudden death unexplained


VAERS ID: 1453036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified (heart problems)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021758982

Write-up: Ischemic stroke; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-745485. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left (left shoulder) on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing Heart disease, unspecified (heart problems). The patient''s concomitant medications were not reported. On 01May2021, the patient experienced ischemic stroke. The reporter reported an ischemic stroke with death at 41 days in a patient with heart problems, after the second dose of Pfizer vaccine. The patient had Thrombectomy, received antibiotic therapy, oxygen, pharmacological therapy for the specific case. Impact on quality of life (10/10). The patient died on an unspecified date. It was unknown if an autopsy was performed. Sender''s comments: 17Jun2021 - Suspected medical substance''s Lot is required, concomitant therapies. Regional Center 18Jun2021 Updated clinical history field, concomitant diseases and therapies and clinical report are required. Reporter comment: heart problems No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1453044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MODURETIC; LOSARTAN; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021759105

Write-up: REPORTED SINCE 118 DEATH FROM NATURAL CAUSES; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number IT-MINISAL02-746217. A 56-year-old male patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number FC5435; expiration date: 30sep2021) via intramuscular, administered in left arm on 11Jun2021 10:45 as dose 1, single for COVID-19 immunization. Medical history included hypertension (from an unknown date and unknown if ongoing) Concomitant medication included amiloride hydrochloride, hydrochlorothiazide (MODURETIC) taken for hypertension; losartan taken for hypertension,; pantoprazole taken for gastrooesophageal reflux disease, start and stop date were not reported for all. it was reported since 118 death from natural causes on 15Jun2021.The patient died on 15Jun2021.It was not reported if an autopsy was performed. The outcome of event was fatal. Reporter''s comments: Patient with hypertension. Heard from the general practitioner who reported that he had not been contacted by the patient following vaccination to report any occurrence of reactions. No follow-up attempts possible. No further information expected; Reporter''s Comments: patient with hypertension. Heard from from the general practitioner who reported that he had not been contacted by the patient following vaccination to report any occurrence of reactions.; Reported Cause(s) of Death: Death from natural causes


VAERS ID: 1453045 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 LA / OT

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: 2021-04-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; CARDIOASPIRIN; GLYCERYL TRINITRATE; DIGOXIN; DEXAMETHASONE; MONOCINQUE; PEMBROLIZUMAB; COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction; Bladder neoplasm; Carcinoma lung
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021759059

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-746245. A 75-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EX0893, expiration date: 31Jul2021), dose 2 intramuscular, administered in left arm on 17Apr2021 10:55, as 0.3 ml single dose for COVID-19 immunisation. Medical history included acute myocardial infarction from 01Jan1975, carcinoma and bladder neoplasm. Concomitant medications included lansoprazole; acetylsalicylic acid (CARDIOASPIRIN); glyceryl trinitrate; digoxin; dexamethasone; isosorbide mononitrate (MONOCINQUE); pembrolizumab; colecalciferol. All concomitant medications were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: ER9470, expiration date: not reported), administered on 27Mar2021, as single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced acute myocardial infarction. The patient admitted after 118 emergency department intervention for AMI (acute myocardial infarction), he was transferred to geriatric palliative care where he died on 19Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the fatal events acute myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1453068 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   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: LANSOX; CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Failure respiratory; Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Name: Desaturation; Result Unstructured Data: <85%
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No medical history was provided by the reporter. The patient''s past medical history included Failure respiratory. Concomitant products included LANSOPRAZOLE (LANSOX) and BISOPROLOL FUMARATE (CONGESCOR) for an unknown indication. On 19-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced CONDITION AGGRAVATED(seriousness criterion death). The patient died on 19-Jun-2021. The reported cause of death was Aggravation of existing disorder. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation decreased: <85% (abnormal) <85%. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported. Very limited information regarding this patient''s death has been provided at this time.; Reporter''s Comments: Lansox 30 mg Congescor 2.5 Lasix 25; Sender''s Comments: Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Aggravation of existing disorder


VAERS ID: 1453119 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest X-ray, Dehydration, Oxygen saturation, Sudden death, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness: Atrial fibrillation; Dilated cardiomyopathy; Heart disease, unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:Slight fever, 37 or lower Centigrade; Comments: After vaccination; Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Test Date: 20210618; Test Name: Chest X-ray; Result Unstructured Data: Test Result:enlarged but no pulmonary congestion; Comments: showed enlarged heart, pulmonary congestion was not observed; Test Date: 20210618; Test Name: SpO2; Test Result: 76 %; Test Date: 20210618; Test Name: urinalysis; Result Unstructured Data: Test Result:dehydration
CDC Split Type: JPPFIZER INC2021739601

Write-up: Sudden death; Dehydration; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory Authority report number: v21115234). The patient was a 65-year and 6-month-old male. The patient''s body temperature before vaccination was not provided. The family history was not provided. The patient had medical histories of ongoing cardiac diseases (dilated cardiomyopathy and atrial fibrillation), for which he was orally taking warfarin. The patient was allowed to receive the vaccination by his attending physician. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies based on the pre-vaccination screening questionnaire. On 11Jun2021 at 16:55 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA7338, Expiration date: 30Sep2021) intramuscular on the right arm as a single dose for COVID-19 immunization. On 19Jun2021 (8 days after the vaccination), the patient experienced sudden death. On 19Jun2021 (8 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had underlying cardiac diseases such as dilated cardiomyopathy and atrial fibrillation. On 11Jun2021 (the day of vaccination), at 16:55, after the vaccination, the patient had slight fever of 37 degrees Celsius or lower and inappetence persisted. On 15Jun2021 (3 days, 7 hours, and 5 minutes after vaccination), the patient had shortness of breath on walking. The patient visited the reporting hospital for a drip infusion. At the hospital visit, the body temperature was 36.9 degrees Celsius and the SpO2 was 76%. The patient had cold feeling of fingers, and he reported that it was usual level. The urinary specific gravity was 1.025, and the body temperature decreased by 1 to 2 kg. Although chest X-ray showed enlarged heart, pulmonary congestion was not observed. Based on the above symptoms, the patient was judged to have dehydration in Jun2021, and a drip infusion was performed. After the drip infusion, the patient felt better, and he went home. On 19Jun2021 (7 days, 7 hours, and 5 minutes after vaccination), before dawn, on the following day, the patient died. The outcome of the event, dehydration, was recovering. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 was not provided. Other possible causes of the event such as any other diseases were dilated cardiomyopathy and atrial fibrillation. The reporting physician commented as follows: Since the patient had dilated cardiomyopathy as an underling disease, the causality between the event and BNT162b2 vaccination was unknown. The patient was visiting another hospital regularly for the underlying diseases. The events had resulted into a physician''s office visit. Additional clinical course was as follows: The patient was regularly visiting a different hospital from the reporting physician for the treatment of underlying diseases, atrial fibrillation and dilated cardiomyopathy. On 18Jun2021, the patient visited the reporter''s hospital with a complaint that had a low fever, could not eat well, and felt short of breath when walking for a couple of days. Considering decreased weight and the results of X-ray and urinalysis, the symptom was determined to be dehydration instead of cardiac failure, drip infusion was performed taking more than twice as much time as usual. On 19Jun2021 in the morning, the patient''s son found the patient dead. The event, ''sudden death'', had resulted in death and physician''s office/clinic visit. An autopsy was not performed.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1453121 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Computerised tomogram, Drug screen, Myocardial ischaemia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Other ischaemic heart disease (narrow), 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: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUVIA [SITAGLIPTIN PHOSPHATE]; METGLUCO; THYRADIN S
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Diabetic nephropathy; Thyroiditis chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: Post mortem; Result Unstructured Data: Test Result:No marked change was noted in the palpebra; Comments: and the mucous membrane of mouth. Pupil: left and right are symmetrical, perfect circle, 5 mm in diameter. There was no petechia. Postmortem lividity: (illegible). Rigor mortis: strong. (at 12:00) Simple urine drug screening showed negative; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210619; Test Name: Rectal temperature; Result Unstructured Data: Test Result:33 Centigrade; Comments: degrees; Test Date: 20210619; Test Name: Postmortem CT; Result Unstructured Data: Test Result:status after the cardiopulmonary resuscitation; Comments: No abnormalities were noted in the bones. Calcification in the great arteries and the left and right coronary arteries and mild swelling in the pulmonary arteries were noted. Diffuse pulmonary congestion was present; Test Date: 20210619; Test Name: Simple urine drug screening; Test Result: Negative ; Comments: (post mortem examination at 12:00)
CDC Split Type: JPPFIZER INC2021739764

Write-up: ischaemic cardiac failure; possibility of pyrexia/Rectal temperature was 33 degrees Centigrade; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This is report was also received from Regulatory Authority. Regulatory authority report number v21115367 and v21115383. The patient was a 71-year and 1-month-old female. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included diabetes mellitus, thyroiditis chronic and early stage of diabetic nephropathy. The patient had no specific family history. Concomitant medications included sitagliptin phosphate (JANUVIA); metformin hydrochloride (METGLUCO); and levothyroxine sodium (THYRADIN S) all taken for unspecified indications and therapy dates. On 18Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY3860, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 at 15:15 (15 minutes after the vaccination), no anaphylaxis was noted and so the patient returned home. Afterwards, the patient had dinner and took a bath without any problems. At 21:00, his family member went to bed, but the patient was watching TV by himself. At around 23:00, the family member noticed that he went to bathroom. On 19Jun2021 at 07:00, his family member went to his bedroom to wake him up and found that the patient was dead in a supine position by the bed. Although they called an ambulance, he was not transferred to a hospital. They reported to police and a post-mortem inspection was performed. This case was not considered to be an incident. On 18 or 19Jun2021 (on the day of vaccination or 1 day after the vaccination), the unspecified event developed. The patient died on 19Jun2021 at around 01:00. On 19June2021 at 12:00, a post-mortem inspection was done. There was no external action. No marked change was noted in the palpebra and the mucous membrane of mouth. Pupil: left and right are symmetrical, perfect circle, 5 mm in diameter. There was no petechia. Postmortem lividity: (illegible). Rigor mortis: strong. Simple urine drug screening showed negative. Postmortem CT indicated the status after the cardiopulmonary resuscitation. No abnormalities were noted in the bones. Calcification in the great arteries and the left and right coronary arteries and mild swelling in the pulmonary arteries were noted. Diffuse pulmonary congestion was present. Rectal temperature was 33 degrees Centigrade (unspecified [illegible] measurement). Judging from those facts, the cause death was due to ischemic cardiac failure. Outcome of the event of pyrexia was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Diabetes mellitus was a possible cause of the event. The reporting physician commented as follows: As rectal temperature was relatively high, the possibility of pyrexia could not be denied. However, given his medical history and the findings from the CT scan, it was reasonable to consider that his underlying disease contributed to the occurrence of the event. Other possible cause of the event such as any other diseases was diabetes mellitus.; Sender''s Comments: The reported event of ischemic heart disease is unrelated with BNT162B2 use. The patient''s underlying DM is likely contributory to the development of the event.; Reported Cause(s) of Death: ischaemic cardiac failure; Autopsy-determined Cause(s) of Death: ischaemic cardiac failure


VAERS ID: 1453265 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Vaccination site pain
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

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: AMLODIPINE; OLMETEC; PRAVASTATIN
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021785449

Write-up: localized pain; Cardiac failure acute; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116434. The patient was a 76-year and 11-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included transient ischaemic attack (on 19Jan2012, the patient was transferred to a hospital on emergency and [illegible] examination performed at the hospital showed no abnormalities and she was discharged from the hospital) and ongoing hypertension. Prescribed concomitant medications for the treatment of hypertension included amlodipine (AMLODIPINE)1 tablet, olmesartan medoxomil (OLMETEC) 1 tablet, pravastatin (PRAVASTATIN) and two other medications (illegible). Family history was not provided. On 08Jun2021 at around 11:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at around 09:00 (16 days after the vaccination), the patient experienced cardiac failure acute and died. An autopsy was performed and the cause of death confirmed by autopsy was cardiac failure acute. The course of the events was as follows: Two days after the patient received the vaccination on 08Jun2021, localized pain improved. On 24Jun2021 at around noon, when the patient''s husband returned home, he found the patient collapsed in the living room. An autopsy was performed by police and the cause of death was determined to be cardiac failure acute. 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. The reporting physician commented as follows: The causal relationship with BNT162b2 was uncertain.; Reported Cause(s) of Death: Cardiac failure acute; Autopsy-determined Cause(s) of Death: Cardiac failure acute


VAERS ID: 1453365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-12
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Gastrointestinal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210701085

Write-up: GASTRIC PROBLEMS MOST LIKELY, BLEEDING; GASTRIC PAIN AFTER JANSSEN VACCINATION; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00594383] concerned a 53-year-old male of unknown race and ethnicity. The patient''s weight was 85 kilograms, and 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 admin, and batch number were not reported, Expiry: Unknown) 1 dosage forms (0.5 ml), 1 total, administered on 02-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-JUN-2021, the subject experienced gastric pain after janssen vaccination. On 24-JUN-2021, the subject experienced gastric problems most likely, bleeding. On 24-JUN-2021, the subject died from gastric pain after janssen vaccination, and gastrointestinal bleeding. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of gastric problems most likely, bleeding and gastric pain after janssen vaccination on 24-JUN-2021. This report was serious (Death).; Sender''s Comments: V0- 20210701085 - Covid-19 vaccine ad26.cov2.s- gastric problems most likely, bleeding and gastric pain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: GASTRIC PAIN AFTER JANSSEN VACCINATION; GASTROINTESTINAL BLEEDING


VAERS ID: 1453425 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2699 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: Prostatic hypertrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021753064

Write-up: A 71-year-old patient died 13 days after receiving 2nd dose of the Pfizer vaccine.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PL-URPL-3-729-2021. A 71 years old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left at age of 70 years on 05Mar2021 13:50 (Lot Number: ER2699) as single dose for covid-19 immunisation. Medical history included free of any disease, except for prostatic hypertrophy. Concomitant medications included sleeping pills. The patient previously took bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left at age of 70 years on 12Feb2021 at 13:49 (lot number: ER0641) for COVID-19 immunisation. The patient died after receiving 2nd dose of the pfizer vaccine (sudden death) on 18Mar2021 13:45. The reporting person assessed the side effects as severe. The Regulatory Authority also classified the report as severe (death). The patient died on 18Mar2021. It was not reported if an autopsy was performed. Sender comment: Death 13 days after the 2nd dose and more than one month after the 1st dose is an unexpected side effect of Comirnaty. Due to the questionable time relationship between the administration of the 1st dose and the response, the causal relationship was assessed as unlikely. There is a time relationship between the second dose of the vaccine and the occurrence of complications. Due to the insufficient amount of information, a cause-and-effect relationship cannot be assessed. The reporting person assessed the side effects as severe. The Regulatory Authority also classified the report as severe (death). The Regulatory Authority expert assessed the casual relationship between Comirnaty and the reported event as Unassessable/Unclassifiable using WHO system for standardised case causality assessment. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: A 71-year-old patient died 13 days after receiving 2nd dose of the Pfizer vaccine.


VAERS ID: 1453426 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 2 LA / 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: 2021-05-23
   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: Cardiac disorder; Cataracts; Liver disorder (Also treated for liver disease.); Surgery (In March this year he underwent (without complications) eye surgery due to cataracts.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021753031

Write-up: Sudden cardiac arrest and death of the patient, despite resuscitation by a specialist ambulance team.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PL-URPL-3-733-2021. The report PL-URPL-3-733-2021 was sent to the database on 02Jun2021. A 66-year-old male patient received BNT162B2 (COMIRNATY) dose 2 intramuscular, administered in arm left on 15May2021 11:53 (Lot Number: FA5715) as dose 2, single for covid-19 immunisation. Medical history included cardiological load was waiting for the heart valves replacement surgery. In Mar2021 he underwent (without complications) eye surgery due to cataracts. Also treated for liver disease. The patient''s concomitant medications were not reported. On 23May2021 at 18:00 post-vaccination reaction occurred. Description of the reaction: Sudden cardiac arrest and death of the patient, despite resuscitation by a specialist ambulance team. The reporting person assessed the side effects as severe. The outcome of event was fatal. The patient died on 23May2021. It was unknown if autopsy has been done. Sender''s comment: Sudden cardiac arrest that occurred 8 days after vaccination is an unexpected side effect of Comirnaty. The report concerns a patient with underlying diseases that are more likely to have contributed to the symptoms than the vaccine. Relatedness of Comirnaty to reaction was assessed as unlikely. The reporting person assessed the side effects as severe. The Regulatory Authority also classified the report as severe (death). Relatedness of drug to reaction(s)/event(s): Cardiac arrest; Source of assessment: Regulatory Authority expert; Method of assessment: WHO- system for standardised case causality assessment; Result of Assessment: Unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1453557 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC2021718548

Write-up: heart attack; The initial case was missing the following minimum criteria: unspecified number of patient. Upon receipt of follow-up information on [26Jun2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP. This is a report based on information received by Pfizer from Llp-Biontech Se 65280, 65333, license party for BNT162b2. The other HCP reported same event for two patients (his grandfather and father). This is the report for father. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included none. The patient''s concomitant medications were not reported. It was reported that ''I would like to receive information about vaccine. I never want to be vaccinated and imposed on my own free will, I don''t want to be vaccinate with an injection that I don''t know what it is. I am healthy, I have seen people around me and my relatives who died after being vaccinated, so I have the right to get information, I submit it to the relevant units and organizations''. As of 26Jun2021, ''''Secondly, my father died, 15 days after the vaccination, it was stated as a heart attack on the death certificate, I doubt the reliability of the vaccine, is there a license for this vaccine or not, they are the subject vaccine, I am not likely to be a vaccine, please inform me.'' ''Dear company employees, respect and love. I am hesitant with the biontech vaccine currently being implemented in our country, and I don''t want to have the vaccine done. I don''t want to have a vaccine approved for emergency use without a license, can you give information about the safety of your medicine? My father did not have any additional disease, but died 15 days after the injection. Death is stated as a heart attack, I always receive news of death around us, and what should I do?'' The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatal myocardial infarction and the use of BNT162B2 cannot be fully excluded. There is limited information in this case precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : TR-PFIZER INC-2021792558 Same reporter/drug/event, different patients; Reported Cause(s) of Death: heart attack


VAERS ID: 1453799 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: d?c?s; Arr?t cardiaque; Malaise; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (d?c?s), CARDIAC ARREST (Arr?t cardiaque) and MALAISE (Malaise) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Smoker. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CARDIAC ARREST (Arr?t cardiaque) (seriousness criteria death and medically significant) and MALAISE (Malaise) (seriousness criterion death). The patient died on 05-May-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Company comment: Very limited information regarding the events has been provided at this time Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 2juL2021 contains translated source document; Sender''s Comments: Very limited information regarding the events has been provided at this time; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1454004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-19
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 17
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: TICLID; ZYLORIC; OMEPRAZOLE; TAMSULOSIN; SIMVASTATIN; LOPRESOR [METOPROLOL FUMARATE]; CORUNO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Diabetic; Hypertension; Nephrectomy; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: CT Scan; Result Unstructured Data: Test Result:parenchymal involvement of around 50%; Test Date: 20210528; Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: BEPFIZER INC2021779018

Write-up: covid19 pneumonia; (positive test) PCR; COVID-19 infection after vaccination; Death; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB BE-FAMHP-DHH-N2021-95404. A 88-year-old male patient received bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on 30Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included double bypass, nephrectomy, hypertension, diabetic, overweight (BMI 29), all from an unknown date and unknown if ongoing. Concomitant medications included ticlopidine hydrochloride (TICLID); allopurinol (ZYLORIC); omeprazole (OMEPRAZOLE); tamsulosin (TAMSULOSIN); simvastatin (SIMVASTATIN); metoprolol fumarate (LOPRESOR [METOPROLOL FUMARATE]); molsidomine (CORUNO), all taken for an unspecified indication, start and stop date were not reported. On 19May2021, the patient experienced COVID-19 infection after vaccination, death. On 28May2021, patient had (positive test) PCR. On 28May2021, the patient was hospitalized for covid19 pneumonia with severe parenchymal involvement of around 50%. The patient was already on antibiotic therapy, anticoagulation therapy and corticosteroids before admission. Intensive care hospitalization, ventilation under LNHD (high flow nasal cannula). The patient underwent lab tests and procedures which included CT Scan resulted as parenchymal involvement of around 50% on 28May2021, COVID-19 PCR resulted as positive on 28May2021. The patient died on 05Jun2021 and the cause of death was COVID-19. It was not reported if an autopsy was performed. The clinical outcome of the event was fatal and outcome of the event drug ineffective was unknown. Sender''s comments: Covid after first dose.; Reporter''s Comments: Summary of reporter''s comments: description of medications used prior to admission, description of hospitalization workup, description of event, lab data, diagnostic procedures, date of vaccination and onset of symptoms; Reported Cause(s) of Death: COVID-19


VAERS ID: 1454023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 2021-06-01
   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: GASTROCID [OMEPRAZOLE]; MAGNESIUM; ASPIRIN PROTECT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (upper limit reached 190 and more/last 6-7 months has maintained a blood count of 140/80-140/90)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BGPFIZER INC2021758890

Write-up: Death/the heart has stopped; This is a spontaneous report from a contactable consumer (patient''s relative) downloaded from the Regulatory Authority-WEB, regulatory authority number BG-BDA-20381. A 51-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular (IM) on 05Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure (The upper limit has reached 190 and more. For the last 6-7 months he has maintained a blood count of 140 / 80-140 / 90). Concomitant medications included omeprazole (GASTROCID); magnesium; and acetylsalicylic acid (ASPIRIN PROTECT), all taken for an unspecified indication, start and stop date were not reported. The patient died, after IM administration of the second dose of bnt162b2 concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) for Covid-19 immunisation. Onset 15 hours after vaccination (Jun2021). According to doctors, the heart has stopped. No autopsy was performed. The patient died on Jun2021. An autopsy was not performed. No follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reporter''s Comments: "He had high blood pressure. ?he upper limit has reached 190 and more. For the last 6-7 months he has maintained a blood count of 140 / 80-140 / 90. According to doctors, "the heart has stopped." No autopsy was performed."; Reported Cause(s) of Death: Death/the heart has stopped


VAERS ID: 1454025 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

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

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris (controlled by medication); Aortic dissection (type 1 and implantation of a biological prosthesis); Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: BGPFIZER INC2021758907

Write-up: Found dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number BG-BDA-20473. A 67-year-old male patient received BNT162B2 (COMIRNATY, concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)) dose 2 intramuscular on 09Jun2021 08:15 (Lot Number: EY7015) as dose 2, single for covid-19 immunisation. Medical history included In Feb2009 he underwent surgery - dissection of the aorta - type 1 and implantation of a biological prosthesis. With concomitant diseases: Chronic obstructive pulmonary disease, hypertension and angina, controlled by medication and during the immunization no contraindications were found. The patient''s concomitant medications were not reported. On 10Jun2021 his wife, immunized with the same vaccine the day before, visited where they worked. According to the investigation, around 12 o''clock, he was found dead, lifeless, and she called emergency assistance, and an ambulance team established the death. The family refuses an autopsy. The outcome of event was fatal. The patient died on 10Jun2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: found dead


VAERS ID: 1454047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, 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), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021794640

Write-up: cardio-respiratory arrest; asphyxia; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter informed that the patient experienced asphyxia after receiving the Covid 19 vaccine, with oxygen, the patient had a cardio-respiratory arrest on an unspecified date. Therapeutic measures were taken as a result of asphyxia. The patient died 10-12 days after the application of the vaccine on unspecified date. It was not reported if an autopsy was performed. The clinical outcome of the events was unknown. Information regarding the batch number will be requested in follow-up activities.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1454634 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral artery embolism, Cerebral 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, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 12
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: Overweight; Pain back
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement (both sides)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021758927

Write-up: Cerebral embolism; Cerebral bleeding; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number CZ-CZSUKL-21007182. A 76-years-old female patient received bnt162b2 (COMIRNATY), Dose 2 intramuscular on 28May2021 (Lot Number: FA4598) as single dose for covid-19 immunisation. Medical history included hip replacement both sides (not ongoing), ongoing pain back, ongoing overweight. No concomitant medication. Patient previously received bnt162b2 (COMIRNATY), Dose 1 intramuscular on 18Apr2021 (Lot Number: EW4815) as single dose for covid-19 immunisation. After the second dose of the Comirnaty vaccine the patient experienced strong headaches, after 10 days, on 10Jun2021 the patient died. The patient experienced cerebral embolism and cerebral bleeding on 29May2021, eventually death. Treatment received of ibuprofen (IBALGIN) to treat the headaches. The patient died on 10Jun2021. An autopsy was not performed, the reported cause of death was cerebral embolism and cerebral bleeding. The events assessed as serious, caused death, hospitalization, medically significant, life threatening. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral embolism; cerebral bleeding


VAERS ID: 1454925 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary disease (Coronary artery disease with left bundle branch block); Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021758617

Write-up: Sudden cardiac death; Fibrillation ventricular; Tachycardia ventricular; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100105617. A 69-year-old female patient received second dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 (Lot Number: FD9234) (at the age of 69-year-old) as single dose for COVID-19 immunisation. Medical history included coronary artery disease with left bundle branch block from 2013 and ongoing and diabetes mellitus from 2013 and ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY) on 20May2021 for COVID-19 immunization and experienced no adverse effect. On 15Jun2021, the patient experienced sudden cardiac death, fibrillation ventricular and tachycardia ventricular. The events were serious, fatal. The patient died on 15Jun2021. It was not reported if an autopsy was performed. No follow-up activities possible, no further information expected.; Reported Cause(s) of Death: Fibrillation ventricular; Tachycardia ventricular; Sudden cardiac death


VAERS ID: 1454927 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), 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: DEPFIZER INC2021758627

Write-up: Cardiac dysrhythmia, unspecified; Arrest cardiac; Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority report number: DE-PEI-202100105622. A 67 years old female patient received BNT162B2 (COMIRNATY, Lot. 1D016A) intramuscularly, at 0.3 mL, single dose, on 02Jun2021, for COVID-19 immunisation. The patient''s weight was not reported, and height was not reported. Relevant medical history and concomitant medication were unknown. On 14Jun2021, the patient experienced cardiac dysrhythmia, unspecified, arrest cardiac, death sudden. The case was assessed as serious (Death). The patient''s outcome was: fatal for cardiac dysrhythmia, unspecified, fatal for arrest cardiac, fatal for death sudden. It was unknown if autopsy was done. Relatedness of drug to reactions/events: arrhythmia, cardiac arrest, sudden death Source of assessment: PEI Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac dysrhythmia, unspecified; Arrest cardiac; Sudden death unexplained


VAERS ID: 1454929 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021758827

Write-up: Infarct myocardial; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100105635. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 31May2021 at age of 61-years-old as dose 2, 0.3 ml single for covid-19 immunisation . The patient previously took the first dose bnt162b2 on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced infarct myocardial on 05Jun2021 , inappropriate schedule of vaccine administered on 31May2021. The patient died on 05Jun2021. An autopsy was not performed. The outcome of event infarct myocardial was fatal. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1454931 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-21
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Pyrexia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021817827

Write-up: Ventricular fibrillation; Hypoxic brain damage; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency -WEB, regulatory authority number DE-PEI-202100116988. A 22-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 12Jun2021 (Batch/Lot Number: FA5833) as dose number unknown, single (at age of 22-years old) for covid-19 immunization. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 21Jun2021, the patient experienced ventricular fibrillation, pyrexia, and hypoxic brain damage. The patient died on an unspecified date. Cause of the death reported as hypoxic brain damage. It was not reported if an autopsy was performed. The Agency considered all the events to be serious (death with fatal outcome). No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Hypoxic brain damage


VAERS ID: 1454969 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021818198

Write-up: COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021107017. A 74-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: ET3045 expiry date Unknown) via unspecified route of administration, on 14Apr2021 (age at vaccination: 74-years-old ) at 0.3 mL as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient became ill with Covid-19, 2 days after the first vaccination and there was development of first symptoms on 16Apr2021. From 25Apr2021 she had to be ventilated, and from 17May2021 Palliative care was given. The affected person died. The outcome of event was fatal. Senders comments: The affected person became ill with Covid-19 2 days after the first vaccination, development of first symptoms on 16Apr2021. From 25Apr2021 she had to be ventilated, from 17May2021 Palliative care. The affected person died. Result of Assessment: Comirnaty/event(s): COVID-19/Regulatory Authority: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1455207 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Oestrogen receptor assay, Progesterone receptor assay, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: Endometrial cancer metastatic (G1 p53wt, MMRp stage IV due to peritoneal carcinomatosis detected in surgery so it is not completed.); Hypertension arterial; Perforated ulcer; Peritoneal carcinomatosis
Allergies:
Diagnostic Lab Data: Test Name: IMMUNOHISTOCHEMICAL STUDY OF ESTROGEN RECEPTORS; Result Unstructured Data: Test Result:in notes; Comments: Expression in intensity 2+ in a 10% of the tumor cellularity.; Test Name: PROGESTERONE RECEPTORS; Result Unstructured Data: Test Result:in notes; Comments: Expression in intensity 1+ in 20% of the tumor cellularity.
CDC Split Type: ESPFIZER INC2021758853

Write-up: Dyspnoea; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB ES-AEMPS-913110. An 81-years-old female patient received bnt162b2 (COMIRNATY), dose 2 unknown on 26May2021 at 81-years-old (Lot Number: FC3558) as DOSE 2, 0.3mL single for covid-19 immunization. Medical history included endometrial adenocarcinoma G1 p53wt, MMRp stage IV due to peritoneal carcinomatosis detected in surgery so it is not completed, hypertension arterial, perforated ulcer from 2009 (12 years ago). The patient had no toxic habits or known allergies. The patient''s concomitant medications were not reported. The patient experienced dyspnoea and pulmonary embolism on 26May2021. The patient underwent lab tests and procedures which included immunohistochemical study of estrogen receptors: Expression in intensity 2+ in a 10% of the tumor cellularity (in notes) and progesterone receptors: expression in intensity 1+ in 20% of the tumor cellularity (in notes). The patient died on 02Jun2021.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: Dyspnoea; Pulmonary embolism


VAERS ID: 1455223 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-28
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatic vein thrombosis, Platelet count, Pulmonary embolism, Pyrexia, Raynaud's phenomenon, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Rectal cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 52000; Test Date: 20210613; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 370000
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Tromboembolia pulmonar; Thrombopenia; Trombosis de vena hep?tica; Raynaud; Fiebre; This regulatory authority case was reported by a physician and describes the occurrence of HEPATIC VEIN THROMBOSIS (Trombosis de vena hep?tica), PULMONARY EMBOLISM (Tromboembolia pulmonar), THROMBOCYTOPENIA (Thrombopenia), RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002183 and 3001532) for COVID-19 vaccination. The patient''s past medical history included Rectal cancer metastatic and COVID-19 (Covid-19) in September 2020. On 30-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RAYNAUD''S PHENOMENON (Raynaud) (seriousness criterion hospitalization) and PYREXIA (Fiebre) (seriousness criterion hospitalization). On 03-Jun-2021, the patient experienced HEPATIC VEIN THROMBOSIS (seriousness criteria death, hospitalization and medically significant) and THROMBOCYTOPENIA (Thrombopenia) (seriousness criteria hospitalization and medically significant). On 17-Jun-2021, the patient experienced PULMONARY EMBOLISM (Tromboembolia pulmonar) (seriousness criteria death, hospitalization and medically significant). On 13-Jun-2021, THROMBOCYTOPENIA (Thrombopenia) had resolved. In June 2021, RAYNAUD''S PHENOMENON (Raynaud) and PYREXIA (Fiebre) had resolved. The patient died on an unknown date. The reported cause of death was thrombosis and tromboembolia pulmonar. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Platelet count: 52000 cells per microlitre (Inconclusive) 52000. On 13-Jun-2021, Platelet count: 370000 cells per microlitre (Inconclusive) 370000. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding events (hepatic vein thrombosis and pulmonary embolism) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death; Tromboembolia pulmonar


VAERS ID: 1455227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-05-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin A, Bronchoalveolar lavage, Eosinophilic pneumonia acute
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   Days after onset: 17
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: EBASTINE; METRONIDAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial lung disease; Psoriasis; Rosacea
Allergies:
Diagnostic Lab Data: Test Name: IgA; Result Unstructured Data: Test Result:1543; Comments: elevated; Test Name: BAL; Result Unstructured Data: Test Result:more than 50% eosinophils
CDC Split Type: ESPFIZER INC2021795776

Write-up: Eosinophilic pneumonia acute; This is a spontaneous report from a contactable physician downloaded from the WEB ES-AEMPS-921209. A 77-year-old female patient received BNT162B2 (COMIRNATY), first dose, intramuscularly on 13Apr2021 (Lot Number: EW9127) as 0.3 mL, single dose for covid-19 immunisation; doxycycline hyclate, orally from 01Mar2021 (Batch/Lot number was not reported) to 30Apr2021, at unspecified dose for an unspecified indication. Medical history included psoriasis, rosacea, and diffuse interstitial lung disease under study. Concomitant medications included ebastine; and metronidazole. The patient experienced eosinophilic pneumonia acute on 01May2021. The patient was hospitalized for eosinophilic pneumonia acute from 09May2021. Admission on 09May2021. Clinical dyspnoea begins between 1 week-1 month (difficult to know exactly) before admission for acute eosinophilic pneumonia (more than 50% eosinophils in BAL and without eosinophilia). High IgA. Elevated IgA 1543. Autoimmunity: negative. The patient was treated with oxygen and methylprednisolone. She was transferred to the ICU and progressed poorly until her death on 18May2021. The action taken in response to the event for doxycycline hyclate was post therapy. The patient died on 18May2021. An autopsy has been performed pending results. The patient received first dose of Comirnaty on 13Apr2021 and second on 04May2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Eosinophilic pneumonia acute


VAERS ID: 1455396 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-05-11
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Heart rate, Oxygen saturation, 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: 2021-05-19
   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: Arterial hypertension; Cognitive disorders (of vascular origin with behavioral disorder); Diabetes; Hemorrhagic stroke; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: heart rate; Result Unstructured Data: Test Result:95; Comments: /min; Test Date: 20210514; Test Name: saturation; Result Unstructured Data: Test Result:89-91 %; Test Date: 20210517; Test Name: saturation; Test Result: 80 %; Comments: under 2L of O2/min; Test Date: 20210511; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210514; Test Name: arterial tension; Result Unstructured Data: Test Result:87/50; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Celsius; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Celsius
CDC Split Type: FRPFIZER INC2021796193

Write-up: Vaccination failure; Test Covid-19 : PCR : positive; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-2021079944. A 92-year-old male patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, Batch/Lot number: EJ6788, Expiration date: Not reported), dose 2 intramuscular, administered in Arm Left on 26Jan2021 as DOSE 2, SINGLE and dose 1 intramuscular, administered in Arm Left on 05Jan2021 (Batch/Lot Number: EJ 6795) as dose 1, single for covid-19 immunisation. Medical history included diabetes, arterial hypertension, haemorrhagic stroke and cognitive disorders of vascular origin with behavioural disorder (degree of dependence GIR 2). The patient''s concomitant medications were not reported. Patient had no history of allergy/ hypersensitivity and COVID-19. On 11May2021, the patient experienced vaccination failure and test covid-19 : pcr : positive. It was reported that person at risk of development of severe form of COVID-19. On 11May2021, no clinical changes for the resident, no respiratory signs. On 14May2021, asthenia with swallowing difficulties, moderate fatty cough, Peripheral circulatory insufficiency and crackles at right base. Hypothesis of inhalation pneumonia with septic syndrome. It was reported that in accordance with family, decision not to hospitalize, no relentless treatment and comfort care. On 14May2021, treatment by subcutaneous hydration, preventive Lovenox, oxygen, ceftriaxone. On 15May2021, fatty cough. Presence of abnormal movements, improved by bolus of midazolam. Patient also treated with scopolamine patch, electric syringe pump of midazolam 1mg/24h and bolus of 1mg midazolam if needed. Stop of treatments via oral route. On 17May2021, Patient calm, conscious, bronchopulmonary congestion. Patient Oxygen increased to 3L/min Then in the evening: very severe vomiting with a sign of shock (marbling) and acute respiratory distress. Agitation, desaturation. Increase of oxygen to 6 L / min. Increase of midazolam to 1mg/h, electric syringe pump of morphine to 1mg/h. On 18May2021, Stationary clinical state without improvement. On the request of the family and after collegial advice, implementation of deep sedation and cessation of all treatments: oxygen, hydration, antibiotics. CONCLUSION: Patient with Covid-19 pneumonia leading to death after two doses of COMIRNATY vaccine. Summary: Man who has Covid-19 pneumonia resulting in his death after 2 administrations of COMIRNATY. Time interval between beginning of drug administration and start of reaction was 127 days; Time interval between last dose of drug and start of reaction was 106 days. The patient underwent lab tests and procedures which included blood pressure measurement: 87/50 on 14May2021, body temperature: 38.2 Celsius on 14May2021, body temperature: 37.6 Celsius on 17May2021, heart rate: 95 on 14May2021 /min , oxygen saturation: 89-91 % on 14May2021, oxygen saturation: 80 % on 17May2021 under 2L of O2/min , sars-cov-2 test: positive (screening following contamination of a caregiver) on 11May2021. Patient was received treatment for event. The patient died on 19May2021 at 8h 40min.. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1455442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 RA / OT

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

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021759094

Write-up: Death NOS; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency. Regulatory Authority Report Number: FR-AFSSAPS-LY20216576. Safety Report Unique Identifier: FR-AFSSAPS-2021076579. A 51-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 08Jun2021 (Lot Number: FD0785) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 10Jun2021. Death of the patient unknown causes and circumstances. No more information available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1455452 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-24
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angina unstable, Angiogram, Blood pressure measurement, Cardiac stress test, Coronary artery occlusion, Coronary artery thrombosis, Echocardiogram, Electrocardiogram, Myocardial infarction, Scan myocardial perfusion, Vascular stent stenosis
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVERAM; NEBIVOLOL; RILMENIDINE; CRESTOR
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac imaging procedure abnormal (gave way to Trinitrin); Dyslipidaemia; Ex-tobacco user; Ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Coronary angiography; Result Unstructured Data: Test Result:distal right coronary occlusion; Test Date: 20210324; Test Name: Blood pressure; Result Unstructured Data: Test Result:168/102 mmHg; Test Date: 20210308; Test Name: Stress test; Result Unstructured Data: Test Result:ischemia induced by stress; Test Date: 20210324; Test Name: TTE; Result Unstructured Data: Test Result:40% LVEF, lower LV hypokinesia; Test Date: 20210324; Test Name: ECG; Result Unstructured Data: Test Result:not shifting from ST inf with anterior mirror; Comments: not shifting from ST inf with anterior mirror, no arrhythmia, no conduction; Test Date: 20210308; Test Name: myocardial scintigraphy; Test Result: Positive
CDC Split Type: FRPFIZER INC2021759055

Write-up: acute coronary syndrome ST +; Angina pectoris unstable; coronary occlusion, thrombectomy; coronary occlusion, thrombectomy; Infarct myocardial; probable stenosis of the stent; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20212331. Safety Report Unique Identifier: FR-AFSSAPS-2021077105. A 73 years old male patient received bnt162b2 (COMIRNATY), intramuscular on 11Mar2021 (at the age of 73 years old) (Lot Number: ET3620) as dose number unknown, single for covid-19 immunisation. Medical history included Ex-tobacco user, ongoing Hypertension arterial, Dyslipidaemia, ischemia induced by stress on 08Mar2021, Positive myocardial scintigraphy with pain on 08Mar2021. Concomitant medications (Usual treatment) included amlodipine besilate, perindopril arginine (COVERAM); nebivolol; rilmenidine; rosuvastatin calcium (CRESTOR). The patient experienced infarct myocardial (death, hospitalization) on 24Mar2021. The patient undergoes myocardial infarction on day 13 for a vaccine by COMIRNATY (batch ET3620), and subsequently died. History of the disease: On 24Mar2021, this patient was hospitalized for treatment of an acute coronary syndrome ST +. Angina pectoris unstable for 2 weeks. On 08Mar2021, stress test which concluded in a contentious test as to ischemia induced by stress, Positive myocardial scintigraphy with pain that gave way to Trinitrin. On 24Mar2021, the patient consulted the emergency room for constricting chest pain without irradiation. On entry, trino-resistant pain, blood pressure at 168/102 mmHg. ECG not shifting from ST inf with anterior mirror, no arrhythmia, no conduction. TTE: 40% LVEF, lower left ventricle hypokinesia. Coronary angiography: distal right coronary occlusion, thrombectomy and active stent. The patient left after 48 hours, on 26Mar2021, under KARDEGIC, EFIENT in addition to his usual treatment. The patient died on 31Mar2021. An autopsy was not performed. It was concluded that there was a probable stenosis of the stent at day 7 of the insertion. The events Infarct myocardial, acute coronary syndrome ST + and Angina pectoris unstable resulted in Emergency Room Visit. The patient hospitalized from 24Mar2021 to 26Mar2021) for Infarct myocardial, acute coronary syndrome ST +, Angina pectoris unstable and coronary occlusion, thrombectomy. The outcome of the event Infarct myocardial was fatal, of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1455463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Haemorrhagic stroke; Thrombosis venous deep; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: SARS-COV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021758954

Write-up: Death unexplained; vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NT20212103. Safety Report Unique FR-AFSSAPS-2021075263. A 95-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Jun2021 morning (Batch/Lot Number: FD4342) as single dose for covid-19 immunisation. Medical history included vascular dementia, deep vein thrombosis, asymptomatic covid-19 (PCR positive on 03Feb2021), haemorrhagic stroke. The patient''s concomitant medications were not reported. The patient resident in facility and only one dose was scheduled due to positive PCR in Feb2021. No notable symptoms following this vaccination. She was found dead in her bed on Sunday 13Jun2021 at 4:30 am. Stools and vomiting were present. No underlying pathology in decompensation, no new treatment instituted. The patient died on 13Jun2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1455899 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-01-21
Onset:2001-09-10
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 521458 / 1 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER NOT KNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-17
   Days after onset: 2014
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Brain mass; This regulatory authority case was reported by a consumer and describes the occurrence of INTRACRANIAL MASS (Brain mass) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 521458) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2001, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Dec-2010, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 10-Sep-2001, the patient experienced INTRACRANIAL MASS (Brain mass) (seriousness criterion death). The patient died on 17-Mar-2007. The reported cause of death was Brain mass. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. Company comment Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Brain mass


VAERS ID: 1455978 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021770937

Write-up: I know 3 people that have died from your covid vaccine; This is a spontaneous report from a Pfizer-sponsored program, Pfizer.com - General Company Information. This is the second of 3 reports. A contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), on an unspecified date (Batch/Lot number was not reported) dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated ''I know 3 people that have died from your covid vaccine''. The cause of death was not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Batch information has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1455998 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Atherosclerosis; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonic infiltrate; Comments: pneumonic infiltrate; Test Date: 20210305; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Comments: positive; Test Date: 20210305; Test Name: general practitioner; Result Unstructured Data: Test Result:referred her to the emergency department with an a; Comments: referred her to the emergency department with an ambulance
CDC Split Type: HUPFIZER INC2021794940

Write-up: drug inefective; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB: HU-OGYI-466621. This spontaneous, serious case was reported by a physician on 08Jun2021, concerning COVID-19 pneumonia after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). A 85-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL0725) dose 1 via intramuscular route of administration in Arm Left on 12Feb2021 as 0.3 ml single for COVID-19 immunisation. Medical history included hypertension, and atherosclerosis both from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Reported as, "On 05Mar2021, due to her complaints, her general practitioner referred her to the emergency department with an ambulance. The patient had been getting weaker, tired, coughing a little, and having a fever and dyspnoea for a few days. The patient''s daughter was confirmed to be positive for COVID-19, with whom she lives. In laboratory tests, high inflammatory markers were observed. Chest X-ray showed pneumonic infiltrate, COVID-19 PCR test became positive, so COVID-19 pneumonia was considered". Combination antibiotic therapy was started in addition to steroids and bronchodilators. The patient still required oxygen support, and despite the complex treatment, the patient''s condition progressed, and she died on 06Mar2021. Autopsy was not done. Senders comments: COVID-19 pneumonia occurred within 3 weeks, and the patient died 22 days after the first dose of Comirnaty. Immunity has not developed after the first dose of vaccine. The event and the vaccine is considered not related. The case is serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1455999 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021794946

Write-up: COVID-19 pneumonia; Covid positivity; Drug ineffective; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-484121. A 62-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: ET7205) via an intramuscular route of administration on 01Apr2021 as O.3 ml single dose and second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EX6537) via an intramuscular route of administration in the left arm on 06May2021 as 0.3ML single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07May2021, the had drug ineffective and had covid positivity. On 15May2021, the experienced covid-19 pneumonia. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 07May2021. The patient died on 04Jun2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient got infected with the virus 1 day after the second dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1456010 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY834 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SILDENAFIL; IBUPROFEN; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Erectile dysfunction; Osteoarthritis; Retinal disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021758677

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-072583, Safety Report Unique Identifier IE-HPRA-2021-072583. A 76-year-old male patient received Second dose of BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Apr2021 at the age of 76-year-old (batch/Lot Number: EY834) as 0.3 ml, single for COVID-19 immunisation. Medical history included retinal disorder, osteoarthritis, erectile dysfunction. The patient was relatively healthy, had no cardiac history, non smoker, minimal alcohol use, and no obesity. Concomitant medication(s) included sildenafil (Manufacturer unknown) taken for erectile dysfunction, start and stop date were not reported; ibuprofen (Manufacturer unknown) at 200mg taken for osteoarthritis, start and stop date were not reported; esomeprazole (Manufacturer unknown) at 20mg taken for an unspecified indication, start and stop date were not reported. The reporter did not know if the patient was taking these medications recently. On 30Mar2021, the patient was vaccinated with his 1st dose of Comirnaty (batch/lot no: ER9480), at a dose of 0.3ml. The patient experienced cardiac arrest (death) on 29Apr2021. On 29Apr2021, the patient suffered a fatal cardiac arrest on the bus, 48 hours after second dose of Comirnaty. The patient died on 29Apr2021. It was not reported if an autopsy was performed. The post-mortem report was pending. The reporter stated that was unclear if the event was connected to vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1456153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis cerebral
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021796379

Write-up: sudden death in full well-being; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-748382. An 88-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection), dose 1 intramuscular on 18Jun2021 17:00 (Batch/Lot Number: fd4555; Expiration Date: 30Jul2021) as 0.3 mL, single dose for covid-19 immunisation. Medical history included: cerebral arteriosclerosis from 01Jan2009 to 21Jun2021.The patient''s concomitant medications were not reported. On 21Jun2021, the patient experienced sudden death in full well-being. Family members reported that the patient died during the night without any symptoms and that the previous evening she was fine. The cause of death was unknown, and it was not reported if an autopsy was performed. The outcome of the event sudden death in full well-being was fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: I report apparently not related to the administration of the vaccine. family members report that the patient died during the night without any symptoms and that the previous evening she was fine; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the fatal event sudden death with no autopsy results ,cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1456155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-23
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: AVODART; SERENASE [HALOPERIDOL]; OMEPRAZOLE; ISOLYTE [MAGNESIUM CHLORIDE HEXAHYDRATE;POTASSIUM CHLORIDE;SODIUM ACETATE TRIHYDRATE;SODIUM CHLORIDE; PARACETAMOL; TRITTICO; PLASIL [METOCLOPRAMIDE]
Current Illness: Acute respiratory failure; Benign prostatic hypertrophy; Hypertension; Hypertensive heart disease
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210701177

Write-up: PATIENT DIED THE DAY AFTER VACCINATION; This spontaneous report received from a physician via a Regulatory Authority [IT-MINISAL02-749540] concerned a 94 year old male of an unspecified race and ethnic origin. The patient''s weight was not reported, and height was 168 centimeters. The patient''s concurrent conditions included hypertension, benign prostatic hypertrophy, hypertensive heart disease, and acute respiratory failure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975, and expiry: unknown) 0.5 ml, 1 total administered on 22-JUN-2021 for Covid-19 immunisation. Concomitant medications included Isolyte (magnesium chloride hexahydrate/potassium chloride/sodium acetate trihydrate/sodium chloride) for acidosis, Avodart (dutasteride) for benign prostatic hypertrophy, Trittico (trazodone hydrochloride) for depressed state, Plasil (metoclopramide) for emesis, Paracetamol for painful joints, Serenase (haloperidol) for psychomotor agitation and Omeprazole used for an unknown indication. On 23-JUN-2021, the patient died the day after vaccination from an unknown cause. 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).; Sender''s Comments: V0;20210701177-covid-19 vaccine ad26.cov2. s- Died the day after vaccination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1456270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Celsius; Comments: before vaccination; degrees
CDC Split Type: JPPFIZER INC2021758537

Write-up: died; This is a spontaneous report from a contactable physician (coroner) received from the Pharmaceuticals and Agency. Regulatory authority report number is v21115669. The patient was a 74-year and 4-month-old female. The body temperature on 18Jun2021 before vaccination was 36.4 degrees Celsius. It was unknown if the patient had medical history and she was receiving concomitant medications. It was unknown if she had relevant family history. On an unspecified date, the patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot # EY4834, expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 at an unspecified time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, lot # FC3661, expiration date 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 20Jun2021 (about 2 days after the vaccination), the patient experienced the event (the symptoms were unknown). On 21Jun2021 (3 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was unknown if there was a possible cause of the event.; Reported Cause(s) of Death: died


VAERS ID: 1456271 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, 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: 2021-06-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite lost
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/54; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: Before vaccination in the afternoon; Test Date: 20210619; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: at around 14:00; Test Date: 20210619; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: at around 21:00
CDC Split Type: JPPFIZER INC2021758560

Write-up: respiratory status was strange/respiratory arrest; Pyrexia/body temperature was 37.0 degrees Centigrade/body temperature went up to 38.0 degrees Centigrade; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21115671. The patient was a 92-year-old (age at the time of event and time of vaccination) male. Body temperature before vaccination was 35.7 degrees Centigrade on 18Jun2021. 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 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 dose 1, single for covid-19 immunisation. On 18Jun2021 at 14:09 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number EY0779, expiration date 31Aug2021) via an unspecified route of administration as dose 2, single for COVID-19 immunisation. On 19Jun2021 at around 14:00 (1 day after the vaccination), the patient experienced pyrexia. On 20Jun2021 (2 days after the vaccination), the patient died. It was unknown if an autopsy was performed. The course of the events was as follows: On 18Jun2021 in the afternoon, body temperature was 35.7 degrees and blood pressure was 100/54. No problems were noted in the screening questionnaire. Therefore, the reporting physician gave the second dose of the vaccination to the patient. During 20 minutes of observation, no change was noted, so the patient returned home. On 19Jun2021 at around 14:00, body temperature was 37.0 degrees Centigrade. At around 21:00, body temperature went up to 38.0 degrees Centigrade. He took an over-the-counter antipyretic drug and went to bed. On 20Jun2021 at around 06:00, since his respiratory status was strange, he was transferred to the emergency outpatient department in a hospital by an ambulance. He was in respiratory arrest. Resuscitation was not performed at his family''s wish, and the patient''s death was confirmed. The reporting physician classified pyrexia as serious (death). The physician considered that there was a possibility of BNT162B2 being the cause of pyrexia yet the relationship between the subsequent situation and BNT162B2 was unknown. It was not reported if there were other possible causes of the event such as any other diseases. The reporting physician commented as follows: The patient was of advanced age and he had been losing appetite these days (medical history). The emergency physician considered that the possibility of death caused by external factors was deniable and determined that the cause of death was geromarasmus. The reporting physician agreed with the emergency physician''s assessment. The outcome of the adverse events was fatal.; Reported Cause(s) of Death: Pyrexia; geromarasmus


VAERS ID: 1456274 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Body temperature, Cardiac failure, Dyspnoea, Heat illness, Left ventricular failure, Malaise, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (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? Yes
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; Percutaneous coronary intervention
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Celsius; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021759151

Write-up: sudden death; suspected acute coronary syndrome; malaise; dyspnoea; heat illness; aggravated cardiac failure; left ventricular failure; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21115744. The patient was a 96-year and 11-month-old female. Body temperature before vaccination was 36.4 degrees Celsius on 09Jun2021. Medical history included cardiac failure chronic and status after coronary intervention. Concomitant medications were not provided. It was not reported if the patient had relevant family history. On an unspecified date, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jun2021 at 11:21 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) an unspecified route of administration at age of 96-years, as a single dose for COVID-19 immunization. On 19Jun2021 at 19:53 (10 days after the vaccination), the patient developed suspected acute coronary syndrome and sudden death. It was not reported if an autopsy was performed. The outcome of event suspected acute coronary syndrome and aggravated cardiac failure was fatal, while remains events was unknown. The course of the events was as follows: On 19Jun2021 at around 18:00, the patient developed malaise and dyspnoea, and the reporting physician made a home visit. The patient had already left ventricular failure. Although it was a serious symptom, blood pressure was maintained. As heat illness and/or aggravated cardiac failure were suspected, fluid infusion and diuretic were administered. However, respiration with mandibular movement was noted and then the patient died. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as un-assessable. Cardiac failure chronic and status after coronary intervention were considered as possible causes of the events. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: suspected acute coronary syndrome; aggravated cardiac failure; sudden death


VAERS ID: 1456357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Facial asymmetry, Facial paresis, Foaming at mouth
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021830164

Write-up: Death; Frothing at mouth; Facial paresis; Facial asymmetry; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is 21-04-02669A. A 36-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on unknown date, at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On an unknown date, 3 day after the vaccination, the patient experienced frothing at mouth (medically significant), facial paresis (medically significant), and facial asymmetry (medically significant). On unknown date, the patient experienced death. The cause of death was no provided. It was unknown if an autopsy was performed. Frothing at mouth, facial paresis, and facial asymmetry were ongoing at the time of death. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1456358 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Death, Musculoskeletal stiffness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Arthritis (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: MYPFIZER INC2021830170

Write-up: Death; Bruise; Limbs stiffness; This is a spontaneous report from a contactable pharmacist received from the Authority. The regulatory authority report number is 21-04-02658A. A 34-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, 4 weeks after the vaccination, the patient experienced bruise (medically significant), limbs stiffness (medically significant) and death. The cause of death was not provided. Bruise and limbs stiffness were not resolved at the time of death. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1456359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dependence on respirator, Lung disorder, Pneumonia
SMQs:, Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
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:
CDC Split Type: NLJNJFOC20210708687

Write-up: COVID PNEUMONIA; DEPENDENCE ON VENTILATOR; LUNG COMPLICATION; DEATH; This spontaneous report received from social media via consumer concerned a 49 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. Patient did not have any concurrent condition and medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. The patient received Johnson and Johnson vaccine in late April and had the flu like symptoms that night but never got better, patient was in ICU within days of the shot then ventilator and patient died on 02-MAY-2021. Consumer claimed that the patient had covid pneumonia. The patient had no health problems and experienced severe lung damage and complications. On 02-MAY-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 02-MAY-2021, and the outcome of lung complication, covid pneumonia and dependence on ventilator was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged and Life Threatening).; Sender''s Comments: 20210708687-COVID-19 VACCINE AD26.COV2.S-Death, COVID pneumonia, Dependence on ventilator, Lung complication. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1456404 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Computerised tomogram, Echocardiogram, Fatigue, Increased bronchial secretion, Malaise, Myalgia, Narcolepsy, Pulmonary oedema, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SILVER SULFADIAZINE; IRBESARTAN; AMOXICILIN; CYRESS; SIMVASTATINE; FUROSEMIDE; FLUCLOXACILLINE [FLUCLOXACILLIN]; METOPROLOL; COLECALCIFEROL; PANTOPRAZOLE; ELIQUIS; EUCREAS
Current Illness: Diabetes; Heart failure; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:No aneurism; Test Name: heart echo; Result Unstructured Data: Test Result:heart failure. Fluid behind the lungs. Mucus in th; Comments: heart failure. Fluid behind the lungs. Mucus in the lungs, removed by means of bronchoscopy
CDC Split Type: NLPFIZER INC2021759030

Write-up: Fluid behind the lungs; Myalgia; Malaise; Fatigue; Mucus in the lungs; cardiac arrest six (!) times; respiratory arrest; severe symptoms of narcolepsy, which started on the day after the 2nd vaccination; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00582254. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EX7823) via an unspecified route of administration on 18May2021 at age of 78-year-old at single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, and heart failure; all were ongoing. No previous COVID-19 infection. Concomitant medications included silver sulfadiazine taken for an unspecified indication from an unspecified date; irbesartan taken for an unspecified indication from an unspecified date; amoxicillin taken for an unspecified indication from an unspecified date; barnidipine hydrochloride (CYRESS) taken for an unspecified indication from an unspecified date; simvastatine taken for an unspecified indication from an unspecified date; furosemide taken for an unspecified indication from an unspecified date; flucloxacilline [flucloxacillin] taken for an unspecified indication from an unspecified date; metoprolol taken for an unspecified indication from an unspecified date; colecalciferol taken for an unspecified indication from an unspecified date; pantoprazole taken for an unspecified indication from an unspecified date; apixaban (ELIQUIS) taken for an unspecified indication from an unspecified date; metformin hydrochloride, vildagliptin (EUCREAS) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (COMIRNATY) on 13Apr2021 for COVID-19 immunisation and experienced no adverse reaction. The patient experienced cardiac arrest six (!) times (death) on 03Jun2021, "severe symptoms of narcolepsy, which started on the day after the 2nd vaccination" on 18May2021, myalgia, malaise, fatigue on unspecified date(s). The diagnostic procedures was as follows: After severe symptoms of narcolepsy, which started on the day after the 2nd vaccination, (duration: 15 days [as reported])), the patient (reporter''s father) suffered a respiratory and cardiac arrest in the evening of 03Jun2021, six (!) times. CT scan after CPR. No aneurism. Heart echo: heart failure. Fluid behind the lungs. Mucus in the lungs, removed by means of bronchoscopy. This underlying suffering played a part, but the narcolepsy was immediately after 2nd vaccination and was so severe that he even fell asleep while eating and talking. This was definitely the big move until the six cardiac arrests and the patient eventual death on Wednesday, 09Jun2021. The General Practitioner also found the time lapse after vaccination extremely suspicious and supported the reporter making this report. Before the vaccinations, the patient''s symptoms were not as explosive as they were after the 15 days of narcoleptic symptoms. The outcome of "cardiac arrest six (!) times" and "respiratory arrest" was death, the outcome of event "severe symptoms of narcolepsy, which started on the day after the 2nd vaccination" was not recovered, the outcome of other events was unknown. The patient died on 09Jun2021. It was not reported if an autopsy was performed. Confounding factors reported as: Heart failure, diabetes, high blood pressure.; Reported Cause(s) of Death: respiratory arrest; Cardiac arrests


VAERS ID: 1456454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021813327

Write-up: Patient died 2 days after receiving the Pfizer Covid Vaccine/ According to their report patient was Covid +; Patient died 2 days after receiving the Pfizer Covid Vaccine/ According to their report patient was Covid +; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation at other facility. Medical history included heart condition and diabetes from an unknown date. The patient''s concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. On an unspecified date, the patient died 2 days after receiving the Pfizer covid vaccine/ according to their report patient was Covid positive. According to the reporter, "wife of the patient admitted that had Covid like symptoms prior to vaccination but the patient was denial and believed that the vaccine would make him well. According to their report patient was Covid positive. Death cause was unknown but due to Covid." The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown but due to covid


VAERS ID: 1456458 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021758738

Write-up: Death, cause unknown; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number PL-URPL-DML-MLP.4401.3.741.2021. The case was sent from the District. A 81-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) intramuscular, in arm left on 18Mar2021 at 09:25 (at the age of 81-year-old) at 0.3 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient''s death on 18Mar2021 at 19:00p.m., cause unknown. It was not reported if an autopsy was performed. Sender Comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) The reporting person classified them as serious. Due to the assessment of the reporting person and the patient''s death, the report was classified as "serious". Due to the lack of additional information (potential other chronic diseases, medications used, allergies, etc.) allowing to establish a cause-and-effect relationship, a non-classifiable relationship was established between vaccination and death.) An e-mail was sent to the appropriate station with a request for additional information, including the Patient''s medical documentation mentioned in the application. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1456720 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021825739

Write-up: Death; This is a spontaneous report from a contactable other health care professional. A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jun2021 at single dose (Lot Number: FE2090; Expiration Date: Oct2021) for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient died on 29Jun2021. It was not reported if an autopsy was performed.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1456871 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: Chronic renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary disease; Diabetes mellitus; Heart insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021758632

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100105620. An 81-year-old female patient received on 29Apr2021 BNT162B2 (COMIRNATY, lot EX3599) at 0.3 ml single intramuscular for Covid-19 immunization at the age of 81-years. Medical history included: ongoing Chronic renal insufficiency, diabetes mellitus, heart insufficiency, arterial hypertension and coronary disease. Concomitant medications were not reported. On 06May2021 the patient experienced sudden death unexplained. The patient''s outcome was: fatal for Sudden death unexplained. No autopsy was performed. Source of assessment: Regulatory Authority: Relatedness of drug to sudden death was B, indeterminate No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1456872 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease; Paroxysmal atrial fibrillation; STEMI
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021770405

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100108931. A 73-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 15Jun2021 (at the age of 73 years old) (Lot Number: FD9234) as dose 2, single for COVID-19 immunisation. Medical history included STEMI (ST-segment elevation myocardial infarction), paroxysmal atrial fibrillation and coronary disease; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient took his first dose of BNT162B2 on 04May2021 for COVID-19 immunisation. On 17Jun2021, the patient experienced unknown cause of death. This report was assessed serious - death. The patient''s outcome was fatal for Unknown cause of death. The patient died on 17Jun2021. An autopsy was performed and results were not provided. The casual relationship of COMIRNATY and event assessed as D. Unclassifiable by the Regulatory Authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1456876 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021779313

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Regulatory Authority-WEB number DE-PEI-202100110228. A 52-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 52 years). The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 18Jun2021. The patient died on 18Jun2021. Outcome of the event was fatal. An autopsy was performed and results were not provided. Event assessment : Comirnaty/ event/Regulatory Authority /Result of Assessment : D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1457793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Alcoholic; Carcinoma epidermoid (Well-differentiated keratinizing squamous cell carcinoma); Emphysema pulmonary (bilateral emphysema, significant emphysema (February 2019)); Gastropathy (Portal hypertension gastropathy); Hypertension arterial; Hypothyroidism (sequential hypothyroidism); Malnutrition; Nodule (8.6 mm pulmonary nodule); Palsy radial (Atypical radial palsy with spontaneous regression); Starvation (Severe malnutrition with placement of a gastrostomy); Thyroidectomy total; Tobacco user (more than 100 pack-years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021817710

Write-up: Patient died; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-2021082112. A 74-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FC1439), intramuscularly in left arm on 22Jun2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history included gastropathy (portal hypertension gastropathy), alcoholic, emphysema pulmonary (bilateral emphysema (nothing to report in Sep2020), significant emphysema (Feb2019)) from an unspecified date in Aug 2018, tobacco user (smoking (more than 100 pack-years)), thyroidectomy total from an unspecified date in 2019, hypertension arterial, carcinoma epidermoid (well-differentiated keratinizing squamous cell carcinoma), starvation (severe malnutrition with placement of a gastrostomy), severe malnutrition, palsy radial (atypical radial palsy with spontaneous regression), nodule (8.6 mm pulmonary nodule) from an unspecified date in Aug2018, hypothyroidism (sequential hypothyroidism). Patient being considered at risk for developing a severe form of COVID-19 disease (neoplasia, undernutrition, emphysema), not having contracted COVID-19, and not having performed a COVID-19 test. Concomitant medications were not reported. On 23Jun2021, patient died. Seriousness of the event was considered as serious (fatal) by the physician. The outcome of the event was fatal. It was unknown whether the patient performed autopsy or not. Cause of death was sudden death, cause unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Patient died


VAERS ID: 1457827 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crossectomy; Diabetes mellitus insulin-dependent; Dyslipidaemia; Hernia inguinal; Hypertension arterial; Knee arthrodesis; Leg fracture; Total knee replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021758673

Write-up: Influenza like illness; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20211481, with safety report unique identifier FR-AFSSAPS-2021076568. This physician reported similar events for two patients. This is the first of two reports. This case is serious. The additional case is non-serious. An 82-year-old male patient received BNT162B2 (COMIRNATY), intramuscular (IM), administered in right arm on 28Apr2021 (Batch/Lot Number: ET6956) as dose 1, single for COVID-19 immunisation. Medical history included dyslipidaemia, Crossectomy -striping 2003, hypertension arterial (HTA), diabetes mellitus insulin dependent, work stopping (AT) severe leg fracture from 16May1972, knee arthrodesis, hernia inguinal, total knee replacement (PTG) right. History of COVID-19 indicated that the person is at risk of developing a severe form of COVID (DID/age), he did not have COVID-19 and has not been tested. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced influenza like illness. Severe influenza in the days following the injection presented by this patient and his wife (who was also vaccinated the same day), no medical consultation. The patient was found by his daughter on 07May2021, lying on the ground after feeling unwell. He would have remained on the ground for 2 days according to the wife (who was confused because of the influenza like illness). Hypothesis of the attending physician: COVID in view of the flu-like condition lasting several days, affecting both persons in the couple. Prolonged bed rest with dehydration, pulmonary embolism? Conclusion: Death at Day 9 (D9) of the Dose 1 (D1) of the COMIRNATY vaccine following a severe influenza syndrome lasting several days. The patient died on 07May2021. An autopsy was not performed. Event outcome was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021769991 Same reporter, suspect product and event, different patients.; Reported Cause(s) of Death: Influenza like illness


VAERS ID: 1457920 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-06-11
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002544 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Diarrhoea, Restlessness, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal impairment
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DECREASED APPETITE, RESTLESSNESS, SOMNOLENCE and DIARRHOEA in a 95-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002544) for COVID-19 vaccination. The patient''s past medical history included Chronic renal impairment since an unknown date. On 26-Apr-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced DECREASED APPETITE (seriousness criterion death), RESTLESSNESS (seriousness criterion death), SOMNOLENCE (seriousness criterion death) and DIARRHOEA (seriousness criterion death). The patient died on 12-Jun-2021. The reported cause of death was Inappetence, Restlessness, Drowsiness and Diarrhea. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reporter''s Comments: Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information is expected. Same batch number is given for both dose in source document, this seems to be incorrect.; Reported Cause(s) of Death: Inappetence; Restlessness; Drowsiness; Diarrhea


VAERS ID: 1458405 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-29
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021794942

Write-up: 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-477721. A 66-year-old male patient received bnt162b2 (COMIRNATY; Solution for injection, Lot/Batch Number: EX6537), dose 2 intramuscular, administered in arm left on 04May2021 as dose 2, 30 ug single for covid-19 immunisation. Medical history included hypertension and arteriosclerosis. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY (Lot/ Batch Number: ET3620) on 30Mar2021 for covid-19 immunisation. On 29May2021 at 15:20, the patient died in his home. An autopsy was performed, and results were not provided. This case assessed as serious (death). The outcome of the event was fatal. Sender Comment: The patient died 25 days after Comirnaty vaccination. Autopsy was done, further information is expected. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to fatal outcome.; Reported Cause(s) of Death: Death


VAERS ID: 1458406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-16
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, venous (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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: Hypertension; Ischaemic heart disease; Post cholecystectomy syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: Chest CT; Result Unstructured Data: Test Result:diagnose of pulmonary embolism and COVID-19 pneumo; Test Date: 20210416; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021827758

Write-up: drug ineffective; covid-19; covid-19 pneumonia; pulmonary embolism; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-520221. An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY concentrate for dispersion for injection, Batch number: ET3620 and Expiry date: Not reported) via intramuscular route of administration, in the right arm on 23Mar2021 as single dose for COVID-19 immunisation. The patient medical history included hypertension, ischaemic heart disease and post cholecystectomy syndrome. The patient concomitant medications were not reported. From 09Apr2021, the patient experienced weakness, cough, chills and dyspnoea. On 16Apr2021, the patient was hospitalized. His COVID-19 rapid POC test was positive. Chest CT showed pulmonary embolism and COVID-19 pneumonia. Despite medical treatment, on 21Apr2021, the patient died. Cause of death reported as drug ineffective, COVID-19, COVID-19 pneumonia and pulmonary embolism. Autopsy was performed, the results were not provided. Outcome of the events was fatal. Sender Comment: COVID-19, COVID-19 pneumonia and pulmonary embolism after vaccination with Comirnaty was not expected. TTO was 2 weeks 3 days until development of symptoms and 3 weeks 4 days until hospitalization. TTO was calculated based on the first dose of the vaccine. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events was considered not assessable per lack of information. The case was considered serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: drug ineffective; COVID-19; COVID-19 pneumonia; Pulmonary embolism


VAERS ID: 1458409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood culture, Body temperature, Bone pain, Brain natriuretic peptide, C-reactive protein, C-reactive protein increased, Cells in urine, Chest X-ray, Dyspnoea, Heart rate, Lower respiratory tract infection, Oxygen saturation, Oxygen saturation decreased, Pleural effusion, Prothrombin time, Prothrombin time prolonged, Pyrexia, Renal function test, Sputum culture, Urine analysis, White blood cell count
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Osteonecrosis (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: 2021-05-21
   Days after onset: 56
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: SANDO K [POTASSIUM BICARBONATE;POTASSIUM CHLORIDE]; ELTROXIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ASPIRIN [ACETYLSALICYLIC ACID]; SERETIDE; PARACETAMOL; BURINEX; LIPOSTAT [ATORVASTATIN CALCIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; COPD; Hypercholesterolemia; Hypothyroidism; Recurrent UTI
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood cultures; Result Unstructured Data: Test Result:no abnormalities detected; Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Date: 202104; Test Name: BNP; Result Unstructured Data: Test Result:within normal limits; Test Date: 202104; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Clear; Comments: patient had a history of COPD but there were no new findings on the X-ray, and there was no fluid present in the patient''s lungs on admission; Test Date: 202104; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Elevated ($g100); Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:high (results unspecified); Test Date: 2021; Test Name: C-reactive protein; Result Unstructured Data: Test Result:remained elevated; Test Date: 2021; Test Name: heart rhythm; Result Unstructured Data: Test Result:unable to restore normal; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Decreased; Test Date: 2021; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:continued to drop; Test Date: 202104; Test Name: Prothrombin; Result Unstructured Data: Test Result:slightly elevated; Test Date: 2021; Test Name: kidney function; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Sputum culture; Result Unstructured Data: Test Result:No abnormalities detected; Test Date: 2021; Test Name: Sputum culture; Test Result: Positive ; Comments: Sputum cultures were repeated, which were positive; Test Date: 202104; Test Name: urine; Result Unstructured Data: Test Result:Cells were present in the patient''s urine; Test Date: 202104; Test Name: WBC; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: WBC; Result Unstructured Data: Test Result:remained the same
CDC Split Type: IEPFIZER INC2021770537

Write-up: Severe pains in bones; Shortness of breath; Chest infection; Fluctuating High Temperature; Oxygen levels dropped; Cells were present in the urine; prothrombin were slightly elevated; Developed Atrial Fibrilation and Fluid on Lungs; Developed Atrial Fibrillation and fluid on lungs; CRP levels high; This is a spontaneous report from a contactable consumer (patient''s relative) downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-076616. Safety Report Unique Identifier IE-HPRA-2021-076616. This is a report received from the Regulatory Authority. A 95-year-old female patient received BNT162B2 (COMIRNATY), (Batch/Lot number was not reported) dose 2 via unknown route of administration on 24Mar2021 as single dose for COVID-19 immunisation. Medical history included Recurrent UTI (urinary tract infection), Hypothyroidism, Arthritis, Hypercholesterolaemia and chronic obstructive pulmonary disease (COPD). Concomitant medications included potassium bicarbonate, potassium chloride (SANDO K); levothyroxine sodium (ELTROXIN); esomeprazole magnesium (NEXIUM); aspirin [acetylsalicylic acid]; fluticasone propionate, salmeterol xinafoate (SERETIDE); paracetamol (Manufacturer Unknown); bumetanide (BURINEX); atorvastatin calcium (LIPOSTAT). The patient previously took first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation and experienced no reactions. On 26Mar2021, 48 hours after receiving the second dose, the patient developed shortness of breath. The patient attended her GP who prescribed Augmentin for a chest infection. The patient''s condition continued to deteriorate, she developed a high temperature (26Mar2021) and her oxygen levels dropped (2021), and the patient was admitted to hospital. On admission, a chest x-ray (Apr2021) was performed, the results of which were clear. The patient was commenced on antibiotics (unspecified). (In 2021) The patient''s oxygen levels continued to drop and the patient''s CRP levels were high (results unspecified). While in hospital (2021), the patient developed atrial fibrillation and fluid on her lungs. On 21May2021, the patient passed away. Further details indicated the patient was admitted to hospital in Apr2021 due to shortness of breath, fluctuating high temperatures, and severe pains in her bones (Apr2021). On admission, the patient''s chest X-ray was clear. The reporter outlined that the patient had a history of COPD but there were no new findings on the X-ray, and there was no fluid present in the patient''s lungs on admission. In Apr2021, Brain natriuretic peptide (BNP) was within normal limits, prothrombin were slightly elevated, C-reactive protein (CRP) levels were $g100, WBC normal. In 2021, kidney function normal, and no abnormalities detected in blood or sputum cultures. (Apr2021) Cells were present in the patient''s urine but reporter noted that the patient had a history of recurrent urinary tract infection. As the patient''s CRP levels were elevated, the patient was treated for an infection with broad spectrum antibiotics and low dose steroids. The patient was hospitalised for three weeks and during that time the patient''s CRP levels remained elevated and the patient''s WBC remained the same. The patient developed fluid in her lungs and was very short of breath, which required oxygen. The patient experienced atrial fibrillation, which the healthcare professionals were unable to restore normal heart rhythm. Three weeks after the patient''s admission, sputum cultures were repeated which were positive. This case was serious for hospitalization, fatal. The outcome of the events was fatal. The patient died on 21May2021. 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: Developed Atrial Fibrilation and Fluid on Lungs; Developed Atrial Fibrilation and Fluid on Lungs; Shortness of breath; CRP levels high; Severe pains in bones; Cells were present in the urine; Oxygen levels dropped; Fluctuating High Temperature; Chest


VAERS ID: 1458499 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Decreased appetite, Drowning, Malaise
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Myocardial infarction; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021757499

Write-up: Acute myocardial infarction; Drowning; Malaise; Appetite impaired; This is a spontaneous report from a contactable physician via Medical information group. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY; solution for injection; Lot #: FA2453; Expiration Date: 31Aug2021) via an unspecified route of administration on 21Jun2021 at 15:21 (also reported as 15:12; the day of vaccination; at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included historical condition of myocardial infarction on an unspecified date that was not ongoing, and a stent was inserted on an unspecified date and unspecified if ongoing. Concomitant medications were not reported; however, it was reported that it was confirmed that there were regularly prescribed drugs. The patient could take oral drugs, but her dosing status was uncertain (as reported). It was also reported that myocardial infarction tended to relapse when the drugs were not taken appropriately. On 22Jun2021 at unknown time (1 day after the vaccination), the patient experienced malaise and appetite impaired; the outcome of these events was not reported. On 23Jun2021 at an estimated time of 01:00 (2 days after the vaccination), the patient experienced acute myocardial infarction and drowning. On 23Jun2021 (2 days after the vaccination), the outcome of the event acute myocardial infarction was fatal. Autopsy was done. The course of the events was as follows: The first vaccination with BNT162B2 was given on 21Jun2021 at 15:12 (the day of vaccination). The estimated death time was 01:00 on 23Jun2021 (2 days after the vaccination). The patient was found dead in the bathroom. Autopsy was performed and just now finished. According to the autopsy results, the direct cause of death was drowning, and the cause of death by drowning was acute myocardial infarction. It seemed that there was no acute condition after the coronavirus vaccination, but it was said that malaise and appetite impaired were noted the next day of the vaccination. It was reported that the patient soaked in the bath in the middle of the night. She habitually took a bath when awakening in the middle of the night and she usually took a bath after taking sleeping pills, it happened a lot. The clinical outcomes of the events malaise and appetite impaired were unknown; the clinical outcomes of the events acute myocardial infarction and drowning were both fatal on 23Jun2021 at an estimated time of 01:00. An autopsy was done and revealed that the direct cause of death was drowning, and the cause of death by drowning was acute myocardial infarction. In my opinion (as a requester), it was difficult to imagine that the event was caused by the adverse reaction of the vaccination. This was my assessment and thoughts, but I am not sure. The seriousness and causality of the events were not reported.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Acute myocardial infarction and Drowning cannot be totally excluded. However, the medical history of myocardial infarction may provide a plausible alternative explanation for the events. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Drowning; Acute myocardial infarction; Autopsy-determined Cause(s) of Death: the direct cause of death was drowning; the cause of death by drowning was acute myocardial infarction


VAERS ID: 1458505 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Loss of consciousness, Troponin T, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), 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), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; JANUVIA [SITAGLIPTIN PHOSPHATE]; MECOBALAMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Facial palsy; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210622; Test Name: abdomen CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210622; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210622; Test Name: chest CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210622; Test Name: troponin T; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021758640

Write-up: Cardio-respiratory arrest; vomiting; loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115706. The patient was an 87-year and 7-month-old male. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had medical history of cerebral infarction, Parkinson''s syndrome, diabetes mellitus and facial palsy. Concomitant medications included acetylsalicylic acid (BAYASPIRIN), sitagliptin phosphate (JANUVIA) and mecobalamin (manufacturer unknown). The patient had no relevant family history. On 19Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization at the age of 87-years. On 22Jun2021 at 18:05 (3 days after the vaccination), the patient developed cardio-respiratory arrest and died. The patient was hospitalized on that day. It was not reported if an autopsy was performed. The course of the events was as follows: On 22Jun2021, after dinner, vomiting was noted and then loss of consciousness occurred. When an emergency service team arrived, the patient was in cardio-respiratory arrest. When entering the reporter''s hospital, he was in asystole. Head CT, chest CT, abdomen CT and troponin T test did not show abnormalities. Cardiopulmonary resuscitation was attempted but it did not succeed. The reporting physician classified the event as serious (fatal outcome and hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. A possible cause of the event was reported as follows: The cause of death was unclear but there was a high possibility that the patient chocked on vomit which resulted in death.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1458526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiac disorder, Coma scale, Depressed level of consciousness, Fall, Pulmonary embolism, Traumatic intracranial haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic thromboembolic pulmonary hypertension (receiving domiciliary oxygen therapy); Oxygen therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: at 08:30; Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210619; Test Name: Coma Scale; Result Unstructured Data: Test Result:100; Comments: at 08:30
CDC Split Type: JPPFIZER INC2021769909

Write-up: blood pressure decreased; Depressed level of consciousness; pulmonary embolism was suspected; Cerebral haemorrhage due to fall or heart disease; Cerebral haemorrhage due to fall or heart disease; fell down; lumbar backache; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21115795. The patient was an 84-year and 7-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included chronic thromboembolic pulmonary hypertension, and for the treatment, the patient was receiving domiciliary oxygen therapy. The patient''s condition stabilized since she was admitted to a nursing home in Jul2020. Other concomitant medications included anticoagulant agent, apixaban (ELIQUIS). Family history was not provided. On 14Jun2021 at 11:00 (the day of vaccination), the patient received the dose number unknown (reported as first dose-pending clarification) of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 15Jun2021 (1 day after the vaccination) in the morning, the patient fell down inside the nursing home. In that evening, lumbar backache appeared. Therefore, the patient was referred to an orthopedic clinic by the physician where no fracture was recognized. Her clinical course was to be followed. Until 19Jun2021 at 07:00, no change had been noted. On 19Jun2021, after the meal at 08:30 (5 days after the vaccination), her blood pressure decreased and depressed level of consciousness was noted (coma scale 100). The patient was transferred to a hospital by an ambulance and was hospitalized on that same day of 19Jun2021. On 21Jun2021 (7 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event of depressed level of consciousness as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: The patient had an underlying disease. Given the sudden onset of the episode, a possibility of pulmonary embolism was suspected. Cerebral haemorrhage due to fall or heart disease could be considered as a cause of the event as well; Reported Cause(s) of Death: Depressed level of consciousness; blood pressure decreased; pulmonary embolism was suspected; Cerebral haemorrhage due to fall or heart disease; Cerebral haemorrhage due to fall or heart disease


VAERS ID: 1458539 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OLMETEC; MAINTATE; LIVALO; AMLODIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021771572

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 81-year-old female at the time of vaccine administered and event onset. On 18Jun2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. The patient had no allergies to medications, food, or other products. Other medical history included hypertension and dyslipidemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received olmesartan medoxomil (OLMETEC) 20, bisoprolol fumarate (MAINTATE) 2.5, pitavastatin calcium (LIVALO) 1, and amlodipine besilate (AMLODIN) 5 within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Jun2021 (2 days after the vaccination), the patient experienced cerebral infarction. The event resulted in emergency room/department or urgent care, hospitalization, and death. Number of days of hospitalization was 2 days. The course of the event was as follows: On 18Jun2021, the patient received the vaccine. On 20Jun2021, the patient developed cerebral infarction, which subsequently aggravated and the patient died. Death date was not confirmed; however, it was 21Jun2021 or 22Jun2021. The reporting physician classified the event as serious (death and hospitalization). Autopsy was not performed. The causality assessment was not provided. The outcome of the event was fatal with unspecified treatment for cerebral infarction.; Sender''s Comments: Based on the information currently available and known drug safety profile, the reported event cerebral infarction more likely represented intercurrent illness, but not related to BNT162b2.The patient''s underlying risk factors/predisposing condition hypertension and dyslipidemia and the advanced age of the patient have been assessed to provide alternative explanations. 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: Cerebral infarction


VAERS ID: 1458573 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Anaphylactic reaction, Blood pressure measurement, Body temperature, Heart rate, Respiratory disorder
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (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), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Myocardial infarction old
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:65/47 mmHg; Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210623; Test Name: Heart rate; Result Unstructured Data: Test Result:90 bpm
CDC Split Type: JPPFIZER INC2021785404

Write-up: Anaphylaxis; consciousness disturbed; respiratory status aggravated; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21116345. An 84-year and 9-month-old male patient received the 2nd dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on 23Jun2021 at 15:42 at age of 84 years old as a single dose for COVID-19 immunization. Medical history included myocardial infarction old and emphysema. Body temperature before vaccination was 36.4 degrees centigrade on 23Jun2021. Family history was not reported. Concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (COMIRNATY, lot number: EW4811, expiration date: 31Jul2021) on an unspecified date for COVID-19 immunisation. On 23Jun2021 at 16:30 (48 minutes after the vaccination), the patient experienced anaphylaxis. On 23Jun2021 (on the same day of the vaccination), the patient was admitted to the hospital. On 23Jun2021 (on the same day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 23Jun2021 at 15:42, the patient received the second coronavirus vaccine. Because of complication of myocardial infarction old and emphysema, the patient waited in the hospital for 30 minutes and symptoms were observed. Since there was no change, the patient got into a private car to return home. Shortly after 16:30, the car was not moving and the patient was found to have respiratory status aggravated and consciousness disturbed in the car. The patient was transferred to the hospital again. Pupils were dilated, blood pressure was 65/47 mmHg, and heart rate was 90 bpm. At 16:44, EPIPEN was injected intramuscularly. While undergoing cardiopulmonary resuscitation by emergency medical technician, the patient was transferred to another hospital. The patient was admitted to the hospital from 23Jun2021 to 23Jun2021. Outcome of the events was fatal. It was unknown if autopsy was performed. The reporting physician classified the event as serious (life-threatening and hospitalization) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was emphysema. The reporting physician commented as follows: Although onset was more than 30 minutes after the vaccination, anaphylaxis was likely. ; Reported Cause(s) of Death: respiratory status aggravated; consciousness disturbed; Anaphylaxis; Emphysema


VAERS ID: 1458622 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-06
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Coronary artery embolism, Death, Intracardiac thrombus
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 82
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Blood pressure
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Blood clots in his heart, embolism
CDC Split Type:

Write-up: Death in 2 1/2 months


VAERS ID: 1458658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune system disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210706459

Write-up: THE IMMUNE SYSTEM HAS GONE HAYWIRE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00594978] concerned a 53 year old female. 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 and batch number were not reported) 1 dosage forms, 1 total, administered on 06-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-JUN-2021, the patient''s immune system had gone haywire. Immune system had attacked the lungs. On 19-JUN-2021, the patient died from lung disorder and immune system disorder. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210706459-COVID-19 VACCINE AD26.COV2.S-Immune system disorder. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: LUNG DISORDER; IMMUNE SYSTEM DISORDER


VAERS ID: 1458746 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC2021835220

Write-up: It got worse after getting the vaccine; pneumonia; This is a spontaneous report from a contactable consumer. This is a report based on information received by Pfizer from Biontech Se, manufacurer countrol number is 70567, license party for BNT162B2. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jun2021, at the age of 24-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. It was unknown if the patient was pregnant. Medical history included ongoing epilepsy. The patient''s concomitant medications were not reported. Approximately 25 days before (on 07Jun2021) the 1st dose with BNT162B2, it got worse after getting the vaccine. She died of pneumonia on the 10th day after the vaccination (approximately 15 days before on 17Jun2021) while she was in the hospital. The patient was hospitalied from an unspecified date. Therapeutic measures were taken as a result of pneumonia. The outcome of the event pneumonia was fatal. The outcome of the event "got worse after getting the vaccine" was unknown. It was not reported if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia


VAERS ID: 1459314 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002616) for COVID-19 vaccination. The patient''s past medical history included Psychiatric disorder NOS and Arterial hypertension. Previously administered products included for Product used for unknown indication: RISPERDAL. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 20-Jun-2021 The patient died on 20-Jun-2021. The cause of death was not reported. An autopsy was not performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021082913 Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Translated document received on 06-Jul-2021, substance information of historical drug updated.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Details regarding the Cause of death/autopsy report or circumstances surrounding the death is required for further assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1459492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2612 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AFPFIZER INC2021778253

Write-up: mazones/patient died; This is a spontaneous report received from a non-contactable other health professional (also reported as a pharmacist) via the Agency. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (Batch/Lot Number: 2612), as dose number unknown, single, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. On an unspecified date, the patient experienced "mazones" (as reported) and died. Treatment was reported as unknown. Date of death was not reported. Autopsy was performed and the cause of death was reported as "vaccine". The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 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: mazones/patient died/vaccine


VAERS ID: 1459499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-31
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adipositas (Obesity); Depression (Depression); Hypertension (Hypertension); Kidney stones (Kidney stones left); Peritonitis (Chronic adhesive peritonitis); Renal cyst (Kidney cyst right); Sigmoid diverticulosis (Diverticulosis of the sigmoid colon); Uterine myomatosis (Uterus Myomatosus); Ventricular hypertrophy (Hypertrophy of the left ventricle)
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy (Gall bladder surgically removed)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021778985

Write-up: Deep vein thrombosis right; Central and peripheral pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-33051. A 54-year-old female patient received first dose of BNT162B2 (COMIRNATY) intramuscular on 19May2021 (Batch/Lot Number: FA4598) as DOSE 1, SINGLE for covid-19 immunization. Medical history included cholecystectomy (Gall bladder surgically removed), ongoing Kidney stones (Kidney stones left), ongoing Renal cyst (Kidney cyst right), ongoing Sigmoid diverticulosis (Diverticulosis of the sigmoid colon), ongoing Depression, ongoing Uterine myomatosis (Uterus Myomatosus), ongoing Hypertension, ongoing Ventricular hypertrophy (Hypertrophy of the left ventricle), ongoing Peritonitis (Chronic adhesive peritonitis) and ongoing Adipositas (obesity). The patient''s concomitant medications were not reported. The patient experienced central and peripheral pulmonary embolism on 31May2021 and deep vein thrombosis right on an unspecified date. The patient died on 31May2021. The autopsy determined cause of death was reported to be Pulmonary embolism. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: central and peripheral pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1459537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: ASAFLOW; BISOPROLOL; BURINEX; CLEXANE; LIPITOR; LORMETAZEPAM; PAROXETINE
Current Illness: Heart failure with preserved ejection fraction; Hip prosthesis user; Left ventricular hypertrophy; Myocardial infarction; Trifascicular block
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210704267

Write-up: DEATH; ASYSTOLE; CARDIOVASCULAR PROBLEM; This spontaneous report received from a physician via a Regulatory Authority [BE-FAMHP-DHH-N2021-99628] concerned a 96 year old female. Initial information was processed along with the additional information received from patient on 07-JUL-2021. The patient''s weight was 75.3 kilograms, and height was not reported. The patient''s concurrent conditions included heart failure with preserved ejection fraction, left ventricular hypertrophy, myocardial infarction, hip prosthesis, and trifascicular block. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1303 expiry: UNKNOWN) dose was not reported, 1 total administered on 29-JUN-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, atorvastatin calcium, bisoprolol, bumetanide, enoxaparin sodium, lormetazepam, and paroxetine. On 30-JUN-2021, the patient experienced asystole (as a result of myocardial infarction) and had cardiovascular problem. On 30-JUN-2021, the patient died due to unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of asystole and cardiovascular problem on 30-JUN-2021. This report was serious (Death).; Reporter''s Comments: Evolution of the ADR - Deceased ADR description - Asystole (as a result of myocardial infarction?) and death in 96-year-old patient with already very high vascular risk - chronic heart failure and trifascicular block.; Sender''s Comments: V0: 20210704267-Covid-19 vaccine ad26.cov2.s- death, asystole and cardiovascular problem. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1461506 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021781063

Write-up: Death NOS; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021050625. A 77-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 22Apr2021 (Batch/Lot Number: EW4815) (at age 77 years old) as dose 1, single for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death NOS (found deceased in bed) on 28Apr2021, day 7 after 1st dose. The patient died on an 28Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1461507 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac disorder, Coma, SARS-CoV-2 test
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), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive bronchopneumopathy; Diabetes mellitus; Spondylarthritis
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021781065

Write-up: coma; Arrest cardiac; heart malaise; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021059483. An 83-year-old male patient received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 06May2021 at 10:30 (Batch/Lot Number was not reported) (at the age of 83-year-old) as single dose for COVID-19 immunisation. Medical history included spondylarthritis, diabetes mellitus and chronic obstructive bronchopneumopathy, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced heart malaise at 10:00 p.m. until 3:00 a.m. (on the 07May2021), cardiac arrest on 07may2021 (mid-afternoon), coma and death on the 08May2021 at 7:05 a.m. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: cardiac arrest; heart malaise; coma


VAERS ID: 1461509 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (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: 2021-05-31
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive airways disease (Post-tobacco COPD); Dyslipidaemia; Hypertension arterial; Obesity (BMI 40)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021781129

Write-up: Arrest cardiac; asthenia; febrile; dyspnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021065682. A 69-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26May2021, at the age of 69-years-old, (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included obesity (BMI 40), chronic obstructive pulmonary disease, dyslipidaemia, hypertension. The patient''s concomitant medications were not reported. Since vaccination the patient experienced asthenia, febrile and dyspnea with outcome of unknown and on 31May2021 the patient experienced arrest cardiac and died. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1461516 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastric disorder, Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Depression; Hypertension arterial; Obesity; Sleep apnoea syndromes
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021781264

Write-up: Rheumatic purpura; serious digestive impairment; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021071097. This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021071097. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 unknown on 12Feb2021 at the age of 73-year-old (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), obesity, hypertension arterial, depression, sleep apnoea syndrome. Patient had not the COVID. The patient''s concomitant medications were not reported. On 25Feb2021 the patient experienced severe rheumatic purpura with serious digestive impairment, with fatal outcome. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Note: 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 possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: serious digestive impairment; Rheumatic purpura


VAERS ID: 1461535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4818 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Ascites, Aspartate aminotransferase, Atrial fibrillation, Blood alkaline phosphatase, Blood creatinine, Blood electrolytes, Blood pressure measurement, Blood thyroid stimulating hormone, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Cardiovascular examination, Cognitive disorder, Creatinine renal clearance, Disorientation, Disturbance in attention, Electrocardiogram, Gamma-glutamyltransferase, Gastrointestinal examination, Haemoglobin, Heart rate, Hyperuricaemia, Lung disorder, Neurological examination, Oxygen saturation, Platelet count, Psychomotor retardation, Pulmonary physical examination, Renal failure, Troponin, Ultrasound abdomen, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GAVISCON [ALGELDRATE;SODIUM ALGINATE]; PANTOPRAZOLE; COTAREG; XARELTO; CORDARONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm of abdominal aorta; Ischaemic heart disease; Mitral valve replacement; Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: glutamo pyruvic transaminase; Result Unstructured Data: Test Result:69 IU/l; Test Date: 202105; Test Name: glutamo oxaloacetic transaminase; Result Unstructured Data: Test Result:118 IU/l; Test Date: 202105; Test Name: Alkaline Phophatase; Result Unstructured Data: Test Result:normal; Test Date: 202105; Test Name: creatinine; Result Unstructured Data: Test Result:116 umol/l; Test Date: 202105; Test Name: creatinine; Result Unstructured Data: Test Result:502 umol/l; Test Date: 20210515; Test Name: creatinine; Result Unstructured Data: Test Result:637 umol/l; Test Date: 202105; Test Name: blood ionogram; Result Unstructured Data: Test Result:shows a serum potassium at 5.4 mmol / L; Test Date: 202105; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20210511; Test Name: blood pressure; Result Unstructured Data: Test Result:161/117 mmHg; Test Date: 202105; Test Name: TSH; Result Unstructured Data: Test Result:0.57 MiU/L; Comments: normal; Test Date: 202105; Test Name: Pro- Brain natriuretic peptide; Result Unstructured Data: Test Result:6331 pg/mL; Test Date: 202105; Test Name: Pro- Brain natriuretic peptide; Result Unstructured Data: Test Result:29362 pg/mL; Comments: difficult to interpret; Test Date: 20210511; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:, rapid, irregular heart sounds; Comments: Moderate edema of the lower limbs on both sides. Clinical degradation suggesting heart failure; Test Date: 202105; Test Name: c-reactive protein; Result Unstructured Data: Test Result:36.3 mg/l; Test Date: 202105; Test Name: clearance; Result Unstructured Data: Test Result:48 ml/min; Test Date: 202105; Test Name: clearance; Result Unstructured Data: Test Result:8 ml/min; Test Date: 20210515; Test Name: clearance; Result Unstructured Data: Test Result:6 ml/min; Test Date: 20210511; Test Name: ECG; Result Unstructured Data: Test Result:fast atrial fibrillation; Test Date: 202105; Test Name: gamma glutamyl transpeptidase; Result Unstructured Data: Test Result:normal; Test Date: 20210511; Test Name: digestive examination; Result Unstructured Data: Test Result:tense abdomen, doubt about the presence of ascites; Test Date: 202105; Test Name: hemoglobin; Result Unstructured Data: Test Result:146 g/l; Test Date: 20210511; Test Name: heart rate; Result Unstructured Data: Test Result:71 bpm; Test Date: 20210511; Test Name: neurological examination; Result Unstructured Data: Test Result:no motor deficit, osteotendinous reflexes..; Comments: ..not found; Test Date: 20210511; Test Name: oxygen saturation; Test Result: 84 %; Test Date: 202105; Test Name: platelet; Result Unstructured Data: Test Result:260 x10 9/l; Test Date: 20210511; Test Name: pulmonary exmaination; Result Unstructured Data: Test Result:decrease in vesicular murmur..; Comments: ..on the right side, dyspnea on slightest effort, presence of hepato-jugular reflux, the patient describes constricting median chest pain; Test Date: 20210504; Test Name: troponin; Result Unstructured Data: Test Result:46 ng/L; Test Date: 202105; Test Name: troponin; Result Unstructured Data: Test Result:112 ng/L; Test Date: 202105; Test Name: troponin; Result Unstructured Data: Test Result:347 ng/L; Test Date: 202105; Test Name: Abdomino-pelvic ultrasound; Result Unstructured Data: Test Result:eliminates a urinary globe..; Comments: ..no dilation of the urinary tract, no renal tumor syndrome; Test Date: 202105; Test Name: leukocytes; Result Unstructured Data: Test Result:9.4 x10 9/l
CDC Split Type: FRPFIZER INC2021779268

Write-up: Acute kidney injury; Insufficiency cardiac/ Flare-up of heart failure/ cardiac decompensation; lung disease; renal failure; Ascites without evidence of portal hypertension, presumably related to cardiac decompensation; Appearance of cognitive impairment with psychomotor slowing and disorientation, probably related to hyperuricaemia; Appearance of cognitive impairment with psychomotor slowing and disorientation, probably related to hyperuricaemia; Appearance of cognitive impairment with psychomotor slowing and disorientation, probably related to hyperuricaemia; Appearance of cognitive impairment with psychomotor slowing and disorientation, probably related to hyperuricaemia; disturbances in vigilance; Fibrillation atrial aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021078843. An 88-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in right arm on 14Apr2021 (Batch/Lot Number: EW4818) as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history included Paroxysmal atrial fibrillation; ischemic heart disease ; mitral valve replacement (2007); abdominal aortic aneurysm. Concomitant medications included algeldrate, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) taken for an unspecified indication, start and stop date were not reported; pantoprazole taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, valsartan (COTAREG) taken for an unspecified indication, start and stop date were not reported; rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; and amiodarone hydrochloride (CORDARONE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced acute kidney injury and insufficiency cardiac (Flare-up of heart failure, as reported). In May2021, patient experienced fibrillation atrial aggravated. Over the next few days/a few days after the 2nd dose (according to the family): onset of dyspnea followed by edematous syndrome and chest pain. The patient was afebrile. He was put on amoxicillin for lung disease. On 04May2021 troponin at 46 ng / L, introduction of LOXEN 20. The patient was finally hospitalized on 11May2021, with at entry: Cardiovascular examination: blood pressure 161/117 mmHg, 71 bpm, 84% oxygen saturation, rapid, irregular heart sounds. Moderate edema of the lower limbs on both sides. Clinical degradation suggesting heart failure. ECG: Fast atrial fibrillation. Pulmonary examination: decrease in vesicular murmur on the right side, dyspnea on slightest effort, presence of hepato-jugular reflux, the patient describes constricting median chest pain. Digestive examination: tense abdomen, doubt about the presence of ascites. Neurological examination: no motor deficit, osteotendinous reflexes not found. In total: table of global cardiac decompensation with a transition to rapid atrial fibrillation. The patient treated with LASILIX at a dose of 80 mg intravenously as well as NEBIVOLOL 5 mg: 1/2 tablet and VALSARTAN 80 mg. CORDARONE was continued. Lab tests in May2021 included Hemoglobin 146 g / L, leukocytes 9.4 G / L, platelets 260 G / L, normal electrolytes, creatinine 116 ?mol / L i.e. a clearance of 48 mL / min, c-reactive protein 36.3 mg / L, glutamo oxaloacetic transaminase 118 U / L, glutamo pyruvic transaminase 69 U / L, gamma glutamyl transpeptidase + Alkaline Phophatase normal, TSH normal at 0.57 mIU / L, Pro- Brain natriuretic peptide, elevated at 6331 pg / mL, troponin at 112 ng / L. Unfortunately, the patient does not respond to diuretic treatment, persistent edema, dyspnea. The patient will gain even a kilo in forty-eight hours. Biologically, renal failure with a creatinine which increases to 502 ?mol / L, ie a clearance of 8 mL / min. Abdomino-pelvic ultrasound eliminates a urinary globe, no dilation of the urinary tract, no renal tumor syndrome. The blood ionogram shows a serum potassium at 5.4 mmol / L, Pro-BNP difficult to interpret at 29362 pg / mL. Troponin also rises to 347 ng / L. Ascites without evidence of portal hypertension, presumably related to cardiac decompensation. In view of the overall cardiac decompensation, no dialysis treatment is considered, which could even be deleterious. LASILIX is reinforced up to 1 g / d by limiting the hydration to 500cc of glucose serum. Very reserved prognosis. Despite the increase in diuretics to 1 g and even 1.5 g / day, still no resumption of diuresis. Appearance of cognitive impairment with psychomotor slowing and disorientation, probably related to hyperuricaemia. The evolution continued towards disturbances in vigilance. No resumption of diuresis. As of 15May, creatinine is 637 ?mol / L, ie a clearance of 6 mL / min. The events fibrillation atrial aggravated, acute kidney injury and insufficiency cardiac (Flare-up of heart failure, as reported) led to fatal outcome; and unknown outcome for the other events. The patient died at the beginning of the afternoon, on 16May2021. No autopsy was done. Reporter''s comments: Appearance of dyspnea with edema of the lower limbs. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Appearance of dyspnea with edema of the lower limbs; Reported Cause(s) of Death: Acute kidney injury; Fibrillation atrial aggravated; Flare-up of heart failure


VAERS ID: 1461537 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-06-13
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, 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: 2021-06-21
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic renal insufficiency (Chronic renal failure); Coronaropathy (coronary artery disease); COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography; Result Unstructured Data: Test Result:objectifying covid-19 infection without bacterial; Comments: objectifying covid-19 infection without bacterial superinfection.; Test Date: 20210613; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: FRPFIZER INC2021779265

Write-up: This is a spontaneous report from a contactable pharmacist. The regulatory authority report number is [FR-AFSSAPS-2021079763]. A 97-year-old male patient received bnt162b2 (Comirnaty, Solution for injection, Lot number: EJ6788), dose 1 via an intramuscular route administration on 27Jan2021 as dose 1, 0.3 ml, single for covid-19 immunization and received bnt162b2 (Comirnaty, Solution for injection, Lot number: EM6950), dose 2 via an intramuscular route administration on 17Feb2021 as dose 2, 0.3 ml, single for covid-19 immunization. The patient medical history included chronic renal insufficiency (chronic renal failure), covid-19, arterial hypertension, and coronaropathy. The patient''s concomitant medications were not reported. On 13Jun2021, the patient experienced vaccination failure. On the night of 13Jun to 14Jun2021, hospitalization for acute coronary syndrome. Screening positive for Sars-Cov-2 (by PCR) on admission to hospital. The chest scanner confirms the pulmonary involvement of COVID-19 without bacterial superinfection. Oxygen-requiring patient, with congestion and productive cough. The patient underwent laboratory tests and procedures which included Computed tomography shows objectifying covid-19 infection without bacterial (objectifying covid-19 infection without bacterial superinfection) on an unspecified date and SARS-CoV-2 test: positive on 13Jun2021. Variant search: unusable because the 2nd sample is negative for Sars-Cov-2. The patient was died due to Covid-19 on 21Jun2021. Autopsy was not performed. The outcome of the event was fatal. Reporter''s Comment: Hospitalization for acute coronary syndrome on the night of 13Jun to 14Jun2021. On admission to the emergency room, tested positive for covid. This is the first episode of covid-19, patient tested negative during several campaigns within the establishment, notably in November 2020. Research for variant in progress. Patient feverless but requiring O2, with congestion and non-productive cough. Computed tomography objectifying covid infection without bacterial superinfection. Follow-up (28Jun2021): New information consisted in investigation results for lots EJ6788 and EM6950 provided by Product Quality group. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Hospitalization for acute coronary syndrome on the night of 13Jun to 14Jun2021. On admission to the emergency room, tested positive for covid. This is the first episode of covid-19, patient tested negative during several campaigns within the establishment, notably in November 2020 [...]; Reported Cause(s) of Death: Covid-19


VAERS ID: 1461566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-28
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, C-reactive protein, Computerised tomogram, Electrocardiogram, Haemoglobin, Intestinal ischaemia, Platelet count, White blood cell count
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; FLUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrodesis; Elbow operation; Hypercholesterolaemia; Hypertension arterial; Orchidectomy (testicular tumor treated by radiochemotherapy and orchiectomy (40 years ago)); Radiochemotherapy (testicular tumor treated by radiochemotherapy and orchiectomy (40 years ago)); Testicular neoplasm (testicular tumor treated by radiochemotherapy and orchiectomy (40 years ago))
Allergies:
Diagnostic Lab Data: Test Name: lactate; Result Unstructured Data: Test Result:increased; Test Name: Abdominopelvic CT scan; Result Unstructured Data: Test Result:calcified atheromatous infiltration; Comments: marked calcified atheromatous infiltration of the abdominal aorta and the dividing branches with a thrombosis of the birth of the superior mesenteric artery over approximately 4 cm with reinjection of downstream and a celiac trunk also pathologically stenotic. Diagnosis of early acute mesenteric ischemia.; Test Date: 20210613; Test Name: Abdominopelvic CT scan; Result Unstructured Data: Test Result:dilated jejunal loops without junction zone; Comments: Permeability of the superior mesenteric artery. A few dilated jejunal loops without junction zone, functional appearance. So no mesenteric ischemia, no occlusive syndrome, no infectious focus.; Test Date: 20210614; Test Name: Abdominopelvic CT scan; Result Unstructured Data: Test Result:millimeter endoluminal defect of the upper artery; Comments: Abdominopelvic scanner: Unlike the scan of the day before, a millimeter endoluminal defect of the upper mesenteric artery at the immediate exit of the stent, with an almost immediate resumption of flow to distality in its collaterals. In addition, defect at the level of the middle third and at the distality of the stent, giving rise to suspicion of the start of a thrombus.; Test Date: 20210615; Test Name: Abdominopelvic CT scan; Result Unstructured Data: Test Result:jejunal mesenteric ischemia; Comments: jejunal mesenteric ischemia with sign of severity (parietal emphysema) + aeromesenteria; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Name: ECG; Result Unstructured Data: Test Result:without abnormalities; Test Date: 20210613; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: hemoglobin; Result Unstructured Data: Test Result:stable; Test Date: 20210530; Test Name: platelets; Result Unstructured Data: Test Result:181 x10 9/l; Test Date: 20210601; Test Name: platelets; Result Unstructured Data: Test Result:166 x10 9/l; Test Date: 20210603; Test Name: platelets; Result Unstructured Data: Test Result:269 x10 9/l; Test Date: 20210613; Test Name: platelets; Result Unstructured Data: Test Result:507 x10 9/l; Test Date: 20210615; Test Name: platelets; Result Unstructured Data: Test Result:459 x10 9/l; Test Date: 20210616; Test Name: platelets; Result Unstructured Data: Test Result:446 and 472 x10 9/l; Test Name: leucocyte; Result Unstructured Data: Test Result:13.5 x10 9/l; Comments: hyperleukocytosis; Test Date: 20210613; Test Name: leucocyte; Result Unstructured Data: Test Result:27.6 x10 9/l
CDC Split Type: FRPFIZER INC2021779156

Write-up: This is a spontaneous report from a contactable physician. The regulatory authority number is FR-AFSSAPS-RS20212003. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 22Apr2021 (Batch/Lot Number: EW4815) as dose 1, single, then intramuscular on 10Jun2021 (Batch/Lot Number: SC1526) as dose 2, single for COVID-19 immunisation. Medical history included testicular neoplasm, radiochemotherapy, hypercholesterolaemia, arthrodesis, hypertension arterial, elbow operation and orchidectomy. Concomitant medications included amlodipine; and fluvastatin. On 28May2021, the patient experienced mesenteric ischaemia. Event details were as follows: The patient received 1st dose COMIRNATY (batch: EW4815) on 22Apr2021. 36 days later, ie 28May2021: the patient presented to the emergency room with a picture of sudden onset abdominal pain associated with vomiting for 24 hours. Tachycardia patient. ECG without abnormalities. Laboratory assessment: Inflammatory syndrome with hyperleukocytosis at 13.5 G / L, increased CRP and lactates. Abdominopelvic CT scan: marked calcified atheromatous infiltration of the abdominal aorta and the dividing branches with a thrombosis of the birth of the superior mesenteric artery over approximately 4 cm with reinjection of downstream and a celiac trunk also pathologically stenotic. Diagnosis of early acute mesenteric ischemia. 29May2021, emergency laparotomy for thrombectomy of the superior mesenteric artery with Fogarty. Stenting angioplasty of the proximal superior mesenteric artery. Ileocecal resection with protective ileo-colostomy in a gun barrel. Favorable evolution during hospitalization: abdominal pain improves. The patient''s transit resumes. The puncture site comes back clean and the scars are clean, non-inflammatory. Hemoglobin is stable. 30May2021: platelets = 181 G / L [N: 150-400G /L]; 01Jun2021: platelets = 166 G / L; 03Jun2021: platelets = 269 G / L. 07Jun2021: discharge to rehabilitation establishment, with resumption of usual treatment and addition of Kardegic 75mg. 10Jun2021: 2nd dose Comirnaty (batch: SC1526). 2 days later, ie 12Jun2021: presents with anorexia, asthenia, nausea, hyperthermia, and several episodes of vomiting. Productive ostomy. Consult the emergency room on 13Jun2021 for this reason. The patient also describes pain in the left arm, which he links to the vaccination. Normal ECG. Organic balance: platelets = 507 G / L. Leukocytes 27.6 G / L. Entry treatment: tamsulosin LP 0.4mg / d, loperamide 8gel / d, Kardegic 75mg, Lovenox 4000 IU / d, pantoprazole 40mg / d. Abdominopelvic CT scan: Permeability of the superior mesenteric artery. A few dilated jejunal loops without junction zone, functional appearance. So no mesenteric ischemia, no occlusive syndrome, no infectious focus. Suspicion of post-vaccination influenza-like illness. Return to the rehabilitation center. On D4 of D2, i.e. 14Jun2021: New hospitalization for abdominal pain. Abdominopelvic scanner: Unlike the scan of the day before, a millimeter endoluminal defect of the upper mesenteric artery at the immediate exit of the stent, with an almost immediate resumption of flow to distality in its collaterals. In addition, defect at the level of the middle third and at the distality of the stent, giving rise to suspicion of the start of a thrombus. Persistence of a discreet dilation of a few jejunal loops without obvious transition zone. No defect of parietal enhancement of the digestive loops or sign of suffering. Marked atheromatous infiltration of the abdominal aorta and its digestive and urinary branches which remain permeable. So relapse of mesenteric ischemia on a thrombosed stent. Stability of the rest of the imagery. Very productive stoma with doubt about the purplish appearance of the stoma. Vascular surgery advice: Heparin IVSE 3000IU / kg, on an empty stomach. 15Jun2021: new operation with failure of recanalization of the superior mesenteric artery and stenting angioplasty of the celiac trunk. Organic: platelets = 459 G / L [N: 150-400G / L]; CT: jejunal mesenteric ischemia with sign of severity (parietal emphysema) + aeromesenteria; Clinically at H4: normotensive, tachycardium. Contractured abdomen. Pink stoma; Re-reading CT: CT appearance in favor of jejunal ischemia with signs of severity probably increased since the CT. Superior mesenteric intrastent thrombosis continuing proximally to the superior mesenteric artery with probable occlusion of jejunal branches. Celiac intrastent thrombosis continuing in the common hepatic artery. Specialist opinion: no action in the face of the very proximal involvement with probable impossibility of raising the stoma to the skin and the absence of therapy for the initial problem. 16Jun2021: platelets = 446 G / L and 472 G / L [N: 150-400G / L]; no testing for anti-PF4 antibodies. Evolution: death of the patient on 06/17/21 as a result of mesenteric ischemia. In total: 66-year-old patient with a history of hypertension and hypercholesterolemia, having presented a first episode of mesenteric ischemia 36 days after D1 of the Comirnaty vaccine with favorable outcome after placement of a stent and then recurrence ve of mesenteric ischemia with thrombosis on a stent without thrombocytopenia 4 days after D2 of the Comirnaty vaccine, ischemia which led to the death of the patient. The patient died due to mesenteric ischaemia on 17Jun2021, an autopsy was not performed. The regulatory authority considered the event as serious, resulting in death.; Reported Cause(s) of Death: mesenteric ischaemia


VAERS ID: 1461583 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021809198

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-APPCOVID-202106261140059230-KCTBZ, Safety Report Unique Identifier GB-MHRA-ADR 25549734. A 86-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 (at the age of 86-years old) as dose 2, single for COVID-19 immunization. The patient medical history included aortic valve stenosis (diagnosed 5 years earlier; did not undergo surgery for stents due to dementia) and dementia. The patient had not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced no adverse event. On 03Mar2021, the patient experienced heart failure. On an unspecified date, the patient experienced shortness of breath. The patient''s hospitalization was prolonged as a result of the events. Clinical course was as follows: The reporter stated that their elderly mother (patient) was in care home with dementia. She had her second COVID vaccine on 03Mar2021 and was rushed into hospital 2 days later with shortness of breath. She had an underlying health condition aortic valve stenosis diagnosed 5 years earlier. The decision at the time was not to undergo surgery for stents given her dementia. The reporter stated that their mother (patient) was confirmed as needing end of life care and subsequently died on 12Mar2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Mar2021 No - Negative COVID-19 test. The cause of death was reported as heart failure. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1462198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Headache, Pneumonia, SARS-CoV-2 test, Skin haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 16
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: 20210312; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021796660

Write-up: Large blood blotches; Headache; Suspected pneumonia; Difficulty breathing; Death; This is a spontaneous report from a contactable consumer from the regulatory authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202106211229570970-ECIJJ. A 98-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) dose 2 via an unspecified route of administration on 01Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunization. The patient experienced death on 17Apr2021, and on an unspecified date, patient experienced difficulty breathing, headache, large blood blotches, suspected pneumonia . The patient underwent lab tests and procedures which included sars-cov-2 test results negative on 12Mar2021. The patient died on 03May2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of event death was fatal and for rest of the events it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1462451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021784423

Write-up: Miscarriage; This is a spontaneous report received from a contactable consumer. This is a report received from the Regulatory Authority report. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech covid-19 vaccine, Solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration on 19may2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19, not had a covid-19 test. Patient was not enrolled in clinical trial. Patient has not tested positive for covid-19 since having the vaccine. On an unspecified date. patient experienced miscarriage (abortion spontaneous). The patient died on 19May2021. It was not reported if an autopsy was performed. Note: The week patient was given first vaccine, baby died and eventually miscarriaged following the discovery of this at 12 week scan. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1462595 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Echocardiogram, Electroencephalogram, Investigation, Magnetic resonance imaging, Respiratory arrest, Resuscitation, SARS-CoV-2 test, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; DESOGESTREL; LAMOTRIGINE; PROPRANOLOL; ZOLMITRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxious mood (This phase may last for about 5 to 10 minutes.); Chest pain - cardiac; Epilepsy; Focal seizures (with atypical features); Hot feeling generalised (at times disconnected and not fully aware of what is going on.); Lactation decreased; Loss of consciousness (being investigated with Neurology and Cardiology); Migraine; Obesity; Pain; Seizures; Sickness; Stomach pain ((as if she has eaten something dodgy) and the urge to defecate.)
Allergies:
Diagnostic Lab Data: Test Name: Echo; Result Unstructured Data: Test Result:normal; Test Name: EEG; Result Unstructured Data: Test Result:no obvious issues; Test Name: Investigated in Cardiology; Result Unstructured Data: Test Result:there were post-ictals; Test Name: MRI; Result Unstructured Data: Test Result:no obvious issues; Test Name: CPR; Result Unstructured Data: Test Result:performed; Comments: transferred to hospital; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021809033

Write-up: This is a report received from the Regulatory Authorities. Regulatory authority report number GB-MHRA-WEBCOVID-202106251523276650-LR5NE. Safety Report Unique Identifier GB-MHRA-ADR 25544473. A 28-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 21Jun2021 (at the age of 28 years old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included Chest pain-cardiac, lactation decreased, seizures, migraine, epilepsy, obesity, pain, usually woken up with a pain in her belly, physically sick, feels very hot and anxious (This phase may last for about 5 to 10 minutes, following which she blacks out and has motor features like seizures), episodes of loss of consciousness and focal seizures (with atypical features). Concomitant medications included amitriptyline, desogestrel, propranolol and zolmitriptan taken for an unspecified indication, lamotrigine taken for seizure start and stop dates were not reported. Unsure if patient has had symptoms associated with covid-19. Patient was not enrolled in clinical trial. On 21Jun2021, the patient experienced seizures/ seizure (known to have episodes of loss of consciousness presumed seizures). On unspecified date, the patient experienced respiratory and cardiac arrest. The patient died on 24Jun2021. The cause of death was seizures, cardiac and respiratory arrest. Since the vaccination, the patient had not been tested for covid-19. The events was serious (death/hospitalized). It was not reported whether autopasy performed or not. The patient underwent lab tests and procedures which included echocardiogram normal, electroencephalogram no obvious issues, investigated in cardiology there were post-ictals, magnetic resonance imaging no obvious issues, covid-19 virus test negative and cardiopulmonary resuscitation performed on unspecified date. Relevant investigations or tests conducted standard post out of hospital cardiac arrest protocol. Treatment was received for the event seizures. Outcome of the events was fatal. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest; respiratory/cardiac arrest; Seizures


VAERS ID: 1462622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-02-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Circulatory collapse, Computerised tomogram, SARS-CoV-2 test, Thrombosis
SMQs:, Anaphylactic reaction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (takes medication for epilepsy); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i.); Stroke (takes medication for stroke)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: CT scan; Result Unstructured Data: Test Result:no clots present no concerns; Comments: He had a full body CT scan with dye 30th December to look at his chest, no clots present no concerns.; Test Date: 20210206; Test Name: CT scan; Result Unstructured Data: Test Result:clot was present; Comments: night collapsed had a major stroke days later when stroke had occurred we got the report back from scan to say clot was present; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021814473

Write-up: Stroke; Circulatory collapse; Thrombosis; This is a spontaneous study report from a contactable Consumer reported for a patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202106281712269070-URO04], Safety Report Unique Identifier [GB-MHRA-ADR 25556248]. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not Known), via an unspecified route of administration on 16Jan2021 as Dose 1, Single for COVID-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing Taking other treatments or medicines, not listed above, known to lower the immune response and epilepsy was taking medication for epilepsy, history of cerebrovascular accident taking medication for stroke. The patient''s concomitant medications were not reported. The patient previously took antibiotics, and lansoprazol. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not tested positive for COVID-19 since having the vaccine. On 06Feb2021 the patient experienced stroke, circulatory collapse and thrombosis. Patient had previous strokes many years ago. But was on medication for that and hadn''t had any further strokes. He had a full body CT scan with dye on 30th December to look at his chest, no clots present no concerns. Patient had vaccine on 16th January, on the day of the 6th February he had a second full body CT scan, came home that night collapsed had a major stroke days later when stroke had occurred we got the report back from scan to say clot was present. Patient never recovered he deteriorated badly and sadly passed away on the 12 February. 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: Cerebrovascular accident


VAERS ID: 1462650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 01-Jan-2021 The patient died on 01-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided Company Comment: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Sender''s Comments: This is a case of sudden death in a female. Due to paucity of medical information is unfeasible to establish neither casual nor temporal association between the event and vaccine administration. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1462692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Cardiomyopathy; Dysrhythmias; Hypertension; Kidney failure chronic; Obesity (extremely obese); Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021794948

Write-up: Death; This is a spontaneous report received from a contactable Physician downloaded from the regulatory authority-WEB-HU-OGYI-484221. A 42-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FC3558), via intramuscular in left arm, on 25May2021 at 0.3 ml single for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EW9127), via intramuscular, on 20Apr2021 at 0.3 mL single for COVID-19 immunisation. Medical history included thyroid disorder, cardiomyopathy, cardiac insufficiency, kidney failure chronic, dysrhythmias, hypertension and obesity (extremely obese), all unknown if still ongoing. The patient was concomitantly under cardiac care. The patient passed away on an unknown date. According to the reporter physician, the cause of death was acute cardiac insufficiency. No autopsy was performed. Sender''s Comments: The reporter physician assessed the case as not related to the vaccine. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently provided, the company concurs with the causality assessment provided by the reporter, considering the event as not related to the vaccine.; Reported Cause(s) of Death: acute cardiac insufficiency


VAERS ID: 1462699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-06-17
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Pneumonitis, Respiratory failure, Sepsis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; REVINTY ELLIPTA; COUMADIN; LASIX [FUROSEMIDE]; DIBASE; DILATREND; DUTASTERIDE; FOLINA [CALCIUM FOLINATE]; ZOLOFT; ZYLORIC; DOBETIN [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Benign prostatic hyperplasia; Cognitive deterioration (on a vascular and degenerative basis); COPD; Hypertensive heart disease; Intracranial injury (with temporal fracture); Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021778823

Write-up: hypoxemic respiratory failure, sepsis, pneumonia; recent cerebral haemorrhage found in recent hospitalization; hypoxemic respiratory failure, sepsis, pneumonia; recent cerebral haemorrhage found in recent hospitalization; hypoxemic respiratory failure, sepsis, pneumonia; recent cerebral haemorrhage found in recent hospitalization; hypoxemic respiratory failure, sepsis, pneumonia; recent cerebral haemorrhage found in recent hospitalization; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-746785. An 83-year-old male patient received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm right on 31Mar2021 at 09:53 (Lot Number: ET7205; Expiration Date: 31Jul2021) as 0.3 mL single dose for COVID-19 immunisation. Medical history included cognitive deterioration on a vascular and degenerative basis, smoker, atrial fibrillation, benign prostatic hyperplasia, hypertensive heart disease, chronic obstructive pulmonary disease (COPD), all from an unknown date and unknown if ongoing and intracranial injury with temporal fracture on 01Jan2011. Concomitant medications included lansoprazole at 15 mg; fluticasone furoate/vilanterol trifenatate (REVINTY ELLIPTA, inhalation powder pre-dispensed, 184 ug/22 ug); warfarin sodium (COUMADIN, tablet, 5 mg) taken for atrial fibrillation; furosemide (LASIX, tablet, 25 mg) at 25 mg; colecalciferol (DIBASE); carvedilol (DILATREND, tablet, 25 mg) at 25 mg; dutasteride at 0.5 mg; calcium folinate (FOLINA); sertraline hydrochloride (ZOLOFT) at 50 mg; allopurinol (ZYLORIC, tablet, 100 mg) at 100 mg and cyanocobalamin (DOBETIN). The patient previously received first dose of BNT162b2 (COMIRNATY) on 10Mar2021 for COVID-19 immunization. On 17Jun2021, the patient experienced hypoxemic respiratory failure, sepsis, pneumonia; recent cerebral haemorrhage found in recent hospitalization. The patient died on 20Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: sepsis; pneumonia; cerebral haemorrhage; hypoxemic respiratory failure


VAERS ID: 1462750 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERDAL; DEPAS [ETIZOLAM]; LENDORMIN; AMLODIPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021777591

Write-up: Acute circulatory failure; suspected ischaemic enterocolitis; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 66-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received risperidone (RISPERDAL), etizolam (DEPAS), brotizolam (LENDORMIN), and amlodipine (AMLODIPINE) within 2 weeks of vaccination. On 24Jun2021 at 13:30 (the day of vaccination), the patient received the dose 1, single (at the age of 66 years old) of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a nursing home. On 25Jun2021 at 00:30 (1 day after the vaccination), the patient experienced acute circulatory failure and suspected ischaemic enterocolitis. The events resulted in death. The outcome of the events was fatal without treatment. An autopsy was not performed. The course of the events was as follows: About eleven (hours) after the vaccination, the patient defecated a large amount accompanied by bloody stools. Thirteen hours after the vaccination, cardio-respiratory arrest was confirmed. The assessment of causality between the events and BNT162b2 was not provided.; Sender''s Comments: A possible contributory role of the suspect drug to the reported events "Acute circulatory failure" and "suspected ischaemic enterocolitis" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: suspected ischaemic enterocolitis; Acute circulatory failure


VAERS ID: 1462758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, 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: 2021-06-15
   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: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021778022

Write-up: Cardio-respiratory arrest; Ascending thoracic aortic dissection; Cardiac tamponade; This is a spontaneous report from a contactable other healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is v21116083. The patient was a 69-year-old male. Body temperature before vaccination was 36.9 degrees Centigrade. The family history was not provided. The patient had medical histories of hypertension, diabetes mellitus, and cerebral infarction. On 12Jun2021 at 16:30 (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 14Jun2021 at 23:00 (2days/6 hours/30 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 15Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Jun2021 (the day of vaccination), at 16:30, the patient received the first dose of BNT162b2 vaccination at the community center. On 14Jun2021, at 23:00 (2 days, 6 hours, and 30 minutes after vaccination), the patient experienced cardio-respiratory arrest and the outcome of the event was fatal. The course of the event was as follows: On 12Jun2021 at 16:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 14Jun2021 at around 23:00 (2days/6 hours/30 minutes after the vaccination), the patient fell near the undressing room at his home. The family member called an ambulance, and the patient was emergently transferred to the reporting hospital. At 23:45 (2 days, 7 hours, and 15 minutes after vaccination), the patient was in a state of cardio-respiratory arrest. Although resuscitation was performed, the spontaneous circulation was not returned. On 15Jun2021, at 0:06 (2 days, 7 hours, and 36 minutes after vaccination), the patient was confirmed to die. An autopsy imaging (AI) was performed, and the patient was diagnosed with ascending thoracic aortic dissection and cardiac tamponade. The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Although it was reported that there is other possible cause of the event such as any other diseases, that was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: Cardiac tamponade; Ascending thoracic aortic dissection


VAERS ID: 1462774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-11
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, Computerised tomogram, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery; Trochanteric femoral fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210612; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210612; Test Name: CT; Result Unstructured Data: Test Result:showed no obvious abnormalities on the brain
CDC Split Type: JPPFIZER INC2021779113

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21116201. The patient was a 91-year-old female. Body temperature before vaccination was 36.6 degrees Centigrade. The family history was not provided. 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 10Jun2021 at 13:30 (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 12Jun2021 at 10:30 (one day and 21 hours after the vaccination), the patient experienced pulmonary embolism. On 12Jun2021 at 10:53 (one day, 21 hours and 23 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was originally being admitted to the hospital for postoperative subtrochanteric fracture of the femur. On 10Jun2021 (the day of vaccination), at 13:30, the patient received the first dose of BNT162b2 vaccination. The course was observed without no acute abnormalities. On 12Jun2021, at 10:30 (one day and 21 hours after vaccination), sudden blood pressure decreased occurred. The patient had cardiac arrest on the monitor. Although cardiopulmonary resuscitation (CPR) was performed, the patient died at 10:53 (one day, 21 hours, and 23 minutes after vaccination). CT after the death showed no obvious abnormalities on the brain. Thus, the patient was diagnosed with pulmonary embolism according to the clinical course. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pulmonary embolism/ CT after the death showed no obvious abnormalities on the brain. Thus, the patient was diagnosed with pulmonary embolism according to the clinical course.


VAERS ID: 1462784 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 15
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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Disuse syndrome; Femoral neck fracture; Pneumonia aspiration; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: at night; Test Date: 20210614; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: at night
CDC Split Type: JPPFIZER INC2021781831

Write-up: This is a spontaneous report from a contactable physician. An 83-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), intramuscular on 14Jun2021 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 83-year-old) as single dose for COVID-19 immunisation. Medical history included repetitive pneumonia aspiration, diabetes mellitus, surgery for left femoral neck fracture and disuse syndrome, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin taken for an unspecified indication, start and stop date were not reported. On 24May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot Number: EY5420, Expiration date: 31Aug2021) intramuscular for COVID-19 immunisation. On 14Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY). On 14Jun2021 (on the same day of the vaccination), the patient experienced pyrexia of 39 degrees centigrade and decrease in SpO2. The outcome of the events was fatal with treatment including meropenem infusion and dopamine. Since the vaccination, the patient has not been tested for COVID-19. The course of the events was as follows: the patient had repeated episodes of pneumonia aspiration and has been admitted to the nursing care clinic of the hospital due to disuse syndrome. On 14Jun2021 in the afternoon, the patient received the second dose of COMIRNATY intramuscular injection. At night, the patient developed pyrexia of 39 degrees centigrade and decrease in SpO2. Subsequently, respiratory failure progressed rapidly. On 16Jun2021, the patient was hospitalized in internal medicine ward of the same hospital. The patient was treated with antimicrobial agent and circulatory support agent; however, the patient died in the evening. The reporting physician classified the event as serious (death and hospitalization). An autopsy was not performed.; Sender''s Comments: The advanced old patient''s death is more likely related to the underlying serious disease unrelated to vaccine use; however, There is no information in the case suggesting a possible contribution of the Pfizer suspect product to the patient death, therefore the event does not meet reportability to EEA. 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: Respiratory failure (due to pneumonia aspiration); Respiratory failure (due to pneumonia aspiration)


VAERS ID: 1462792 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY9860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Aortic dissection, Back pain, Blood pressure immeasurable, Body temperature, Computerised tomogram, Loss of consciousness, Respiratory arrest
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), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Cardiac failure chronic; Hypertension; Old cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:revealed aortic dissection and aortic; Comments: revealed aortic dissection and aortic aneurysm rupture; after the vaccination
CDC Split Type: JPPFIZER INC2021785369

Write-up: CT revealed aortic dissection and aortic aneurysm rupture; CT revealed aortic dissection and aortic aneurysm rupture; Back pain; Loss of consciousness; Respiratory arrest; blood pressure not palpable; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116231. The patient was an 87-year and 4-month-old female. Body temperature before vaccination was 36.0 degrees centigrade on 15Jun2021. Medical history included hypertension, arteriosclerosis, cardiac failure chronic, and old cerebral infarction. Family 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 an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 15Jun2021 at 21:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY9860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 18Jun2021 at 17:00 (2 days 20 hrs after the vaccination), the patient experienced back pain. On 18Jun2021 at unknown time (reported as 3 days after the vaccination), the patient experienced loss of consciousness and respiratory arrest. On an unknown date (after the vaccination), computerised tomography (CT) revealed aortic dissection and aortic aneurysm rupture. Events back pain, loss of consciousness, respiratory arrest resulted in emergency room visit and with treatment received. On 18Jun2021 (reported as 3 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: The patient was regularly visiting the reporting clinic for conditions including hypertension, cardiac failure chronic, and old cerebral infarction On 15Jun2021 around 21:00 (the day of vaccination), the patient received the second BNT162b2 vaccination. On 18Jun2021 at 17:00 (3 days after the vaccination), the patient visited the reporting hospital with a complaint of back pain. She experienced loss of consciousness while waiting in the waiting room. Respiratory arrest occurred, and the blood pressure was not palpable. While continuing cardiopulmonary resuscitation (CPR), the patient was transported by ambulance to the hospital. After transport, she was confirmed dead. CT revealed aortic dissection and aortic aneurysm rupture. 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 events such as any other diseases were hypertension and arteriosclerosis.; Reported Cause(s) of Death: respiratory arrest; CT revealed aortic dissection and aortic aneurysm rupture; CT revealed aortic dissection and aortic aneurysm rupture; back pain; loss of consciousness


VAERS ID: 1462793 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-25
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021785371

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116272. The patient was a 75-year-old male. Body temperature before vaccination was 36.5 degrees Centigrade. The family history was not provided. 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 07Jun2021 at 15:11 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as dose 1, single (at the age of 75 years) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 25Jun2021 (17 days/8 hours/49 minutes after the vaccination), the patient experienced death. On 25Jun2021 (18 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 07Jun2021 (the day of vaccination), at 15:11, the patient received the first dose of BNT162b2 vaccination. Although the patient was followed up for 15 to 30 minutes after the vaccination, no abnormal findings were observed, and he went home. On 25Jun2021 (17 days, 8 hours, and 49 minutes after vaccination), the police contacted that the patient died before dawn on the same day. The details were unknown. 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. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: According to the vaccination coupons, the patient had no diseases which were being treated, and he was not orally taking any drugs. The patient also had no history of allergy. Since 18 days had passed after the vaccination, the causality between the event and BNT162b2 vaccination could not be judged.; Reported Cause(s) of Death: Death


VAERS ID: 1462794 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Dyslipidaemia; Hypertension; Prostatic hypertrophy
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 INC2021785381

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21116227. The patient was an 83-year and 1-month-old male. Body temperature before vaccination was 36.6 degrees centigrade. The family history was not provided. The patient had medical histories of hypertension, dyslipidaemia, and prostatic hypertrophy. On 22Jun2021 at 11:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On unknown date in Jun2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in Jun2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 22Jun2021 (the day of vaccination), at 11:30, the patient received the first dose of BNT162b2 vaccination. On 23Jun2021 (12 hours and 30 minutes after vaccination), the police contacted to the reporter that the patient''s wife found the patient dead in the morning of 23Jun2021. The reporting physician classified the event as serious (serious) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Death


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